Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Lord Lansley Excerpts

Monday 12th July 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend the Minister for his introduction to these regulations. I agree with the noble Lord, Lord Rooker: my noble friend has acquired a rhetorical flourish or two today.

We can see the powers that we debated on the Medicines and Medical Devices Act coming into use already. The powers in Section 15 are being used for this purpose, but my noble friend will of course recall that Section 16 related to the criteria, including the effect that any regulations made would have on the life sciences industry in the UK. The Explanatory Memorandum argues persuasively that this validation process will increase the resilience of the supply chain and may even encourage domestic suppliers. It also refers to the discount available to SMEs, which is welcome. But paragraph 12.8 of the Explanatory Memorandum says that an impact assessment would be published in time for the parliamentary debate. I could not find one yesterday or today. Will my noble friend say where it is and whether it confirms that it is the Government’s clear view that the life sciences industry and SME interests are fully protected?

There is a clear case for validation of these tests, given the reported failure rates of tests submitted for public procurement, to which my noble friend referred. We need to use lateral flow tests to support the return to school in the autumn, to enable employers to bring their staff back to their workplaces, and to counter outbreaks—in particular with large-scale surge testing—when we have achieved a lower prevalence again, which I hope will be in the late summer.

Studies including the Cochrane review, published in April, suggest that lateral flow tests will reliably confirm that someone without Covid is negative; in that sense, they have very high specificity. Where their sensitivity is concerned, they will confirm infection in someone with symptoms in an average of 72% of cases, but will on average identify the infection in asymptomatic cases only 58% of the time. Those results will vary according to the location and experience of the tester—where it is done and by whom. We need these tests to work at home and not just in the hands of healthcare professionals.

I support the regulations but I have three issues to raise. First, the tests procured by the Government will not be subject to validation because that would essentially be duplicatory, as the test approval is based on that same procurement process. But that procurement process has been used by the Government principally for the procurement of the Innova tests, which, as the noble Lord, Lord Rooker, made clear, are essentially manufactured by Xiamen Biotime Biotechnology in China. The Government, of course, had an intermediary company—Disruptive Nanotechnology, in Northampton—which, as far as I can see, was effectively a non-trading company at the end of December 2019. It is Innova Medical Group that is essentially the intermediary.

Innova is a Californian company. It is reported that it has sold 380 million tests to the Government. But on 10 June, the Food and Drug Administration issued a safety communication that the Innova rapid antigen tests should be withdrawn. Indeed, its communication suggested that the people who had them should simply throw them away. The question I come to is this: if we are confident in the Innova tests, what has been the nature of the discussions we have had with the Food and Drug Administration? My understanding is that, essentially, the Food and Drug Administration took the view that Innova was advertising the tests for use with asymptomatic people, but that they were authorised for use with those who have symptoms and that their sensitivity is greater for those with symptoms. Is that why the FDA issued its class I recall on these tests? That being the case, why did my noble friend say when he introduced the regulations that it is really important that we have tests that work for those who are asymptomatic? These tests are not sufficiently specific for those who are asymptomatic.

I know that it is a legal case, so my noble friend might hide behind his inability to speak about it, but why has Mologic, a Bedford company that has a track record, found it necessary to sue the Government in relation to their validation processes for the public procurement? What does that tell us about the validation they propose to use for this purpose?

I have two very quick other points. To put at rest the mind of the noble Lord, Lord Rooker, could my noble friend update us on the plans announced last month for Innova and Sharp packaging to build a factory in Caerphilly to produce up to a million tests a day, starting in July—this month? It is absolutely right that we should have leading medical technology companies in this country and manufacturing supply alongside them.

Thirdly, to further endorse what the noble Lord, Lord Rooker, said, could my noble friend explain what the Government’s intention is on charging for tests, particularly for employers, who will want to institute testing regimes to bring their staff back into their premises and to protect the public and their customers while doing so? They have had 18 months, in many cases, during which they have lost revenues. Should we really expect them to meet this further cost at this stage? Their taxes will sustain us in the future, but should we not now support them to get back to work? I would be grateful for my noble friend’s response.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Baroness, Lady Brinton, has withdrawn, so I call the noble Lord, Lord Scriven, in her place.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Lansley Excerpts

Monday 12th July 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend the Minister for his clear introduction to these regulations. I want to take the opportunity to comment on just one aspect of these arrangements: the processes for a conformity assessment on medical devices placed on the market in Northern Ireland.

A European conformity assessment, a CE mark, is to continue to be recognised in the Great Britain market until 30 June 2023. Likewise, the certificates issued by EU notified bodies will continue to be recognised until that date. It seems to me that, if one is a Northern Ireland-based manufacturer of a medical device—the Explanatory Memorandum estimates that there are some 300 such businesses—for the next two years the CE mark should be a sufficient basis for placing a product on the market, whether in the EU, Northern Ireland or Great Britain. I would be grateful if my noble friend were in a position to confirm what I say or correct me.

If a Great Britain manufacturer is meeting EU requirements then, from 2023, it will require a UK conformity assessment, but this in itself will not enable its product to be placed on the market in Northern Ireland—hence the references in these regulations to the “UK(NI) indication”, which appears to become of greater significance after 1 July 2023. From that time onwards, British manufacturers will be required to adopt dual marking and conformity assessment through two systems, with the attendant cost and complexity. Obviously, the same is true for non-EU third-country suppliers.

At the heart of this problem is the failure of the trade and co-operation agreement to provide for mutual recognition of conformity assessments, given the simple fact that, as my noble friend Lord Empey adverted to, our MHRA undertook 40% of the most significant assessments in the EU. We do not have divergent technical standards; what we have, unfortunately, are divergent political priorities. I personally do not blame Theresa May’s negotiators for our failure to secure that mutual recognition.

One option now would be to roll forward our recognition of European conformity assessments—the CE marking—beyond 2023. Frankly, I do not expect that to happen, because it would undermine the role of the MHRA and British notified bodies, but can my noble friend explain what the position will be for Northern Ireland manufacturers post 1 July 2023? Given the principle of unfettered access to the UK market, will they be able to sell in Britain on the basis of their CE mark or will they require dual marking? This regulation makes provision for the UK(NI) indication, which is useful for UK manufacturers using a previous EU approval and for British devices to access the Northern Ireland market, but it seems to me no more than a face-saving approach to cover the harsh reality that we are going to put our highly successful medical devices sector through significant additional cost, disruption and bureaucracy.

Covid-19 Update

Lord Lansley Excerpts

Tuesday 6th July 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, I support the move from legislation to guidance in relation to the measures in the Statement. But does my noble friend agree that there is a case for continuing regulation of the circumstances where somebody is the contact of somebody who has tested positive? Can he update the House on what the Government are proposing regarding relaxing some of the restrictions for those who are contacts of positive tests?

[Lord Bethell (Con)]

My noble friend puts it very well. Clearly, with the infection rates rising but with a very large proportion of the country vaccinated, it is worth reviewing this. As the Secretary of State said in his Statement earlier this afternoon, from 16 August the Government intend to exempt people who have been fully vaccinated from the requirement to self-isolate if they are a contact of a positive case, with a similar exemption for under-18s. Anyone who tests positive will still need to self-isolate regardless of their vaccination status. Symptomatic testing will continue to be available. This is a proportionate direction, given the state that we are in.

Health Security (EU Exit) Regulations 2021

Lord Lansley Excerpts

Monday 5th July 2021 Grand Committee

[Lord Lansley (Con) [V]]

My Lords, I am pleased to contribute to this short debate. I thank my noble friend the Minister for introducing the regulations, which, as the noble Lord, Lord Hunt of Kings Heath, quite rightly said, are self-evidently necessary in these circumstances. I have no reservations about introducing them but I want to take this opportunity to explore a number of issues, including how my noble friend anticipates our relationship with the European Union developing in future.

First, the question of where the common frameworks are concerned inside the United Kingdom is fairly straightforward. However, I am not entirely sure how the UK health protection committee will coincide with, or work directly with, the four Chief Medical Officers; perhaps my noble friend can tell me. Certainly in England, the Chief Medical Officer appears to have a different future role in relation to health security than was formerly the case for his predecessors.

So far as the relationship with the European Union is concerned, my noble friend felt that the TCA created a full process for co-ordination. I am afraid I do not agree with him. I think the TCA creates a bare-bones relationship with the European Union for the future. I am not even sure that what is in the TCA has yet been in any sense implemented, since it includes a memorandum of understanding between us and the European Centre for Disease Prevention and Control, and I see no evidence of that being negotiated. Perhaps my noble friend can tell me whether that is the case. One has recently been concluded between the ECDC and Mexico, but not with us.

When one looks at the ECDC, which was established in the wake of SARS in 2004 to enable the European Union to be prepared for a future pandemic, I am afraid one is not impressed. It retreated from its media functions with anything other than national authorities and health professionals—it retreated from public communication—and it needs radically to change its approach. Indeed, as an organisation, it is hamstrung by the simple fact that under the Treaty on the Functioning of the European Union it is dependent on the activities of national authorities. It complements the work of national authorities but in no sense co-ordinates or controls them. For example, by 3 April last year, four European Union member states had failed to supply the ECDC with the necessary data for surveillance purposes. So unless and until the ECDC is in a position to inspect and secure data surveillance in all EU member states, I am not sure that it has the necessary powers and control.

The European Commission, albeit producing reports explaining how well it has done, freely acknowledges this in the way in which it is approaching the development of a European health union, as the noble Lord, Lord Hunt of Kings Heath, suggested. We may no sooner have this in force later this year, and start to create a relationship between the health security committee and the ECDC, than we find that the European Union has created a health emergency preparedness and response authority, which it anticipates should be operational in 2022. There may be a European Union chief epidemiological officer. There may be a major manoeuvre on the part of the European Commission, proposing to legislate for a European health union. It may well move from competence being entirely for national authorities on major cross-border health threats to an EU competence shared with national authorities. That may make a considerable difference. However, when it comes to us co-operating with the European Union on cross-border health threats, it means that we have to be prepared for much more substantial activity on its part and a much more complex relationship with a range of European Union actors.

I shall mention one final thing. In all this, nobody appears to have referred to the role of the World Health Organization’s regional office for Europe. I am reminded that there are 27 member states of the European Union, but 53 participating states—at the last count, but I think it might have gone up to 55—in the World Health Organization’s region for Europe. A number of those states, such as us, Switzerland, those in the western Balkans and so on, will be integral in responding to a cross-border health threat of the kind we have experienced during the pandemic. If, as we wish, and I think the European Union wishes, there is to be enhanced global health security, there is no alternative to us reforming the World Health Organization and, in the process, vesting greater potential in its regional structures. Those have been poor in the past but could be much more effective in future. They take responsibility in relation to all the countries likely to be affected rather than, as in the case of the European Union, only just over half of them in Europe. I hope my noble friend will be able to say something about the Government’s plans for strengthening the WHO in Europe.

Covid-19 Update

Lord Lansley Excerpts

Tuesday 29th June 2021 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is entirely right: those three things are linked. We cannot live in a world where there is a high infection rate in large parts of it, where new variants prosper and where we cannot travel. That would be inhuman and unpragmatic. I met with the CEOs of the major companies that manufacture the vaccines in Oxford during the G7, and we discussed this point in great detail. It is frustrating, but I also have optimism that the manufacturing capability in the hubs around the world—in the geographical places where populations live—are being built today and, by the middle of next year, there will be a huge amount of vaccine capacity in order to address this problem. It is frustrating that it cannot happen overnight, but vaccine manufacturing capability takes time to build up, as we know only too well. However, those investments are taking place, and I believe that, as a world, we can beat this pandemic together.

[Lord Lansley (Con)]

Notwithstanding the disclosures of the past few days, may I tell my noble friend that I, for one, very much appreciate what Matt Hancock did and the immensity of the effort he put in to combat Covid infection? Step 4 is not a return to normality, so, for example, self-isolation requirements will continue after contact tracing. The Government now have a lot of research to look at whether daily lateral flow tests can replace self-isolation both for schools and for businesses, which are must disrupted by self-isolation. Can my noble friend say when the Government may be able to proceed to allow some schools and businesses to shift to daily lateral flow tests?

[Lord Bethell (Con)]

My noble friend’s comments are very much appreciated and taken on board. On his question about daily lateral flow testing, he is very perceptive and correct. This is an area that we have been exploring for some months, and we are working extremely hard to bottom it out with rigorous clinical trials—clinical trials are difficult to nail down, by their nature, but we have invested substantially in them. He is right that, for schools, for international travel and for contacts—those three things—daily testing may well offer an alternative to 10-day isolation. That would be a huge relief to many in the country, and it is something that we are very focused on delivering.

Social Care Reform

Lord Lansley Excerpts

Tuesday 29th June 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, new legislation will increase integration between health and social care by removing barriers to data-sharing, enabling joint decision-making and putting more power and autonomy into local systems. The noble Baroness is entirely right on that. The Bill has been published and the noble Baroness is very welcome to engage in some of the engagement sessions that I have had on it already. I should be glad to run more, if that would be helpful to her. A White Paper and a public consultation are not planned.

[Lord Lansley (Con)]

My Lords, press reports suggest that the Prime Minister is in favour of including in social care reform the Dilnot commission recommendations that are now a decade old. In doing so, he could bring into force Sections 15 and 16 of the Care Act 2014, which this Parliament passed seven years ago. Will the Government now consider doing exactly that to enable a cap on care costs to be implemented rapidly?

[Lord Bethell (Con)]

My Lords, we are extremely respectful of the Dilnot commission report and the recommendations in it, particularly those highlighted by my noble friend on Sections 15 and 16. It is one of many proposals that we will look at very carefully. We cannot make a commitment to anyone in particular at this stage but, as I said to the noble Baroness, we will put forward a full plan by the end of the year and will remain true to that commitment.

Health Protection (Coronavirus, Restrictions) (Steps and Other Provisions) (England) (Amendment) (No. 2) Regulations 2021

Lord Lansley Excerpts

Wednesday 16th June 2021 Lords Chamber

[Lord Lansley (Con) [V]]

My Lords, speaking from Cambridgeshire, like my noble friends Lord Cormack and Lord Blencathra I intend to support the Government’s regulations, but I do so with significant reservations. When we discussed the previous iteration of these regulations, I think my noble friend the Minister and I agreed that the time was fast approaching when we should move from legislation and enforcement to guidance. I think that moment is now very close.

Why have the Government decided to defer the date from 21 June? Looking at the four tests, it seems to me that they can have taken the decision only on the fourth; that is, if noble Lords recall, whether variants of concern have “fundamentally changed” their risk assessment. I do not think the data supports a fundamental change in the risk assessment, but Ministers quite understandably do not yet know why, for example, a Public Health Scotland study found that hospitalisations were at twice the levels of the alpha variant. I think they want to know why this is the case.

The observation from my noble friend the Minister that 1.2 million people over 50 or clinically extremely vulnerable have yet to receive their second vaccine dose is relevant but, at 175,000 second doses a day at present, there is no reason why in the week ahead—or a fortnight at most—those requiring a second dose who are most at risk should not all receive it.

This fortnight is about finding out whether the delta variant is a variant of concern or a variant of high consequence. It has not been designated as such by the WHO, the CDC or anyone else yet. It would be so designated only if it substantially reduced the effectiveness of vaccines against it. I do not think that has yet been proven, and I hope that Ministers will look at the data literally daily and, if it is obvious that the vaccine doses are effective against the delta variant, intervene and lift the remaining legal restrictions while keeping in place so many of the social distancing and other precautionary measures we should all take as matters of individual responsibility.

Health Protection (Coronavirus, Restrictions) (Steps and Other Provisions) (England) (Amendment) Regulations 2021

Lord Lansley Excerpts

Monday 7th June 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to follow the noble Lord, Lord Scriven, although I will not follow him in the criticism of process. I think the need for rapid legislation from time to time has meant that we are always catching up on some of the processes. I want to use this opportunity—which my noble friend has highlighted—to look at where we are and where we need to go in the week or two weeks ahead.

My first point, which I think my noble friend rightly emphasised, is that we are at the stage where we should move from legislation to guidance. One problem associated with the latest step 3 shift is that the public thought that everything the Government are asking them to do has to be in legislation. The enforcement of that has been quite burdensome from time to time. At the same time as moving to step 3, the Government added guidance, for example in relation to the eight local authorities that had the delta variant present. They did not publicise the guidance sufficiently and the confusion that arise from that was really regrettable.

Likewise, on 17 May, the ban on international travel was relaxed but at the same time Ministers were talking about the absence of international travel in ways that suggested that they were still enforcing a ban on non-essential travel. That was not the case. It is quite understandable that the public have become very confused. When the announcements are made for 21 June, we should stick with that date and make it very clear that we are shifting from a position where legislation has been required to one where guidance on future social distancing and preventive measures should be much clearer and consistent.

We should not be emphasising that from 21 June we are lifting all restrictions—we are moving to a new phase. In that respect, the noble Lord, Lord Scriven, is right, but I do not think that we need permanent legislation for this purpose. We need permanent adjustments in behaviour. We should be encouraging people to do things such as wearing masks, social distancing, working from home, ventilation, or having outdoor gatherings much more than indoor ones.

We have made enormous progress. I echo what my noble friend said about that. Obviously, vaccination is a really impressive achievement. Where testing is concerned, I do not share so many of the criticisms. The problem was not that test and trace did not expand its capacity but that people overestimated what it was capable of doing last year. We are at risk of underestimating what it is capable of doing this year.

When we shift the guidance, we should make large-scale lateral flow testing freely available, as we are doing now. On the basis of what we have seen in schools, we should encourage workplaces and employers to use lateral flow tests every other day to enable them to be confident that their staff are free of the infection. On that basis they can return to work, they can meet and they should be able to undertake international travel.

At this stage we need to make a distinction between travel for leisure and travel for work. British companies should be able to send people abroad and bring them back without long periods of isolation as long as they are having lateral flow testing. We have to get away from four PCR tests. That is a very burdensome thing to ask people to do, whether for leisure or for employment purposes. It is something approaching £400 per person, per visit and that should not be applied over the months ahead. We have a substantial vaccination programme that is giving people a high degree of protection. We are seeing every hope that we are breaking the link between infection, severe disease and hospitalisation. To the extent that that happens with doubly vaccinated people, we should go with it.

Finally, on international travel, I ask my noble friend why are we not including some countries on the green list? Look at Malta, for example. It now has no cases and the best vaccination record among European Union countries. It is iniquitous that we are not distinguishing those countries that should be on the green list and giving them the benefit of that designation.

Osimertinib Cancer Treatment

Lord Lansley Excerpts

Tuesday 18th May 2021 Lords Chamber

[Lord Bethell (Con)]

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

[Lord Lansley (Con)]

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

[Lord Bethell (Con)]

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

Botulinum Toxin and Cosmetic Fillers (Children) Bill

Lord Lansley Excerpts

2nd reading
Friday 16th April 2021 Lords Chamber

[Lord Lansley (Con)]

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

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

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

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

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

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

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