Health and Care Bill

Debate between Lord Rennard and Lord Lansley

Lords Hansard - Part 1 & Committee stage
Monday 24th January 2022 Lords Chamber

[Lord Rennard (LD)]

My Lords, I support Amendments 109 and 226 in this group, both of which are in my name and that of the noble Lord, Lord Hunt of Kings Heath. I will address them from the perspective of people with diabetes and with the support of the Juvenile Diabetes Research Foundation and Diabetes UK.

It is just over 100 years since insulin was discovered. Before 1921, a type 1 diabetic would live for no more than a year or two from when the condition became discernible. In the 1920s, my father, a World War I veteran, developed diabetes, and he was very fortunate that this was the decade in which insulin was discovered. It was so successful that it enabled him to have a long and happy life—indeed, I was born when he was 71, and my younger brother was born when he was 73.

Much progress has been made in the treatment of diabetes over the last 100 years, but we are not making the most of technological developments relating to insulin use and diabetes management. I have struggled with these issues myself, and I have learned much about them since I became dependent on insulin in 1994. I personally have enormous reason to be grateful to the diabetic team at St Thomas’ Hospital, just over the river from us, but not everyone with diabetes gets that standard of care, and progress with the adoption of the most recent technology is simply too slow.

There have been great developments in wearable medical technology, such as insulin pumps, flash glucose monitoring and continuous glucose monitoring. We are making progress with such innovations and in NICE’s obtaining approval for them, but they are often not widely accessible. Access to technology, including linking a person’s insulin pump and a continuous glucose monitor, may help a person to self-manage their condition in the absence of routine NHS support. The long-term cost savings are demonstrated by the wider use of such technology in insurance-based systems, where the outlay must be justified by reducing the costs of later complications, which can be very considerable.

Diabetes probably now takes up 10% of the NHS budget, and 80% of the cost of diabetes relates to complications, with the largest costs arising from excess in-patient days, cardiovascular disease and damaged kidneys and nerves. The latest technology may enable parents of young people with type 1 diabetes to obtain a full night’s sleeping soundly, knowing that their child’s glucose monitor will issue an alarm and wake them up if they experience a severe high or low-glucose episode. New technology has been shown to support blood glucose stability and to lower average blood sugar levels, reducing potential health complications and hypos or hypers, which can lead to coma or even death if not treated. There are great benefits to physical and mental health from better long-term control of blood sugar levels.

Research by JDRF shows that barriers to the uptake of this technology include the fact that many clinicians are not trained in it and that the pressure on appointments means that there is often not time to discuss treatment options. Amendment 109 would require NHS England’s oversight framework for integrated care systems to include a metric on the percentage of diabetes patients in their area accessing diabetes technology. An embedded requirement that would better support the prescription of technology would incentivise better training for clinicians and encourage more time to be provided in appointments to discuss technological treatment options and any potential fears or concerns of the patient.

Amendment 226 concerns the promotion of self-management using the latest technologies. We need it in order to reduce the number of people with diabetes suffering from complications, which may include sight loss and problems with their feet, presently resulting in around 6,000 amputations per year. When in hospital, people with type 1 diabetes require five times more secondary care support than people without diabetes, so it is essential that the NHS invests in technology that can significantly reduce the instances of hospitalisation and adverse health outcomes for people with type 1 diabetes.

[Lord Lansley (Con)]

My Lords, I thought those were very interesting and helpful remarks from the noble Lord, Lord Rennard. They serve to remind us of the importance of self-management in securing the best possible outcomes for patients. I just add the thought that, when the Government promulgate regulations relating to patient choice, one of the things we want to include is shared decision-making between clinicians and patients. In my observed experience, that too can deliver better outcomes. I think we have made significant progress in recent years in encouraging shared decision-making, and I hope we will see that come forward.

In moving Amendment 72, the noble Lord, Lord Warner, touched on a range of issues. I will not go down one or two paths, but I highlight that we will need to think hard about the interconnections between the question of patient choice and how far patients continue to be given choice. We need to ensure that it is not just talked about in the constitution or in regulations that say it is generally a good thing. For choice to happen in practice, subsequent clauses in the Bill relating to procurement, such as Clause 70, need to enable a choice of providers. The noble Lord made that perfectly clear.

The clause relating to payment systems—Clause 68, if my memory serves me correctly—still needs to have a “money follows the patient” approach. It is not me saying that these are all good things; they were put in place by the Blair Government, not the coalition Government, who did not do away with them but entrenched them.

I am worried. I will just make this point about Clause 70, the effect of which is to repeal Section 75 of the 2012 legislation. Included within that was that one of the requirements of the procurement regulations would be to support the right to patient choice, and the Government are proposing to repeal that.

The Minister may well, perfectly correctly, say, “That may be so, but we have the power in this Bill to set regulations relating to patient choice”, but this is separate, and, in the event, we may find that the link is broken between procurement and payment and patient choice. The net effect would be that patient choice is vitiated. I am worried, for exactly the reasons that I think the noble Lord, Lord Warner, is worried, that what has been around for some 18 years in one form or another—the expectations on the part of patients that they can exercise choice—may not be able to be exercised in practice because the preference of the NHS in many of these localities is to operate as a monopoly and not to give any opportunities for that choice actually to function.

Our debate on this group would be far better and easier to have—and might not even be needed—if the Government published the regulations under Clause 68 in draft so that we can see what they are proposing to do. They have not done it; between now and Report they could do it. When we get to Report, we are going to have a very difficult—certainly from my own personal point of view—set of conversations about how patient choice is to be exercised, how the NHS is to get best value from its procurement, and how trusts and providers are to be paid appropriately, rather than simply go back to block budgets. How do we get out of that debate? The answer is: let us see what the regulations the Government are proposing—in this case relating to patient choice—actually look like, and let us see it before Report.

Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Debate between Lord Rennard and Lord Lansley

Monday 30th September 2019 Lords Chamber

[Lord Rennard (LD)]

My Lords, I begin by declaring my interests as in the register. My work with the British Healthcare Trades Association has identified concerns among the manufacturers of medical devices about what might happen with the future regulation of their products as a result of Brexit.

The regulation of medical devices and medicines is, of course, very necessary to protect patient safety, and it enables businesses to sell their products in the UK market, the much larger EU market and overseas. The evident need for the technical amendments that we are now considering suggests that the Government’s preparations to leave the EU are being made in great haste. It is also clear from them that there will be no benefit to anyone in changing the basis of the existing provisions for the regulation of medicines and medical devices.

Most countries recognise the great worth of current EU standards when they consider whether to allow products to be imported and sold to their citizens. If we leave the EU on 31 October, existing products that have been approved by the EU regime will of course continue to be approved, but surely problems will arise with new products as standards diverge in future—as inevitably they will. Will the Minister therefore say something about the potential impact of this legislation on the innovation of medicines and medical devices? British businesses will in future have to apply for licences to UK authorities if they want to sell new products here, and they will also have to seek approval from EU bodies if they wish to sell those new products in the European market and in the many other countries that already respect EU standards. This will mean two application processes, a potentially longer wait for approval and two sets of costs incurred in securing approval for new products.

Does the Minister accept that some businesses will feel inhibited in seeking approval for new products on that basis, that they might be tempted just to continue trying to sell old products that have already been approved, and that such inhibition might have a damaging impact on patient care and on the capacity of businesses to grow, especially if they seek to export new products? Will the Minister say something about how this impact on innovation might be ameliorated?

Most fundamentally, will the Minister confirm that leaving the EU on a no-deal basis will mean that we deny ourselves, and the rest of the EU, the benefits of sharing costs and expertise concerning the regulation of medicines and medical devices? Furthermore, does he accept that in the long run we need to work towards greater worldwide acceptance of standards to avoid new products requiring the approval of multiple agencies in the UK, the EU and elsewhere?

[Lord Lansley (Con)]

Perhaps I may add a few words on the subject of medical devices. I apologise that I was not able to be here to talk about these regulations earlier in the year, but I would like to say something about the regulation of medical devices now. The world has slightly moved on and, from my own point of view, that is rather helpful. I want to focus on medical devices in particular.

I remember the 2017 European regulations, to which the noble Baroness, Lady Thornton, referred and which will come into effect next year for medical devices and in 2022 for in vitro diagnostics. The ones on medical devices stemmed from the breast implant activity from way back when I was Secretary of State. I remember a conversation with my then French counterpart, Xavier Bertrand—now, I think, in charge of the Nord-Pas-de-Calais region. In response to that activity, his contention was that we had to change EU regulation so that all medical devices went through exactly the same authorisation process as all medicines. That would have been a complete disaster for the industry. Happily, that did not happen, but these regulations represent a considerable tightening of the risk classification processes under the EU regulations.

I think that the answer to the question from the noble Baroness, Lady Thornton, is that the intention—I think it is already in our regulations in preparation for a no-deal exit, if necessary—is to continue to recognise EU regulations for medical devices and in vitro diagnostics, and to recognise them in the future. Clearly, we would do that under a transitional process with the withdrawal agreement and I think our intention is to do so in any case. That means that, if we leave and are treated as a third country, we will recognise a CE marking from the European Union but it will not recognise an authorisation made in the United Kingdom. It will not be a mutual recognition process, which ideally is what we are aiming for and which a transition process under the withdrawal agreement would have enabled us to negotiate for a future relationship. That is much to be wished for.

This is not a small deal. In the European Union context, something like 40% of the highest-risk medical devices in Europe have in the past been authorised by the UK’s Medicines and Healthcare products Regulatory Agency. Approaching 50% of bodies requiring a certificate of conformity have gone to UK notified bodies, so the UK notified bodies are in an extremely strong position and, as a necessity of our leaving the European Union, to some extent they will lose that position. For example, the British Standards Institution will be a notified body in the United Kingdom, but it is also a notified body in the EU by virtue of being based in Amsterdam—as indeed the European Medicines Agency has gone to Amsterdam. There is a transition process which, unfortunately, is not the one under the withdrawal agreement but one away from the United Kingdom, which is to be regretted.

The point I particularly want to make today—and all of this will be well known to the Minister and the department, and I am not asking him to comment on all of it—is about the combination of changes all occurring at one time. We may leave the European Union at the end of October or at the beginning of next year. In either case, it is very close to the point at which the medical device regulation comes into force in May 2020. The European Union is not ready. In a report published by KPMG a couple of weeks ago, only 27% of the 200 manufacturers of medical devices sampled said they were ready for the changes in the regulations next May. They may be ready by May, but they have had quite a lot of notice and are finding the new requirements very difficult.

The European Commission has recognised this and given a grace period for a number of products to enable the introduction of the new requirements to be pushed off to 2024. Frankly, at this stage it would be in our interests to encourage the European Commission to extend that grace period for all products through to 2024. New products coming in would be required to be certified in line with the new regulation, but all existing products would be grandfathered through and given until 2024 to go through the process. At the moment, there are only five notified bodies in the whole of the European Union, and that is not enough. If we leave at the end of next month without a deal, UK medical device manufacturers will have to go to notified bodies in the European Union to secure authorisation for their products within the EU—they cannot place them on the market by virtue of a United Kingdom authorisation. There are a range of coincident changes, and the more we can do at the moment to try to encourage the European Commission to push all existing products off from the requirements of this new regulation into 2024, the better it will be. I hope our Government, even if they seem to have taken the rather perverse decision not to engage with the European Commission while we are planning to leave, should engage with the European Commission and ask for this to happen.

Perhaps the European Commission might even embrace the thought that they were not ready, because the new Commission President, Commissioner Ursula von der Leyen, has decided to shift the responsibility for medicines and medical devices from DG Grow to DG Santé. Perhaps DG Santé, recognising that it has this new responsibility in the midst of all this transition—yes, even more—can say that the starting point is to put in place an extended grace period for all manufacturers, given the lack of capacity in the EU notified bodies system in the short run.

I do not expect my noble friend to reply on that, but I hope he will at least say that he will encourage the department to see whether it and the MHRA might engage their counterparts in the European regulatory system with that view in mind.

Tobacco and Related Products Regulations 2016

Debate between Lord Rennard and Lord Lansley

Monday 4th July 2016 Lords Chamber

[Lord Lansley (Con)]

My Lords, from my point of view, my noble friend Lord Callanan chose to talk very selectively about the record of the Conservative Party and the coalition Government in relation to tobacco control. I think he should bear in mind that Conservatives—myself, my noble friend Lord Young of Cookham—worked hard from the Opposition Benches in another place, and succeeded in securing the ban on smoking in public places. When we came into the coalition Government together, we implemented the ban on sales through vending machines and a progressive ban on displays in shops. I also initiated the consultation on standardised packaging, following discussions with Nicola Roxon, who was then Health Minister in Australia, which my successors have taken forward. The product of all that is that we have not only secured continuing reductions in the overall prevalence of smoking—albeit I could wish this rate was faster—but we secured, I think three years ago, recognition that we had among the toughest tobacco-control regimes anywhere in the world. That is right and we should strive to make that the case.

I know it would not be the effect of the Motion in the name of my noble friend Lord Callanan, but were it passed it would indicate your Lordships’ desire to withdraw the regulations if they could. That would be an entirely retrograde step. I will not go through all the ways in which the tobacco products directive helps to strengthen the tobacco control regime other than in relation to e-cigarettes, but it certainly does.

I will isolate one important point which has not yet been mentioned. Much of what we have done in recent years, from my point of view and that of my colleagues—Anne Milton when she was Public Health Minister, and I believe it was among Anna Soubry’s and Jane Ellison’s objectives subsequently—was to focus on reducing the initiation of smoking among young people. We have some 200,000 young people a year initiating smoking. That is what we have to bring down. We want to arrive at the point where the initiation of smoking is minimised. As part of that, we have to look frankly and critically at how electronic cigarettes and vaping can contribute to the reduction of smoking, through access to smoking cessation services. It is absolutely right and I do not have any brief against e-cigarettes in that respect. But, to pick up the final point made by the noble Lord, Lord Faulkner of Worcester, we have to understand what the social and behavioural impacts of large numbers of people continuing to smoke e-cigarettes in the long term look like. I am not sure that promoting it through advertising is necessarily the right way to go.

We should enable smokers to access e-cigarettes and vaping, and do everything we can through the public health budget. Noble Lords will know—I will go into it on another day when more time allows—that my objective in creating a separate public health budget with local authorities was to maximise and protect our preventive activity, not to see it subsequently reduced. I deplore that fact because we were making considerable progress with smoking cessation services, as we should. But we also have to ensure, in addition to the use of e-cigarettes in a way that reduces smoking, that we do not create a new mechanism which might entrench in young people an expectation that they should initiate any kind of smoking, be it through vaping and using e-cigarettes or, even worse, through smoking tobacco. For that reason I agree entirely with many other speakers that it would be undesirable to support my noble friend’s Motion, and I hope that the Minister will agree that we should reject it.

[Lord Rennard (LD)]

My Lords, the noble Lord, Lord Lansley, is to be greatly congratulated on his tremendous record of achievement in this area, and his advice this evening should be followed very carefully. I must declare my interest as a former director of Action on Smoking and Health. There is a consensus in the debate that using e-cigarettes is much safer than smoking. Together with other clean nicotine products, they have an important role to play in cutting tobacco consumption and improving public health, but I do not agree with the e-cigarette trade body brief which has been circulated. It claims that nicotine is not itself dangerous. As the noble Baroness, Lady Hollins, pointed out so effectively, we have to recognise that nicotine is a known toxin that is poisonous when swallowed and is also addictive.

I do not want to see e-cigarettes subject to more regulation than is necessary, but I do want to see them subject to all the appropriate regulation necessary to support public health objectives. We know that the best chance of success for people seeking to quit smoking is to use smoking cessation services as well as alternative nicotine products in order to help reduce withdrawal symptoms. The regulatory regime required for e-cigarettes and related products must be one that supports their use by smokers trying to quit. It is also right to discourage their use by children and young people who have never smoked. Both these objectives are supported by the regulations being introduced.

I agree with the many noble Lords who have said that we need a public information campaign to reassure smokers that electronic cigarettes are less harmful than normal smoking but, as the Motion in the name of the noble Lord, Lord Hunt, points out, there have been major cuts to the media campaigns to persuade smokers to quit. That is very regrettable because such campaigns can be highly cost effective in supporting quitting. We know that alternative nicotine products for smokers have most public benefit when they are used together with expert behavioural support. That is one reason why we need to make sure that such products can be available on prescription for people seeking help to quit tobacco products. Our approach to e-cigarettes, therefore, must be to treat them not as an exciting new social drug or as a cash cow for e-cigarette companies, many of which are owned by the tobacco industry, but as a potentially important means of improving public health and reducing the toll of death and disease caused by smoking.

The regulations under discussion are not perfect, but they include important steps in tobacco control that must not be lost and must be part of a tobacco control strategy that must be properly resourced to produce real public health dividends.