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
(4 years, 1 month 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.