Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.

The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.

Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?

Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

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[Lord Lansley (Con) [V]]

My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.

On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.

The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.

I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.

What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.

So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.

We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.

Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.

The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.

The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises

“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”

That surely must be right.

At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause

“will not change the very good reasons why delegated powers are necessary.”—[Official Report, 19/10/12; col. GC 327.]

I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.

[Lord Naseby (Con) [V]]

My Lords, in the past I have had the privilege of working with two pharmaceutical companies, a US pharmaceutical company Upjohn and Reckitt pharmaceuticals. I think that as a country we face a unique opportunity at this point caused by Brexit and a situation where we have a major industry which has all the potential to be a world leader. But this point in time is going to go away unless we act. This is a watershed Bill. It creates an opportunity to enhance the role of the UK Medicines and Healthcare products Regulatory Agency. The industry and all of us should want the UK to be an attractive market for investment in medicines, medical devices and therapies for all our UK patients. It creates an opportunity to make significant improvements in UK clinical research environments and, very importantly, it increases the commercial trial activity to make the UK the number one destination for life sciences supporting UK public health.

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[Lord Naseby (Con) [V]]

My Lords, I disagree with this amendment. I had the privilege of being the Chairman of Ways and Means and Senior Deputy Speaker in the other House from 1992 to 1997—possibly, legislatively, one of the most challenging periods. I certainly found that MPs were highly creative in their interpretation of the rules of debate and in holding the Government to account.

Noble Lords have only to read Erskine May to see that we have two procedures for SIs that are normal and have been with us for decades: the negative procedure, where no amendments can be taken in your Lordships’ House; and the affirmative resolution. The affirmative resolution is not just a weak tool that puts us on the side; it is a very powerful tool if used properly by Members of Parliament and those of your Lordships’ House who take an interest in these matters. They can ensure that the Government of the day have to listen.

Frankly, I find that the super-affirmative procedure does no more, really, than involve an additional stage of scrutiny where Parliament has considered a proposal for a statutory instrument before the statutory instrument is formally presented. Today this procedure is used for statutory instruments that are considered to need a particularly high level of scrutiny. Quite frankly, we have Select Committees, in the other House in particular, dedicated to particular departments, and there is a very active Select Committee on health matters.

In addition, yes, there are some specialised categories of statutory instruments that are used for those particular purposes, and they can be considered under the super-affirmative procedure. But these statutory instruments usually amend or repeal Acts of Parliament. Examples would include legislative reform orders, localism orders, public bodies orders, regulatory reform orders and remedial orders. It is not usual to have them as part of the primary legislative process.

It is time that we as politicians understood that this country will be successful only if we get on and understand the needs of British industry. It has to have some certainty that things are going to proceed at pace, not be delayed even further because some noble Lords feel that they want to have another bite of the cherry. We already had quite enough bites, in my judgment, on this Bill as we worked through it, and it is being done very thoroughly. It has been done in Committee and is being done on Report. But we have to understand that this all adds to delay and, even worse, possible confusion in the commercial world.

I think adequate procedures are already available. All this does is stretch the thing out for very little marginal benefit. I personally will vote against this proposal with enthusiasm.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,

“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]

The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:

“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”


As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.

I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.

The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.

We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.

[Baroness Jolly (LD) [V]]

My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.

Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.

The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.

One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.

We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.

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Transparency is, of course, critical to open government and it should be welcomed, but I understand this as being retrospective. Is that right? Is this included in regulations, perhaps, where there will be an important opportunity to debate signal detection to prevent harm, and whether these regulations would be prospective measures? Avoiding harm, rather than actually seeing what has happened in the past, seems much more preferable. Can that be part of this whole exercise of what we will discuss in regulations?

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege. She posed a very tough question to the Minister. I could not help reflecting on her report and the issues around surgical mesh, where we clearly had a situation where for some women the surgical mesh operation was successful and seemed to be effective, but for others it had devastating consequences.

The question of a threshold is surely very important. I doubt very much that the medical device regulation we have is up to dealing with it. It would be good to know from the Minister how the Government will take forward discussions in this area, which of course involves ethical as much as safety considerations. Generally, though, I very much welcome the government amendments. I think that my noble friend’s amendments add to the debate.

I have always wanted the UK to be safe in terms of medicine and medical devices and outcomes, but I also want this country to be attractive to pharmaceutical and medical device companies to research, develop and launch their products in the UK. The UK’s record in the current crisis, in the development of both vaccines and treatments, is second to none. I hope that it will be a huge boost to our future attractiveness. But as I have raised on a number of occasions, one of the big problems we have in this country is the general slowness of the NHS to adopt new medicines and new treatments. If we really are to be attractive and have a favourable climate, we have to get around that. We have to be seen, particularly post Brexit, as not only a place that has fantastic scientists and clinicians, and a very good science base—in fact, a brilliant one—but where the NHS is itself innovative, forward thinking and keen to use new medicines and treatments. That is a huge challenge. It would be good to hear the Minister respond and spell out how he thinks we can make this country safe, but attractive too.

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[Baroness Jolly (LD) [V]]

My Lords, this amendment would require the appropriate authority to have regard to the protection of the environment when making regulations about human medicines. We have left the EU and need to be sure that our replacement regulations are fit for purpose. Many of us have spent a lot of time checking that these replacements are in such a fit state; but, while the health and safety of patients remain paramount, it is reasonable and, indeed, important, given the climate crisis, to consider the environmental implications of any policy stemming from these regulations.

The manufacture of human and veterinary medicines, and medical devices, does not happen in an environmental vacuum. Manufacturers have a duty to protect their environment—and manufacturers of medicines will need to be open about how they deal with chemical and other waste. I live in Cornwall where oestrogen has found its way into local rivers, ecosystems and oysters. Wastewater from pharmaceutical manufacturers could also find its way into local waterways. Will the Minister outline how this is dealt with by regulators, and how it is covered by the Bill?

Much waste from pharmaceutical plants is toxic and dealt with appropriately by manufacturers but, in a Brexit world, the regulation regime will have different regulations from the very strict ones that applied when we had to follow EU regulations. We can buy our medicines and medical devices from all over the world; we know that not everyone has the same high environmental standards governing manufacture that we have. What criteria are appropriate in the commissioning and purchasing of medicines from the rest of the world? Can the Minister please outline for us the nature of discussions with regulators about these issues?

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about 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 in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.

In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—

[The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)]

We appear to have lost connection with the noble Lord, Lord Hunt. We will give it a few seconds. We have now reconnected but we missed about 30 seconds of his speech; perhaps the noble Lord could take us back about 30 seconds.

[Lord Hunt of Kings Heath (Lab) [V]]

I thank the noble Lord; that is a temptation to be eagerly accepted. I was referring back to what the noble Baroness, Lady Bennett, said in Committee and the example in Sweden of Stockholm county council, which grades medicines on their environmental effects. Doctors can choose to prescribe a drug that is less harmful in relation to the environment where that option exists.

We have also had the 2014 report by UK Water Industry Research, which found that in most of the 160 sewage treatment works studied, several common drugs were present in the final effluent in concentrations high enough to potentially affect ecosystems. The noble Baroness, Lady Jolly, referred just now to the amount of pharmaceutical effluence entering waterways, and according to a 2018 study by the Delft Institute for Water Education, that could increase by two-thirds before mid-century.

In Committee, my noble friend Lady Wheeler referred to the Environment Agency also having found examples of contaminated hospital waste being illegally exported to developing countries such as Malaysia for disposal. What steps are we taking to prevent the illegal export of such waste and ensure that we dispose of our own waste in this country? There are also concerns about the use of incinerators for hospital waste and the health impacts on those living nearby. We must ask whether the Government are doing enough to ensure that chemists and GPs’ surgeries provide a secure depository for unused medicines, so that they do not contaminate the water supply by being washed down the sink or ending up in landfill.

The noble Baroness, Lady Bennett, said today that the Government’s approach has been to say that legislation is already on the statute book regarding the impact on the environment more broadly, including legislation to address the impact of producing and disposing of manufactured goods such as medical devices. But there is a persuasive argument that we should go further and that it is appropriate that in this Bill on medicines and medical devices there should be a way of ensuring that the environmental impact is not a damaging one. I hope that the Minister can respond with a positive reflection that this is an area that needs further exploration.

[Baroness Penn (Con)]

My Lords, when considering Amendment 7, tabled by the noble Baroness, Lady Bennett of Manor Castle, I draw the attention of noble Lords to our earlier discussion on the government amendments to this clause, introducing the requirement that safeguarding public health is the overarching objective when making regulations. The clause sets out a number of important factors that the appropriate authority must have regard to, and it is important to note that this is by no means a closed list of factors to be taken into account when making regulatory changes. I recognise that the intention is to put this important issue at the forefront of our minds, and that the factors involved in environmental protection, while broader than the remit of this Bill, may indeed be relevant as something to have regard to—and in those situations, this will happen. Let me explain.

In Committee, the noble Baroness raised important points about tackling the causes of environmental damage and listening to relevant stakeholders. As she knows, the Bill now includes Clause 43, which states that a public consultation must be carried out before regulations are made. This would provide an appropriate platform for relevant stakeholders in the production, distribution and consumption of human medicines, including manufacturers, healthcare practitioners and patients—and the noble Baroness will surely think also of campaigners—to raise their concerns and provide suggestions regarding regulations, which may include factors involving environmental protection. We would all agree that considering the environmental impact of what we do is important, but the power in Clause 1 is restricted to amending and supplementing the law relating to human medicines.

However, as I have reassured the noble Baroness previously, that law does not stand in isolation. The regulations made under this Bill must be considered within the wider context of other existing legislation that makes provision for environmental protection and access to medicines and healthcare services. The collective picture of legislation across the statute book ensures that environmental concerns are taken seriously. It includes provisions around packaging, safe management of medicines waste and medicines disposal. An example is the Environmental Protection Act 1990, which makes provision for the safe management of waste. This Act, which must be complied with by community pharmacies, 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.

I also reassure the noble Lord, Lord Hunt, on that point with regard to the management of waste and the noble Baroness, Lady Jolly, on the fact that the Government have made a clear commitment that, post Brexit, our environmental standards will not be reduced. As the noble Baroness, Lady Bennett of Manor Castle, pointed out, the upcoming environment Bill will be a further opportunity to debate many of those matters in detail.

On the question put by the noble Baroness, Lady Bennett, of why the environmental impact of veterinary medicines has been included in the Bill, whereas the environmental impact of human medicines is not specifically provided for, the situation with veterinary medicines is slightly different. The environmental safety aspects of the regulatory framework on veterinary medicines relate to their potential impact on the terrestrial and aquatic ecosystems and their flora and fauna—soil, micro-organisms, fungi, algae, plants, invertebrates, fish, et cetera—so veterinary medicines occupy a slightly different space in our regulatory framework. I also point out to her that animals receiving veterinary medicines form part of the human food supply chain, so that is also taken into account.

I hope that the noble Baroness has heard sufficient from me to be persuaded that, while the issue of environmental protection is of course vital, the law in this area is already well established and, in the light of this, that she will feel able to withdraw her amendment.

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Moved by

[Lord Hunt of Kings Heath]

13: Clause 2, page 2, line 32, at end insert “, or
(o) the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.”Member’s explanatory statement
This amendment would enable regulations under Clause 1(1) to make provision about the use of human tissues or cells in relation to human medicines.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am delighted to move my amendment, which follows constructive and very helpful discussions with the Government. I am particularly grateful to the noble Lords, Lord Bethell and Lord Ahmad, the noble Baroness, Lady Penn, and their officials for their help, and to my fellow sponsors, the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lords, Lord Ribeiro and Lord Alton, for the huge support they have given. I should also mention the enormous help I have had from Victoria Ledwidge of the end transplant abuse in China campaign.

The world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—a process leading to inevitable murder— has recently been found by the China Tribunal to be happening extensively.

Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities are also being held in labour camps, such as Tibetan Buddhists, Falun Gong practitioners and Christians. This modern-day slavery has been entering the UK supply chain, and there is no doubt that we are currently complicit. I must say that I welcomed the Statement made today by the Foreign Secretary.

Last year, the China Tribunal concluded:

“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one – and probably the main – source of organ supply”


and that:

“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”


I hope the Government will seek to put pressure on the World Health Organization to take this seriously.

Domestically, the Bill provides an opportunity to prevent British complicity in such crimes and to send an important message to other countries. My amendment is designed to deal with gaps in current UK human tissue legislation. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. Currently, neither the Human Tissue (Quality and Safety for Human Application) Regulations nor the Human Tissue Act require appropriate consent for imported human tissues for use in medicines. My amendment gives powers to Ministers to put this right. I should explain that the words “tissues” and “cells” are terminology which encompass all the human material that is used for the purposes of medicines. This includes organs.

The amendment would not include the prohibition of the dreadful travelling circus of Real Bodies exhibitions, nor would it include medical equipment manufactured and exported from the UK for the purpose of extracting or preserving human organs if exported to China. The noble Lord, Lord Alton, will come back to that point, and I know he has had some very helpful discussions with the noble Baroness, Lady Penn.

None the less, the passing of my amendment would be a significant action. By giving Ministers the power to make regulations, this is a specific act by the UK in relation to the abhorrent practices in China that I have spoken of. Of course, we need to see those regulations introduced and passed through Parliament. But, internationally, the UK’s action will be seen as a marker and a real signal to other countries.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this has been a short but incredibly important debate. In addition to the noble Lords that I have already thanked, I pay tribute to the noble Baroness, Lady Jolly, and my noble friend Lord Collins, for their sterling support throughout the passage of this Bill. It is much appreciated.

I stress that this amendment is not the definitive response to the horrific abuse taking place in China. It is enabling legislation, and there is much to do, as the noble Baroness, Lady Finlay, said. We need greater vigilance over exports. Transplant tourism is another area of real concern.

The noble Baroness, Lady Northover, and the noble Lord, Lord Alton, spoke about the HTA and its rather relaxed approach to the “Real Bodies” exhibitions. I find it extremely embarrassing that one of these exhibitions took place in Birmingham, but I am glad that the Commonwealth Games are coming to the city next year and that it has adopted a robust ethical policy which, if extended to the National Exhibition Centre in the future, would ensure that we would not see these exhibitions again.

The noble Lord, Lord Alton, has identified a number of other areas, to which the Minister responded to today, and the noble Lord, Lord Ribeiro, spoke very forcefully about the role of the World Health Organization. Again, I am very glad that the Government and the FCO in particular are talking closely to the WHO about it.

The noble Baroness, Lady Penn, sent a number of very important messages at the end: the revision and toughening up of the HTA’s code of practice and licensing procedures; and she talked about exports of medicines and devices. These are all welcome. However, we cannot be complacent. As my noble friend Lord Collins says, we cannot as a country show any tolerance towards these barbaric acts. This amendment is significant, particularly because it shows that the UK, with the support of government Ministers, is taking it seriously, and I am very grateful to all noble Lords who have helped to make this happen.

Amendment 13 agreed.

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[Lord Clement-Jones (LD) [V]]

My Lords, on 4 November in Grand Committee, the noble Baroness, Lady Thornton, and my noble friend Lady Jolly introduced amendments designed to limit the ambit of the information-gathering powers under Clause 3, which deals with falsified medicines. I raised the subject at Second Reading but was unable to be present for the debate in Grand Committee.

The Minister, the noble Lord, Lord Bethell, said in resisting the amendments:

“We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.”


It was not at all clear what the Minister meant by “exploring creative uses of information”, and in fact it was quite concerning given that these have not been set out anywhere in any consultation document. However, he went on to say:

“I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.”—[Official Report, 4/11/20; col. GC 326.]


Of course, as the result of the very welcome government Amendment 4, the safeguarding of public health is the key objective, and by Amendment 6, Clause 1(3) has been tightened up too. However, having carefully considered these amendments and the Minister’s previous response, I must still question his interpretation of Clause 3 and how it interacts with Clause 1. Clause 3(1)(b) currently says that the regulations may make provision about

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”

At best there is a conflict between the two clauses, and at worst Clause 3 is open-ended and gives the Government far too much discretion in the scope of regulations under Clause 3.

In the discussions we have had with the Minister between Committee and Report—for which I am grateful—it became clearer that we need to ensure that this information regarding falsified medicines is used for limited purposes. The Minister cited a whole range of possible uses for the data, which came as a considerable surprise. As I said earlier, there has been no industry consultation, despite considerable ambition on the department’s behalf. That is why in this amendment we have tied the purpose to “ensuring patient safety”. What possible objection could there be to this limitation? Why would the Government want any wider scope, especially if the Minister believes that Clause 1 already provides a limitation?

I have now seen the brief announcement issued by the department on the consultation on the regulations to be carried out on a new national scheme. It says:

“We are committed to public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme.”


That lacks detail, to say the least.

Many noble Lords have been briefed by the Company Chemists’ Association about the commercial sensitivity of this data. As my noble friend Lady Jolly said in Grand Committee:

“The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.”—[Official Report, 4/11/20; col. GC 324.]


Given this access and the known sensitivities about falsified medicines directive data, it is unclear why the department has included this sweeping provision in Clause 3(1)(b). I described this as “legislative creep” at Second Reading. It goes well beyond the EU falsified medicines directive of 2011 and the associated delegated regulation of 2016. Of course, this was not acknowledged in the Commons by the Minister, Jo Churchill. As a result of the efforts of several noble Lords, the changes proposed to the FMD provisions are now out in the open—but that does not make it any more acceptable.

This might seem rather a specialised part of the Bill, but clarity about the scope of Clause 3 is vital if we are to have confidence that a suitable scheme for falsified medicines data will be put in place that does not go well beyond the current scheme in terms of the sensitive data that is collected and used. I hope the Minister can do better than last time in giving greater assurance about the ambit of Clause 3 so that I do not need to divide the House. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to support the noble Lord, Lord Clement -Jones, and my noble friend Lady Thornton. I urge the Minister to respond, as the noble Lord asked, on how Clause 3 will actually be used. It did not help that the Explanatory Notes made no mention of what the noble Lord described tonight and at Second Reading as “legislative creep”.

We have had submissions from a number of organisations that make the point that the wording goes beyond the current EU legislation, which was carefully implemented after extensive consultation with the relevant bodies. That is from the Company Chemists’ Association. The ABPI said that the falsified medicines directive was introduced as a barrier to counterfeit and falsified medicines entering the supply chain, thus reducing the potential risk of harm to patients, that the ABPI and its members have worked to fund and implement the falsified medicines directive, and that any future considerations under this clause must include full consultation with industry.

So there is general concern in the industry about how the clause will be used. We know that the department already has access to a wide range of data on medicines sales and use in the UK under the Health Service Products (Provision and Disclosure of Information) Regulations. Given this and the known sensitivities around falsified medicines data, I am still unclear why the department wants to extend the purposes for which data is collected under a future UK system. I know that we were very privileged—

[Baroness Penn (Con)]

My Lords, unfortunately the noble Lord cut out again briefly. If he could rewind about 30 seconds, that would be appreciated.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab) [V]]

I am sorry, I have had a very poor connection tonight. Can you hear me now? All I was going to say was this: we were privileged to have a discussion with the noble Lord, Lord Bethell, and his officials before Christmas. The impression I had was that this is regarded as a useful clause to be used at some point in the future when a clearer purpose has emerged. I do not think that this is the way we should go forward. Like the noble Lord, Lord Clement-Jones, I hope the Minister can give some assurances tonight about how this clause and the information stored will be used.

--- Later in debate ---

[Baroness Masham of Ilton (CB) [V]]

My Lords, I thank the noble Lord, Lord Field of Birkenhead, who moved this amendment so movingly. This debate has gone on for many years.

It has been found by parents that medical cannabis can help some children who have multiple seizures due to epilepsy. I need to know: has NICE approved it? If it is waiting for more research, there will have to be more people using medical cannabis so that the information can be collected. If it is helping, doctors who understand the problems need to be the people who prescribe it. It should be carefully monitored. If it gives better quality of life, why should it not be prescribed? I hope the Minister will do his best to see that it is.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am really grateful to the noble Lord, Lord Field, and the noble Baronesses, Lady Meacher and Lady Walmsley, for sponsoring this amendment and for the powerful speeches they have given.

Last week, I heard Hannah Deacon talk on the “Today” programme about her son Alfie and the devastating consequences of Brexit and the impact of the inability to import Bedrocan from Holland. I know the Government have been active, and I very much hope the Minister will be able to report progress tonight.

That is the immediate issue, but of course there is then the long-standing issue that, when Parliament agreed to the legalisation of medical cannabis under prescription, there was a distinct impression that NHS patients would receive medical cannabis where appropriate. It is very clear that the NHS is not prepared to do that. The small number of prescriptions and the approach of the various bodies that advise the health service on commissioning make it abundantly clear that, unless Ministers intervene, patients will simply not be able to get these products in a legal way.

I say to Ministers that, with the campaigns, it is obvious there will be increasing noise, increasing concern. They really will have to step in and find a way of getting access to these products for patients. It is inevitable that it will happen, and it is better than they do this now rather than wait for another three, four or five years. I remind them that, when the legislation went through, the Home Secretary at the time said:

“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”


That simply has not happened.

I suggest four approaches: first, the All-Party Parliamentary Group on Medical Cannabis under Prescription believes that the only way to help families at the moment, and to make sure the policy does not stall completely, is to set up a small fund called something like the medical cannabis access fund, which can be used to help those families, until the blockage on NHS prescription eases.

Secondly, we have to come to the issue of research. I know the Minister is frustrated—he repeated this today—because he thinks the companies producing these products should come forward and undertake clinical trials and tests. I am not an expert, but I have listened very carefully to noble Lords and to advice that I have received, which suggests that randomised control trials are very difficult in this area. In that case, surely the Government should revisit the NHS England report, Barriers to Accessing Cannabis-based Products for Medicinal Use on NHS Prescriptions. The report looked at the issue of research, and said that there should be randomised controlled trials but, alongside this:

“NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT.”


I gather that this has not happened. The Minister really should inquire into this. It would basically be an observational study; it would allow medical cannabis to be prescribed for large numbers of people and for proper research to be undertaken. I suggest to him that it would be a way forward, so that the current frustration of so many patients is responded to in a sympathetic but also practical way.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.

When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.

I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.

Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Thursday 7th January 2021 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am very grateful to the Minister and declare my interests as a member of the GMC. As we enter lockdown, the NHS finds itself in a critical position, with the four Chief Medical Officers warning that it is at risk of being overwhelmed in parts of the country. This week, NHS Providers has given a sobering analysis of some of the pressures. Indeed, since Christmas Day, the NHS has had 5,000 more Covid in-patients, equivalent to filling 10 hospitals. It also has fewer beds in use than this time last year because of the need for tight infection control to protect patients and staff.

Areas with a high Covid load are suffering from a double whammy of high numbers of Covid patients and high levels of staff absence. Trusts are utilising every last ounce of capacity available and are seeking to maximise the number of patients being safely discharged into community beds and being looked after at home. However, there is understandable concern about the impact of this on already tired and exhausted staff who are now being asked to delay leave, work extra shifts and transfer to new roles, for instance to help in critical care.

I would like to hear from the Minister what plans are under way to try to relieve at least some of the immediate pressure. I have asked him before about the nearly 30,000 additional doctors who were brought on to the GMC’s supplementary list; I know there is an issue around the bureaucracy involved, but is there also an issue of philosophy? Is the NHS, per se, reluctant to use this incredible facility that could be made available? Can he assure me that, as we come out of this critical situation, thought is being given to what support needs to be given to the thousands of staff who will inevitably be scarred and deeply affected by what they have gone through?

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 2) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Wednesday 30th December 2020 Lords Chamber

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I remind the House of my membership of the GMC board. We meet while the NHS is under huge pressure, with a record 53,000 Covid cases reported yesterday. Yet the Government’s record has been one of delay, indecision and vacillation.

The errors in the spring were compounded by the Government’s decision to ignore the advice of SAGE given in September for a two-week circuit breaker. Then on 2 December, a consensus statement signed off by SAGE warned that additional mixing to be allowed at Christmas could have a large impact on prevalence. Again, this was ignored by the Government. On 9 December, the Health Service Journal was reporting a rise in admissions. Yet still Christmas plans remained unchanged. On 14 December, the Secretary of State updated the Commons on the new variant associated with the faster spread in the south-east of England. The next day, the Health Service Journal and the British Medical Journal called for the Government to respond to this worsening situation by cancelling their plans to allow household mixing over Christmas and tightening the tiered restrictions immediately. This was ignored. On 16 December, Boris Johnson dismissed concerns raised by Sir Keir Starmer. Three days later, we saw the U-turn which sent thousands of people on to overcrowded trains, exporting the new variant far and wide.

Have the Government finally learned their lesson? I hope that this afternoon they will show they are prepared to act decisively. I also hope that, with the fantastic news today of the approval of the Oxford AstraZeneca vaccine, the Government are able to raise the weekly vaccination rate up to 2 million a week, as Professor Neil Ferguson has recommended. I also hope to hear from the Minister what plans they have to reduce the immediate pressures on the NHS. Are the additional nearly 30,000 doctors who were brought on to the GMC’s supplementary list really being used sufficiently to help the NHS?

Covid-19 Update

Lord Hunt of Kings Heath Excerpts

Tuesday 15th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

I thank my noble friend for providing this opportunity to scotch that unhelpful rumour. I confirm that there are absolutely no animal components in the vaccine. That point has been endorsed by the British Islamic Medical Association, members of which issued a fatwa earlier this year confirming that the vaccine was halal. My noble friend is right that there are stories on social media that are extremely distracting. We engage with sympathy with those who are concerned about the vaccine, but these stories are completely wrong, and I would like to put them to bed.

[Lord Hunt of Kings Heath (Lab) [V]]

May I continue on the theme of vaccines? Has the Minister seen the very recent survey by King’s College and Ipsos MORI, which found that 46% of all 16 to 34 year-olds say that they have seen or heard messages discouraging the public from getting the vaccine? Alarmingly, 27% of them believe that the real purpose of a mass vaccine programme against coronavirus is to track and control the population. Social media is playing such an important role in vaccine disinformation. Is the Minister really satisfied that all is being done to combat it?

[Lord Bethell (Con) [V]]

My Lords, the noble Lord, Lord Hunt, is right to be concerned. Some of the data we have on public attitudes is of extreme concern and the statistics he has referred to show exactly why we have focused on this area as much as we have. We have worked extremely closely with social media platforms to try to minimise the availability of this material, and we have a large communications programme to engage with those concerned about taking the vaccine. I reassure him that our experience to date has been that when those who are considering taking the vaccine reach the moment of decision, their confidence increases, and I am hopeful that that will continue.

Ockenden Review

Lord Hunt of Kings Heath Excerpts

Monday 14th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

On behalf of the Chamber, I thank my noble friend for his touching testimony. He is entirely right; there are two CCGs in the local area: the Telford and Wrekin CCG and the Shropshire CCG. They did exactly what they should have done in 2013, launching an investigation into the levels of service at the Shrewsbury and Telford Hospital NHS Trust. It is not clear why the findings of that report turned out as they did; nor is it clear why other interventions, or potential interventions, by the CQC and other regulators did not get to the bottom of the problem. Those questions will be addressed in the second of Donna Ockenden’s reports, in 2021; there has not been time for them all to be addressed in the interim report, but there is much more to go into, and this is undoubtedly one of the important points she will need to address.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I declare an interest as a member of the GMC board. Nothing can excuse the repeated failures and the lack of compassion and kindness exposed by the review. What is so striking is the paragraph in the report that refers to the eight chief executives working in the trust over a period of 10 years and 10 chairs over 20 years —no wonder there is a leadership and governance issue in the trust. I ask the Minister: what on earth have NHS England, NHS Improvement and the CQC been doing? It seems that their interventions, which I suspect have been punitive in nature, have not provided the kind of support that is needed.

Does the Minister agree that we need a wholly new approach to this trust, which gives it high-level attention and provides stability in leadership—not a constant turnover because of an intervention by one or other of the many regulators that can do this—and above all, support from neighbouring services that can provide help? I suspect that this trust needs an awful lot of help to get out of this terrible situation.

[Lord Bethell (Con) [V]]

My Lords, I completely take on board the noble Lord’s observations. It is true that Donna Ockenden’s report alludes to the failure by senior leadership to monitor and intervene where clearly there were problems. However, let us not confuse correlation with causation. This was not caused by a failure of senior leadership, but by a breakdown in the basic management systems and culture of the maternity services within the trust. That should have been addressed by the senior leadership, but it was not necessarily caused by them. I completely endorse the observation of the noble Lord that neighbouring trusts have an important role to play in checking in and benchmarking behaviours. That is a point made very clearly in the Ockenden report, and one that I hope they will step up to.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Thursday 10th December 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I have every sympathy with the Minister being in isolation and thank him for introducing these SIs. Clearly, Covid-19 testing is a critical part of the response to the pandemic, so these regulations are important in ensuring that there is a robust process in place to ensure transparency, effective monitoring and appropriate accountability.

In proposing the new regulatory regime, the Government have argued that it is necessary to remove barriers to entry into the market and that, by removing the CQC’s responsibility and replacing it with an accreditation process through the UKAS, they will achieve the agility in the market that is required, alongside rigorous safety standards.

I say at once that I am a long-standing admirer of the UKAS, but it is reasonable to ask whether it has the expertise to undertake this important task. Under the CQC, providers of testing services were required to meet the fundamental standards of quality and safety set out in the 2014 regulations. The CQC monitors the quality, safety and effectiveness of care and can take action when it identifies that people using services are at risk of harm. How much of this is UKAS going to be able to do? Does it have the expertise and capacity to do it? What happens if there is a problem? Who is able to intervene and stop the service?

I also ask the Minister about timing, and the three stages he referred to. Clearly, one of the concerns is that the current process takes too long. I note from the UKAS website, which I was referred to by the Library, that it indicates a normal lead-in time of approximately three months to arrange the first assessment visit. Will that apply in this case?

Finally, could the NHS be contracting with the private organisations covered by the regulations? The Minister will be aware of the NAO report a couple of weeks ago on the £8 billion of contracts awarded by the Government using emergency procurement regulations. It found specific examples where there was insufficient documentation on key decisions and actual conflict of interests had arisen, which diminished public transparency. If the public sector could procure those private services, can we be assured that the contractual process will be rigorous?

Coronavirus Vaccine

Lord Hunt of Kings Heath Excerpts

Thursday 3rd December 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Baroness is right about the NHS volunteers. We would very much like to work with those who stepped forward. Their move was extremely welcome and kindly meant. However, the deployment of the vaccine is a precise affair. We are relying on people having to put in long hours—often not at their own discretion or convenience. Volunteers may well play a role, but the backbone and functional aspect of the deployment will rely on professional staff.

I appreciate her conundrum about the military. It is a delicate dilemma. I do not want to live in the kind of country where we turn our back on the military because some people might feel uncomfortable at the sight of uniforms on the streets. We need to build trust with communities. I want to use this moment of the vaccine to build a bridge of trust between those whom the noble Baroness reasonably described and the military. We must not make the mistake of disrespecting the military by turning them away from this important task.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, as the Minister who established the MHRA, I strongly endorse the Minister’s congratulations. I pay particular tribute to the outstanding leadership of Dr June Raine. I note what the Minister said about unpaid carers and the justification for not giving them priority but would the Government be prepared at least to discuss this with Carers UK? On care homes and visitor testing, which are mentioned in the Statement, is the Minister aware of calculations by Care England that the infection control fund will not cover the cost of implementing the new testing regime, let alone all the other areas for which the fund is intended? Will the Government consider increasing the fund?

[Lord Bethell (Con)]

My Lords, the support we are giving to social care throughout this period is incredibly important. I should be happy to meet with Care UK to discuss this. I cannot duck the issue. The JCVI has made its prioritisation clear. It is based on thoughtful science, infection rates and the calculation of how best to save life. While I feel compassion for carers, including some in this Chamber, we have to live with this tough decision. I cannot pretend I am going to try to change it. The inspection control fund is generous; we have put a large amount of money into it. If it proves not to be enough, we will be happy to revisit it. Protecting social care through these final few months is a big priority. I should be happy to discuss how we can do this better with the noble Lord at his convenience.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Tuesday 1st December 2020 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, this promises to be a very important debate, going to the heart of how we are handling this terrible epidemic. I do not support the noble Lord, Lord Robathan, but he is right to pose challenges about the Government’s management of the pandemic, which has been less than consistent. In fact, when one thinks of the Prime Minister’s ducking and weaving, the half promises and the hopes that relaxation will be lifted, it is not surprising that it has not inspired confidence among members of the public; I do not think the impact assessment published yesterday inspired confidence either. It looks very much like a cut-and-paste job, strewn with errors.

A much more accurate assessment of where we are was given in the Financial Times yesterday. It was a very sober analysis, which showed that the UK was spending proportionately more money than any other country in fighting the pandemic, and that we were languishing at the bottom of the league table of economic performance and virus deaths. The conclusion of that analysis is that, essentially, our poor performance came about because we allowed the virus to become prevalent in the spring before enforcing social distancing. That meant that the Government were ultimately forced to impose the more draconian restrictions that undermined the economy so grievously.

The noble Lord referred to the economic difficulties that we will face in generations to come. Noble Lords will know that the OBR said in its central forecast last week that the UK economy was set to shrink by 11.3% in 2020 with a deficit set to hit £394 billion. We are spending more than most G7 countries yet suffering a deeper decline in economic output than any of them —and, sadly, this does not seem to have saved lives, as the current total number of deaths per 100,000 people from coronavirus puts us at the bottom of the international league table. When reviewing the data, Jonathan Portes, professor of economics and public policy at King’s College, said the errors came in locking down too late in March, allowing the virus to spread in care homes and then delaying a second set of national restrictions well after most scientists had realised this was inevitable.

It is unforgiveable that the Government repeated their error in the autumn. At the 58th meeting of SAGE on 21 September, it was noted that Covid-19 instances were increasing, even though the effects of schools and universities reopening were only just beginning to come through. At that meeting, SAGE asked for a package of interventions including a circuit breaker. As in the spring, however, the Government resisted decisive action.

The advice from SAGE in the run-up to Christmas has once again been clear. It points to the potential threat of substantial mixing of people over a short period of time, representing a significant risk for widespread transmission. This is not the time to relax our guard or underestimate the pressures on the National Health Service.

I would like to suggest an answer to the questions raised by the noble Lord, Lord Robathan, about the NHS. I understand there have been a series of comments from Conservative MPs that the NHS is now under less pressure than it was a year ago and, essentially, has the capacity to cope with more patients from a relaxation of social-distancing rules. The analysis published over the weekend by Chris Hopson from NHS Providers offered a very strong refutation. As he said, the NHS is actually at full stretch, juggling the demands from Covid-related care with urgent and emergency treatment for other conditions. Stringent infection controls are required, so every hospital has to be divided into three areas. That has reduced their capacity from between 5% and 20% depending on the conditions in each local hospital. We know that demand for theatre space is hugely outstripping supply and that trusts in areas of high infection rates are losing large numbers of staff because of self-isolation, family responsibilities and staff falling ill with Covid.

Much of this would not show up in hospital demand and bed occupancy data, but the best guess is that today’s 85% total bed occupancy is the equivalent of the normal 95% rate when the NHS is probably overoccupied and going at full pelt. Similarly, ICU capacity is not a good indicator of hospital provision because it accounts for only a small proportion of a hospital’s total bed capacity, with many more Covid patients now being treated in general wards. As for the Nightingale hospitals, it would be fair to say that they were always intended as a last resort. Also, they do not have the staff there; staff would have to be diverted from our other hospitals, which would reduce the standard of care there, so it really is a last resort.

Frankly, the NHS is at full stretch. It has not yet hit the real winter pressures. Vaccines, more testing and new drugs offer us the way out. This is the last moment we should relax our guard. I should also say that a semblance of competence from the Government might help.

Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020

Lord Hunt of Kings Heath Excerpts

Wednesday 25th November 2020 Grand Committee

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow my noble friend and I congratulate him on a fine maiden speech. As he said, he brings to your Lordships’ House a wide range of experience in the trade union movement, service on the GLC and as chair of ILEA, where he was a forceful champion of comprehensive education. However, I rather think that his being the first actuary to enter the Lords for more than 50 years will cause the most challenge to your Lordships. He will discover that we float figures around the House like confetti to justify whatever position we happen to take. Happily, this usually goes unchallenged, yet with my noble friend in place I suspect that we will need to be on our mettle and to expect robust scrutiny in the future.

As my noble friend said, it has not been necessary to use the powers in the regulations and their removal is warmly welcomed. Although the regulations are concerned with the requirements under the Mental Health Act 1983, this debate inevitably raises wider issues in relation to mental health provision during the pandemic and beyond.

We know that the pandemic has had a significant impact on the country’s mental health and well-being. What is the Minister’s assessment of this and what measures are being taken to restore services and deal quickly with the backlog of patients? Does he agree with the assessment of Scientists for Labour that there has been a stark decline in the availability of services? Research by Mind from May 2020 reported that the restrictions on seeing people, being able to go outside and worries about the health of family and friends are the key factors driving poor mental health. The Centre for Mental Health predicts that at least half a million more people may experience a mental health problem as a result of the pandemic. Does the Minister agree?

As part of the lockdown in March, dramatic changes were made by NHS mental health services, including discharging patients from in-patient community services and moving to online provision. Has the impact of that been measured? Does he accept that eye contact often plays an important role in cognitive behaviour therapy? We need to reflect on that before assuming that services can always be online in the future. Will the Minister agree to publish a comprehensive plan to restore levels of service, including a thorough assessment of what changes in demand for services are arising from the pandemic?

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, the noble Baroness, Lady Warsi, has withdrawn from the debate and so I call the next speaker, the noble Baroness, Lady Fox of Buckley.

Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Cumberlege (Con) [V]]

My Lords, as noble Lords are well aware, First Do No Harm, the report of my review, was published in July of this year. Our ninth and final recommendation was that the Government should set up a task force to implement the other recommendations and the many actions for improvement contained in the report. That task force has not been set up, and the Government remain silent on whether they will agree to do so and, indeed, on the report as a whole.

This proposed new clause would require the Secretary of State to set up a task force within three months of the Bill becoming law. I would much rather not find myself tabling it; I would much rather the Government saw the urgency and had already set up the task force, because it is designed to help the department and the wider healthcare system to do the thinking, to make sure we get the details right and to set out a pathway and a timeline for implementing the report’s recommendations.

I believe it must be a collaborative venture; it should involve not just the department and its arm’s-length buddies but also patients. It would be a missed opportunity were it not to include the representatives of my review, because we have the knowledge and the expertise, acquired over two and a half years of work. To inspire confidence among people who have suffered, it needs to be independently chaired and overseen by a government board.

We feel that the task force is the right way to approach the job of implementing the review’s recommendations. My noble friend the Minister may well tell us that the Bill is not the right place for this measure—that is as may be—in which case, if he were able to reassure me that the task force would be set up separately by the Government, as we envisage in this proposed new clause, and on a similar or shorter timescale, I would be more than satisfied.

These matters are pressing. Our recommendations need to be implemented if we are to help people who have suffered so much already, many of them for decades. We must try to prevent further avoidable harm to more patients and families in the future. The task force is the key to making this happen, and those of us who have run organisations know that they need some discipline and something like a task force—a body that will ensure that the task set out is actually implemented and that it happens. I beg to move this amendment, and I look forward to the Minister’s reply.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and to support what she is saying. At the heart of her argument is the concern that, although the Minister said earlier in Grand Committee that the Government are weighing it up with all “seriousness and intent”, the Government are not going to run with the core of the noble Baroness’s recommendations. Because the Government have been so reluctant—very unusually—to respond immediately to the thrust of her report, there remains a lot of uncertainty about how far the Government are prepared to implement it.

Of course, the opportunity given to us with the medicines Bill enables us really to press the Government to be more detailed about what they are going to do. On Tuesday, we had a very good debate on the recommendation for the appointment of a patient safety commissioner. The Minister made a very extensive response, which essentially set out the measures that the Government are taking to embed patient safety throughout the NHS. I shall just mention a few: promoting a positive learning culture at the heart of the NHS; taking steps to help staff to speak up when things go wrong; establishing the Healthcare Safety Investigation Branch to examine the more serious patient safety incidents and promote system-wide learning; appointing medical examiners to provide much-needed support to bereaved families and improve patient safety; introducing a duty of candour, so that hospitals tell patients if their safety has been compromised, and apologise; and commissioning the NHS national director of patient safety, Dr Aidan Fowler, to publish a strategy, which, of course, has been done.

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Moved by

[Lord Hunt of Kings Heath]

122: After Clause 38, insert the following new Clause—
“Medicines and Medical Devices Redress Agency
The Secretary of State must, by the end of the period of 12 months beginning with the day on which this Act is passed, bring proposals before Parliament to establish a Redress Agency for those harmed by medicines and medical devices.”

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this is a probing amendment. Although I am a member of the GMC board, I make it clear that I am not speaking on behalf of the GMC.

It is very difficult to move on to the nitty-gritty of a redress agency after the hugely eloquent and moving speech made just now by the noble Baroness, Lady Cumberlege. The Minister said in his response to the noble Baroness that this is not the Bill to respond to the report. What I say to him is that this is the only Bill in town. Medicines and medical devices are at the core of patient safety. He promised that the Minister responsible for patient safety would make a Statement on the report in December. My assumption is that that will be made after the Bill has passed through the House of Lords, and therein lies the problem: we will not be told the Government’s response before we come to the critical Report stage. We just have to work on the assumption that, as the noble Baroness, Lady Cumberlege, said, the Government are not going to embrace her core recommendations. We will therefore have to take action on Report on that basis. I do not see what other course of action the House of Lords can take, unless the Government are prepared to bring forward their Statement so that we can see it before we reach Report.

I have just one other point. I listened to the Minister, and he has been very helpful in setting out some of the initiatives that the Government are taking. However, as with the patient safety strategy—we have been here before—the department seems to have collected all the examples of good practice it can find, bunged them into a report and called it a strategy. That is the problem, because it ain’t a strategy. It does not address the fundamental crunch that the NHS has been run far too hot and is unsafe. When you really tackle that, you have to tackle the issues of resources, work force and targets. That is a huge challenge to the Government, which is why they are so reluctant to go down that course.

What does that have to do with the redress agency? I will try to come to that in a moment. However, I want to ask the Minister whether he can say anything about this recommendation. The noble Baroness, Lady Cumberlege, argued powerfully for a redress agency to be set up on an avoidable-harm basis that looks to systematic failings, rather than blaming individuals, encourages reporting and should provide faster resolution for claimants. She argues that it should be a consensual process rather than a judicial one. Redress would be offered, not awarded, and proceedings under the scheme would be voluntary. She also said that the redress agency would have an important role to play in harm prevention as claims for adverse events would be centralised, enabling data to be provided that would help regulators detect signals earlier.

This is not the first time that a redress scheme has been proposed. Indeed, 17 years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. It included no-fault compensation for babies born with severe brain damage, and payments of up to £30,000 without litigation for patients whose treatment went wrong. Under the scheme, parents would get a managed medical care package for their child, monthly payments for other care of up to £100,000 a year, lump sums for home adaptations and equipment of up to £50,000, and compensation for pain and suffering capped at £50,000. The other arm of the redress scheme, for smaller negligence claims, would have provided a package including an explanation and apology, remedial treatment, rehabilitation and care where needed and financial compensation up to £30,000 where authorised. Legislation followed in 2006, but 14 years later it has, as I understand it, yet to be implemented. The aim of the Act was to provide a genuine alternative to litigation, but it has languished on the statute book. I would be grateful if the Minister would tell me whether that is it and whether the Government do not think it the appropriate way forward.

I also ask the Minister to say something about the increase in negligence costs to the NHS. The latest annual report from NHS Resolution shows that the total cost of payments made in respect of clinical negligence in 2019-20 was £2.32 billion. Of that figure, a substantial amount was paid in legal costs: nearly £500 million to claimant legal costs and £143 million for NHS legal costs. We know that it often takes years for cases to be resolved.

Is the Minister confident that we are getting this right? Does the noble Baroness’s recommendation not deserve examination, at least? I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, it is hard to follow the very well-researched contribution to this whole issue from the noble Lord, Lord Hunt. It was interesting to hear about Sir Liam Donaldson’s report, which got on to the statute book but was not implemented. Is that not a disgrace? It is really dreadful.

Very near to where I live is the centre for Chailey Heritage, now the Chailey Heritage Foundation, for children who suffered through their mothers having taken the drug thalidomide. I chaired its governing body for years. It is interesting that that redress system still continues; it is supported by a trust, which inherited the disaster of the medication, and it has honoured that and receives government support. So we have examples where this is working.

The redress agency that we recommend is really about the future. My amendment is about the present. We know that so many patients and their families have suffered such harm, and we need a system that is more compassionate and a much more certain route for obtaining redress to compensate them. We are talking not about compensation as such, but about redress. You have to go to the courts to achieve compensation, and it is a very miserable experience—we have heard that from patients. It also takes a very long time and, as the noble Lord, Lord Hunt, said, very often the people who benefit most are the lawyers.

We are talking about Primodos, sodium valproate and pelvic mesh—the three interventions through which people have suffered avoidable harm. The suffering they endure now is terrible. All three have caused and are causing avoidable psychological and, of course, physical and neurological harm. These families really need a little help with the conditions they are living with. Indeed, some are looking after some very disabled children. We do not believe that their needs are adequately met by the healthcare, social care or benefits systems. Some of these people are actually very elderly—the parents of the children who took Primodos. It would be a scandal if those people were to live their lives unable to access the redress they need and the outcome they deserve. After all, the harm was caused not by them, but by the state.

In the case of these three interventions, there is a moral and ethical responsibility to provide ex gratia payments in respect of the avoidable damage that occurred. That responsibility falls on the state and the manufacturers of the products in question. The schemes that would be established through this proposed new clause would provide discretionary payments, and each of the three schemes would have tailored eligibility criteria.

The payments the schemes make would not be intended to cover the cost of services that are already available free of charge, such as healthcare and social security payments. They would be for other needs—for example, the cost of travel to medical appointments. We have met and talked to many of those people, and they have said that it is a significant cost burden. The payments might be for respite breaks or emergency payments where a parent has had to stop work to cover care. These redress schemes would not be in place of litigation, nor will they be to deliver compensation. People should retain the right to take legal action if they wish to obtain compensation—of course they should; that is in our law. The schemes I am talking about should be set up in such a way that they can be incorporated into the wider redress agency that the noble Lord, Lord Hunt, spoke about, once it is established.

These people have suffered for decades. They have tried to obtain compensation through the courts. That action has failed in the case of valproate and Primodos, although I am aware that a new Primodos action is under way. I have been told by solicitors that, in fact, the report does not in any way affect that action. There have been some awards and settlements in the case of mesh, but legal action takes time, as the noble Lord, Lord Hunt, said. It creates added stress and much more personal cost can be involved.

I believe that a measure of a decent society is how well it looks after those who have suffered harm, especially when that harm was avoidable. From having met many hundreds of people who have suffered and heard from many more, I am clear that help is needed and deserved. People should not be made to wait any longer. I hope my noble friend the Minister will agree with that.

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[The Deputy Chairman of Committees (Lord Lexden) (Con)]

My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I think this has been an excellent debate. I fully accept, as my noble friend Lady Thornton said, that my Amendment 122 covers a much wider area than Amendment 123, which focuses on the specific issues relating to the report of the noble Baroness, Lady Cumberlege.

My Amendment 122 was definitely a probing amendment, because the current situation in relation to clinical negligence is wholly unsatisfactory. It combines the bureaucracy and slowness which the noble Baroness, Lady Bennett, referred to in relation to Windrush and she is absolutely right to draw parallels. It combines a hugely frustrating process for patients and their relatives with a system that increasingly becomes ever more expensive for the NHS. The noble Lord, Lord Bethell, was not going to be drawn on these wider considerations, but the noble Lords, Lord Lansley and Lord O’Shaughnessy, have both dealt with these—we know that it is a very complex issue, but surely, at the end of the day, we have to recognise that the current system simply is not working.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I hesitate to disagree with my noble friend, but I think it is on page 34—but then, of course, I might have an old edition of the Bill as well, just to confuse things.

The reason for supporting this is the unease about provisions in Clause 27 and Schedule 1. The Delegated Powers Committee concluded that

“in the absence of a full justification … allowing the ingredients of criminal offences … and … the penalties for existing offences to be set by delegated legislation”

amounts to “inappropriate delegations of power”. The Constitution Committee said:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The Minister has made certain modifications, but I think the general principle still holds good.

The guidance to be issued under paragraph 13 of the schedule is likely to be extensive, including: the imposition of a monetary penalty; the notices to the person it is proposed to fine and the grounds for so doing; the representations that have been made; the appeals process; and the consequences of non-payment. As my noble friend said, lines 9 and 10 on page 34 provides that

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph”.


Given that the Secretary of State is the person publishing the guidance, it is puzzling that he or she is required only to “have regard to” the very guidance that he or she has published—hence my noble friend’s amendment to require the Secretary of State to “act in accordance with” the guidance. I look forward to hearing from the Minister as to why the Bill is drafted to give the Secretary of State wider discretion on that.

[Lord Patel (CB) [V]]

My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.

I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?