Covid-19

Lord Lansley Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Lansley (Con)]

My Lords, the figures today for the number of cases and deaths are deeply worrying. It is a 20% increase in the week in the number of cases and, of course, the number of cases that we have seen in recent weeks is now tragically leading to a much-increased number of deaths, so there are no grounds for complacency. However, as I think we all understand, this is a marathon, not a sprint, and there is an inevitable tension in the question of how far businesses can be shut down on a permanent basis—and we want to avoid that.

I put it to the Minister that to support businesses that are Covid-secure and keeping open, we need compensating measures to try to limit the transmission in social circumstances. Would the Government consider extending the advice across England that, when indoors, people should mix only in their own household and social bubble, and that the rule of six, while continuing to apply, is not sufficient indoors? We need to limit the mixing of households indoors.

[Lord Bethell (Con)]

My Lords, my noble friend’s observation is entirely right. In Manchester alone there have been more coronavirus infections already in October than in July, August and September combined. The average daily hospital admissions in Greater Manchester are now higher than they were on 26 March, and there are now more Covid-19 patients in Greater Manchester hospitals than in the whole of the south-west and the south-east combined. These are illustrative of one region but it is a story that has already played out in others, and we naturally fear that it will play out in others in the future.

My noble friend’s advice on the mixing of households is very perceptive. One thing with that we cannot do anything about is the kind of infection that the noble Baroness, Lady Thornton, described among her friends, where it spreads within a household. That is something that no household can reasonably fight against. However, stopping the spread of disease between different households is something that we can lean into. It requires an enormous amount of social distancing and a return to the kind of lockdown measures that we had at the beginning of this year. That is something that we are extremely anxious to avoid because it has enormous social impact, it is disruptive to our way of life, and it has an economic impact because it has implications on social distancing and on some businesses. Still, my noble friend is entirely right that that is exactly the kind of area that we will need to look at if we are to contain the spread of the virus.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

Therefore, I strongly urge Her Majesty’s Government to consider these amendments seriously. A three-year timeframe seems a perfectly reasonable one in which to move towards consolidated legislation. In addition to all the benefits that I have already laid out, there is an additional benefit: ultimately, this Parliament should be working towards improving legislation and the context in which it is presented to our fellow citizens. This is an ideal opportunity to address a vital area that touches on the lives of every citizen and to deal effectively with matters that have built up over a long period and do not necessarily sit well together, through the opportunities presented to us by coming out of the European Union and, therefore, the terms of the European Communities Act and all that has been enacted and codified as a result.

[Lord Lansley (Con)]

My Lords, I am grateful for the opportunity to speak on this group of amendments. May I, however, begin by seeking clarity about the grouping of the amendments? Amendment 116 is also to be found in the eighth group and is more appropriately to be found there. It is my amendment; I know where it should sit properly. It does not belong in this group and is not relevant to this subject. However, I think the Marshalled List should list Amendment 116 in the name of the noble Baroness, Lady Thornton, who raises what is effectively the sunset issue in that amendment. The noble Lord, Lord Patel, who I always think of as a friend, referred to his Amendment 141, which is not listed in the grouping but should be here; Amendment 142 is listed in group five and also should be here. With those two changes, I think that we are talking about the right group.

I could stop now, but I will be quick and refer to just two things. First, as a former Leader of the House of Commons, responsible for the legislative programme, I view with deep unhappiness the idea of attaching three-year sunset clauses to all the legislation we put through the House. If we start down that path, we will never introduce new legislation but will constantly be revisiting old legislation and trying to renew it. There is an argument about the nature of this Bill but it is an argument I am proposing to have when we debate the next group of amendments. It is skeletal, and there are things we can do to make the power not only clearer in its purposes but much more accountable if used. So, I am against the sunset clause.

My other point relates to Amendments 50, 67 and 115 in the names of the noble Lords, Lord Patel and Lord Kakkar. I have great sympathy with these. I think it was the noble Lord, Lord Patel, who referred to the consolidation of human medicines regulations in 2011 or 2012. There is a great deal to be said for the regular consolidation of legislation to make it more accessible. I do not regard consolidation as a purely technical legal exercise; it should always be used as an opportunity to simplify and clarify. It is not, in my view, sufficient to say, as I think Ministers might well reasonably do, “We consolidated human medicines legislation and we will continue to keep the regulations in as clear a form as we can”. From time to time, there is a purpose in coming back to primary legislation and looking for clarity and consolidation. That is often what we use the Law Commission to do, because it has particular expertise in this area. It may be inappropriate to do so at this stage for human medicines because of the necessity of making the regulations and of transposing former EU regulations and directives into UK law. It is perfectly reasonable for that to happen over some period of time, but I hope that Ministers will consider that.

Where medical devices are concerned, there may be a better argument. The noble Lord, Lord Patel, was quite right—navigating medical devices legislation is, if anything, harder than navigating human or veterinary medicines legislation. There is a lot to be said for finding the consolidation instrument for medical devices regulation, once we know what it looks like and we have brought it into force. My friends the noble Lords, Lord Patel and Kakkar, are on to something; I just do not think that new primary legislation within three years is the route. However, for Ministers to recognise the value of consolidating instruments including, from time to time, consolidating primary legislation is certainly desirable.

[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.

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[Lord Bethell (Con)]

My Lords, Amendments 2, 7, 51, 54, 56, 68 and 72 are a package intended to respond to the comments made at Second Reading and the consideration of the Bill by your Lordships’ Delegated Powers and Regulatory Reform Committee and the Constitution Committee.

I have said at both the Dispatch Box on Second Reading and in meetings with a number of noble Lords that I am listening and ready to make improvements to the Bill where they are necessary. I am ready to provide reassurance about how the powers are intended to be exercised. Amendments 2 and 68 would require that regulations may be made only if the appropriate authority is satisfied that the regulations promote the health and safety of the public. A number of noble Lords spoke in favour of clarity regarding how the considerations applied in making regulations and whether the first consideration—that of safety—had primacy. This was a point made by the noble Baronesses, Lady Barker, Lady Andrews and Lady Walmsley, and by the noble and learned Lord, Lord Woolf. Their remarks on how the Government could improve the nature of the framework Bill were ones that I paid particularly close attention to. In making legislation, there is a delicate balance between making it absolutely clear that regulatory change will not be made that is contrary to promoting the health of the public and not binding the Government so completely that necessary regulatory change that is not explicitly for the purpose of promoting the health of the public is not possible. This amendment seeks to provide that comfort: that the Government’s making of regulations must satisfy that obligation.

Amendment 51, on veterinary medicines, is drafted differently to reflect the specific circumstances of how veterinary medicines are made. For example, a medicine that might be suited to the health of an animal might unhelpfully contribute to antimicrobial resistance in humans. An overarching requirement to be satisfied that regulatory change promotes the safety of animals, without reflecting that we must also consider the safety of animals as food products in the food chain, would have inadvertent consequences. Amendments 7, 54, 56 and 72 are consequential to these.

I have considered carefully the alternative constructions tabled by your Lordships. I wanted to demonstrate our absolute commitment to patients’ health and safety that is at the heart of this Bill. My noble friend Lady Cumberlege’s report has highlighted the importance of this.

My amendments do not fetter our ability to make good regulations that will enable the development of new medicines and devices in the UK and ensure the availability of those medicines. But, in doing so, the requirement to be satisfied will protect against the inadvertent impact on the health of the public. This will answer the requirement to make it clear how the Bill is a framework Bill, as opposed to a skeleton Bill, providing that test against which regulations can be measured.

I hope that these amendments provide assurance not only to those in this House who sit on the Delegated Powers and Regulatory Reform Committee and the Constitution Committee but to others who are keen to see the Government reflect my noble friend’s recommendation that patient safety be put first. I beg to move.

[Lord Lansley (Con)]

My Lords, I am glad to have this opportunity to speak to my Amendment 5 and to Amendments 70 and 76 in this group. I am particularly grateful to the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Jolly, for putting their names to Amendment 5. As the Minister rightly said, he set out to respond in government Amendment 2 to the remarks of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. We discussed this a lot at Second Reading. The essence of the argument that I among other noble Lords made was that the Bill was a skeleton, the skeleton approach was criticised by the Delegated Powers Committee and we needed to move it from a skeleton to a framework by making it clear that the power to make regulations is for a purpose. The noble and learned Lord, Lord Woolf, and I set out to do that in our amendment: to express a purpose rather than have a power that essentially had no test other than whether the Secretary of State had had regard to certain factors—there was no objective test that could be examined, because it is very easy for Ministers to say that they have had regard to something.

Why did we have the objective of safeguarding public health? The relevant EU regulation, which is the EU human medicines directive 2001/83/EC, as amended, says at what is essentially its first article:

“The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.”


Therefore, rather than invent our own purpose, we thought that the starting point for the legislation should be to reflect the same objective as incorporated into the regulation-making power up to now. The Minister may well say, “But the EU regulation is not only based on the public health treaty objective but on the internal market objective”. However, Article 3 of the EU regulation, which follows that, is quite clear:

“However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.”


Therefore, the other legal bases, if anything, tend to act alongside and be balanced with the original treaty objective, which is to safeguard public health. It seems that there is therefore nothing inherently wrong in our own power to set out the objective, which is to safeguard public health, and then to set alongside it in the subsequent subsection the other considerations to which the Secretary of State must have regard. We will go on to discuss those, but they include the safety of human medicines, the attractiveness of the UK as a place to conduct clinical trials, and so on.

This is the test: why are we moving from the current legislative basis to a new one? What is inherently better in saying that Ministers must be satisfied that they will promote the health and safety of the people and in what sense is that different from safeguarding public health? Noble Lords might well say, “You have won—you put your amendment down and the Minister has put government Amendment 2 down, and they say more or less the same thing”. We submit that they do not quite say the same thing, since the government amendment’s construction is that the Secretary of State “must be satisfied that”. Our construction is that it

“must have the objective of”.

I am not qualified to say any more about this matter; I will leave that to my noble friend in this regard, the noble and learned Lord, Lord Woolf. An objective test should be expressed in the legislation in objective terms, not in subjective terms of whether the Secretary of State is satisfied.

Amendment 70 does a similar thing in relation to medical devices. Amendment 76 begs the question: is the safety of a medical device to be assessed in the absence of knowing its therapeutic use? It may well be that the answer is that assessing the safety of a medical device must necessarily consist not only of the approval process but of understanding its use in therapeutic settings. If the answer is that that will necessarily be the case and if Clause 12 of the Bill means that anyway, I am perfectly happy to accept that. However, I am looking for an assurance from the Minister that that is what Clause 7 means: safety of a medical device is not simply through its approval processes but through understanding in the approval process how it will be used in therapeutic practice.

In conclusion, from what I have said we do not think that government Amendment 2 is better than our Amendment 5. However, government Amendment 2 is clearly better than what is in the Bill at the moment, because it gives us a purpose for which the regulation-making power is to be used. I make a plea to noble Lords. At this stage, in Committee, I would far rather change the Bill by accepting the government amendment and its sequelae, as we would say, and therefore send the Bill to Report in at least a form that one Front Bench agrees with than not change the Bill and have to have this same debate all over again on Report. We might have the same debate, but it would clarify for the benefit of noble Lords on Report if at least the Bill has moved from where it has been to show how the Government are seeking to meet the objectives set out at Second Reading and by the Delegated Powers Committee so that we can look at it again properly on Report. I of course reserve my position and that of my noble friends whose names are attached to this amendment, as we might well want to come back to the issue on Report and say that our formulation with an objective test is better than the subjective test that government Amendment 2 implies.

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[Lord Sharkey (LD) [V]]

Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.

Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.

In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.

The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.

When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.

Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.

Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.

Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities. CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.

[Lord Lansley (Con)]

My Lords, I am glad to follow the noble Lord, Lord Sharkey, because he made some important points and it saves me having to make the same points less well.

The purpose of Amendment 35—in my name and that of the noble Lord, Lord Kakkar—is precisely to explore the issues that the noble Lords, Lord Sharkey and Lord Hunt, raised. I am concerned that, as it stands, the provision may mean that we do not align sufficiently with the clinical trials regulations as they exist in the European Union. That is a great pity because we have gone to an enormous amount of trouble to try to improve the clinical trials regulations in the European Union; indeed, we arrived at a point where they were significantly better than the previous regulations. To depart from them now seems a retrograde step.

We cannot be sure that we will stay aligned with those regulations for ever but having the objective of seeking to have our clinical trials regulations correspond to those in the European Union opens the option for us to be in the clinical trials information system. If we start to diverge from the EU clinical trials regulations, I am not sure how we can then be incorporated into that system. That automatically means significant difficulties in trying to manage multi-state clinical trials in Europe with a view to an authorisation process through the European Medicines Agency because the information system will, I think, be an essential pre-condition for marketing authorisation applications to the EMA. The purpose of Amendment 35 is precisely to explore this issue. What do the Government mean by “or similar”? Do they intend to diverge or not? If they intend not to diverge and to retain corresponding regulations, that is excellent. If they intend to do otherwise, that is not so good.

I do not intend to enter into the argument about aligning with the European Medicines Agency for the simple reason that we have been here before. We legislated in the Trade Bill in the last Session to align ourselves with the agency and to participate in its processes. Unfortunately, I do not think that that is going to be available to us, so legislating for it in the United Kingdom will be, I am afraid, without effect. I will focus on the Clinical Trials Information System because there is likely to be a willingness and interest on the part of our European partners to retain the United Kingdom in this process. I hope that is so, that we might be able to attain that, and that that will be the Government’s objective.

Coronavirus Act 2020: Temporary Provisions

Lord Lansley Excerpts

Monday 28th September 2020 Lords Chamber

[Lord Lansley (Con)]

My Lords, it is a pleasure to follow the noble and learned Lord, Lord Judge, although in this instance I have to disagree with him that we must face up to a conflict of interest between national wealth and national health in any simple sense. The relationship between the measures that we take in response to this crisis and the impact on our economy is very complex, and it may well be that we can find our way to reconcile the two. I point out that back in August Ministers were encouraging people to go back to work. In my experience, many people who had been so encouraged chose not to do so but stayed and worked at home. As it happens, it took only three weeks for Ministers then to agree with them. What that demonstrates is that we are beginning collectively, not just as a Government but as a people, to understand the nature of this virus and how we need to respond to it.

I am looking forward to all three maiden speeches, not least that of my noble and learned friend Lord Clarke of Nottingham, whose presence here brings another joy to me, which is that it has restored to eight the number of my former bosses in this House.

I cannot agree with my noble friend Lord Robathan in his Motion of Regret. I think we need these powers and the speed of response necessary is such that it would be inappropriate for us to require parliamentary approval before the exercise of such powers. However, I share with the noble and learned Lord, Lord Judge, the view that we ought to be debating more frequently. That is something which, if in no other way, the usual channels might be able to engineer.

One of the main reasons I support the Act’s provisions is not only the ability to bring people who have recently retired into the NHS and return them to practice; I also hope that, in the time available, we will think that this is not simply a temporary provision but may need to be something that we have in place for some considerable time. I have said before and will say again that we may need something similar to the Reserve Forces for the benefit of the NHS, if we are to recover in the next few years the position that we have lost over the many treatments that have not been able to be undertaken these last six months. We are going to need a lot of help to make that happen.

I want to say three things about further restrictions. First, it is time for those who have been shielded—the vulnerable groups—to have renewed and updated guidance. I was somebody the NHS regarded as shielding because of my past cancer treatment, but I have had no communication about the resources that might be available to those who have shielded since early July, even if I can work it out for myself.

Secondly, my noble friend on the Front Bench knows that I did not think the rule of six was scientific, and he more or less confirmed that. It is rather absurd when you have Ministers debating whether it should be a rule of six or a rule of eight; I wonder why they did not decide on a rule of seven. The point is that it is not rational, as such, but simple. What is rational, and a necessary adjunct to it, is to avoid the mixing of households in circumstances where the most vulnerable people are present in those households.

My third and final point is one I made to my noble friend weeks ago. Universities should be in a position to test students before they return home from university. That will mean a lot of additional testing being available in December.

Coronavirus

Lord Lansley Excerpts

Wednesday 16th September 2020 Lords Chamber

[Lord Bethell (Con)]

That list is already published. I would be glad to send the noble Lord a link.

[Lord Lansley (Con) [V]]

My Lords, one of the big risks this autumn is from students going to university and, perhaps more particularly, returning from university in the run-up to Christmas. How has the guidance been prepared with universities to try to mitigate that risk? I know that Cambridge University is looking even at the possibility of testing all its students on a weekly basis.

[Lord Bethell (Con)]

My Lords, I thank colleagues at the DfE for their hard work in providing guidelines to universities and to vice-chancellors for implementing thoughtful arrangements for the return of students. It is very much the ambition of this Government that universities are brought back to life and that education and the impact of their work continues. None the less, it is not just the campus environment that concerns us—it is also the off-campus activities of students. For that, we look to universities to provide pastoral guidance to students to ensure that they are socially distanced and behave responsibly. We are keeping an eye on those behaviours and, should outbreaks or prevalence rise among students, we will have to review those guidelines.

Covid-19 Update

Lord Lansley Excerpts

Thursday 10th September 2020 Lords Chamber

[Lord Lansley (Con) [V]]

My Lords, the consistency of messaging over time is immensely important to secure public support and adherence. Over the last six months, we have consistently explained that indoor and outdoor gatherings are significantly different, and that the scientific evidence has clearly shown much greater risk for indoor gatherings. Can my noble friend the Minister explain to the House why the Government appear to have abandoned this important distinction in their current guidance?

[Lord Bethell (Con)]

My noble friend is right to point out this important change. The truth is this: from the feedback we had from the public, and from our own analysis of the facts, we see that our guidance was growing increasingly complicated and was confusing the public. While the science may suggest all sorts of clever differences between one situation and another, and between inside and outside, the guidance is effective only if it is clear, understood and obeyed. At the end of the day, what we have done is to clarify some of the more complex areas of our guidance to make it more effective.

Health Protection (Coronavirus, Restrictions) (England) (No. 3) Regulations 2020

Lord Lansley Excerpts

Thursday 3rd September 2020 Lords Chamber

[Lord Lansley (Con) [V]]

My Lords, I am grateful to my noble friend for his very clear introduction to and explanation of these regulations. I will make two points. I was very pleased to hear my noble friend make it clear that Regulation 3, on the powers of the Secretary of State, has not been used. It would effectively be a failure were that to happen, so it is very good news that the collaborative work to which my noble friend referred is continuing.

As my noble friend will recall and noble Lords may remember, one of the central arguments I have made from the beginning is that the public health infrastructure established from 2013 onwards was intended to rely substantially on the work of local authorities, to which public health functions and capacities were returned. However, that capacity was not supported with the funding required in subsequent spending reviews. The public health infrastructure should have had increasing resources, at least at the pace of increase provided to the NHS as a whole.

My two points to my noble friend are, first, will he undertake that the Government will continue to work with local authorities so that the powers in these regulations continue to be used collaboratively, with local authorities working with central government rather than by way of Secretary of State directions, which should be avoided wherever possible? Secondly, we must rebuild the capacity in local authorities, not simply for the Covid crisis, but for public health infrastructure more generally.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

[Lord Lansley (Con)]

My Lords, I welcome the Bill. As my noble friend rightly said in a very positive opening speech, it is not only a necessary Bill but one which presents us with opportunities. I hope that, during the passage of the Bill, we will look to realise those opportunities, and I want to refer to one or two.

My noble friend talked about the Delegated Powers Committee’s remarks, which made the very compelling point that, in reproducing the regulation-making powers, we are moving from the power to make regulations to meet EU legal requirements to the ability of Ministers to set down their own legal requirements; these are very different things. What we need to do in the latter case is not to move from where we are now, as my noble friend might have suggested, to something that sets out in primary legislation the detail of these regulations—nobody is intending that—but to something that moves us from a skeleton Bill to a framework Bill. What is the difference? The difference, in my mind, is a very straightforward one. The framework Bill is purposive. It sets out why regulations are being made and gives an ability to look at the primary legislation and ask, “Do these secondary instruments fulfil the purposes of the primary legislation?” During the passage of the Bill, we must look very carefully to meet that test.

I want to make three quick points. First, I think we are already among the best places in the world for medicines innovation. We may be 3% of the pharmaceuticals market but we are 10% of medicines innovation. I want to continue that. One thing the industry has told us, including me, over past years is that it wants to see our NHS take up new medicines and make them available to patients—a point that my noble friend reiterated. There is a commitment in our manifesto that says:

“We will extend the successful Cancer Drugs Fund into an Innovative Medicines Fund”.


I think the time has come for that and I hope that the Bill will make provision for that to happen.

Secondly, the MHRA is a world leader—for example, in the assessment of medical devices—but we have a problem, as the noble Lord, Lord Hunt of Kings Heath, said. We will be accepting CE markings through to 2023. I am pretty sure, unless somebody tells me otherwise, that the EU is not going to accept UK conformity assessments any time soon. So we are in an asymmetric relationship, and we have to think very hard about how we can sustain the MHRA. In the course of that, what the noble Baroness, Lady Barker, said is absolutely right: we must not be pulled between American FDA standards and EMA standards. We should be trying to move everybody to international standards, and that is something we will have to look at hard.

As we put more registries in place, I hope that they will include patient-reported outcomes: that is important. For medical devices, I hope that we will show how we are going to take them up in the NHS as well. On the consultation that ended last year on the medtech funding mandate, the time has come to do it. Ministers have not said that it will be brought into place this year or next. I think that the Bill should bring forward the medtech funding mandate, as the medicines mandate is in place. Finally, on clinical trials, the EU has not implemented its clinical trials information system and is not at present expected to do so until the end of 2021. We need to be in it. The legislation says “corresponding or similar to” but I do not know what “or similar to” means. We are either in it or not in it, and I hope we will be in it.

Covid-19: Response

Lord Lansley Excerpts

Monday 27th July 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, I pay tribute to my colleague Helen Whately, the Minister for Social Care. She has worked incredibly hard and tirelessly on this area, which is her ultimate responsibility. There is a social care team which handles those negotiations, and I thank all those in the social care industry who are engaged. The social care industry is highly fragmented so engaging with the entire industry is a massive challenge. That is why we have put in place new structures, new dialogues, new guidelines and new ways of working to ensure that we are match-fit for the winter.

[Lord Lansley (Con) [V]]

My Lords, a number of countries, including Hong Kong and Austria, undertake testing at ports of entry. Under certain circumstances, that can limit the time that people have to spend in quarantine. Will the Government offer such testing at UK ports and airports?

[Lord Bethell [V]]

My Lords, that is not in the current guidelines. The noble Lord is entirely right that it is incredibly time-consuming and not currently practicable. For the reasons I outlined in answer to an earlier question, a test today does not guarantee that someone will not be infectious either tomorrow or the next day. That is why we have not focused on testing at ports, but we remain open to suggestions. We assess a large number of options and, as evidence and trials emerge that may demonstrate the efficacy of different policies, we will of course consider them and remain open-minded.

Independent Medicines and Medical Devices Safety Review

Lord Lansley Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is right that regulation is important, but so is culture. I emphasise the importance placed by the Cumberlege report on a change in attitude in the healthcare service as much as on a change in regulation. I cannot guarantee that the EMA and the MHRA will be aligned on regulation in all matters, but I can guarantee that the MHRA will be given the resources it needs to do the job properly.

[Lord Lansley (Con) [V]]

My Lords, as a former Secretary of State for Health, perhaps I may say that I and all my colleagues who have taken responsibility for the NHS over decades should join in expressing our deep regret at the systemic failures laid bare in the report of the noble Baroness, Lady Cumberlege. Will my noble friend reiterate the point about cultural change? It is not just about implementing the recommendations, important as that is, but about achieving cultural change. I direct that point in particular to patient involvement. By that I mean not just consultation, not just a patient voice, not just decision aids but patient-reported outcomes being a central part of the measurement of the performance of our health service and its accountability.

[Lord Bethell]

I completely endorse the comments of my noble friend. To embellish his point, it has been very interesting to see through Covid how patients have had to track their own symptoms, take advice on 111 for themselves and, in millions of cases, look after themselves at home, possibly with telemedicine to support them. This may an inflection point in the attitude of many people to their health. I certainly welcome a revolution of patient power and putting patients first in our healthcare system.

Covid-19 Update

Lord Lansley Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

The noble Lord is entirely right. I have four children, all of whom have returned to school this week, and they are all attending smaller classes for smaller amounts of time on different days of the week. As a parenting challenge this is considerable, but it has meant that they have returned to both the social and disciplinary aspects of school. I embrace this development and entirely agree with the noble Lord’s prioritising of this important subject.

[Lord Lansley (Con) [V]]

My Lords, will my noble friend the Minister commit the Government to maintaining their financial support for the Covid-19 volunteer testing network? He will know the important work that it is doing.

[Lord Bethell]

My noble friend is right to raise this important subject. I know the volunteer testing network; I value it enormously and am extremely grateful for its support. I am currently looking into its funding, and I would be glad to write to my noble friend to provide a clearer answer on that.