Grand Committee
Arrangement of Business
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
My Lords, the hybrid Grand Committee will now begin. Some Members are here in person, respecting social distancing, others are participating remotely, but all Members will be treated equally. I must ask Members in the Room to wear a face covering except when seated at their desk, to speak sitting down and to wipe down their desk, chair and any other touch points before and after use.
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Medicines and Medical Devices Bill
Monday 26th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Earl Howe (Con)
My Lords, it may be for the assistance of noble Lords if I make a short statement before we recommence proceedings. As noble Lords will be aware from my noble friend Lord Bethell’s letter to Peers of 13 October, the Government have tabled a number of amendments for consideration in Grand Committee. Many of these amendments are designed to address criticisms of the Bill expressed by noble Lords at Second Reading, and in particular by your Lordships’ Delegated Powers and Regulatory Reform Committee and Constitution Committee, in an endeavour to provide reassurance to this Committee at an early moment.
Unfortunately, it has since come to light that the Government’s intention to move these amendments in Grand Committee, which we had believed was implicit in my noble friend’s letter and understood from subsequent discussions, had not in fact been clearly and properly communicated. I further understand that there was a two or three-day delay in noble Lords on the Labour Front Bench, and perhaps others, receiving the letter. I apologise to the Official Opposition, Liberal Democrat Peers, noble Lords on the Government Benches and those on the Cross Benches for the shortcomings in our communications, which, I need hardly add, we shall use our utmost endeavours not to see repeated.
There is a substantive reason why the Government wished to move their amendments in Grand Committee. It is that, according to the clear advice we have received, a legislative consent Motion by the Northern Ireland Assembly cannot be put in motion until such time as the government amendments to which I have referred become part of the Bill. Were we to delay approval of the amendments until Report, our clear advice was that this would put back the Northern Ireland legislative consent process by up to three months. Such a delay would in turn have serious consequences for the completion of this Bill, whose importance in the context of the United Kingdom’s exit from the European Union cannot be overemphasised. It is very important for the health of the public that we achieve a timely completion which does not leave us without a means of passing necessary regulations at the start of 2021.
These were the reasons why, in the short adjournment that took place during last Monday’s Grand Committee proceedings, we asked noble Lords to allow two government amendments to go through on that day. We did so particularly bearing in mind that the alternative to moving the amendments was to withdraw them, which might in turn have signalled to the Northern Ireland Executive that the amendments no longer represented government policy. We are sincerely grateful to noble Lords for their understanding and for the agreement reached on that occasion. As I have indicated, we made that request to noble Lords in good faith, driven by clear legal advice relating to the process around Northern Ireland consent Motions. Since then, some doubts have been cast on whether that advice was in all respects accurate. It is still our belief that it was, but we are seeking urgent confirmation of this, which we shall convey to noble Lords at the earliest opportunity.
More importantly, however, for this Committee, we have received unequivocal legal advice from the Public Bill Office that, notwithstanding any amendments approved in Grand Committee by unanimity, it is open to the House, and indeed to individual noble Lords, to return to the issues covered by such amendments on Report and to debate and vote on any further amendments that noble Lords wish to table. That means that by allowing government amendments to go through in Grand Committee, noble Lords would not be precluded from returning to those issues, in any way they chose, on Report. On behalf of the Government, I undertake that the Government will raise no objection to this if it is the wish of noble Lords that such further debates take place. If, notwithstanding the assurances I have given, any noble Lord wishes to object to a government amendment spoken to in Grand Committee, the Government will withdraw that amendment. In the meantime, it is the Government’s wish to enable all noble Lords to engage with Ministers and officials as fully and as regularly as they may require in an effort to achieve what we all desire for this important Bill, which is understanding and, if possible, consensus across the House.
Baroness Thornton (Lab)
I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.
Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.
However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.
We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.
If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.
Baroness Jolly (LD) [V]
With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.
Earl Howe (Con)
I am grateful to both noble Baronesses for their responses. I think that this provides a basis on which to proceed with our Grand Committee debate today, pending further clarification on the matters that I referred to earlier between now and Wednesday, our next Grand Committee day. I can assure noble Lords that my colleagues and I will endeavour to achieve that clarity, which we will disseminate at the earliest opportunity.
Baroness Thornton (Lab)
I thank the noble Earl. I think that we probably need to continue this discussion, to make sure that we end up in the right place, with a Bill that we can take forward to Report.
Baroness Thornton
Member’s explanatory statement
This amendment places a duty on the Secretary of State to act with a view to ensuring, rather than have regard to, safety, availability and UK attractiveness when exercising powers.
Baroness Thornton (Lab)
The amendment, in my name and that of my noble friend Lord Hunt, gives the Secretary of State a duty to act with a view to ensuring, rather than having regard to, safety, availability and UK attractiveness when exercising the powers in the Bill. The Bill states:
“the appropriate authority must have regard to … the attractiveness of the relevant part of the United Kingdom”,
and we want to change that. However, there is no definition of attractiveness in the Bill.
The Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, published in July, focused on safety issues with just three medical interventions. Along with these, recent scandals such as those relating to metal-on-metal hips and PIP breast implants, show the need for strong regulatory oversight. Patient safety must be prioritised, including where there are competing considerations, such as the attractiveness of the UK as a place to conduct clinical trials and supply medicines and medical devices.
To address this, we believe that either the attractiveness clauses should be removed, or a statutory definition of attractiveness should be included in the Bill, along with a further provision that the appropriate authority should always prioritise safety. I beg to move.
Lord Sharkey (LD) [V]
I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read
“In making regulations under subsection (1), the appropriate authority must have regard to”,
followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.
Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).
Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,
“the safety of human medicines”,
it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.
Baroness Cumberlege (Con)
I shall speak to Amendments 10, 12, 74 and 75 on the second Marshalled List, and I thank the noble Lords who have supported these amendments—the noble Baronesses, Lady Burt of Solihull and Lady Hollins, and the noble Lords, Lord Patel and Lord Hunt of Kings Heath.
This Bill chimes perfectly with the review that I led into two medications and a device. The review culminated in the report First Do No Harm, which states:
“Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”
In conducting the review over two and a half years, my team and I listened to hundreds of women and their families, with their stories of anguish, acute suffering, destroyed relationships and parents whose children have been harmed, deformed and had their potential lives ruined.
I have been told that this Bill is not a safety Bill. If it is not, what is it, for goodness’ sake? How can safety not be the overriding purpose of the Bill? My modest amendments, and those of other noble Lords, seek to make it so.
In paragraphs (a) to (c) of Clause 1(2), safety is not the primary consideration but is on an equal footing with the availability of medicines and the UK as an attractive place in which to conduct clinical trials and the supply of medicines. These aspirations are of course important but in the way in which the Bill is drafted safety is simply an “also ran”. It should not be; it should be of overriding importance. As the noble Lord, Lord Patel, said in his amendment on the first day of Committee, the construction of this clause needs improvement.
My review found safety seriously wanting. We were commissioned to review two medications given to women. The first was Primodos. Between the 1950s and the 1970s, two little pills were given to women to test whether they were pregnant. From the late 1950s, concerns were raised that these tests could harm and cause abnormalities in a developing baby. Although disputed, there is a body of opinion that has linked these hormone pregnancy tests to a wide range of various malformations. We discovered opportunities where action should have been taken and was not.
These pregnancy tests were taken off the market in 1978 following concerns over their safety—more than a decade after safety concerns were first raised. No one listened. The risk to patient safety was not prioritised, one result of which has been a 40-year battle to get an independent review of the regulations that were found wanting. I accept that regulation was in its infancy in the 1960s and 1970s, but patient safety should have been the overriding consideration then, as it must be now.
In the course of our review, we met the children—now adults—who suffered so much and their families. Many dreadful impacts have been associated with these pregnancy tests, such as loss or shortening of limbs—we have seen other examples of this happening in the past—heart defects, spinal issues, seizures, dysmorphic facial features, digestive and bowel issues, and so on. We were struck by the unremitting guilt felt by the women who took the pills. They feel to blame for their children’s disabilities. They suffer enduring psychological harm, and although we told them, “It wasn’t your fault; you weren’t told; how can you be blamed?”, I fear that we did not convince them.
The second medication reviewed was sodium valproate. It is a very effective drug for controlling epilepsy but it has a history that should never be repeated. When first licensed in 1972, it was known to be teratogenic in animals. Prescribing doctors were warned that it should be used only in severe and resistant cases of epilepsy in pregnant women. In the 1980s, academic literature drew attention to the risks. In the 1990s, the risks of neural tube defects and other congenital malformations were known. Even then, women were saying that exposure to sodium valproate had caused damage to their offspring.
In early 2000, doctors were again warned of an association with delayed development in children, with delayed speech, IQ affected and reports of autism. Throughout this tragic history, clinicians have been warned and women and their families have not been listened to; they have been dismissed and had their knowledge denied. It took 40 years after sodium valproate was introduced to the market to produce a toolkit, the purpose of which was to provide information to women of childbearing age and healthcare professionals about the harm that could be caused. Two years later, in 2018, a pregnancy prevention programme was introduced; it stipulated three measures that were designed to prevent further harm.
You would suppose that this is the end of a tragic story—problem solved—but that is not so. It is truly shocking that, today, epileptic pregnant women on sodium valproate have a one in two chance of having a disabled child. They are still exposed to huge risks because they are not told what those risks are. Babies continue to be been born with lifelong disabilities due to exposure to this drug. We know that the results are catastrophic.
The third and final area that we were asked to review was surgical mesh, a device inserted to support pelvic organ prolapse and to treat stress urinary incontinence. For many women, mesh surgery is trouble-free and leads to improvements in their condition, but that is not the case for all. A BMJ article published on 10 October 2018 had the arresting headline “How mesh became a four letter word”. In the article, Jonathan Gornall charts the rapid rise and fall of vaginal mesh; it is, as he says,
“a story that offers lessons for the entire medical community, and for manufacturers and regulators”.
Unlike many other devices, polypropylene mesh is intended to remain in situ for life. We heard from countless women who sought to have it removed but were unsuccessful; sometimes attempts even caused further serious damage.
Why would they want it removed? Because mesh ruins their lives. We were told by hundreds of women that they suffer excruciating pain, recurrent infections and haemorrhages, bowel issues, recurring or new incontinence, and nerve damage that restricted their mobility. Fit young women were confined to a wheelchair for the rest of their lives. I will always remember one little boy telling us, “I just want my old mum back.”
We heard about sexual difficulties leading to the loss of a sex life and broken marriages. We heard from women how the constant pain resulted in the loss of employment—that is, their job—so they lost their income. Because of that, they could not afford the mortgage or rent so they lost their homes, and because they were homeless, they were fearful that their children would be taken into care. One woman told us:
“This is not a life. It is an existence.”
We were so shaken by what we heard that, in July 2018, we recommended that vaginal mesh should be paused. Our recommendation was immediately accepted by NHS England and the Department of Health and Social Care. The scandal is that our recommendations were not new; all had been suggested before, but no action had been taken. It should not have been for us to recommend this. If safety was of paramount importance, the healthcare system should have picked this up decades before. After all, mesh was first used in the 1960s. It gathered pace in the 1990s; by 2001, it was the most common operation used for ameliorating stress urinary incontinence—a very unpleasant condition, but not life-threatening.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and her enormously powerful contribution. I wholeheartedly endorse her concerns about safety and share her worry that patient safety is still not being prioritised after so many years of disaster stories. One cannot but note the gender aspects of the failure of medicine over so many decades—not listening to patients, particularly female patients. Clearly we need to make this Bill better, with a focus on safety.
The report by the noble Baroness spoke to me very personally. My late mother suffered decades ago from endometriosis. She was not listened to or taken seriously and I have been distressed and angered by hearing, just this week, reports of how difficult endometriosis patients still find it to get taken seriously and obtain the treatment they need. The noble Baroness, Lady Cumberlege, has done a brilliant piece of work in highlighting these issues, with a focus on particularly abusive cases.
I have been following the story of vaginal mesh with a sinking heart for some years. It is such a familiar account of vulnerable, suffering individuals being trampled over, ignored and even derided by commercial interests. “First do no harm” is, indeed, a principle that a company —every company, not just those in healthcare—should be forced to consider as a key part of its approach.
However, at this point I will speak chiefly to Amendment 59, which is in my name. I apologise for not coming in to support earlier excellent amendments, or indeed others in this group. With our small Green group juggling crucial issues tangled up in the Government’s legislative pile-up, I just did not manage to get there. I thank the small number of Peers who are carrying a huge weight in this Committee. Amendment 4, tabled by the noble Baroness, Lady Thornton, was particularly important, but many amendments contain constitutional and legal principles that make it a particular regret that so many potential contributors—both last week and today—are in the main Chamber. However, as I plan to speak at some length to the group starting with Amendment 18, I will be brief here.
Amendment 59 seeks to ensure that the welfare of animals is considered when making regulations about veterinary medicines. I can see that some might think that health and welfare go together, but that is not always the case, particularly in the world of factory farming and considering the context in which noble Lords are seeking, on the Agriculture Bill and Trade Bill, to defend existing veterinary and farming standards against the introduction of truly dreadful health and welfare standards from elsewhere.
There has been a tendency to use drug treatments as an alternative to decent husbandry. Animals might be protected from disease arising from miserable, crowded, inadequate conditions, but their welfare is not being protected. Any intervention should improve their welfare, not block disease caused by misery.
Animals might also be given drugs. I am thinking here particularly of the use in the United States of antibiotics, as growth promoters, and of growth hormones, which leads to animals becoming overly large—sometimes too large to move themselves around, which can be a great source of misery. We might find drugs being sought or used as sedatives to keep animals in conditions in which they would otherwise be uncontrollable or dangerous. The answer is not to drug them but to ensure proper conditions. Health and welfare must go together. That needs to be in the Bill and I hope that the Government will consider including this amendment.
Lord Hunt of Kings Heath (Lab)
My Lords, although I am a member of the GMC board, I am not speaking on behalf of the GMC on this group of amendments.
I speak on behalf of my noble friend Lady Thornton’s Amendment 8, which seeks to beef up the duty of the Secretary of State to make regulations under Clause 1(1) in relation to the safety and availability of human medicines and the attractiveness of the relevant part of the UK as a place to conduct clinical trials or supply human medicines. Amendment 73 does essentially the same for medical devices. As she said, the concept of attractiveness is rather vague and open to misunderstanding, which makes a statutory definition so important. I have also put my name to Amendments 74 and 75 tabled by the noble Baroness, Lady Cumberlege, and will speak in support of her Amendment 12.
Apart from teasing out from the Government what attractiveness means, this is essentially an opportunity to draw out from the Minister their response to the noble Baroness’s report, First Do No Harm. The report is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I have met many of the campaigners involved and their stories were heart-rending, as she has said. I am particularly grateful to the organisation known as Sling the Mesh, whose representatives I had the pleasure of meeting. Noting that the noble Lord, Lord O’Shaughnessy, is speaking later, I say that I remember, after I asked an Oral Question about mesh, that he met campaigners and talked to them for some considerable time. That was very helpful in getting across to the Government and Ministers just what damage had been done by a procedure that for many women proved to be positive and life-affirming. The awful thing is that the women who had terrible outcomes were ignored, because it was inconvenient and the operation was so successful for quite a large percentage. The system completely pooh-poohed them. Even now, under the counter, there is a lot of resistance to the noble Baroness’s recommendations.
The noble Baroness found that the healthcare system—in which she included the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers—was disjointed, siloed, unresponsive and defensive. That is why her core recommendation is the appointment of an independent patient safety commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. Obviously we are debating this later, but it would be helpful to get some sense of the Government’s response. No doubt the Minister might point to the work of Aidan Fowler, the NHS national director of patient safety, and the strategy produced under the auspices of NHS England and NHS Improvement last year. That is fine so far as it goes; it makes the point that patient safety is about maximising the things that go right and minimising the things that go wrong for people experiencing healthcare.
I commend Aidan Fowler for his efforts and commitment. Does the strategy go far enough? Does it represent a systems approach to safety where that becomes the No. 1 objective of the NHS? Does it mean that all equipment and buildings in future will be designed with safety as the first consideration? Will boards of NHS trusts treat safety as their No. 1 responsibility? Will that lead to a wholly different approach by the CQC, because I do not think that safety is a priority so far as it is concerned in its inspections? The big question is: will NHS England and NHS Improvement change their approach and make it clear that safety is an important priority for them? Unless they do, I do not think that any change will take place. The strategy—an NHS England strategy, of course—feels like a collection of good practices, but not something that will change the system, which clearly needs to happen.
To get some sense of this, I looked back to the report by Don Berwick, whom I regard as the guru on patient safety internationally, entitled A Promise to Learn and produced in 2013 in the wake of the Mid Staffs inquiry. Berwick was clear that the quality of patient care, especially patient safety, should be placed above all other aims. He said:
“Patient safety problems exist throughout the NHS as with every other health care system in the world. NHS staff are not to blame—in the vast majority of cases it is the systems, procedures, conditions, environment and constraints they face that lead to patient safety problems. Incorrect priorities do damage: other goals are important, but the central focus must always be on”
patient safety.
What Berwick said in 2013 holds good today. The NHS has made progress since then—I readily accept that—but on no count has safety been embedded as the No. 1 concern. That is what makes the report by the noble Baroness, Lady Cumberlege, so important and why she wants an external champion of patient safety, because it clearly ain’t going to come from inside. It is too diffuse. No one is responsible for patient safety. If Aidan Fowler were directly accountable to the Secretary of State and resided in the Department of Health and Social Care, I would begin to believe that that was a serious attempt, but because the Government have decided that all the national clinical directors should be placed under an NHS management system, direction and accountability at the top of the office have been lost. Therefore, the report by the noble Baroness, Lady Cumberlege, makes sense and will have to be listened to positively.
Baroness Burt of Solihull (LD) [V]
My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.
We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.
It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,
“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.
Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.
Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.
Lord Patel (CB) [V]
My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.
I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.
The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.
The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.
There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.
A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.
Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.
I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.
Baroness Hollins (CB) [V]
My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.
In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:
“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”
I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.
I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.
Lord O'Shaughnessy (Con) [V]
My Lords, I have spent far too much time with patients harmed by medicines and medical devices going wrong—valproate, mesh and Primodos—and many people affected adversely by other treatments in which they had vested so much hope to be unconcerned about the issue of patient safety. I applaud all noble Lords who have tabled amendments on this topic, and especially pay tribute to my noble friend Lady Cumberlege, whose exemplary work on this issue through her review has given the issue, and the women—because it is mainly women who have been affected—the profile that they should always have had.
I certainly agree with all noble Lords that safety should be considered of greater importance than the attractiveness of the UK. There is and should be no trade-off necessary between attractiveness and high regulatory standards. I also agree with the point made by the noble Lord, Lord Hunt—that there is so much more to patient safety than the regulatory regime for medicines and devices that we are discussing today, but that is what we are discussing.
Having said all that, I have something nagging slightly at me about the topic, which I want to explore in my comments. I wonder whether there is some tension between availability of medicines and devices on the one hand and their safety on the other. As the Bill stands, it fails to elucidate this tension properly. The question that we need to solve is whether it is always right that safety should trump availability and access to medicines.
I start by looking at the purpose of our regulatory regime. The homepage of the MHRA says that it is to
“maintain the safety, quality and effectiveness of our medicines, devices and diagnostic tools”.
Of course, its reputation stands on its ability to make judgments against those criteria, which can sometimes be in tension: a drug can be safe but not efficacious, and it can be effective but not acceptably safe. If there are shortages, which sometimes happens, quality variation might be needed to access necessary medicines and devices. Striking a balance between all those factors and getting the right balance between risk and reward is where the hard task of regulating occurs.
We have heard many examples already on Second Reading and in Committee today of the tragedies that have happened when there have been regulatory and other failures of medicines and medical devices. However, it is also true that some of the greatest success stories in medicines have come about through a more pro-risk approach. I mentioned the HPV vaccine last time, which of course has been extended to boys, even though there continues to be some concern about the level of adverse events. The early access to medicines scheme allows patients to be treated with unlicensed medicines that have not yet had regulatory approval but where there might be a transformative opportunity for patients. Of course, in considering these issues, the words of the noble Lord, Lord Saatchi, and Baroness Jowell in the debate that they so wonderfully led, inspiring us all, also ring true. Creating more access to experimental therapies for ordinary patients can often be the right thing to do for them. It is not that we want unsafe medicines—of course not. But what matters ultimately is the safety of the patient, and sometimes that might mean—or their health and best interests might mean—better access to riskier medicines for some patients that would be unacceptably risky for most patients. Indeed, it is quite possible that the move to personalised medicine will make this more and more likely.
I am strongly supportive of the patient safety agenda, and encourage my noble friend the Minister to commit the Government to taking forward the recommendations made in my noble friend Lady Cumberlege’s review. However, I am a little worried, perhaps wrongly, about the potential impact of these amendments on patients’ ability to access experimental medicines and devices, or even the availability of standard medicines that are experiencing a shortage that might improve people’s lives. In a spirit of this being Committee, though not quite as iterative as it usually is, I wondered whether a different approach would be to amend the Bill so that Clause 1(2)(a) instead reads,
“the safety, quality and effectiveness of human medicines”,
which could then unambiguously be made the overarching priority of the legislation, involving as it would recognition of the trade-offs and tensions in the standard to which regulators are currently held, then applying this approach to medical devices. Whether this is the right way forward is up to noble Lords, but I hope that my noble friend the Minister is open minded on this issue and will consider very carefully the various arguments being made.
Baroness Watkins of Tavistock (CB) [V]
My Lords, it is a pleasure to follow other noble Lords, the majority of whom I completely agree with. I put my name down to speak to this group as I wish strongly to support the amendments tabled by the noble Baroness, Lady Cumberlege, Amendments 10, 12, 74 and 75.
Last year, I was on the pre-legislative scrutiny committee for the Health Service Safety Investigations Bill, which did not proceed as a result of the election. Therefore, I believe that putting patient safety at the heart of this Bill and making it a safety Bill as other noble Lords have outlined makes complete sense. It would protect our population and make our country far more attractive for medical research, because we would be seen internationally as a leader in safety in that work and in any licences we gave to medicines and medical devices.
As well as medical devices inserted in the way that was so eloquently outlined by the noble Baroness, Lady Cumberlege, and my noble friend Lord Patel, there are other pieces of equipment used regularly in intensive care and other care settings, including the community settings, where safety is paramount, particularly for the safe delivery of very small amounts of medication. Engineers in our country are developing far safer equipment for that kind of healthcare, which is largely delivered by nurses and other community health- care workers. Therefore, if we can make these issues clear in the Bill, we will be an extremely attractive country to sell such pieces of equipment internationally. For that reason, the priority of the Bill must be for patient safety, because it will result in much-increased attractiveness for us as an exporting nation in this field.
Lord McColl of Dulwich (Con) [V]
I fully support the amendments in the name of my noble friend Lady Cumberlege, and pay tribute to her for all the hard work that she put in—and for her coping with such harrowing experiences.
I hope very much that the Bill will prevent any such disaster as the use of mesh in operations in the pelvis. If experts had been consulted, they would almost certainly have warned that putting rigid materials under tension in such a position would run a very serious risk of acting just like a cheese cutter.
I emphasise what my noble friend said about safety, which is of overriding importance. I feel certain that, as many speakers have already said, it must become an essential part of the Bill.
Baroness Masham of Ilton (CB) [V]
My Lords, I wholeheartedly support Amendment 74 and similar amendments in this group. Nothing is more important than safety in all medicines and medical devices. First Do No Harm, the excellent report by the noble Baroness, Lady Cumberlege, highlights that patients should be listened to. They are the people taking medicines and using medical devices. In the last few months, coronavirus has cast a shadow over other needs, but safety is paramount for everyone. Masks and all PPE are in demand worldwide. Has the UK got an ongoing adequate supply?
The correct dressings for patients with wounds is an important safety issue. There is a lack of tissue viability nurses to give expert advice in rural areas. If NHS trusts and CCGs had joint working in local areas, this would increase capacity and save resources. If the correct treatment is not given, there can be long-term problems.
Patient safety will be improved if patient experience is listened to. Patient groups, academic researchers and medical research charities should work together to find the best solutions. Some of the technologies for blind people and people with speech problems are amazing. It is essential for the safety of patients that all staff and patients using medical devices should be trained in their use. A medical device turned off when it should be on can cause a disaster; the wrong substance in a drip can be fatal; and not listening to patients or their families about allergic reactions to medication, with doctors ignoring this information and prescribing the wrong medicine, can be a serious safety issue.
I hope that the Minister agrees that safety in everything should be paramount and should be the overriding consideration of this Bill. I hope that the Minister will do his very best to help with this matter.
Lord Kakkar (CB) [V]
My Lords, I would like to support Amendments 10, 12, 74 and 75, in the name of the noble Baroness, Lady Cumberlege, and in so doing recognise the very powerful and thoughtful interventions by many noble Lords on this group.
It is clear that there is really no dispute in recognising that safety, availability and attractiveness are all important elements in securing, promoting and safeguarding public health. The question simply is whether safety should be given priority. The report of the noble Baroness, Lady Cumberlege, is clear in having identified, in a number of specific instances, why the system failed because safety was not at the forefront of the obligation and, in particular, the regulatory obligation.
The question is how best to ensure safety going forwards when as a country we have the opportunity to establish a new regulatory environment for medicines, medical devices and veterinary medical products. The four amendments in the name of the noble Baroness, Lady Cumberlege, and other noble Lords provide the opportunity to explore the Government’s thinking in this regard.
Why would Her Majesty’s Government not prioritise safety over the other two important objectives? The noble Lord, Lord O’Shaughnessy, in his thoughtful intervention, has suggested that there may be potential for patients to be denied experimental or targeted interventions as the result of inadvertent limitation by way of the regulatory regimen. At present, of course, we have the capacity to intervene with such medicinal products to ensure that, where it is appropriate, sensible and in the interests of the individual patient, interventions can be provided with less extensive clinical evaluation. However, as a general rule, for the entirety of the population where there is broad and relatively unfettered prescription, surely it is right that fellow citizens should expect that interventions—medicinal or medical devices—that are available to their clinicians for a prescription in their individual cases are, first and foremost, safe.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
We seem to have lost the noble Lord, Lord Kakkar.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
Lord Kakkar, please keep going. We lost you for a minute.
Lord Kakkar (CB) [V]
Is the Minister able to indicate why there might be anxiety about giving priority to safety? Is it because methodology by way of clinical trials evaluation is not sufficiently well developed to make that a statutory principle for the availability of medicinal products or medical devices? Is it that there might be some basis for legal challenge that would make this ill-advised? If not, it appears that putting safety at the forefront is in the interests of patients, our healthcare system, clinicians and the standing of our country as a place to lead in the development of the life sciences.
Lord Lansley (Con)
My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.
We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.
However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.
Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?
Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:
“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.
The end of the paragraph says that applications for marketing authorisation for a medicinal product must
“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”
For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.
That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.
Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,
“have two special objects in view with regard to disease, namely, to do good or to do no harm.”
The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.
Lord Alton of Liverpool (CB)
My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.
At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.
I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,
“the safety of human medicines as the overriding consideration”
the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.
Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”
The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.
As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.
I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was
“disjointed, siloed, unresponsive, and defensive.”
Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.
The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.
At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have
“lived a life wracked by guilt.”
Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.
Baroness Sheehan (LD) [V]
My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.
I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read
“the appropriate authority must act with a view to ensuring”.
This offers greater purpose of intent on the part of the Government of the day than the existing
“the appropriate authority must have regard to”.
It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.
It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I give profound thanks for the debate on this group and start by reassuring the Committee that safety is very much at the heart of the Bill. Doing what is right for patients is at the heart of it but I acknowledge the remarks alluded to by my noble friends Lord Lansley and Lord O’Shaughnessy: patients are also entitled to have conversations with their doctors about what is right for them. That sometimes goes beyond a conversation about safety. To have those balanced, personal conversations to offer them hope, with innovative new treatments or in a clinical trial, we need other considerations to work together; we need the full picture and I want to make a few remarks on getting that balance right.
Before I do, I acknowledge the very touching and moving human stories that a number of noble Lords remarked on in this debate. I always find this subject extremely moving, and it is entirely right for us to remember the tough anecdotes and testimony of those groups which have advocated on behalf of the victims of terrible misadventure and clinical mistakes in the past. I also acknowledge what the noble Lord, Lord Alton, referred to as misogyny and what the noble Baroness, Lady Thornton, referred to as being ignored by the clinical profession. These two aspects of the situation weigh most heavily on my mind.
Before I move on to the testimony of the noble Baroness, Lady Cumberlege, I thank her for the hard work that she and her team put into her report. I reassure her and others that there is no question of the report in any way being buried or overlooked, or not cared about. The report, which was delivered in late July, is being weighed up with seriousness and intent. I reassure all those who are part of this debate that the Minister for Patient Safety, Nadine Dorries, is working up a response to it which will be delivered thoughtfully and with impact when the time is right. I completely and utterly recognise the support from across the House and from patient groups for the report’s recommendations and import.
However, patient safety is not the only aspect of the Bill, which we think needs to get the balance right between different aspects. Perhaps I may flag to noble Lords our amendment on this, Amendment 2, which inserts on page 1 at line 6:
“The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
We think that Amendment 2, agreed last Monday, gets the proportionate and balanced approach correct and that we have practical regulation which can rise to the challenge of public health. I spoke last week to the reason for Amendment 2; it is a floor, not a ceiling. It means that the appropriate authority must be satisfied that regulatory changes promote public health, which is an important introduction to the Bill.
Whenever we reach this House, we deal with matters of nuance. We have discussed my noble friend’s amendments to change the way in which considerations apply, to one of an “objective”. With Amendments 8, 55 and 73 the noble Baroness, Lady Thornton, has proposed additional curbs. She has asked for regulations to be made that
“act with a view to ensuring”
that three considerations are met. I would expect to be asked under what circumstances regulations might be made that do not
“act with a view to ensuring”;
It would not be scrutiny by noble Lords if I did not. When we looked at this construction, it seemed likely that matters we might well wish to regulate on that were not specific to the considerations would fall out of scope. The burden of proof that those regulations met the bar the noble Baroness would set would be very high. “Ensuring” is the question here.
Government Amendment 2, which was passed last week, sets that threshold for regulation, where the authority must be satisfied that regulation would promote public health. I hoped that it would satisfy, but I am open to further conversation with the noble Baroness on this and, of course, other matters.
If the root of the issue is how the considerations will be applied by the appropriate authority, the noble Baroness will be aware that the Government have tabled amendments to Clause 41. Those amendments would change the way in which consultation is run. We would be obliged to include initial thinking on how the considerations have been applied to the development of regulatory change proposals so far.
The noble Lord, Lord Sharkey, has with Amendment 9 also suggested that an assessment of impact on these three considerations be published alongside draft regulations. He knows that an Explanatory Memorandum and an impact assessment must be produced when making a statutory instrument. While we are not there yet, I draw his attention to government Amendment 131, which would oblige the Secretary of State to report to Parliament every two years. That report must contain concerns raised during consultation, with that consultation informed by the Government’s initial assessment of the considerations. Parliament will therefore have the Government’s assessment but also the public’s assessment of the Government’s assessment. I hope that that is reassuring to the noble Lord.
I started this group by touching on the importance of patients and I am grateful to my noble friend Lady Cumberlege for her Amendment 10. She has support for it. I fully understand and support the rationale for wanting medicines and medical devices to be safe for patients. However, Amendment 10, placing the safety of medicines above all other considerations, could inadvertently put patients at risk.
The noble Lord, Lord O’Shaughnessy, alluded to availability, for example. During the pandemic, much has been done to ensure supplies of medicines—new experimental medicines, old medicines for different purposes or medicines that are at least available when others are in short supply. We have introduced a number of regulatory flexibilities, which have been widely welcomed by industry. They have helped to secure continued supply in a very challenging situation.
While patient safety underpins everything that the MHRA does, these changes were introduced for the primary purpose of ensuring continued supply. If we placed the safety of a medicine above all other considerations, we might put the safety and health of the patient and wider public at risk should they not receive the medicines that they need.
It would also potentially mean challenges in getting patients new medicines. A medicine that is novel or offers a great deal of hope might be inadvertently ruled out because of concerns regarding poor clinical practice or potential use in patients for whom it is not appropriate. We do not want to deny a potentially effective medicine to all patients in all circumstances. By placing safety as the primary consideration, clinical trials would also be almost impossible to conduct. By their very nature, they seek to test the safety of medicines.
I understand the noble Baroness’s concerns. She is deeply motivated by a desire to prevent what has happened before from happening again. I have spoken to patient groups. I am a father of daughters and a husband to a wife. I was deeply affected by the speeches made at Second Reading. However, I think that her objective—the safety of patients, not the safety specifically of medicines and medical devices—is protected by the government amendments that were passed last week. We will not be able to make regulations if we cannot be satisfied that they promote public health. That rules out deregulation for deregulation’s sake, for instance, but it allows, particularly in the case of an emergency, getting treatment to patients.
I hope that the noble Baroness will understand that we are aligned in intent, if not in delivery. We have designed that overarching test—that the appropriate authority is satisfied—to deliver on the safety of patients without preventing, for example, regulation in a pandemic. I know that she has spoken to my officials. I welcome ongoing conversations through the passage of the Bill, in Committee and beyond.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I have received one request to speak after the Minister, from the noble Lord, Lord Hunt of Kings Heath. Once we have heard from the noble Lord, I will try one more time to establish contact with the noble Baroness, Lady Jolly. However, I have to tell the Committee that so far we have not been successful.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.
Lord Bethell (Con)
I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.
I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I thank the Minister for his reply and all noble Lords who took part in what has been a worthwhile, interesting and sometimes rather impassioned debate.
The Minister is probably being slightly optimistic in thinking that we will not attempt to implement as much of the report of the noble Baroness, Lady Cumberlege, in this legislation as we can, because we are not sure when the next Bill where we could do so will come along. He might think about that. A little while ago, we had a Bill that would have been perfect for this report’s purposes but, unfortunately, we never got any further than Second Reading.
I thank the noble Lord, Lord Sharkey, for his support as we have moved through slightly difficult times in the past few days. The noble Baroness, Lady Cumberlege, knows that she has our support for the recommendations in her amazing report. We will do everything that we can from this side of the House to make progress.
The noble Baroness, Lady Bennett, is quite right to remind us of the fact that we are dependent on animals for making sure that our medicines are safe. We should never forget that.
My noble friend Lord Hunt was quite correct when he said that patient safety needs to be central. In fact, my noble friend’s remarks reminded me of the time when I was number two to the noble Lord, Lord Darzi, when he was a Minister in the House. He was absolutely passionate about patient safety and how it could be implemented. He also made a coherent argument for the fact that you could ultimately save money if you got patient safety right from the broad GP level all the way through to the implementation of new drugs and so on.
The remarks from the noble Lord, Lord Patel, were a tour de force. They illustrated again to us, if we did not already know, that his experience and knowledge are of enormous use to the Committee.
The noble Lord, Lord O’Shaughnessy, was doing a balancing act, saying “Ooh, attractiveness, ooh, patient safety, how is that going to work out?” He started off by saying that there should not be a trade-off but I think that he might have come to the conclusion that there will be one.
Between them, the noble Lord, Lord Kakkar, and the noble Baroness, Lady Watkins, brought enormous wisdom to this discussion. Both of them were balanced in the way that they expressed the need to put patient safety at the centre of the Bill.
The Minister and my team and I need to discuss the difference between “having regard to” and “with a view to ensuring”. The two things are not the same; this is not just about semantics. We probably need to have that discussion between now and the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
We now come to the group beginning with Amendment 14. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 14
Lord Bethell
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 1(2)(c) in the Bill as brought from the House of Commons.
Lord Bethell (Con)
My Lords, in moving Amendment 14, I will also speak to Amendments 57 and 77 in my name. These all relate to clarification of the Government’s use of “attractiveness” in the Bill.
Our life sciences sector is critical to this country. It achieves great things. We have the RECOVERY trial. We have an industry that rose to the ventilator challenge issued earlier this year. It contributes to the economy and jobs; in turn, the Government have committed to ensuring that it continues to do so.
Our approach to regulation is a pivotal part of supporting that. I know that much was said at Second Reading as to how attractiveness might be defined. A number of amendments have been tabled to define it, all of which demonstrate the importance of this part of regulatory consideration. I look forward to hearing the debate on them.
To provide greater clarity on our meaning and intent of the “attractiveness” consideration in Clauses 1, 8 and 12, I have brought forward Amendments 14, 57 and 77. They set out that, as an integral part of the development of proposed regulatory changes, regard will be given to the favourability of the UK as a place to conduct critical medicine and device development, manufacturing and supply processes.
They also clarify our intent that Clauses 1(2)(c), 8(2)(c) and 12(2)(c) reflect that the Bill is a platform for us to continue to support increased investment in the UK to develop and supply medicines and devices, by ensuring that we make regulation that is sympathetic to that need. That is why the amendments strengthen the consideration regarding the likelihood of the relevant part of the UK to be seen as an attractive or favourable place in which to trial and supply human medicines or develop and supply veterinary medicines and medical devices.
I am pleased to see that this focus on favourability echoes language in amendments put forward by the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Hunt. Many of the proposed amendments on the definition of attractiveness provide an explicit list of specific elements that could underpin a consideration of favourability or attractiveness of the UK as a place to develop and supply medicines and devices, but I am confident that the current drafting already captures the multiple different stages that are inherent in seeing these goods placed on the market and supplied to patients.
The noble Baroness, Lady Thornton, and others have commented on the fact that this is a new term in legislation. Attractiveness means doing everything reasonable to be the first place where new treatments are identified, developed, rolled out and adopted, where investment in life sciences takes place and where the enrolment of patients in clinical trials is supported. It is neither necessary nor helpful to set out in the Bill all the different factors and stages of the development and supply landscape that will enhance the attractiveness and favourability of the UK. Providing a narrower definition limited to specific factors and elements of the current development and supply landscape risks excluding aspects of supply that are not yet in place. If we cannot currently predict the scale of innovation that these sectors may offer in future, can we accurately predict all the factors that will ensure that the UK is an attractive place to bring those innovations?
Government Amendments 14, 57 and 77 work together with government Amendments 2, 7, 51, 54, 56, 68 and 72. These place an obligation on the appropriate authority to be satisfied that the effect of the changes will be to promote the health and safety of the public or, in the context of veterinary medicines, that the regulations promote the health and welfare of animals, the health and safety of the public or the protection of the environment. It is part of that assessment into whether health and safety would be promoted that the appropriate authority must have regard to safety, availability and attractiveness.
In combination, I am firmly of the view that these amendments will ensure that appropriate rigour is given to how the key powers in Clauses 1, 8 and 12 are exercised. These amendments provide additional nuance. They clarify but they do not proscribe. They rule in rather than ruling out. I beg to move.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the next speaker was to have been the noble Baroness, Lady Jolly. I am afraid we have not been able to establish a connection with her, so I call the next speaker, the noble Lord, Lord Lansley.
Lord Lansley (Con)
I want specifically to refer to Amendment 16 in this group, which is in my name and that of the noble and learned Lord, Lord Woolf. The purpose of that was prompted by looking at subsection (2)(c), and this question of attractiveness, or
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”
In this particular instance, we concluded that while one might think that the United Kingdom was, or was not, an attractive place to supply human medicines and derive certain conclusions from that, the process of medical innovation is not well captured by a simple reference to clinical trials. The process of medical innovation is a wider set of factors than clinical trials alone. In particular, I think that in our minds, in looking at the United Kingdom, one of the underlying strengths of the United Kingdom as a place in which to develop medicines is because of our strengths in discovery.
For example, I remember as a resident of and former Member of Parliament for South Cambridgeshire that my constituency included the Laboratory of Molecular Biology which, among its other attributes, is the single research institute with the largest number of Nobel prizes in the world. The strength of discovery is an absolutely central aspect of the fact that AstraZeneca, Cancer Research UK and Addenbrooke’s and Papworth hospitals are close by and the biomedical campus at Cambridge is bidding to become Europe’s single strongest location for life sciences. If you delved back over the last 50 years and asked what the distinguishing characteristic of that was, you might well say Cambridge University—and people would well understand that—but you might equally say the Medical Research Council’s Laboratory of Molecular Biology and all that went with it. This is not because the LMB does clinical trials; it is because it does discovery. I think our intention was to say that, if the medicines regulator is having regard to these factors, maybe it should have regard to discovery as well.
I entirely take the point that perhaps, where the medicines regulator is concerned, discovery is something that happens before it really gets involved. However, if it is thinking about the environment for life sciences, I find it very hard for it to think about it in parts, and not as a whole. That is what Amendment 16 is intended to explore.
There is another question conveyed by a number of these amendments, which, as my noble friend the Minister has quite rightly highlighted, is this interesting use of the word “attractiveness”. I may well have regard to the attractiveness of many things, but that does not necessarily mean I do anything about it. That the Minister has brought forward his own amendment to point to
“the likelihood of the relevant part … being seen as an attractive”
place is very interesting and takes us much closer to where we want to be. However, it still begs the question of what the medicines regulations should require the regulator to do about it, having had regard to this thing. There are other amendments which, I think, perfectly properly raise the question of whether the regulator should seek to enhance the attractiveness of the United Kingdom as a relevant place, et cetera. I think it raises a very interesting question. I get the impression that the Minister is trying very hard to move to the right place; I am just raising the question of whether we are quite there yet without something like the word “enhancing”.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.
Lord Hunt of Kings Heath (Lab)
Can I just follow the noble Lord, Lord Lansley? Clearly, we are going to continue teasing out “attractiveness”. I have no doubt that I want the UK to be attractive in terms of the development of medicines and medical devices, and I think the noble Lord, Lord Lansley, was absolutely right when he paid testimony to the underlying strength of our medical innovation and discovery, and indeed the life science sector as a whole. I think one of the questions we are going to consistently talk about is that we do have a problem with the attitude of the National Health Service to those very medical innovations that take place in this country. As I will touch a bit on procurement, I should declare an interest as president of the Health Care Supply Association, because clearly it is involved in procurement decisions.
As I think was discussed in the first day of Committee, the ABPI has reported that for every 100 European patients who can access new medicines in the first year, just 15 UK patients have the same access. It is a major problem that we are so slow to take advantage of developments in new medicines and devices, both in our country and globally. We are seeing in the NHS essentially an unprecedented level of rationing, both locally and nationally. My own view is that NICE has developed into more of a rationer than it was ever intended to be. Locally, clinical commissioning groups are making almost perverse decisions, ranging from cutting out health promotion programmes to being very restrictive on some operations or, again, on access to innovative drugs.
Of course I understand that the drugs budget cannot be open-ended, and the NHS must achieve value for money. But the fact is that we are at great risk of losing our place at the top table when it comes to medicines and medical devices innovation, despite the excellence of the people we have, which the noble Lord, Lord Lansley, referred to. At the moment, I think we have developed around 14% of the top 100 global medicines, but 20 years ago it was 25%, and the risk, of course, is that we go lower and lower.
Similarly, in relation to access to devices, we have a very innovative devices sector, but again it is utterly frustrated by the NHS’s record in adopting innovation. Its suppliers are forced to battle against a fragmented marketplace—they lack a clear route to market—budget silos that impact on buyers’ ability to release savings directly, and a short-term focus on cash-releasing savings at the expense of longer-term benefits. As an example, I was approached by the Urology Trade Association, which represents the suppliers of the majority of urology projects to the NHS, which pointed out that, in normal times, urinary tract infections are the greatest single cause of unplanned hospital admissions, so it has a big impact on quality and duration of life and on use of NHS resources. If we were prepared to invest in improved devices, it could have a major benefit. But essentially, whatever the Government say about procurement and value-based procurement, they always go for the lowest price, and I am afraid that we often buy the lowest-quality products.
The ABHI has told me of one company in the dialysis sector which now sees the UK as a second or third-tier sector, due to the prices it commands here. I know that on the first day of Committee the noble Lord said he cannot talk about reimbursement; the problem is that Ministers will never talk about reimbursement. It is interesting that, in general, if we are increasing staff—the numbers of doctors and nurses—I think Ministers tend to proclaim that as a good thing. However, increased budgets in devices and medicines is a shock, because the whole philosophy of his department and the NHS is to hold down the budget.
The problem is that, essentially, we do not invest in the great things that are happening. It is naive to think otherwise. There are a lot of things we can do to encourage the kinds of things that are happening in Cambridge—through tax incentives, for example, and schemes for faster access—but they relate only to a few selected medicines and devices. Overall, we are at great risk. I am afraid that the NHS has to face up to some responsibility for that, both in terms of the industry, and in terms of patients. Why should we in this country have to wait so long for medicines that in other European countries are available much sooner? This is a major issue which we need to tackle.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I am sorry. We could not hear you and we still cannot see you.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Ah! You are with us in all your glory. Please continue.
Lord Patel (CB) [V]
Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I understand that the noble and learned Lord, Lord Woolf, who was due to speak next, is not with us this afternoon. I am saying this very slowly in case he is, but I do not think so. In that case, I call the next speaker.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I support Amendment 20 in the name of the noble Baroness, Lady Thornton, to which I have added my name. Its purpose, together with Amendment 21 in the name of my noble friend Lord Patel, who has just spoken so eloquently in favour of it, are to provide a definition of attractiveness for clarity and the primacy of safety, while maintaining an environment that promotes the UK as a centre for global life science research and innovative working with academic partners in all continents across the globe. In addition, Amendment 20 should ensure that the UK population has prompt access to new medicines once they have been approved in line with Her Majesty’s Government’s philosophy for the future.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
That was commendably brief. I call the next speaker.
Baroness Masham of Ilton (CB) [V]
My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.
In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.
To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.
Lord O'Shaughnessy (Con) [V]
My Lords, I echo the point made by the noble Baroness, Lady Masham, about the noble Baroness, Lady Jolly. I am sure that we all send her our very best wishes.
I speak on the amendments tabled by my noble friend the Minister. However, on a quick clarification on something that the noble Baroness, Lady Thornton, said in the last debate, which is germane to this debate, I was not making the point that I believe that there can be trade-offs between safety and attractiveness as the Bill currently defines it. Rather it was around the effectiveness and efficacy of medicines and medical devices—points that were, thankfully, made much more clearly by my noble friend Lord Lansley than they were by me—and the impact on what that means for safety and its overridingness as a priority, even if it is always our most important consideration.
On the substance of the amendments, I am sure that my noble friend was not expecting complete consensus around his amendments and he certainly has not found it yet. However, I applaud him for his clarifications on the impact of the attractiveness subsection and also applaud him for moving so quickly in response to noble Lords’ concerns. None the less, there is an issue around this, which the noble Lord, Lord Hunt, brought out. It is an unfortunate truth that the NHS has a poor history of performance in scaling up innovative medicines and devices. I know that that is something that my noble friend is very concerned about.
I have a specific question in this area. In asking it, I draw attention to my entry in the register of interests, in particular as an adviser to Healthy.io. Do my noble friend’s plans for improving the attractiveness of the UK include improving the attractiveness of the UK as a place to develop, trial and scale data-driven health technologies? I know that we will come to that topic later, when the noble Lord, Lord Freyberg, has his amendments, but can my noble friend confirm that they are included in the definition of devices and explain his intentions in this regard?
Baroness Walmsley (LD) [V]
My Lords, this group begins with the Government’s minimal attempt to define the word “attractiveness” in Clause 1(2)(c). I am afraid that I preferred the version in Amendment 20 in the name of the noble Baroness, Lady Thornton, and others. I think that it became clear to the Minister in meetings before Second Reading and in the debate itself that many of us felt that a word such as “attractiveness”, which is very unusual in a piece of health legislation, requires a clear definition in the Bill.
“Attractiveness” is one thing, if properly defined, but “ambition” is another. That is what my noble friends Lord Sharkey and Lady Jolly—to whom I send my best wishes—seek to do in Amendment 15, for human medicines, Amendment 58 for veterinary medicines and Amendment 78 for medical devices. I am sure that my noble friend Lord Sharkey will say more about these in a few moments. But if Brexit must happen, which unfortunately it must, there is really no point if it does not allow us to do better than we have done before. That is why inserting the words “maintaining or improving” is so important. As others have said, the UK has hitherto been a very attractive place to conduct clinical trials, partly because of our massive access to patients through the NHS, partly because of our expertise and high standards and partly because of our alignment with the EU and its 400 million citizens.
This is particularly important for rare diseases, where the numbers of sufferers in the UK alone are too small for a trial of statistical significance. Alignment with the EU is, therefore, particularly important for maintaining our attractiveness, and this is dealt with by other amendments that the Committee will debate later. However, we should be wary of throwing away the advantage of that alignment; to do so would give us a much bigger mountain to climb if we are to improve our attractiveness. I hope that the Minister will bear that in mind when he replies.
Lord Sharkey (LD) [V]
My Lords, I will speak to Amendment 15, but I begin by supporting Amendment 16, in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I strongly agree about the importance of the UK being seen as an attractive place to promote medical innovation.
Amendment 15 is in my name and those of my noble friend Lady Jolly and the noble Baroness, Lady Finlay of Llandaff, and I am very grateful for their support. The amendment addresses Clause 1(2)(c). As we have just discussed in the previous group, subsection (2) lists what an appropriate authority must have regard to when making regulations under subsection (1). Subsection (2)(c) specifies that the appropriate authority must have regard to,
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.
But we have, in extraordinary circumstances, accepted the Minister’s Amendment 14, so that the text will now read,
“the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines”.
That is not a formulation that lends itself to easy measurement.
I listened very carefully to the Minister’s brief explanation of the merits of his amendment, but I was unable to see a clear and actionable distinction between his new version and the old one. It was all getting a little theological—“angels dancing on the head of a pin” sprang to mind. In any case, the new Government amendment shares two defects with the old version.
The first is that they are both completely unambitious. We should be looking at least to maintain, and preferably to increase, the attractiveness of the UK as a place to do clinical trials or supply human medicines. I spoke last Monday about the critical importance of clinical trials to the UK’s global leadership in the life sciences. I have already noted that the number and share of clinical trials has declined since 2016, and we now rank behind the US, Germany and Spain. Because of Covid, we have abandoned 1,500 trials and suspended 9,000 more. We need to do better than simply to have regard to the attractiveness or the likelihood of being seen to be attractive. We need explicitly to maintain or improve that attractiveness, as our amendment proposes.
The second defect in both the Minister’s first and second versions of subsection (2)(c) is that they fail to mention manufacturing. Why is the appropriate authority not required to have regard to maintaining or improving the attractiveness of the UK as a place to manufacture human medicines? The ABPI raised this issue in its briefing for Second Reading, saying that, in addition to having regard to the attractiveness of the relevant part of the UK to conduct clinical trials or supply human medicines, the ABPI would also value an assurance from the Government that secondary legislation will support the attractiveness of the UK as a destination to develop and manufacture human medicines.
The ABPI has a point. I raised this question, and the ABPI’s position, with the Minister in a meeting on 13 October. In that meeting, the Minister’s officials replied that they thought that manufacturing was covered in other regulations. Will the Minister confirm that and tell us which regulations explicitly require the appropriate authorities to have regard to the attractiveness of the UK as a place for developing or manufacturing human medicines? If, however, there is no such statutory requirement elsewhere, would the Minister consider adopting Amendment 15?
Amendments 58 and 78 would make the same provisions as Amendment 15 but for veterinary medicines and medical devices.
I should also say that there are obviously enough opposing or various views on the attractiveness issue to make it clear that we will want to return to this subject on Report, not only in the context of Amendment 14. I look forward to the Minister’s response to Amendment 15.
Baroness Thornton (Lab)
I thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.
Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.
My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.
We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.
Lord Bethell (Con)
My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.
The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as
“favourability to the establishment of research, design or manufacture of medicinal products or related services”
I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.
I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.
That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.
I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.
In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, we now come to the group beginning with Amendment 17. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 17
Lord Lansley
“( ) the effect of the regulations on the ability of the National Health Service to meet the needs of patients;( ) the result of any consultation under section 41.”Member’s explanatory statement
This amendment adds further aspects to which the appropriate authority must have regard in making regulations under section 1(1) , to include the impact on the NHS and the results of consultation undertaken in accordance with section 41.
Lord Lansley (Con)
The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar issues. I hope that he will find some common ground between us.
Amendments 17 and 79 would add to the considerations to which the Secretary of State should have regard when making medicines regulations and medical devices regulations respectively—Amendment 17 referring to the former and Amendment 79 to the latter. They would bring the same factors into play.
The first factor is the effect of the regulations on the ability of the National Health Service to meet the needs of patients. There could be two interpretations of how this might be seen. The first is that the medicines regulations could give rise to the authorisation of medicines that the NHS was not in a position at that point to fund. I do not think that it is about that. If the NHS has difficulty in paying for such medicines, it has a power under the National Health Service Act to vary the funding mandate that would otherwise be applicable under NICE. The NICE funding mandate for medicines is in that Act and not in the regulations for medicines. What I think this is about is the NHS being increasingly keen to secure the benefits of innovation. We have had a decade or more of reports telling the NHS that while there is a great deal of innovation there is poor diffusion of its benefits through its adoption in the National Health Service. This is about the ability of the medicines regulations to help the NHS to meet unmet medical need, to bring forward innovations and to deploy them. One might say, “Well, the medicines regulator just authorises medicines”, but let me give a couple of examples.
The first is the early access to medicines scheme, which is precisely about giving the NHS the opportunity to bring forward innovative new medicines that meet unmet medical need and to do so more quickly and in ways that often require collaboration between the NHS, MHRA and NICE. The second example is the Accelerated Access Collaborative, which also looks at other schemes such as the small business research initiative. Its purpose is to bring products through to authorisation and approval, which is quite often in relation to medical devices.
The amendments would require the Secretary of State when making the regulations to have regard to the potential for innovative medicines and medical devices respectively, so that they might be accelerated through processes of authorisation in order to realise their benefits more quickly and hence help the National Health Service to meet its objectives.
The second factor to which the amendments would require the Secretary of State to have regard is consultation. Clause 41 places a requirement on the Secretary of State to consult when making the regulations. A later amendment, Amendment 131, requires the Secretary of State to make a report on any such consultation—I think that my noble friend the Minister referred to it earlier—but there is nothing that links back the consultation to the making of regulations. The amendments say not only must the Secretary of State conduct consultation but he must have regard to the outcome of it—these are specifically “have regard to” factors; they are not factors that should be placed above any other factors in the hierarchy that we are talking about or conflict with them.
Amendment 85 is a bit different. I freely admit, before my noble friend the Minister explains it to me, that trying gently to insert it into Clause 13 is probably quite difficult in terms of the legal structure, because that is a place where requirements are to be laid on those who bring products forward for marketing and supply, whereas the amendment would place a requirement on those who are effectively buying medical devices—that is, the NHS in particular. However, I want to ask my noble friend to consider that we are trying to stimulate innovation in medical devices and bring them through into practice. We know that there are significant potential benefits to the National Health Service in such innovations, which improve outcomes for patients and can reduce costs—it can be a win-win. However, there is no funding mandate for medical devices which mirrors that for medicines, so that when NICE produces a positive evaluation the NHS after a period of delay has an obligation to bring forward the funding for those devices.
In January 2019, the NHS Long Term Plan said that the NHS wanted to accelerate proven affordable innovations into use in the NHS. In November 2019, a consultation was launched to look specifically at what is known as the medtech funding mandate—that is, to give that funding mandate to medical technology devices, not just medicines. By March this year, the Accelerated Access Collaborative was meeting and agreeing—this was one of its objectives—that, in the financial year beginning in April 2020, three such products would be brought forward. Those three products were placental growth factor-based testing, whose title more or less explains what it is; SecurAcath, which, as the title again implies, makes catheters more secure, reducing infection; and HeartFlow, which piloted at the Royal United Hospitals Bath NHS Trust and is a 3D model mechanism for imaging coronary arteries in ways that reduce intensive testing and enable clinicians to work with a highly developed form of imaging in their practice.
Those three products were to come forward in 2021. The intention, as reported to the board of the Accelerated Access Collaborative, was to do more in future years. As I understand it, NHS England intended to establish this as a medtech funding mandate—perhaps with slightly different characteristics and requirements than that of medicines but, none the less, to give medical device manufacturers the same sense of assurance that, if they bring this forward in the United Kingdom, the NHS, with a positive evaluation, will bring them into practice. However, that has stopped. I have seen nothing since April; it seems to have fallen by the wayside. I seek from my noble friend the Minister an assurance that NHS England wants to do it, that the Accelerated Access Collaborative will help to push it forward and that we will see action on this—if not this day, then this year. I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, my Amendment 124 concerns NICE’s current review of its methods and processes as part of the agreement of the voluntary scheme for branded medicines pricing and access—commonly known as the VPAS. I will also speak to Amendment 85 in the name of the noble Lord, Lord Lansley, because he made some important points in his opening remarks.
I have a particular interest in NICE. Under Frank Dobson, I was the first Minister and worked closely with it for the first few years. It was established because of concern that effective new treatments, including medicines and devices, were not getting to NHS patients. This is a continuing problem. At the beginning, we put an additional sum into baseline budgets to cover the estimated cost of technology appraisals.
I have to say that pharmaceutical companies were obviously reluctant to embrace NICE, but so was the NHS. As early as December 2001, I was responsible for a funding direction to the NHS—the original one, referred to by the noble Lord, Lord Lansley—which required NHS bodies to implement their technology appraisals, because research showed that they were not doing so. They had been given the money, although it was not identified but put into baseline budgets, which is an interesting point.
The funding directions have been modified a few times since then and, to an extent, have reduced the impact. But the fact is that the NHS remains a reluctant partner—and you can add that to the unprecedented level of rationing taking place locally. There is a tendency, even when NICE has approved drugs or a technology appraisal, and even when the funding direction applies, for local mechanisms to be used to restrict access by patients. I have already referred to clinical commissioning groups: they are informed by regional medicines optimisation committees. Essentially, these are rationing committees designed to legitimise decisions by CCGs to ration treatments. I come back to this point: why do we tolerate NHS patients missing out on medicines and devices that are available to most patients in most European countries?
We come to the NICE review. I am a great admirer of NICE, which has done a fantastic job and has some brilliant people. It works with some fantastic universities, and we are world leaders in this field. However, I hope that the methods review will lead to tangible change and that we will get a fair and effective assessment of the true value of innovative medicines.
We are clearly at a crossroads: exiting the EU represents a significant threat to the attractiveness of the UK for pharma and devices companies. What factors do companies take into account? Clearly, the strength of our life sciences sector is one of them. Secondly, there is the regulatory system, which we are discussing in Grand Committee. Thirdly, there is the ability to launch medicines and technologies quickly into a market, getting medicines to patients who need them quickly. These are clearly part of the equation for any company, and pharmaceutical companies tend to be global, to all intents and purposes. The risk is that we will start to lose our reputation as a leader at the cutting edge of medical science. My hope is that NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation.
I shall give an example of where NICE’s current rules rule against this. Gene therapy is a prime example of a medical technology that the UK should embrace, but a procedure called discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses the 3.5% rate but can apply a lower 1.5% rate for therapies that offer longer-term health benefits. I understand that it chooses to do that only on exceptionally rare occasions. Post the new 2019 voluntary scheme, negotiated to deliver a triple win for patients, government and industry, we now see NHS England doing bespoke commercial agreements, which of course significantly undervalue innovation.
There is always a tension, but the tension is that the main interest of NHS England is to pare down drug costs. The impact that that has is that, for all the brave words about innovation, it simply does not play out in the field. I was very interested in what the noble Lord, Lord Lansley, had to say. There is a HealthTech Connect portal, but I am told that not a single innovation submitted via that portal was adopted by NHS Supply Chain during the first year of operation, March 2019 to April 2020. Are we to assume that none of the submissions meets the criteria in terms of evidence, efficiency or satisfying unmet needs, or are they simply being thwarted by a process that raises the bar to unrealistic levels?
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, unfortunately, a connection has not been made with the noble and learned Lord, Lord Woolf, who was due to contribute remotely.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a pleasure to be able to follow the noble Lords, Lord Hunt and Lord Lansley, on these amendments. The issues that they raise could not be more important. Indeed, they have both been assiduous, particularly the noble Lord, Lord Hunt, when he was opposite me at the Dispatch Box, in raising this issue of the NHS’s attitude to medical innovation. His point about the methods review is very well made. He is also right to raise the fact that the voluntary pricing scheme for medicines is designed with a cap-to-cap growth of 2%. It is hard to explain how, with the cap in place, rationing attempts are still going on within the NHS, because the cap is precisely meant to give that protection. The problem is that, with the benefits of the cap, the rebates go to the Treasury, whereas the costs of paying for medicines bite locally. Until we get that imbalance sorted out, I fear that we will have strong imperatives on local trusts and CCGs to ration as he has talked about. I regret that, as the Minister responsible for negotiating that scheme, that was not something we were able to resolve—but I hope that my noble friend will be able to next time around.
The reason why I wanted to speak in this group was to offer my strong support for the amendment proposed by my noble friend Lord Lansley, Amendment 85 on medtech funding guidance. I declare another interest here in that this was one of mine, in its current incarnation, in the industrial strategy life sciences sector deal 2 from autumn 2018. It was hard won with the NHS, for obvious reasons, but the case for doing it was very powerful, and was brought home to me by a device—a diagnostic tool by Roche Diagnostics for pre-eclampsia. It had sailed through all the medtech evaluations and had gold star guidance next to it but had only something like 5% of the uptake that we would expect, despite the fact that it saved money and lives and did everything that we would want of it. In a way, that was a powerful emblem of why we could not go on as we were and needed some sort of medtech funding guidance.
It has been two years. My noble friend Lord Lansley is quite right in tabling his amendment to, I hope, elicit a response from my noble friends at the Dispatch Box on a commitment to when a full introduction of this will be done. As we are, I hope, in that kind of positive mood, perhaps I could entice my noble friend the Minister to commit also to exploring two things: to extending the eligibility criteria for the guidance, which were very strictly drawn and quite limiting; and, as is very germane to our Covid efforts, to consider how it could be used specifically to support the diagnostic industry.
Lord Blunkett (Lab)
My Lords, although I was the shadow Health Secretary for two years in the 1990s, I speak with some temerity because the three contributors that we have just heard have expertise on this issue that I do not. I rarely say that when I decide to speak in Committee or on the Floor of the House.
I want to make three points. One was made by my noble friend Lord Hunt but reinforces the points made by the noble Lords, Lord Lansley and Lord O’Shaughnessy. It is about innovation and the way in which the acceleration of known therapies—in this case, gene therapy—can make such a difference. My much-missed and much-loved friend, the late Baroness Jowell, pioneered the idea of rapid, speedy throughput of potential new therapies, including gene therapy, and ideas to fruition. As a Minister at the time, the noble Lord, Lord O’Shaughnessy, was extremely helpful and supportive. I will always be grateful to him for attending Tessa’s funeral and being really committed to seeing her ideas go forward. I am glad that he was able to contribute this afternoon. I hope that the Minister will bear in mind the reality of what happens to individuals in practice and not forget the continuing campaign and support of Tessa’s family, particularly her daughter and her son.
I want to touch on two tangential issues. One is the real problem we have with substituting for procedures that are withdrawn because overseas manufacturers decide that they will not sell to us, including how we can initiate alternatives within the research available to us. Eighteen months ago, I had a procedure on my hand. I was told by the consultant that this procedure avoided having to have surgery; your Lordships and those who are taking any notice of this debate will be aware that hands are rather critical to me in a whole range of ways, so it was a very attractive alternative. However, she told me that I was one of the last patients to benefit from it because it had been withdrawn by an American supplier.
The very opposite happened in my old constituency, where Swann-Morton, a mutual that has existed for more than 80 years, produces a large number of cutting-edge facilities, from old-fashioned scalpels to the most modern and up-to-date tools for doing the job. I want to know what we will be able to do post Brexit to protect the likes of Swann-Morton, which is a big employer in the locality—it is a mutual in every sense, including the decisions taken by the employees themselves —from being excluded from markets that they previously had obvious access to, which reduces their competitiveness and ability to proceed. They have also been hit by Covid, of course; the fewer the procedures undertaken through the NHS, the more this hits the budgets of those who rely on a continuing flow of orders.
I could not find another niche in this particular group of amendments to make my point, so I have used my ingenuity. I am grateful for not having been heckled.
Lord Patel (CB) [V]
My Lords, there is no need for me to speak at length because I agree with much of what has been said. It has been fascinating to listen to how people who were Secretary of State and Minister of Health change, once they are not in that position, in fighting for resources and more innovation to be brought into the NHS quicker. I commend that, but I wish it had happened when they were in charge. I say this tongue in cheek to tease them, of course.
I support the amendments in the names of the noble Lord, Lord Lansley, and Amendment 124 in the name of the noble Lord, Lord Hunt of Kings Heath. What they both said is correct: the NHS is very slow to bring in innovation. Also, when innovations are available that will benefit patients, trying to use them is very difficult as a clinician because they are sometimes quite unique and not routinely used.
I will give noble Lords an example. Standard radiotherapy is used for cancer treatment, but occasionally the cancer does not respond, so the radiotherapist and medical oncologist would on very rare occasions want to use what is known as CyberKnife—focused radiotherapy that deals with the tumour but does not damage the surrounding tissue. I am told that to do this would require a request to be sent through the NHS trust system to the CCGs to get their approval, but this treatment is usually required now—today—not in about three weeks’ time, because the patient is in the advanced stages of cancer.
This is just one example; there are lots of others. What the noble Lord, Lord Hunt, said at the end of his speech was right: while this debate is maybe not directly linked to regulatory issues in medicines and devices, a much wider debate needs to be had on whether we have evolved processes that are counterproductive to bringing in or even developing innovations, as the noble Lord, Lord Lansley, referred to on a previous group of amendments. I am slightly hesitant to say that.
The original concept of NICE was to have an opportunity to bring modern innovations rapidly into the NHS. Yes, there was another side to it: that it should be effective and not increase costs unnecessarily. I know this because I was associated with it at the time of its formulation. I took a different route; I did not continue to be involved with NICE, but I became chairman of a similar organisation that the Scots established, at the time called the Clinical Standards Board for Scotland. I deliberately separated bringing innovations into the clinical area from the area of medicines by having the Scottish Medicines Consortium be quite different. However, the concept was the same in England and Scotland. Unfortunately, we need to get back to finding how we can bring in modern innovations more quickly and how we can use our science and the NHS as the core to make more innovation. However, I commend what the noble Lords, Lord Lansley and Lord Hunt, had to say.
Baroness Barker (LD)
My Lords, I thank your Lordships for allowing me to come off the substitutes’ bench to take part in place of my noble friend Lady Jolly. I did not have the opportunity to speak on the last group, but if I had I would have strongly echoed the words of the noble Baroness, Lady Thornton. I do not believe that the Government’s amendments go anywhere near strengthening, clarifying or taking away the reservations that many of us have that the definition of “attractiveness” is one that largely depends on the watering down of regulation and standards and the increasing of commercial competitiveness. That is very much germane to this set of amendments, because it is against this backdrop that the amendments from the noble Lord, Lord Lansley, sit.
Baroness Wheeler (Lab)
My Lords, we are grateful to the noble Lord, Lord Lansley, and my noble friend Lord Hunt for amendments that would ensure that the future role and funding of NICE are placed firmly in the Bill. Amendments 17 and 79 to Clauses 1 and 13 —in the name of the noble Lord, Lord Lansley—underline for both human medicines and devices the importance for the appropriate authority making regulations under the Bill to consider the ability of the NHS to meet the needs of patients and ensure consultation in accordance with Clause 41.
Amendment 85 to Clause 13, in the name of the noble Lord, Lord Lansley, and Amendment 124 in the name of my noble friend Lord Hunt, which proposes to insert a new clause after Clause 38, deal with the funding mandate to the NHS, the availability of human medicines and medical devices, timescales, and ensuring effective monitoring and reporting arrangements by the Secretary of State to both Houses of Parliament.
Noble Lords speaking to this group, particularly those with experience as former Ministers, have made powerful arguments based on their expertise. Those speeches have been very illuminating. I hope, therefore, that the Minister will respond in a positive way that reflects these concerns and these amendments’ intentions.
My noble friend Lord Hunt’s amendment, in particular, places a duty on NICE to take account of the availability of innovative medicines and medical devices for human use on the NHS. It also requires the Secretary of State to report to Parliament on the anticipated impact of new medicines and devices on inward investment and the attractiveness of the UK life sciences sector, whose vital importance to patients and the UK economy we all recognise fully.
As we have heard, my noble friend’s Amendment 24 is very much embedded in the current review of the methods and processes of NICE, amid widespread concerns that despite its recognition as a world-class institution, there is still a major problem with the take-up of new medicines by the NHS, with many CCGs financially or structurally unable to deliver the innovation that NHS patients deserve and must have. The recent report from the cancer charities showing how UK patients are missing out on new innovative treatments that are readily available in any other comparable country shows that stark reality. The NHS’s record on implementation of technical appraisals of new drugs by NICE says it all.
We must therefore ensure that the review of NICE’s methods, which is under consultation until the end of the year, and the consultation on changes to NICE’s processes, which is due to follow early next year, deliver real and effective change, and are open and transparent. The Bill should set out clear responsibilities for both NICE and the Secretary of State on their role in funding; they will be more important than ever in getting that change and innovation.
My noble friend expressed a genuine fear, which is shared across the NHS, about the de facto rationing of innovative medicines and the role that NICE often ends up playing in this without having the clear funding mandate from the NHS that these amendments would provide. His amendment is important because it would inject some parliamentary oversight into the review of NICE’s methods and process, which many consider as having been progressing very much under wraps for a while.
I declare an interest as vice-chair of the cross-party Specialised Healthcare Alliance. We have heard worrying noises about the rarity modifier consideration on rare diseases being removed. I have heard real concerns from rare disease charities among our 100-plus members that the review could be taking a worrying turn in terms of impeding access to treatments for rare diseases. This remains to be seen but it would certainly be a retrograde step; I hope that the Minister will provide me and rare disease charities with some reassurance on it today. I hope that the Minister will at least commit to more parliamentary scrutiny of the review’s work as it reaches its conclusions over the coming months. It is crucial for NICE to be obliged to improve, rather than frustrate, access and for Parliament to be given a view on these matters.
Amendment 85 in the name of the noble Lord, Lord Lansley, would ensure that the NHS has to implement NICE’s recommendations on medical devices as swiftly as for medicines. It is squarely in line with the Government’s stated aims, in so far as the Government have promised a medtech funding mandate of the kind referred to by the noble Lord himself and the noble Lord, Lord O’Shaughnessy.
However, the reality of the Government’s limited proposals—which are now delayed until next year at the earliest—is rather different. Many of the SHCA’s charities represent patients who have already had to shield this year, and now have to do so again, and the newest medtech innovations stand to help them care for themselves at home better. Does the Minister acknowledge that the Government’s medtech funding plans need to be expanded and accelerated rather than delayed? I hope that the Minister will commit to this important issue.
Finally, the threat to the UK life sciences industry from leaving the EU, and the steps that must be taken by the Government to ensure that the NHS does not start to lose its reputation as a global leader in medical science and innovation, have been fully explored. They are a constant theme from these Benches and across the House on the Brexit legislation that we have considered so far. A statutory duty on NICE to take account of the need for improved availability of innovative medicines and medical devices for NHS patients, with a duty on it and the Secretary of State to work together to ensure that the latest medicines are able to provide the care and treatment that patients need and deserve, will be a key part of supporting a world-leading life sciences sector in future.
Baroness Penn (Con)
My Lords, if the noble Lord, Lord Blunkett, speaks with temerity given the other speakers on this group, I ask noble Lords to consider how it feels to be the Minister responding.
I assure the noble Lord, Lord Patel, that Health Ministers may not be completely transformed on leaving government, but discussions that may have taken place in private can become much more public once they are on the other side of the fence.
I turn to Amendment 17, with which it may be convenient to take Amendments 79, 85 and 124 in the names of my noble friend Lord Lansley and the noble Lord, Lord Hunt. On the first half of Amendments 17 and 79, my noble friend conceded that the Bill likely already delivers what is within its scope to deliver. The consideration of the availability of medicines and medical devices when making regulations is relevant. This is what sits behind the ability of the NHS to meet the needs of patients, where it relates to regulation. The Bill simply does not deal with matters related to the NHS supply chain. It supports it by ensuring that medicines and medical devices that are safe are available on the UK market. As my noble friend knows, and has referred to, these matters are set out in other pieces of legislation. NICE was established as a statutory body by the Act that he took through as Secretary of State. I know that his Amendment 85 also probes on issues to do with the NHS supply chain.
I was interested to hear my noble friend Lord Lansley’s fuller explanation of the intention behind the amendment: to enable access to innovative medicines in the NHS. I know that he has done a huge amount to improve such access in the NHS. Although the Government do not think that this amendment is necessary to achieve his goal, I hope that when we come to debate later groups of amendments, including on the Innovative Medicines Fund, I can provide him with further reassurance on this matter.
On the second parts of Amendments 17 and 79, which deal with the results of the consultation on subsequent regulations that flow from the Bill, my noble friend Lord Lansley may have noted government Amendment 126, which we shall reach in a later group. This would add to the consultation requirements in the Bill. On the result of any consultation, I assure him that there is already case law requiring that consultation responses are taken into account. This is reflected in the Cabinet Office consultation principles, which require the Government to explain the responses that have been received from consultees and how these have informed the policy. A public consultation must be formally responded to. Not only that, the Explanatory Memorandum that must accompany a statutory instrument must explain the consultation outcome. Between these various documents, the Government must not only take into account the consultation but set out what has changed as a consequence of that consultation. I therefore think that the amendment may render these changes unnecessary, as the requirement to respond and explain is already there.
My noble friend Lord Lansley also tabled Amendment 85. While I understand his interest in ensuring that we have the appropriate funding and frameworks in place so that NICE-approved devices are made available to patients—an issue already touched on in the previous discussion on attractiveness—he may have anticipated my saying to him, once again, that the Bill is not necessarily the appropriate vehicle.
None the less, my noble friend and other noble Lords have raised an incredibly important issue. I reassure him and others that the NHS medtech funding mandate will be launched in April 2021. It will get selected NICE-approved, cost-saving devices, diagnostics and digital products to patients more quickly and ensure that specified innovations are funded locally. In advance of the mandate’s launch and to support adoption of relevant technologies, the NHS standard contract has been updated to include reference to the medtech funding mandate. I hope that that provides my noble friend with the reassurances that he seeks from me. We are on the way. This Bill is not the means to the end, and I hope he feels sufficiently assured to refrain from pressing his amendment to a Division, when we reach it.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call the noble Lord, Lord Lansley, to conclude the debate on this group.
Lord Lansley (Con)
I am most grateful to all noble Lords who participated in this debate, which I thought was very good, with a lot of points well made, including points by the noble Lord, Lord Blunkett. There were good points throughout, with hardly any that I would take issue with.
Both the noble Lord, Lord Hunt, and my noble friend Lord O’Shaughnessy will have anticipated some of the arguments that we can perhaps develop a little further when we come to Amendment 28. It may enable us to cut to the chase, as it were.
I was prompted, in listening to my noble friend and the noble Lord, to wonder what the collective noun is for former Health Ministers. I had always imagined that the appropriate collective noun for those who leave the job was a “release” of Health Ministers. I was struck, after today’s further discussions, by the thought that maybe we should be called a “frustration” of ex-Health Ministers. In every case, we know that we have become enmeshed in and, generally, absolutely fascinated by and engaged with all the issues that we get involved in in the Department of Health, but we never stay long enough to see them through in the directions that we wanted them to go or the conclusions that we wanted them to reach. Perhaps when we come to Amendment 28, I shall have a chance to talk about value-based pricing, which was something that I started but which did not happen after I left. I am thinking in this particular instance of the December 2011 report on innovation in the NHS. Many of the things that we have been talking about today were there nine years ago and continue to be there today, and we need to keep pushing forward with them.
In that context, what my noble friend the Minister said by way of reply about the consideration that the medicines regulator should give to the availability of medicines will certainly cover the ground. If, for example, the NHS makes it clear that it wants earlier access or what we might think of as breakthrough designation for medicines, that will definitely get into the “availability of medicines” consideration, so I take that point entirely. I am grateful for her explanation about the requirements laid on Ministers where they engage in consultation—that satisfies that factor.
I am particularly grateful that we have a date for the medtech funding mandate. I am glad that we are making progress. I know that that will mean that it is not subject to the vagaries of the Covid-19 crisis, which has delayed so many of the objectives that we were hoping to progress during this year and next. For NHS England, it is important. It will enable it to look after patients more effectively and potentially save costs. I am grateful to my noble friend for that. With that positive response, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, we now come to the group beginning with Amendment 18. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 18
“(d) the environmental and social impact of such medicines, including their manufacturing.”Member’s explanatory statement
This amendment seeks to ensure that the environmental and social impact of medicines is considered in the making of regulations.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I shall speak also to Amendments 25, 41, 80 and 91, which are also in my name.
My intentions in participating in this Committee and engaging on this Bill were originally modest. As a feminist and someone concerned about the impact of the profit motive on healthcare, I wanted to back up the work of the brilliant, ground-breaking and terribly important report prepared by the noble Baroness, Lady Cumberlege. However, when I looked at the Bill, I saw some gaping holes, which I have done my best to fill with assistance—which I wish explicitly to credit—from the British Society for Antimicrobial Chemotherapy; Dr Felicity Thomas, co-director of the WHO Collaborating Centre for Culture and Health at the University of Exeter; and, on the medical devices side, Team Consulting, which has provided me with a great deal of pro bono assistance. I am informed also by participants in the Westminster Health Forum event on sustainability in healthcare that I chaired recently.
The context in which this Bill comes before us is an ageing demographic, the rise of chronic health conditions in our deeply unhealthy society, and the advent of “lifestyle” drugs, all of which have been key drivers in increasing use of pharmaceutical medicines and, although I do not have any statistics on it, I would also believe in medical devices. Prescriptions for just one type of statin used to reduce cholesterol rose from 12.8 million items to 18.2 million items over one year alone. One in six 18 to 64 year-olds was prescribed antidepressants at some point in 2017, rising to one in five of those aged 65 and over.
Critics of the pharmaceutical industry have highlighted how a “culture of optimism” generates new drugs, which increases the demand for such treatments while exaggerating their benefits and not counting their flow-on costs, including the environmental. Medicines and medical devices already have significant environmental impacts which, in the context that I have outlined above, are likely to grow rapidly. As we tackle many other causes of environmental damage, the proportionate impact of medicines and medical devices will grow unless we act.
The point that I am about to make is crucial. I note that the veterinary medicines section of the Bill states that
“the appropriate authority must have regard to … the safety of veterinary medicines in relation to animals, humans and the environment.”
I ask the Government why “the environment” appears only in the veterinary medicines section, when, as I will set out, human medicines and medical devices have significant environmental effects.
There are well-known concerns about veterinary medicines—I note in particular the impact of anthelmintics on insect life—but these issues are not contained to them. Why is there no parallel provision in the medicines and medical devices parts of the Bill? I ask the Government to consider parallel provisions from the veterinary part in the human medicine and medical devices part, which is what my amendments aim to achieve.
I am well aware that people will say that human health is different and has to be the top priority, and I agree with many of the issues about safety and health that we talked about in earlier groups of amendments. But this is not a case of saying that we have to weigh health benefits against environmental ones; it is not either/or. As Covid is reminding us, public health is very dependent on the state of the environment, whether that is in the rising danger of zoonoses; the spread of antimicrobial resistance; the well-documented impact of air pollution on health; or the as yet little understood but extraordinarily pervasive existence of microplastics in the air, soil and water in our lives. This is systems thinking—the sustainable development goals approach to which the Government are signed up.
If we look for an overarching way to think about this, the phrase “green pharmacy” recognises the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment or their packaging. It is clear to me that the expectation of this approach should be built into this legislation.
There are some examples of this happening. A project under the EU’s innovative medicines initiative aims to develop tools to screen environmental properties earlier in drug development. I hope to see that transferred into automatic practice in the UK through this legislation. In Sweden, Stockholm county council grades medicines on their environmental effects and doctors can choose to prescribe a less harmful drug where the option exists. If the Government want to be world-leading, that is the standard to be ahead of. The organisation Health Care Without Harm has elaborated 15 recommendations to the European Union for sustainable healthcare. I hope the Government are already well aware of those.
With the exception of Amendments 41 and 91, the amendments do not spell out in detail, in keeping with the Bill’s status as a framework Bill, what kind of provision should be made, although I suggest that they should be included in regulation. They set out the environment as a key issue in the development of medicines and medical devices, and their manufacture, distribution and use. I suggest that that is essential.
Amendments 18 and 25 both look at environmental impacts, with Amendment 25 explicitly about the disposal of unused medicines and the impact of medicines that otherwise reach the environment. That often, although not always, means talking about how medicines reach waterways and get into our drinking water. A 2014 report by UK Water Industry Research found that, in most of 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. With current trends, the amount of pharmaceutical effluence leaching into waterways could increase by two-thirds before mid-century, according to a 2018 study by the Delft Institute for Water Education.
There are three ways in which drugs can enter into our waterways: by passing through the body, through being disposed of in waste, or during or after manufacturing. It is worth noting that, globally, over half of all medicines are prescribed, dispensed or sold inappropriately, and that half of all patients fail to take them as directed. Unused and waste medicines are also a problem, when they stay within the healthcare system. In the UK, the estimated cost of dealing with medicine waste in the NHS ranges from £100 million to £300 million a year. Research undertaken in Germany found that up to 16,000 tonnes of pharmaceuticals were disposed of annually from human medical care, with 60% to 80% of these drugs flushed down the toilet or placed in normal household waste.
I am aware that, in this context, there are often disproving statements of, “Patients are not disposing of the drugs properly”, but there is often very little information on drug packets or in information given to patients. I have heard anecdotal reports of people taking drugs back to their GP for appropriate disposal and being told, “Why are you doing that? Just throw it in the bin.”
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, the noble Baroness, Lady Sheehan, has withdrawn from the debate so I call the noble Baroness, Lady Barker, who will once again speak in place of the noble Baroness, Lady Jolly.
Baroness Barker (LD)
It is a great pleasure to follow the noble Baroness, Lady Bennett of Manor Castle, who introduced these amendments in her customarily thorough and diligent way; I thank her for taking the time to do that. I also thank her for bringing to the Committee information about the sources from which she brings forward these amendments. They not just represent the aspirations of politicians who wish to pursue their own green agenda; they present the thinking on the part of clinicians and people in the health services about the impact of medicines and medical devices and what they do.
It is no bad thing to remind ourselves that, in the NHS long-term plan, there is a specific commitment to the sustainability of the NHS. It is perhaps no wonder that, when the NHS Sustainable Development Unit reports that the NHS is responsible for 25% of public sector CO2 emissions, there is a recognition that large entities such as the NHS and the British Army will be crucial if the Government are to reach our carbon reduction targets within the timetables set.
As the noble Baroness, Lady Bennett of Manor Castle, said, the NHS is an organisation that British people value very highly. It is an institution that British people do their best not to demand much of—indeed, to minimise their demands on it. It is an ongoing source of frustration for many people that it is difficult for patients to assist with recycling medicines and devices. I know that I am not alone in saying this: when I came to empty the house of my mother, who not only depended on medical devices—hearing aids—but had multiple conditions for which she took medication, I could not dispose of things such as batteries or medicines in an acceptable way. I could not take them to pharmacies and get them recycled for people who needed them. I know that many people have found themselves in that position; it is a source of great frustration for people who do not want to waste precious NHS resources and for whom being in that position is offensive.
I rather suspect, as the noble Baroness, Lady Bennett of Manor Castle, suggested, that the NHS is, at a corporate level, beginning to make some progress in looking at its use of single-use plastics, its disposal mechanisms and, in particular, its use of water. I also suspect that Covid has had a huge and damaging impact on all of that. I do not expect that we will see the NHS able to prioritise this subject for the whole of next year. That is all more the reason for us to do what the noble Baroness said we should do: make sure that this remains an aspiration towards which the NHS should work and should have an obligation to work. With that in mind, I would be very pleased to support the noble Baroness’s amendments.
Baroness Wheeler (Lab)
My Lords, I am very grateful to the noble Baroness, Lady Bennett, for tabling these amendments so that we can discuss these important issues in the context of the Bill. Many of the broader issues she addressed will of course be under detailed scrutiny in the forthcoming Environment Bill, but it is valuable to consider them in the context of the supply of human medicines and devices. I very much value the detailed information she provided on a range of issues of concern, here in the UK and globally.
To touch on a few of the points the noble Baroness raised, Labour strongly opposes the production of single-use plastics and agrees with the Government’s policy of producer responsibility when it comes to new plastics being manufactured, but they have been slow to introduce it. As we have stressed, waste, including plastic waste, pollutes our land and seas, kills wildlife and contaminates our food. We are committed to making producers responsible for the waste they create and for the full cost of recycling or disposal. Sustainable design and manufacturing are crucial to this. Can the Minister reassure the Committee that producer responsibility will extend to the manufacture of medical devices? What incentives are being provided for hospitals to use reusable metal equipment, which can be sterilised after each use?
The Environment Agency has found examples of contaminated hospital waste being illegally exported to developing countries, such as Malaysia, for disposal. What steps are the Government taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in the UK? As we know, there are also major issues about the use of incinerators for hospital waste and concerns about health impacts on those living nearby. What alternative means of secure disposal are the Government planning which will protect the environment and cut the impact of carbon emissions?
Are the Government doing enough to ensure that chemists and GP surgeries provide a secure depository for unused medicines, so they do not contaminate the water supply by being washed down the sink or end up in landfill? Is the Department of Health working with the water companies to prevent the water supply being permanently contaminated by drugs that are flushed into sewers and cannot be refined out of the clean water system? There are concerns that the contraceptive pill might be affecting male fertility through the water supply, but high levels of cocaine are also being identified. What research is taking place on the effects of residual medicine in the water supply on human health?
We also know the deep concerns about the huge expansion of single-use PPE during the Covid pandemic. What arrangements are being made for the safe disposal of this equipment and what consideration is being given as to whether these materials can be sterilised and reused? There is strong concern about the widespread distribution of single-use masks to the general public, which are now causing a huge litter problem, as we have heard, as well as being washed away into our oceans. What are the Government doing to encourage the use of cotton masks, which can be washed and worn again?
On decontamination standards, as we have heard, decontamination and sterilisation are key topics for many medical device companies, particularly those involved in reusable surgical instruments and dental and endoscopy businesses. Key issues include prion removal, healthcare-acquired infections and the logistics of moving medical devices along the contamination chain. What engagement has the DHSC had with manufacturers, medical device decontamination and sterilisation providers and medical device users? Can the Minister tell the Committee what plans the Government have to review the decontamination guidance that is currently in place?
Finally, the important issue of antimicrobial resistance was pursued by Labour in Committee in the Commons by an amendment stressing the need to recognise its importance in the development of new medicines, and which would have laid a duty on the Secretary of State to produce an updated report to Parliament, setting out progress on a UK-wide strategy for tackling AMR. The Government’s 2019 five-year plan—which is part of the 20-year strategy, as we know—has been welcomed and has been the subject of considerable discussion in your Lordships’ House. The noble Baroness, Lady Bennett, is right to underline the awareness of AMR for those participating in clinical trials. The focus must be on developing new medicines to tackle AMR and curb the spread of bacterial diseases requiring antibiotics, and on the prevention and control of infection to contain the emergence and spread of resistance to antibiotics.
Baroness Penn (Con)
My Lords, the noble Baroness, Lady Bennett of Manor Castle, is a tireless champion of matters environmental and I am at one with her in wanting to consider sustainability in all that we do. However, I do not think these amendments are necessary and they are not strictly within the realms of regulating medicines and medical devices, which is what the Bill seeks to deal with.
Legislation is already on the statute book regarding the impact on the environment more broadly. In fact, I suggest that the Bill is part of a wider legislative canvas that delivers what the noble Baroness seeks reassurance on. Within that wider canvas is legislation on packaging waste, which is enforced by the Environment Agency in England. That imposes obligations on packaging producers to seek to reduce the amount of packaging produced, reduce the amount of waste going to landfill and increase the amount of packaging waste that is recycled. I will pick up her point on the production of medical devices being within this principle of producers being responsible for manufacturing waste and write to her on it.
Turning to elsewhere on the canvas, I say that there is also legislation on the statute book to address the environmental impact of producing and disposing of manufactured goods such as medical devices. This includes the Waste Electrical and Electronic Equipment Regulations 2013, which require the recycling of certain types of electrical equipment, including some types of medical devices. I hope that provides the noble Baroness with reassurance that these regulations are part of a wider whole.
The noble Baroness, and the noble Baroness, Lady Wheeler, also raised the importance of the appropriate use of reusable medical devices, which is essential to the provision of health services, with many medical devices being reusable in some form. I think we all agree that it is vital to ensure that decontamination of those devices is possible and, where it is, that it is efficient, effective and safe for patients to reuse. I assure the noble Baronesses that, under Clause 13, we would have the power to make provisions specifying that reusable medical devices must be designed and manufactured in such a way as to facilitate decontamination.
Amendment 25 deals with the important issue of medicines waste and medicine disposal, also touched on by the noble Baronesses, Lady Barker and Lady Wheeler. The environmental impacts of these are taken seriously, but dealt with by other legislation. For example, the Environmental Protection Act 1990 makes provision for the safe management of waste. The Act imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health. Community pharmacies must comply with this legislation, and the NHS community pharmacy contractual framework makes specific provision for pharmacies in England to act as collection points for the public’s unwanted medicines. These returned medicines are then stored securely by pharmacies until they are collected for safe disposal.
I understand that the noble Baroness and others may also want to know what we are doing to reduce waste medicines in the first place. Medicines optimisation is a key workstream within NHS England’s medicines value programme; it aims to ensure that the right patients get the right choice of medicine at the right time. Through focusing on patients and their experiences, the goal is to help patients to improve their outcomes, take their medicines as intended, avoid taking unnecessary medicines, reduce wastage of medicines, and improve medicines safety.
The Secretary of State for Health and Social Care has asked Dr Keith Ridge, the chief pharmaceutical officer for England, to carry out a review of overprescribing in the NHS. Following a pause due to the Covid-19 pandemic, the review is due to report later this year. This work is looking at reducing inappropriate prescribing with a particular focus on the role of digital technologies, research, culture change and social prescribing, repeat prescribing, and transfer of care. The report will provide recommendations to reduce overprescribing, which will help to reduce medicines wastage.
Amendment 41, proposed by the noble Baroness, Lady Bennett, highlights the serious and growing global problem of antimicrobial resistance, or AMR. It has been placed on the National Risk Register of Civil Emergencies as a “longer term trend” likely to change the overall risk landscape for the UK over the coming decades. Already it is estimated to cause more than 700,000 deaths each year globally. That figure is predicted to rise to 10 million, alongside a cumulative cost of $100 trillion by 2050 if no action is taken. She will be aware that in January last year the Government set out the UK’s vision to contain and control AMR by 2040. This vision is supported by a five-year national action plan that includes comprehensive One Health action across the spectrum of human and animal health, agriculture, the environment and food.
While recognising the serious threat of AMR, I respectfully suggest that this amendment, specifically in the context of a clinical trial, is not necessary. Clinical trials of medicines, including those of antimicrobials or antibiotics, have strict requirements for reporting adverse events and for continuous monitoring of the benefits of the medicine under investigation versus the risks, as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated good clinical practice guidance. Development of AMR during a clinical trial may manifest as an adverse event or as a lack of efficacy to the medicine being investigated. In either case, the investigators and trial sponsor have obligations to take action to protect the safety of the trial participant. This action might include taking an urgent safety measure, amending the trial protocol or terminating the trial early. These actions would require notification to the medicines regulator—the MHRA—and a research ethics committee. Development of AMR during a trial would also be expected to be transparent via the publication of the results of that trial.
The Health Protection (Notification) Regulations 2010 places a legal duty on the operator of a diagnostic laboratory to notify Public Health England of the identification of specified causative agents in a human sample within seven days. On 1 October, those regulations were updated to require diagnostic laboratories to report the results of any antimicrobial susceptibility test results and any resistance mechanism identified in respect of a sample. I hope that provides reassurance of the Government’s focus, not just to maintain high levels of surveillance of rates of AMR but to successfully contain and control its spread for future years. Given the existing provisions and ongoing work in the department, I hope I have reassured the noble Baroness that additional powers in this regard are unnecessary and she now feels able to withdraw her amendment.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, I thank the noble Baroness, Lady Barker, for adding to the outline that I provided on the importance of the greenhouse gas emissions of the NHS and bringing in the issue of the use of water, which is becoming an increasingly rare resource in the UK. I thank her for providing her personal account of the frustrations of individuals who want not to waste NHS resources, based on her own experience.
I thank the noble Baroness, Lady Wheeler, for focusing on plastic waste. I shall restrain myself from commenting on the broader points of this issue, but thank her for highlighting the particular importance of illegal exports of medical waste and the big issues around Covid-19 and the waste unavoidably being generated at this point, as she said.
Coming to the Minister’s response, at the start there was a suggestion that this was a provision to go somewhere else—that all these issues could be in the Environment Bill or packaging regulations, et cetera. I do not accept that. If we take a systems-thinking sustainable development goals approach, then we have to make sure that all these issues are in every piece of legislation. Everything has to be considered as a whole. Rather than saying “We’ll deal with it somewhere else”, given the issues of legislation being delayed—we do not know when the legislation that we have not yet seen will arrive—it needs to be built into every element of our thinking on this fragile, much-abused planet.
Coming to some specifics, the Minister commented on current arrangements for recycling of devices. I note that there was a disturbing report out this morning through the waste industry about the number of fires occurring in waste management facilities as a result of the inappropriate disposal of batteries. I do not know how many of those involved medical devices, but I would think it highly likely that, in some cases, they would be. There is clearly a real problem with our current disposal systems. The Minister referred to Clause 13 dealing with the contamination issues. I will take that back to my technical advisers. I was pleased with her comments about the efforts on medicines optimisation. If we think about this in the context of a waste period more broadly, we know that “reduce” is always the best option.
I am also pleased with the overall tenor of this debate and the focus that we have seen on antimicrobial resistance. If we think back—gosh, it is two Prime Ministers back now—David Cameron gave a major speech on antimicrobial resistance and we have seen growing awareness of this issue. I am pleased that this debate has been an opportunity to highlight it and focus on the need for more action. For the moment, I beg leave to withdraw my amendment, but I reserve the possibility of further consultation, and potentially bringing it and my other amendments back in this or a different form.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 19. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 19
Baroness Sheehan
“(d) citizens’ right to access medicines as part of the right to the highest attainable standard of physical and mental health as stated in the International Covenant on Economic, Social and Cultural Rights of 1966; (e) the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) which include but are not limited to—(i) the right to grant compulsory licences and the freedom to determine the grounds upon which licences are granted;(ii) the right to determine what constitutes a national emergency and circumstances of extreme urgency;(iii) the freedom to establish the regime of exhaustion of intellectual property rights.”
Baroness Sheehan (LD) [V]
My Lords, I metaphorically rise to move Amendment 19, which is in my name and that of my noble friends Lady Jolly and Lord Sharkey and the noble Lord, Lord Alton, whose support is always very welcome. I look forward to the contributions from other noble Lords who have signalled their intention to speak. It is a matter of deep frustration that a number of noble Lords who wished to contribute to this debate are instead committed to the equally important debate on the internal markets Bill, which is pitted directly against this Bill.
Amendment 19 has been tabled simply to ensure that fair access to medicines is a core aim of the Bill. It would root the Bill in the International Covenant on Economic, Social and Cultural Rights of 1966, which is a binding international human rights treaty that we in the UK ratified in 1976. The amendment would put into the Bill the fundamental right of every citizen
“to access medicines as part of the right to the highest attainable standard of physical and mental health.”
Fair access to medicines is an issue at the forefront of concerns expressed by patients’ groups. There are regular reports in the media about price gouging by pharmaceutical companies. Furthermore, one of the key calls in the collated briefing of the Royal College of Physicians, the Faculty of Pharmaceutical Medicine and the British Association of Dermatologists is that:
“The Bill must include provisions which allow for review of processes for issuing sole manufacturing licenses and consider the use of price control mechanisms in relation to costs of production, to increase access to medicines at fair prices.”
Yet this issue was not brought up during the Bill’s passage through the other place, nor does it feature directly in any other amendment before the Committee. So I hope that your Lordships will forgive what will be a rather full presentation of the important issues raised in the amendment.
Lord Alton of Liverpool (CB)
My Lords, in her prescient, topical and important speech, the noble Baroness, Lady Sheehan, asked a number of important questions of the Minister. I look forward, as I know other Members of the Committee will, to his response later in his remarks. The noble Baroness was right to remind us of the importance of fair access to medicine and the role of pharmaceuticals. Any vaccination programme for Covid-19 should be equitable and fair. She referred in her remarks to some work done at Liverpool University, which I will return to a bit later in my remarks. In her amendment specifically, she draws our attention to the International Covenant on Economic, Social and Cultural Rights of 1966, and, as she has done in her remarks, reminds us of the public health safeguards within the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights—TRIPS.
Earlier this year, with other noble Lords who serve on the International Relations and Defence Committee, I participated in hearings which led to the publication on 10 July of our report entitled The UK and Sub-Saharan Africa: prosperity, peace and development co-operation. The inquiry was chaired by the noble Baroness, Lady Anelay of St Johns. We became acutely aware of the potentially catastrophic effect of Covid-19 on already fragile economies and societies. John Hopkins University suggests that across the continent of Africa, with its population of around 1 billion people, there have been about 37,000 deaths, compared with 230,000 in Europe. Indeed, there have been more deaths in the United Kingdom than in the whole of Africa. But we must treat the data with some caution and even scepticism. Reporting in many places is rudimentary, with Nigeria carrying out just 2.7 tests per 1,000 people, compared with 381 in the United Kingdom, so the data may have to be treated with caution.
Mercifully, the reported death rate—18,000 in South Africa, for instance—does seem to be lower than in some parts of the world, perhaps assisted by younger populations; few homes for the elderly; less common incidence of type-2 diabetes and obesity; more outdoor living and low travel; and experience of dealing with Ebola, malaria and AIDS. We should nevertheless be concerned that, as recently as last week, the World Health Organization said there had been a substantial rise in deaths and recognised that disparities in our health systems and economic power could still see an acceleration in infections and fatalities.
The smouldering pandemic in Africa has been held at bay by swift and significant lockdowns in many African countries, leading inevitably to significant loss of jobs. That cannot be sustained indefinitely. These fragile economies will see increases in destitution and chronic poverty if we are unable to ensure protection for all as and when a vaccine becomes available.
James Duddridge MP, the Africa Minister, told the inquiry that, as a consequence of Covid-19, the World Bank projected 40 million to 60 million additional individuals falling into extreme poverty, and it has been projected that the economy of sub-Saharan Africa will be between 2.1% and 5.1% smaller by the end of the year. The London School of Hygiene & Tropical Medicine told the inquiry that the region was likely to face particular contextual challenges from Covid-19, including
“economic, social and cultural inequalities, lack of personal protective equipment … and the additional health burden of communicable and non-communicable diseases”.
It cited three factors which could worsen the impact:
“overcrowding and large household sizes”,
which increases transmissibility, a
“high baseline prevalence of co-morbidities”
and
“lack of intensive care capacity”.
Lord Crisp (CB) [V]
My Lords, I support Amendment 19, which would have been important at any time, but is, of course, as we have already heard, particularly important at the moment. I will speak briefly, and I can do so thanks to the eloquent contributions by the noble Baroness, Lady Sheehan, in moving the amendment and by my noble friend Lord Alton.
There are points of principle here, and practical points. I start with the points of principle. First, the UK signed up to the International Covenant on Economic, Social and Cultural Rights in 1976, which guarantees access to medicines as part of the right to the highest attainable standard of health. This should be integral to all our medicines regulation.
Secondly, as we have heard, the World Trade Organization’s TRIPS Agreement explicitly included public health standards, giving countries the right to grant compulsory licences and to determine where there is a national emergency, and the freedom to establish a regime of exhaustion of intellectual property rights—in other words, taking control of access to medicines on behalf of their populations. Both these principles are underpinned by the basic responsibility that Governments have for maintaining, protecting and improving the health of their people, but also by the wider points that my noble friend Lord Alton just talked about on our interconnectedness and responsibilities to our fellow citizens of the world, in our own self-interest as well as from other motivations.
However, as the noble Lord and the noble Baroness said, in addition to principles there are very practical issues that should guide our thinking on this. The first is that there is good precedent. The UK and other Governments have used, and/or threatened to use, these rights on several occasions over the years with good effect for the benefit of their people. They are useful and viable measures, and should be at the front of our minds at this time, because—here the point is being made again—the response to Covid is bringing with it a frankly unprecedented number of new treatments and vaccines in a relatively short period of time. It is vital that these are made available as quickly, widely and cheaply as possible, not just in the UK.
I echo the questions from the noble Baroness, Lady Sheehan. I will be interested to hear the Minister’s response about our participation as a country in the global sharing and the global effort.
It was good to hear my noble friend Lord Alton’s description of the situation in Africa and of the imperative need for us to bear that in mind in our policy-making here in the UK, while also bearing in mind the great reputation that we have had over several years for doing so. On Friday, I got in touch with the World Health Organization in Africa. Some of the figures that the person I spoke to talked about, regarding the impact of the pandemic on wider health issues, were formidable indeed. I was told that we have lost the gains of 25 years in the past 25 weeks—an extremely depressing statement.
Just as depressing, as both noble Lords mentioned, is the fact that we are already seeing signs of the way in which some pharmaceutical companies will approach this extraordinary period of new vaccines and treatments in what is happening with remdesivir, with shortages and treatment rationing here in the UK, let alone anywhere else.
This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.
Baroness Walmsley (LD) [V]
My Lords, the Government take an enormous number of powers to make regulations in the Bill.
In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.
Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.
Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.
The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.
However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.
The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?
Baroness Penn (Con)
My Lords, I suggest that this is an appropriate moment at which to pause our debate for today. I beg to move that the debate on this amendment be adjourned.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that concludes the work of the Committee for today. The Committee stands adjourned. I remind Members to wipe their desks and chairs before leaving the Room.
House of Lords
Introduction: Lord Hammond of Runnymede
Arrangement of Business
The Lord Speaker (Lord Fowler)
My Lords, the Hybrid Sitting of the House will now begin. Some Members are here in the Chamber, respecting social distancing, others are participating remotely, but all Members will be treated equally. Oral Questions will now commence. Please can those asking supplementary questions keep them short and confined to two points. I ask that Ministers’ answers are also brief. I call the right reverend Prelate the Lord Bishop of London to ask the first Oral Question.
Covid-19: Social and Economic Inequalities
The Lord Bishop of London
To ask Her Majesty’s Government what plans they have to ensure that (1) social, and (2) economic, inequalities are addressed in their plans for economic recovery from the impact of the COVID-19 pandemic.
Baroness Penn (Con)
My Lords, the Government have taken unprecedented action to keep people in work and to support businesses since the pandemic began. We are committed to carefully considering the social and economic impact of new policies and to tackling inequalities. Initiatives such as the Kickstart Scheme, the Job Support Scheme and enhanced welfare provision continue to support people, particularly those in groups at risk of higher unemployment due to the pandemic.
The Lord Bishop of London [V]
I thank the noble Baroness for her reply. Given the multiple layers of inequality that the pandemic is revealing, can the Minister tell the House whether Her Majesty’s Government will implement the recommendations made in the recent 10-year Marmot review and set up a taskforce that will focus on understanding the social and economic determinants of health from a holistic, society-wide perspective?
Baroness Penn (Con)
My Lords, the update to the Marmot review was an incredibly important piece of work and the Government are committed to tackling health inequalities. Indeed, a piece of work that we have started since the pandemic is looking at the impact of Covid, particularly on people of different ethnicities. That work is ongoing and has revealed that while there are still some unexplained factors, it is the socioeconomic ones that play a major part in providing for different outcomes for people during this pandemic.
Baroness Blackstone (Ind Lab)
The Government say they want to level up, yet the gap between the haves and have-nots continues to widen. There are few areas where this is more apparent than education. Unnecessarily lengthy school closures have magnified the differences, as many predicted at the time. Can the Minister tell the House precisely what the Government’s new educational programme to support school-age children from poor families is? How much is being spent on it, over what timescale, and how is it being evaluated?
Baroness Penn (Con)
My Lords, one of the best things we can do for school-age children is ensure that they are back at school and able to stay there, and that is our focus. To help those children who missed out because of school closures during the pandemic, we have a £1 billion catch-up plan, which includes £350 million for a national tutoring programme targeted at disadvantaged children. We also put £100 million into remote learning to ensure that children from disadvantaged backgrounds have free laptops and tablets, and access to the internet, to help them learn from home.
Lord Roberts of Llandudno (LD) [V]
My Lords, one matter that can be tackled immediately is that of free school meals for kids in the holiday season. If Scotland, Wales and Northern Ireland can manage it, why cannot England? We also had long-term inequalities even before the pandemic. How can one person be worth £7,000 a day, when another just manages to get £7,000 a year? We need somebody like William Beveridge, who led the great revival and change in 1942, which brought in the welfare state and National Health Service. Will the Government consider setting up a new commission that will bring about more equality?
Baroness Penn (Con)
My Lords, the Government will always consider new ideas to tackle inequality in this country. The support we have provided to people during this pandemic is unprecedented. Nearly £200 billion of support has gone into people, the economy and livelihoods since the pandemic began, and our support will continue while we need measures in place to stop the spread of the disease.
Baroness Warsi (Con) [V]
My Lords, my noble friend answered part of my question in response to the noble Baroness, Lady Blackstone. But what assessment have the Government made of the impact of the pandemic on the learning and attainment of children from lower socioeconomic backgrounds? How do they propose to reverse any negative impact to ensure that these young people do not suffer from a permanent socioeconomic pandemic penalty?
Baroness Penn (Con)
My Lords, as I said to the noble Baroness, Lady Blackstone, the Government have invested a huge amount to ensure that children are able to catch up on the schooling that they lost. We are conscious that those from the most disadvantaged backgrounds have been affected most; that is why our focus is also on ensuring that schools stay open while we deal with the rest of the pandemic, and ensure that children’s learning is not interrupted again.
Baroness Meacher (CB)
My Lords, UK inequality has increased greatly over the past decade, in part because of the Cameron Government’s swingeing benefit cuts as universal credit rolled out, as evidenced by the huge increase in the use of food banks. As the Government review this year’s benefit uplift, will the Minister attempt to persuade her colleagues to take account of 10 years of real-terms cuts?
Baroness Penn (Con)
My Lords, I cannot anticipate the outcome of future fiscal events in this House, but I assure the noble Baroness that I will take her contribution and views back to the Treasury to ensure they are heard.
Lord Browne of Ladyton (Lab) [V]
My Lords, in January 2019, the Environmental Audit Committee, accusing the Government of turning a blind eye to malnourishment, called for the appointment of a Minister of Hunger. In July this year, the Defra committee urged the Government to appoint a Minister for Food and, last week, before the FSM vote, the chair of the Education Committee called on his party and Government to come up with a long-term strategy to combat child hunger. If building back better does not include one of the above, just what is the plan to address the increasing inequity being forced on the rising number of children facing hunger in this country?
Baroness Penn (Con)
My Lords, the Government are conscious that families are facing an incredibly difficult time at the moment, which is why we have increased the generosity of universal credit by £20 a week. I also remind the noble Lord that the Government have expanded eligibility for free school meals: all children in reception, year 1 and year 2 have access to free school meals, as well as eligible students from low-income families in FE colleges and, during the pandemic, children from low-income families who have no recourse to public funds.
Baroness Scott of Needham Market (LD) [V]
My Lords, rebuilding the economy post-Covid will largely depend on schemes that are tailored to local circumstances and use local knowledge. Does the Minister agree with the recent ResPublica report, which argues that devolution must become the default position of government and not be conditional on a centrally determined local government structure?
Baroness Penn (Con)
My Lords, I have not seen that particular report, but I will look at it. The Government are absolutely committed to devolution, both of power and funding, so that local areas can look at what they need and allocate resources most effectively to support local jobs and businesses.
Baroness Jones of Moulsecoomb (GP) [V]
My Lords, despite the Government’s best efforts, some people have fallen through the gaps. Have the Government considered a trial of universal basic income? This has been and is being trialled in other countries. It really seems to work.
Baroness Penn (Con)
The Government have previously had representations in favour of introducing a universal basic income. It is not a policy to which the Government are attracted.
Lord Balfe (Con) [V]
My Lords, we seem to forget that this huge amount of money we are spending will have to be paid back by the same future generations about whom we are talking. Do the Government have any plans to cut back on expenditure and to examine, for example, the triple lock? It seems to exempt people in my age group from making any contribution at all towards building back.
Baroness Penn (Con)
The Government are conscious of this. We distinguish between short-term help during the pandemic—where the extra support we are putting into families and livelihoods will prevent the worst outcomes that could occur during this recession—and the medium term, when we will need to get the public finances back on to a sustainable footing.
Lord Bird (CB)
My Lords, I declare my interests as in the register. Does the Treasury know about the Ride Out Recession Alliance? This is bringing businesses, communities and individuals together to try to stop the mass arrival of homelessness in this country by creating jobs and training. Is it also aware that the cost of preventing people falling into homelessness is about half that of allowing them to do so?
Baroness Penn (Con)
I will certainly ensure that the Treasury finds out about the Ride Out Recession Alliance, if it is not aware of its work already. I agree with the noble Lord about the benefits of preventing homelessness and many other issues. During the pandemic we have increased the value of the local housing allowance to help people stay in their own homes, even if they have suffered adverse economic effects from the pandemic.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed. We now come to the second Oral Question.
Covid-19: Cultural and Creative Industries
(3 years, 6 months ago)
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Lord Colgrain
To ask Her Majesty’s Government what fiscal steps they are taking to support cultural and creative industries affected by the COVID-19 pandemic.
The Parliamentary Under-Secretary of State, Department for Digital, Culture, Media and Sport (Baroness Barran) (Con)
My Lords, this Government stand with the cultural and creative sectors. We are making the biggest ever one-off investment of £1.57 billion in them. To date, more than £500 million has been allocated through the Cultural Recovery Fund to organisations across England. During the coming weeks, further Cultural Recovery Fund awards will be announced, including more from the British Film Institute’s independent cinema fund and the Heritage Stimulus Fund, as well as further grants of more than £1 million and the repayable finance awards.
Lord Colgrain (Con)
I thank the Minister for her reply. I congratulate the Government on the creation and deployment of the Cultural Recovery Fund, its broad geographical distribution and its application across all types and sizes of artistic enterprise. I know that the Government continue to consider a variety of forms of fiscal exemption, such as the theatre tax relief and government-backed insurance schemes. The approach of winter, when all outside performances are being driven inside, will be a cruel time for these creative industries, which are particularly dependent on live performances. Can the Government confirm that they will consult the industry and look sympathetically at all forms of additional support, such as giving grants to cover the costs of temperature checking for those whose only operations will now comprise socially distanced audiences in covered venues?
Baroness Barran (Con)
I thank my noble friend for his recognition of the scale and breadth of the Cultural Recovery Fund. He is right to ask how we can think of innovative ways to support the sector to reopen. There have been great examples of that during the summer. We have formed a venues working group with key sector leaders to look at how we can maximise the safety of fuller opening, including in the area of ventilation. We are happy to continue to commit to consulting the sector on this.
Lord Mackenzie of Framwellgate (Non-Afl) [V]
My Lords, Arts Council England has supported freelancers with £2 million, compared to £5 million has been allocated in Scotland, £7 million in Wales and £4 million in Northern Ireland. What assessment have the Government made of the impact of such a disparity in arts funding across the UK?
Baroness Barran (Con)
I do not wholly recognise the numbers that the noble Lord cites. We are very clear that we stand by our freelancers across the creative industries, both directly through the Self-employment Income Support Scheme, as well as through major packages such as the £500 million Film and TV Production Restart Scheme. We estimate that this will directly support between 40,000 and 50,000 new jobs in the sector, many of which will be taken by freelancers and the self-employed.
Lord Flight (Con) [V]
My Lords, what is the estimated value of the total annual output lost by the cultural and creative industries as a result of Covid-19? What proportion of GDP per annum does this represent?
Baroness Barran (Con)
As my noble friend knows, the cultural and creative industries have been a critical and rapidly growing part of our economy, representing about £111 billion of gross value added in 2018—or 6% of GDP. We estimate that, up to August 2020, output in arts, entertainment and recreation was about 28.1% lower than in February 2020.
Lord Stirrup (CB)
My Lords, the recent grants to arts organisations are very welcome but, if we are not careful, we risk winding up with too few artists to perform in many of them. What further action are the Government considering to stem the exodus from the profession of many musicians—perhaps more than 40% of the total? They can neither find employment nor access the relief schemes currently in place.
Baroness Barran (Con)
The noble and gallant Lord makes an important point. Our approach through the Cultural Recovery Fund has been to try to support the cultural ecosystem. Enabling those institutions to remain viable in turn supports jobs, including those of the musicians who work within them.
Lord McConnell of Glenscorrodale (Lab)
One of the best ways to help those working in the creative industries—whether self-employed or otherwise—would be to allow them access to paying customers. We are still far behind many other European nations in providing safe access, based on safe design, for people to attend sporting and cultural events. Surely there is now an opportunity for the Government—in advance of the winter, when so many families will be feeling so much pressure from being locked down and under other restrictions—to create a proper plan to reopen our cultural and sporting venues nationally and locally, with limited, safe access. This would ensure that families could go out and enjoy themselves without going into other spaces or staying at home and becoming clinically depressed.
Baroness Barran (Con)
The noble Lord is right that culture and the arts play an important part in our mental health and sense of well-being. That is why we have worked so hard with the sector, providing guidance on reopening; we are now permitting indoor performances with socially distanced audiences. We continue to look at a variety of ways, including wider use of testing and better ventilation so that we can achieve exactly what the noble Lord hopes for.
Baroness Bonham-Carter of Yarnbury (LD) [V]
I join the noble Lord, Lord Colgrain, in thanking the noble Baroness’s department, Arts Council England and others for the grants and funding given during this crisis. However, a major stumbling block for those wanting to put on live events or planning them for the future is the availability of affordable contingency insurance. I know the noble Baroness has been asked this before, but please could she and her department work with theatres, venues and insurers to get a solution in place? A precedent exists in the form of cover that was needed for terrorism acts insurance in the 1990s and early 2000s, when the Government stepped in and intervened.
Baroness Barran (Con)
Again, I thank the noble Baroness for her kind words regarding the Cultural Recovery Fund. With regard to government-backed insurance, particularly for theatres, the same applies across the arts. There is a very high bar for intervention in the insurance market, and the Government would need to be absolutely clear that access to insurance is the remaining obstacle to reopening if they were to intervene. However, we continue to work with UK Theatre and colleagues in the Treasury and others so that we leave no stone unturned.
Baroness Gardner of Parkes (Con) [V]
My Lords, I ask the Government whether they agree that the mental health and well-being benefits of the arts, museums and galleries are now even more important and to so many a lifeline during this pandemic, when they are placed under so many strains? Will the Government assure me that they will keep this lifeline going to help those people?
Baroness Barran (Con)
I agree with my noble friend that there are many brilliant examples of where the arts have helped to promote positive mental health. Indeed, the launch of the National Academy for Social Prescribing is an important recognition of exactly that point.
Lord Stevenson of Balmacara (Lab) [V]
My Lords, the music sector is the original gig economy: no play literally means no pay. To its credit, the sector has come up with several suggestions to help it reboot, including a cut in VAT on tickets and, as the noble Baroness, Lady Bonham-Carter, said, backing an insurance scheme to encourage venues to reopen. The Minister seemed sympathetic to this last point; what more information does she need before she can support it?
Baroness Barran (Con)
As I said to the noble Baroness, Lady Bonham-Carter, we need absolute clarity that insurance is the real barrier to reopening, and, at a time when the pandemic is changing from week to week, obviously a number of wider issues have to be taken into consideration.
The Lord Speaker (Lord Fowler)
My Lords, I regret that the time allowed for this Question has elapsed.
Covid-19: Catch-up Premium
(3 years, 6 months ago)
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Lord Carrington
To ask Her Majesty’s Government what assessment they have made of the impact of the COVID-19 catch-up premium on disadvantaged pupils.
Lord Carrington (CB)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper and declare my educational interests as in the register.
The Parliamentary Under-Secretary of State, Department for Education and Department for International Trade (Baroness Berridge) (Con)
My Lords, understanding the impact of Covid disruption on attainment and progress is a key research priority for the Government, and we have commissioned an independent research and assessment agency to consider catch-up needs and monitor progress over the course of the year. Alongside the £650 million universal catch-up premium, we have announced a new £350 million national tutoring programme for disadvantaged pupils, which will increase access to high-quality tuition for the most disadvantaged young people.
Lord Carrington (CB)
I thank the noble Baroness for her reply. However, could she explain why, at the same time as announcing the catch-up premium for schools, the Government have stopped the year 7 catch-up premium? Extra funding for this stream recognised that, even in normal times, additional effort was needed in poorer catchment areas to get relevant students ready for secondary school. In some schools, subtracting this from the one-off catch-up premium significantly reduces the additional funds that they will receive and spells a reduction in income over time, thereby putting the disadvantaged in danger of not reaching their full potential.
Baroness Berridge (Con)
My Lords, the low prior attainment year 7 sum of money that the noble Lord is referring to was increased by £49 million, so nearly £1 billion of the national funding formula recognises low prior attainment, and it is spread across all five years at secondary level. That £49 million represents the year 7 low prior attainment figure, so there has been no reduction: it is included in the wider additional needs section of the national funding formula.
Baroness Blower (Lab) [V]
I listened carefully to a previous answer to my noble friend Lady Blackstone. However, on 16 October, Schools Week ran the following headline:
“£140m of tuition catch-up cash remains unspent.”
Of course, much of that will have been destined for disadvantaged students. Can the Minister assure the House that there is no intention to reconsider this funding and that it has not become reliant on the next funding review? Does she agree with Tom Richmond, from the EDSK think tank, that schools want to see this funding
“handed out as a matter of urgency”?
Will the Minister also provide a timetable for the delivery of the promised but as yet undelivered laptops to young people who need them for ongoing learning as well as for catch-up?
Baroness Berridge (Con)
My Lords, the £350 million is made up of three sections: early years, 16 to 19, and two elements to the schools funding programme. As of November, we will see the first mentors entering our schools, and tuition partners will be announced as a result of the programme.
The Lord Bishop of Durham [V]
My Lords, I declare my interests as set out in the register. I welcome the Government’s ongoing support of pupils through the catch-up premium and encourage the Minister to continue to give attention to disadvantaged pupils, who require significantly greater support than the average pupil. Given the specific difficulties relating to digital access for remote learning, can the Minister explain why access to computers for home use appears to have been drastically reduced just as schools have been legally required to provide online learning for those who have to stay at home?
Baroness Berridge (Con)
My Lords, the number of laptops made available was 250,000 and it is now over 300,000, so the number has increased. Over 100,000 of those have been delivered. The allocation is now responding to the data so that disadvantaged students who do not have a laptop have access to one. However, we need to prioritise disadvantaged students who do not have a laptop, are currently not in education and who are self-isolating at home. We are responding to the data; that describes about 4% to 5% of secondary school pupils and 12% of primary. We have to get those laptops, and that is why these changes have been made to get them to pupils who need them today.
Lord Storey (LD) [V]
Disadvantaged and vulnerable pupils have been the hardest hit during this pandemic. The right reverend Prelate raised a point about the announcement from the DfE that there would be an 80% cut in laptop allocations. I was interested when the Minister said that that cut was so that laptops could go directly to those young people at home; is that the case? Can the Minister assure the House that every pupil who is in need of a laptop, particularly those from disadvantaged and vulnerable backgrounds and children in care, will receive one?
Baroness Berridge (Con)
My Lords, the laptops are being delivered to young people either via the local authority, if they are in a maintained school, or via the academy trust. The change is that we have responded to the data to make sure that disadvantaged students without a laptop, who are currently self-isolating or at home, can get access to a laptop. If there are any other exceptional cases, where schools have that situation, then I urge them to contact the department, but we are trying to ensure that laptops get to those students who are already outside of school face-to-face tuition and need remote education.
Baroness Fall (Con) [V]
My Lords, I welcome the money available from the Covid catch-up premium, which acknowledges what we all know to be so true: that a generation of children have been hugely damaged by Covid, especially the most disadvantaged. Will the Minister consider whether we should be encouraging a generation of new graduates, who are having difficulty finding jobs in such a difficult time, to support these kids who have such a lot of catching up to do by funding a programme of Saturday schools across the country for our most disadvantaged pupils?
Baroness Berridge (Con)
My Lords, the Government already give £9 million to fund holiday activities. In relation to the catch-up fund, Teach First is one of the delivery partners which are recruiting the mentors who will go to schools in our most disadvantaged areas to provide a mentor, or maybe more than one, per school. I anticipate that Teach First will be recruiting just the type of person my noble friend outlines.
Lord Singh of Wimbledon (CB) [V]
My Lords, if properly used, the pupil premium can make a huge difference to an individual’s life chances once they are in school. Does the Minister agree that, for maximum impact, it is equally important for parents and carers to be encouraged, and helped if necessary, to boost the attendance, self-esteem and aspirations of those from disadvantaged backgrounds?
Baroness Berridge (Con)
We all know the importance of parents’ aspirations for their children. Of course, we also want to make sure that disadvantaged students are given every assistance, so £2.4 billion is given in pupil premium, but the Education Endowment Foundation also makes available to schools the best research on how to spend that money effectively.
Lord Watson of Invergowrie (Lab) [V]
My Lords, it spoke volumes about this Government’s attitude to poverty that last week their MPs were ordered to vote against a Labour motion to provide food vouchers for disadvantaged children during school holidays. Even the Secretary of State for Education and the Children’s Minister supported sending them into further hardship. With almost one-fifth of the school year completed, the Covid catch-up premium is barely under way, while the national tutoring programme—as the Minister confirmed a few moments ago—has not yet begun. How can parents and teachers have any confidence in the Government developing a properly funded long-term strategy to support disadvantaged pupils suffering from lockdown, when its short-term strategy is in such disarray?
Baroness Berridge (Con)
I have already outlined the considerable support that is given through the pupil premium. Over the course of the pandemic the Government spent £380 million on food vouchers, but most schools are back now—approximately 89% of children are back in school—so the traditional way of delivering free school meals via the kitchens in the schools has been up and running and responding to those pupils who are self-isolating. I assure the noble Lord that 25% of the £650 million has been allocated to schools, and the reason why 100% has not been allocated is because we want to do that on actual pupil numbers, not on pupil-number data that is out of date.
Baroness Garden of Frognal (LD)
We are a far cry from the Liberal Democrat pupil premium policy, which really targeted disadvantaged children. Can the Minister say what support is being given to teachers to enable them to give more face-to-face time to hungry, disadvantaged pupils without proper technology to help them to catch up on all the education they missed during lockdown?
Baroness Berridge (Con)
My Lords, part of the catch-up fund is £650 million that is going directly via schools, with an increased allocation, of course, to AP and to special schools. That assists in the delivery of education, and it is up to schools that we trust the most to be able to deliver that. As I say, it is a tribute to teachers and school leaders that approximately 89% of students are back in school.
The Lord Speaker (Lord Fowler)
My Lords, the time allowed for this Question has elapsed.
Pension Credit
(3 years, 6 months ago)
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Lord Foulkes of Cumnock
To ask Her Majesty’s Government what has been the increase, if any, in the uptake of Pension Credit in each of the past 12 months.
The Parliamentary Under-Secretary of State, Department for Work and Pensions (Baroness Stedman-Scott) (Con)
My Lords, it is too early to tell if claim numbers in the past 12 months have resulted in a net increase in the overall number of people eligible for, and in receipt of, pension credit, particularly with the scale of uncertainty surrounding the impact of Covid-19 and the changes to the over-75 free TV licence concession. The latest figures, however, show that more than 1.5 million people receive pension credit, of whom 900,000 are over 75.
Lord Foulkes of Cumnock (Lab Co-op) [V]
My Lords, I am grateful to the Minister, but does she accept that the combined effect of the Government’s awareness campaign, online claims and the threat of losing their TV licences has resulted in fewer than 30,000 of the more than 1 million eligible non-claimants claiming? Will she and her colleagues therefore convene a meeting with the officers of the All-Party Parliamentary Group for Ageing and Older People, and most importantly of all, all the age charities, so that we can launch together a much more effective, powerful and imaginative campaign?
Baroness Stedman-Scott (Con)
That is a very good suggestion and, as always, I try to be responsive and helpful, so I am going to take that back to the department and I will personally come back to the noble Lord with an answer.
Baroness Altmann (Con)
My Lords, I congratulate my noble friend on the Government’s campaign in GP surgeries and post offices earlier this year to increase pension credit take-up. This is vital for the poorest pensioners to avoid poverty, and it makes them eligible for vital support such as housing benefits, cold-weather payments and free TV licenses. As the triple-lock does not apply to the pension credit, can the Minister say if there are further plans to improve take-up, such as using new channels, as suggested by the charity Independent Age?
Baroness Stedman-Scott (Con)
My Lords, as my noble friend says, the triple lock is a manifesto commitment. In February this year we launched a nationwide campaign to raise awareness of pension credit and to help dispel some of the misconceptions that people might have about their eligibility. We engage with stakeholders including Age UK, Age Scotland, Age Cymru, CAB and Independent Age, among others, to help spread the word. The point that my noble friend makes is a very good one, and we would welcome ideas from stakeholders and any noble Lords about how to best improve the understanding of what pension credit is.
Baroness Watkins of Tavistock (CB) [V]
My Lords, in the evidence given to the Scottish Social Security Committee inquiry into benefit take-up in January this year, it was confirmed that the DWP has no written strategy to increase the uptake of pension credit. Without an action plan that sets out a programme of activity and overall objectives, any future awareness-raising activity risks taking place in isolation divorced of a wider strategy. Does the Minister agree with the charity Independent Age that an action plan is needed, possibly to include auto-enrolment? Will she commit to returning to her department to recommend producing one?
Baroness Stedman-Scott (Con)
I would like to make it clear to all noble Lords that the Government are absolutely committed to as many people getting pension credit as are eligible. We have no plans, at the moment, to introduce targets on take-up. However, the noble Baroness makes a very good point, which can be joined up with the point that the noble Lord, Lord Foulkes, made. As I have said, I will go back to the department, and I will personally come back with a response.
Baroness Drake (Lab) [V]
My Lords, given excess death rates, the Government must be increasingly concerned about vulnerable, low-income pensioners. Pension credit is targeted on the poorest. Some 1.5 million pensioners claim it but, worryingly, four out of 10 eligible pensioners do not, and they are missing out on other benefits, too. Will the Government increase the guaranteed pension credit by at least the cash value of a triple-lock increase to the new state pension? Those eligible for, but not claiming, pension credit will get a TV licence demand for £157.50. How will the Government protect them, given that their campaigns are not enough?
Baroness Stedman-Scott (Con)
The noble Baroness makes the point that there are, I think, 1.1 million people who could have pension credit if they made a claim and were eligible. I know of no plans at the moment to uprate the other benefit to which the noble Baroness referred, but I will go away and find out and respond to her in writing.
Baroness Janke (LD) [V]
Does the noble Baroness agree that many pensioners who do not claim pension credit feel stigma and shame in submitting to means testing? If so, will the Government consider revisiting auto-enrolment, to ensure that the poorest pensioners receive their full entitlement to financial support?
Baroness Stedman-Scott (Con)
The noble Baroness raises a very important point about the reasons why people do not claim pension credit. Some believe that they are not eligible; others think that they have too many savings; others think that there is a stigma to it; and others think that they might get only a small amount, so it is just not worth the effort. The noble Baroness raises valid points about the vulnerable; we must do all we can to make sure that those people are aware of pension credit and that they make a claim where appropriate.
Baroness Sherlock (Lab) [V]
My Lords, the take-up campaign launched in February, which has been mentioned, does not seem to have had much of an effect. The government website said that its main feature was a video to be shown in 800 GP surgeries and some post offices. However, once the pandemic hit, the chance of its target audience being in GPs’ surgeries and post offices went through the floor. So did the DWP refocus its work in the light of the pandemic, or is it planning a fresh campaign—and how much money is it putting behind it?
Baroness Stedman-Scott (Con)
The noble Baroness raises a valid point about the impact of Covid on GPs’ surgeries and post offices, and that people were not able to access the information. At the moment there are no plans for a new campaign. We are working with stakeholders, who again are absolutely swamped by the impact of Covid, to ensure that the message gets out. Once I have gone back and spoken to the department, I will come back to the noble Baroness with a written response, as I will to the noble Lord, Lord Foulkes, and the noble Baroness, Lady Watkins.
Baroness Eaton (Con) [V]
My Lords, will my noble friend explain how vulnerable pensioners can be supported to make a claim for pension credit during the pandemic?
Baroness Stedman-Scott (Con)
On 6 May, we launched the online Apply for Pension Credit service. Around 50% of claims are made through this medium. In addition, people can claim by calling a freephone number, and I am sure that our stakeholders will help in those instances.
Baroness Lister of Burtersett (Lab) [V]
My Lords, it is nearly a decade since the DWP conducted research into non-take-up of pension credit. Will it therefore now instigate new research into who non-claimants are, their reasons for not claiming, and where they are concentrated, as a crucial element of any effective action plan to increase take-up, which I agree with colleagues is essential.
Baroness Stedman-Scott (Con)
As I have said before, there is no plan at the moment for a campaign and I am not aware of any research being commissioned of the kind that the noble Baroness requested.
Lord Shipley (LD) [V]
My Lords, Citizens Advice in my home city of Newcastle upon Tyne reports that, during the Covid pandemic, there has been a rise in the number of young people seeking advice, but a proportionate decline among people over 55. This may relate to the lack of availability of face-to-face advice. But does the Minister agree that there should now be a new campaign to promote pension credit and that, without that, a lot of pensioners who would qualify are not going to have as much money as they otherwise might?
Baroness Stedman-Scott (Con)
I can only agree with the noble Lord that many people over 50 prefer to do business face to face, and I appreciate that that opportunity has been curtailed. I have no desire to be dismissive, but I think I have already answered questions about a new campaign, and I will come back to the House with an answer.
The Lord Speaker (Lord Fowler)
My Lords, the time allocated for that Question has now elapsed, and it is also the end of Question Time.
Arrangement of Business
The Deputy Speaker (Lord Haskel) (Lab)
My Lords, hybrid proceedings will now resume. Some Members are here in the Chamber, respecting social distancing; others are participating remotely, but all Members will be treated equally. If the capacity of the Chamber is exceeded, I will immediately adjourn the House.
We come to Committee on the United Kingdom Internal Market Bill. I will call Members to speak in the order listed in the annexe to today’s list. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including Members in the Chamber, to email the clerk if they wish to speak after the Minister. I will call Members to speak in order of request and will call the Minister to reply each time.
The groupings are binding and it will not be possible to de-group an amendment for separate debate. A Member intending to press an amendment already debated to a Division should have given notice in the debate.
Leave should be given to withdraw amendments. When putting the Question, I will collect voices in the Chamber only. If a Member taking part remotely intends to trigger a Division, they should make this clear when speaking on the group.
United Kingdom Internal Market Bill
Monday 26th October 2020
(3 years, 6 months ago)
Lords ChamberRead Full debate United Kingdom Internal Market Act 2020 View all United Kingdom Internal Market Act 2020 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 135-II Revised second marshalled list for Committee - (26 Oct 2020)
Baroness Hayter of Kentish Town (Lab)
My Lords, in moving Amendment 1, I welcome that today we are not starting on Part 5 of the Bill, as there are two other major issues which need to be reformed. Indeed, the Bill’s genesis never involved including Part 5, but concerned how to use repatriated competitive and other regulatory powers post transition. Today we will deal with two of these: first, how to give the new competition regime a consumer focus; and secondly, how to organise returning powers into the devolved structure the UK will operate in 2021, as opposed to the 1973 position when we entered the EU.
Amendment 1 deals with the whole point of market intervention and competition policy: to promote the interest of consumers where, for whatever reason, they are operating in an imperfect market. But it also acknowledges that helping businesses to grow or consumers to benefit must not be at the expense of our precious environment. The amendment would write into Part 1 that its purpose is to benefit consumers and to safeguard the environment.
Anyone who has worked in regulation or in the courts knows that these overarching objectives, or duties, are essential in interpreting or enforcing the specific clauses, resulting legislation or indeed future legal cases arising from the Act. The overarching purpose is usually taken into account. Before he left the CMA, the noble Lord, Lord Tyrie, as its chair, called on government to strengthen the CMA’s consumer duty, writing that the internal market will work for consumers only if it is
“fair, competitive and adequately, proportionally and properly regulated.”
Amendment 1 would ensure that legislation on how the internal market is governed has this objective hardwired, or mainstreamed, into its overarching purpose.
A clear example of why this is so necessary is the Agriculture Bill. The Government refused to accept a UK-wide commitment to retaining food standards. I gather that Prue Leith has resigned from the Conservative Party in reaction to that rejection. More importantly for this Bill, just because the UK Government do not want to guarantee high food standards for consumers does not mean that the other countries of the UK do not.
As we roll out a new internal market for the UK, it is essential that an overarching objective of the legislation—the interest and well-being of consumers—be written into the Bill. Given the role of the CMA with regard to this Bill, it is similarly important that it has the duty to the consumer at the forefront of its work. As the noble Lord, Lord Tyrie, said, for the internal market to work for consumers, the CMA must be fit for this task:
“Until Brexit, much of the competition work lay with the Commission. If we are to ensure our companies play fair, do not profit at the expense of ripped off customers, are overseen ... by a competent authority, we need ... changes to the ... composition and duties of the CMA”,
which
“needs new duties to act quickly and with the consumer interest paramount and powers to make this possible”.
The amendments in this group are part of the effort to achieve these aims. Amendment 1 adds the duty to the purpose of the Bill, and Amendment 112, also in my name, adds it to the CMA’s objectives.
The group addresses two other issues: what is known in EU-speak as proportionality, and procurement. Amendment 2 in the names of my noble friend Lord Stevenson, the noble Lord, Lord Anderson, and the noble Baronesses, Lady Bowles and Lady McIntosh, would write the principle of proportionality into law to make sure that the Government, in exercising their powers under the Bill, do not go further than is necessary to effect mutual recognition and non-discrimination; and, vitally, that they respect the principle of subsidiarity whereby matters are agreed at the most local level possible. This would make sure the Government act only when their objectives cannot be achieved by the devolved authorities and would be better done at UK level.
The Government recognise and use this principle of proportionality. Indeed, just last week they tabled an amendment to the Medicines and Medical Devices Bill—which I believe is in Grand Committee even as we speak—stating that disclosure of information relating to medicines covered by international agreements may take place only where it
“is proportionate to what is sought to be achieved by it.”
That same principle needs to be hardwired into this Bill to make sure the powers are not used—for convenience or whatever—by the UK Government when they could be used better by the devolved authorities.
As the Minister will know, having been around the EU for some time, subsidiarity was not always in the EU mandate but, once introduced, influenced all decision-makers’ thinking, making them think twice before taking powers to themselves at too global a level. For those reading this in Hansard, the Minister at this point has a very disbelieving look on his face.
Finally, Amendment 59 in the name of my noble friend Lord Stevenson aims to retain public procurement as a devolved matter, thus exempt from market access principles. This is not to say that public procurement should not adhere to recognised principles, but to ensure that these are covered in the existing work on common frameworks in a public procurement framework. Since 1998, public procurement has been devolved, and our leaving the EU is no reason to alter this or for it suddenly to become a reserved matter, especially when a framework is already being developed. The Government have given no rationale for trying to make it reserved. In the White Paper, they said, without any reasoning:
“For goods, non-discrimination will apply within certain excluded areas such as procurement.”
They said they were considering—only considering—whether and to what extent non-discrimination should apply to public procurement. Perhaps the Minister could provide an update on their thinking. Perhaps he could also explain why Whitehall thinks it can deal with procurement any better than the devolved authorities, particularly given the recent example of UK-wide public procurement under Covid.
There are real concerns about simply handing public procurement to the Government, given that the WTO’s general procurement agreement, which would replace the UK’s 2015 regulations, would not include socially responsible public procurement provisions unless they were nailed down in advance. Amendment 59, therefore, aims to prevent the loss of these safeguards and keep public procurement devolved so that price-quality ratio, rather than simply price, is included in tender evaluation criteria and can be maintained by the devolved authorities along with the normal requirements of value for money et cetera. We want a UK-wide internal market to work for consumers and business, to safeguard standards, maintain the environment and ensure that competition does not fuel a race to the bottom. That would be good for neither workers nor consumers, nor indeed for businesses. These modest amendments would help to achieve that objective. I beg to move.
Baroness Bowles of Berkhamsted (LD) [V]
My Lords, I am pleased to support Amendment 2; I was about to do my own version when I discovered that the noble Lord, Lord Stevenson, had already tabled a similar one, and it is pleasing that it has cross-party signatories. There is a lot in this Bill about the internal market that is either premature or inadequately or inappropriately worded. It may be that amendments elsewhere referencing the common frameworks will help, but just as the common frameworks have a set of principles that are being followed in negotiations, a bit more about the flavour of the internal market is needed here, beyond mutual recognition and non-discrimination.
One of the principles for the common frameworks is to maintain, as a minimum, equivalent flexibility for tailoring policies to the specific needs of each territory, as is afforded by current EU rules. Therefore, it seems wholly appropriate to utilise the principles of subsidiarity and proportionality that have been a defining part of the EU internal market and which have helped form the current flexibility. It would also chime with the recommendations of the Constitution Committee in its report The Union and Devolution, which set out six principles of solidarity, diversity, consent, responsiveness, subsidiarity and clarity. We could use all those principles here too, and certainly they should guide how we approach amending this Bill throughout.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I support Amendments 1 and 2, to which I have lent my name; they are probing amendments to ask the Government a number of questions. The concept of the internal market in European Union terms is relatively recent: we have only had the single market since 1992. Of course, devolution followed some five years later, so both are still relatively new in terms of the British constitution.
British competition rules are loosely based on—and generally have always reflected—the original competition rules of the EU treaty on state aid in Articles 85, 86 and 92. The noble Baroness, Lady Hayter, has been right to highlight that, in what we have been used to in terms of both EU competition rules and British competition law as applied by the CMA, what is missing in the Bill is a reference to consumers. The flip side of competition policy to make sure that companies behave well is to ensure fair competition as well as protection of the consumer. I wonder whether leaving out any reference to consumers, both here and in later parts of the Bill, was deliberate. Why is there is no specific reference to consumers in the Bill, as Amendments 1 and 112 would provide?
Equally, Amendment 1 relates to safeguarding and the environment. That begs another question. We are told that our current regulations setting out food safety can always be changed by secondary legislation and that we do not need an Act of Parliament to do so. But that could lead to the situation—particularly if it remains devolved, and the Government have repeatedly stated that this is their intention—where we have to ask: to what extent will divergence be tolerated? For example, if the Food Standards Agency of England made substantial changes to our food safety requirements, would Food Standards Scotland simply diverge and not necessarily follow those changes? In future, could a product produced in Scotland, meeting Scottish environmental and animal welfare standards—I will be supporting the forthcoming amendments regarding those—still be allowed to be imported into England if it no longer met those same standards? This seems to be an obvious potential crisis for Scottish, Northern Irish and Welsh farmers some way down the road. The Government might want to rethink their idea of not having UK-wide standards. I would be most grateful if, when summing up, my noble friend could turn his attention to that potential conflict and the potential for divergence.
Turning to proportionality and subsidiarity, I absolutely agree with Amendment 2, to which I have lent my name, and later amendments. The Bill must clearly set out only what is necessary to achieve its stated objectives. My noble friend will probably answer that this is self-evident, but it bears repetition. Personally, I see some merit in having it on the face of the Bill. The principle of subsidiarity might seem clear now, but I ask my noble friend to consider the horrific situation, some five or 10 years down the road, when we may face a federal Britain. What impact would that have on subsidiarity?
On procurement, does my noble friend share my concern that despite all the potential benefits around procurement provisions that I envisage us enjoying by leaving the European Union—for example, we would no longer be bound by the threshold of €136,000, beyond which any public contract must be put out for tender, meaning that we could source many more of our English, Scottish, Welsh and Northern Irish foods into public institutions such as schools, hospitals, prisons and others—we have completely lost that advantage because through the Trade Bill we are joining the Agreement on Government Procurement, which, surprisingly, has exactly the same threshold of $135,000? We seem to be jumping out of the frying pan and into the fire, without getting all the opportunities that were promised to our farmers by leaving the European Union, such as sourcing more local food to schools, hospitals and other public institutions. That will in fact not come about, because we will be bound by international rules on public procurement. Have the Government done a cost-benefit analysis on how much competition we will face from other providers to source their foods into our public institutions, as opposed to the potential benefits our farmers might have from tendering in other international jurisdictions to source our home-produced food there?
I look forward to hearing my noble friend’s reply to this little debate.
Lord Hope of Craighead (CB) [V]
My Lords, I want to add a few words in support of Amendment 2. Proportionality and subsidiarity are part of the language of EU law which, while relatively new in historical terms, we are now very familiar with. It would be a mistake to think that as we reach the end of the transition period, we should leave these concepts behind. Proportionality, after all, is deeply embedded in our own public law, and has been for decades. It has long since been recognised that black-letter law alone is not a good guide to the way in which public law and public affairs should be administered. One simple example can be found in the civil litigation rules, where the word appears to make it clear that the courts should seek to obtain a just result with appropriate speed and expense in giving effect to the rules that are set out in the document. The point is that individual facts and circumstances vary greatly across the spectrum. Proportionality allows them to be taken into account and avoids blunt decisions where a greater need is to fit the facts together with the rule to find a suitable result that will achieve the desired object.
Subsidiarity too is now deeply ingrained in our constitutional arrangements. It is part of the thinking behind devolution, and the word is used with reference not only to Wales, Northern Ireland and Scotland but to devolution throughout England. The great advantage of this is that local decisions are best taken with regard for local circumstances. For them to be taken centrally sometimes misses the point and leads to solutions that are inappropriate given the local circumstances. It is a useful tool best used in the administration of our affairs to make sure that things are properly organised across the whole of our United Kingdom, which, after all, is what our new internal market is all about.
Both these principles are sound and appropriate guides as to how the two basic principles which are set out in Clause 1 should be administered. I support the argument that, somehow, these principles should find a place in the Bill. Quite how that is done I leave to the draftsmen, but Amendment 2 is at least an important start to make sure that the significance and relevance of these principles are appropriately recognised.
Baroness Noakes (Con)
My Lords, I offer a few comments on these amendments. It seems to me that Amendment 1 has the effect of confining the concept of the internal market to consumers and the environment. That completely misses the point. If we go back to the Government’s White Paper in July, we see they were clear that the policy objectives were economic opportunities across the UK, increasing competitiveness and making the UK the best place to do business, thereby supporting the general welfare, prosperity and economic security of all UK citizens. The amendment in the name of the noble Baroness puts the cart before the horse, trying to make that an overarching requirement when it should be a consequence of achieving all the other things.
I emphasise that this is about frictionless business—about making it easy to do business across the UK. In all our debates, we should not lose sight of the importance of this to the devolved nations. About 60% of the exports of Scotland and Wales go to the rest of the United Kingdom; for Northern Ireland, it is a fraction below 50%. They are important to those economies. We are trying to create an environment in which trade can prosper and grow within the UK, without barriers, which will in turn allow the other objectives to be achieved—for example, the protection of consumers and supporting the general welfare of the country.
Lord Morris of Aberavon (Lab) [V]
My Lords, I support Amendment 1. There is very little that needs to be said in addition to what my noble friend Lady Hayter so clearly set out. In her speech she prayed in aid the Government’s attitude to the Agriculture Bill—which I also took part in—hence the necessity of the amendment. In my innocence, I am assuming that the Government will accept it, but perhaps I am too innocent.
I also support Amendment 2. The purpose of my speech is to serve as a pre-emptive strike to preserve the position of devolved legislatures, as I did in my Second Reading speech. I will make the same point regarding other amendments. Agriculture is a devolved matter. The single market is important throughout the United Kingdom. However, I am wary when power given to devolved Administrations and legislatures is taken away from them. The onus is on Her Majesty’s Government to prove necessity—hence the importance of the words in paragraph (d) in the amendment, which I particularly support.
Lord Purvis of Tweed (LD)
My Lords, I agree with the first point made by the noble Baroness, Lady Noakes, who said that this group of amendments and this debate are about whether it is necessary and desirable to agree with the Government on the definition of mutual recognition and non-discrimination. The question is therefore whether the Government have made their case sufficiently that the Bill’s definitions meet the criteria that the White Paper sets out for the functioning of the single market, which is something that we all value.
I think that the Government have made a less than convincing case on the necessity of these definitions. However, even if it were necessary to make a strategic case for defining these market access principles, such a case was not set out in the consultation, the White Paper, the Commons stages or the Minister’s speech on Second Reading. Have the Government explained why they have deviated from our current approach or from the approach we had before we joined the European Union? We had a functioning single market before we joined the EU and while we were members, as we do now, and it has served our country well. Even before devolution, our internal market before we joined the EU allowed for different laws and approaches and historic divergences in many areas, including in economic development, trading standards and other areas linked to the economy. The question is why the Government have decided to move away from the earlier British approach or the British approach as it was adapted and adopted through the European Union.
Before I turn to the matter of definitions, I want to speak to Amendment 59 on procurement. Noble Lords who took part in the early Committee sittings on the Trade Bill will recall that we debated the procurement aspects. I specifically asked why procurement was mentioned in the White Paper but not in this legislation. The noble Baroness, Lady Hayter, has also asked that question, and I hope the Minister will give us a clear answer. As the noble Baroness, Lady Noakes, indicated, if procurement continues to be a devolved matter—as it has been, in many respects, under the framework of the European standards and the GPA international agreement—and the Scottish Government, for example, wish to have a procurement policy within an overall framework which sets standards for infrastructure or public buildings used for health or education, every supplier will have to meet those standards. That would not necessarily be discriminating against Scottish, English or Welsh construction firms; it would be a standard that they would be expected to meet. I fear that the Government want to have a uniform standard for the delivery of procurement policy across the United Kingdom. That would be worrying because it would be a significant move away from the flexibility we have had within the approach taken by the European Union.
There has been an assessment of the current approach taken within the EU single market—which we have left—which was updated in April 2020 in Regulation 2019/515. The current approach has a well-defined assessment procedure to be followed by competent authorities when assessing goods, which the Government’s approach lacks. The current approach has obligatory elements to be included in an administrative decision that restricts or denies market access. However, that is left open to UK Ministers to decide in a vacuum, and thus is lacking in the Government’s approach. Our current approach offers a voluntary mutual recognition declaration which businesses can use to demonstrate that their products are lawfully marketed in one EU country in a business-friendly, problem-solving procedure through the European single digital gateway for businesses and service providers on how this operates. These important aspects are missing in the new approach. I think it is therefore justifiable to ask on behalf of businesses across the UK which need to prepare for this, why the Government are not ready.
As will become clear in the debates on following groups, the Government are not ready for the implementation of this because the framework relationships are not yet in place. But even if they were, the Government have also failed to state why the nature and scope of the application of these market access principles are different from what we have understood and worked with for many years. For example, as Professor Nicola McEwen of Edinburgh University pointed out, the definition of indirect discrimination is not the same and is now more complicated than EU law. Not only that, Professor McEwen highlighted the circumstances in which mutual recognition rather than the non-discrimination rule will apply, or vice versa, which is different from the position under EU law. It is unclear how certain types of trading rules would be classified. She gives an interesting example of restrictions on the use rather than the sale or marketing of a product, such as the current ban on the use of electric shock training collars in Wales. There is no consistency in the Government’s approach on that. In further groups of amendments we will also need to explore why the range of exclusions and exceptions from the mutual recognition and non-discrimination principles is significantly narrower than under EU law.
The Government should tell us why the UK’s new approach is far more restrictive and more bureaucratic than the position we are moving away from. With a more restrictive approach, and without the previous flexibility that had been obvious in some areas, businesses, service providers and public authorities will have a much more burdensome single market to operate. The Government have presented no justification whatever for that. My noble and learned friend Lord Wallace of Tankerness raised this issue at Second Reading. In a reply, the Minister said why the Government are taking a different approach:
“The market access principles have been designed to take account of the UK’s unique circumstances, reflecting that our market consists of four highly integrated, highly aligned parts. Conversely, EU provisions deal with 27 countries, all with diverse histories, cultures, and competing marketing priorities”.
I note that the Government do not think that our nations have a diverse history and culture, but they most definitely do. If they did not, we would not have had devolution in the first place. However, it does not follow that our current approach, even with devolution, has been more streamlined, and the Government seek to have a more complicated approach going forward.
My noble and learned friend asked about subsidiarity and proportionality, and the Minister replied as follows, which is interesting, given the very well-argued speech of the noble and learned Lord, Lord Hope of Craighead. He said:
“Turning to your comment on subsidiarity and proportionality, we have now left the EU and are free to organise our internal market in a way that is better suited to the UK’s unique constitutional arrangements and common law system.”
The noble and learned Lord, Lord Hope, stated categorically that these approaches of subsidiarity and proportionality are deeply embedded in our constitutional arrangements, so why have the Government chosen to move away from them? I fail to understand why they are even changing their position from that of the frameworks agreement that had been in place. Regarding the principles agreed among all the nations, the second paragraph of the agreement on common frameworks states:
“Frameworks will respect the devolution settlements and the democratic accountability of the devolved legislatures, and will therefore”—
this is the second bullet point—
“maintain, as a minimum, equivalent flexibility for tailoring policies to the specific needs of each territory, as is afforded by current EU rules”.
So the Government agreed with the devolved nations that the current flexibilities and approach afforded by current EU rules would continue to apply, but this Bill argues that they will not. Given that this has implications for Scotland’s decision on minimum unit pricing or for a live case of the deposit return scheme that has been put in place, there are considerable concerns about why the Government have opted not to include environmental objectives in these restrictions.
I will close with another point on the environmental side. Can the Minister clarify the position on the relevant requirements for environmental aspects, which were formulated before this Bill but have yet to come into force? The Scottish deposit return scheme, which has been legislated for but is due to come into force in 2022, would, on my reading, come within the scope of this legislation. It has been made but is not yet in force. That legislation was fully compliant with the European approach because of the environmental objectives. Is it the Government’s intention that the Scottish deposit return scheme regulations will now be within the scope of this Bill? If not, this is just one example of why there are real difficulties with the Government not following the common-sense approach. The UK operated a single market before joining the EU and during its membership of the EU, and indeed our approach allowed for devolution to be accommodated within it. Why are the Government putting that at risk with their approach to these market principles, which are more restrictive, less certain, more bureaucratic and less clear? Why are they not seeking continuity?
Lord Cormack (Con)
My Lords, in that extraordinary vote on Tuesday last, your Lordships’ House indicated what it felt about the most objectionable part of the Bill, and I hope that we will have a chance to develop those arguments further next week. However, the noble Baroness, Lady Hayter, was right in her opening words to remind us that, although they are the overwhelming matters of concern in the Bill, they are not the only ones. Indeed, I find myself echoing what a number of your Lordships said in last week’s debate: what is the point of this Bill in its present form?
I draw your Lordships’ attention to the very trenchant comments in the devastating report of our Constitution Committee published last week. It indicated the committee’s unanimous real concern on the whole issue of devolution. Way back in the 1970s, I was not an advocate of devolution, and I sometimes think that my fears have come to pass. However, the fact is that we have devolution, and we cannot ignore what we have or we will truly endanger the future of the union, and that we must not do. Therefore, I very much hope that when my noble friend comes to wind up this debate, he will make it quite plain that he has taken on board our Constitution Committee’s comments on devolution.
Baroness Jones of Moulsecoomb (GP) [V]
My Lords, when the Conservative Party came up with its absolutely brilliant slogan about taking back control, many of us, for whom it resonated, felt that it meant that our Parliament would be taking back control. However, over the past year it has become obvious that that is not how the Government see it. In fact, they are using Brexit as an excuse to take more control of the country, which of course is extremely undemocratic. In this Bill, they are trying to seize control from the devolved Governments and Parliaments, and that, as the noble Lord, Lord Cormack, has just said, is extremely unhealthy for the UK. The Bill pretends to replicate what exists in EU law, but it has created a sort of Frankenstein’s monster, which is not at all what any of us were expecting. It is like a legal framework creating a bureaucratic bulldozer that the Government will use to grab more power.
It is obvious that this Government cannot win any seats in Scotland, Northern Ireland or Wales, so they are using this Bill—this bureaucratic bulldozer—to force the elected Governments of the devolved nations to fall in line with Conservative Party policy. These amendments are important because they would stop that undemocratic move. Without them, devolution will be replaced with a sort of lowest-common-denominator system in which the devolved Governments will have to wait for the UK Parliament to take action on any policy or law that relates to the production, distribution and sale of goods and services in the UK before they can take action. That is clearly not what any of us expected. The devolved Parliaments must continue to have the right to make decisions on improving environmental standards and implementing other legitimate policies that will benefit their nations. Your Lordships’ House must amend this Bill and prevent yet another government power grab, and of course protect the rights of the devolved nations.
Lord Inglewood (Non-Afl) [V]
My Lords, now that we are leaving the scope of the single market, the characteristics of the UK internal market become very important; that is why I put my name down to speak to this group and, in particular, to Amendments 2 and 59.
Superficially, it is easy to assume that the UK internal market should, and will, share the principal attributes of the EU single market but, of course, that is far from certain, not least because of the circumstances surrounding it all. After all, the creation of the EU single market was first agreed by member states in an IGC, which is very different from what we are looking at now in this country. The new arrangements have come into being in somewhat different circumstances and across a single territory in which there has been devolution—and within that, the different components clearly have different perspectives.
There is now much less consensus and no prior agreement. In these circumstances, within a devolved as opposed to a federal system, there are potential procedural problems where the UK Government and the English Government—if I might be allowed to call them that—are coterminous. It is not desirable for the repatriation of European competencies to drive a coach and six through the devolution settlement in these islands. For this reason, I believe strongly that Amendment 2 is important to provide a legal framework around the political procedures repatriating these powers. In my view, it is particularly important—I speak as both a unionist and a supporter of the devolution settlements—that England does not emerge as a bully boy imposing its will on the other countries. To do that would be to take the high road to the break-up of the UK.
I also want to touch on Amendment 59, in the context of my chairmanship of the Cumbria local enterprise partnership. As a border region and part of borderlands, any form of potential discrimination—be it direct or indirect, intended or unintended—poses a very real threat to our economy, much of which is focused on both sides of the Solway Firth. Competition law, environmental law and a number of other more general categories of social law are essential components of market economies in our kinds of societies in the 21st century. As a number of speakers have said, there is a real conundrum at the heart of this between local autonomy, which matters, and British cohesion and homogeneity, which also matter. I very much hope that the Minister will spell out exactly how the Government see these things interacting, because, as always, the devil lies in the detail.
Lord Empey (UUP) [V]
My Lords, my concern in this group of amendments and, indeed, with the Bill as a whole is that a fundamental collision is taking place between what is happening in London and what is happening in the regions. I was never struck by the Sewell convention. I believe that we have not properly explained the source of funds to the devolved nations, and I do not believe that any country like ours should leave itself unable to function in certain parts of its own territory. Nevertheless, I believe that we are now paying the price for the haphazard, ill-thought-through lurch to different types of devolution that have been going on over the last 20 years in a virtually unco-ordinated way.
This collision is demonstrated by the fact that we had discussions taking place on the various common frameworks, which have been sort of set to one side and replaced with some of the provisions in the Bill. Probing amendments such as Amendment 2 are important. The Minister and his colleagues have to reassess where they are with all this because there is a pattern emerging—we have devolution and people are now more focused on their local identity. We see this happening in parts of England with the Covid crisis; it is really concerning. Some Members have already expressed their concern about the future of the union as a whole; I very much share that and have done so for some time.
Looking at the best way ahead, while the term “subsidiarity” is European, the general principle that you take decisions at the closest point to the people who are affected by them is a solid and sound way of doing business. There are examples of where the United Kingdom was until relatively recently still a very centralised country compared to some of our European colleagues and other countries around the world.
One other element not mentioned so far is that my own region of Northern Ireland will be subject to different laws on a whole variety of subjects, and it is not entirely clear to me where this will leave us. For nearly all of our economic activity, we will remain to all intents and purposes within the European Union, subject to European and state aid regulations, and there will be a whole, as yet unresolved, customs conundrum as far as our trade is concerned. How all these different measures are to be brought together in a coherent way is entirely unclear to me at this stage. I feel that this probing amendment and others in this group are important because they force the Government to explain to us how this will work in practice.
I accept the concept of common frameworks, in which you get general agreement from the devolved regions. Whether you agree with it or not, this Parliament has given them the power—the fact is that they have it and they are entitled to exercise the functions that have been devolved to them. We should not find ourselves in a situation where ultimately we sow the seeds of further clashes. That would undermine the union and our economy, and I certainly do not want to see that. The Government need to revisit these amendments and this section of the Bill. Unless it is clear and people know where they stand, we will have the sources of further friction built into our legislation—and we have more than enough of those at the moment.
I ask the Minister to address my point specifically: if Northern Ireland is effectively in the EU from an economic point of view, where is the line drawn between functioning under EU laws and regulations and, in the future, such things as market access being involved? I can see circumstances where there could be a significant clash. Procurement is one of the most obvious areas. A lot of small suppliers throughout the United Kingdom have felt that they have been discriminated against because Governments and various authorities have always tended to go to the bigger players. As was pointed out at the beginning of this debate, we could end up with almost the same threshold as we currently have as part of the EU. Will the Minister and his colleagues take seriously the concerns that Members of this House have been expressing about the fundamental clash—the collision—between our devolved settlements and our internal market? To me, that will be the key to making sure that this legislation does good and does not end up doing harm.
Lord Naseby (Con)
My Lords, it is worth reminding ourselves that we are talking about the Committee stage of an internal market Bill. I frankly do not see the relevance of the part of Amendment 1 which talks about the environment. We do of course have environmental laws. They are ever being strengthened and are an important part of our society. What they are not is anything specifically to do with an internal market.
We turn to look at consumers. I am a marketing man by profession. After university, having read economics, I joined the Reckitt and Colman Group as a marketing executive and later a marketing manager, in the UK, India and what is now Sri Lanka. I understand marketing. Marketing is about more than just the consumer. It is about those elements of a market that are all working within it. A whole host of bodies is working there. I share the view of my noble friend Lady Noakes. While the UK was in the EU, which I voted to stay in, we had all sorts of restrictions, some of which were very adverse to industry and commerce in this country—not all by a long way, but some were. We want an internal market where people who manufacture, sell, distribute, research and devise new products can succeed. We want that market there, without the stranglehold of having to agree with half a dozen other nations. That is absolutely key. It is not a simple matter of just worrying about the consumer. I think it was the noble Baroness who opened who spoke about driving competition to the lowest level.
Competition is very healthy but, of course, there must be safeguards. That is why in the Bill there is this new body, the office for the internal market, working alongside the CMA. I criticised the CMA at Second Reading and I believe those criticisms were valid. I want to see this office for the internal market really have teeth and really be able to operate. Reflecting on Second Reading, frankly, it is not right in the Bill to just have a review after five years. We have enough evidence in modern society to recognise that things move much more quickly these days than they ever used to. I put it to the Minister that Her Majesty’s Government should consider a three-year review of that body.
On Amendment 2, it is already part of our public law, so why does it have to be written here—if that is right? It comes later, under Part 5, but we cannot have a situation whereby all parts of the UK can have their own minor arguments on whatever product or service it may be. Then we would end up with everybody having a different viewpoint. That does not seem to me at all sensible. My plea to the Minister is that this is a very exciting time if you are a UK manufacturer, trader, in financial services, in hospitality, in the professions, a retailers or wholesaler, or an online trader. Certainly, in my former constituency of Northampton, they look forward to this internal market.
Lord Fox (LD)
My Lords, if the Ministers shepherding this Bill expected an easy ride, this gives a taste of things to come. It serves a purpose in setting the scene, and a lot of arguments and debates will come in other groups as we go through this process. I shall not labour those points. An overriding sense I got from my noble friend Lord Purvis is that the question everybody wants to know the answer to is: why have Her Majesty’s Government decided to turn away from a process of managing markets that has been extremely successful? It was successful before we joined the European Union and successful afterwards. This is the overriding question that hangs over this whole debate.
On Amendments 1 and 112, if ever we needed convincing that things such as the environment need to be written into the Bill, the speech by the noble Lord, Lord Naseby, convinced me that they do. This is because we cannot take things for granted. Governments come and Governments go, but the law stays, and we need to be sure that our public policy is being directed properly. I uncharacteristically find myself somewhat agreeing with the noble Baroness, Lady Noakes: we have to be careful not to constrain the nature of this Bill. We need to find a way to write in issues such as those of the consumer and the environment. I would add some of the points made by my noble friend Lady Bowles and food safety to that. We need to ensure that there is an assessment of the success of this internal market in some of those areas, including the environment, the effect on consumers, the effect on jobs, et cetera. I share the view of my noble friend Lady Bowles that perhaps more work is needed, but the issue is live and very important. I thank the proposers of the amendment.
Turning to Amendment 2, I do not think proportionality pops up anywhere in other amendments. We had a brief discussion of this extremely important subject from various speakers. I take my lead on this from the noble and learned Lord, Lord Hope, who understands the law, and my noble friend Lady Bowles, who knows a thing or two about regulation. If they are concerned about proportionality, so are we on these Benches. The Government need to find a way of writing that issue into the Bill.
On public procurement, we need to understand what the Government mean by what they seek to do in this legislation. The issue highlighted by my noble friend Lord Purvis is live and real: how will this legislation affect those issues? It is a probing amendment, but for it to work we need answers.
We have started. There are issues we shall return to, but proportionality and public procurement are two on which I hope the Minister will respond at length.
The Parliamentary Under-Secretary of State, Department for Business, Energy and Industrial Strategy (Lord Callanan) (Con)
My Lords, let me open by thanking noble Lords for their contributions at Second Reading last week. Again, the contributions have demonstrated the tremendous breadth of expertise in this House. This is indeed a crucial piece of legislation. In this respect, I agree with the noble Lord, Lord Fox, and I look forward to providing the scrutiny it deserves and that I am sure it will receive from noble Lords, beginning today and in the days and weeks ahead.
Let me reassure, and to some extent disagree with, my noble friend Lord Cormack, which will not come as a surprise to him. We are not riding roughshod over the devolution settlements. The devolved Administrations will acquire dozens of new powers that they have not exercised before once we leave the EU transition period. The Bill is about ensuring that those powers are exercised in a non-discriminatory manner, but they will acquire new powers and new responsibilities. Before I address the specifics of Amendments 1, 2, 59 and 112, which we are discussing in this first group, I want to remind to noble Lords of why we need this Bill and the context of Part 1.
By opening with the purpose of the Bill, I hope to explain why these four amendments, which seek to alter the Bill’s core principles, are not necessary. The Bill aims to allow the continuing smooth functioning of our UK internal market at the end of the transition period. As we set out in the White Paper, and as I explained at Second Reading, the Bill will establish a market access commitment by enshrining mutual recognition and non-discrimination in law. Part 1 concerns itself with delivering this market access commitment for goods. The principle of mutual recognition is that goods and services from one part of the UK will continue to be recognised across the country. This will ensure the devolved Administrations will benefit from their additional powers and freedoms outside the EU. As the transition period ends, they will gain increased powers, as I said to my noble friend Lord Cormack, to set their own rules and standards across a wide range of policy areas within their competence. At the same time, it provides firm assurance to our businesses that their goods can continue to flow freely throughout the United Kingdom. Non-discrimination ensures that there is continued equal opportunity for companies to trade in the UK, regardless of where in the UK the business is based.
I say to the noble Lord, Lord Empey, that the measures in the Bill will also ensure that Northern Ireland qualifying goods benefit from the market access commitment and receive mutual recognition in the rest of the UK. The Bill will also affirm the principle that those goods are not subject to checks, controls or administrative processes as they move from Northern Ireland to Great Britain. I hope that I can reassure the noble Lord on that point. This means we will fulfil our commitment to legislate for unfettered access, as we promised to the people and businesses of Northern Ireland. This will ensure that businesses and citizens in the United Kingdom can continue to trade freely across the four nations.
With this context in mind, I turn to Amendments 1 and 112 together. These seek respectively to limit the purpose of Part 1 and the Office for the Internal Market’s statutory objective to the protection of the environment and consumer interests. Now, it goes without saying that the protection of the environment and consumers is hugely important, and something that we as a Government are already committed to. The UK, as I never tire of repeating, has some of the highest standards in the world, and we will continue to improve these ahead of others. We remain committed to being at the forefront of environmental protection and a leader in setting ambitious targets to prevent damage to our natural world, building on our already strong environmental record. For example, we have set out a range of new policies in the Environment Bill that are designed to drive up environmental standards in line with the UK’s priorities.
The statutory objective of the Competition and Markets Authority—acting as the Office for the Internal Market—ensures that the office is able to effectively operate as the monitoring body for the internal market, and that there is no confusion between the pre-existing powers of the CMA and those newly conferred on it as the OIM. Distinct objectives will prevent any operationally problematic blurring of functions.
As my noble friend Lady Noakes observed, the office will operate for the benefit of all those with an interest in a smooth-functioning internal market, whether that be regulators, businesses, professionals, the four legislatures or indeed consumers. Explicitly narrowing its focus to consumers would be to the detriment of all the others that I have listed.
Moreover, the functions set out in Part 4 of the Bill clearly establish that the office will consider the economic impacts of regulatory measures on the internal market. Although some of these will of course be environmental protection measures, it will not be authorised to opine on the extent to which these measures safeguard the environment, because this would risk duplicating the role of existing public bodies with a purely environmental focus. As such, given how much the Government are already doing in the area of consumer and environmental protection, I consider that these amendments, which seek to change the purpose of the Bill, are unnecessary, and I hope that I have been able to persuade my noble friend Lady McIntosh and the noble Baroness, Lady Hayter, to withdraw Amendment 1 and not move Amendment 112.
Amendment 2 aims to introduce the principles of proportionality and subsidiarity into the Bill as additional market access principles. These are European law principles. We have now left the EU and are free to organise our internal market in a way that is better suited to the UK’s unique constitutional arrangements and common-law systems. I agree with my noble friend Lady Noakes that the market access principles will protect seamless trade and jobs across all four corners of the United Kingdom following the end of the transition period in December 2020. They have been designed for the UK’s specific devolution arrangements and legal approach, and they already take account of the need for reasonableness and respect for devolution. In contrast, the proposed amendment would muddy the waters with EU concepts that in our view are ill-fitting in the UK. For these reasons, the Government cannot accept this amendment and I hope that noble Lords will not move it.
Amendment 59, on which there was considerable discussion, seeks to disapply the market access principles from the public procurement rules. I assure the noble Baroness, Lady Hayter, and the noble Lords, Lord Purvis and Lord Fox, that the principles proposed in the Bill will not typically operate in the area of public procurement, and indeed that we intend to legislate separately in this area via a wider package of procurement reform, on which we will shortly consult. The market access principles are not relevant to procurement as they are about how business is regulated. The procurement rules cover how public authorities carry out their procurement function. We believe that the risk of divergence can be effectively managed through a combination of close devolved Administration engagement and use of the common frameworks, and we are working to develop a concordat on expected public procurement practices and policies between the four UK nations.
The Deputy Chairman of Committees (Lord Alderdice) (LD)
My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Purvis of Tweed.
Lord Purvis of Tweed (LD)
My Lords, while I am grateful that the Minister has confirmed to me that a piece of legislation that has been made fully compliant with our single market—the deposit return scheme—will now come into scope under this legislation, because it is not yet in force in Scotland, that will be of very significant concern to Members of the Scottish Parliament, who legislated in good faith in a perfectly legal way. This Government have now said that that will come into scope, contrary to the market access principles, because it will not be able to be afforded protection if it is challenged in court because of the lack of environmental objections. I take the Minister’s point that he believes that it will be brought under the scope of market access principles, so I would be grateful if he could write to me to explain how indeed that will happen. If it is under a framework, we are back to exactly where we started, which is that the best approach on all these aspects is a framework.
That leads me to the question that I wish to ask him, because he did reply to the question that I asked about the status of the agreement made between the UK Government and the devolved Administrations on the framework agreement. In the document of September 2020 on the framework analysis, the Government repeated what that agreement was. I will quote from it again for the Minister: it was to
“maintain, as a minimum, equivalent flexibility for tailoring policies to the specific needs of each territory, as is afforded by current EU rules”.
The document goes on to say:
“These principles continue to guide all discussions between the UK Government and the devolved administrations on common frameworks.”
What is the basis of that document and that commitment, given what the Minister has just said in responding on this group: namely, that that is an ill-fitted set of agreements because we are now out of the EU? What is the status of the agreement that was made over the frameworks?
Lord Callanan (Con)
Well, as I have said before to the noble Lord, we remain completely committed to the framework process and we remain committed to frameworks that have already been agreed—but we see this legislation as complementary to that, as it underpins the entire framework process. As I said to him with regard to the deposit return scheme, if it comes into force when it is predicted to do so, then indeed it will be covered by the market access principles, but we are confident that the deposit return scheme can be brought into effect in full compliance with the market access principles.
Baroness Hayter of Kentish Town (Lab)
I am slightly lost on that, but we will come back to it. I thank the Minister for his response and I am grateful for the very interesting debate that has happened. I will say a few words about what was said by the noble Baronesses, Lady Noakes and Lady Bowles, about the point of competition and why it should be here. I agree with the noble Lord, Lord Naseby, that competition is extremely good for consumers. We want to see a successful economy, and I see no difference whatever in what he was spelling out and what we want to achieve.
The problem, of course, is where, for whatever reason, there is not a perfect market. Although here we are talking about goods rather than financial services, I was involved in the Financial Services Consumer Panel, and even though we had and still have—although Covid is throwing everything out—a thriving financial services market that has been good for the economy, for consumers and for the taxpayer, it has sometimes been, as we know from all the compensation that had to be paid, at the expense of consumers. So we cannot assume, simply because we have a good, thriving economy and lots of competition, that there are not sometimes disadvantages for consumers. That is why it is important, while we want a competitive, thriving market, to make sure that those protections are there. So as we look forward to the internal market being all the things that have been described, it cannot be at the price of consumers.
As I have said, I really support competition—we all used to wear NHS glasses until someone freed up the market, so we are all able to get nice red ones now. I doubt there is anything much between us on that. It is important, though, as we look forward to a market that is going to work for the whole UK, that it is not at the expense of consumers or the environment. I have been buying plants recently, hoping that one day we will have some good weather, but they should not be in peat pots. That is not good for the environment. Something may be good for consumers and at a good price, but you also need to consider the environmental aspect.
Consumers are not just interested in price; they are interested in safety and the longevity of products. However, that is not always something they can see at the point of purchase. Price is very easy for consumers: they can look at it and compare. Other things behind the price are also important. It is important as we look to a new market mechanism that we take that into account. I am sorry to have gone on a bit about this issue but as we will come back to it on Report, it is probably helpful for the Minister to understand. We may not have got the wording quite right: I am not trying to trump the Government but to point out why those elements need to be included.
On the devolution issue, the noble Lord, Lord Empey, is right that there is a clash between the settlements and what we are now trying to do with the internal market; I think he called it a collision between London and the regions. I hear very much what the noble Lord, Lord Cormack, said: that if we get this wrong, we are threatening something much bigger than any of us thought. No Brexiteer wanted to challenge the union; that was not what divided some of us who had divisions on that issue.
We need to look at how we deal with devolution. I was really taken by the example that the noble Lord, Lord Inglewood, gave of the IGC process that led to the single market and other things. I will come on to that way of working when we consider a different group of amendments. The confidence to do things in a shared and consensual way is important. The noble and learned Lord, Lord Hope, said that it would probably be important to put in the Bill retention of the subsidiarity and proportionality principles. They have guided us well and there is no reason why we should lose them, just because we are leaving. I think we will return to that issue.
On procurement, I think the arguments were fairly common between us. I am afraid I was slightly thrown by what the Minister said and will have to read later exactly what he said about separate legislation. Maybe we can exchange correspondence on that issue, and on the timing. Clearly, we will need to come back to procurement to ensure that we have something that will work for all four nations. For the moment—and I am sorry about the length of my response—I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Alderdice) (LD)
We now come to the group beginning with Amendment 3. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. Anyone wishing to press this amendment or anything else in this group to a Division should make that clear in the debate.
Amendment 3
“( ) This Part only has effect during any time when the United Kingdom is fully in compliance with—(a) the terms regarding the United Kingdom internal market set out in the Northern Ireland Protocol, and(b) the terms of the Good Friday Agreement which are relevant to the United Kingdom internal market.”
Lord Hain (Lab)
My Lords, in moving Amendment 3 I wish also to speak to Amendments 157 and 177, standing in my name and those of the noble Baronesses, Lady Ritchie, Lady Altmann and Lady Suttie, for whose support I am most grateful. I spoke on this Bill at Second Reading and set out my fundamental objections to it then. In particular, along with a clear majority in this House, I totally rejected Part 5, which deliberately and cynically drives a coach and horses through the UK’s respect for the rule of law. Not only that, it drives that same coach and horses through the protections we need for the Good Friday/Belfast agreement that successfully brought an end to most of the Troubles, which had blighted life in Northern Ireland since the 1960s.
In that Second Reading debate and in the Committee stage debate on the Trade Bill, I put on the record of this House the horror and disbelief felt well beyond the shores of this United Kingdom. The most striking reaction was that in the United States, where the current President’s Northern Ireland envoy—his former chief of staff—agreed fundamentally with their rivals in the Democratic party that they cannot do any trade deal with the UK if the UK acts against the Good Friday agreement. That is exactly what is happening here in this Bill. It is a legal document that works against the peace agreement for Northern Ireland. In proposing this, the Government have pulled off a spectacular feat in uniting Republicans and Democrats at a time when they have never been more divided. This, of course, is not a feat but a spectacular own goal, even by the standards of this Prime Minister and this Government.
Since I last spoke, the front-runner in the US presidential election has made his position even clearer, in case people were not listening the first time. I want to add to the record of the House the relevant lines from his policy paper, Joe Biden, Irish-America and Ireland, published on 18 October: Joe Biden
“will support active US engagement to advance the Northern Ireland peace process”
and will ensure that there will be
“no US-UK trade deal if the implementation of Brexit imperils the Good Friday agreement.”
There is nothing subtle here. The front-runner to be President of the United States does not like what he sees as this Government seek to implement Brexit. He is sending a strong warning to us, and we in this House have it in our power, through this Bill, to force the Government to change course.
I am sad to note that the Government’s weak and pathetic defences include the wholly spurious argument that this Bill actually protects the Belfast/Good Friday agreement. Words such as “consent” are thrown about in a misleading way—to put it charitably—in order to create an impression that the purpose of these clauses is to protect all those who brought about the peace agreement. Let us look at all those who did that.
First and foremost, there are the people of Northern Ireland. They voted overwhelmingly for the agreement in 1998 and voted firmly against Brexit in 2016. They went on to vote overwhelmingly for parties opposed to Brexit in last December’s parliamentary election. Secondly, there are the political parties themselves. The majority of parties, representing the majority of the people of Northern Ireland, are opposed to this Bill. Thirdly, the Irish Government, the UK Government’s co-guarantor of our peace process, are opposed to this Bill. Fourthly, the United States, which provided the broker for the agreement in Senator Mitchell and has supported it ever since, is unanimous in its opposition, whatever the result of the forthcoming presidential election. Fifthly, the European Union, which backed up the agreement through PEACE funding and through the openness of the single market, is clear that the Bill is in breach of the Protocol on Ireland/Northern Ireland.
Not one of these groups supports what the Government are attempting through this Bill, so whose consent exactly do the Government think they have? I have been racking my brains to think of anyone, but all I have come up with are the Brexit extremists in the Conservative party and the most Brexit-obsessed end of one political party in Northern Ireland, the DUP—that is it. It has now emerged that both Brexiteer and Unionist-sympathising MPs were, late last year, promised an opportunity to address their concerns about the protocol in order to persuade them to pass the European Union (Withdrawal) Bill into law. It therefore seems most probable that No. 10 always had a step like this in mind, even at the very time of signing the withdrawal agreement. So much for the British Government negotiating in good faith.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, it is a pleasure to follow my noble and honourable friend Lord Hain, who is instructive in this regard as a former Secretary of State for Northern Ireland, and who has quite clearly shown the need for these amendments as safeguards to protect the Good Friday agreement and the withdrawal agreement, with direct reference to the Northern Ireland/Ireland protocol.
As somebody who grew up in Northern Ireland and comes from a democratic nationalist tradition but seeks reconciliation with my unionist neighbours, I am in absolutely no doubt that the Bill as currently drafted in terms of trade could cause innumerable problems for north-south co-operation, east-west co-operation between Ireland and Britain, and internal co-operation in terms of the need to build relations between unionists and nationalists—the very thing that the Belfast/Good Friday agreement, as an international treaty, sought to address.
As the noble Lord, Lord Hain, has referred to, in that regard we had the support of the European Union, underscored by peace funds underscored by the United States of America. It is significant that the front runner and others, such as the US envoy to Northern Ireland, have quite clearly stated that this current Bill, with the fracturing of the agreement and the fracturing of the Northern Ireland protocol, could imperil the Good Friday agreement and imperil those relationships. They would not countenance, at this stage, the Bill remaining in its current form, with particular reference to Part 5 on a trade deal with the UK. That is a particular warning signal from one of the biggest Administrations in our global world.
These amendments focus on the need to ensure that the provisions of the Bill cannot be enacted unless they are compliant with the Good Friday/Belfast agreement and the Northern Ireland protocol—and, as my noble friend Lord Hain said, they do provide that necessary safeguard and protection.
Amendment 3 seeks to ensure that the “UK Market Access: Goods” section—Part 1—will have effect only when the UK is fully compliant with the terms regarding the UK internal market set out in the Northern Ireland protocol and the terms of the Good Friday agreement that are relevant to the UK internal market.
Amendment 157 requests the insertion of a clause specifically about the Good Friday agreement to
“address the unique political circumstances on the island of Ireland … maintain the necessary conditions for continued North-South cooperation … avoid a hard border between Northern Ireland and the Republic of Ireland”—
which is what the Northern Ireland protocol was designed to do, and which is clearly and specifically referred to in the withdrawal agreement that was signed by the Prime Minister last year with the European Union—and
“support, protect or implement the 1998 Good Friday/Belfast Agreement”
in so far as it is relevant to the UK internal market.
Amendment 177 is quite instructive, in that it states in the rubric explanatory section:
“No provisions of this Act come into force unless the United Kingdom is … fully in compliance with … the Northern Ireland Protocol … and … the terms of the Good Friday Agreement which are relevant to the United Kingdom internal market.”
Each of these amendments builds on the others, stressing the importance of the Belfast agreement and the Northern Ireland protocol to British-Irish relations and underscoring the bipartisan approach between Britain and Ireland that I have already referred to. In fact, the protocol stresses the essential elements of strands 2 and 3 of the Belfast agreement in respect of north-south economic co-operation and British-Irish relations. So it is important: we need to utilise the machinery of the Good Friday agreement to develop such relations as the North/South Ministerial Council and the British-Irish Council.
It does sadden me that the Government insist that they are trying to protect the Good Friday agreement. Nothing could be further from the truth, because in actual fact, through this United Kingdom Internal Market Bill, the Government are quite specifically fracturing that agreement and fracturing the withdrawal agreement that they signed up to this time last year.
The European Union Committee report, which was published some 14 days ago, has also been particularly instructive in relation to this issue. The committee states that there has been an “inherent tension” at the heart of the Northern Ireland protocol from the outset, due to the divergent expectations of the two parties: for the Government, it is
“maintaining the territorial integrity of the United Kingdom, and its internal market”
and for the EU it is
“to maintain the integrity of the Single Market and the customs union.”
Originally, the idea was to negotiate, in good faith, a pragmatic compromise, providing proportionate safeguards to protect the 1998 Good Friday agreement in all its dimensions. The Lords European Union Committee argues that, instead, the Bill elevates one element—the integrity of the UK internal market—above the others. That is the danger with this particular Bill.
Baroness Altmann (Con) [V]
My Lords, I have added my name to these amendments, moved so excellently and explained clearly by the noble Lord, Lord Hain, and of course the noble Baroness, Lady Ritchie of Downpatrick. So I will not spend too much time going through the proposals of these particular amendments. I would just like to ask the Minister, from these Benches, why the Government are objecting to these amendments being in the Bill.
I understand that one of the arguments is that they are superfluous or not really required. However, given the clear lack of trust or concerns about some aspects of recent statements, and given that, I assume, the Conservative and Unionist Party is indeed committed to the Good Friday agreement, to no hard border on the island of Ireland and to the terms of the Northern Ireland protocol—on which this Government were so recently elected and which our Prime Minister signed up to—this amendment merely aims to ensure that measures in the Bill are fully compliant with both the Good Friday agreement and the Northern Ireland protocol, which was part of the great deal that the Government negotiated and put to the country. If Part 5 is a negotiating tactic and the Government really do not intend to use it and are aiming to get a deal, or if there is no deal, surely we still need to respect the Good Friday agreement, and our internal market needs to respect the promises made that this Northern Ireland protocol will be part of our future relationship with the EU.
I ask my noble friend to explain why the Government are unwilling to accept these amendments and to confirm that our party wishes to maintain our country’s reputation for upholding the legal agreements that we have reached with other countries in good faith.
Lord Carlile of Berriew (CB) [V]
My Lords, I start by apologising to the noble Baroness, Lady Ritchie, for speaking over her earlier; I had not realised that I had already been unmuted.
The issue of the Northern Ireland protocol is about nothing more nor less than peace and stability in Northern Ireland and peace and security in the United Kingdom. I share the view given with such clarity a moment ago by the noble Baroness, Lady Altmann, that this matter should be explicitly declared in the Bill. There is nothing more important to national security and public safety than the Good Friday agreement. It celebrates the 21st birthday of its effectiveness on 2 December this year. My interest in the Good Friday agreement arose from my time as Independent Reviewer of Terrorism Legislation and the years that followed. I have followed very closely both the sometimes fractious, but surviving, political process in Northern Ireland and the recent history of residual terrorism in Northern Ireland. Although it still exists, it is much reduced and is well understood, now, at least, by the authorities.
The Good Friday agreement has secured the United Kingdom. If you visit Northern Ireland and look at its political and business institutions and public authorities, you will see that it has given them a sense of benefit which is sometimes not matched in other parts of the United Kingdom.
I pay tribute to the political parties in Northern Ireland, some of which were regarded as enemies of the people until the Good Friday agreement—and whose presence at St Andrews caused a good deal of criticism of the then Government—for the way in which they embraced constitutional activity in the political issues of Northern Ireland. I once spent some time with some ex-terrorists who had, by then, become respected politicians. I was hugely impressed by the way in which they embraced those constitutional proprieties, both in Northern Ireland and the Republic of Ireland.
There is no more important issue in the context of Brexit than ensuring that nothing is done to undermine in any way the Good Friday agreement. Everything else fades into unimportance. We must be clear that no sacrifices of the stability that the Good Friday agreement has brought will be made in the name of Brexit.
I will listen with great care to what is said by the noble Lord, Lord True, in replying to this short debate. I hope we will hear unequivocally from him not only that nothing will be allowed to happen that undermines the Good Friday agreement but that the Government are prepared to declare that in the Bill.
Lord Cormack (Con)
My Lords, after that speech from the noble Lord, Lord Carlile of Berriew, I am tempted to say “Amen” and sit down, but I will just add a few words. We will, of course, return to this subject when we debate the crucial Part 5 of the Bill.
All I really want to say to your Lordships is this: the Good Friday agreement is the greatest cross-party agreement since the war. It is the achievement, of course, of the Blair Government, but it is also the achievement of the John Major Government. As Tony Blair himself has admitted on a number of occasions, particularly when we had that great ceremony with the Taoiseach in Westminster Hall shortly after the Good Friday agreement, without the groundwork of John Major, Albert Reynolds and others, this could never have come about.
It would be an act of supreme folly if anything we did in this Parliament endangered the continuity of the Good Friday agreement. It is absolutely crucial that each and every one of us recognises this. In whichever party we sit, or on the Cross Benches, this agreement is our heritage and it is our duty to conserve it. It is nothing to do with whether you are on the Brexit or remainer side; that argument is over. What is not over is the continuing relevance and importance of an island of Ireland without hard borders and the principles and achievements of the Good Friday agreement being maintained.
I had the honour to serve as the chairman of the Select Committee on Northern Ireland in the other place. There were many memorable moments, such as addressing a meeting in Crossmaglen with my committee, which would never have been possible without the agreement, but my most memorable moment is this: being asked by the late Lord Bannside, or Ian Paisley as he was then, if I would be kind enough to have a private meeting with him. This was soon after the joint Executive had come into being, and of course Lord Bannside had not been altogether helpful at the time that the agreement was forged. When I congratulated him on working with Martin McGuinness, he said to me, “I have discovered that Martin McGuinness has a spiritual dimension.” I could have fallen off my chair. When I went to Ian Paisley’s farewell at Hillsborough, attended by the Taoiseach and others, a panegyric—and it was that—was delivered by Martin McGuinness, thanking his friend and mentor. We have come a long way and had some rough passages since then, but I will always remember that as an extraordinary illustration of what a political agreement can achieve. We must not jeopardise that.
I am glad that this was introduced by the noble Lord, Lord Hain—he was himself a notable contributor to all these things and has been since. We must not put this at risk.
Baroness McIntosh of Pickering (Con)
My Lords, it is a pleasure to follow my noble friend Lord Cormack, who has spoken so passionately, as did the noble Lord, Lord Carlile. I, too, also pay tribute to the contribution made by the then Conservative Government at the start of the Good Friday agreement. Speaking on the eve of the US elections, never has it been more timely to remind ourselves of the ongoing importance of that agreement.
Given that I do not think that there will be another opportunity to do so, perhaps I may briefly refer to the original Clause 1(3) which states that the principles set out in that clause
“have no direct legal effect except as provided by this Part.”
If they have no direct effect, presumably statutory instruments will need to be introduced for them to have effect. Will they become directly applicable at the same time in all four constituent parts of the United Kingdom?
I welcome in particular the probing nature of Amendment 3. I shall refer in passing to the evidence that we took in the EU Environment Sub-Committee. I am disappointed by the seeming lack of urgency reflected by the Government in preparing, in particular, farmers, producers, the road haulage industry and other interested parties involved in the production of or associated with agri-food, which of course is a mega business for Northern Ireland. In our letter to the Secretary of State, we concluded:
“We urge the Government to consider the likely impacts on Northern Ireland businesses and consumers of the increased levels of checks and controls that will be required as a consequence if the UK-EU future relationship negotiations are not successful.”
We noted that in his original reply the Secretary of State did not acknowledge the challenging timetable to implement the protocol in this regard. I know that when we come to discuss Part 5, there will be opportunities to consider this in more detail, but Clause 11 already looks at some of the details in Part 1 that relate to this.
I will use this opportunity to ask the Minister to assure us that in parallel with the consideration of this Bill, that what the Secretary of State said in reply to the sub-committee on 7 October, which was that the Government are actively engaging with the Northern Ireland Assembly, along with Northern Irish farmers, producers, hauliers and all those who are involved in the agri-food industry to enable them to be fully prepared to do business on 1 January 2021, is the case. Leading up to July, the evidence we took indicated to the contrary. There had been no direct contact of any specific nature with the Northern Ireland Assembly and certainly not with those interested parties from which we took evidence. Can my noble friend put my mind at rest that this has now moved on and that there have been direct contacts with the Northern Ireland Assembly and with the parties that will be affected in this regard?
Baroness Suttie (LD) [V]
My Lords, it is a pleasure to follow the noble Lord, Lord Cormack, and the noble Baroness, Lady McIntosh. Along with the noble Baroness, Lady Altmann, they have shown that there is much agreement about this matter on all sides of the House. The noble Lord, Lord Cormack, always speaks with passion, conviction and experience on matters to do with Northern Ireland, especially on maintaining the progress made since the 1998 agreement. I hope that his wise counsel was listened to by the Government Front Bench today. The noble Lord, Lord Hain, and the noble Baroness, Lady Ritchie, set out very clearly in their powerful speeches why we feel that these amendments are necessary, and I am very glad to have been able to add my name to Amendments 3, 157 and 177. As my noble friend Lord Carlile said so clearly, this is a matter of peace and stability.
I would like to make four points. As the noble Baroness, Lady Ritchie, and the noble Lord, Lord Hain, said, it is frankly staggering that the Government are claiming that they are acting to protect the Good Friday/Belfast agreement through the introduction of this Bill. As has been said by many noble Lords, it is the Government’s own withdrawal agreement and protocol that they are now trying to reverse through measures set out in this Bill. They were either wrong in their assessment of the impact of the withdrawal treaty on the Good Friday/Belfast agreement 10 months ago or they are wrong now. Can the Minister clarify which is the case?
My second point is that ahead of the Brexit negotiations, the European Union carried out an extensive exercise mapping the connections between the Belfast agreement and the single market. Clearly, it is important to recognise that north-south co-operation under strand 2 of the Good Friday/Belfast agreement has moved on extensively since 1998. Can the Minister say whether a similar mapping exercise was carried out by the UK Government on the potential impact on the Good Friday/Belfast agreement ahead of the drafting of this Bill?
My third point concerns the hugely important area of rights, safeguards and equality of opportunity. The Northern Ireland Human Rights Commission and the Equality Commission for Northern Ireland have expressed understandable anxiety about the protection of these rights following the introduction of this Bill. Can the Minister confirm that there will be no reduction in the rights as set out in the Good Friday/Belfast agreement and that the relevant obligations in the withdrawal treaty will be implemented in full? Can he also clarify whether an impact assessment was carried out specifically on the potential impact on rights and equalities?
My final point is about the Good Friday/Belfast agreement itself. We are blessed to have many noble Lords from all sides of the House who were directly involved in negotiating that agreement. We have several former Northern Ireland Secretaries, including the noble Lord, Lord Hain, who I have appreciated working closely with in producing these amendments. As my noble friend Lord Alderdice said in the Second Reading debate on this Bill last Monday:
“Those of us who spent many years of our lives negotiating and implementing that agreement had assumed that if we could find a new future for the people of our islands, we could find a way of maintaining our relationships with the rest of the European Union.—[Official Report, 19/10/20; col. 1357.]
This Bill now puts a very real strain on that relationship with our European partners, not least because of the potential impact on the Good Friday/Belfast agreement. When the Government committed to the Northern Ireland protocol, it was on the understanding that it was to
“be implemented so as to maintain the necessary conditions for continued North-South cooperation, including for possible new arrangements in accordance with the 1998 Agreement”.
Following the introduction of this Bill, do the Government still stand by that commitment?
It is deeply depressing, as the noble Lord, Lord Hain, has said, that Brussels and Washington appear to understand with greater clarity than this Government what is at stake if we start to disrupt the careful checks and balances based on trust and consent that are so essential to the Good Friday/Belfast agreement. That is why these amendments are necessary. We need to have this continuing commitment in the Bill. I look forward to hearing the Minister’s response.
Lord Falconer of Thoroton (Lab)
My Lords, it is a privilege to speak in this important debate. I say straightaway that we on these Benches support the principles that have been outlined by my noble friend Lord Hain, and the noble Baronesses, Lady Ritchie of Downpatrick, Lady Altmann and Lady Suttie, who have all put their names to the amendment. The essence of this amendment is that the Government should commit themselves to doing nothing that breaches the Good Friday agreement.
There is no noble Lord who has spoken in this debate who does not agree that a critical part of the Good Friday agreement is an open border between north and south. No noble Lord does not agree that, if the border is closed, one of the essentials of the peace agreement goes—and that threatens security and lives in Northern Ireland. That view is obviously accepted not just by the Democratic Party in the United States of America but by the Republican Party.
The dilemma the Government faced in reaching a conclusion about how to Brexit was how to keep the border open yet, at the same time, leave the single market while giving the European Union security whereby the border between north and south would not be an open door for goods from the north of Ireland flowing into the single market to the south. The solution reached, which the current Prime Minister said was “brilliant” and which he formally endorsed “strongly”, was that goods in Northern Ireland and those brought into it which were at risk of going to the south would be compliant with the single market regulations—both regulatory requirements and the payment of duty. That would be achieved with checks on goods, in so far as necessary, coming from Great Britain to Northern Ireland. That was a good solution to the problem and was, as I said, adopted by the British Government.
It was also agreed that there would be four protections in the Northern Ireland protocol to ensure that the constitutional arrangements would not create difficulty for the unionist community in the north. First, there would be a joint committee to settle the detailed arrangements. Secondly, there would be an arbitration provision if there was a dispute about whether they went too far one way or the other. Thirdly, Article 16 would allow the British Government to impose their own measures, in accordance with the terms of the Northern Ireland protocol, if they were concerned about a threat to society, the economy or cultural links between the two. Fourthly, there is a provision for democratic consent if the people of Northern Ireland no longer wish to comply with the Northern Ireland protocol.
Those were the arrangements agreed by the UK Government. Now the Government say that we may not continue to comply with the Northern Ireland protocol. They are signalling to the European Union, to the Republic of Ireland and to the United States of America that you cannot rely on us in relation to the provision that keeps the border open. This Government have the impertinence to say that it is the European Union that is threatening the border. If you say, having just entered into an agreement, “We may not continue to agree or comply with it”, then of course the other side is going to think that you are not reliable. As it happens, you also trash our reputation as a country by doing it. You make this Government an absolute laughing-stock. First, Brandon Lewis said that they were breaking the agreement. Then the noble and learned Lord, Lord Keen, said that they were not. Then Brandon Lewis said, “Oh yes we are”. Then the noble and learned Lord resigned because of what Brandon Lewis said. Then Michael Gove said, “Maybe we are; maybe we aren’t”. That is the position of the Government of the United Kingdom, which has a reputation for complying with the law.
Could the Minister explain? First, are we breaking the law or not? Secondly, if we are, why are we doing so—or even threatening to—when we entered into those four protections to ensure that there was no pressure on the border between Northern Ireland and Great Britain? Thirdly, can he give the assurance required by my noble friend Lord Hain, and the noble Baronesses, Lady Ritchie of Downpatrick, Lady Altmann and Lady Suttie? We all require that the Government will do nothing that threatens the Good Friday agreement. Finally, will the Minister explain how it does not threaten an open border to say, as the British Government do, “We may not stand behind the Northern Ireland protocol”?
The Minister of State, Cabinet Office (Lord True) (Con)
My Lords, I thank all noble Lords who have spoken, particularly the noble Lord, Lord Hain, the noble Baroness Ritchie of Downpatrick, my noble friend Lady Altmann and the noble Baroness, Lady Suttie, who all signed the amendment. I congratulate the noble Lord, Lord Hain, on the measured and thoughtful way in which he presented his case, and on his ingenuity in getting this amendment in so early in the Bill, so that the Committee can debate this important topic, which is one of the abiding matters of interest in the Bill. I do not demur from sensing the opinions the House has expressed on aspects of the Bill, even if I do not agree with them.
I will and must, as invited, repeat the assurances that the Government gave to the House at Second Reading last week, and will do so again when the Committee turns more fully to the Part 5 clauses. I say again, without demur or cavil, that the Government’s overriding priority has been, and will remain, to protect the Belfast/Good Friday agreement and the gains of the peace process. We agree with all noble Lords who have spoken on that fundamental objective. I assure the noble Baroness, Lady Suttie, that Her Majesty’s Government always give the most careful consideration to the impact of any of their actions in this important respect.
I was asked about the human rights aspect. The Government are, of course, committed to the European Convention on Human Rights. We have made that clear before, time and again. However, we have brought forward amendments to the Bill clarifying that regulations made under clauses which the Committee will discuss later will be subject to judicial review on public law grounds. That will provide an effective remedy in the theoretical and limited scenarios in which regulations might conceivably interfere with convention rights. My noble friend has obviously made the due statement on the European convention on the face of the Bill.
The Government’s commitment to the Belfast/Good Friday agreement and to the peace process is beyond question. We all acknowledge the importance of the delicate balance across communities in Northern Ireland. We should all reflect on the importance of not letting opinions and comment flow which suggest, either within or outside these shores, that this Government, this party, the party opposite or any Member of this House do not believe that this agreement is fundamental. We do. Where we differ is that the Government do not agree with many noble Lords who have spoken that the United Kingdom Internal Market Bill undermines the Belfast agreement. On the contrary, the Bill delivers on our commitment to unfettered access for Northern Ireland businesses to the whole UK market. In so doing, it supports the economic and social links between Northern Ireland and the rest of the United Kingdom. In that way, it complements the provisions of the protocol which avoid a hard border on the island of Ireland. It is, and remains, the Government’s position and policy that there should be no such border. The Bill supports the interlocking and interdependent elements of the Belfast/Good Friday agreement.
The Committee will come back to the questions of the rule of law in detail in Part 5, but I repeat what I said at Second Reading: the Government believe that presenting this Bill to your Lordships’ House, and the fact that it passed through the other House, is in accordance with our constitutional norms and does not infringe the rule of law.
Northern Ireland Peers voted, by a majority, against the amendment moved by the noble and learned Lord, Lord Judge, at Second Reading. That was not every Peer from Northern Ireland and I accept that it reflects differences of opinion. We have to note and respect that. The noble Lords, Lord Kilclooney and Lord Trimble, both of whom negotiated and signed the Belfast/Good Friday agreement, voted against the amendment your Lordships agreed to at Second Reading. I repeat: it is the firm resolve of the Government to maintain, and ensure compliance with, the Belfast/Good Friday agreement, and so I disappoint noble Lords who have spoken. I do not believe that the addition of these amendments to the Bill is necessary.
Turning to the references in Amendments 3 and 177 to the Northern Ireland protocol, again, as I have set out, the Government are committed to implementing the withdrawal agreement and the Northern Ireland protocol and have already taken many practical steps to do this, and continue to do so. I assure the noble and learned Lord, Lord Falconer, and others that we are continuing to work with the EU in the joint committee to resolve outstanding issues arising from the Northern Ireland protocol. Our priority is to secure the outcomes that we need in that forum, working in a spirit of good faith, so that the protocol can be implemented in the pragmatic and proportionate way intended. This is intended to give the best platform for it to command support across the whole community in Northern Ireland. Let me repeat: as a responsible Government, we cannot allow the economic integrity of the UK’s internal market to be compromised inadvertently by certain provisions in the protocol without a safety net in place. The Government have been clear in our statements, including on the criteria set out by the Government on 17 September, that these provisions would, in any case, be used only where, in the Government’s view, there had been a material breach by the EU of duties of good faith or other obligations, and be used in parallel with the dispute resolution procedures that the protocol itself establishes.
These amendments as drafted could remove, prevent or suspend our ability to act in the interests of the people of Northern Ireland, and so ensuring they are treated as our countrymen and countrywomen with equal access to the UK internal market. Furthermore, they could leave core elements of unfettered access—not only the safety net provisions—in a state of consistent uncertainty and open to persistent litigation. It is far from clear how compliance with the Northern Ireland protocol, for the purposes of these amendments, would be assessed or who would make the assessment. For example, it is possible that all the provisions in the Bill could cease to have effect if the EU alleged a breach of the Northern Ireland protocol. Any dispute then would be resolved by the appropriate dispute resolution mechanism, which in some cases would include the jurisdiction of the CJEU. That cannot be the means by which we safeguard the links between Northern Ireland and its most important market, Great Britain, which is the subject of the Bill. That cannot be the means by which we safeguard the interests of Northern Ireland from the end of the transition period and beyond.
I am well aware that we will return to these important matters in great detail later in Committee. At this point, however, I urge noble Lords to withdraw or not move the amendments. Before I do, I refer my noble friend Lady McIntosh to the whole of Clause 1(3), which says, as she quoted:
“Those principles have no direct legal effect except as provided by this Part.”
If she looks at the Bill, she will see that in the rest of that part there are number of provisions for secondary legislation. I apologise for that divergence, but I felt I should answer that point. I return to the fundamental position: this Government are wholly committed to the Belfast agreement, they cannot accept these amendments and I urge the noble Lord to withdraw his amendment.
Lord Hain (Lab)
My Lords, I thank the Minister for his courtesy and all those who have spoken in support of these amendments. I note that a third of the speakers are from the Minister’s own Benches. I think that shows that there is cross-party, cross-Bench support for the principles that these amendments enunciate.
My noble friend Lady Ritchie of Downpatrick spoke with passion about how this Bill, without these protections, imperils the Good Friday agreement. I want to return to that point when I pick up some of the arguments used by the Minister in a moment.
The noble Baroness, Lady Altmann, made a telling point: why are the Government not accepting their own policy? If their policy is, as the Minister states—I accept that in good faith—that the Government support the Good Friday agreement and the Northern Ireland protocol in protecting the Good Friday agreement, why are they not accepting these amendments? If there is some technical issue, and I will return to one of the issues he raised, we could discuss wording and come to an agreement. I ask the Minister to look carefully at what the noble Baroness, Lady Altmann, said about the Government’s own policy being reflected in these amendments. At least, we think it is the Government’s own policy.
The noble Lord, Lord Carlile of Berriew, spoke with great authority because he has spent many years on this. As Secretary of State, I worked with him on this and his review of terrorist legislation, as did the noble Lord, Lord Cormack, who was a distinguished chair of the Northern Ireland Affairs Committee in the other place. He was hugely respected on the island of Ireland for his diligence and the conscientious empathy he showed towards the situation in Northern Ireland.
The noble Baroness, Lady McIntosh, again speaking from the Minister’s own Benches, was compelling on the fact that this should be a cross-party matter. It was, of course, John Major, as she said, who played a crucial role in the lead-up to the Good Friday agreement that enabled Tony Blair to pick up the baton and drive it forward.
Another contributor to this debate, the noble Baroness, Lady Suttie, to whom I am also grateful to for her support for these amendments, speaks with real authority, particularly about what is at stake here. This is not some technical issue; this is about the future of peace in Northern Ireland. My noble and learned friend Lord Falconer, spoke also about the importance of keeping that border absolutely open on the island of Ireland, to take the process of peacemaking forward.
I ask your Lordships’ House to note that the Minister did not explain how the Bill upholds the Good Friday agreement. He asserted it, but he did not explain how it upholds is, especially given that it repeals the Irish Northern Ireland protocol. On Report, I would urge him to explain in great detail—if necessary, in technical detail—how he thinks the Bill actually upholds the Good Friday Agreement. The majority of contributors to this debate—in fact, everybody except him—dispute that. That is the problem that the Government face in setting their face against these amendments.
Unless there is an ulterior motive here, and I am not suggesting that of the Minister personally but of No. 10 Downing Street, I do not understand. If there are concerns about the implementation of the Northern Ireland protocol, there is a committee, as I mentioned in my speech, co-chaired by Michael Gove with a representative of the EU, to iron out the detailed implementation points. It is a joint committee. That makes us all think that there is something much more serious at stake here, which is undermining the whole foundation of the protocol and, indeed, of the Good Friday agreement with which it sits in partnership.
To conclude, this is a series of very modest amendments. They ask the Government to uphold their own professed policy. That is all they are doing. They are not suggesting some revolutionary change in the Government’s policy. They are asking them to uphold their professed policy on the island of Ireland, in particular on continued progress in Northern Ireland. Meanwhile, I will seek leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Haskel) (Lab)
My Lords, we now come to the group consisting of Amendment 4. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. Anybody wishing to press this Amendment to a Division should make that clear in debate.
Amendment 4
“Purposes of Parts 1, 2, 3 and 4
(1) Parts 1, 2, 3 and 4 promote the continued functioning of the internal market for goods (see Part 1) and services (see Part 2), including the recognition of professional and other qualifications (see Part 3), in the United Kingdom by establishing the United Kingdom market access principles.(2) The United Kingdom market access principles are—(a) the mutual recognition principle for goods and services, and(b) the non-discrimination principle for goods and services.(3) Those principles have no direct legal effect except as provided by Parts 1, 2, 3 and 4, and only to the extent that they have been agreed in a memorandum of understanding by—(a) the Secretary of State,(b) the Welsh Ministers,(c) the Scottish Ministers, and(d) a Northern Ireland department.(4) The Secretary of State must lay before Parliament the memorandum of understanding, which must also set out—(a) how the agreed policy frameworks on the functioning of the internal market in the United Kingdom will operate,(b) any agreed exclusions from the market access principles,(c) proposals for the establishment of a council or councils, comprising representatives of the Secretary of State, the Welsh Ministers, the Scottish Ministers, and a Northern Ireland department to oversee the operation of agreed policy frameworks and the functioning of the internal market in the United Kingdom, and(d) proposals for the establishment of an agreed dispute resolution mechanism relating to the internal market in the United Kingdom for any disputes among the Secretary of State, the Welsh Ministers, the Scottish Ministers, and a Northern Ireland department.(5) A statutory instrument containing regulations under section 56(3) may not appoint a day for the commencement of Parts 1, 2, 3 or 4 until the requirement in subsection (4) is met.”
Lord Fox (LD)
My Lords, as I said in winding up at Second Reading, the eight hours of speeches broke the Bill down into three areas of serious concern: its illegality, its threat to the union, and its structural contradictions. As the noble Baroness, Lady Hayter, said, even if Part 5 is removed one way or another, there will still be great dangers lurking within the Bill. This amendment focuses squarely on putting the threat to devolution on ice.
The Minister was right when he said that the devolved authorities get new powers through the Bill, but these new powers are heavily constrained—more so than they were before when there was EU flexibility. We have heard some of this debate already. More importantly, both Ministers have omitted to mention that, at the same time, the Government are taking significant powers away. These losses are far more significant than any notional gains. This has already been correctly characterised by the devolved authorities as rolling back the devolution settlements.
The Governments of Wales and Scotland need only look over their respective borders to see how the UK Gossvernment are treating their regions and cities—where there is only piecemeal devolution—to conclude that taking power back to the centre is not an accident; it is a pattern of behaviour. As an aside, this is not a unique pattern of behaviour. My Scottish friends tell me that the Scottish Government are very enthusiastic about centralising power away from their local councils.
Returning to the Bill, we should not worry when it comes to Westminster’s reputation in Scotland. I read in the press that Michael Gove is heading up a new unit to tackle the secessionist movement in Scotland. What could go wrong there? Perhaps a better way of dealing with the unpopularity of Westminster is to deal with the central devolution issue in the Bill.
There are many later amendments concerning parts of the problem with the Bill. This amendment seeks to deal with it all in one go, taking it head on. It is driven by a central principle which we on these Benches share. We do not believe that it is only the UK Government or this Parliament that should dictate how the future internal market should work. It has to be a collaborative effort between Westminster, Edinburgh, Cardiff and Belfast. To achieve this, Parts 1 to 4 of the Bill need to be rewritten by consensus, not imposed, which is why this amendment seeks to halt the progress of Parts 1 to 4 until a joint process has created the future market structure. In essence, it will put on ice the Bill’s implementation until agreement is reached on the operation of the internal market frameworks.
In order to do this, the amendment rewrites the purpose of the Bill. What stays is the promotion of the continued functioning of the internal market for goods, in Part 1, and services, in Part 2. It includes the recognition of professional and other qualifications in the UK—in Part 3—by establishing the UK market access principles, including, as now, the mutual recognition and non-discrimination principles for goods and services. It adds the important rider that those principles have to be agreed in a memorandum by the Secretary of State, the Welsh and Scottish Ministers and a Northern Ireland department. This memorandum would cover how the agreed policy frameworks on the functioning of the internal market in the United Kingdom would operate and any agreed exclusions from market access principles. It would establish a council or councils, comprising representatives of the Secretary of State, the Welsh and Scottish Ministers and a Northern Ireland department to oversee the operation of the agreed policy frameworks and the functioning of the internal market in the United Kingdom. The current Joint Ministerial Council would need to be strengthened to achieve this objective.
The amendment would also establish an agreed dispute resolution mechanism, relating to the internal market of the United Kingdom. It requires the Secretary of State to lay this memorandum before Parliament. In short, this amendment makes the Government do what it should already have done. Amendment 4 requires them to consult and reach agreement with the devolved nations of the United Kingdom. By pausing and putting this on ice, Her Majesty’s Government can then create the consensus that is needed. It can also address the holes in the Bill, including the role of the common frameworks, which will be discussed in much more detail later, and it can put in place a process of dispute resolution. The deliberate absence of detail around dispute resolution can be viewed with great suspicion by those who are so minded. It seems that in the end, the Westminster-based UK Minister will decide disputes if the Bill remains unamended.
Why should the Government agree to this amendment? The first reason is due process. I met the noble Lord, Lord Callanan, on Friday. His key anxiety was about discipline and time in order to get through all this. If he were to accept this amendment, he would, at a stroke, remove large portions of the subsequent debate up to, but not including, Part 5 of this Bill. He would then meet his time objectives. Much more seriously, by accepting this amendment, the Government could step back from a truly appalling act of political vandalism. To say that this Bill drives a coach and horses through devolution is not hyperbole. This cynical approach to the balance of powers established between Westminster and Scotland, Wales and Northern Ireland, is calling down issues that, once started, will not easily be halted. This amendment seeks to avert this disaster, creating a role for the devolved authorities, including the operation of the internal market frameworks, robust dispute resolution, agreed exclusions from market access principles and representation for all four nations on oversight councils. I beg to move.
Baroness Neville-Rolfe (Con) [V]
My Lords, I refer to my interests in the register as this is the first time I have had the honour of speaking in Committee. Amendment 4 introduces an expanded purpose for the Bill. The noble Lord, Lord Fox, has explained the rationale for his wide-ranging proposal. I can understand his wish to refer to services at this introductory point in the Bill, given that they comprise over 80% of GDP, and to professional and other qualifications, harmony on which is so important to the UK’s single market.
I accept that the changes to subsections (1) and (2) merit consideration. However, I am very uneasy about the proposed new subsections (3) and (4). I fear that they make this a wrecking clause. They give the devolved Administrations a veto over the way internal market arrangements will work, in addition to the substantial powers and money that they have already been given in the various devolution settlements and EU exit Bills. This is a recipe for the politics of national resentment, chaos and delay, at a time when we need rapid agreement on the new order so that the country can move forward and make the EU exit work, difficult though this may be.
Resources are already massively redistributed out of London and the south-east to other parts of the UK, with Scotland alone having a fiscal deficit of £15 billion—namely, a subsidy from richer England—according to a recent article by David Gauke, who served in the Treasury for seven years. We do not want yet another stand-off at this moment in time with the devolved nations, able to hold things up. There has been quite enough of such delay in the exit negotiation process, now more than four years long, I remind noble Lords.
Where I have more sympathy with the noble Lords, Lord Fox and Lord Purvis of Tweed, is on the fact that we need clarity now, before the Bill takes effect. Perhaps I can explain why by way of analogy.
When I was at Tesco, one of the key reasons for success was a clear understanding of who had responsibility for what and a readiness to accept the rules for the greater good. Procurement was done centrally by buyers, who could work with the supply chain, such as British food producers, understand their needs, strengths and innovations, agree a reasonable deal and ship goods to the stores in line with customer demand. When it came to other areas, such as who to hire as employees and how to schedule their hours, that was locally determined. The key was that everyone knew and accepted the division of labour because it contributed to the success of the whole. There was no council where everyone could waste hour after hour arguing the toss, as appears to be proposed in this amendment.
Let us have clear divisions and let us decide them now, not leave them for a great fight over a memorandum of understanding or yet more devolved government bodies backed up by dispute resolution. That is just an invitation to politically motivated folk to stop the country adjusting to the new norms and getting ahead with economic recovery and international ambition.
The proposals in the Bill are a good start, and, as noble Lords can see, I am uneasy about this particular amendment. I served for nearly three years as the single market Minister in the EU and for years as a British official negotiating in Brussels and Luxembourg, and the truth is that, subject to some minor subsidiarity, internal market rules for goods were set at the EU level in the interests of the efficient functioning of the market. By analogy, rules for the UK single market should be set at the UK level. EU services were less streamlined, but we all recognised that and wanted to bring about improvement, which was one of the main objectives of the UK presidency in 2017, but that never happened. I look forward to hearing from my noble friend the Minister, but I will take a lot of convincing that subsections (3) and (4) make sense.
Lord Morris of Aberavon (Lab) [V]
My Lords, I fear I must disagree with the noble Baroness, Lady Neville-Rolfe. I support this amendment. The House will be aware of my approach as a devolutionist, and I will not repeat my general views. However, for my part, the key is subsections (3) and (4) of Amendment 4 on what should be contained in a very necessary and vital memorandum of understanding.
At Second Reading, I raised the divergence in understanding between the Welsh Government and Whitehall. The Welsh Government spelled out that they were losers from the Bill—their powers would be changed. There were two particular differences in understanding between HMG and the Welsh Government. First, they said that the Bill takes powers to spend money over the heads of devolved Ministers on devolved matters; and, secondly, that the Bill amends the Government of Wales Act to add the decision on and operation of state aid policy to the list of reserved powers. In the factual briefing on the Bill, the Government actually claim that they are increasing the powers of the devolved legislatures. Indeed, in the discussion on the previous amendment, the Minister claimed again that new powers were being given to the devolved legislatures. They cannot both be right. A recent meeting of Peers with the Welsh Secretary failed miserably to clarify the position. I now specifically ask for the Government to publish a reply to the Welsh Government’s document on their concerns about the Bill.
Baroness Randerson (LD) [V]
My Lords, I regret that I was unable to take part at Second Reading, but that does not mean that I am not deeply concerned—[Inaudible.]
The Deputy Chairman of Committees (Lord Alderdice) (LD)
We seem to have a technical problem.
Baroness Randerson (LD) [V]
[Inaudible]—needed at all, certainly at this stage. The earlier parts of the Bill, which deal with the establishment of new rules to maintain the internal market now that we have left the EU, have received much less publicity than Part 5. However, these parts are just as constitutionally significant because, under the cover of Brexit, the Government are attempting to slip through the unravelling of devolution. They have claimed that this Bill will increase the powers of the devolved Administrations, which is akin to President Trump claiming that the virus is waning in the USA: the facts demonstrate its falsity, as the clauses in this Bill demonstrate multiple ways in which it undermines current devolved powers.
The UK’s internal market appears to function perfectly well at the moment. The barriers cited by the Government as the reason for this Bill are hypothetical and unlikely to materialise because they are clearly against the interests of the devolved Administrations. There is no clamour to diverge from existing standards set by the EU because they are both high and universally recognised. Therefore, taking the Bill at face value, it seeks to solve a problem that does not exist, but that judgment is rather too kind because the details betray the Government’s real purpose.
Until now, devolution in the UK has functioned under the umbrella of EU legislation. Most of the fundamental devolved powers have operated in that way, and EU regulation has been accepted with noticeably little argument because it operates on such a large scale that there is little perception of party-political bias. The new arrangements set out in this Bill will be very different. Obviously, England will dominate, come what may, but the Government are not content with relying on size alone. This Bill steals all the remaining cards from the devolved nations.
We have a ragged devolution settlement—lopsided, confused, and already under huge strain. Leaving the EU has destabilised it further. Because there is no proper devolution in England, UK Government Ministers are effectively hybrid Ministers. One minute they are acting as Ministers for England and the next they are UK Ministers. Indeed, in some cases, such as agriculture, the Secretary of State is largely just the Minister for England, so it is essential that there is a strong dispute resolution mechanism: there will be problems if that fell back on the Secretary of State alone. This Bill itself will become a protected enactment, which devolved Administrations cannot repeal or modify. However, the UK Parliament will, in practice, be able to override the market access principles when legislating for England. Hence it will have an inherently asymmetrical effect.
Looking at how the market access principles will be enforced, we see a much tighter definition than allowed under EU law. It narrows the territorial scope of devolved legislation, which will no longer be able to apply to all activity within that nation. The Senedd could still vote to ban a wide range of single-use plastic items, for example, but that ban could no longer be applied to products entering Wales from the rest of the UK, nor could it ban sales of those goods. Such a ban would therefore be pretty meaningless. Amendment 4 applies the Government’s own market access principles, but with a framework of respect for the decisions and views of the devolved nations. With all due respect to the noble Baroness, Lady Neville-Rolfe, the UK is not a supermarket. The nations of the UK have individual and proud heritages and identities.
The Government’s regulatory impact assessment recognises that the broad application of the market access principles will limit the ability of the devolved Administrations to introduce distinct approaches to environmental and social policy, which will of course undermine the fundamental purpose of devolution. In the interests of centralisation of power, the Government are attacking innovation. The freedom provided by devolution has encouraged new approaches, such as plastic bag pricing, in Wales and minimum alcohol unit pricing in Scotland and Wales. There is an insidious pattern in many of the controls in the Bill. It allows the status quo to stand in some instances, but removes the right of devolved Administrations to change regulations in the future. This looks like the path to a stagnating economy.
Amendment 4 seeks to strengthen the hand of the devolved Administrations so that their voice can be heard. It replaces the very weak duty to consult with a much stronger principle of consent. That would force the Government to return to a normal approach of partnership and respect. The Bill scythes its way through devolved powers, and the amendment attempts to tackle some of that. The Government have lately reminded me of a drunk in a bar, who swaggers around aggressively challenging the other customers over imagined insults and picking unnecessary fights. This really is an unnecessary fight with the devolved Administrations. Devolution was always incomplete and uneven, and UK identity has been stretched pretty thin recently. Throughout the Bill there is a thread seeking to reverse devolution and recentralise the state, and this Government simply must not be allowed to get away with it.
Lord Dunlop (Con) [V]
My Lords, I want to comment on some of the issues raised by the amendment. It is useful in that, so far as this Bill is concerned, it draws attention to—if I may put it this way—the dog that did not bark. The dog in this case is the agreement reached at the Joint Ministerial Committee in October 2017, between the UK Government, the Scottish and Welsh Governments and the senior civil servant representing the Northern Ireland Executive, on the principles to guide the work on common frameworks. There will be an opportunity to debate in more detail how common frameworks intersect with the Bill’s provisions in the next group of amendments, but looking at the JMC principles is a good starting point.
In its report on the Bill, your Lordships’ Constitution Committee, of which I am a member, concluded:
“We consider that adhering to the principles agreed for formulating common frameworks would improve the likelihood of reaching agreement on how to progress the Bill. We are not convinced that the opportunities for managing the UK internal market through the common frameworks have been exhausted”.
The JMC principles embody what can reasonably be assumed to be core UK Government concerns: the effective functioning of the UK internal market; compliance with international obligations; the ability to negotiate, enter into and implement new trade and international agreements; the management of common resources; and cross-border justice and security. They also address those issues likely to be of most concern to the devolved Administrations: respect for the devolution settlements; devolved competence not normally adjusted without consent; and equivalent flexibility for local tailoring of policies as is afforded by current EU rules, as we have heard.
One of the witnesses from whom the Constitution Committee took evidence— Professor Nicola McEwen from Edinburgh University—contrasted the approach adopted for common frameworks, which she characterised as a co-operative and co-owned process, with the provisions of the Bill, which she described as more top-down. It is fair challenge to wonder whether a top-down approach might be necessary because one of the participants in the common frameworks negotiations is often seen as provocative and difficult to deal with, and of course committed to the break-up of the United Kingdom. The introduction this summer in the Scottish Parliament of a second continuity Bill, designed to give Scottish Ministers powers to maintain dynamic alignment with the EU, might well have been seen by the UK Government in this light. However, I would make three observations about this:
First, the Welsh Government, who, unlike the Scottish Government, gave their legislative consent to the European Union (Withdrawal) Act 2018, are a unionist Government but nevertheless as concerned as the Scottish Government about the implications of the internal market Bill for devolution. Secondly, we have now had eight of the statutory quarterly common frameworks reports from the UK Government mandated by the 2018 Act. Each has confirmed that common frameworks are making progress and that the Government have not felt the need to exercise their power to freeze devolved competence to counter any imminent risk of policy or regulatory divergence. Thirdly, even at a time when relations between the UK Government and the Scottish Government are at a low ebb, and the Scottish Government initially insisted that they would withhold legislative consent as a matter of principle for all Brexit-related Bills, the Scottish Government have in recent months recommended legislative consent—albeit with some qualifications—to the Fisheries, Agriculture and Trade Bills.
In conclusion, the amendment in the names of the noble Lords, Lord Fox and Lord Purvis, seeks to inject into the Bill the spirit of the JMC principles—here I am concerned more by its spirit than its precise terms—and to provide a more co-operative intergovernmental architecture for taking forward the UK internal market, which is currently missing from the Bill. I therefore hope that Ministers—despite the challenges, which I do not underestimate—will not give way to pessimism about the governance of the union, nor give up on a collaborative “four nations, one country” approach to protecting free trade within the UK. As such, I hope they will work constructively to address the concerns raised about the Bill during this debate.
Lord Bruce of Bennachie (LD) [V]
My Lords, I am delighted to follow the noble Lord, Lord Dunlop. That was a thoughtful contribution, and I hope the Government will reflect on it, because it is in the interests of both the Government and the future of the United Kingdom that that kind of approach is thought through.
I speak in support of the amendment, which I contend is a constructive approach to maintaining trust in the existing devolution settlements, which are strained, and establishing a consensual way forward. I believe it is consistent with the report of this House’s Constitution Committee, which, along with others, has questioned the need for the Bill at all—a point that has been mentioned by a number of speakers. Very late in the day, it appears that some in this Government show signs of a growing awareness of the dangerous game they are playing with the devolution settlements and the implications for the future of the United Kingdom. The question arises why the Government are in such a hurry to get this through with totally inadequate consultation with business or the devolved Administrations. The Minister’s claims of business support during Second Reading was, frankly, extremely thin.
The devolved Administrations are, as has been said, opposed to the Bill as it stands, and amendments have been tabled on their behalf on a cross-party basis. When challenged as to why the powers in the Bill are needed, the Government’s responses are wholly unconvincing. From everything I have seen and heard, the Bill appears to be a solution looking for a problem. When Ministers airily suggest, for example, that Scotch whisky distillers may be prevented from buying malting barley from England, without any shred of evidence, they refer to different building standards, apparently in ignorance of the fact that Scotland has different standards that well predate devolution.
Given the flimsiness of the Government’s case and knowing what we do about the high-handed, centralising, cavalier approach of the Government, we are surely entitled to be suspicious about their intentions. After all, as the noble Lord, Lord Dunlop, pointed out, three years ago it was possible to set out in a communique the principles and approach behind the common frameworks process. The language is detailed and consensual. Specifically, the communique setting out the common frameworks describes the objective as enabling the function of the UK internal market while acknowledging policy divergence. It further stated that the devolution settlement should be respected and frameworks will
“be based on the established conventions and practices, including that the competence of the devolved institutions will not normally be adjusted without their consent.”
This approach and language are entirely missing from the Bill, so the question to the Minister is not only why the Bill is needed, but, even if that case can be made, why the hurry? More pertinently, having rejected letting common frameworks take all the strain, can the Minister explain why the eminently sensible and constructive approach of the common frameworks is not incorporated into the Bill, as I hope subsequent amendments will allow it to be? We will return to that.
That said, there remains a flaw in the common frameworks approach, which must be addressed and attached to the Bill if it goes forward, and it is identified in this amendment. It is that the devolved Administrations must be fully involved throughout the process and represented in the institutions that progress the frameworks. The proposals for the office for the internal market to be incorporated into the Competition and Markets Authority has been widely criticised. First, the CMA has a dedicated and reserved function, and there is no provision for the devolved Administrations to be represented, but they surely must be represented on the OIM or a better alternative.
As has again been commented on, so far, the common frameworks are progressing with all the appearance of a high degree of consensus and the dispute mechanism has not been called into play. It might be thought that, given the constructive, consensual approach to date, the likelihood is that if dispute resolution reached the apex, it would be accepted. However, it would not be satisfactory as it stands, and certainly not fit for purpose in relation to this Bill. The weakness is that as a dispute escalates, first to Ministers of the devolved Administrations, which includes UK Ministers acting for England, the final resolution lies with UK Ministers. The noble Baroness, Lady Neville-Rolfe, was concerned that the devolved Administrations might be the cause of delay, but I fear she underestimates the resentment of UK English Ministers overruling the devolved territories. That, I suspect, sadly helps explain the rather smug responses from UK Ministers: devolved Administrations may huff and puff, but UK Ministers can blow their houses down.
The Government have quoted examples from abroad to justify their approach but, ironically, they are mostly drawn from countries with properly established federal constitutions, notably Australia and Canada, where state and provincial governments’ views are fully involved in decision-making. In the case of Australia, a two-thirds qualified majority is required.
According to weekend reports, Michael Gove is establishing a unit to combat the SNP and its pressure for independence. I certainly believe that the largely unchallenged fantasy and lies which are fuelling the case for independence that would be so disruptive and damaging on a disastrous scale on top of Brexit and post-Covid recovery need to be challenged, but Mr Gove should have enlightened his colleagues that in its present form, the Bill will make his task almost impossible. Amendment 4 would greatly help him by delaying implementation of Parts 1 to 4 until an agreed approach is confirmed.
As the party with the deepest commitment of any to home rule—we battled for it for over a century—Liberal Democrats are determined to protect the devolution settlement against a centralising government in London and the separatist thrust of the SNP. Scotland’s best interests lie in using the powers that have been secured, ensuring they are not eroded and gaining a positive relationship with the other devolved Administrations and the UK Government. As we rebuild after a botched Brexit and a mishandled Covid-19 crisis, businesses do not need further disruption over constitutional arguments.
With the mechanisms in place and goodwill to seek the best for Scotland, the devolved territories and the UK, confidence can be restored. Ideally, the Government should abandon this Bill, which is at best premature and probably unnecessary but, so long as they push ahead, Liberal Democrats will push to secure this responsible and constructive amendment and save us from an unwanted and unnecessary constitutional crisis. Surely we have had enough disruption for one year—or even 10.
Lord Purvis of Tweed (LD)
My Lords, it is a pleasure to follow my noble friend. Amendment 4 was ably moved by my noble friend Lord Fox, and I want to outline some further considerations based on principles and on practical considerations.
I start by reflecting on the important contribution of the noble Lord, Lord Dunlop. I first met the noble Lord when he was the adviser to Prime Minister David Cameron in Downing Street and I was chair of the cross-party Devo Plus group in Scotland, which was arguing for enhanced powers for the Scottish Parliament, which subsequently came into legislation with the Scotland Act 2016. The noble Lord considered our proposals carefully, he has been a very thoughtful contributor to our debates and I look forward to the conclusions of his review on intergovernmental relations. The fact that he has asked for a degree of pause on what could be considered a constitutional rush is important and should be taken seriously. If despite his wise counsel and the thrust of the amendment—which has been tabled sincerely—the Government insist on moving forward on their current trajectory and in their current manner, it will be the first time in a quarter of a century that a major constitutional change will have been imposed on the nations without any form of public or parliamentary consent. That will not serve the start of a new functioning internal market well. The principle of consent is therefore not a theoretical argument; it is important at the political level for those of us who believe strongly in the continued functioning of the United Kingdom and its internal market.
That is in stark contrast with the following groups that we will be considering, where, as the Minister has heard, the frameworks process has been good and we have supported it. The fact that it has been supported across all parties and, indeed, the nations is important.
I reflected on the point indicated by the noble Baroness, Lady Neville-Rolfe, which is that we need the Bill to prevent a veto by one of the nations. That argument would have some form of justification if we had seen that approach within the common frameworks. They cover the policy areas that are being repatriated: 154 of them, of which only four remain where there is not agreement whether they are reserved or devolved. Two of them will be resolved only after we know what is the agreement with the European Union, because they concern geographical indications and state aid—we don’t know what the Government’s proposals are for those two areas because we don’t know what the agreement with the European Union is. That will leave only two. For the 18 that require legislation, it is well under way to being proposed.
So it is not the case that there will be a major gap on the statute book at the beginning of January, and nor is it the case that any of the nations that are in receipt of these powers are seeking to exercise their veto. What those nations are asking, justifiably, is whether the powers being repatriated under the Bill—not the frameworks—are being constrained in a manner that is significantly different from how they were exercised under the single market in the European Union? These are justifiable concerns. So, with the greatest respect, I do not think that the point made by the noble Baroness, Lady Neville-Rolfe, holds any water at all.
It is of concern that in the first group the Minister was not able to categorically reinforce what has been referred to so far, which was the agreement made among the Ministers of Wales, Scotland and the United Kingdom and the representative from Northern Ireland of the principles of moving forward on the framework agreement. I hope that, when the Minister responds to this, he will be more clear in supporting that. If the approach of this amendment had been followed from the outset, I believe that we would have been able to secure consensus, because it would have been consistent with the manner in which we have been approaching it so far.
The point that my noble friend Lady Randerson indicated, which I thought was a very powerful one and which I hope the Minister is not only aware of but very sensitive to, is that this Bill, probably more than most, brings into stark reality the fact that we do not have a federal Government, which means that there are not designated Ministers for England on devolved areas for England. So we will continue to have UK Ministers who will be operating both at a UK level and effectively as Ministers for England. When it comes to areas of the functioning of the internal market, which is about the four nations, and then separately a consideration at the supra-United Kingdom level, the direct conflict of interest that exists in a Minister making the decision in the interests of England, and thus being the arbiter of the approach of Wales or Scotland as to whether they are in breach of the market principles, is a very valid concern.
We have already heard the example of a decision made on legislation in Scotland, the deposit return scheme, where the Minister himself said in the debate on the first group that, under the Bill, it could be disapplied unless UK Ministers decided that it could be within the principles. Now UK Ministers will decide on that. The Minister is shaking his head. If he is shaking his head, it is on the basis of agreement—which is my point. Consensus would be secured on agreement for that.
What is certainly the case—and the Minister cannot shake his head at this—is that the Bill states that decisions made for England by the UK Parliament cannot be bound by any successor UK Parliament. But if decisions made in Scotland or Wales are overridden by the UK Parliament, those parliaments themselves cannot subsequently legislate within those areas. That is why paragraph 88 of the Constitution Committee report asked the Government to
“explain why clause 6 treats legislation intended for England differently from that passed by the devolved legislatures.”
This is the reality—which is why there is justifiable concern. If there is such a concern, what is a better way of approaching it? A better way, as my noble friend Lord Fox and others indicated, would be to look to other countries.
Before I move on to outlining why I think we could look at international precedents, I would like to pick up a further point regarding dispute resolution. My noble friend Lord Fox and I met the Minister and the noble Lord, Lord True, and I am very grateful to the Minister for sending a long letter answering the points that we raised in the question that we asked about when these issues would inevitably arise in disputes. The Minister’s reply of 13 October was very interesting. He said that
“dispute resolution between Administrations will be managed through the appropriate intergovernmental relations fora and are interlinked with the outcomes of the review of intergovernmental relations which is due to conclude in the autumn. The Office for the Internal Market will have a role in providing independent advice in the dispute resolution process.”
Lord Naseby (Con)
My Lords, I shall resist the temptation to follow the noble Lord, Lord Purvis, in what he has said. However, I reflect that in the other place I was responsible for, and chaired most of, the Maastricht Bill, with 500 amendments and 24 days of debate. Even there, I think that I would have been really stretched to have enabled what is labelled here as a new clause to be put into the purpose of Part 1 on an introductory basis.
I understand the feelings of Scotland, Wales and Northern Ireland. I had the privilege of being Parliamentary Private Secretary in Northern Ireland, and I was a local government leader. Of course they feel strongly, as I do about local authorities and the Covid situation. Nevertheless, it is quite clear that the purpose of Part 1 is
“the continued functioning of the internal market for goods in the United Kingdom by establishing the United Kingdom market access principles.”
It then lists what the mutual recognition and non-discrimination principles should be.
If the Opposition and those who do not like what is in Part 1 want to make a point, there is a case for having a small amendment including just the words “and services”. I see merit in that because, as I said earlier, that seems to have some validity, but to suggest in the introductory part, under “Purpose of Part 1”, that we have to await a statutory instrument
“containing regulations under section 56(3)”,
et cetera, is extraordinary. I cannot believe that there have ever been many Bills where that sort of new clause has been inserted into the introductory part.
Therefore, I say to my noble friend on the Front Bench that there are valid questions arising from this alleged new clause to be asked in the right place, but this is certainly not the right place in this Bill.
Lord Stevenson of Balmacara (Lab) [V]
My Lords, as the noble Lord, Lord Dunlop, said, this debate is a sort of appetiser for the main course to come in later groups, when we will dig much deeper into the right approach to ensuring that our current well-functioning internal market continues after the transition period ends and that we can manage the necessary and inevitable policy divergences that we need across the United Kingdom and should welcome.
The noble Lord, Lord Bruce, said that the key questions are why we need the Bill at all, let alone now, why the Government are ignoring the evident successes of the co-operation and constructive progress which have been hallmarks of the common framework programme, why threaten the devolution settlement so directly, and what it is about the top-down approach that the Government wish to introduce that is so attractive, given the huge risks to devolution. Those are very important questions and I look forward to hearing what the Minister says when he comes to respond.
The noble Baroness, Lady Neville-Rolfe, said that she recognised the value of proposed new subsections (1) and (2) in the amendment but was worried that proposed new subsections (3) and (4) made it a wrecking amendment. I do not think that it is. Indeed, I make the same points about the need for a pause before we implement in my Amendment 178, which is in a later group.
I hope that the Government will think very hard about the clear message that seems to come from this debate. We need to carry on down the road well travelled in recent years, encouraging the devolved Administrations to continue to collaborate, to work together with mutual understanding until agreement is reached, and then to go further so that there is agreement on all the issues that need to be agreed and a way of resolving any issues that are left over. This is the way in which we make progress—not by imposing a top-down solution. Indeed, anything else risks destroying the complex but pretty successful devolution settlement that we currently enjoy.
Lord Callanan (Con)
My Lords, Amendment 4, tabled by the noble Lords, Lord Fox and Lord Purvis, would prevent the market access principles applying by the end of the transition period. As my noble friend Lady Neville-Rolfe pointed out, that would produce a considerable delay in providing certainty to businesses that free trade can continue within the UK’s internal market.
I heard the noble Lord, Lord Bruce, query my assertion at Second Reading about business support for these measures, but over 270 businesses and organisations responded to the public consultation on our proposals and, overwhelmingly, businesses supported our approach. Particularly as they look to recover from the impacts of Covid-19, businesses need certainty, and that is what this Bill, as drafted, seeks to provide.
I repeat that the aim of the Bill is to ensure that there are no internal barriers to trade within the UK, while respecting the devolution policies. All devolved policy areas will stay devolved. The proposals ensure only that no new barriers to UK internal trade are created. The Bill aims only to procure frictionless trade, movement and investment between all nations of the UK. The policies that different parts of the UK choose to pursue in the future is a matter for those Administrations. The Bill ensures that these local policies can be pursued while, at the same time, maintaining seamless trade in the UK internal market.
The noble Lord, Lord Bruce, asked me specifically about barley, and indeed the noble Lord, Lord Purvis, has written to me on the same subject. We believe that this provides a good example of the risks that businesses could be exposed to. Food produce placed on the market must comply with rules on pesticide maximum residue levels. These are currently set at EU level, and so are consistent across the United Kingdom, meaning that food can be traded across the devolved Administrations. This is an example of a policy area which will be devolved after 1 January. At the moment, all Administrations are supported by the same regulator—the Health and Safety Executive. That will, to a certain extent, aid consistency, and we are of course committed to working closely with the devolved Administrations to jointly agree consistent maximum residue levels across Great Britain.
However, without the Bill’s mutual recognition provisions, there would be the possibility of divergent decisions being taken, which would then introduce new trade barriers on food between different parts of our country. Depending on any particular decision, this could affect any agricultural or horticultural produce that has been previously treated with pesticides. For example, different residue rules might mean that it is not lawful to sell in Scotland barley grown in England.
More broadly, without the principles set out in the Bill, harmful divergence would be possible, in spite of the important protection provided by industry standards. That is because industry standards are voluntarily agreed between private economic actors and so cannot provide the same certainty for businesses and investors as the legislative principles set out in the Bill.
The consent process proposed in the amendment would remove that certainty and make operating conditions for businesses across the UK dependent on a number of fairly onerous conditions. These conditions include matters that would cut across ongoing collaborative work with the devolved Administrations. I say to the noble Lord, Lord Bruce, that these include the common frameworks programme and the intergovernmental relations review, both of which the Government are fully committed to pursuing. Indeed, in the next group, we will examine the common frameworks principles in more detail, and my noble friend Lord True will explain our position in more detail.
However, I assure noble Lords that the Government have already committed to appropriate consultation with the devolved Administrations on these matters. Furthermore, we are engaging them in all suggestions for how practically to improve intergovernmental relations, including both the machinery, such as dispute resolution, and the way in which these joint forums are run.
The noble Lords, Lord Fox and Lord Purvis, asked a question about dispute resolution. I can tell them both that the office for the internal market will support existing arrangements for dispute resolution. Its non-binding reporting will ensure that evidence-based dispute resolution takes place in line with the current memorandum of understanding on devolution. The OIM’s reporting will be available to all four Administrations and legislatures on an equal and purely advisory basis. It will provide information and support separate political processes to resolve any disagreements and enable intergovernmental engagement. The amendment would cut across all ongoing collaborative work with the DAs and remove our ability to give businesses the certainty they need at this time.
The noble Baroness, Lady Randerson, said that the Government would override the rest of the UK when legislating for England. That is certainly not our intention. The nature of our constitution is that the UK Parliament will be able to legislate over existing legislation, but the Bill aims to treat all domestic legislation in the same way. Her Majesty’s Government will be cognisant of the importance of market access principles in supporting any extra legislation.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
I have received three requests to speak after the Minister: from the noble Lord, Lord Wigley, the noble Baroness, Lady Neville-Rolfe, and the noble Lord, Lord Purvis of Tweed.
Lord Wigley (PC) [V]
My Lords, the Minister cited the example of pesticides, a subject on which there will almost certainly be unanimity. But on matters such as subsidy control, where there may be a justifiable difference in approach, does the Minister not accept that unless the Government are willing to accept a mechanism such as this to secure consent from the devolved Administrations, he is in effect imposing his solution on them, and cannot in any way claim that this Bill is agreed by the devolved nations—with all the consequences that flow from that unfortunate situation?
Lord Callanan (Con)
The Bill would legislate for subsidy control becoming a reserved matter. We are committed to consulting further with the devolved Administrations before proceeding, if we do, to any further legislation.
Baroness Neville-Rolfe (Con) [V]
I have two questions. First, I called for clarity, trying to explain its importance to organisational success, which, frankly, is very relevant. I noticed almost no support for this from the Benches opposite, yet businesses, citizens and professionals will have to manage in the new market, and if the rules are at risk of changing in different ways regularly, that could be a problem. Obviously, sensible consultation and collaboration are needed, but we must be wary of a political veto. Does the Minister agree that this is a problem, or is the noble Lord, Lord Purvis, right?
My second question is whether the noble Baroness, Lady Randerson, is right or I am. At Second Reading, I mentioned with approval the ability of the devolved territories to do their own thing and gave two examples: minimum pricing of alcohol and carrier-bag charges, both of which I supported at the time. The noble Baroness, Lady Randerson, suggested that the powers to do such things will be undermined, and quoted exactly the same examples. Am I right or is she right?
Lord Callanan (Con)
My noble friend is putting me in the very difficult position of choosing which noble Baroness is correct. If I might venture to say, on the measures she has quoted my noble friend is correct. The Bill has no effect on minimum pricing of alcohol; that is excluded as a policy area, as are all pre-existing measures. This would also apply to carrier-bag prices. The Bill provides clarity and certainty for businesses, which is what we seek.
Lord Purvis of Tweed (LD)
My Lords, I take it as a little chink of victory that the Minister found it difficult to say whether he agreed with his noble friend or me. I will secure that as an achievement of the day, if he does not mind. I will return in a future group to minimum unit pricing and single-use carrier bags, because I am not convinced about that position.
I suspected that the Minister would refer to pesticides, so I took the liberty of reading the Health and Safety Executive’s board report on the framework, which has now been agreed, on pesticides and maximum residue levels. That agreement has been reached, so the concern the Minister is putting forward, of a threat to the operation of the single market, does not exist. That will be a UK-wide provision, and the regulations for Scotland are about policing it. The approach of the HSE has been well established for many years, and the regulation required to police this in Scotland is quite different from what the Government are asserting, which is the exercise of a power that would effectively prohibit goods from entering a Scottish market. That is notwithstanding the fact that if it concerns what is ultimately used for produce such as whisky, it is an industry standard, based on the minimum base that would be taken. The chemicals and pesticides framework from Defra and HSE has been resolved, so perhaps the Minister should stop using this an example. It is not convincing.
Regarding the office for the internal market, the Minister has now said something new: that the CMA, the parent body of the OIM, is involved in existing disputes under the Joint Ministerial Committee’s memorandum of understanding that was agreed after devolution. This will be news to the CMA. Can the Minister repeat that the CMA has a role in the Joint Ministerial Committee’s disputes, under the memorandum? That is what he said in response to the question, but it is not the case. As outlined in the Bill, the OIM has no role in disputes. If the Minister is saying that the dispute resolution mechanism for the internal market is the JMC memorandum of 20 years ago that was agreed for devolution, it simply will not work, because it does not provide for the operation of the single market.
Lord Callanan (Con)
The noble Lord asked a number of questions, and I am sure he will be quick to write to me if I do not answer all of them. On the famous subject of barley and pesticides, he is correct, but the whole point about frameworks is that they are voluntary agreements. Any one of the Administrations can walk away at any time. We are committed to agreeing voluntary frameworks and will continue to take part in those discussions and advocate them, but the point of this legislation is to provide a legislative underpinning for all of the work taking place on frameworks.
Could the noble Lord remind me what the other questions were?
Lord Purvis of Tweed (LD)
I am grateful to the Minister and may well be writing to him on that basis, as he predicted. Can he clarify what the intended role of the office for the internal market will be under the CMA? In a previous answer, he indicated that it has a role in the dispute resolution mechanism in the devolution memorandum of understanding. My understanding is that it does not. Which is the case? If the intention is that the OIM has a role in the dispute resolution mechanism, there is no reference to that in the legislation.
Lord Callanan (Con)
The purpose of the office for the internal market is to provide advice, reports and monitoring to all four Governments and legislatures. It will have no direct role in dispute resolution, which will be a matter for the Joint Ministerial Committee to discuss.
Lord Fox (LD)
My Lords, I apologise to the Deputy Chairman of Committees for having jumped in so soon. I thank all noble Lords for their contributions; the subsequent questions were worth waiting for, so I am glad that I did not plough on.
This has been an interesting debate; however many more hours we will have in Committee, it has uncovered above all else how half-baked—how completely undercooked—this Bill is. It is not worked through. The point of this amendment was to highlight, and give the Government, an opportunity to step back and admit that there are so many open questions and so many issues. I feel sorry for the Minister—I rarely do, but on this occasion I do—because he is having to respond to things that have not been properly locked down in this legislation. So I will look at Hansard, but it is quite clear that, one way or another, we will have to come back on Report to these absolutely central issues. Having said that, I beg leave to withdraw Amendment 4.
The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)
My Lords, we now come to the group beginning with Amendment 5. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. Anyone wishing to press this or any other amendment in this group to a Division should make that clear in debate.
Amendment 5
Lord Hope of Craighead
“Common frameworks process
(1) The United Kingdom market access principles shall only apply to subjects within a description listed in Schedule (Common frameworks) when the common frameworks process in relation to that subject has been exhausted.(2) The common frameworks process is a means by a measure of regulatory consistency in relation to policy areas within devolved competence may be mutually agreed between the United Kingdom and devolved governments.”
Lord Hope of Craighead (CB) [V]
My Lords, I wish to speak to Amendments 5, 11 and 53 in this group, which are in my name and, in the case of Amendment 5, that of the noble Lord, Lord Wigley. They are directed to an issue that, as we have heard, lies at the heart of the way the internal market is to operate in the best interests of all parts of the United Kingdom. The problem to which they and all the other amendments in this group are directed is this: how can the common frameworks programme fit in with the centrally driven market principles laid out in the Bill?
I must declare an interest in the common frameworks programme, as I am a member of the Common Frameworks Scrutiny Committee, chaired by the noble Baroness, Lady Andrews. For us, scrutiny of a number of these frameworks is already work in progress. So we are looking for an answer to that question, too, quite apart from the need to address it for the purposes of the Bill.
I shall introduce this subject as succinctly as I can, but the issue is one of fundamental importance to the devolved Administrations and to the future progress of the Bill, so I hope I shall be forgiven if I take some time to say what common frameworks are and why they matter. The common frameworks are a means by which the UK and the devolved Governments can agree on a measure of consistency across the United Kingdom for those policy areas returned to us from the EU that are within devolved competence. The process has been going on since the European Union (Withdrawal) Act 2018, which mandated it, was enacted. It is founded on the principles that were agreed by the JMC at its meeting in 2017, to which the noble Lord, Lord Dunlop, referred in the previous group.
To begin with, the UK Government identified 142 distinct areas that might need to be addressed. While we were within the EU, legal and regulatory consistency was maintained across the UK in these areas by EU law—but EU law does not insist on complete regulatory uniformity. The degree to which this has to be so depends on the nature of EU law in each given area. In some cases, minimum standards are set by EU law, leaving a measure of discretion to member states. In other areas, EU law is more prescriptive, leaving little room for variation. The devolved settlements were arrived at against that background. The key to their success is that they allowed for policy divergence within the UK in areas that were not reserved to Westminster.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I support almost all the amendments in this group—particularly those tabled and introduced with such great clarity by my noble and learned friend Lord Hope—because they all tend in the same direction: to narrow the focus of the Bill on to areas where agreement cannot be reached with the devolved Governments, on ways of managing the tension between safeguarding the internal market and safeguarding the rights of the devolved institutions to take measures they have been elected to take. I shall address these issues myself later in the debate.
My role in this group is more specific: to explain why I believe that Clause 51 should not stand part of the Bill. Clause 51, regrettably, reflects the general powers of the Bill—powers which are sweeping in the Bill’s attack on the very nature of devolution. The clause would make the whole of the Bill a “protected enactment”. In other words, it would prevent a devolved legislature amending any part of the legislation as it applies in a devolved nation, even if that change would otherwise be within devolved competence.
There is precedent for that, but those precedents reflect the fact that such protection should be applied only to legislation of fundamental importance to the constitution or to human rights. Currently, only the Human Rights Act, the Civil Contingencies Act and the soon to be revoked European Communities Act are protected in their entirety. Even in the case of the European Union (Withdrawal) Act, the Government undertook a clause-by-clause analysis of the Bill to set out the case why some clauses, but not every clause, should be protected. Not only is this Bill clearly not of an equivalent weight to those that I have named; the Explanatory Memorandum even claims that this is an economic Bill, not a constitutional one. That is worryingly inconsistent. If the Bill is not constitutional, there is no justification for making any part of it a protected enactment.
I therefore ask the Minister to explain why each and every clause in the Bill should be protected. Can he please explain why the Bill shows indifference to the whole edifice of devolved government? This House needs a clause-by-clause analysis and explanation of the Bill. That is what happened with the European Union (Withdrawal) Bill, as it then was. Now we need a sound justification, before Report, for the rationale behind the Government’s asking Parliament to pass legislation that requires it to be protected in its entirety, and an explanation of the adverse consequences that would result if it is not protected when it becomes an Act of Parliament.
Baroness Hayter of Kentish Town (Lab)
My Lords, it is always somewhat intimidating to follow an introduction such as the one we have just heard from the noble and learned Lord, Lord Hope. I think I heard him correctly when he said at one point that he did not have a monopoly of wisdom. That was the only bit of his speech that I really disagreed with.
As we heard from the noble and learned Lord and from the noble Baroness, Lady Finlay, we need a mechanism to ensure that the common frameworks are at the start of the process before market access principles are applied. How exactly that can be finessed between the menu of options we have in front of us, with these and other amendments today, can be a question for discussion—as indeed the noble and learned Lord, Lord Hope, indicated. But, essentially, the role of the common frameworks undoubtedly needs a statutory basis. The consensual mode of working that we have seen via the common frameworks surely has to take priority over other modes of rule setting, and a failure-to-agree process—which must be exhausted before other action is taken—needs to be in the Bill, as it is in the common frameworks mechanism.
Like other Members of your Lordships’ House, I was involved in the work of the European Parliament. I was a party functionary rather than an elected Member. Through that I witnessed the discussions, arguments, concessions, joint working, co-determination, consultation, redrafting and mutual respect that went into the emergence of EU regulations. There was no simple imposition by one all-powerful body. Negotiation and agreement were needed between the European Council, the Commission and the European Parliament for action to be taken. As the noble Lord, Lord Inglewood, mentioned, some really big decisions were referred to the IGC—the Intergovernmental Conference. It was a way of working that produced outcomes to which everyone could sign up. Now, consensus building might have taken time; there was the odd time when clocks were stopped at midnight, which we may have to do again today, but the position reached each time meant that all the parties involved could live with the resulting decision.
My view—and I think the view of all of us—is that the internal market process ought to be replicating, albeit on a smaller and much easier scale, those sorts of international and intranational methods that allow for joint working and consensus building as the prime route for decision-making. Of course, some issues will prove not to be amenable to consensus—this too was mentioned earlier—in which case there has to be an agreed adjudication and decision-making mechanism in place, but with the common frameworks procedures exhausted before any of that has to be set in train.
I turn to Clause 51, which has just been mentioned by the noble Baroness, Lady Finlay. This is understandably of major concern to the devolved legislatures and their Governments. In three quite simple, short subsections it amends the Scotland Act 1988, the Government of Wales Act 2006 and the Northern Ireland Act 1998—and all without a word of warning, far less the agreement of any of those elected authorities whose established settlements it undermines. Few of us expected to read a clause like that, dropped into a Bill on a quite different subject, which would blatantly amend these long-developed settlements.
We heard from the noble Lord, Lord Dunlop, in the previous group and we will hear from him shortly in this group. I hope he will not mind if I quote from what he said at Second Reading. He said:
“Devolution is now integral to the UK’s constitutional arrangements. At a time … when it has never been more important for central and devolved Governments to work together … to risk destabilising those arrangements seems careless, to say the least.”
He went on to ask whether
“we want our country’s future to be all about endless intergovernmental competition and conflict or about co-operation and confidence”.
His preference, of course, was for
“a modern, thriving, forward-thinking and inclusive UK union … to look and feel like a joint endeavour”.—[Official Report, 19/10/20; col. 1336.]
That is what this group of amendments is seeking to achieve, but it is not where the Government are going at present. They seem to be thinking of asking us to pass this Bill without legislative consent from the very authorities whose powers are being diminished. I cannot believe that the Minister wants such an outcome, but how seriously does he take this? Is he really happy to completely override the Sewel convention, set aside the success of the common frameworks process and challenge the devolution settlements that have served us so well for so long?
Baroness Humphreys (LD) [V]
My Lords, I will speak to the amendment to Clause 51 in the name of the noble Baroness, Lady Finlay of Llandaff, to which I have added my name. The amendment opposes this clause standing part of the Bill. In a Bill that stands accused of breaching international law and impacting on devolution settlements, this clause is probably one of the most harmful, in the power that it hands to Ministers, and through them the Executive, to make regulations.
As the Explanatory Memorandum explains, regulations made by Ministers under these powers are to be made by statutory instrument and may be used to amend, repeal or modify the effect of legislation, including Acts of Parliament, which of course include the Government of Wales Act 2006—and, as the noble Baroness, Lady Hayter, has just pointed out, all without consultation with the devolved Administrations.
However, the prime function of this clause, and the whole of Part 7, is to ensure that all clauses of this Bill become protected enactments. It neuters the powers of the devolved legislatures, ensuring that they are unable to put forward Acts in their own Parliaments, in their own areas of devolved competence, to modify this Bill if or when it becomes an Act. This is almost unprecedented. The noble Baroness, Lady Finlay, has already told us that, since devolution, the only other examples of protected enactments covering all sections of an Act are the Human Rights Act and the Civil Contingencies Act.
Even in the case of the withdrawal agreement Bill, which was initially intended as a protected enactment, the UK Government produced a clause-by-clause analysis justifying protected enactment status, which eventually resulted in only a few clauses being protected. Why is this approach not applicable to this Bill? The Welsh Government have asked for a clause-by-clause discussion of why each clause should be protected. I would be grateful if the Minister could outline the Government’s response to this request.
Up to now, the Government have not produced any detailed justification of why protected enactment status is necessary, which exemplifies their cavalier attitude to devolution in general. In Wales this is seen as an assault on our devolution settlement, heralding the return of direct rule from England.
We are faced here with another example, as with the Covid-19 response in England, of Whitehall insisting on managing from the centre rather than understanding and empowering local decision-making. The powers of our devolved legislatures and regional mayors, although limited, seem to be resented and distrusted by the Government, and the automatic response seems to be to claw back control to the centre. My fear is that this Government’s unthinking, knee-jerk reactions all add to the perception that the union is not working for the devolved nations and, as I have said in previous contributions, this is encouraging an increasing percentage of people in Wales to conclude that the future lies in independence.
My colleagues and I on these Liberal Democrat Benches want to see true devolution of power to all four nations, including England, in a federal UK where each nation is equal to the other and treated with equal respect. For our party, the union is important because, as federalists we know, that without a union, federalism cannot exist, but we also know, that without federalism, this union will not exist into the future.
Clause 51 is truly indicative of the UK Government’s attitude towards the devolved parliaments and their powers and the desperate need they seem to have to curtail those powers by a show of strength. It is vital to the devolved nations that this clause does not stand part of this Bill, and if the noble Baroness is minded to reintroduce a similar amendment on Report, she will again have my support.
Lord Mackay of Clashfern (Con) [V]
My Lords, I am a very strong supporter of the common framework system, explained so well by my noble and learned friend Lord Hope. One of the defects I find in this successful system, which I think was a very good invention at the conclusion of the withdrawal agreement Bill when it was set up, is that it is without formal parliamentary recognition. I do not know with any degree of completeness what sort of results it already has, except in the reports produced in accordance with the statutory requirement. One does not know the exact detail of the decisions made. I hoped that as the principles went along in the common frameworks procedure, the principles to be set up in the Bill for the internal market in the UK would become evident. However, so far, that has not been fully revealed in Parliament. I am very anxious that some form of recognition in Parliament of decisions taken and agreed should be set up. This is the purpose of the new clause that I propose in Amendment 170. I do not stand closely on the wording, but some recognition of what is happening in Parliament and ensuring that it is regarded as part of the law would be a useful addition to the present procedure.
The situation between the devolved Administrations and an internal market was regulated by the European Union, therefore some form of renewal of that may be required. I notice that the Scottish Government have said they would not introduce any changes that would damage the internal market, pending legislation. Of course, that is only on the basis that legislation would be something to which they were able to agree. I am very anxious that the results of what we do now should not damage the arrangements for devolution in a way that would point towards independence.
Lord Foulkes of Cumnock (Lab Co-op) [V]
My Lords, I am speaking in support of my Amendments 172 and 173, which, in two different ways, as the noble and learned Lord, Lord Hope, said, seek to achieve the same as his amendment. Like the noble and learned Lord, Lord Hope, I am a member the Common Frameworks Scrutiny Committee chaired by the noble Baroness, Lady Andrews, and I am pleased to be so. Also a member is the noble Lord, Lord Bruce of Bennachie, who spoke earlier on Amendment 4. He described it as a consensus amendment. I wondered—if it was a consensus amendment—why he did not seek a consensus within the House on it, but I discovered why when I opened my Scotsman this morning and saw the big story, which sought to imply, I think, that the Liberal Democrats were taking credit for opposing this Bill and not wanting others to get any credit for that, but he got the support of the SNP in doing so.
Like the noble Lord, Lord Bruce, I am a long-term supporter of devolution. As some here will recall, I campaigned for it in the 1960s and 1970s, when there were few supporters of it in the Labour Party—John P Mackintosh, Donald Dewar and myself were three of the few—there were even fewer in the Tory party and none in the SNP, who wanted then, as they do now, complete separation. When people are picking up arguments in the cause of the SNP, they should never forget that.
Devolution is different from the unitary state we had. I recall well when in Westminster we were dealing with education in Scotland, which was administratively devolved. That was one of the main arguments for devolution: to have legislative control over what was administrative devolution. Devolution is also totally different from separation, but the SNP now see devolution as a means to achieve their aim, as a slippery slope to independence, and that is something we must be wary about. To the noble Lord, Lord Cormack, who spoke in a debate earlier, I say that Westminster remains ultimately sovereign in relation to all matters, although, if it oversteps the mark and tries to do something unacceptable, there must be other consequences.
As others have said, unfortunately devolution was never followed through in England, and we are left with a difficult situation, difficult most of all for the UK Government who regularly try to act on behalf of England as well as their overall responsibility for the United Kingdom. We have seen that in stark perspective in the pandemic. It does not help when the noble Lord, Lord Inglewood, describes them as the English Government. Successful devolution needs understanding and co-operation between both levels. Incidentally, as some people tend now to forget, it was envisaged originally that powers might be transferred back to Westminster if experience has shown something could be dealt with more appropriately at that level.
What I find a bit alarming is how some colleagues—those who were not in favour of devolution before—now seem to believe that the devolved Administrations are always right. It reminds me of the zeal of the convert. There is no greater critic of the Tories than me—I think the noble Lord, Lord Callahan, the Minister, will confirm that. Incidentally, they are not always wrong, but, thankfully, they are not going to be in power forever here at Westminster, so we need to have a more long-term perspective. On this transfer of powers from the European Union, the SNP describes it as a power grab and the Tories describe it as a power surge. Neither is true or helpful.
Before our regrettable withdrawal from the EU, we accepted that all these powers were better dealt with for all of the United Kingdom—Scotland, Wales, Northern Ireland and England—at a European level because we were all part of a common market. Now, we continue to have a common market here in the United Kingdom, so it is sensible that as many of the transferred powers as possible should be dealt with on a common basis. However, it is my view—as it was that of the noble and learned Lord, Lord Hope, and others—that this is best done by agreement through a common framework procedure and by ensuring there is, as one of my amendments says, no regression or diminution of the standards that we take back from Europe. That is what my amendments seek to achieve in different ways.
It could be, as some noble Lords have said, that all four countries have to agree or—the Minister might like to think about this—it may be appropriate to have a qualified majority, so that one Government could not block something useful by mischievous means.
Incidentally, there has been mention again today, from the noble Lord, Lord Purvis, of the threat to minimum alcohol pricing in Scotland. The Minister dealt with it well. It is, therefore, useful to recall that there was a challenge to minimum alcohol pricing, but it came from within Scotland, from the Scotch Whisky Association, based on it breaking European Union law. Interestingly, the ruling was that it did not break European Union law, and it was the United Kingdom Supreme Court that made that ruling. It is important that we separate party politics, which is not easy for us party politicians, and look at what is best for consumers and the public in general. That may be that things are decided at the UK level, or by Wales, Northern Ireland and Scotland separately.
We will soon need to sort out the English democratic deficit, which is real for the people in England and the regions in particular. We need to make devolution complete with a scheme for England, then the United Kingdom Parliament can properly carry out its federal role, maybe with a somewhat different role for the second Chamber.
Meanwhile I, like the noble and learned Lord, Lord Hope, hope that the common frameworks procedure sets a good co-operative working example. It is a better way than the Bill. I say to the Minister—I have not disagreed with him on everything—that it is a better way of dealing with this than the Bill in its current form, as the noble and learned Lord, Lord Hope, rightly said in his introduction. I hope the Minister will accept the general principle of these amendments, before we return to the Bill on Report. It would certainly make his life a great deal easier.
Lord Hain (Lab)
My Lords, it is a pleasure to follow my noble friend, with whose speech I completely agree. I speak to Amendment 175, which is also in the names of the noble Baronesses, Lady Altmann, Lady Suttie and Lady Ritchie. It ensures that no regulations may be made under the ensuing Act affecting matters that were within the devolved competence of Scottish Ministers, Welsh Ministers or a Northern Ireland department prior to 31 January 2020, unless a common framework on the United Kingdom internal market or the relevant aspect of it has been agreed between the United Kingdom Government and the relevant devolved Administration or Administrations. In this respect, I agree with all the speeches so far, which began so eloquently and compellingly with the noble and learned Lord, Lord Hope.
Sadly, the Government believe that the best method to achieve their objectives in negotiations with an international partner is to stick out their metaphorical tongue and say that, if they do not cave in, they will tear up an agreement made less than a year ago, even when Britain has more to lose than the EU if there is no agreement. Despite the Sewel convention that the UK Parliament
“will not normally legislate with regard to devolved matters without the consent”
of the devolved legislatures, the Government chose to ignore that all three devolved legislatures denied consent to the EU (Withdrawal Agreement) Bill. I suppose we should not be surprised that, when it comes to the devolved nations of these islands, the Government seem to believe that they hold all the cards and have nothing to lose—apart from, perhaps, destroying the United Kingdom once and for all.
The Government claimed, in their White Paper published in July 2020, that the proposals for the UK internal market would provide frictionless trade, fair competition and protection for businesses and consumers in the UK. However, as pointed out by the think tank UK in a Changing Europe, there is no urgency to introduce such internal market rules because all parts of the UK have been within the integrated EU single market for decades; we have all been together.
The provisions of the Bill are highly controversial. Those in relation to the Northern Ireland protocol have provoked legal action by the European Union and could yet undermine the basis for an EU-UK trade deal. Others cut into the ability of the devolved Governments in Scotland and Wales to regulate economic activity. Not surprisingly, the Scottish Parliament has voted against consent to the Bill, which it said
“constrains the competence of the Scottish Parliament and breaches international law.”
The Welsh Government have recommended that the Senedd follows suit.
So far as Northern Ireland is concerned, what is finally agreed—or not—at a UK-EU level will have far more impact on Northern Ireland’s trade with the rest of the UK than will this Bill. That is because the powers of the Northern Ireland Assembly are already constrained by the Ireland/Northern Ireland protocol, under which Northern Ireland will continue to follow the same EU rules on goods and on customs that it follows now.
For this reason, the market access principles set out in the Bill will not deliver unhindered trade within the UK, as Brexit itself will introduce such friction. After 31 January, the greater Great Britain’s divergence from EU rules in a race to the bottom, the greater the friction on the movement of goods from Great Britain into Northern Ireland, as goods will not be allowed into Northern Ireland unless they meet EU standards. There will also be an impact in the other direction, as lower standards in Great Britain would put Northern Ireland goods at a competitive disadvantage.
These market access measures in the Bill therefore appear to be a power grab against the devolved authorities, especially those of Scotland and Wales. This is because the provisions of the Bill will narrow the territorial scope of devolved legislation, which will apply only to goods produced in that territory, not to those imported from other parts of the UK. The Bill includes a much more restricted set of public policy justifications for exemptions from the market access principles than is permitted under EU law. This, as acknowledged in the business department’s impact assessment of the internal market White Paper, will curtail the ability of the Scottish and Welsh Governments to introduce targeted measures, for example, for social and environmental objectives.
Without the protection of these amendments, therefore, the market access principles will significantly undermine the ability of the devolved Administrations to address their own local needs or political preferences, which is surely the whole purpose of devolution. The Welsh Government have confirmed:
“The Bill automatically applies market access principles without requiring intergovernmental agreements, which will effectively nullify/override Welsh rules on product standards, environmental standards and professional qualifications.”
Referring to “this unnecessary Bill”, the Scottish Government called it an “unprecedented threat” to the Scottish Parliament’s powers. For example, if lower food and environmental standards were allowed elsewhere in the UK, Scotland would be forced to accept them. They also noted that, under the proposals, the UK would take over key devolved spending powers and
“the devolved policy of state aid”.
As for Northern Ireland, the UK Government have ignored a Motion passed by the Assembly in June, calling for an extension to the transition period. Matthew O’Toole, a Member of the Northern Ireland Assembly for the SDLP, has said that the Bill may go down in history
“as one of the most disreputable and damaging pieces of legislation ever proposed at Westminster”
on the grounds that
“it jeopardises all the protections against a hardened border between the north and south”
and that it has undermined trust in one of the signatory parties to the Good Friday agreement.
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In 2017, despite deep differences on Brexit, the UK and the devolved Governments announced that they had agreed the principles that would guide the development of common frameworks to set out a common UK or GB approach, and to managing the internal market. The UK Government reiterated their commitment to respect the devolution settlements. Common frameworks are not mentioned in the Bill and it is unclear whether regulatory rules established through the common frameworks process would be subject to the market access principles. For example, the Nutrition Related Labelling, Composition and Standards Provisional Common Framework, published on 9 October, notes
“The framework arrangements within this framework will also link into any future arrangements for the UK Internal Market.”
However, that does not provide any clarity on how the two will be linked. This programme, which admittedly is as yet a largely subterranean creature with little visibility to your Lordships’ House, has made good progress. It is true that not all will have completed the process by the end of the transition period, largely thanks to the disastrous negotiation strategy of the Government which led to two abortive sets of no-deal preparations. However, I understand that most if not all have been agreed on a provisional basis and that the devolved Governments have undertaken to fully respect them until they have been through legislative scrutiny.
Moreover, since all parts of the UK will inherit retained EU law, it is completely misleading to claim that there will somehow be a dangerous void in the statute book without this Bill. The only void there will be is where the UK Government want to leave one, notably on state aid policy. What there would be in the absence of this Bill is a restraint on the UK Government being able to tear up retained EU law on environmental standards, food standards, the mutual recognition of qualifications, and would de facto force the devolved Governments to follow suit. That is why this is so objectionable. If pressed, this Bill would undermine the good progress made in many of the areas where common frameworks are being developed, and it is not clear how the provisions of the Bill and the common frameworks could function alongside each other. I hope that the Minister will respond to that point.
I shall take just two examples. If this Parliament decided to permit English farmers to use certain antibiotics that are currently banned for treating animal disease, the sale of English products containing those antibiotics could not be prevented in Wales unless the Welsh Government could demonstrate an immediate threat to public health rather than the slow erosion of antimicrobial resistance. If Scotland wanted to introduce a new requirement for headteachers to obtain a specialist qualification in identifying and dealing with mental health issues in young people, the Scottish Government would struggle to prevent an English or Welsh teacher without that specialist qualification being appointed to a headteacher post in Scotland. For this reason, I wholly endorse the other Cross-Bench amendments suggested by the Welsh Government and tabled by the noble Baroness, Lady Finlay, and others, which would restrict the application of the so-called market access principles to areas where negotiations over common frameworks have broken down. This would give the Government every incentive to work with the devolved institutions to agree common frameworks and the chance to come back to this House and the other place if they believe that a devolved Government were attempting to wield a veto. Surely the way forward is to negotiate common framework agreements in all areas where the UK Government feel they have an interest, but which cover areas within devolved government competences. That is what the amendment seeks to achieve, and for the life of me, I cannot comprehend why the Government will not accept it. Perhaps the noble Lord the Minister will explain.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I declare an interest as a member of the Common Frameworks Scrutiny Select Committee, ably chaired by the noble Baroness, Lady Andrews. The noble Lord, Lord Foulkes, and the noble and learned Lord, Lord Hope of Craighead, are also members of the committee. I am a signatory to Amendment 175 along with the noble Lord, Lord Hain, and the noble Baronesses, Lady Altmann and Lady Suttie. The specific purpose of the amendment, as ably demonstrated by the noble Lord, Lord Hain, is to state that no new UK regulations can be made affecting any area that devolved prior to Brexit, including any area with cross-border impacts, without a common framework agreement with the devolved Governments concerned.
As has already been explained, these amendments, particularly this one and others in this group, focus on the primacy of the common frameworks and the importance of devolution. In many instances, throughout this Bill, the Government seem intent on power grabs from devolution to bring power directly to Whitehall. Quite clearly, the aim of our Amendment 175 is to protect devolution. I can think of those special devolution arrangements in Northern Ireland—of which I was once a part as a member the Northern Ireland Assembly and also as a former Minister—that arose out of the Northern Ireland Act 1998 and as a consequence of the Good Friday Agreement. They were based around those interlocking sets of three relationships within Northern Ireland: between north and south on the island and east-west between Ireland and Britain, and the accompanying infrastructure arrangements. These were reflected in the Northern Ireland protocol, and in the Withdrawal Agreement that the Government now seem intent on scuppering through this UK Internal Market Bill.
Interestingly—as the noble and learned Lord, Lord Hope of Craighead, and others have referred to—this Bill does not contain common frameworks. I was at a recent briefing with others, such as the noble and learned Lord, Lord Hope. It was very well organised by the Minister and the noble Lord, Lord Callanan. It was attended by the Minister for the constitution, Chloe Smith. She indicated that the reason why the frameworks were not in the legislation is because they are not all legislative. I found that reason very odd, but also very hollow and flimsy. As the Centre on Constitutional Change has stated, common frameworks are not mentioned in the Bill and it is unclear whether regulatory rules established through the common frameworks process will be subject to the market access principles. This is an issue that has also been addressed by the Lords Constitution Committee and by a group of academics for the Centre on Constitutional Change in their paper entitled UK Internal Market Bill Devolution and the Union, which was published last week.
To go back to the Lords Constitution Committee, it states at point 15 in its conclusions that:
“The Government should explain why the Bill does not mention common frameworks and how it expects the arrangements for the UK internal market will relate to the common frameworks.”
It further states at point 16 that:
“The Government has failed to explain why a combination of retained EU law, its existing powers to amend that law, and common frameworks could not provide the certainty required at the end of the transition period to secure an effective UK internal market. Such an approach would obviate the need for the Bill.”
Academics for the Centre on Constitutional Change who published their paper last week stated:
“By abstracting the internal market from these frameworks and pushing ahead unilaterally against opposition from the authorities in Scotland and Wales, the UK Government is putting the common frameworks approach at risk.”
They also state that the market access principles in the Bill weaken devolution, reduce divergence and risk undermining the objectives and principles that have guided frameworks discussions.
The market access principles within the Bill undermine devolution competences in two ways. The UK Internal Market Bill itself will become a protected enactment, which the devolved legislatures will be unable to repeal or modify—hence our Amendment 175.
The Bill also narrows the territorial scope of devolved legislation. Currently, devolved legislation applies to all relevant activity within the devolved territory. This will no longer be the case as a result of this Bill, if it is enacted. The effect of the market access principles would, therefore, significantly undermine the purpose of devolution, which was to enable the devolved nations and regions to legislate according to their own local needs and political preferences. While I am supporting and speaking to Amendment 175, I also support other amendments in this group because they clearly specify the importance of devolution and, above all, the common frameworks scheme.
Baroness Altmann (Con) [V]
My Lords, I have added my name to Amendment 175 in this group, led and excellently explained by the noble Lord, Lord Hain, and in the names of the noble Baronesses, Lady Ritchie of Downpatrick and Lady Suttie. I also support Amendments 5, 11 and 53, so excellently moved and spoken to by the noble and learned Lord, Lord Hope, and others that seek similar objectives.
This is not a party-political matter. Our devolution settlement was originally pioneered by a Labour Government, then deepened and extended by the Conservatives—as explained by my noble friend Lord Dunlop—and clearly supported by the Liberal Democrats, giving the devolved Administrations additional powers. As other noble Lords have said, common frameworks are important and our existing carefully crafted settlements have kept our union united. Surely, a successful devolution of power cannot consist of dictating to the constituent nations what will happen, informing them what they have to agree to and then saying that they have been consulted, so all is agreed. This is how the measures in this Bill have clearly been perceived by the devolved Parliaments.
We are a federal nation, comprising four proud countries. Until now, our devolution settlement has allowed divergence, even on matters such as taxation, where Scotland has different tax rates. These divergences have been well accepted across the country and ensure clear powers for each of our constituent nations. I will ask my noble friend two questions. First, is he able to confirm that the Government respect and accept the devolution settlement, which has served our United Kingdom so well? Secondly, Amendment 75 and others in this group merely insert proposals to ensure that future regulations will be introduced with a consensual approach. Could my noble friend explain the Government’s objection to such a consensual approach?
Baroness Suttie (LD) [V]
My Lords, I have added my name to Amendment 175, which is, once again, a cross-party amendment, tabled by the noble Lord, Lord Hain—who very powerfully and comprehensively explained it in great detail—and the noble Baronesses, Lady Ritchie and Lady Altmann. In the debate on this group of amendments, as well as on the previous group, noble Lords from all sides of the House have acknowledged that the common framework process has been a positive one. Therefore, I shall concentrate my brief remarks on the Bill’s impact on the delivery of the common framework agreements, which play such an important role, not least in avoiding future disputes and building consensus.
The Bill has illustrated the very worst of a top-down No. 10 decision-making process, with little or no engagement with the devolved Administrations in advance of its publication and in spite of the very real impacts that it will have on every part of the United Kingdom. I would argue that this top-down approach almost always results in rushed and poorly thought-through legislation, which will almost inevitably lead to unnecessary disputes with the devolved Administrations. As the noble and learned Lord, Lord Hope, explained in his excellent and very comprehensive speech at the beginning of this debate, it is, frankly, extraordinary that common frameworks are omitted from the Bill.
In a report published earlier this month, the Institute for Government stated:
“This legislation will cut across many of the areas where common frameworks are due to be developed. It is not clear how the bill and the frameworks are intended to function alongside each other.”
This gives rise to a number of questions. Will the Minister clarify exactly how the common frameworks will be linked to future arrangements for the UK internal market? Does he accept that, as it stands, the Bill risks undermining the ongoing joint review of intergovernmental relations, including the development of common frameworks? Does he acknowledge that this process has been significantly further complicated by the introduction of this Bill?
Lord Dunlop (Con) [V]
My Lords, I support the group of amendments tabled by the noble and learned Lord, Lord Hope. They address a central question: how does this Bill sit alongside the common frameworks process? Common frameworks are the process established to ensure that once the UK has left the EU’s legal orbit, policy and regulatory divergence does not damage the seamless operation of the UK’s domestic market. Unimpeded trade within the UK is something we all agree on.
The common frameworks process was initiated while I was still a Northern Ireland and Scotland Office Minister. The frameworks analysis informing it—the latest iteration of which was published only last month—provides a full assessment of the risk areas arising from EU powers flowing back directly from Brussels to Edinburgh, Cardiff and Belfast. As the noble and learned Lord, Lord Hope, explained, the latest analysis identifies 154 policy areas—115 are deemed to require no further action and 22 require a non-legislative framework, leaving just 18 identified as needing such a legislative framework. Examples in the latest analysis include food standards and labelling, mutual recognition of professional standards, the provision of services, and chemicals and pesticides. As an aside, I am even more confused about the position on pesticides than I was before. When winding up, perhaps the Minister could clarify whether chemicals and pesticides will be a legislative framework. I thought I heard my noble friend Lord Callanan say that it would be a voluntary agreement, from which the devolved Administrations could walk away.
So far as one can tell, this process of common frameworks is making progress—though more slowly than originally intended as a result of Covid. Seven will be in place by the end of the year with a joint commitment from all Governments to deliver the remainder during 2021.
In its detailed report on the Bill, the Constitution Committee concluded:
“The Government has failed to explain why a combination of retained EU law, its existing powers to amend that law, and common frameworks could not provide the certainty required at the end of the transition period to secure an effective internal market.”
When responding to the Second Reading debate, my noble friend Lord True argued that common frameworks are insufficient because they are sector-specific and cannot guarantee the integrity of the entire market. In responding to this debate, I hope that my noble friend will take the opportunity to explain in greater detail the Government’s concerns and the rationale for the approach adopted in the Bill.
There are three specific points that I hope the Minister will address, relating to necessity, urgency and proportionality. First, on necessity, my noble friend Lord True said in his wind-up speech last week:
“The Bill ensures that areas without a common framework will still benefit from the regulatory underpinning and, crucially, market coherence will be provided for issues that fall around, or between, individual sector-focused frameworks.”—[Official Report, 20/10/20; col. 1427.]
I am puzzled by this explanation, as my understanding has always been that the portfolio of legislative and non-legislative frameworks was intended to represent a comprehensive package for managing the identified risks of divergence arising from EU exit. As I have already mentioned, many of the areas identified to be covered by frameworks are cross-cutting, and not simply sectoral, such as public procurement, recognition of professional standards and the provision of services in general. Therefore, can the Minister be more specific in identifying what the issues are that the Government are so concerned about that fall in and around individual sectors, which have not already been identified in the common frameworks analysis?
Secondly, on urgency, I hope the Minister will explain why the Government are legislating in such haste. Yes, this is a major and important piece of economic legislation, but it is also a Bill with significant constitutional implications, not least for the stability of our devolution arrangements and the future of the union. This matters because there are important gaps in the scheme created by this Bill. For example, where in this scheme are the conclusions from the review of intergovernmental relations? When will the review be concluded and published, associated as it is with the work on common frameworks? How will the provisions of the Bill be enforced, and how will disputes between the UK Government and the devolved Administrations be managed?
The timetable for the Bill appears to be predicated on the end of the transition period on 31 December this year, but what is the real risk of regulatory divergence between then and the completion of the common frameworks process in 2021? The House is aware that the European Union (Withdrawal) Act 2018 already confers on Ministers so-called Section 12 powers to freeze devolved competence in relation to EU retained law. It is worth reminding ourselves of its provisions. Ministers can make regulations to restrict the ability of devolved Administrations to change EU retained law for up to two years after our formal exit from the EU. Should they make such regulations, these could remain in force for up to a further five years, so by my reckoning to January 2027. Therefore, on the face of it, there is ample time for the Government to put in place—in co-operation with the devolved Administrations—the necessary protections in the form of common frameworks and the associated intergovernmental architecture to protect the seamless operation of the UK domestic market. In light of the existing legislative protections that are already in place, will the Minister explain the need to legislate on this accelerated timetable, which, as we have heard, has not allowed sufficient time for more than the most cursory consultation? On the subject of consultation, can the Minister confirm whether all the responses to the consultation have been published? If not, will he give a commitment today that they will all be published in full and in short order?
Thirdly, and finally, on proportionality, the Government may be motivated in bringing forward this Bill by Mr Rumsfeld’s famous “unknown unknowns”. Ministers may indeed be confident that a portfolio of common frameworks can do most of the job, but still want to put in place an insurance policy to cater for unforeseen circumstances or to have a mechanism for monitoring the cumulative effects of policy and regulatory differences, which on their own may be entirely harmless. That is fair enough, but if that is so, then is not the scheme in this Bill the wrong way around? Instead of effectively overriding from the outset the practical ability of devolved Administrations to regulate differently to reflect local priorities and to suit local circumstances—and in the process potentially compromising a core benefit of devolution—would it not have been preferable for the Bill to provide a safety net of last resort? Would that not provide a better balancing of the needs of free trade within the UK with the need to respect the roles and responsibilities of the devolved institutions? Would not this create better incentives for all parties to agree sooner rather than later the full package of common frameworks? We all agree with the aims of this Bill. However, I suspect the Government will need to do more to convince the House that the legislative scheme in the Bill is the best way to achieve those aims.
Baroness Andrews (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Dunlop, and indeed to agree with much of what he said. I support the amendments in the name of my noble and learned friend Lord Hope.
I should declare an interest as the chair of the Common Frameworks Scrutiny Committee. The House will judge that I have a formidable group of Peers to do the work, and we have heard from some of them this evening. It has been splendid to hear so much exposure given to common frameworks because, as many other noble Lords have said, the Bill is silent on them.
It is a particular pleasure for me personally to support these amendments because they are a model of clarity and common sense. They track the history and purpose of, and the co-operation involved in, the common frameworks in the context of our membership of and exit from Europe, holding firm to the principle and practice of devolution.
The Government are silent on the common frameworks and silent on the years of hard negotiation that has gone into them so far to ensure that the principles that govern them bear fruit. I am surprised at that silence because in everything that the Ministers have said so far—and they have said it informally in communications with us, which we very much welcome—they have insisted that they still support the principles of the common frameworks and their role in stabilising the internal market, yet in effect these clauses drive a stake through them.
As my noble and learned friend Lord Hope said, the common frameworks allow for reconciliation across an enormous range of highly sensitive areas of policy—from the safety of baby milk to protections relating to the location and storage of hazardous waste, to maintaining future emissions trading. It has been a slow and careful process because the dispute mechanisms and the legislative frameworks have to be resilient if the internal market is to work with integrity in the future.
As the noble Lord, Lord Dunlop, said, at Second Reading the Minister defended these clauses in the Bill on the grounds that this matter needs regulatory underpinning, because there are issues that fall around and in between the frameworks. First, as he also said, they are not entirely sector based, but the real puzzle for all of us is where these identifiable gaps are. If there are indeed gaps, could not other frameworks be developed as appropriate? We already have the models in front of us. Therefore, like the noble Lord, Lord Dunlop, I would be very interested if the Minister could now tell us in more detail what these issues are that fall around or between the individual sectors. What is the problem to be solved here?
The best clue that we have is that the Minister has suggested that the Bill is needed in case there are future developments that cut across seamless trade. Again, it is impossible to know what the Government think is likely to happen, why they cannot share that with us and why such developments cannot be accommodated. So far, no Minister and no officials, in formal and informal conversations, has come up with an instance of what this means.
It is the more frustrating because, by definition, the frameworks are dynamic. They will be under regular review—they are work in progress. If there is a push for further divergence, the reconciliation and dispute processes kick in. The union becomes the stronger because it acknowledges that culture, demography, local economics and geography drive diversity. If the Government fear that somehow, and at some point, unacceptable barriers to trade will be erected across the union, surely the frameworks are the solution and not the problem.
The Bill is important. It is also important not to exaggerate, but I believe that these clauses will exact an enormous price if they are not amended, as my noble and learned friend Lord Hope suggests. The mutual recognition principle becomes the default position, no matter what the devolved nations hope to achieve. The Government argue that, for example, we have the highest environmental standards in the world. Indeed, we might, but how can these be upheld in a highly competitive market where cheaper food invites cutting standards? How can each nation continue to drive down salt content in food if a cheaper product with a higher salt content becomes available for sale across the UK?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the noble Lords, Lord Naseby and Lord Cormack, have withdrawn. I therefore call the next speaker, the noble Lord, Lord Rooker.
Lord Rooker (Lab) [V]
I was attracted to speak to this group of amendments by Amendments 5, 11 and 53, in the name of the noble and learned Lord, Lord Hope of Craighead, and, as I have listened to the debate, I have begun to wonder even more why the Bill is required in the first place. At the risk of upsetting my good and noble friend Lord Foulkes—and I certainly do not want to get involved in Scottish internal politics; that is my caveat for what I am about to say—as a Minister in MAFF, Northern Ireland and Defra, and as chair of the Food Standards Agency, I worked very closely with several Ministers in the Scottish Government, and I always found them totally professional and focused on the issue at hand at the time.
Nobody has asked me to make a speech today on this matter, but I am going to raise matters raised by Food Standards Scotland in consultation in August and in the recent letter in October. The very reason the Food Standards Agency and Food Standards Scotland exist is to ensure that policy formation, regulation and enforcement in relation to protection of consumers’ interests are clearly separated from those responsible for food industry growth and promotion. Food Standards Scotland says the Bill blurs that distinction, which has been in place since the FSA was formed after the BSE crisis in the 1990s. Both the FSA and the FSS have a legal duty to
“protect public health from risks which may arise in connection with the consumption of food”.
That comes from the Food Standards Act 1999 and the Food Scotland Act 2015.
Only a few weeks ago, the UK Government confirmed in their report on the common frameworks that the powers they have to restrict devolved competence under Section 12 of the European Union (Withdrawal Agreement) Act—referred to by the noble Lord, Lord Dunlop—had not been used precisely because
“significant progress is being made across policy areas to establish common frameworks in collaboration with the devolved administrations.”
No party has ever expressed the need for, or provided evidence in support of, a statutory framework to regulate the UK internal market in the way that this Bill tries to do.
It is worth pointing out that the current internal market makes provision to allow the devolved Governments to impose conditions such as labelling and composition requirements or price mechanisms on food business operators in order to meet a public health objective, provided that the proposal meets an overriding public interest test. The Bill makes no equivalent provision and, indeed, makes clear that business cost is the primary driver, with no consideration of either public health costs or non-financial consumer interests and protection. The Bill does not advance the protection of consumers, other than in cost reduction. If consumer interest is defined solely by cost, it is inevitable that it will drive down standards, because lower standards are less costly.
I will briefly deploy three examples of existing responsible policy-making that is fully in line with current UK market issues and industry pressures. They are all evidence based, taking account of industry impacts as well as consumer interests. These three examples of why the present arrangements work were all given in August to the Business Secretary, Alok Sharma, by Food Standards Scotland—to which he has never responded.
The first is the fortification of flour with folic acid to improve pregnancies affected by neural tube defects. This policy has been advocated for some time by the Scientific Advisory Committee on Nutrition and I have raised it in your Lordships’ House on several occasions since November 2013. In the absence of UK Government action, Food Standards Scotland was asked by the Government there to carry out an assessment for Scottish Ministers. It did, and concluded that the nature of the UK market was such that all flour would require fortification and differentiation in product lines was not possible. Food Standards Scotland concluded that a separate Scottish solution should not be followed. UK-wide action is currently under consideration, of course.
The second example is the prohibition of the sale of raw drinking milk in Scotland. The original wide ban has been continued in Scotland, based on illness and deaths and the advice of the Advisory Committee on the Microbiological Safety of Food. Controls in England, Wales and Northern Ireland are less restrictive than in Scotland, so different rules apply. The current system works, and Food Standards Scotland is at a complete loss to understand why the Bill appears to save the existing unique provisions; it is clear that future provisions introduced on public health grounds are not protected. In other words, what will be saved now would not be protected if further provisions were introduced. The Government are making assertions that, without legislative underpinning, unnecessary regulatory barriers could emerge between different parts of the UK. The Government have given not a shred of evidence to support this assertion.
The third example concerns allergen information for consumers on “prepacked for direct sale” foods—that is a unique type of food. Working with Defra, the Food Standards Agency and Food Standards Scotland developed proposals to improve information following the tragic death of a teenager eating a baguette containing undeclared sesame seeds. Four options were considered as part of a UK-wide consultation. In short, option 4 was recommended as in the best interests of consumers, even though option 1 was the cheapest for industry. Under the Bill, if, for example, one of the bodies had opted for option 3—slightly less than option 4—the body that had chosen option 4 would have to go for option 3. Worse still, using the Competition and Markets Authority, it is likely that option 1, which was simply aimed at raising consumer confidence without regulation, would be chosen. It would be the cheapest for industry but the most unsafe for the consumer. These three examples of responsible policy-making show that the current common frameworks system should be used, and be shown to fail, before we move to the mutual recognition system outlined in Clause 2.
Finally, as was referred to earlier, diet conditions might in future require labelling of, for example, high fat and high sugar on public health grounds. This can work perfectly well under the current arrangements. Under the Bill, however, one part of the UK could be lobbied to reduce information on packaging which other parts would be required to follow. I cannot support the lowest common denominator; it is unsafe for consumers. I hope that, in due course, the noble and learned Lord, Lord Hope, will press his solution.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I am delighted to speak to and support the amendments in this group. The debate demonstrates that it is not just Part 5 of the Bill that has created concern. In particular, I support Amendments 5, 11 and 53 in the name of the noble and learned Lord, Lord Hope of Craighead, and Amendment 170 in the name of my noble and learned friend Lord Mackay of Clashfern.
The House owes a great debt of service to the two noble and learned Lords for so clearly identifying the problems with the Bill and its complete oversight and omission of the common frameworks. In particular, they identify the problem of future common frameworks and their relationship to the Bill. But my concern is that, as there has not yet been agreement on the 18 common frameworks that may require legislative decisions, there may be some uncertainty. I note in passing that, of the 18, a large majority relate to issues being dealt with by Defra. They primarily concern agriculture, food and, to a certain extent, the environment, and that is a source of concern.
I express a concern over Schedule 1 and the impact on movements of animals and farm goods, in the event of threats to human, animal or plant health. The noble Baroness, Lady Andrews, referred to the default position appearing to be mutual recognition. Paragraph 2(2) of Schedule 1 refers to the “first condition” that would form an exclusion:
“the aim of the legislation is to prevent or reduce the movement of unsafe food or feed into the part of the United Kingdom in which the legislation applies … from another part of the United Kingdom”.
As the noble Lord, Lord Rooker, set out in some detail—I entirely endorse what he said—it is all very well when the Food Standards Agency in England and Food Standards Scotland take a similar view. I put to the Minister, for his reply when summing up the debate, my view that Schedule 1 indicates the need for common standards of human, animal and plant health to ensure free movement between England, Scotland, Wales and Northern Ireland. I thought that was the whole purpose of the Bill.
What will happen in future if the Food Standards Agency in England and Food Standards Scotland take different views on food, animal feed or a product from either state? Will Scottish produce be blocked from entering other parts of the United Kingdom, under Schedule 1 and other parts of the Bill? That would cause me great concern.
Finally, I endorse and support Amendment 170, in the name of my noble and learned friend Lord Mackay. He has identified the problem that there is simply no statutory basis for common frameworks. If so, would it not be better to have a common frameworks statutory basis to deal with all the problems that have been addressed during the debate?
Baroness Noakes (Con)
My Lords, it seems that most of the noble Lords who have taken part in this debate have looked at the Bill through one end of a telescope, which focuses on the powers of the devolved Administrations and the threats or perceived threats to them. There is another end of the telescope you could use to look at the Bill, which shows that businesses in all parts of the UK need the certainty of knowing how they will be able to trade within the UK, going forward. That is important for those businesses trying to build a successful economy, particularly coming out of the Covid pandemic.
Lord Vaux of Harrowden (CB) [V]
My Lords, it is a pleasure to follow the noble Baroness, Lady Noakes, and for once find myself in agreement with much of what she said. In his winding-up speech at Second Reading, the Minister said:
“Under our proposals, the devolved Administrations will continue to have power to regulate within devolved areas, in so far as these do not cause a barrier to internal trade.”—[Official Report, 20/10/20; col. 1426.]
The noble Lord, Lord Callanan, has repeated the same point today. Well yes, the devolved Administrations will be able to continue to regulate, but those regulations will become effectively meaningless if they can be undermined by unfettered market access from other parts of the United Kingdom. The Minister seems unwilling to address that simple point. Within the EU single market the devolved nations have enjoyed a level of discretion to diverge within a wider framework of agreed standards. Despite that divergence, our internal market has operated smoothly, and I do not think that many would argue otherwise.
Like it or not, devolution is a fact and we cannot and should not back-pedal on it. The Government recognised that in the frameworks agreement when they agreed that the common frameworks should
“maintain, as a minimum, equivalent flexibility for tailoring policies to the specific needs of each territory as is afforded by current EU rules”.
Can the Minister please confirm that the Government still stand by that agreement, in spirit as well as letter?
This Bill is a blunt instrument which effectively removes that flexibility for tailoring policies. What would be the point in, for example, the Welsh Government legislating against single-use plastics, if they are unable to block such items coming in from other parts of the UK; or of Scotland tightening labelling requirements, if goods sold in Scotland from other parts of the UK do not need to follow those requirements? Does the Minister seriously argue that those kinds of actions have created or would create significant barriers to internal trade?
The common frameworks programme, as we have heard, provides a simple solution that already exists. The programme is generally thought to have been a positive and consensual process to try to find the right balance. Indeed, as the revised frameworks analysis published by the Cabinet Office states:
“The cooperative approach on frameworks so far demonstrates the progress that can be achieved through proceeding collaboratively”.
As we have heard, however, the Bill as drafted ignores the common frameworks completely. There is not so much as a reference. The Minister said at Second Reading that the Bill does not make the common frameworks redundant, but it is very difficult to agree with that. As explained earlier, any divergence of regulation by a devolved Administration will be undermined by the precedence that this Bill gives to unfettered market access. I really do not see that that is an arguable point. It is the logical result of this Bill.
It is hard not to sympathise with the view of the devolved Administrations that the hard work and constructive engagement on trying to reach agreement on the common frameworks has effectively been torn up by this Bill. The Government cannot, in all honesty, be surprised that the devolved Administrations have rejected it. It is precisely this kind of heavy-handed, non-collaborative behaviour that is adding to the impetus towards the breaking up of our United Kingdom, which I am extremely worried about.
I said at Second Reading that I am not fully convinced that this Bill is actually necessary to achieve its stated aims. The Constitution Committee, and a number of noble Lords, has made the same point. However, I can see that there is some argument for the market access rules it creates, provided that they genuinely work alongside the common frameworks. However, for that to work without undermining them, the common frameworks must be recognised in the Bill, and any agreed permitted divergence from common standards allowed by the common frameworks must take precedence over the mutual recognition and non-discrimination principles of the Bill.
There are a number of ways to achieve that end, and the amendments in this group try to do this in different ways. I am particularly attracted by the approach taken by my noble and learned friend Lord Hope of Craighead in his Amendments 5, 11 and 53, and by Amendment 170, in the name of the noble and learned Lord, Lord Mackay of Clashfern. These seem to be a neat and simple way of recognising the common frameworks explicitly in the Bill and giving them precedence over the market access principles where appropriate, without undermining the Bill as it stands. I am also drawn to the introduction of the proportionality and subsidiarity principles in Amendment 2, which were discussed earlier.
I was heartened by the Minister’s commitment at Second Reading that the Government will
“study carefully the observations of your Lordships’ Select Committees on this part of the Bill”.—[Official Report, 20/10/20; col. 1427.]
Accepting these amendments, or something like them, would recognise that the internal market can work perfectly smoothly in a more nuanced, flexible and collaborative manner, just as it has in the past. That would show sensitivity to the legitimate and reasonable concerns of the devolved Administrations, and the respect for devolution that the noble Lord, Lord Callanan, referred to earlier today, without undermining the smooth-running internal market that we all want and which this Bill is intended to achieve. I would therefore urge strongly the Government to consider these amendments in a constructive light.
The Duke of Montrose (Con) [V]
My Lords, it is a great pleasure and honour to be able to participate in this very important legislation. The search for common frameworks is something that has concerned me from the minute we went down the Brexit road. I would like to support the amendments that were put forward in the name of the noble and learned Lord, Lord Hope. I was also interested to hear the analysis by the noble Lord, Lord Vaux, of ways of solving problems.
It is very important that we go into this area in great detail. I congratulate the noble and learned Lord, Lord Hope, for bringing it in, in this way, this early in our discussion. What he gave us is a very fair and understanding analysis and I hope the Government will pay due attention to the issues that he outlined. We have also been privileged this evening to hear from four Members who have worked on the frameworks committee, and it is of course also very important to look at what they said. I was interested in the way that the noble Lord, Lord Foulkes, supported the issue from the Scottish point of view.
I would like to offer my support to Amendment 170, in the name of the noble and learned Lord, Lord Mackay, which he moved in his intervention. It is very important that agreements that are achieved are formally notified to Parliament, and that was the point he was making.
It is not a direct parallel, but noble Lords will probably remember that, on the introduction of the Scottish devolution Bill, the parties concerned when it was brought into practice in the Scottish Parliament found that they had to achieve a memorandum of understanding. One of the things that was contained in the memorandum of understanding was the Sewel convention. Here in Westminster, we received no details of what this memorandum of understanding contained. One was left wondering how some of the agreements were arrived at. This of course was rectified when we next looked at the Scottish devolution Act and the actual practice was brought in, in a legislative form, under that Act. We need to be kept fully up to date with the agreements that Governments come to. I support that amendment.
Lord Bruce of Bennachie (LD) [V]
My Lords, I also am a member of the Common Frameworks Scrutiny Committee. I would like to give my appreciation to the noble Baroness, Lady Andrews, for the way in which she is chairing the committee. It has a hugely demanding task, which we are all learning extremely fast.
The noble and learned Lord, Lord Hope, is of course a member of that committee. The combination of his work and his expertise in the law has been demonstrated to be one of the strengths of the House today in the amendments that he has drafted, moved and explained in such meticulous detail. This is of huge benefit, and I hope that the Minister will recognise that he should give very serious consideration to what is being proposed.
I do not have the audacity to summarise the noble and learned Lord, other than to say that his basic questions were these: how do the frameworks fit into the Bill, and how will future arrangements be conducted if there is not a proper correlation between the frameworks and the Bill, and indeed the principles behind the frameworks? That is something that we have all been asking the Government to explain.
Lord Stevenson of Balmacara (Lab) [V]
My Lords, this has been an excellent debate, brilliantly introduced by my kinsman, the noble and learned Lord, Lord Hope of Craighead, and with some other excellent speeches, particularly from those who were members of your Lordships’ Select Committee and, of course, the chair, my noble friend Lady Andrews.
The weight of the arguments deployed in this group and the virtual unanimity of views expressed from all sides of the Committee were to be expected, but Ministers might not have expected to be offered a route out of the mess that they have got themselves into. If common sense prevails, there is a win-win here. As the noble Lord, Lord Dunlop, said, the Bill currently has things the wrong way around. The Government need to signal tonight that they will take away the amendments in the name of the noble and learned Lord, Lord Hope of Craighead, and work with him to find a structure that better delivers the aims of the Bill.
They should use this legislative opportunity to encourage the completion of the current work on the common frameworks, to encourage the process to cover the remaining outstanding issues and to anticipate future needs. They should then draft an effective safety net for the Bill, based on mutual recognition and non-discrimination, while, as the noble Lord, Lord Vaux, said, having regard to subsidiarity and proportionality. They should ensure that the current informal processes have a light-touch underpinning, with a regulatory framework that commands trust and the confidence of the devolved Administrations. If they do this, we will happily work with and support them.
The Minister of State, Cabinet Office (Lord True) (Con)
My Lords, it has been a most fascinating debate. I endorse what the noble Lord, Lord Stevenson, has just said. While I sadly cannot claim to be his kinsman, I thought the opening speech by the noble and learned Lord, Lord Hope, was a masterclass in how to present a case. That does not necessarily mean that the Government accede to the case, but it was entirely clear. I also pay tribute to those members of your Lordships’ Select Committee on common frameworks who spoke. Their experience is obvious and the work of that committee is important. I believe it will shortly meet or hear from my honourable friend Chloe Smith.
Many businesses welcome this Bill. They welcome it on the basis that, after the end of the transition period, they hope, expect and require that they will be able to operate in a period of certainty, not buffeted by any unexpected or unreasonable developments. I respond to the general tone of the debate by saying that it is, of course, the Government’s intention—it always has been and remains so—that the functioning of the UK internal market will be driven by co-operation with the devolved Administrations. The market access proposals here are designed not to replace but to complement the common frameworks; I know that is a phrase I have used before. The common frameworks are the key. They support coherent policy-making across the UK by setting out terms of engagement between the UK Government and the devolved Administrations as well as, where appropriate, common strategic goals and policy approaches.
The Government remain committed to the common frameworks programme. As many noble Lords have said, it is progressing well. The UK Government and the devolved Administrations continue to co-operate closely as we jointly develop the programme. Yes, progress overall has been slower than we would have liked, and I acknowledge the effect of the resource constraints driven by the response to Covid, and the need to prioritise planning in advance of the end of the transition period. However, all parties remain committed to the programme. At a recent JMC (EN) meeting last month, both the UK Government and DA Ministers reconfirmed their strong commitment to it.
The Deputy Chairman of Committees (Baroness Morris of Bolton) (Con)
My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Bruce of Bennachie.
Lord Bruce of Bennachie (LD) [V]
I shall not detain the Committee for long but the Minister came up with the example of flour. I think that as the Bill progresses we can all dream up examples of hypothetical possibilities. However, the question that arises from that example is: why should we not follow the principles and dispute resolution model of the common frameworks? Indeed, as the noble Baroness, Lady Andrews, said, where are the gaps that cannot be filled by the common frameworks? Why do the Government need to take such extreme powers for fast Executive action when, in nearly all these cases, the problem will emerge over time? Everybody agrees that if legislation is required, we should have it, but the Government seem to want to take powers in anticipation of unknown challenges. Therefore, why cannot the principles and model of the common frameworks be the basis on which these cases are taken forward and disputes resolved?
Lord True (Con)
My Lords, I should have acknowledged the very thoughtful speeches of the noble Lords, Lord Bruce and Lord Stevenson. I hoped that I had made clear that the common frameworks process would continue. I was asked to give an example of how circumstances might change in the future and how matters that need to be addressed might arise. The emergence of an unregulated new technology might be another example. However, I think it is better that we address these questions in the further discussions that we might have.
So far as pace is concerned, the transition period ends at the end of the year and there is a need to provide a climate of certainty for business when the EU system falls away. Therefore, I do not resile from the fact that it was necessary and sensible for the Government to bring proposals before Parliament to address the post-31 December situation.
Lord Hope of Craighead (CB) [V]
My Lords, first, I thank the Minister for his courteous and careful reply. I also thank all noble Lords who have contributed to this fascinating and very well-informed debate. I shall not attempt to sum it up because the noble Lord, Lord Bruce of Bennachie, did that very ably for me in his contribution before the interval.
I was very grateful to the Minister for his kind opening words. Of course, I am disappointed that there is not more of an indication of movement on his part, but he said that he would consider the arguments, which I am sure he will, and that he was open to further engagement and discussion—for my part, I certainly am, and I am sure that others across the Committee are too. Of course, there is not much point in those discussions unless he has a rather more open mind in appreciating the problems than he has indicated so far.
One point mentioned from time to time was the fact that this measure, and indeed the White Paper that preceded it, emerged with very little consultation with the devolved Administrations. I hope that the noble Lord will forgive me but I have the feeling that there was a certain amount of lack of consultation across the Government.
If I may offer the Minister a little bedtime reading, there is a clause in another Bill which is still before Parliament that illustrates the problem: Clause 39 of the Agriculture Bill. I do not suppose that the Minister knows what I am talking about so I will say a few words about it. It may help him—the Minister sitting in Westminster, looking at the matter from the other side of the fence—to see how things appear from the perspective of the devolved Administrations.
Clause 39 attempts to set marketing standards. It lays down a basis for the setting of market standards in relation to agricultural products that are marketed in England. It contains a long list of matters that will be covered by regulations—there are 15 of them. I will not go through the list, but one or two of them are important. They refer to regulations or cover matters about the type of farming and production methods, as to the use of certain substances and practices—one might think of pesticides, additions of flour—packaging and so on. At the discussions on the Agriculture Bill, I asked the Minister what this means for the farmers in Wales, Scotland and Northern Ireland, given the volume of goods that they move for marketing in England, since these are matters that have been set for all goods marketed in England. There is no reference in this clause to consultation, let alone consent, and my suggestion was that there should be, on the face of the Bill, a provision that if these standards are to be set and people coming from other parts of the UK are obliged to comply with them, then surely that would have to be done with consent. I do not think that the Minister responding to me had any idea that the Internal Market Bill was on the horizon. I mentioned that the White Paper had just come out, but I got no response from him about that either.
The effect of the mutual principles set out in Clause 2 solves the problem as far as farmers in Wales and Scotland are concerned. They need not trouble themselves about regulations, additives, pesticides, packaging, production methods and so on, because they have a complete opening to the market. The question is: is there any point in going through this huge list and laying down carefully regulated provisions for England when the Minister knows perfectly well that people can come from the other parts of the UK under his Bill and ignore them? I am not talking about a lowering of standards, but about different standards which are not provided for. That is the kind of problem that I mean. Can the Minister look at this before he goes to sleep tonight, think it through and see how it looks from the other side of the fence? These are really big issues. Although the Bill is still going through ping-pong, I wonder whether Clause 39 can survive and whether the regulation- making power in that clause will ever be exercised.
These are fundamental points and, to be honest, I do not think that the Minister has really grasped the importance of them. I would like to think that he will, and I look forward to further discussions with him before Report. For the time being, however, I beg leave to withdraw the amendment.
The Deputy Speaker (Baroness Morris of Bolton) (Con)
My Lords, we now come to the group beginning with Amendment 6. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate, and anyone wishing to press this or any other amendment in the group to a Division should make that clear in debate.
Amendment 6
“Legislation to which market access principles apply
(1) Legislation on market access principles may only apply—(a) when the common frameworks process in respect of subjects within a description listed in Schedule (Subjects to which market access principles may be applied) has been exhausted, and(b) only so far as it relates to a subject specified in regulations made by the Secretary of State.(2) Regulations under subsection (1) may specify a subject only if it is within a description listed in Schedule (Subjects to which market access principles may be applied).(3) The Secretary of State may by regulations amend Schedule (Subjects to which market access principles may be applied).(4) Regulations under this section are subject to the affirmative resolution procedure.(5) Before laying a draft of a statutory instrument containing regulations under this section before either House of Parliament, the Secretary of State must give notice of the proposed regulations to—(a) each devolved authority, and(b) the Competition and Markets Authority.(6) The Secretary of State may not lay the draft instrument before either House of Parliament until—(a) the Secretary of State has received—(i) a statement in relation to the proposed regulations from each devolved authority, and(ii) a report or advice on the proposed regulations from the Competition and Markets Authority, or(b) the period of 12 months beginning with the day on which notice was given under subsection (5) has ended.(7) When a draft of a statutory instrument containing regulations under this section is laid before either House of Parliament, the Secretary of State must at the same time lay before that House copies of any statements, report or advice mentioned in subsection (6)(a).(8) In this section, “devolved authority” means—(a) the Scottish Ministers;(b) the Welsh Ministers;(c) the Department for the Economy in Northern Ireland.”Member’s explanatory statement
This amendment means that the United Kingdom market access principles only apply after the process for agreeing common frameworks has been exhausted. It introduces a new Schedule, inserted by another amendment in the name of Baroness Finlay, listing the subjects to which the common frameworks apply and for which regulations may be made if common frameworks are not agreed.
Baroness Finlay of Llandaff (CB)
My Lords, I have tabled both the amendments in this group. Amendment 6 is arguably the most important of all the amendments that I have laid, because it aims to do what many of the amendments in the previous group also intended to achieve. In the light of the disappointing ministerial response to the amendments in the previous group, so superbly introduced by my noble and learned friend Lord Hope of Craighead, it could be said that I am having another go, in a more watertight way. Amendment 6 puts common frameworks on the face of the Bill. Amendment 44 is consequential on Amendment 6, since it would make the point at which the regulations came into force the trigger point from which the market access principles would apply. I assure the Government that these amendments are drafted with the Welsh Government, who want the process on the face of the Bill.
I am grateful to the Minister for meeting me and other Peers last week and for his letter of yesterday. In it he states:
“The common frameworks programme was designed to find effective, pragmatic and flexible ways of working with the devolved administrations. The purpose of frameworks is to ensure that intra-UK policy-making is based on agreed structures for cooperation across the UK. They are voluntary in nature and allow the UK Government and devolved administrations the opportunity to find common approaches to the exercise of powers returning from the EU. One of the main benefits of the programme is its inherent flexibility to adapt to changing circumstances.
Enshrining common frameworks in legislation would remove the voluntary element on which the common frameworks programme is based. As frameworks are developed jointly with the devolved administrations, any change of this nature which departs from the agreed principles of the programme would need to be agreed with the devolved administrations. It would also likely eliminate the flexibility which makes frameworks effective in managing intergovernmental policy development in the long term.”
I agree that they are voluntary, but without them in this Bill it reads rather like a blunderbuss, sweeping over all in its path. That is precisely why the devolved Government in Cardiff want common frameworks to be the starting point for this legislation, not hidden away and never referred to, like the first Mrs Rochester. These principles of frameworks were first agreed in October 2017. More than 150 areas have been identified where EU law intersects with devolved competence, including 24 areas, now narrowed down to 18, where legislation may be needed. Thirteen of them are well on their way for early delivery. In the Minister’s response to the first group of amendments today, he flagged up that there will be “dozens of new powers” and responsibilities for the devolved Governments—I hope I have quoted his words correctly. This will inevitably mean wider divergence and, I suggest, is an even stronger reason for an agreed mechanism to find consensus and avoid the situation outlined by the example of flour. Only when that hits the buffers should Parliament step in.
The reason they need to be in the Bill—I believe that Scotland would strongly support this approach—is that they provide an agreed framework, whereas the Bill as drafted empowers the imposition of market access principles across all areas of economic activity, regardless of whether divergence between the devolved nations on a specific issue would pose a threat to the coherence of the internal market. It ignores the frameworks process that has been developed. It seems to assume such frameworks will fail without spending time listening to both sides to reach agreement, which may—let us be realistic—be an agreed compromise. It fails, if I may draw on John Lennon, to “give peace a chance”. It may not be the intention—though some may fear it may be—to launch a full-frontal attack on the current system of devolution, but whether it is or not, its approach feels overbearing and intolerant of difference.
This amendment and equivalent ones in respect of Parts 2 and 3 reverse the burden of proof. This would require the frameworks to be worked through properly, not in a tokenistic way. Failure to reach agreement would trigger action. It would create a system where the market access principles could then be brought into effect by affirmative resolution of this House and the other place. The principles would then, and only then, apply to specified areas of economic activity: areas where attempts to agree a common framework by negotiation between the four Governments of these islands had failed and where the Government could make a credible argument that there was a threat to the economic coherence and well-being of the United Kingdom.
Lord German (LD)
My Lords, these amendments have been prepared by the Welsh Government and have their support; I am pleased to support them. The Welsh Government, as noble Lords know, are committed to the union of the United Kingdom. These proposals before us today seek to find a route through in the way that the Bill has been put together. In fact, they intend to put the horse before the cart rather than the cart before the horse. In the discussions that we had on the previous group and subsequently, there have been for me some very puzzling matters, and I am trying to work out quite where the Government have placed themselves.
First, on timing, the Government seem to argue that we must have the Bill in place in its entirety so that on 1 January they can move forward and have something absolutely concrete to work from. I will come back to that point in a moment. The second point is that the Government have not been able to find any way to describe something which falls outside the area of the structure.
In the last round of amendments, the Minister described additives for flour. Flour and additives are part of the common framework on nutrition. I am told that the three frameworks which are already on the way to early delivery and will be fully operational by the end of the year cover nutrition, hazardous substances and emissions.
I am puzzled why the Government are not able to provide any specific examples of what falls outside the framework, apart from “the future”. We do not know what the future is, but as it arrives we will sort out legislation and frameworks as we move along. That is bound to happen.
Timing is another puzzle because the Government do not want to proceed with the common frameworks as the underpinning structure for this Bill. They seem to want to use what the noble Baroness, Lady Finlay, called a blunderbuss. Battle axe might be another way of putting it. Basically, they do not want the co-operative approach which has been at the forefront of these frameworks.
In September, the Government published their view of the frameworks. Right at the front—on the first page—were the principles which the Government are now seeking to break about the way in which they intend to govern, and about giving and not taking away powers from the devolved Administrations. They were right at the top of the Government’s own papers as recently as last month. If the Government want to put them front and centre, but need something temporary, why not say so? Why not put in a sunset clause, or some form of clause which says this will be a temporary measure until particular frameworks are in place?
The Government’s position is not defensible inside Wales as I know it. The Welsh Government have sought to bring forward a proposal which meets the Government’s aspirations. It says, “Put the common frameworks first and then, if there is any dispute whatever, use the backstop which is being put into this Bill through regulations.” We all want to see an alteration to the way in which they have been carried out and for there to be adequate consultation and debate.
My concern is that I am not certain that the Government know where they are going. I am not certain that they know what they mean by “putting the common frameworks front and centre”. Is this a timing issue? I hope that the Government will be able to answer all these questions.
I want to talk briefly about the one-use plastic teaspoon. They will be banned next year by the Welsh Government, through the Welsh Assembly, because they are bad for the environment and do not degrade in the soil. One-use cutlery is damaging for us as a country and for our environment. However, if that legislation is passed, there is nothing to stop a whole generation of English single-use plastic spoon manufacturers bringing them across the border and distributing and selling them wholesale in Wales. This is an extreme example, but it illustrates that there are bound to be some divergences if the power exists. If, as a Government, you have been given powers and you want to enable them, but you find you are being stopped because of this sort of extraordinary behaviour by a Government somewhere else, that is not going to help the union. The union of this United Kingdom is to be treasured, but to treasure it you have to respect it. I do not believe that the Government are doing so in this Bill. So I ask them all those questions about the direction in which they are going. Will they try to outline whether these frameworks will be placed front and centre? Is it a timing issue? Can they come up with some examples—one would do—which would tell us where the gaps are?
Baroness Andrews (Lab) [V]
My Lords, I can speak more briefly to this amendment than the one I spoke to earlier, because my arguments will be much the same. What attracts me particularly about this amendment is that it once again asks the Government to look at the possibility of putting in the Bill the process whereby the Bill becomes the default position and the common frameworks process has to be exhausted before the market principles kick in. I have said before that I think that this is logical. It helps the Government to achieve their own objectives.
When the Minister replied to the previous debate, it was very welcome to hear him say that he was prepared to give more thought to things he had heard the House say this evening. He seemed to think that this process of exhaustion was somehow going to be rather difficult and messy to achieve. From what we have seen in the Common Frameworks Scrutiny Committee, the dispute resolutions are worked out very clearly and in detail. I do not see a problem with that process at all and I would be happy to talk to the Minister about it. If he is worried about that, we can provide some reassurance and, as we scrutinise it, there may be some things we can do to improve the process. If it is a technical problem, then that is what we are here to solve. If it is a problem in principle, then we need to know; he needs to tell us.
The rest of the amendment is slightly more legislative in structure than the amendments from the noble and learned Lord, Lord Hope of Craighead, but I continue to support it in principle because it flags up the significance of common frameworks and the importance of the need for a fit between the Bill and the common frameworks.
The noble Baroness, Lady Finlay, asked me whether we had come across any areas where there was deadlock or difficulty in securing agreement. In the summaries of the frameworks that we have seen so far, and in the one completed framework, we have not seen anything that would alert us to the fact that there is a continuing problem. The problem that the framework negotiators have is the unsettled nature of European negotiations and the issues posed by this Bill itself. They are bound to be waiting for resolutions of different sorts. The processes that they are establishing are clear, transparent and robust. As I say, they offer a solution in practical terms, as well as, frankly, in ethical and political terms, as far as the Government are concerned.
With that, I simply say that I am pleased to support the amendment in principle. I look forward to the Minister, the noble Lord, Lord Callanan, having another go at some of these very specific questions that I think we have a right to hear some answers to.
Baroness Neville-Rolfe (Con) [V]
My Lords, I will speak to Amendment 6. I have already expressed some concerns about delays and problems that could arise in trying to satisfy devolutionary feelings beyond the existing devolution settlements and the withdrawal Act, which have already given many powers to Scotland, Wales and Northern Ireland.
We need always to bear in mind the need for a well-functioning single UK market. That is in the interests of citizens, and of charities and businesses which operate across the borders of Northern Ireland, Scotland, Wales and England. My noble friend Lady Noakes cited some figures which bear repeating. I think she said that 60% of Welsh and Scottish exports and 49% of Northern Ireland exports come to other parts of the UK. Incidentally, I was glad to hear my noble friend the Minister committing the Government to high regulatory standards.
We heard from the noble and learned Lord, Lord Hope, in an impressive speech, and from the Minister in an equally persuasive one, about the role of common frameworks in relation to Amendment 5. I heard what my noble friend the Minister said, but it may be that a brief reference to these common frameworks could make everyone more comfortable with this Bill—I was thinking of an annual report on how they are working and how consultations have progressed. It seems odd, given their importance, that there is no reference to them at all.
Lord Hope of Craighead (CB) [V]
My Lords, it is a pleasure to follow the noble Baroness, Lady Neville-Rolfe. I found myself in agreement with some of what she was saying, and I respect very much the background in business and marketing from which she comes, which of course is of great value to the House in this discussion. She said that we were all agreed on the need for a fully functioning internal market and, as I tried to make clear in my speech, I am in absolute agreement with that aim. Obviously, everything we would do is working towards that aim, despite the differences of perspective across the various nations of the United Kingdom.
The noble Baroness said that a brief reference might be a way of making the devolved Administrations more comfortable. For my part, I have been trying to adopt a light-touch approach, which may not be too far away from what she is talking about—but it would have to be pointed enough to meet the concerns of the devolved Administrations and give them the assurance that they need for the future. So in a way I find myself in a rather frustrating position. I cannot believe that we are all that far apart, but the gulf that divides us at the moment is very deep. I would love to find a ladder, or something, that would take us across this gulf and solve the problem. That is why I am certainly open to discussion.
Before I go any further, I should say that I am entirely behind the noble Baroness, Lady Finlay of Llandaff, on the principles that lie behind her amendment. Indeed, I am extremely grateful to the Welsh Government, who have done so much to inform us about the background to the issue and who have done a great deal of drafting work to show us what amendments might be made to work to solve the problem as they see it. Although they look very different, my own amendments were inspired by the work that they have done, and I owe a considerable debt of gratitude to them for that, and for their generosity when I indicated that I would want to take a rather different approach in the way that the amendments should be worded. The principles behind us are exactly the same and, for that reason, I entirely support, in principle, the amendment in the name of the noble Baroness and applaud the way in which she introduced it.
This issue is simply not going to go away. We will be pursuing it in various ways on Report. For the time being, I encourage the Minister to appreciate that there is some force in the point made by noble Baroness, Lady Neville-Rolfe. If her approach were adopted, one could see this frustrating gap narrowing slightly—and I would love to see it closed over so that we could solve the problem completely, to the satisfaction of both sides.
The Deputy Chairman of Committees (The Earl of Kinnoull) (Non-Afl)
I call the noble and learned Lord, Lord Morris of Aberavon. Do we have Lord Morris of Aberavon? We will move on.
Lord Naseby (Con)
My Lords, I apologise to the House. I understand I was on the list for Amendment 5, but I never applied to speak on that one.
This is an interesting amendment. My colleagues, the noble Baronesses, Lady Noakes and Lady Neville-Rolfe, have already made the point that we are very close to 1 January—in fact, we are 66 days away, by a quick calculation—and so I look at that time dimension against the complications within this proposed new clause.
As I said much earlier in the evening, I am a marketing man by profession; I worked very closely with a large number of manufacturers when I was a senior director in one of the major advertising agencies. I find some of the elements of this amendment, or proposed new clause, too prescriptive. Take subsection (1)(a), where the whole principle is that nothing is going to happen until the
“access principles may be applied”
and have been “exhausted”. We are in a time framework where that is not going to work. It may be necessary, later on, to look at how it does work in principle, and maybe some changes should be made then.
I worry deeply. We are a creative nation. We are in an enormous period of change. One sees now what is happening in the fintech world: it is moving forward at an enormous rate, and it does not want to be stultified by a whole series of restrictions before it can be added to a particular schedule or not. All of us are conscious that there is a whole variety of different companies, across the world, trying to find an answer to Covid-19 through new drugs and vaccines.
Personally, I am terribly practical, and I just do not see the elements of this amendment helping the United Kingdom move forward. There may be bits of it that have some relevance—I am sure there are—and I recognise that they are put forward with a genuineness by people who want things to work. But when I listen to the noble Lord opposite talk about the Welsh Government, and having observed what is happening down in Wales now, one has to say that it is not terribly practical. I am not sure that the credibility of the Welsh Government is very strong in today’s world.
I hope my noble friend on the Front Bench will understand that, perhaps in the future, some of these elements may need to be applied, but, as matters stand today, with 66 days to go, frankly, I do not think that this proposed new clause helps at all.
The Deputy Chairman of Committees (The Earl of Kinnoull) (Non-Afl)
I call the noble and learned Lord, Lord Morris of Aberavon.
Lord Morris of Aberavon (Lab) [V]
It has been a most interesting debate. I do not think I have anything to add. I await the Minister’s reply with great interest.
Baroness Randerson (LD) [V]
My Lords, the concept of common frameworks is notable for its absence from this Bill, as many noble Lords have said. For three years, they have been accepted as the way forward, on which the future operation of the UK internal market would be built. Now, they have been silenced.
I, along with a number of other noble Lords who have spoken on this and previous groups, am a member of the Common Frameworks Scrutiny Committee, ably chaired by the noble Baroness, Lady Andrews. I can report that common frameworks are alive and well and that a great deal of work has gone into them. There is general agreement from stakeholders, the devolved assemblies and UK Government representatives that they can provide a sensible and effective way forward. Amendment 6 seeks to flesh out the principles of co-operation on which they should work. That common frameworks process should be exhausted before the market access principles come into place.
The Government respond by saying that there is no need for common frameworks, as a concept, to be enshrined in legislation. I am sceptical. There are already signs that the Government are attempting to sidestep common frameworks—for instance, on the emissions trading scheme, where they have announced their intention to consider replacing it with a carbon tax, which would be a UK responsibility and would effectively take away the devolved powers. That is despite the fact that the common framework on this issue—emissions trading—has just about got to the final point. Despite the Minister’s assurances, I fear that the Government are poised to put the principles in the Bill into effect with the excuse that common frameworks have not proved workable.
Amendment 6 has cross-party support. Noble Lords have emphasised that it has been designed in consideration with the Welsh Government and reflects the well-founded concerns of the devolved assemblies. As with a number of issues, there is a lack of clarity on how common frameworks will link with the market access principles. Common frameworks set up a system—a framework—for the operation of markets, complete with dispute mechanisms. They allow for changing standards over time. So, I ask the Minister: how does this fit in with the provisions in the Bill that remove the right of devolved Administrations to introduce new standards in many circumstances? If the Government genuinely support common frameworks as the fundamental building blocks of the way forward, will the Minister agree to accept Amendment 6, which states that the Bill’s market access principles apply only after the common frameworks process has been exhausted? Will she clarify the relationship of the Bill to common frameworks? Will she accept our assurances that the Welsh Government, for instance, want common frameworks in the Bill?
Will the Minister also explain precisely how the measures in the Bill will guarantee that the devolved Administrations will be able to experiment and develop novel approaches, as they have in the past? That is how a great deal of social and environmental progress has been made in the last two decades. I give the example, used earlier in the debate, of single-use plastic bags. Wales experimented with the concept of paying for single-use plastic bags and was dramatically successful in reducing their use. The English approach to this, taken by the UK Parliament, was very sceptical, but Parliament saw that it worked and, in due course, England followed suit. Wales is an ideal size as an experimental sounding board.
Amendment 44 to Clause 9 refers to the non-discrimination principle. For clarity, can the Minister spell out to us where the requirement for the provision of, for example, labelling in the Welsh language would stand in relation to that principle? There is a legitimate reason for the need for Welsh labelling in certain circumstances, and as policy in relation to the Welsh language matures, it is fairly certain that there will be increasing demand and need for labelling in the Welsh language. How will that fit with the Bill?
Lord Stevenson of Balmacara (Lab) [V]
My Lords, at the end of the previous group the Minister, the noble Lord, Lord True, kindly said that his mind was not closed to further discussion on this issue about common frameworks and how they relate to the Bill. I welcome that. In a sense, the amendments in this group are part of the same debate. I therefore hope that they will also be included in the next-stage discussions, as they are a variation on the theme.
I set out my route map for progress in my response to the previous group and I will not repeat it. However, I endorse the points made by the noble Baroness, Lady Finlay, my noble friend Lady Andrews, the noble Lord, Lord German, and the noble and learned Lord, Lord Hope, particularly their growing confusion about what exactly is in the Government’s mind on this issue. Perhaps the noble Baroness, Lady Bloomfield, coming fresh to the debate, can persuade us that there is indeed a coherent logic to the Government’s position—because it certainly eludes me.
Baroness Bloomfield of Hinton Waldrist (Con)
I hate to disappoint the noble Baroness, Lady Andrews, but it falls to me to respond to this debate. I will now speak to the two amendments—Amendment 6 and the consequential Amendment 44—concerned with how UK market access principles, as proposed in the Bill, will apply. I understand that the noble Baroness, Lady Finlay of Llandaff, has tabled these amendments on behalf of the Welsh Government. Accordingly, I would like to begin by thanking the Welsh Government for their positive engagement on this Bill so far. The UK Government look forward to continuing constructive future engagement with the Welsh Government.
As my noble friend Lord True said earlier, we continue to work closely with the Welsh Government to develop common frameworks, in line with the framework principles agreed by the Joint Ministerial Committee (EU Negotiations) in October 2017. I know the Senedd were happy to see the Joint Ministerial Committee provisionally confirm the first two frameworks of the programme on hazardous substances and nutrition. Work continues in earnest to reach further such agreements in the coming months and beyond.
Before I turn to the detail of the amendments, I want briefly to cover the context of the Bill in order to explain the approach the Government took to applying the market access principles. At the risk of repeating the arguments of my noble friend Lord True, now that we have left the EU and as we recover after our fight against Covid, it is vital that we deliver legislation which allows the continuing smooth function of our UK internal market at the end of the transition period. The Bill aims to ensure frictionless trade, movement and investment between all the nations of the UK. The policies that different parts of the UK choose to pursue in the future is a matter for each Administration. The Bill ensures that these local policies can be pursued while maintaining seamless trade in the UK internal market. There is no question of the UK Government intending to bypass the common frameworks; the Bill is intended to complement them.
The approach we have taken in the Bill will give businesses the regulatory clarity and certainty they want. It will ensure that the cost of doing business in the UK stays as low as possible, and without damaging and costly regulatory barriers emerging between the nations of the UK. With this context in mind, I turn to the amendments. They would, in combination, prevent the market access principles from applying at the end of the transition period. The lengthy process they put in place before the principles can apply, including the need to exhaust frameworks discussions, would mean a considerable delay in securing business certainty that trade can continue unhindered within the UK’s internal market. The resulting threat of unmanaged regulatory divergence would not provide the certainty businesses need and could deter businesses that wish to expand and supply customers across the UK. This is not desirable, especially as we continue our recovery from Covid-19.
The amendments would also limit the areas to which the market access principles can apply. Again, this would unduly constrain the scope of the principles and fail to protect the internal market fully. In contrast, the Government’s approach is more comprehensive and ensures that businesses in all sectors can continue to trade across the UK without facing new barriers or discrimination.
The amendments also present a challenge in defining the exhaustion of the frameworks process. In all cases, common frameworks are designed as living arrangements, capable of change by agreement as required. Thus, the process is never wholly exhausted. The new clause also specifies a consultation process with the devolved Administrations and the CMA, or, failing that, a 12-month delay before any regulations can be made specifying areas to which the market access requirement would apply. The Government are already committed to appropriate consultation with the devolved Administrations; however, under the terms of the amendments, the time limits proposed would create unnecessary delay.
The noble Lord, Lord German, asked about the timing of the Bill. Reduced certainty would indeed be a disaster to our recovery from Covid-19. We do not believe that it is acceptable for businesses to have less certainty on trade with their UK supply chain after 1 January 2021 than they have today and have had for centuries. The UK Government are committed to ensuring that the status quo of seamless internal trade is maintained for the shared prosperity and the welfare of people and businesses across all four nations of the UK. Without the internal market, livelihoods would be at risk. There is also the issue of future-proofing the Bill to allow that, for the jobs of the future, mutual recognition will apply across areas that we may know nothing about today, including things such as the artificial intelligence industry.
My noble friend Lady Neville-Rolfe and the noble and learned Lord, Lord Hope, asked whether reference should be made to the common frameworks should be made in the Bill. We already have a statutory obligation to report quarterly on progress on the common frameworks, so there is no need to put this in the Bill as well. Far from being silenced, as the noble Baroness, Lady Randerson, suggested, as she knows, two common frameworks have already been agreed. However, some 38 more have yet to be considered, with only nine or 10 weeks until the end of the transition period. They do indeed provide a very sensible framework, but they remain voluntary. Ultimately, the common frameworks depend on continued co-operation. In spring 2019, the Scottish Government walked away from the internal market project. This legislation is required to provide certainty for business and consumers.
The noble Baroness asked about labelling in Welsh. There is nothing to prevent labelling in Welsh for goods produced in Wales. I was also asked about the use of plastic teaspoons. The Welsh Government can still ban their use, but perhaps not their sale.
For these reasons, and for the uncertainty and confusion that it would generate for businesses and consumers, unfortunately the Government cannot support the amendments in this group and I would ask noble Lords to withdraw or not move them.
The Deputy Chairman of Committees (The Earl of Kinnoull) (Non-Afl)
I have received one request to speak after the Minister. I call the noble Lord, Lord Purvis of Tweed.
Lord Purvis of Tweed (LD)
My Lords, I listened very carefully to what the Minister said about the need for certainty, which seems to be the overriding approach. But, having listened to my noble friend Lord German and the noble Baroness, Lady Finlay, I would refer to the Food Standards Agency report, Food and Feed Safety and Hygiene Common Framework Update. Paragraph 3.15 states, in relation to adopting mitigating measures against mutual recognition, which we will discuss in another group on another day, makes a quite interesting point that
“where common approaches are taken, mutual recognition will not apply.”
If that is the case in this Bill, the common approaches across the nations—the mutual recognition and certainty that she indicated—will not apply. But we do not yet have full agreement on all the common frameworks, so how can that apply under this Bill, given that we have not reached the agreements yet? However, the Government’s own position is that mutual recognition will not apply if common approaches are taken on any regulatory changes. So which is it? Is it in this Bill or is it within the common frameworks?
Baroness Bloomfield of Hinton Waldrist (Con)
I am afraid that the noble Lord has the advantage of me in that I have not seen that bit of the food standards framework. I would rather look at his question again in Hansard tomorrow and reply to him in detail. I do not think that I am able to give him a full answer now.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I am most grateful to all noble Lords who have spoken. I am grateful to the Minister for her response but it is disappointing.
I must say that I appreciate the noble Lord, Lord German, pressing the Government on why they cannot specify any examples of potential disruption to the internal market, because we really need to hear those. Perhaps the Minister might write to me with some of those specific points following this debate. I note that the noble Baroness, Lady Andrews, confirmed that there is no evidence that common frameworks are breaking down, nor that there is an inability to be fast.
I can see that the timing in the amendment needs to be looked at and renegotiated, and I am sure that would not be a problem. I know that the Welsh Government are sincerely committed to bridging the gap that the noble and learned Lord, Lord Hope, outlined so clearly; at the moment it is a chasm, but it can be bridged.
I agree with the noble Baroness, Lady Neville-Rolfe, and the noble Lord, Lord Naseby, that we all want the UK to prosper and things to work, but we must find a way to make them work by not splitting the UK, which is what the Bill seems to be doing at the moment.
I am grateful for confirmation from the noble Baroness, Lady Randerson, and the noble Lord, Lord Stevenson, of cross-party support for this approach. I have to agree with the noble Baroness that there is little evidence of the Government’s good will towards devolution in the Bill as drafted, and that at the moment the logic of the Government’s approach is quite difficult to discern.
The amendment was a genuine attempt to restore confidence between the central Westminster Government and the devolved Governments. I hope we will return to it because I think we need to. This was a hand of peace, an olive branch, and we must return to it later on Report. For the moment, though, pending further discussions and negotiations, I beg leave to withdraw the amendment.