Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

[Lord Freyberg (CB)]

My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.

The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.

Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.

I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.

The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.

[Lord Lansley (Con) [V]]

My Lords, I am very glad to follow the noble Lord, Lord Freyberg, who has made some very cogent points, both in that speech and when we discussed these clauses in Grand Committee.

I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.

My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:

“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.


Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.

In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.

My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.

At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.

I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?

I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?

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The amendments in the name of my noble friend Lady Wheeler seek to create greater certainty by substituting “must” for “may”. Surely that is right, and I certainly support her on that.

[Lord Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a very welcome move on the Government’s part. The analogy with the Commission on Human Medicines is helpful. As regards translating the Devices Expert Advisory Committee into a statutory role, in effect, in the process, as the noble Lord, Lord Hunt, suggested, there is considerable scope to think about how the Government’s new and expanded roles in the regulation of medical devices can be supported by the advisory committee.

I have a number of points. The first reflects the point made by the noble Lord, Lord Hunt, which is that the MHRA has an enviable reputation as a regulatory authority for the approval of medical devices. If I recall correctly, among the European regulatory bodies something like 40% of the most important or significant medical devices were authorised by the MHRA. Other regulatory authorities in other countries will seek to supplant that. However, our reputation should enable us to establish an international position, and I hope that the advisory committee will not be confined to expertise from within the United Kingdom. There is a lot to be said for positioning the MHRA as a body providing internationally recognised authorisations for medical devices, and its scientific evaluation in that respect should be something that others look to. I therefore hope that that will assist if we have some international participation in the advisory committee structure.

Secondly, I recall, not least in the context of the vexed experience of the PIP breast implant issues back in 2010-11, that the role of notified bodies is very important. Hitherto they have, in essence, been regulated by the European Commission, not by the UK Government, but they fall to be UK-regulated in future. There are not many of them, but there is considerable benefit in there being an advisory committee sub-committee which is focused on the work of the notified bodies. That was the weak link that probably led to the PIP breast implant problems. The regulation is all very well but we have to have bodies that we are confident are able to deliver on these things. The few notified bodies we have in this country are highly respected but we want to make sure that that is maintained even as further notified bodies are authorised.

Thirdly, I recognise that the Devices Expert Advisory Committee has leading clinicians from Scotland and Wales in its membership. However, this must be a UK advisory function, as the MHRA is. I wonder whether it would be appropriate for there to be in addition a Northern Ireland representative on the committee and for there to be perhaps some specific mechanisms to ensure that Scotland, Wales and Northern Ireland are represented in the regulations that establish the advisory committee.

I have one further point, which is that I hope that the various categories of medical devices are very carefully examined and the relevant expertise is available in relation to those. So, for example, on digital devices it is important that we have not only the clinical expertise to deal with the safety of medical devices we have at the moment but the technical expertise in the advisory committee to understand how digital devices will work in the future. That must also be the case in the special interests section related to in vitro diagnostic devices. I hope that that also will have its own special advisory committee function.

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

My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can be optional and makes the regulations weaker, and people might miss important aspects of care. There is no doubt that clear, correct information is the way to better patient safety. In many ways, communication within the National Health Service should be improved.

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

My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.

I am very happy to support Amendment 66 in the name of the noble Lord, Lord Hunt of King’s Heath. The availability of medicines and medical devices is top of my priority list. In fact, antibiotics have saved my life on several occasions. It is important that NICE adheres to health equality: everyone who needs medicines or medical devices should be treated equally and there should be no delay. Unfortunately, with this devious coronavirus, this has not happened, but we hope for better days.

Having experienced a member of my family dying, I know that sometimes it seems worth trying anything that might help and that is in the research process. There are many really rare diseases which need orphan drugs; they can be a lifeline to the individual. I hope that NICE will consider them without delay and realise their importance and value to these small patient groups. It is so frustrating when patients in Scotland and other European countries can get medicines and medical devices, when those in England cannot; patients here have to wait—unless the public come to their rescue by crowd funding.

Many users of devices also need instruction on their use, and staff and patients need training. Personal medicine is so important and patient safety is absolutely paramount.

[Lord Lansley (Con) [V]]

My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.

I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.

In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.

What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.

What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.

Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.

Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.

There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.

We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.

[Baroness Jolly (LD) [V]]

My Lords, these amendments relate to NHS access to medical devices, and Amendment 46 from the noble Baroness, Lady Finlay, would ensure early access for NHS patients to medical devices and allow monitoring of safety and efficacy in real-time use. This amendment is pre-empted rather by the Government’s amendment, which removes the concept of attractiveness.

Amendment 66 from the noble Lord, Lord Hunt of Kings Heath, would require NICE to ensure that its recommendations support the NHS in the ways outlined in subsection (1) of the proposed new clause. This includes ensuring access to new medicines and medical devices for patients with rare diseases. Those of us who have been involved in rare diseases will be all too well aware of the problems of access to appropriate treatments for so few patients.

The interesting thing about this debate is that two of the House’s big health thinkers have been speaking, and both the noble Lord, Lord Hunt of Kings Heath, and the noble Lord, Lord Lansley, have given us a really good big-picture look which takes us slightly above legislation.

The noble Lord, Lord Lansley, spoke of social and innovation benefits and the need to value innovation, but with innovation does not always come success: we may have to try again. He spoke about the innovative medicines fund and the necessity for NICE and NHS England to work together. When it is put like that, it sounds very straightforward: why is that not normally happening? He talked about the importance of value-based pricing and getting the best value from the drugs budget—which, after all, is finite. He also talked about the health technology assessment, which is of course qualitative, not quantitative. I valued the contribution of this debate on the fourth group of amendments, and I will read it again with great interest.

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[Lord Lansley (Con) [V]]

My Lords, I am very glad to follow the noble Baroness, Lady Bennett of Manor Castle, and prior to her the movers of Amendment 67. I welcome the fact that we have this opportunity to say something about redress. Amendment 68 is to follow in the next group, and I think it important to distinguish between the need to establish a scheme of redress where the NHS or government have been responsible for something which subsequently turns out to have damaged or harmed people, and the need to establish a scheme to provide proper support to those who have been harmed. That has been done on an ex gratia basis but, if the Government sought to do so, I think it would be possible to commence the NHS Redress Act 2006 and to establish such redress schemes under a statutory footing. It is not necessary to pass legislation to make that happen.

Those are different and distinct from the process of recognising that those harmed as a result of clinical negligence or failures in treatment processes should be able to secure a remedy and redress. I say remedy advisedly because often, in my experience of talking to people who have been harmed as a result of clinical negligence—these are often cases involving harm to babies during birth—it is as important to understand what happened, to accept where responsibility lies and to understand that others will not suffer in the same way, as it is to secure redress, compensation and support, which is often support for the child throughout their life. We need to understand that that is what we are talking about, not just the question of compensation.

I am slightly surprised by Amendment 67. I wonder what we think NHS Resolution is, if not an agency within the NHS with responsibility for securing redress for those who have been harmed as a result of clinical negligence. We need to recognise the need for, and I hope the Minister will tell us that the Government have not abandoned thought of, further reform. Certainly, when we were in opposition, we argued during the passage of the NHS Redress Bill that there should be a fact-finding phase. We argued that, rather than having an adversarial process with expert witnesses and all the associated costs, we should have a phase during which a claim is brought and the facts are established on an independent basis. That could lead to arbitration procedures and a settlement, rather than court-based proceedings, and we might escape some of the burden of cost. We should remember that nearly half the total cost of compensation in the clinical negligence process through NHS Resolution is actually legal fees. If we can escape some of that through an independent fact-finding phase, an arbitration process and financial settlements which recognise the support that the NHS and taxpayers give to those who have been harmed and have enduring problems and disabilities as a result, we might escape some of the burden of cost.

As the noble Lord, Lord Hunt, said, the potential contingent liability—not on an annual basis, but in the future—has risen to £83 billion. It is an enormous sum. The amounts paid by way of premiums to NHS Resolution are a significant aspect of the cost of NHS providers. There continues to be a good argument that the Government should consider this area still in need of reform.