Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

I will be very interested in the Minister’s response. The one thing for sure is that, unless we change the dynamics, we are going to starve a fantastically important industry in this country, NHS patients will not get access to new medicines and we will all be the loser.

[Lord O'Shaughnessy (Con)]

My Lords, I thank the noble Lord, Lord Patel, for moving this amendment. I also pay tribute to my noble friend Lord Lansley for laying the amendment and for creating the template for the innovative medicines fund—the Cancer Drugs Fund—in the first place. The noble Lord, Lord Patel, described the tens of thousands of patients who have benefited from that scheme. It has been a fantastic innovation and something I am sure we all want to build on.

It also seems entirely appropriate that I am following the noble Lord, Lord Hunt, who gave a powerful speech. When I was a Minister, he was unrelenting in pointing out the weaknesses in the PPRS when it came to supporting innovation. He was right then and he is right now. That is why I needed no persuading to support this idea and this amendment. It was something that I tried and failed to introduce in the VPAS when I was a Minister, but perhaps a seed was planted then. It was fantastic to see the commitment made in the Conservative party manifesto in 2019 to create an innovative medicines fund.

As the noble Lord, Lord Patel, said, there are many areas, particularly, but not exclusively, rare diseases—and I have a daughter with a rare genetic condition—where experimental drugs seem to offer great hope, whether that is cannabinoids for epilepsy in children, or gene therapies for children with spinal muscular atrophy, or the many other conditions where the promise seems huge but the data does not yet convince. It feels to me that if we accept circumstances in which it is right to give cancer patients access to those kinds of therapies, it should also be right to give all other patients access to those kinds of therapies too. That is really what the innovative medicines fund is about.

I think that we have seen the shape of the future innovative medicines fund and what it would look like. The VPAS allows for confidential, complex deals for the first time. We have seen CAR-T therapies come through that route. We have also seen a deal signed for Inclisiran—originally from the Medicines Company, now Novartis—with testing of that in a real-world situation following a very successful large-scale clinical trial that was largely focused in the UK. This provides a template for how we might go about doing business for common conditions, as well as for rare ones.

I am sure my noble friend the Minister will agree with everything she has heard today, so I want to ask her what the timetable is for introducing the scheme. Questions have been raised by the BIA and ABPI and others, and I very much agree with them that an ambitious definition of innovation is required. The noble Lord, Lord Hunt, made an excellent point when he forcefully said that we must make sure that the rebate is recycled into innovative medicines, rather than just going back to the Treasury—there does not need to be an additional expenditure control mechanism. I will be grateful for my noble friend’s guidance on that.

One other thing that has come up in our debate in Committee so far—and of course this is more difficult because it takes it outside medicines and into other areas—is the exciting potential in devices, digital and diagnostics. There is no rebate scheme or automatic source of third-party funding that could provide for that. Is the Minister prepared to entertain exploring the potential for expanding the innovative medicines fund into something broader, and beyond medicines, perhaps not in its first iteration but in the future? I look forward to hearing what she has to say.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I call the noble Baroness, Lady Finlay of Llandaff. Lady Finlay? I think we had better move on and we can come back. I call the noble Baroness, Lady Jolly.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have also received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

I apologise for my email ineptitude.

I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.

I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.

[Baroness Penn (Con)]

I am reminded that my noble friend Lord Lansley referred to the collective noun for former Health Ministers as a “frustration” of former Health Ministers. I can tell my noble friend that the engagement exercise will involve the pharmaceutical industry, the NHS and associated bodies and patient groups. That is the level of detail that I can give to him today. I was very pleased with being able to say “quarter 1” next year; it felt to me like a very specific timeframe for when that engagement exercise would be undertaken.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Lord Kakkar (CB) [V]]

My Lords, I shall speak to Amendment 97 in my name and that of my noble friend Lord Patel. In so doing, I of course recognise the important points the noble Baroness, Lady Cumberlege, made. I will answer some of her questions in a moment.

The particular purpose of Amendment 97 is to extend the reach of Clause 16, which already gives powers to establish information systems for assessing

“the safety and performance … of medical devices that are placed on the market”,

to include provision for the establishment of an information system for the safety and performance of medical devices before they are placed on the market via a form of provisional licence. It would provide for the Secretary of State to require, under certain circumstances, that new devices would in the first instance be given a limited approval based on clinical evidence and clinical trials. However, it recognises that further information would be required and that a provisional licence, or formal marketing authorisation, would therefore be given only for information gathering purposes. This would ensure that the level of evidence provided prior to broad unfettered use of a device would be much greater than is currently available.

This approach is both important and practical. It is important, as we have seen in the report from the noble Baroness, Lady Cumberlege, because implanted devices can have serious, harmful effects for patients. Not all devices have the capacity to be harmful, but where there is concern, where there are limited data or where the argument is based on equivalence using the kinds of arguments that the noble Baroness has made, the introduction of a device into routine clinical practice would be limited by a provisional licence, with the need for careful, pre-specified monitoring and evaluation, both for efficacy and for safety. This will protect the patient. It will protect innovation and it will ensure that we continue to facilitate innovation but in a responsible way.

Arguments are made about the practicality of such an approach. During this debate, we have heard that there are differences between the standards required for the authorisation for marketing a medicinal product compared with a medical device. The reality is that medical devices have profound implications for the management of patients. Implantable devices, in particular, also have profound implications for patient safety. The approach is practical because successive Governments have emphasised and prioritised the ability of the National Health Service to collect data and to develop its digital capacity.

We have seen the benefit of these investments and this emphasis during the Covid-19 national research effort. The regulator working, for example, with NHS Digital could devise integrated data-acquisition platforms and clinical research methodologies, potentially applied in specialist clinical centres. Data might then be collected prospectively to a high level and a high quality on the devices selected for such a provisional licensing process. These devices would also be used under appropriate and informed clinical supervision by experts before widespread adoption across the entire health system was allowed.

Rather than stifling innovation, which is a concern, I believe such an approach would ensure that our country could secure a position of leadership in the increasingly important field of medical devices development. These are going to play an increasingly important role in the delivery of healthcare. We would provide a fully facilitated environment for the appropriate clinical evaluation of medical devices, both their efficacy and their safety. In much the same way that the establishment of NICE and the Scottish Medicines Consortium, of which my noble friend Lord Patel was a founding leader, helped establish our country at the forefront of the evaluation of medicine and the responsible adoption of innovative medicines, the proposals included in this group of amendments and the proposal for provisional licensing outlined in Amendment 97 would allow us to develop unique leadership in the development, evaluation and responsible advocacy for the use of medical devices in a way that is clearly not available currently.

The noble Baroness, Lady Cumberlege, made an important point about devices that are designed for implantation in a patient and whose removal is dangerous or practically impossible. What must be demanded here is a much higher level of evaluation in development and research—she made the clear point that equivalence is not an appropriate approach in those or any circumstances. Moreover, offering the opportunity after appropriate clinical evaluation for such devices to be introduced in a limited fashion—still in routine clinical practice but with careful, pre-specified evaluation and monitoring—ensures, as she said, that if there are early reports of adverse events, those might be identified quickly prior to any opportunity for such devices to be provided across the entire healthcare system, where reporting on their implantation and follow-up may be less rigorous. In a provisional system, data acquisition and reporting would be pre-specified, using platforms provided by the regulator and the NHS. With the remarkable capacity we now have for data acquisition and analysis in the NHS, such methodologies, applied in a routine fashion in appropriate circumstances, would provide the greatest opportunity to protect patient safety while driving forward innovation and making use of all the opportunities that the NHS provides in this regard.

[Lord O'Shaughnessy (Con) [V]]

My Lords, it is a pleasure to follow that excellent exposition of his and other amendments by the noble Lord, Lord Kakkar. I want particularly to speak in support of amendments aimed at putting post-marketing reporting requirements for medical devices on a par with those for medicines.

My noble friend Lady Cumberlege has again given a powerful and moving testimony of the reports that she uncovered in her review of the dangers for some patients of pelvic mesh, but severe problems have emerged in other medical devices, be that metal-on-metal hip replacements, PIP breast implants or elsewhere. They have shown how potentially dangerous medical devices, particularly, as other noble Lords have pointed out, those implanted into body tissue, are simply not regulated enough.

The regulatory regime for licensing medical devices distinguishes between different categories of risk. Higher-risk devices of course have to clear a higher bar, and the UK’s notified bodies are renowned for taking on such work—prior to Brexit, they carried out more higher-risk assessments than any other notified body in the EMA family. We therefore have potential strength in this area. However, these tragedies demonstrate that even this strong regulatory regime does not go far enough. We need a broader definition of risk which takes account of the nature of the device, the therapeutic ways in which it can be used and the places in a patient in which it can be put, as well as much better post-market surveillance and wider use of registries, including coverage of the independent sector, which is where some of the most acute problems arose.

It goes without saying that these are recommendations from my noble friend Lady Cumberlege’s report. Like other noble Lords, I strongly urge my noble friend the Minister and the Government more broadly to adopt them and reduce the unacceptable gap between the safety regimes for medicines and medical devices.

Having expressed my concerns the other day about access to experimental medicines, I applaud the intention behind the idea of provisional two-year licences, but we obviously have a job of work to do to reconcile these two sometimes competing imperatives—the noble Lord, Lord Kakkar, explained how he thinks that can be achieved. It may be stealing the thunder of a future group of amendments that we hope to deal with tonight, but I wonder whether a better answer would be the expansion promised in the Conservative manifesto of the Cancer Drugs Fund into an innovative medicines fund more broadly, as well as continuing and early access to compassionate-use schemes for medicines post Brexit.

Both the noble Lords, Lord Hunt and Lord Kakkar, raised the idea of these conditional licences being applied to devices, and my noble friend Lady Cumberlege mentioned safety concerns which might apply. I wonder whether the right approach would be to open the innovative medicines fund up to devices, digital and diagnostics. It would mean a name change, but that presumably would not be a problem. They could then qualify as well as medicines, so the kind of early access possible under these two-year conditional licences could take place in that specific, heavily monitored and controlled environment that has already demonstrated huge value when looking at transformative cancer drugs before they have achieved their full licence. Within these ideas is the right approach to balancing these two risks, and in fact merging them and getting something stronger as a result. I look forward to hearing from the Minister how the Government intend to move forward on these issues.

--- Later in debate ---

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

My Lords, that was a very interesting opening speech from the noble Lord, Lord Patel, and I am very glad to have put my name to his amendment—although, of course, he went wider and commented on the government amendments. I very much agree with his desire to minimise delay for the UK to get access to new medicines. That has been a constant theme of our debates.

There are a number of elements in this, including the attractiveness of the UK to pharma companies, for our life sciences, our approach to access to early phase trials, the regulatory system for licensing medicines and the NHS’s willingness to take up those medicines, including the role of NICE. We have debated all of those.

The Minister on the first day in Committee responded to a number of those issues and said that the Government wanted to

“build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials … The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards”.—[Official Report, 19/10/2020; cols. GC 357-8.]

The issue is, that being said, will we in the end be aligned with Europe so that companies do not have to go through separate processes in which, because the market that we offer in this country is so small compared to the EU market, we will not be a country of first choice for developing new medicines and seeking a licence?

I refer the Minister to a comment that I picked up in the last few days from Britain’s pharmaceutical industry: it has appealed to the Prime Minister to strike a swift side deal with Brussels to avoid delays and shortages of medicines if we leave at the end of the year with a no-deal Brexit. We have heard continuously from the Prime Minister that he was preparing for—indeed, he would embrace—no deal on 31 December. The Government’s departure from any rationality or seeming concern for Britain’s industry and their posturing have left industry without the agreement on mutual recognition of standards that is needed to avoid hugely costly duplication of red tape to maintain the flow of trade in vital drugs. The one phrase that the Minister has not articulated in our debate so far is “mutual recognition of standards”. The fact is, if we are seriously going into a new world where we do not believe that mutual recognition between ourselves and the EU is a sensible or serious proposition, I am afraid that all the talk about this country being an attractive place for pharma will fall on rather stony ground.

The noble Lord, Lord Patel, has done a great service in bringing this matter back with a slightly different approach. I hope we can look for a positive response from the Government.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.

In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.

The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.

The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.

I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.

[Lord Clement-Jones (LD)]

My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.

I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?

Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?

I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord O'Shaughnessy (Con) [V]]

My Lords, I have spent far too much time with patients harmed by medicines and medical devices going wrong—valproate, mesh and Primodos—and many people affected adversely by other treatments in which they had vested so much hope to be unconcerned about the issue of patient safety. I applaud all noble Lords who have tabled amendments on this topic, and especially pay tribute to my noble friend Lady Cumberlege, whose exemplary work on this issue through her review has given the issue, and the women—because it is mainly women who have been affected—the profile that they should always have had.

I certainly agree with all noble Lords that safety should be considered of greater importance than the attractiveness of the UK. There is and should be no trade-off necessary between attractiveness and high regulatory standards. I also agree with the point made by the noble Lord, Lord Hunt—that there is so much more to patient safety than the regulatory regime for medicines and devices that we are discussing today, but that is what we are discussing.

Having said all that, I have something nagging slightly at me about the topic, which I want to explore in my comments. I wonder whether there is some tension between availability of medicines and devices on the one hand and their safety on the other. As the Bill stands, it fails to elucidate this tension properly. The question that we need to solve is whether it is always right that safety should trump availability and access to medicines.

I start by looking at the purpose of our regulatory regime. The homepage of the MHRA says that it is to

“maintain the safety, quality and effectiveness of our medicines, devices and diagnostic tools”.

Of course, its reputation stands on its ability to make judgments against those criteria, which can sometimes be in tension: a drug can be safe but not efficacious, and it can be effective but not acceptably safe. If there are shortages, which sometimes happens, quality variation might be needed to access necessary medicines and devices. Striking a balance between all those factors and getting the right balance between risk and reward is where the hard task of regulating occurs.

We have heard many examples already on Second Reading and in Committee today of the tragedies that have happened when there have been regulatory and other failures of medicines and medical devices. However, it is also true that some of the greatest success stories in medicines have come about through a more pro-risk approach. I mentioned the HPV vaccine last time, which of course has been extended to boys, even though there continues to be some concern about the level of adverse events. The early access to medicines scheme allows patients to be treated with unlicensed medicines that have not yet had regulatory approval but where there might be a transformative opportunity for patients. Of course, in considering these issues, the words of the noble Lord, Lord Saatchi, and Baroness Jowell in the debate that they so wonderfully led, inspiring us all, also ring true. Creating more access to experimental therapies for ordinary patients can often be the right thing to do for them. It is not that we want unsafe medicines—of course not. But what matters ultimately is the safety of the patient, and sometimes that might mean—or their health and best interests might mean—better access to riskier medicines for some patients that would be unacceptably risky for most patients. Indeed, it is quite possible that the move to personalised medicine will make this more and more likely.

I am strongly supportive of the patient safety agenda, and encourage my noble friend the Minister to commit the Government to taking forward the recommendations made in my noble friend Lady Cumberlege’s review. However, I am a little worried, perhaps wrongly, about the potential impact of these amendments on patients’ ability to access experimental medicines and devices, or even the availability of standard medicines that are experiencing a shortage that might improve people’s lives. In a spirit of this being Committee, though not quite as iterative as it usually is, I wondered whether a different approach would be to amend the Bill so that Clause 1(2)(a) instead reads,

“the safety, quality and effectiveness of human medicines”,

which could then unambiguously be made the overarching priority of the legislation, involving as it would recognition of the trade-offs and tensions in the standard to which regulators are currently held, then applying this approach to medical devices. Whether this is the right way forward is up to noble Lords, but I hope that my noble friend the Minister is open minded on this issue and will consider very carefully the various arguments being made.

[Baroness Watkins of Tavistock (CB) [V]]

My Lords, it is a pleasure to follow other noble Lords, the majority of whom I completely agree with. I put my name down to speak to this group as I wish strongly to support the amendments tabled by the noble Baroness, Lady Cumberlege, Amendments 10, 12, 74 and 75.

Last year, I was on the pre-legislative scrutiny committee for the Health Service Safety Investigations Bill, which did not proceed as a result of the election. Therefore, I believe that putting patient safety at the heart of this Bill and making it a safety Bill as other noble Lords have outlined makes complete sense. It would protect our population and make our country far more attractive for medical research, because we would be seen internationally as a leader in safety in that work and in any licences we gave to medicines and medical devices.

As well as medical devices inserted in the way that was so eloquently outlined by the noble Baroness, Lady Cumberlege, and my noble friend Lord Patel, there are other pieces of equipment used regularly in intensive care and other care settings, including the community settings, where safety is paramount, particularly for the safe delivery of very small amounts of medication. Engineers in our country are developing far safer equipment for that kind of healthcare, which is largely delivered by nurses and other community health- care workers. Therefore, if we can make these issues clear in the Bill, we will be an extremely attractive country to sell such pieces of equipment internationally. For that reason, the priority of the Bill must be for patient safety, because it will result in much-increased attractiveness for us as an exporting nation in this field.

--- Later in debate ---

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

My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.

In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.

To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I echo the point made by the noble Baroness, Lady Masham, about the noble Baroness, Lady Jolly. I am sure that we all send her our very best wishes.

I speak on the amendments tabled by my noble friend the Minister. However, on a quick clarification on something that the noble Baroness, Lady Thornton, said in the last debate, which is germane to this debate, I was not making the point that I believe that there can be trade-offs between safety and attractiveness as the Bill currently defines it. Rather it was around the effectiveness and efficacy of medicines and medical devices—points that were, thankfully, made much more clearly by my noble friend Lord Lansley than they were by me—and the impact on what that means for safety and its overridingness as a priority, even if it is always our most important consideration.

On the substance of the amendments, I am sure that my noble friend was not expecting complete consensus around his amendments and he certainly has not found it yet. However, I applaud him for his clarifications on the impact of the attractiveness subsection and also applaud him for moving so quickly in response to noble Lords’ concerns. None the less, there is an issue around this, which the noble Lord, Lord Hunt, brought out. It is an unfortunate truth that the NHS has a poor history of performance in scaling up innovative medicines and devices. I know that that is something that my noble friend is very concerned about.

I have a specific question in this area. In asking it, I draw attention to my entry in the register of interests, in particular as an adviser to Healthy.io. Do my noble friend’s plans for improving the attractiveness of the UK include improving the attractiveness of the UK as a place to develop, trial and scale data-driven health technologies? I know that we will come to that topic later, when the noble Lord, Lord Freyberg, has his amendments, but can my noble friend confirm that they are included in the definition of devices and explain his intentions in this regard?

[Baroness Walmsley (LD) [V]]

My Lords, this group begins with the Government’s minimal attempt to define the word “attractiveness” in Clause 1(2)(c). I am afraid that I preferred the version in Amendment 20 in the name of the noble Baroness, Lady Thornton, and others. I think that it became clear to the Minister in meetings before Second Reading and in the debate itself that many of us felt that a word such as “attractiveness”, which is very unusual in a piece of health legislation, requires a clear definition in the Bill.

“Attractiveness” is one thing, if properly defined, but “ambition” is another. That is what my noble friends Lord Sharkey and Lady Jolly—to whom I send my best wishes—seek to do in Amendment 15, for human medicines, Amendment 58 for veterinary medicines and Amendment 78 for medical devices. I am sure that my noble friend Lord Sharkey will say more about these in a few moments. But if Brexit must happen, which unfortunately it must, there is really no point if it does not allow us to do better than we have done before. That is why inserting the words “maintaining or improving” is so important. As others have said, the UK has hitherto been a very attractive place to conduct clinical trials, partly because of our massive access to patients through the NHS, partly because of our expertise and high standards and partly because of our alignment with the EU and its 400 million citizens.

This is particularly important for rare diseases, where the numbers of sufferers in the UK alone are too small for a trial of statistical significance. Alignment with the EU is, therefore, particularly important for maintaining our attractiveness, and this is dealt with by other amendments that the Committee will debate later. However, we should be wary of throwing away the advantage of that alignment; to do so would give us a much bigger mountain to climb if we are to improve our attractiveness. I hope that the Minister will bear that in mind when he replies.

--- Later in debate ---

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

My Lords, unfortunately, a connection has not been made with the noble and learned Lord, Lord Woolf, who was due to contribute remotely.

[Lord O'Shaughnessy (Con) [V]]

My Lords, it is a pleasure to be able to follow the noble Lords, Lord Hunt and Lord Lansley, on these amendments. The issues that they raise could not be more important. Indeed, they have both been assiduous, particularly the noble Lord, Lord Hunt, when he was opposite me at the Dispatch Box, in raising this issue of the NHS’s attitude to medical innovation. His point about the methods review is very well made. He is also right to raise the fact that the voluntary pricing scheme for medicines is designed with a cap-to-cap growth of 2%. It is hard to explain how, with the cap in place, rationing attempts are still going on within the NHS, because the cap is precisely meant to give that protection. The problem is that, with the benefits of the cap, the rebates go to the Treasury, whereas the costs of paying for medicines bite locally. Until we get that imbalance sorted out, I fear that we will have strong imperatives on local trusts and CCGs to ration as he has talked about. I regret that, as the Minister responsible for negotiating that scheme, that was not something we were able to resolve—but I hope that my noble friend will be able to next time around.

The reason why I wanted to speak in this group was to offer my strong support for the amendment proposed by my noble friend Lord Lansley, Amendment 85 on medtech funding guidance. I declare another interest here in that this was one of mine, in its current incarnation, in the industrial strategy life sciences sector deal 2 from autumn 2018. It was hard won with the NHS, for obvious reasons, but the case for doing it was very powerful, and was brought home to me by a device—a diagnostic tool by Roche Diagnostics for pre-eclampsia. It had sailed through all the medtech evaluations and had gold star guidance next to it but had only something like 5% of the uptake that we would expect, despite the fact that it saved money and lives and did everything that we would want of it. In a way, that was a powerful emblem of why we could not go on as we were and needed some sort of medtech funding guidance.

It has been two years. My noble friend Lord Lansley is quite right in tabling his amendment to, I hope, elicit a response from my noble friends at the Dispatch Box on a commitment to when a full introduction of this will be done. As we are, I hope, in that kind of positive mood, perhaps I could entice my noble friend the Minister to commit also to exploring two things: to extending the eligibility criteria for the guidance, which were very strictly drawn and quite limiting; and, as is very germane to our Covid efforts, to consider how it could be used specifically to support the diagnostic industry.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Walmsley (LD) [V]]

My Lords, I support the attempts in this group to put a sunset clause into the Bill. I have a great deal of sympathy with the demands of the noble Lord, Lord Patel, for consolidation. It is vital that through these amendments and others to later clauses, we are able to review the use of the Bill’s powers by this failed Government, who have made so many mistakes. A Government who cannot even secure the free trade agreement that was supposed to be the easiest thing ever, who disastrously and expensively have not produced the promised world-beating test and trace system and who have presided over one of the worst rate of Covid-19 deaths in Europe due to their dithering and failure to put health first, must have their powers fettered. But, as has been said, this is a skeleton Bill and gives the Government extensive powers with little ability for Parliament to intervene.

A lot is changing. The Brexit transition phase is coming to an end in a couple of months. We have learned many lessons from Covid-19, which should be implemented. The NICE review is coming up, and every month new medicines and therapies are coming on to the market. It would be folly not to have a sunset clause in the Bill. I therefore support what was said by my noble friends Lady Jolly and Lady Thornton, and urge the Government to consider, in all humility, that in two or three years’ time they may not be in power, and the whole landscape will have changed. It is therefore essential that we have an opportunity to review how the powers in the Bill have been used to change things, especially if all has not gone well.

[Lord O'Shaughnessy (Con)]

My Lords, I point out to noble Lords my interests as set out in the register. On Second Reading, when taking a somewhat unfashionable stance in defence of the delegated powers, I said that I was not going to die on that hill again—but, to mix my metaphors, I have been drawn, like a moth to a flame, back into this argument.

I want to make two brief points. The first has been perfectly well made already by my noble friend Lord Lansley, and is about the sheer impracticality of sunsetting legislation. Committing to an arbitrary deadline of that kind is not something that any Government could responsibly do, particularly at this time, and given the uncertainty that has already been discussed.

The second point is that many of the criticisms raised by the Delegated Powers and Regulatory Reform Committee and by the Constitution Committee have been dealt with, to some extent, by changes that the Minister, my noble friend Lord Bethell, has proposed to the affirmative procedure, which we are not discussing today. It is therefore worth recognising the progress that the Government have already made to try to meet those concerns, which were set out so well by the noble Baroness, Lady Thornton, and others, about the powers being given to the Government.

Again echoing my noble friend Lord Lansley, I would say that if we were to go down that route, the amendments tabled by the noble Lord, Lord Patel, represent the right approach, which is to commit not to a sunset clause, with all the cliff edges that that would involve, but to providing draft consolidated legislation. There is a good case in its own right for doing that, particularly in the circumstances. Like my noble friend Lord Lansley, I encourage my noble friend the Minister to look seriously at that idea.

[Lord Sharkey (LD) [V]]

My Lords, we have Amendment 139 in this group. It would require all the delegated powers in the Bill to expire on the third anniversary of its passing. We chose the three-year time limit because that had been discussed in the Commons. But, having heard what other noble Lords have said on the issue of expiry, I am persuaded that two years may be more appropriate, as the noble Baroness, Lady Thornton, has argued, given the wide-ranging and carte-blanche nature of the delegated powers. I am also persuaded that a sunset provision is absolutely necessary.

As many noble Lords noted on Second Reading, this is a skeleton Bill. It contains no, or very little, policy, and allows policy to be made by secondary legislation. This clearly avoids meaningful parliamentary scrutiny, and is a direct and flagrant abuse of the delegated powers system.

In its 16th report of the 2017-19 Session, The Legislative Process: The Delegation of Powers, our Constitution Committee noted that the Government had designated

“functions for which delegated powers may be appropriate”.

These included

“providing for the technical implementation of a policy; filling in detail that may need to be updated frequently or is otherwise subject to change; and accommodating cases where the detailed policy has to work differently in different circumstances. Such purposes constitute reasonable uses of delegated powers.”

The Constitution Committee’s view of all this was clear. It considered the use of delegated legislation to formulate policy, or to create new criminal offences or public bodies, to be “constitutionally unacceptable.”

The Delegated Powers and Regulatory Reform Committee, in its recent report on the Bill, points out that the Government say nothing about why it would not be appropriate to have aspects of the regulatory regimes which are not detailed or technical on the face of the Bill, combined with more focused delegated powers to fill in the detail. This is still the case.

--- Later in debate ---

[Lord O'Shaughnessy (Con)]

My Lords, my only intention in speaking on this group is to ask a question. Given the flag raised by my noble friend Lord Lansley in his Amendment 76, I am glad that I am not the only one with the question, which is whether the concept of medical devices inherently includes their therapeutic usage. My understanding is that they are regulated as medical devices, not simply devices, and therefore the way in which we regulate and risk-stratify them as we regulate them inherently includes therapeutic use. The fact that my noble friend raised the question in his amendment made me slightly worried, so I seek the Minister’s reassurance on that point.

I have also become aware during this discussion of another issue worth considering. There has been some debate about the appropriateness of government amendments being approved in Committee. I concur with the view of my noble friend Lord Lansley that a Bill on which only half the Front Benchers agree is better than one on which none agree. I have been in my noble friend’s shoes and have been frustrated, as I know noble Lords opposite have been, by the need to stick to concession strategies, holding back concessions and amendments until Report. I do not agree with that approach. My noble friend has done absolutely the right thing in bringing forward amendments at the earliest possible opportunity, however imperfect they are. The problem with leaving everything to Report is that it is an all-or-nothing approach, as we do not tend to amend at Third Reading, whereas this potentially leaves open the iterative approach that I would like to see more of. Maybe my noble friend has even set a precedent, heaven forbid, in doing this. We would all welcome it as giving more than one opportunity to improve legislation, on Report. I hope that we can agree the government amendments because, as everyone has said, they are an improvement on where we were and we would have another opportunity, if the House felt it necessary, to improve them further on Report.

[Baroness Walmsley (LD) [V]]

My Lords, I support Amendment 5, which would insert the words

“objective of safeguarding public health by promoting the availability and supply of human medicines”.

While the purpose of the Bill is to bring some sort of order out of the chaos of Brexit, it is vital that we put those words up front. In the first words on page 1, before Clause 1, the purpose of the Bill is described as

“the protection of health and safety, in relation to medical devices”.

Why does it not say, “in relation to medicines and medical devices”? That is why we need Amendment 5.

Government Amendments 2 and 7 are weak, in my view. For example, the words “promote health and safety” in Amendment 2 and “considering whether they would” in Amendments 7 and 72 are well meaning and better than the original but, I dare to say, legally useless.

The word “promote” also appears in government Amendment 68. In contrast, the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf, use the much stronger word “safeguard” in their Amendment 70, which I support. I also support their probing amendment for clarification in Amendment 76 that therapeutic practice is also included. I will be interested to hear whether the Minister can explain whether this is needed or, perhaps, not.

--- Later in debate ---

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

I have received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O’Shaughnessy (Con)]

I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.

[Lord Bethell (Con)]

I would be happy to conduct that follow-up.

--- Later in debate ---

[Lord O’Shaughnessy (Con)]

The noble Baroness, Lady Thornton, got to the heart of this when she said that these discussions are central to our debate on the Bill and its purpose.

I preface my comments on the amendments by drawing on my experience as a Minister with responsibility for preparing the health and social care sector for Brexit and for medicine regulation. During that time, I spent hours and hours—days and days—of time with pharma and medical device companies, patients and others. There was a consistent message from almost all of them about the desirability of remaining part of the EU family if possible and the importance of the MHRA and our notified bodies as regulators within that regime. I, together with others, worked extremely hard to make sure that that was recognised in the withdrawal agreement that was agreed at the time. We managed to create a special category of safety products. For those who remember back two or three years, there were chemicals, pharmaceuticals and medical devices in the withdrawal agreement and, indeed, the political declaration. I worked very hard to achieve that position and supported it.

It might also be worth reminding noble Lords that Parliament passed up the opportunity to agree that withdrawal agreement. It did not succeed. That has led to a different Government with a different agenda and with a majority, which might be something for us all to reflect on.

I make those points only so that noble Lords will understand that my concerns with the amendments on aligning with the EMA and European regulation in general are not ideological but practical. Actually, this is a very heterogenous group of amendments: it ranges from alignment through to collaboration to similarity where possible. When considering the issues around this, we need to tread very carefully as to what we commit ourselves to. The fact is that, as negotiations have progressed, it has become completely clear that the European Commission will not tolerate any meaningful associate membership: you are either in or you are out, and there is no possibility of the UK participating in making the rules that bind it. Clearly, being in is not compatible with leaving the European Union, so the question that falls to us is what we do when we are out. What should we do as a sovereign regulator that is not part of the EMA?

This is where I disagree with those amendments that seek to align us with the EMA. The truth is that we cannot have the best of both worlds; we cannot—as the Prime Minister might put it—have our cake and eat it. We cannot be in and take advantage of the opportunities that being out gives us. Tying ourselves in advance and in perpetuity to EU regulation over which we have no control or, critically, judgment of quality, would be a big mistake.

It is quite right that we should seek to mitigate the negative impacts of leaving the EMA family. I have never sought to sugar-coat those—I do not take a Panglossian view of the consequences—but tying ourselves in such a way is not the way to do it. Multiple stringent regulators in the world do just as good a job, if not better, as our MHRA—in Japan, Switzerland, Canada, Singapore and bits of the EFTA. We should as a nation be seeking to accept licensing applications and modelling our regulatory structures on all and any of those that we think are the best. That is the way to take advantage of our freedoms and give us the best possible opportunity of getting innovative medicines and products as they come on to market in any market in the world.

We do not need, as the noble Lord, Lord Hunt, and others, said, to create our own bespoke, novel, difficult regulatory system that puts up more barriers to innovation; nor should we tie ourselves to one other regulatory regime. I use just one example to exemplify why I think that is true. It is a well-worn example but is worth rehearsing: the introduction of the HPV vaccine. That was something that most regulators in the EMA family did not want to proceed with. The MHRA provided a very compelling case for us to do so. European countries did so. The effect of that in England alone has been to reduce HPV infections among 16 to 21 year-old women—the figures are a couple of years out of date but are probably still accurate—by 86%. Bear in mind that HPV causes 80% of cervical cancers among women. We might be tying ourselves to things that we regret and which cause harm; I know that that is not something that anyone would want to do.

I note from the ABPI’s briefing—obviously, I have worked closely with it—that it does not call for alignment with the EMA. It calls for making sure that

“the information or data required by the EU regulator is consistent with other leading regulators around the world and benchmarked against them for speed and approval.”

It also calls for the UK to apply for full membership of the ICH, as the amendment in the name of the noble Baroness, Lady Jolly, calls for—I quite agree with that—and generally to look to provide leadership on developing global regulatory standards in human medicines.

I utterly understand the impulse. The Government have partly got themselves into this difficult situation by creating a vacuum into which people are seeking to put policy. That is completely understandable but it would be a mistake to tie ourselves to one particular regulator. It may not be quite as true of clinical trials—I defer to the expertise of others—although I note that the ABPI briefing paper does not talk about the clinical trials directive; instead, it uses a much broader palette and says that future clinical trials and regulations in the UK should both support and enable international collaboration.

I know that that is not the only position and that people take a different view, but as we move forward, we will want to tread carefully over which regulators we seek to collaborate with, emulate and draw on, rather than tying ourselves to an in-perpetuity relationship that we may come to regret on occasion.

[Baroness Walmsley (LD) [V]]

My Lords, Amendment 3 makes clear the desirability of alignment with the EMA and the EU clinical trials regulations. It sets out early in the Bill the store for those of us who feel that the advantages we have gained from such alignment must not be sacrificed on the altar of some mistaken ideology of this failed Government. I point out to the noble Lord, Lord O’Shaughnessy, that we managed to introduce the HPV vaccine before we left the European Union.

Amendment 22 attempts to define the rather vague expression “attractiveness”. We have other definitions in later clauses; we certainly need to choose one of them but I will leave my preference for a later debate.

I support Amendments 34 to 39 to Clause 4 on clinical trials. As my noble friend Lord Sharkey pointed out, they tighten up the wording in the Bill to emphasise the benefits and avoid the damage of diversion from EU clinical trials regulations. British patients benefit from alignment, British bioscience research and development benefits, and the whole system is worth millions of pounds to the Exchequer. I and other noble Lords have received briefings from a number of organisations working on behalf of patients, such as the British Heart Foundation, emphasising that any diversion from these regulations will affect the rapid availability of new medicines and treatments to British patients. They are also concerned to protect the large amount of EU research funding that they currently receive. Diversion could also affect, to use the Government’s favourite word, the attractiveness of the UK as a place to conduct clinical trials. The problem is that the Government have not told us what they might want to change unilaterally in future, as a number of noble Lords have pointed out. I invite the Minister to tell us now.

Amendment 39 asks the Government to establish a clinical trials portal that aligns us with the EMA regulations for medicines for rare diseases. This is particularly important if we are independent from the EU as our population of 68 million is so much smaller than the EU population of more than 400 million, which would make it harder to find a big enough cohort of people with rare diseases for a clinical trial. The noble Lord, Lord Patel, pointed that out.

The EU clinical trials portal, which will come into play with the new and improved EU clinical trials regulations in 2022, was to a great extent designed by British participants. This shows how important it is considered to be by British scientists because it makes applications for clinical trials so much easier and less time-consuming. In its previous inquiry, the Science and Technology Committee heard from a number of witnesses about the issues with the current system, which wastes a lot of their time. So, like the noble Lord, Lord Lansley, I feel sad to know that we will be out of the system by the time the improvements are put in place.

Our current alignment also encourages British scientists to go abroad to broaden their expertise and EU scientists to come here and become part of our very successful research teams. I know the Government are in favour of that because I heard Amanda Solloway, the Science Minister in BEIS, say so last week to your Lordships’ Science and Technology Select Committee. I hope, therefore, the Minister will be minded to accept the amendment.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord O'Shaughnessy (Con)]

My Lords, I declare my interests as set out in the register, in particular as an adviser to Intuitive Surgical, to Healthy.io and, until the end of August, to the Department of Health and Social Care.

I congratulate my noble friend on bringing this Bill to the House; I know how hard he has worked to do that. For those of us concerned to make sure that British patients get access to the best drugs and devices—and, frankly, after the past six months, who is not concerned with that?—this is the most important piece of legislation we have in front of us.

My belief is that the Bill gives the UK the chance to create the most rigorous, innovative and safety-conscious regulatory scheme in the world. While there are many downsides to leaving our current system in the EU, as noble Lords have pointed out, there are many benefits, too. Just look at the way that the US FDA has embraced digital and algorithmic therapeutics, while the EMA has lagged behind. To make the most of these new freedoms, we need a regulatory system that can evolve in response to new discoveries and advances in medicine.

Considerable concern has already been expressed in the House today, and no doubt will continue to be throughout the afternoon, about the use of delegated powers in the Bill to provide this kind of flexibility. Having been in my noble friend’s shoes, and having been not so gently admonished by the DPRRC in the past, I can only say that this is not a hill that I wish to die on again. But it seems to me that we are exchanging one system of delegated powers for another, with the added benefit that the authority that will be using these powers has the virtue of being elected by the people it seeks to regulate. At the very least, this is surely an improvement on the status quo ante.

There are two substantive issues that I would particularly like to focus on, already raised by my noble friend: innovation and patient safety. On innovation, we currently benefit from being in one of the top two markets in the world for medicines and devices, and our regulator is rightfully regarded as one of the best in the world. As other noble Lords have said, leaving the European system could bring challenges when it comes to patients accessing innovative therapies, but these can be more than mitigated by a new joined-up approach to research, regulation and uptake. This would require the creation of a world-beating, digitally powered clinical trials infrastructure to test ground-breaking medicines and devices; a rapid but rigorous regulatory process for the most promising technologies; as my noble friend Lord Lansley has pointed out, the creation of an innovative medicines fund to bring those to market; and harnessing the collective might of the NHS to adopt and scale those therapies.

My noble friend the Minister pointed out that during the Covid crisis this is precisely what we have done for therapeutics, vaccines and other technologies that can help. The pandemic has shown British science and medicine at its best. Does he agree that we now need this kind of regulatory regime for all medicines and devices in the future? If so, will he tell the House when comprehensive plans for creating such a regime will be published?

Even as we go about producing the most pro-innovation regulatory regime in the world, we must never forget, as my noble friend Lady Cumberlege put it in her excellent report, that our obligation is first to do no harm. Too many people—often, it seems, women—have borne the brunt of an approach to post-licensing surveillance that, historically, has been too analogue and too unresponsive to patients’ needs. The sad consequences of this are movingly documented in my noble friend’s report. I wholeheartedly endorse her recommendations, and I am delighted that the government amendments in the other place will improve the use of data for patient safety.

But let us be clear: there is much more to do, so I ask my noble friend the Minister, when will the Government respond to the Cumberlege report’s thoughtful and sensible proposals? Does my noble friend agree that we should use the next few weeks to make progress on implementing its recommendations? Otherwise, as I am sure he is aware, he might find that the House does that work for him.

I have every confidence that my noble friend will work with noble Lords to produce a pro-innovation, safety-conscious regulatory system for the UK. He has my support for those efforts, and I am happy to welcome and support his Bill.

Independent Medicines and Medical Devices Safety Review

Lord O'Shaughnessy Excerpts

Thursday 9th July 2020 Lords Chamber

[The Deputy Speaker]

I call the noble Lord, Lord Willis of Knaresborough. No? In that case, I call the noble Lord, Lord O’Shaughnessy.

[Lord O’Shaughnessy (Con) [V]]

My Lords, as a former Health Minister I add my apologies to these women on behalf of the Government I served. They were let down over many years and I pay tribute to their courage in coming forward for this review. I also pay tribute to my noble friend Lady Cumberlege and her review team for a superb, landmark piece of work. I want to press my noble friend the Minister on one issue: he mentioned that Aidan Fowler is the national director of patient safety in NHS England. That is quite right and very welcome, but the report recommends that somebody from outside the system—someone whose first loyalty is to patients themselves, not to the NHS—should be the gateway, the representative on behalf of patients. I know my noble friend wants to consider these recommendations carefully, but will he not rule out the idea of a new, patient-focused commissioner simply because there is someone leading on patient safety in NHS England already?

[Lord Bethell]

I thank my noble friend for his comments and for his role in commissioning this important report. His point on the safety commissioner is extremely well made. I am not ruling out anything whatever, but we need time to study the report before we can make any commitments.

Covid-19: Contact-tracing App

Lord O'Shaughnessy Excerpts

Wednesday 6th May 2020 Lords Chamber

[Lord Bethell]

My Lords, the app works by using the Bluetooth tags which are shared once you have declared symptoms or you have had a positive test. It does not rely on GPS tracking. If the terms and conditions are broader, that is because we want to try to provide the most thorough set of conditions that encompass all the data provided by the user’s telephone. However, I can reassure the House that it is Bluetooth tagging that is used by the app and the surveillance system.

[Lord O’Shaughnessy (Con)]

My Lords, what work is going on to make sure that the app that NHSX is developing is interoperable with other countries’ apps? Clearly we all want to get back to a situation where people can move freely from one country to another for business or leisure, so interoperation is important. I will be grateful if my noble friend can update us.

[Lord Bethell]

My noble friend Lord O’Shaughnessy is entirely right. We all wish to move as quickly as possible back to normal, but I am afraid that travel will be one of the aspects of our former lives that will be slowest to return. That said, we are working extremely hard with other countries to make sure that interoperability can be baked into our arrangements. Of course, the app has not yet been launched and few other countries are ahead of us. We sat with the Irish Government on 24 April in order to work out interoperability protocols since that border is the most important and proximate to us.

Coronavirus Bill

Lord O'Shaughnessy Excerpts

2nd reading & 2nd reading (Hansard - continued) & 2nd reading (Hansard - continued): House of Lords
Tuesday 24th March 2020 Lords Chamber

[Lord O’Shaughnessy (Con)]

My Lords, I draw attention to my interests set out in the register, particularly in health and education.

I join other noble Lords in registering my gratitude to and admiration for the NHS and care staff who are at the front line in battling this disease. We know they do an extraordinary job in ordinary times, but these are not ordinary times. Many of them are putting their lives at risk to keep us safe, and they deserve our eternal thanks for doing so. There are other workers whose work will also be important: the police, school teachers, postal workers, bin men and those working in shops and supermarkets. I add to that list my noble friend, other Ministers and the civil servants who are working so hard. Let us not forget the sacrifices that they are making to keep us safe and resolve to do everything we can to lead by example to show that we are listening to the Government’s advice about how we should go about living our lives.

The purpose and content of the Bill would ordinarily be anathema to a freedom-loving people like the British, but in these circumstances there is something we prize even more than liberty—security, which is what the measures in the Bill will provide. For that reason, and in accordance with other noble Lords, I am very supportive of this legislation, while sincerely hoping that we will not need it for the two years the Bill provides for.

I have a few specific questions that I would be grateful if my noble friend the Minister could address, if not today in his response, which necessarily will be loaded with content and questions already, then subsequently by letter. The measures to allow for the urgent registration of health and care staff are sensible, necessary and proportionate, but can my noble friend explain how his department is using technology to meet the challenge of registration, credentialing and deployment of staff in the NHS and care systems? He will also know that this will be reliant on very good and fluid data flows within the NHS, which has not always proved possible because of GDPR. I understand that a public health exemption for GDPR has now kicked in, but can he provide reassurance that those exemptions are well understood when it comes to front-line practice and that the GDPR regulations, which are understandable in peacetime, are not being used to provide barriers, however unwilling, to the proper deployment of the staff we desperately need to keep us safe?

I commend the Government’s idea for emergency volunteering leave. It is an excellent innovation, but the current plan allows for only up to four weeks’ leave. If the pandemic lasts longer than we hope for, are the Government open to extending this leave if there is need in society? In particular, what plans do the Government have to use the labour force, whose wages the state are now subsidising, which the IFS has estimated could be up to 10% of workers, to fill critical gaps in health, care and the wider economy? We do not necessarily want to get to the Ministry of Labour-type approach that we had in the Second World War, but there is nevertheless a moral obligation on those whose wages have been subsidised. We need to make sure that we can make the best of their good will.

I confess that I am slightly confused about the situation regarding the DBS checks set out in the legislation. There seem to be clauses covering Wales and Scotland, but not England. Making sure that we can safely but urgently redeploy people in the health and care system without suffering from this bureaucratic bottleneck will be critical. Can my noble friend clear up my confusion?

Clause 10 provides indemnity for those in the NHS and care systems who are moved on to Covid-19 work. That is excellent news. However, the EVL scheme is also likely to raise issues of employer indemnity outside the health and care system. Are the Government open to extending indemnity to the wider economy to cover those under the EVL scheme to reduce the barriers across the entire economy to using this pool of willing labour?

I would also be specifically grateful to my noble friend if he could provide more clarity on the responsibility of employers. I have just been on the LBC lunchtime programme, where this was raised by many listeners who felt that some employers are not acting responsibly by insisting that people should go to work. What provisions exist to force recalcitrant employers who are posing a health risk to their staff to obey the guidelines? Do the enforcement powers extend to organisations as well as to people? Many people would want to know that.

Finally, regarding education, schools across the land are managing heroically to provide physical key worker schooling while delivering online education for everyone else. I declare an interest as a parent of three children going through online education at the moment. No doubt we will muddle through to the Easter holidays, but schools simply are not set up for this eventuality in the long run. What plans do the Government have to provide financial and technical support to enable rich, high-quality learning from home? I reassure my noble friend that, notwithstanding the answers to these questions, which I know he will be able to give, the Government have my full support on these measures and I will do whatever I can to support the national effort.

As my noble friend Lord Bethell pointed out, the Bill is one part of the national response to Covid-19, but it is not the full armoury. Many other interventions are needed besides. That means, for example, making sure that as borders close, we do not interrupt the supply chains of the medicine and medical device industries and that they stay open; mercifully, that seems to be the case at the moment. The Government are ramping up ventilator and ICU capacity, which is extremely welcome, and we have unprecedented financial help for all those families whose livelihoods are at stake. Government should be and are being applauded for their actions, even while we know that much more is needed.

If my noble friend will allow me, I will make two more suggestions about policy interventions that I believe will be needed. The first is diagnostic testing. We simply are not yet at the capacity that we need to be at; we ought to be aiming for nationwide population-wide testing so that we can understand who is infected and who is not, to be able to redeploy them in the economy as soon as possible. Can my noble friend give me some idea about when that might happen? The cost-benefit analysis is overwhelming. It might cost £5 billion or £10 billion a year to provide such a scheme, which is a lot of money, but that is set against the £330 billion-plus package to keep our economy going through this time. I am sure that all Members of the House will appreciate some information on this. We also need a social policy package that is as ambitious as the economic and health plans we have in place. That is essential if we are to get through this crisis as a stronger and more cohesive society.

To conclude, we find ourselves, sadly and unexpectedly, in the most difficult of times, but I believe there is cause for hope. On the health side, we see the potential for vaccines and new treatments coming on stream. However, more than that, we will display our real character as a nation. The good news is that, according to the University of Delaware’s Disaster Research Centre, when faced with these crises we become kinder, not more selfish. Let us use this opportunity, which of course nobody wanted, to demonstrate just what the British have in their character.

Covid-19: Critical Care Capacity

Lord O'Shaughnessy Excerpts

Monday 23rd March 2020 Lords Chamber

[Lord Bethell]

My Lords, the bravery and commitment of our front-line staff are to be commended. I think I speak for all of us when I pay tribute to everyone who has put their safety and health on the line. There is no doubt that those in the NHS who are working with those affected with Covid-19 are taking a huge risk, and it is our commitment to support them where we can. Hotel rooms are being booked for NHS staff who are reluctant to return home and who would quite wisely prefer to seek alternative accommodation. Tests are absolutely essential in order to get not only front-line clinical and ancillary staff but the whole country back to work. The Government are committed to finding a way to roll out a testing programme that gives British people confidence that we can beat this virus.

[Lord O’Shaughnessy (Con)]

My Lords, can the Minister be a bit more specific on the diagnostic front? The deal with the private sector is incredibly welcome, and the situation with Northwick Park demonstrates how important it is. However, it is not just about beds and ventilators but people. We know that staff are having to self-isolate because someone at home seems to be ill but they themselves may not be. What kind of numbers are we talking about? The Prime Minister has talked about getting up to 25,000 a day; there are 65 million people in the country. What is the ambition, not just in four weeks but in eight and 12 weeks, of what we might get to and how we will get there?

[Lord Bethell]

My noble friend Lord O’Shaughnessy asks entirely reasonable questions, and he is quite right to press me for numbers. The tests we are talking about for this virus are new—some of them are only a few weeks old. It requires the tests to be tested to ensure that they are delivering accurate results, and for that reason it is difficult to commit to the kinds of numbers my noble friend searches for. However, it is very much the Prime Minister’s desire to have testing as a central part in our battle against the virus, and that is why we are putting enormous resources into it.

Coronavirus

Lord O'Shaughnessy Excerpts

Thursday 12th March 2020 Lords Chamber

[Lord O'Shaughnessy (Con)]

My Lords, I am grateful to my noble friend for repeating that Statement and providing that reassurance. We all respect that this is an incredibly difficult and finely balanced decision, and, to some degree, we all need to trust in the process and those who are leading it. We have great scientists who are doing so.

Will my noble friend do two things? First, can he talk a little about the welcome funding that was in the Budget yesterday to support the economy and the health system through this outbreak? What exactly will that be spent on and what can be spent quickly to good effect? Secondly, to pick up an issue that was raised by the noble Baroness, Lady Thornton, but was also mentioned yesterday about capacity in the system, particularly in care homes, I am very worried about vulnerable people who require domiciliary care whose workers might get sick. Who will care for those people? We may need to think completely out of the box in how we do this. Can we stand up a volunteer army of post-infected people who have DBS checks to take on these kinds of responsibilities? Going about things in the ordinary way will not deal with the consequences of this crisis when it really hits. I would be grateful if my noble friend could expand on some of the plans the Government are making for these consequential impacts, which are not to do with the virus, but are very much to do with the impact on the health system.

[Lord Bethell]

I thank my noble friend for those questions. In terms of funding, the Treasury has provided immediately a £5 billion contingency fund to ensure that not only the NHS but local authorities have the resources necessary for both clinical and social care. The kinds of items that the money can immediately be spent on include boosting staffing, particularly in the NHS, which might include re-employing retired doctors and nurses and recruiting and offering compensation to volunteers who agree to help provide health and social care services full-time for the period of surge.

The precise arrangements for how that volunteering army can be put together will have to wait until we have the legal provisions for that army because there are important questions of indemnity, legal registration and DBS checks, all of which have been raised in this Chamber previously and which we take very seriously. But it would be premature to describe plans that are being worked on at the moment until we have tabled the sorts of legal requirements that we will need.

Funding will also ensure that we have the right drugs, supplies and equipment. Lastly, there will inevitably be a backlog of care after the virus has passed. We are conscious that this backlog will put a long-lasting strain on our medical and social care arrangements, and we are putting in the resources today to ensure that the backlog can be addressed in the future.