Osimertinib Cancer Treatment

Lord Lansley Excerpts

Tuesday 18th May 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, we are watchful of the concerns to which the noble Lord refers but it is our hope and aspiration that there will not be the kind of delays or trouble that he explained. The Northern Ireland protocol means that Northern Ireland will stay aligned with EU rules, particularly for this kind of specific cancer medicine, but that does not mean that there need to be any delays. However, we are watching the situation carefully and the report that he described will give a full account of the problems, if there are any.

[Lord Lansley (Con)]

Can my noble friend, in this instance at least, explain the divergence between the MHRA and the European Medicines Agency? On 22 April, the EMA’s Committee for Medicinal Products for Human Use gave a positive opinion under an accelerated assessment, but the EMA has not yet given the new indication of marketing authorisation. What is the potential gap between MHRA authorisation and EMA authorisation?

[Lord Bethell (Con)]

My noble friend is, as ever, all over the detail. It is my understanding that the gap is a matter of weeks rather than there being any clinical divergence in assessment of the evidence. However, I am afraid to say that I would have to leave it to the EMA to think for itself on that.

Botulinum Toxin and Cosmetic Fillers (Children) Bill

Lord Lansley Excerpts

2nd reading
Friday 16th April 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, I congratulate my noble friend on bringing this Bill forward and on her excellent presentation, which set out very clearly its purposes and justification. I very much support it.

My noble friend will know, and the House may well recall, that the Bill is in line with one of the recommendations from the Review of the Regulation of Cosmetic Interventions led by Sir Bruce Keogh and published in April 2013. Of course, as Secretary of State, I asked him to lead that review back in January 2012, following the PIP breast implant scandal disclosed the previous month. It is fixed in the memory of Health Ministers across the globe—the problems were disclosed by the French Government the day before Christmas Eve, so we all lost our Christmas in 2011. One of the consequences was that the many issues and problems associated with cosmetic interventions and medical devices were exposed. Indeed, the Keogh review did a great deal to help to bring that forward. I think this Bill will be extremely welcome.

While I have this moment, I would mention the Cosmetic Surgery (Standards) Bill in my name, which is way down in the Lords list of Private Members’ Bills. It is not going to have the benefit of the House’s attention in this parliamentary Session; I hope it may in a future one, perhaps even with the benefit of support from the Government at some point. It also follows up one of Bruce Keogh’s recommendations. It was very good that our honourable friend the Member for Sevenoaks was able skilfully to bring this Bill through. I know how difficult it is in another place to get a Private Member’s Bill through, even if one is fortunate to get a place in the ballot.

I briefly mention two other things. First, Kevan Jones, who also supports my Bill, spoke in the other place about the issues associated with advertising cosmetic interventions, increasingly on social media these days, and he was right to do so. That is an issue raised in the review that needs to be followed up. I also hope that, in line with my Bill, the Government will encourage the General Medical Council, regardless of legislation or otherwise, to use the Royal College of Surgeons interspecialty committee’s work on certification for cosmetic surgery to try to ensure that it is indicated on the medical register, so that people can identify who is properly certified and qualified to provide cosmetic interventions.

Bruce Keogh’s review said—I think I quote correctly—that, in

“our view … dermal fillers are a crisis waiting to happen.”

It is not a crisis in respect of which young people should be the victims. I am very glad that my noble friend has brought the Bill forward, and I hope that we will be able to pass it into law before the end of this Session.

Covid-19: One Year Report

Lord Lansley Excerpts

Thursday 25th March 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend for his introduction to the debate. I hope he will forgive me if I do not look back at all. I want to look forward. There will be occasions to look back and review what has happened, but what is more important at the moment is to look forward constructively at how we take things from here.

Therefore, I will focus on the road map. I would be very surprised if this is not the experience of noble Lords across the House and those in the other place: we are constantly being asked by people what the rules are and what it is they are supposed not to do, or are allowed to do. The noble Baroness, Lady Donaghy, just illustrated the point. One can see the point about homes overseas on page 70 of the steps regulations. If one owns properties abroad, one is able to go there for the purpose of buying it, selling it, letting it and enabling people to move in; one is not allowed to go there to have a holiday in it. That may or may not be the right decision, but that is what the rules say. It is absolutely illustrative of the general problem. The public are becoming very confused about whether we are going back to tiers. What is a “step”? What are the four steps relative to the tiers? What are the four tests that we have to apply?

However, I think the public have in their minds, correctly, that there has been a first modest relaxation, there will be a second on 12 April, a third on 17 May and a final one on 21 June. These instruments will then expire on 30 June. I urge my noble friend the Minister and the Government not to shift those dates. Although I would not go all the way with my noble friend Lady Noakes’s argument, she was quite correct to say that the down sides associated with maintaining a lockdown are now substantial. We have suffered a tragic loss of life and a deeply depressing loss of livelihood, but we are now getting on top of the virus in this country.

My point is that, of those tests, the vaccine rollout is doing better, the reduction in hospitalisations is going faster and the reduction of pressure on the NHS is going better than any of us dared to hope. The only other is variants of concern, which are clearly being managed well by test and trace and the approaches we are taking in this country, but less well in other countries. The issue is not about sustaining large-scale lockdown in this country but about focusing on the borders. Let us look at the circumstances in which people enter this country. I am with my noble friend Lady Noakes: I do not think we are in the business of stopping people leaving the country, but we have to be very careful about the circumstances in which they return and what then happens. That does not mean hotel quarantines for the population generally, but obligations to self-isolate and to undergo testing.

I strongly urge on my noble friend Minister that we focus on that, and insist that we want to maintain this road map and those dates, and that we want to end the lockdown. We do not want further mental health problems, isolation for the elderly and loss of livelihood for many industries. We therefore need to co-operate collectively very strongly on making sure that if any of these variants—Brazilian, South African or any others that may come along—emerge here, we get test and trace to hit them very hard. The arguments about test and trace have always been misplaced. When the virus is widespread in the community, test and trace can barely do its job, but with the variants of concern, where there are relatively few, test and trace is—and has shown that it can be—a very effective instrument. I urge that that is where we put our effort and that we focus on our borders.

Covid-19 Update

Lord Lansley Excerpts

Thursday 4th March 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, the speed and scale of the vaccine rollout is indeed a remarkable achievement and reflects great credit to all involved. The House will have noted the publication this morning of the REACH study based on data from February. Among its findings was that there was some regional variation in prevalence, particularly in the later part of February. Will the Government on this basis consider regional variation in the pace at which restrictions are lifted, rather than necessarily assuming that it will be a uniform, national approach?

[Lord Bethell (Con)]

My noble friend is entirely right to raise the issue of regional variation. It had been our profound hope to be able to adjust and to focus lockdown arrangements on geographical locations so that national measures were not the only tool in our toolkit. The evidence from last year suggests that the amount of travel that individuals do makes regional and local lockdowns only partially effective. This has put a massive question mark over the way in which we can use regional and local lockdowns. There is more work to be done to understand exactly how that works but he is right to raise it as a considerable issue.

Covid-19 Vaccines Deployment

Lord Lansley Excerpts

Thursday 11th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I have heard the noble Lord’s concerns about this matter when he has brought them up previously, but I simply do not recognise the story he is telling. I would remind him that 95.6% of those aged 75 to 79 have had the vaccine. This is not the story of people who are concerned about going to mass vaccination centres. There are GP centres up and down the country that are closed because they do not have supplies, and it is supply that is undoubtedly the rate-limiting factor. That is because, as he knows, the supply comes in large boxes. If GPs do not have enough people to use up a large box, we have to prioritise those who have longer lists.

[Lord Lansley (Con) [V]]

My Lords, I want to ask my noble friend about the Moderna vaccine. I understand that we have 17 million doses on order, the first batches of which are likely to arrive in the spring—let us say, in May. Where will the vaccine be used? It seems that with a trial taking place in America of its use among 12 to 17 year-olds, there is an argument for it to be reserved for use in vulnerable younger people or, indeed, given its relative significant effectiveness, to be reserved for use later in the year as a booster vaccine for the most vulnerable groups. Can he tell us the Government’s thinking about the use of this vaccine?

[Lord Bethell (Con)]

As ever, my noble friend is extremely perceptive in his insight. The Moderna vaccine is indeed an interesting one that may well prove to be a useful complement to the Pfizer and AstraZeneca vaccines, which are the bulwarks of our vaccination deployment at the moment. As he probably knows, the MHRA has already sanctioned the use of existing vaccines in some children where there may be a strong clinical need, and under the advice of their clinicians. However, it is our aspiration to spread the vaccines as widely as possible. Unfortunately, children are a vector of infection and it may be that there are strong arguments for vaccinating not just vulnerable children, but perhaps a large number of children. We will look at various different vaccines for that, and Moderna may possibly be a candidate for the kind of A-B double-dose vaccine that I alluded to earlier.

Social Care Funding (EAC Report)

Lord Lansley Excerpts

Thursday 28th January 2021 Grand Committee

[Lord Lansley (Con)]

I am pleased to follow the noble Lord, Lord Campbell. It is an abject failure on the part of our political system that the reform of social care funding has not been achieved to date. I will refer briefly to what was my responsibility. In 2010, I asked Andrew Dilnot to prepare a review and make recommendations. His proposals continue to form a part of what should be the reform of social care funding in the future, but I do not think that people quite appreciate the value of what he proposed. It was not just that there would be a cap on the costs people would have to meet, creating, as it were, a fundable and insurable proposition. It is also that there would be a substantial increase in the capital thresholds and a taper, such that under his proposals nobody would have had to lose more than 40% of their total assets.

That would give people the reassurance, even if they were to self-insure or be self-funders, that they would not work all their lives and then find, as a consequence of the catastrophic effects of Alzheimer’s or dementia, for example, that they lost everything and their families got nothing. We have to arrive at this point and make this funding reform happen. I absolutely agree with the noble Lord, Lord Forsyth, and his committee that the cost will not be met simply by the Dilnot reforms. It will require a major injection of government funding. The cost of personal care support should be shared between individuals and the state. To my mind, the great benefit of Andrew Dilnot’s proposals is that people pay towards their costs with only a proportion of their assets; they do not lose all that they have built up during their lives.

I want to make one other point. Why did it not happen? We legislated for it in the Care Act 2014 and it was supposed to happen after the 2015 election. I was not a part of government at that point. I remember somebody in the Treasury saying to me that because part of the process of paying for this involved removing the domiciliary care exemption for people’s own homes, 200,000 people would pay more and only 100,000 would benefit. This quite ignored the fact that most of the 100,000 who would benefit at any time would themselves, on some previous occasion, have been the recipients of domiciliary care.

The noble Lord, Lord Hunt of Kings Heath, is quite right: if we go down this path and do not remove the anomaly of the domiciliary care exemption for one’s own home, we will have an enormous increase in domiciliary care relative to residential care. This would not be desirable, so it has to be paid for. National insurance on older workers is clearly one part of it and removing the domiciliary care exemption is another, but a broader contribution from taxpayers will inevitably be part of it too. But it should not be taxpayers alone, otherwise the intergenerational lack of fairness of young people contributing to the future care of older people, in circumstances where those older people do not contribute but have large assets, would be intolerable.

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.

Medicines and Medical Devices Bill

Lord Lansley 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 Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Baroness, Lady Ritchie of Downpatrick, who asked some good questions. Indeed, many noble Lords have asked good questions about the functioning of a patient safety commissioner. All are agreed that we have come very far, very quickly, and the Minister and my noble friend Lady Cumberlege are to be congratulated on having brought this proposal from her excellent report to primary legislation so rapidly. Knowing how difficult it is, I commend the Minister and his team for securing collective agreement to such a significant policy innovation so rapidly, to the point that we can put it into the Bill on Report.

I want to make two points. First, as I know from the past, independence can be instrumental to the functioning of an organisation, but the NHS can, if one is not careful, see independence as something outside the system. It is somewhat discounted because of that. We must always think of the patient safety commissioner in two important respects. First, it should be not only independent but influential. A number of noble Lords have spoken about how that might best be achieved. That influence is terrifically important.

Secondly, patient safety is central across the NHS and is regarded as such. As the Minister and the noble Lord, Lord Patel, evidenced, we have come a long way with safety in the NHS—for example, in the reduction in healthcare-acquired infections. I was responsible for introducing never events and a range of other factors. Mainstreaming safety to become a central concern of commissioners and providers across the NHS has been a recurring feature of the work of this Government and their predecessors, and of my successors, Jeremy Hunt in particular.

I stress that that work on safety inside the NHS is clinically led and data-driven. The patient safety commissioner has a remit focused on hearing from, understanding and working with patients. That distinction is tremendously important and must be made clear to all those working across the health and care systems, from the outset. There is something new and distinctive about the patient safety commissioner, and it is not simply another accretion to the many organisations that those who work in the health system feel impede their lives. On the contrary, this is a representative of patients who, by virtue of that, attracts special attention from their point of view and brings a distinctive and unique voice into the NHS systems. I am pleased to have had this opportunity to say those few things and to support the government amendment in the name of the Minister.

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

My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have listened. Patient safety is vital, especially now when the NHS is under so much stress and demand. Over the years, some tragic incidents could have been avoided if patients had been listened to and there had not been cover-ups.

The noble Baroness feels that the words

“so far as reasonably practicable”

should be removed. She may feel that they would weaken the amendment; is this the case? This is important, because patients need clear information about how they are to communicate with the patient commissioner, so that they trust the system.

--- Later in debate ---

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

My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation together for human and animal medicines will help prevent mistakes. We are an island and crossing the borders has already caused problems with filling in the forms. With much-needed medicines there should not be a risk of not receiving them.

[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.

--- Later in debate ---

[Lord Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who again has raised an important issue. The amendment in this group which more broadly encompass all those elements that go to make the United Kingdom a favourable location for research and the manufacture and supply of medicines gives us an opportunity to make sure that we have got that right.

I support the government amendments in this group and add my thanks to those expressed to the Minister and the Bill team for the immensely constructive way in which they responded to the amendments that we brought forward in Committee and in many related discussions. At Second Reading, the noble and learned Lord, Lord Woolf, and I were worried that the Bill was skeletal. We wanted to put a bit of flesh on its bones and make it more of a framework Bill—I think that is a bit of a theme. In the spirit of the remarks of the noble Baroness, Lady Thornton, it might be helpful if I briefly explained what we were trying to achieve, and how these government amendments appear to have responded well to that.

First, even following the initial changes, the structure of the powers was not objective; they were that the relevant Minister was satisfied that the regulations met certain requirements. What we were looking for from the outset was an objective test. My noble friend Lord O’Shaughnessy asked what that objective test was and why we chose to continue with the structure of safeguarding public health? The short answer is that it is because that is the objective in the European Union regulation; it is not an objective in that context which relates to the internal market provisions. To have moved away from the objective of safeguarding public health would run the risk of it being interpreted as somehow different from the past objective on the basis of which decisions had been made and regulations pursued. That seemed entirely appropriate as an encompassing and overarching objective for all these related requirements. I am happy that the Government’s amendment has taken that forward as an objective measure against which the regulations, the use of these powers, can be tested.

Secondly, we wanted to make sure that safety was built into the structure of regulation-making powers. We had an extremely helpful debate about that, and I think that it was clear that, while we wanted to make safety central to what was being achieved, it would not be appropriate to make it an overriding objective. That would have led to the regulator being required effectively to eliminate risk. That brings me to the point made by my noble friend Lady Cumberlege. We then came to the further question of how, if safety is the issue, we then manage the test of whether benefits outweigh risks, sufficiently so for regulations to be proceeded with. The answer is that the objective is not to eliminate risk; it is to eliminate harm. We must make a distinction between those two things.

Making safety the overriding objective would have meant us having to eliminate risk. At the moment, we balance benefits and risks, not benefits and harms. When my noble friend Lady Cumberlege asked her question, I think she was suggesting that we were having to balance benefits and harms, whereas on pretty much every occasion the regulator is asked to undertake an authorisation they have to balance benefits and risks, because we can never eliminate risk. The question is: can we quantify it? That is what the trials and the data are meant to enable us to do—to quantify the benefits and risks. In making an authorisation, can we make sure that we have avoided harm but at the same time realised those benefits?

These amendments get us to that balance. They enable us to give an objective test against which the powers can be measured; they enable us to put safety clearly at the heart of the thinking about how the powers are to be used, and they enable the regulator to undertake that appropriate measurement of benefits and risks. I support the amendments and appreciate the way in which we have arrived at this place by constructive discussion.

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

My Lords, I welcome Amendment 5 and others in this group. I echo the noble Baroness, Lady Thornton, in complimenting both the Minister and the Bill team on their expert handling of this part of the Bill.

I find the sentiment behind Amendment 12 attractive and endorse entirely the words of my noble friend Lady Cumberlege and others who have supported her in wanting to avoid “harm”. The idea of a threshold, as solicited in Amendment 12, seems helpful. I have a question for my noble friend the Minister to which I would be grateful for a response. We are told in the explanatory statement that the amendment would require the Secretary of State

“to publish the criteria that will be used by the appropriate authority”—

obviously not yet set up—

“to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk”

and

“to allow for greater transparency and scrutiny.”

My noble friend said that the Government intended to publish the initial assessments. It would be helpful to know when that would be.

There currently seems to be a gap in the law; for example, as regards the vaccinations—I know that this was debated earlier today. The Government have unilaterally extended the time between the first dose and the second dose of Pfizer and AstraZeneca vaccines from three weeks—21 days—to up to 12 weeks. No other European country that I am aware of has done this. It is true that Denmark is looking to extend it to a maximum of between four and six weeks, which is nearer the initial three-week period. I presume that, if what is proposed by Amendment 12 were law, the Government would be obliged to publish the arguments in the interests of transparency, openness and scrutiny as to how they had reached that decision. If that were the case, I would be minded to support Amendment 12.

Otherwise, I welcome Amendments 4 and 5 and others in the group, which look to establish the overarching objective as being public health. I like the formulation of words that the Government have hit on and hope that they will stick with it. I shall be interested to hear how my noble friend responds, but, as I see it, there is some merit in Amendment 12.

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

Lord Lansley Excerpts

Thursday 7th January 2021 Lords Chamber

[Lord Lansley (Con) [V]]

My Lords, we are repeatedly told that we are in a race against time. It is in fact a race against the virus; presently, the virus, tragically, is winning. This must change. These restrictions may be regrettable but they are necessary and must be persisted with. Will the Government make it clear that a relaxation of restrictions can happen only when the alert level is brought down to three, and not fully relaxed until it is down to two? Even if the most at-risk population is immunised, this will not be 100% effective, and we should maintain social distancing while we drive cases down to the point where test, track and trace can suppress outbreaks.

I want to ask about two issues. First, on the NHS Covid-19 app, we have 20 million-plus downloads and 750,000 QR codes, but how many positive tests are being registered on the app? It should be some 25,000 a day, and we should expect more than 100,000 alerts to be sent out each day. Without them, contact tracing and isolation will miss most of the contacts in public places. Can our app, like those of some other countries, have the option to provide a mobile phone contact number to allow track and trace to follow up those testing positive?

Secondly, we must now maximise the capacity for vaccination, using the military medical support units and community pharmacy. We should not have arrived at the point yesterday where the pharmacy sector was saying that it did not know whether it would be used. Thousands of trained vaccinators are an essential resource. Can my noble friend confirm that they will be integral to our vaccination programme?

Ockenden Review

Lord Lansley Excerpts

Monday 14th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

My Lords, I respectfully disagree with the noble Baroness’s insight—the Ockenden review does not point the finger at staffing levels in relation to the problems; it points the finger at a number of items, particularly the cultural problems that emerge when differences of opinion between clinicians and midwives arise and where a culture of respect breaks down. Those cultural differences can be improved by what we would politely call education; it is essential that we invest in the right kind of education in order to bring midwives, obstetricians and gynaecologists closer together and to break down the hierarchical differences and the ideological differences about the best way to have a baby.

[Lord Lansley (Con)]

My Lords, as a Secretary of State responsible for the health service for some of this period—two years out of two decades—I share in the responsibility for what happened here and for the fact that it was not known about and that action was not taken sooner. I am sure that others who have been Ministers in the department over these two decades will feel likewise.

What is shocking is not only the individual trauma that parents have suffered but the scale of what the Ockenden review discloses—we are grateful to Donna Ockenden and her colleagues for persisting in trying to understand and disclose the scale of what has happened. I ask my noble friend about our responsibility, which was, of course, that there should be external oversight and action taken when these things go wrong. From my point of view, one of my objectives was that there should be more clinically led commissioning so that local clinicians would understand what was happening and have the power to step in.

The Ockenden report shows that, in May 2013, the clinical commissioning groups set up a review that, in October 2013, reported:

“The overall findings of the review demonstrate that this is a safe and a good quality service”.


I encourage Donna Ockenden and the department to look very carefully at how they could ensure that local clinicians responsible for commissioning take that responsibility seriously and act upon it.

[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.