Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

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

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and I join her and other speakers in thanking the noble Baroness, Lady Thornton, for tabling the amendment, which I think is largely intended to start a debate and get some focus on this terribly important issue.

My approach to the whole issue of disinformation about harmful content on the internet is slightly different from those of some of the other speakers. We need to take the same approach as we do with the vaccine, which is to think about vaccination being better than treatment—prevention being better than cure. Ensuring good public communication, information and education about Covid and many other issues is the best possible way in which to take on misinformation, rather than after the fact—after the infection—and then trying to treat it. As soon as one starts trying to combat such messages, it is difficult to avoid repeating them. As any communications professional will tell you, you are then trapped in a difficult cycle of raising the issue up the agenda and raising it up the hashtags.

When we are talking about problems on the internet more generally, we need much broader education on media literacy and critical thinking throughout our education system. That will not help us in the immediate future but, when we are talking about Covid, we can think about the nature of the Government’s communications and public information campaigns that will, in effect, inoculate people against the disinformation so prevalent in cyberspace. We need calm, factual, often quite detailed information that will educate the public about what is going on.

It is telling that we have seen a great deal of hunger among the public for briefings involving senior scientific officers and advisers. Some of them now have their own fan clubs and T-shirts. There is a real hunger for that kind of quality of information with clear scientific facts. That needs to come from all levels of the Government, including the politicians, not just the technical people. Let us trust the public with more information, data and facts, and with more of the difficulties and uncertainties, than we do now.

If one looks at the messaging in countries such as New Zealand and Germany, one can see that the level of detail and facts, and the quality of the information, given to their publics is much better than ours. Nearly every time there is a major government announcement or bit of advice, I see good technical people, senior professors and consultants on social media screaming in frustration about the quality of the presentation, data and messaging. I am talking not just about the shape of the graphs being wrong or whatever; we need to get the whole of government communications much better. That is the best way in which to tackle all these issues.

We all, even those of us with a scientific background, have learned a great deal more about IgG versus IgM versus IgA antibodies. A huge amount of information is out there, as is a hunger among people to find it. We must make sure that the good sources are there. That is the best way to tackle this problem when it comes to Covid and, indeed, much more broadly.

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

My Lords, this is an interesting debate and I am grateful to my noble friend Lady Thornton. We know that there is a problem with vaccine uptake, which is linked to anti-vaccine sentiment—though not necessarily always.

Looking back over the past few months, I note that there was in November a survey by Savanta ComRes on behalf of ITV News that found that almost 70% of people in the UK would like to receive a vaccination. More recently, in December, the Royal Society for Public Health published a poll showing that 76% of people would take the vaccine but, significantly, that only 57% of people from BAME backgrounds would do so. There was also a lower response among lower-income groups.

No doubt the Minister will give us figures, but my understanding is that the initial results on vaccine uptake are encouraging. However, we cannot be complacent in the face of the pernicious anti-vaccine sentiment around. Even before the pandemic, vaccine hesitancy was described by the WHO as one of the top 10 threats to global health.

We are interested in what the Government are doing. Last month, we debated this issue and the noble Baroness, Lady Evans, the Leader of the House, referred to the work of a central government unit on it. I should like to hear from the Minister about what is happening. We clearly need strong pro-vaccination campaigns, and the majority of people who may be described as vaccine hesitant are not necessarily anti-vaccine. Most people who are hesitant can be persuaded by good public health messages.

However, as my noble friend and other noble Lords have said, there has been a huge amount of misinformation across social media in the past few months. This is obviously cited by survey respondents as an area of concern when it comes to levels of trust in those delivering public health messages. As Scientists for Labour pointed out, since the recovery from the false findings around the MMR vaccine and autism from Mr Andrew Wakefield, the UK overall now ought to be in a good place when it comes to routine vaccine uptake. For example, the HPV vaccine has a consistent uptake of between 80% and 85%, which is an excellent return for a vaccine that is not part of early childhood schedules.

We do not have too much in the way of well-organised anti-vaccine groups, unlike the USA or, indeed, even the Republic of Ireland, so the likelihood is that the UK population will show less hesitancy about recently introduced vaccines compared with other countries. But the level of misinformation out there is high and we have to learn lessons from other recent vaccine scares. Clearly the Government have a huge challenge in making sure that the uptake of the vaccine is as high as possible—which is why I welcome this debate and the amendment, and very much look forward to the Minister’s response.

[Lord Naseby (Con) [V]]

My Lords, I declare an interest in that I am married to a retired general practitioner.

I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.

I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.

In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.

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

My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.

We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on 7 December. There was no debate or discussion about the new Clauses 7 and 12 and the new subsection in Clause 37 when they were introduced in Grand Committee. On both counts it is therefore vital that we get to grips with them today. I welcome the Minister’s new amendments, which he has spoken to and which take us a step further in terms of patient consent, definition of information and relevant persons. But I have signed, and these Benches support, the additional amendments to those clauses and subsection put forward by the noble Baroness, Lady Thornton, to ensure that we further tighten these provisions. Specifically, we want to tie this to international co-operation on pharmacovigilance or in monitoring the performance and safety of medical devices, and a public interest test put around the disclosure of health data, for all the reasons put forward by the noble Lord, Lord Patel.

As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the

“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”

I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.

Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.

At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.

There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.

On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.

I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. 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 Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.

I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.

My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.

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[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information system requirements as an important step towards bringing more transparency to the devices system and ensuring that the regulator seeks independent expert advice on the safety of devices.

As will be seen from Amendments 51, 52, and 53, however—I am moving Amendment 51 on behalf of my noble friend Lady Thornton—we want the requirement on the Secretary of State to establish the MDAC as a “must do” commitment, rather than the “may” in proposed new subsections (1), (2) and (3) of the amendment in relation to: the need for the regulations; providing advice; and making key provisions, such as how independent members should be from the Secretary of State. I know that numerous debates have been held during the course of legislation going through this House about the differences between “must” and “may”. However, “must” is surely the necessary language to require the Secretary of State to establish the committee and ensure its independence.

The Government’s briefings on the amendment—and the Minister today—as well as referring to the committee providing independent expert advice, emphasise that this will include “the views of patients”, complementing the work of the patient safety commissioner and giving patients a voice within the system of regulating medical devices. Through every stage of the Bill, noble Lords have underlined the importance of consultation with patients and end-users of medicines and medical devices. Can the Minister explain the thinking behind not including a subsection in the amendment which underlines the importance of the patient’s voice and perspective? I would also be grateful if he could tell the House what he considers will be the impact on the advisory role and scope of the change to a statutory footing for the committee.

We acknowledge the need for the two technical government Amendments 64 and 96. On Amendment 64, I note the explanation from the Minister today, and in his briefing letter to Peers of 5 January, of the need to reinstate provisions in the Medical Devices Regulations 2002 extending time limits for bringing proceedings in relation to medical devices offences. Amendment 96 is a necessary consequential amendment in relation to the added clause on the MDAC under Clause 18, bringing the whole clause into force two months after the Bill is passed.

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

My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.

We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.

At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.

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Moved by

[Lord Hunt of Kings Heath]

66: After Clause 40, insert the following new Clause—
“Availability of medicines and medical devices for human use on the National Health Service
(1) The National Institute for Health and Care Excellence must have regard to the need—(a) to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices,(b) to support early patient access to effective new medicines and medical devices, including by accepting a greater degree of uncertainty and risk in recommending their use,(c) to ensure patients with rare diseases have access to medicines and medical devices that they need, and(d) to support the use of curative therapies involving medicines and medical devices.(2) The Secretary of State must lay a report and impact assessment before both Houses of Parliament setting out how the National Institute for Health and Care Excellence has implemented its duty under subsection (1), in particular in its manual on process and methods for developing NICE guidelines.”Member’s explanatory statement
This new Clause would require the National Institute for Health and Care Excellence to ensure that its recommendations support the NHS in the ways described in subsection (1).

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

My Lords, before I start, perhaps I may make the point to the clerks that the noble Baroness, Lady Thornton, needs to be unmuted every time the Deputy Speaker goes through the amendments so that she can move them or not. It is very frustrating; we can see it happening, and it is impossible for us to come in on this situation. That is why there is such a hiatus.

My Amendment 66 concerns NICE’s current view of its methods and processes as part of the agreement on the voluntary scheme for branded medicines pricing and access, happily known as VPAS. If NICE is to maintain its global relevance, it is critical that the methods review delivers tangible changes to ensure that it can fairly and effectively assess the true value of innovative medicines.

The UK life sciences sector is at a crossroads. Without meaningful intervention from the Government, exiting the EU obviously presents significant threats to the attractiveness of the UK. We know that global boardrooms take a holistic approach when considering where to place their investment, including the attractiveness and speed of the commercial environment—we have debated these earlier in the Bill. The ability quickly to launch medicines and technologies into our market and to get medicines quickly to the patients who need them is one of the main factors that shape boardroom sentiment on future investment, alongside the quality of scientific research and the possibility of collaboration. It was the Labour Government who set up NICE to do that: to get innovative new medicines and devices to the NHS and implemented as quickly as possible.

But the UK risks missing out on a wave of breakthrough therapies, with the potential to transform outcomes, if the NICE review does not lead to meaningful change in the way it does its business. Not only do we risk losing our reputation as a leader at the cutting edge of medical science but, more importantly, patients will not be able to assess the most innovative treatments available elsewhere. So NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation and demonstrate that the UK Government are committed to supporting a thriving, world-leading life science sector post Brexit.

In relation to my amendment, I would like to raise issues of barriers to new innovative technologies, such as gene therapy. Gene therapy is a prime example of a medical technology that the UK should embrace, and, indeed, the Government have rightfully lauded the UK’s efforts in this regard. But a procedure called the discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses a 3.5% rate. It can apply a lower 1.5% rate for therapies that offer longer-term health benefits, but it has chosen to do this only on exceptionally rare occasions. I wonder whether the Minister will commit to working with NICE to review the circumstances in which the policy solution can be applied to unlock the potential of such innovations.

The VPAS was negotiated with the aim to secure a triple win for patients, government and industry. But NHS England’s current bespoke commercial agreements significantly undervalue innovation, and this is something global boardrooms look at for evidence in the NICE review—that speedy access to new medicines will be improved.

Why should the Government commit to doing an impact assessment of the changes? Well, warm words and promises from Ministers are not enough; we need a clear commitment from them that they will place the emphasis on NICE to ensure meaningful action. In Committee, the Minister argued that my amendment was not necessary, and that the issues I raised were already dealt with in existing legislation and were outside the remit of the Bill. She went on to say:

“NICE, like the rest of the health system, is constantly keeping methods under review to ensure they are appropriate and support the speed of innovation in the life sciences sector,”


and she agreed about the need to get new innovations into the hands of patients quickly. In so doing, she referred to the methods and process manual produced by NICE

“in consultation with a range of stakeholders, including industry and academics.”

She said:

“NICE will publish a revised manual and related impact assessment when that process is completed.”—[Official Report, 26/10/20; col. GC 52.]


Is that sufficient?

The Ethical Medicines Industry Group has identified that medicines and medical devices often face challenges when being assessed by NICE, due the rigid focus on cost-effectiveness. Failing to consider other factors, such as the benefits of treatment in reducing health inequalities or the wider impacts on quality of life, often hinders patients’ ability to access innovative life-saving treatments. The EMIG argues that introducing a health inequalities modifier would be critical to demonstrate that NICE recognises the importance of reducing the high levels of unmet medical needs in the population and to benefit the most disadvantaged and underserved patient groups. There is strong support for the introduction of this modifier among experts involved in the development of the consultation, with a document noting that there is evidence that people are willing to generate less health overall if the health is generated in disadvantaged groups, particularly for socioeconomic disadvantage.

My amendment seeks to build on expert support to ensure equitable access to innovative treatments for conditions that are not adequately treated, to drive down health inequalities and benefit the most marginalised patients. I argue that NICE must also review its appraisal system for rare disease treatments to ensure that the system in place enables patient access. Inherently, rare disease treatments serve small patient populations, and generating sufficient data to meet NICE’s cost-effectiveness requirements is often challenging.

I have received a briefing from another organisation, Global Blood Therapeutics, on sickle cell disease. It argues that, in relation to the UK’s most prevalent genetic disorder, SCD treatments are currently limited to managing the condition rather than addressing the underlying causes. But there is hope that a new range of therapies may change this.

On occasion, NICE has also considered treatments which may not meet its traditional cost-effectiveness thresholds but which would have a significant impact on health inequalities. But consideration of health inequalities remains rare, and I think that this needs to be revisited. If NICE is truly committed to designing an appraisal process which reduces health inequalities and provides equitable access for the most disadvantaged patients, the introduction of a health inequalities modifier, as set out in my amendment, is vital.

The UK life science sector faces a great challenge. It is a huge asset. We have to ensure that organisations such as NICE play their part in making sure that the NHS and the UK are attractive for major investment in the future. In a nutshell, that is the crunch point of my amendment. We have as well to make sure that its methodology deals with health inequalities sufficiently. I beg to move.

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[Baroness Penn (Con)]

My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.

The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.

Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.

In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.

I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.

In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.

Proposed new subsection 1(c) would require NICE to have regard to the need

“to ensure patients with rare diseases have access to medicines and medical devices”.

The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.

Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.

Proposed new subsection 1(d) would require NICE to have regard to supporting

“the use of curative therapies involving medicines and medical devices.”

The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.

While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.

NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.

Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.

I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.

The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.

The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.

The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.

I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.

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

My Lords, I wanted to stimulate a debate on the NICE review and it certainly succeeded, because we had a very high-quality debate. I am very grateful to the Minister for what was a comprehensive and encouraging response, in a number of ways.

I will start with the noble Baroness, Lady Finlay, because she made a powerful speech and argued very convincingly for the speeding up of approval processes, alongside speeding up the introduction to the National Health Service of proven, innovative new medicines and treatments. The noble Baroness, Lady McIntosh, asked about patient safety, but my amendment and, I believe, that of the noble Baroness, Lady Finlay, would do nothing to undermine patient safety. In the first place, the Minister has already tabled an amendment to Clause 1, which we debated on the first day of Report, which gives priority to considerations of patient safety. It is clear from the explanation given for Amendment 46 from the noble Baroness, Lady Finlay, that her proposals for a preliminary licence would allow for monitoring of safety and efficacy in real time. That could be a real bonus indeed.

I thought that the noble Baroness, Lady Masham, asked the fundamental question: why are we so slow to introduce new medicines and devices? Why are we behind so many other developed countries?

The noble Lord, Lord Lansley, gave a very thoughtful contribution. He is absolutely right to argue that we need more support for innovative medicine. The tragedy is this. We have the excellent VPAS agreement whereby, essentially, industry accepts that if the cost of medicines goes above a certain agreed level it will pay a rebate back to the Government, or ideally the National Health Service. If this worked properly the resource going back would be used for innovation, but for reasons that I have never quite understood the money does not seem to go back directly in an identifiable form to the NHS. We have the bizarre situation where, locally, the NHS worries about its drug costs. When it goes above a certain level there is a rebate, but unfortunately that rebate does not seem to find its way back in a tangible, transparent form, to the NHS. We have not created out of the agreement the kind of win-win situation that surely was envisaged when the previous voluntary agreement was first developed.

The noble Lord, Lord Lansley, mentioned one of the big issues: the need for NICE and NHS England to work together. I do not get the impression that they do work together that well, because NHS England regards most innovation as costly and therefore tries to dampen it down. I agree with the noble Lord, Lord Lansley: we need a much better partnership where we build in value for innovation and dealing with inequalities—one where NHS England would actually be on board.

The noble Baroness, Lady Jolly, and my noble friend Lady Thornton talked about this being a big-picture debate. Of course, this is not something that can be solved by an amendment to a medicines Bill, but Parliament ought to debate these important issues and, at the very least, raise some issues that the review should undertake to address.

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Moved by

[Lord Hunt of Kings Heath]

67: After Clause 40, 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, I want to come back to the debate on clinical negligence and the recommendation made by the noble Baroness, Lady Cumberlege, in her report for a redress agency. I declare my interest as a member of the GMC board.

We have reached a very serious position, with an exponential rise in clinical negligence costs. Twenty years ago, contingent liability was £3.9 billion; it is now £83 billion. Even allowing for inflation, I hardly think that we have become 20 times more negligent over that period. Indeed, the Minister, Nadine Dorries, told the House of Commons in a Written Answer last November:

“The continued rises in clinical negligence costs are eating into resources available for front-line care”.


It is not delivering for patients and their families, either. There are huge delays in getting cases settled and huge lawyers’ fees, in a quite remarkable situation where the NHS ends up paying damages in 80% of litigated clinical negligence claims. There is something wrong in the way we deal with these cases.

There have been endless reviews over the past 20 years, but precious little has happened. Seventeen years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. Legislation followed in 2006 but, 14 years later, it has yet to be implemented—and I doubt it ever will be. Since then, there has been much debate about the sustainability of Section 2(4) of the 1948 Law Reform (Personal Injuries) Act, which essentially promotes increased costs because it provides that

“there shall be disregarded, in determining the reasonableness of any expenses, the possibility of avoiding those expenses or part of them by taking advantage of facilities available under”

the NHS. In other words, the NHS tends to pay twice.

In 2017, the department and the Ministry of Justice commissioned the independent Civil Justice Council to draw up a new claims handling process for clinical negligence claims of up to £25,000, together with proposals for fixed recoverable costs for these cases. The report was published, with recommendations, in October 2019. Since then, there has been silence.

In that context, the noble Baroness, Lady Cumberlege, argued in her report First Do No Harm for a redress agency to be set up on an avoidable harm basis, which looks to systematic failings rather than blaming individuals. This, she thought, would encourage reporting and provide faster resolution for claimants. She argued that this

“would provide a standing structure to administer decisions using a non-adversarial process. This model is simple for patients to access as there is one point of contact. This structure enables flexibility to adapt and respond to situations as they arise.”

The proposed scheme of the noble Baroness, Lady Cumberlege, is well intentioned and has popular appeal. I recognise that details need to be spelled out in relation to eligibility, qualifying criteria or conditions of entitlement for her proposed redress scheme. Of course, causality is at the heart of any consideration of patient safety remedy. Causation is at the heart of tort. The Vaccine Damage Payments Act 1979 is limited to persons disabled as a result of vaccination. Even the NHS Redress Act 2006, to which have just referred, is concerned with arrangements for redress in relation to liability in tort. The noble Baroness’s approach is of course quite different from that.

The noble Baroness the Minister in Committee was not enthusiastic. In the past 48 hours we have heard the Government’s response that they have,

“no current plans to establish a redress agency”,

as set out in the recommendations of the noble Baroness, Lady Cumberlege. The reply went on to say:

“The government and industry have previously established redress schemes without the need for an additional agency.”


Well, that is a rather disappointing dismissal and misses the point, because the noble Baroness was essentially calling for a wholesale reform of the current clinical negligence system. I urge the Minister to reconsider this matter.

Can we really go on with the exponential rise in costs to the NHS—a system in which it loses 80% of cases that reach the courts, and where huge delays take place in patients getting access to an outcome? The system is completely bust. We need a new one and I hope that the Minister will, with his colleagues, consider what action needs to be taken to improve the current situation. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I warmly thank the noble Lord, Lord Hunt. His determination is awe-inspiring. I am so pleased that he has not left this issue mouldering on the Committee Floor but has picked it up again.

I understand what the noble Lord said about the Government not being enthusiastic. However, I have known other issues on which the Government have been less than enthusiastic. It is the way in which we put forward persuasive arguments—although setting up this agency will take a lot of work, with a lot of detail to be considered. However, other schemes have been successful. I think about the one in my area—thalidomide. That trust is still running and getting redress for people who need it. So I strongly support the amendment of the noble Lord, Lord Hunt.

In our review, we tried to achieve a very simple and accessible structure for patients through the proposed redress agency. In an update on our recommendations, the Minister in the House of Commons, Nadine Dorries, said that the Department of Health and Social Care had delivered ex-gratia payments with individual schemes without the need for a redress agency. Indeed it has.

There are four or five schemes for infected blood alone, with eligibility based on whether the patient was a haemophiliac with HIV; a haemophiliac with hepatitis C; a non-haemophiliac with HIV; or a non-haemophiliac with hepatitis C. These different schemes addressed what type of payment should be awarded according to the patient’s need. What we—I am talking about my team and I—were advocating is a single point of contact for avoidably harmed patients. We felt very strongly that they had suffered enough without the necessity of finding out how to access the schemes that are relevant to them. The noble Lord, Lord Hunt, has said that something is wrong. He is right: it is wrong. This is not the way to help people who have been seriously harmed.

The problem is that, without a redress agency, each ex gratia scheme starts from scratch, which we felt was grossly inefficient. We need a standing administrative structure, funded by contributions from manufacturers and the state—both have a responsibility. At the moment, litigation is the only route, as the noble Lord, Lord Hunt, has said, for injured people to get serious compensation. We know that the process is very damaging to people. They do not like going to court, they do not like having to put forward all the information that is absolutely necessary—and sometimes not so necessary—and they do not like the fact that it is an adversarial system. We felt that the redress agency could remove the need for adversarial litigation that focuses on blaming individual doctors and nurses. The agency would be non-adversarial and would look at the systems failings that led to avoidable harm. This would help develop an open culture in healthcare and facilitate learning—we are not good at that. We know that the same mistakes happen over and again, and we felt that this was another tool to ensure that there would be much less of that.

Gathering information in one place—the agency—would make it so much easier to learn from the data that is collected and would strengthen the ability of the healthcare system to learn from the mistakes made. We have only to look at the cost of litigation of some £83 billion a year—I was very interested in what the noble Lord, Lord Hunt, said. We know that, often, the majority of those costs go to the law firms, not the individuals who have suffered so grievously. We felt that it would be much better if those huge sums of money, which are much needed by the NHS, should be used with a redress agency, which would have other advantages, as I have just outlined. A stand-alone agency, with a single entry point, would be a much better and more cost-effective way to award redress to those who suffer such avoidable harm—and many of them suffer for decades.

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However, for the reasons set out, and as announced yesterday in the Written Ministerial Statement on the review, we currently have no plans to establish a redress agency. As the noble Lord, Lord Hunt of Kings Heath, is aware, and as the noble Baroness, Lady Bennett, might like to remember, the Government will respond to the issues raised in the amendment, in full, as part of our formal response to the independent medicines and medical devices safety review. I therefore hope the noble Lord has heard enough, so that he is reassured and able to withdraw Amendment 67.

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

My Lords, again, this has been an interesting debate. As was said by the noble Baroness, Lady Cumberlege, there are persuasive arguments to change the current approach to redress and clinical negligence more widely. I agree with the noble Baroness, Lady Bennett, that the Government’s response was short and not really sweet.

The noble Lord, Lord Lansley, is right to draw a distinction between schemes of redress and wider clinical negligence issues. The noble Baroness, Lady Cumberlege, has a later amendment dealing with specific recommendations on redress for the patient groups that she examined in her report. I took her argument for a redress agency to have much wider implications and considerations. The noble Lord, Lord Lansley, expressed surprise at the wording of my Amendment 67. I simply sought to bring this back, so that we could have a wider discussion, as well as deal with the issues raised around the three patient groups in the noble Baroness’s report.

I have never understood why the redress Act was put on the statute book but never implemented. It is clear from talking to experts that it is regarded as flawed, but it is interesting that no Government have picked this up. Equally, we all accept that redress schemes for individual patient groups are an appropriate way forward. However, we are left with a system for clinical negligence that I simply do not believe works.

I heard what the Minister said about improvements for NHS Resolution, but the fundamental argument is that the system is getting more and more expensive—the £80 billion-plus question, as the Minister said. For patients and their relatives, it can be a daunting process, even though, as he said, more can be dealt with prior to going to court. But when the cases do go to court, NHS Resolution tends to lose them. We go back to the size of awards, where the issue, in essence, is that the NHS has to pay twice because of the way that the 1948 legislation was drafted.

At the end of the day, surely we need a thorough review of the whole issue of redress and clinical negligence. I can see that the Government do not yet accept the recommendations of the noble Baroness, Lady Cumberlege. In the end, we have to start with a clean sheet of paper to see if we can do better by patients, the NHS and all the individuals affected. Having said that, I beg leave to withdraw my amendment.

Amendment 67 withdrawn.

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[Baroness Jolly (LD) [V]]

Amendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State

“to create redress schemes for those who have already suffered avoidable harm”

related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.

I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.

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

I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.

The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.

We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.

[Lord Bethell (Con)]

My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.

I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.

In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.

My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.

The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.

The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.

I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.

Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.

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

My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.

What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.

These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.

Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.

Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?

Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.