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.

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.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

[Lord Kakkar (CB) [V]]

Is the Minister able to indicate why there might be anxiety about giving priority to safety? Is it because methodology by way of clinical trials evaluation is not sufficiently well developed to make that a statutory principle for the availability of medicinal products or medical devices? Is it that there might be some basis for legal challenge that would make this ill-advised? If not, it appears that putting safety at the forefront is in the interests of patients, our healthcare system, clinicians and the standing of our country as a place to lead in the development of the life sciences.

[Lord Lansley (Con)]

My Lords, I am glad to have the opportunity to contribute to this important debate, to which I have very much appreciated listening. I want to talk about Amendments 10, 12, 74 and 75, in the name of my noble friend Lady Cumberlege, on which I think I very much follow and share the views of the noble Lord, Lord Kakkar.

We are all agreed about what we are trying to achieve at this stage; the issue is how we go about putting it into effect in this Bill. My first point is on patient safety. In the excellent report of my noble friend Lady Cumberlege and her colleagues, what I read is the imperative to minimise harm and to stop avoidable harm. It is clear in the report that stopping avoidable harm is what is being sought and I am assuming that that is what is meant by the proposition that we must make patient safety a prime consideration. In my view, we are all agreed that patient safety is a consideration above those of availability of medicines and the attractiveness of the United Kingdom as a place for life sciences. I do not object to that; I think that that must be true. Indeed, as a number of noble Lords have said, the achievement of a regulatory regime that properly prioritises the safety of patients is absolutely right.

However, when we think about how we translate that into law, we have to look at all the considerations for a medicines regulator. Let me take two angles on that. First, what do my noble friend Lady Cumberlege and her colleagues expect the MHRA to do? In their report, they say that they expect the MHRA to engage with patients and understand better patient-reported outcomes and patient-reported experiences in order better to be able to assess the benefits and risks of the medicines that it regulates—I emphasise “benefits and risks”, not just risks. In that sense, I want the legislation to tell the MHRA that that is indeed what it should be doing.

Secondly, we start with the medicines regulations that we have from the European Union. To some extent, as noble Lords will have gathered from my incorporation of the phrase “safeguard public health” into Amendment 5, which we debated last week, I think that that proposition enables that consideration by the regulator to be incorporated into its operations. It should be there. Otherwise, how can safeguarding public health be demonstrated if one is not properly assessing both the benefits and risks of new medicines?

Indeed, one of the early paragraphs of EU directive 2001/83/EC on medicines for human use says:

“The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other”.


The end of the paragraph says that applications for marketing authorisation for a medicinal product must

“demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.”

For this reason I wanted to incorporate safety and therapeutic efficacy in an early draft of my Amendment 5, since both are essential. It is correct to prioritise safety over availability, attractiveness or other considerations, but to attach to patient safety the proposition that it is an overriding consideration seems wrong. It is not an overriding consideration; it is an essential one, alongside the therapeutic efficacy of the current or new intervention being examined, whether a device or medicine.

That is not reflected in the amendment’s language at this stage, entirely due to where we are in Committee: we should understand that and decide how to capture that thought. It might be that we have done it already by capturing the proposition of safeguarding public health—in my view we have. However, we should make safety not an overriding consideration but a primary consideration for the medicines regulator. That is a difference. Perhaps my noble friend Lady Cumberlege and the Minister might like to think hard about how we might reflect that.

Finally, I think Hippocrates would agree. “Do no harm” is of course not in the Hippocratic oath, but it derives from Of the Epidemics, in which he wrote,

“have two special objects in view with regard to disease, namely, to do good or to do no harm.”

The two must be together. The medicines regulatory system must ensure that we can do good through better outcomes for our medicines and devices, but also do no harm.

[Lord Alton of Liverpool (CB)]

My Lords, I support Amendment 12 and the other amendments in the name of the noble Baroness, Lady Cumberlege. In doing so, I also express my support for the amendments in the name of the noble Baroness, Lady Thornton.

At Second Reading I referred to the Primodos scandal. I remind the Committee of my interest as vice-chair of the All-Party Group on Hormone Pregnancy Tests. I know that the Committee will join me in wishing Yasmin Qureshi, Member of Parliament for Bolton South East, the chair of that group, a full and speedy recovery to good health following her discharge from hospital last week, having contracted Covid-19. Ms Qureshi and I have been working with Marie Lyon and the campaign group seeking justice for Primodos victims since 2011.

I am not surprised that the redoubtable and admirable noble Baroness, Lady Cumberlege, has chosen to make, in the words of Amendment 10,

“the safety of human medicines as the overriding consideration”

the standard or battle flag to raise through these amendments. The paramountcy of patient safety is a battle flag to which anyone who has read her compelling report will flock. I concur with the remarks of my noble friends Lord Kakkar, Lady Masham and Lady Watkins of Tavistock on putting the centrality of patient safety at the heart of the Bill, but I also listened carefully to what the noble Lord, Lord Lansley, just said about the use of the word “overriding” and the need to balance conflicting needs. I do not think that there needs to be any conflict between the United Kingdom being a place that upholds patient safety as an overriding concern and a leader in life sciences. However, it might be that the words need to be considered further between now and Report.

Too often after a public outcry over something such as surgical mesh or Primodos, Governments say that they will set up a committee to carry out a review and then everything will be all right. The committee goes away, evidence is gathered and hearings take place. By the time it reports, public indignation and media interest have often moved on to some other injustice. Recommendations are politely acknowledged, those who compiled the report are dutifully thanked and, after promises are made to consider appropriate action, the report is found covered in dust on a basement shelf in a padlocked room in the department, preferably marked “Confidential”, with a get-out clause to tell anyone who inquires, “We can’t say anything because there are legal proceedings pending, but don’t worry, everything will be all right.”

The noble Baroness, Lady Cumberlege, told us at Second Reading that she had learned that attempts were being made to bury her report and to rely on the passage of time, the constant shuffle of ministerial chairs, the comings and goings of elected representatives and the shifting sands of changing priorities to assist in that task. But the people making those attempts made three serious miscalculations. The first is the noble Baroness, Lady Cumberlege. They are significantly underestimating the noble Baroness—a former Minister in the Department of Health and a highly experienced and effective parliamentarian—if they believe that they can bury her report; she will bury them first. Secondly, they have the misfortune of a Bill before Parliament—this one. It provides a legislative vehicle to give effect to some of her central recommendations. Across both Houses, in all parties and none, she has allies who will not be easily bought off. Thirdly, the House knows that it has a duty to act in response. We have heard so many accounts. I listened again to the moving testimony of the noble Baroness, Lady Burt, about victims of mesh. We have an overriding responsibility to act because of the abject failure to protect the public. As legislators we have an overriding duty to ensure that the law protects the public. Manifestly, the law has failed to do that and the amendments seek to put that right.

As we just heard from the noble Lord, Lord Lansley, and from the noble Baroness, Lady Cumberlege, herself, the noble Baroness’s report takes inspiration for its title from the Hippocratic oath: First Do No Harm. I say in parenthesis that the Hippocratic oath should be restored to a central place in the training and teaching of doctors and all those involved in the medical profession. Having systematically and sensitively investigated, winning plaudits from all those with whom she dealt, she found that “avoidable harm” had been caused to women by the drug Primodos—an oral hormone pregnancy test—but also by the epilepsy drug sodium valproate, and by vaginal mesh.

I first raised Primodos a decade ago, in the House in Questions and in letters to the noble Earl, Lord Howe, who we heard from at the beginning of our proceedings, after a Primodos victim, a man called Karl Murphy, had been to see me at my university office in Liverpool. On Primodos, the report laid bare widespread and systemic failings, repeatedly ignored, again and again, for decades. The review rightly concluded that the system was

“disjointed, siloed, unresponsive, and defensive.”

Despite repeated requests—I have written to the noble Lord, Lord Bethell, and tabled Parliamentary Questions —I regret that the Government have so far declined to say how and what redress will be provided. They have also failed to set out clear guidance on how those who have suffered should receive better care and support and, most notably, have failed to set out a timeline.

The Minister could put that right and tell us that there will be no ritual burial of the report. He could tell say why, as the noble Baroness reminded us, we are lagging behind the Scottish Government, who have already started to implement some of the report’s recommendations, notably the crucial appointment of a patient safety commissioner. Perhaps he could also tell us whether the Government will assist the German Government, who have finally set up a similar review after years of refusing to engage with parliamentarians or with Primodos victims in Germany.

At the beginning of this month the leaders of the SNP, the Liberal Democrats, the DUP, the SDLP, Plaid Cymru and the Green Party all wrote to the Prime Minister, urging him to implement the findings of the noble Baroness’s review. They make the point that many mothers who took Primodos, believing it would help their pregnancy, are “now elderly” and have

“lived a life wracked by guilt.”

Yet this was through no fault on their part. They also point out that, as the noble Baroness reminded us, even today sodium valproate is given to women, who are unaware of its potential consequences, with a 50% chance of a baby in the womb being severely damaged if the drug is taken during pregnancy. In their letter, the political leaders point out that 15 patient groups, along with the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the BMA have all called for the report’s recommendations to be implemented.

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

My Lords, the next speaker was to have been the noble Baroness, Lady Jolly. I am afraid we have not been able to establish a connection with her, so I call the next speaker, the noble Lord, Lord Lansley.

[Lord Lansley (Con)]

I want specifically to refer to Amendment 16 in this group, which is in my name and that of the noble and learned Lord, Lord Woolf. The purpose of that was prompted by looking at subsection (2)(c), and this question of attractiveness, or

“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”

In this particular instance, we concluded that while one might think that the United Kingdom was, or was not, an attractive place to supply human medicines and derive certain conclusions from that, the process of medical innovation is not well captured by a simple reference to clinical trials. The process of medical innovation is a wider set of factors than clinical trials alone. In particular, I think that in our minds, in looking at the United Kingdom, one of the underlying strengths of the United Kingdom as a place in which to develop medicines is because of our strengths in discovery.

For example, I remember as a resident of and former Member of Parliament for South Cambridgeshire that my constituency included the Laboratory of Molecular Biology which, among its other attributes, is the single research institute with the largest number of Nobel prizes in the world. The strength of discovery is an absolutely central aspect of the fact that AstraZeneca, Cancer Research UK and Addenbrooke’s and Papworth hospitals are close by and the biomedical campus at Cambridge is bidding to become Europe’s single strongest location for life sciences. If you delved back over the last 50 years and asked what the distinguishing characteristic of that was, you might well say Cambridge University—and people would well understand that—but you might equally say the Medical Research Council’s Laboratory of Molecular Biology and all that went with it. This is not because the LMB does clinical trials; it is because it does discovery. I think our intention was to say that, if the medicines regulator is having regard to these factors, maybe it should have regard to discovery as well.

I entirely take the point that perhaps, where the medicines regulator is concerned, discovery is something that happens before it really gets involved. However, if it is thinking about the environment for life sciences, I find it very hard for it to think about it in parts, and not as a whole. That is what Amendment 16 is intended to explore.

There is another question conveyed by a number of these amendments, which, as my noble friend the Minister has quite rightly highlighted, is this interesting use of the word “attractiveness”. I may well have regard to the attractiveness of many things, but that does not necessarily mean I do anything about it. That the Minister has brought forward his own amendment to point to

“the likelihood of the relevant part … being seen as an attractive”


place is very interesting and takes us much closer to where we want to be. However, it still begs the question of what the medicines regulations should require the regulator to do about it, having had regard to this thing. There are other amendments which, I think, perfectly properly raise the question of whether the regulator should seek to enhance the attractiveness of the United Kingdom as a relevant place, et cetera. I think it raises a very interesting question. I get the impression that the Minister is trying very hard to move to the right place; I am just raising the question of whether we are quite there yet without something like the word “enhancing”.

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

My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.

--- Later in debate ---

Moved by

[Lord Lansley]

17: Clause 1, page 1, line 12, at end insert—
“( ) the effect of the regulations on the ability of the National Health Service to meet the needs of patients;( ) the result of any consultation under section 41.”Member’s explanatory statement
This amendment adds further aspects to which the appropriate authority must have regard in making regulations under section 1(1) , to include the impact on the NHS and the results of consultation undertaken in accordance with section 41.

[Lord Lansley (Con)]

The amendment is in my name and that of the noble and learned Lord, Lord Woolf. This group includes four amendments, three of which are mine. I am glad to see in it too Amendment 124, in the name of the noble Lord, Lord Hunt, because it goes to similar issues. I hope that he will find some common ground between us.

Amendments 17 and 79 would add to the considerations to which the Secretary of State should have regard when making medicines regulations and medical devices regulations respectively—Amendment 17 referring to the former and Amendment 79 to the latter. They would bring the same factors into play.

The first factor is the effect of the regulations on the ability of the National Health Service to meet the needs of patients. There could be two interpretations of how this might be seen. The first is that the medicines regulations could give rise to the authorisation of medicines that the NHS was not in a position at that point to fund. I do not think that it is about that. If the NHS has difficulty in paying for such medicines, it has a power under the National Health Service Act to vary the funding mandate that would otherwise be applicable under NICE. The NICE funding mandate for medicines is in that Act and not in the regulations for medicines. What I think this is about is the NHS being increasingly keen to secure the benefits of innovation. We have had a decade or more of reports telling the NHS that while there is a great deal of innovation there is poor diffusion of its benefits through its adoption in the National Health Service. This is about the ability of the medicines regulations to help the NHS to meet unmet medical need, to bring forward innovations and to deploy them. One might say, “Well, the medicines regulator just authorises medicines”, but let me give a couple of examples.

The first is the early access to medicines scheme, which is precisely about giving the NHS the opportunity to bring forward innovative new medicines that meet unmet medical need and to do so more quickly and in ways that often require collaboration between the NHS, MHRA and NICE. The second example is the Accelerated Access Collaborative, which also looks at other schemes such as the small business research initiative. Its purpose is to bring products through to authorisation and approval, which is quite often in relation to medical devices.

The amendments would require the Secretary of State when making the regulations to have regard to the potential for innovative medicines and medical devices respectively, so that they might be accelerated through processes of authorisation in order to realise their benefits more quickly and hence help the National Health Service to meet its objectives.

The second factor to which the amendments would require the Secretary of State to have regard is consultation. Clause 41 places a requirement on the Secretary of State to consult when making the regulations. A later amendment, Amendment 131, requires the Secretary of State to make a report on any such consultation—I think that my noble friend the Minister referred to it earlier—but there is nothing that links back the consultation to the making of regulations. The amendments say not only must the Secretary of State conduct consultation but he must have regard to the outcome of it—these are specifically “have regard to” factors; they are not factors that should be placed above any other factors in the hierarchy that we are talking about or conflict with them.

Amendment 85 is a bit different. I freely admit, before my noble friend the Minister explains it to me, that trying gently to insert it into Clause 13 is probably quite difficult in terms of the legal structure, because that is a place where requirements are to be laid on those who bring products forward for marketing and supply, whereas the amendment would place a requirement on those who are effectively buying medical devices—that is, the NHS in particular. However, I want to ask my noble friend to consider that we are trying to stimulate innovation in medical devices and bring them through into practice. We know that there are significant potential benefits to the National Health Service in such innovations, which improve outcomes for patients and can reduce costs—it can be a win-win. However, there is no funding mandate for medical devices which mirrors that for medicines, so that when NICE produces a positive evaluation the NHS after a period of delay has an obligation to bring forward the funding for those devices.

In January 2019, the NHS Long Term Plan said that the NHS wanted to accelerate proven affordable innovations into use in the NHS. In November 2019, a consultation was launched to look specifically at what is known as the medtech funding mandate—that is, to give that funding mandate to medical technology devices, not just medicines. By March this year, the Accelerated Access Collaborative was meeting and agreeing—this was one of its objectives—that, in the financial year beginning in April 2020, three such products would be brought forward. Those three products were placental growth factor-based testing, whose title more or less explains what it is; SecurAcath, which, as the title again implies, makes catheters more secure, reducing infection; and HeartFlow, which piloted at the Royal United Hospitals Bath NHS Trust and is a 3D model mechanism for imaging coronary arteries in ways that reduce intensive testing and enable clinicians to work with a highly developed form of imaging in their practice.

Those three products were to come forward in 2021. The intention, as reported to the board of the Accelerated Access Collaborative, was to do more in future years. As I understand it, NHS England intended to establish this as a medtech funding mandate—perhaps with slightly different characteristics and requirements than that of medicines but, none the less, to give medical device manufacturers the same sense of assurance that, if they bring this forward in the United Kingdom, the NHS, with a positive evaluation, will bring them into practice. However, that has stopped. I have seen nothing since April; it seems to have fallen by the wayside. I seek from my noble friend the Minister an assurance that NHS England wants to do it, that the Accelerated Access Collaborative will help to push it forward and that we will see action on this—if not this day, then this year. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, my Amendment 124 concerns NICE’s current review of its methods and processes as part of the agreement of the voluntary scheme for branded medicines pricing and access—commonly known as the VPAS. I will also speak to Amendment 85 in the name of the noble Lord, Lord Lansley, because he made some important points in his opening remarks.

I have a particular interest in NICE. Under Frank Dobson, I was the first Minister and worked closely with it for the first few years. It was established because of concern that effective new treatments, including medicines and devices, were not getting to NHS patients. This is a continuing problem. At the beginning, we put an additional sum into baseline budgets to cover the estimated cost of technology appraisals.

I have to say that pharmaceutical companies were obviously reluctant to embrace NICE, but so was the NHS. As early as December 2001, I was responsible for a funding direction to the NHS—the original one, referred to by the noble Lord, Lord Lansley—which required NHS bodies to implement their technology appraisals, because research showed that they were not doing so. They had been given the money, although it was not identified but put into baseline budgets, which is an interesting point.

The funding directions have been modified a few times since then and, to an extent, have reduced the impact. But the fact is that the NHS remains a reluctant partner—and you can add that to the unprecedented level of rationing taking place locally. There is a tendency, even when NICE has approved drugs or a technology appraisal, and even when the funding direction applies, for local mechanisms to be used to restrict access by patients. I have already referred to clinical commissioning groups: they are informed by regional medicines optimisation committees. Essentially, these are rationing committees designed to legitimise decisions by CCGs to ration treatments. I come back to this point: why do we tolerate NHS patients missing out on medicines and devices that are available to most patients in most European countries?

We come to the NICE review. I am a great admirer of NICE, which has done a fantastic job and has some brilliant people. It works with some fantastic universities, and we are world leaders in this field. However, I hope that the methods review will lead to tangible change and that we will get a fair and effective assessment of the true value of innovative medicines.

We are clearly at a crossroads: exiting the EU represents a significant threat to the attractiveness of the UK for pharma and devices companies. What factors do companies take into account? Clearly, the strength of our life sciences sector is one of them. Secondly, there is the regulatory system, which we are discussing in Grand Committee. Thirdly, there is the ability to launch medicines and technologies quickly into a market, getting medicines to patients who need them quickly. These are clearly part of the equation for any company, and pharmaceutical companies tend to be global, to all intents and purposes. The risk is that we will start to lose our reputation as a leader at the cutting edge of medical science. My hope is that NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation.

I shall give an example of where NICE’s current rules rule against this. Gene therapy is a prime example of a medical technology that the UK should embrace, but a procedure called discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses the 3.5% rate but can apply a lower 1.5% rate for therapies that offer longer-term health benefits. I understand that it chooses to do that only on exceptionally rare occasions. Post the new 2019 voluntary scheme, negotiated to deliver a triple win for patients, government and industry, we now see NHS England doing bespoke commercial agreements, which of course significantly undervalue innovation.

There is always a tension, but the tension is that the main interest of NHS England is to pare down drug costs. The impact that that has is that, for all the brave words about innovation, it simply does not play out in the field. I was very interested in what the noble Lord, Lord Lansley, had to say. There is a HealthTech Connect portal, but I am told that not a single innovation submitted via that portal was adopted by NHS Supply Chain during the first year of operation, March 2019 to April 2020. Are we to assume that none of the submissions meets the criteria in terms of evidence, efficiency or satisfying unmet needs, or are they simply being thwarted by a process that raises the bar to unrealistic levels?

--- Later in debate ---

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

My Lords, I have received no request to speak after the Minister, so I call the noble Lord, Lord Lansley, to conclude the debate on this group.

[Lord Lansley (Con)]

I am most grateful to all noble Lords who participated in this debate, which I thought was very good, with a lot of points well made, including points by the noble Lord, Lord Blunkett. There were good points throughout, with hardly any that I would take issue with.

Both the noble Lord, Lord Hunt, and my noble friend Lord O’Shaughnessy will have anticipated some of the arguments that we can perhaps develop a little further when we come to Amendment 28. It may enable us to cut to the chase, as it were.

I was prompted, in listening to my noble friend and the noble Lord, to wonder what the collective noun is for former Health Ministers. I had always imagined that the appropriate collective noun for those who leave the job was a “release” of Health Ministers. I was struck, after today’s further discussions, by the thought that maybe we should be called a “frustration” of ex-Health Ministers. In every case, we know that we have become enmeshed in and, generally, absolutely fascinated by and engaged with all the issues that we get involved in in the Department of Health, but we never stay long enough to see them through in the directions that we wanted them to go or the conclusions that we wanted them to reach. Perhaps when we come to Amendment 28, I shall have a chance to talk about value-based pricing, which was something that I started but which did not happen after I left. I am thinking in this particular instance of the December 2011 report on innovation in the NHS. Many of the things that we have been talking about today were there nine years ago and continue to be there today, and we need to keep pushing forward with them.

In that context, what my noble friend the Minister said by way of reply about the consideration that the medicines regulator should give to the availability of medicines will certainly cover the ground. If, for example, the NHS makes it clear that it wants earlier access or what we might think of as breakthrough designation for medicines, that will definitely get into the “availability of medicines” consideration, so I take that point entirely. I am grateful for her explanation about the requirements laid on Ministers where they engage in consultation—that satisfies that factor.

I am particularly grateful that we have a date for the medtech funding mandate. I am glad that we are making progress. I know that that will mean that it is not subject to the vagaries of the Covid-19 crisis, which has delayed so many of the objectives that we were hoping to progress during this year and next. For NHS England, it is important. It will enable it to look after patients more effectively and potentially save costs. I am grateful to my noble friend for that. With that positive response, I beg leave to withdraw the amendment.

Amendment 17 withdrawn.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

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

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

My Lords, I am glad to add my name to Amendments 23 and 29. I am a strong supporter of community pharmacies. Over the past few months, they have done magnificent work. They stayed open, took pressure off the rest of the NHS, and are a central part of community resilience. We cannot take them for granted. They face a number of extra costs at the moment: increased prescription numbers, extra staff costs from the increased demands for advice and medicines, covering for sickness and the rise in locum rates, and one-off costs such as decontaminating pharmacies when someone infected has visited. Before Covid-19, the community pharmacy network was already pretty vulnerable.

I am glad that, at the end of March, the Government agreed to inject £300 million-worth of advance payments into community pharmacy. A further £50 million was paid in May, followed by £20 million in June. That £370 million cash advance was of course very welcome, but it will not relieve the ongoing financial pressures because it is set against future income. Instead of this being treated as a loan to be repaid, there should be a recognition of the extra costs that community pharmacies have had to carry since Covid-19. Will the Minister consider that? I also ask her to consider what further financial support needs to be given to the sector over the next few potentially very difficult months.

That is the background to the debate about hub and spoke. As the noble Lord, Lord Clement-Jones, pointed out in previous debates, we have to go to the impact assessment to find any reference at all to hub and spoke. Clearly, it could offer many advantages. Mobile deliverers will be able to partner with dispensing pharmacies to deliver their prescriptions; he spelled out the key advantages. Equally, there are fears that it could undermine the whole community pharmacy network. My concern is about the impact on smaller pharmacy groups and individual companies and shops.

The Minister in the other place, on Third Reading, said that she intended

“to give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy.”—[Official Report, Commons, 23/6/20; col. 1239]

That is a good statement, but I say to our Minister that Governments often make statements about the importance of small businesses and, when it comes to the actual arrangements, those business often struggle to compete. I hope that this is not being done to try to rationalise the community pharmacy network, because it is a great strength that we have so many pharmacies on our high streets, where people can walk in and get immediate access to health advice and help.

The amendment is very reasonable. It simply asks that the Government consult the sector again on their plans. A previous consultation, started in 2016—two Parliaments ago—has never been concluded. Given the impact on the sector and on patients, surely the Government should undertake a proper consultation, to make sure that any legislation follows that rather than the anticipatory approach referred to by my noble friend Lady Wheeler. I hope that the Government will signal their support for the community pharmacy sector as a whole.

[Lord Lansley (Con)]

I thank the noble Baroness, Lady Wheeler, and the noble Lord, Lord Clement-Jones, for tabling their amendments, which allow us to have a useful debate; we might not otherwise reach into what some implications of the use of these powers might be. I particularly thank them for the way in which the amendments were introduced, which set out clearly and fairly the context and facts with which we need to work.

I recognise that Amendment 23 is a probing amendment. I am sure that the noble Baroness knows that, if she actually wanted to remove the capacity for legislating to introduce hub and spoke models, Clause 2(1)(g) would have to go as well as paragraph (c) to make that effective, but I do not think she wants to do that; I do not either. We all want to express our support for the pharmacy sector. In my view, the Government’s proposals in the Bill will allow that support to be given additional expression; they seem a positive step to have taken.

As someone who was shielded earlier in the year, about the only place I ever visited in April and May was the local pharmacy—not that often, but the fact that it was there and working, and the way in which it worked, was immensely impressive. Over the years, I have had a great deal to do with the pharmacy industry. In some cases, I am not sure that it was altogether happy about that. The noble Lord, Lord Hunt of Kings Heath, may remember that I worked with the National Audit Office in about 2008, when I was shadow Secretary of State, to establish the extent to which the pharmacy sector benefited through the category M reimbursement system by hundreds of millions of pounds more than it was supposed to. Those large-scale additional funds that were going into the sector had to be clawed back, as happened in the early part of the decade that we have just gone through.

That led to considerable turbulence in pharmacy incomes and values. They were overinflated and the incomes were higher between about 2015 and 2018, and the considerable clawback had a negative impact. Most recently, it is telling that the value of pharmacies—and the price increase—has gone down. It is also interesting to read the commentaries that say that pharmacy in Scotland attracts greater value because the flow of resources into it there is regarded as more stable than in England.

That is a great pity, because we have reached a point where there should be more stability and funding for pharmacies, and I want to pick up a point made by the noble Lord, Lord Hunt of Kings Heath. He suggested that the Government consider turning the advance payment into not a loan but a grant. It is a large sum of money, so it is not as easy as that. However, whereas earlier this year the global fund for pharmacies was set at about £2.6 billion and was going to be retained at that level in cash terms over five years, we have to think hard about whether that is reasonable under the circumstances. There is a good case for recognising additional costs met by pharmacies this year, and potentially into next year, and for reimbursing them perhaps through a change to the establishment fee before it disappears, with a considerable sum to recognise that.

We must also recognise that pharmacies will need real-terms increases in their resources—much as other parts of the NHS-related system are seeing real-terms increases in resources—and not to stand still in cash terms. Over the next four years, that might be something like £130 million extra.

All the way through, we have never achieved as much as we should in terms of pharmacies delivering additional services, particularly clinical services. It is partly because clinical commissioning groups have never quite recognised the flexibility they have in budget terms to use pharmacies. The noble Lord, Lord Clement-Jones, referred, quite rightly, to medicines use reviews—which are being phased out—new medicine services, nicotine-replacement services, sexual health services, minor illness services and so on. A wide range of additional services can be provided by pharmacies. If they can do it, frankly, the GPs, as those at the heart of the clinical commissioning groups, will find that it benefits them directly in reduced demand on their surgeries, which is of course one of their principal stresses at the moment. I hope that the Government will think about all that.

In this context, with these powers in the Bill, the Government do not need to know whether a large number of independent pharmacies will take advantage of the hub and spoke model. It is entirely permissive; they can choose to do so or not. The fact that they cannot at the moment is a significant potential constraint on the ability of independent pharmacies to access the benefits of automation in their sector. I am absolutely clear that we ought to give them access to this potential benefit. I do not know how many would take advantage of it or to what extent the large company chains would make their hub and spoke model available to allow independent pharmacies to get the benefits of that automation. It seems to me that they should, because there are many parts of the country that they do not reach and where they are not in competition. It is perfectly reasonable for them to allow them to access to it, particularly in some of those more remote parts of the country where dispensing is more difficult.

Many of the concerns raised about this in the debate seem to come down to the separate question that I can remember debating on legislation 15 or more years ago about whether we retain the role of the responsible pharmacist. This does not change that. The responsible pharmacist will remain as is; I do not see any plan to change that part of the pharmacy regulation. The change to hub and spoke seems potentially desirable.

While Amendment 29 does not need to be in the Bill, it makes a very good point, which is that there should be consultation and an agreed framework with the industry, and we should ensure that the framework is one that is seen to link resources and changes in the regulations, to enable it to compete more effectively. To that extent, I hope the Minister will take on board and support the intentions of Amendment 29.

[Baroness Jolly (LD) [V]]

My Lords, I thank noble Lords for their kind words and messages. I now have a tentative diagnosis and when I get my medication I hope to be functioning at 100% soon.

These amendments are on hub and spoke dispensing, where a hub pharmacy dispenses medicines on a large scale, often by making use of automation, preparing and assembling the medicines for regular spoke pharmacies that supply the medicines to the patient. My noble friend Lord Clement-Jones has given a detailed account of how hub and spoke works.

When the five-year funding contract for pharmacy in England was announced, the Government also pledged to change legislation so that independent pharmacies could operate this hub and spoke dispensing model. My noble friend tabled Amendment 29, which would ensure that the Government consult stakeholders on how hub and spoke is used and agree a framework with the support of the relevant sectors. This will ensure that the expected savings and efficiencies, and new healthcare services via pharmacies, can be delivered.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I am most grateful for the kindness of all your Lordships. Lacking having all those wonderful papers in front of me really showed. It is the first time that I have missed walking into the Chamber with a large stack of papers.

Amendment 91A builds on the concept that we had in the previous debates of an innovative medicines fund, which had been carefully thought through, including how it was to be financed. It struck me then that we have fantastic potential in medical engineering in this country to develop new and innovative medical devices. I should declare an interest because my son is involved in developing devices for use in cardiology, for oblation procedures and so on.

The real issue, as the Minister pointed out in the previous debate, is about developing a piece of equipment which is a custom-made device, for one reason or another. When that happens it can turn out to be, serendipitously, something that solves a problem for clinicians in undertaking a procedure of some sort. However, when that happens, if it is a small clinical team in a district general hospital, it will not be linked into a commercial enterprise and funding its ongoing development is extremely difficult.

In previous debates, I referred to the investment that went on in Ireland—in Galway—to create an innovation hub and ensure that there is investment in innovation. This amendment would allow the Government to explore having a medical devices fund similar to an innovative medicines fund, and would allow that fund to be used to develop a device and test and trial it within the NHS, with it being available to NHS patients and clinicians much more rapidly than the current procedures require. It does not in any way suggest that the usual ethical approval processes and all the checks that go with it should be curtailed; it would simply be a way of making sure that, where a custom-made device that solves a major problem could be rolled out widely, it can be used for the benefit of UK plc, if you like to call it that. It would make sure that we have that investment, and that the clinicians do not have to give it away for the whole thing to be developed commercially elsewhere and then sold back to the NHS at huge cost. I again express my gratitude to the Committee and I beg to move.

[Lord Lansley (Con)]

My Lords, I am grateful to the noble Baroness, Lady Finlay of Llandaff, for tabling and moving this amendment for a number of reasons, the first of which is that it allows me to express my appreciation to the noble Lord, Lord Patel, for moving Amendment 28, in his name and mine, last week on the innovative medicines fund and to say how much I welcomed the debate on it, which I have read, and the Minister’s response.

I am also grateful to my noble friend the Minister for his subsequent letter about the innovative medicines fund. There is of course a direct parallel in that Amendment 91A would look for the innovative medical devices fund to be funded in a similar way. I just gently dispute one proposition with my noble friend: he said that the use of the rebate on the voluntary pharmaceuticals access scheme would not be appropriate for the innovative medicines fund because the amounts could vary sharply from one year to the next. This would be a problem only if there were a direct hypothecation for the amount, and that is not necessarily implied. The amount of the innovative medicines fund could be established as a fixed amount that would then be funded by the rebate or, in the absence of a rebate, by the Exchequer or though NHS England’s total budget. It would not necessarily rise or fall with the rebate. The same would of course be true for the innovative medical devices fund.

There is a central proposition that supports both an innovative medicines fund and a medical devices fund; it is not that we in the United Kingdom lack innovation, it is that we lack the adoption of innovation in the National Health Service. That was the starting point for the Cancer Drugs Fund, on which this proposition is based. The Cancer Drugs Fund arose, in policy terms, from an analysis by Professor Mike Richards, who was then the cancer tsar under the last Labour Government, that there was a significant lack of availability of the latest cancer medicines for cancer patients, compared with other, principally European, countries. At the time that was not true for some other disease groups and medicine available for other diseases. It was a problem particular to cancer.

Why does this happen? It is not simply about funding; there is a systematic issue here, separate from the amount of resource, which is that the United Kingdom has a single-payer system. A single-payer system necessarily makes decisions about the availability of medicines on the basis of the whole system moving together. I suspect the same is true for devices. Pretty much all of the other European systems are not single-payer systems, but insurance-based systems, where, essentially, clinicians advise, patients choose and insurers pay. That brings innovations into use much more rapidly. There is potentially a problem with the diffusion of innovation in the NHS, which we have seen before and we have to continually guard against.

I put this question to the Minister for when he responds to this debate: are patients in the NHS getting access to new, effective medical devices as quickly as patients in other countries? I do not know the answer to that. I am absolutely clear that there was a good case for the Cancer Drugs Fund. I am clear that there is a continuing need for the innovative medicines fund, because there is sometimes a continuing gap between the availability of the most effective new medicines here and in other countries. I do not know about devices.

To this extent I offer an apology to the noble Baroness, Lady Finlay of Llandaff, because a medical devices fund might be premature, in the sense that we do not know to what extent there is a gap in the adoption or diffusion of innovation where medical devices are concerned. We identified real potential in the previous debate on Amendment 85 about the funding mandate for medical devices. If that is rolled out, as I think is the intention, and extended to a faster and larger pipeline of medical devices going through the NICE evaluation process, then we may find there is not too much of a problem. There may well be a case for understanding to what extent medical devices are being adopted by the NHS, relative to other health economies. I hope the Minister will agree that is worth looking at.

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

My Lords, it is a great pleasure to speak to the amendment tabled by the noble Baroness, Lady Finlay, and to follow the noble Lord, Lord Lansley. Because this is about devices, I should remind the Committee that I am president of GS1 UK, the barcoding association, and chair of the advisory board of TenX Health.

I thought the noble Lord, Lord Lansley, posed a very interesting question about whether NHS patients have less access to innovative new medical devices than those in other European countries. My gut feeling is that they do, but I agree that the more information we can obtain the better so that we can debate whether the fund that the noble Baroness, Lady Finlay, proposed is a good way forward. On the face of it, I think it is. We have a situation in this country that is rather the case for medicines, where we have a very important health technology and medical devices sector. The ABHI informed me recently that the health technology industry employs over 127,000 people, generating a turnover of £24 billion. That is very substantial.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

In conclusion, I also support Amendment 101 in the name of the noble Baronesses, Lady Finlay and Lady Bennett. These amendments will give patients a voice and ensure that they consent to the information used about their care.

[Lord Lansley (Con)]

My Lords, I am very glad to have the opportunity to follow my noble friend Lord Ribeiro and to speak to my Amendment 104. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for bringing forward her amendments as well. They highlight some useful points and—particularly Amendment 101—focus on the necessity for patients to be provided with information and for patient experience to have its place in the information systems to be created under Clause 16. My noble friend Lord Ribeiro very helpfully illustrated that the benefit of the joint registry and similar information systems is not simply to promote safety but also to improve outcomes. We can certainly look forward to seeing both happening in the future.

My Amendment 104, to which the noble Baroness, Lady Finlay, and the noble and learned Lord, Lord Woolf have added their names, requires that the regulations made under Clause 16 include specific reference to the Caldicott principles. Noble Lords will recall the establishment of those principles back in 1997. They say that an organisation should:

“Justify the purpose for using confidential information”


and that the NHS should not

“use confidential data unless absolutely necessary”.

The NHS should:

“Use the minimum necessary personal confidential data”,


while

“Access to personal confidential data should be on a strict need-to-know basis … Everyone with access to personal confidential data should be aware of their responsibilities”


and, when using data, NHS personnel should “comply with the law”. In 2003, a seventh principle was added:

“The duty to share information can be as important as the duty to protect patient confidentiality.”


In a sense, a balancing principle was added as number seven. The amendment refers to those two reports, which have given rise to those principles. I am interested generally in the proposition of how certain we are that the Caldicott principles are being applied in every case. I think in these regulations it would be to the benefit if they were restated, given the importance of this as an information system.

I will ask three questions of my noble friend. First, can he assure us that the regulations themselves will make specific reference to the Caldicott principles? This would mean that we did not need to put it in the Bill. Secondly, in establishing these information systems, can we be assured that Caldicott Guardians will be appointed specifically in relation to each of the information systems that are to be established? Thirdly, can my noble friend tell us any more about the National Data Guardian’s consultation, which opened in June and closed in September, on an eighth principle:

“Inform the expectations of patients and service users about how their confidential information is to be used”?


This ties very directly into Amendment 101 in the name of the noble Baroness, Lady Finlay of Llandaff.

If it is endorsed by the National Data Guardian, that principle would give rise to an additional principle being reflected in the regulations. I freely confess that this is a good reason not to put my amendment in the Bill, because the nature of the Caldicott principles might well change in the immediate future, so it is not very helpful to entrench it in its current form. If we get the assurance that we are looking for from my noble friend, I hope the regulations, when they are made, will be able fully to reflect the Caldicott principles.

[Baroness Burt of Solihull (LD) [V]]

This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.

The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are

“few and far between and all too often prompted by catastrophe”

in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.

This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,

“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”

This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.

Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.

I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.

Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

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

The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.

[Lord Lansley (Con)]

My Lords, I am in the position that my noble friend Lord O’Shaughnessy was in earlier, as much of what needs to be said has been said, but I want to add a few remarks on the two amendments.

I echo what my noble friend Lord O’Shaughnessy said. In the light of the First Do No Harm report, we have to be careful to address ourselves to the issues before us and put in place schemes of redress on the three causes. I am not an expert on those, but when I was Secretary of State for Health I was only too aware, when dealing with the Thalidomide Trust or infected blood payments, for example, that when we reviewed and made payments that were more generous, we were working in what was, in effect, an administrative structure that did not necessarily have coherence or consistency. We were making what we thought were the right decisions at the time, but those who had been harmed all suffered, from their point of view, from two problems. The first was the relative lack of generosity of the payments, which were made to reflect specific needs but were not representative of the overall harm that had been done. Secondly, there was no admission of liability, which is always an issue. Liability matters. Those who are harmed want to see liability determined and accepted.

I am sympathetic to the view that not only should redress schemes be considered for the three causes in the report, but the Government should take the opportunity to think about what a redress scheme might look like more generally. My noble friend Lady Cumberlege and her colleagues looked carefully at a number or international examples. They might well have thought, with some justification, that the French scheme—I will not attempt its title in French, but it is a national office for indemnity in relation to medical accidents—is an interesting basis on which to examine the issue. We might include not only the redress schemes from previous years but the present schemes that need to be established. This is something that Ministers might want to say in relation to the continuing review into infected blood accidents.

Again, like my noble friend Lord O’Shaughnessy, I do not want to confuse what are related but distinct issues. The schemes relate to what are, in effect, systemic failures. Recommendation 3 of my noble friend Lady Cumberlege’s report appropriately says that the schemes are to provide redress in relation to avoidable harm resulting from systemic failures. There is a question, which is not entirely resolved in the report, about which test should be applied. The Government should look carefully at where liability genuinely lies. Where there is harm as a result of systemic failings, the Government have a responsibility. That is fairly straight- forward. However, that is not the same as assuming that such a scheme should encompass all the many other cases that give rise to most of the clinical negligence claims against the NHS, which result not from systemic failings but from the failings of medical practice in particular circumstances. Those are different and separate. This debate is not the right place to go on about that at length.

I was interested to hear the noble Lord, Lord Hunt of Kings Heath, talk about the NHS Redress Act 2006. The noble Baroness, Lady Thornton, will recall that in 2009 she was not able to bring that Act into force. I was the shadow Secretary of State during the passage of that Act and Secretary of State after 2010. One reason for not bringing it into force, to which my noble friend referred, was the Government’s intention to undertake tort law reform in general and this was a tort-based liability scheme.

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

My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—

[Lord Lansley (Con)]

I sent an email.

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

With apologies to the noble Lord, Lord Lansley, who does wish to speak after the Minister, I now ask him to do so.

[Lord Lansley (Con)]

I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.

[Lord Bethell (Con)]

My Lords, I will seek to provide an answer to my noble friend. Should it not be quite the right answer I will endeavour to write to him. It is my understanding that no substantive provision of an Act should be brought into operation earlier than two months after Royal Assent. However, some sections of the Act can be brought into force on Royal Assent, typically those setting out how the Act is to be cited and what the procedure is for making regulations or commencing them. It is under those arrangements that the sequencing which he describes can be undertaken.

Medicines and Medical Devices Bill

Lord Lansley Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Lansley (Con) [V]]

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

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

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

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

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

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

The noble Baroness feels that the words

“so far as reasonably practicable”

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

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

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

[Lord Lansley (Con) [V]]

My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.

On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.

The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.

I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.

What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.

So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.

We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.

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

My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.

Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.

The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.

The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises

“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”

That surely must be right.

At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause

“will not change the very good reasons why delegated powers are necessary.”—[Official Report, 19/10/12; col. GC 327.]

I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.

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[Lord Lansley (Con) [V]]

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

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

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

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

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

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

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

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

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

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

obviously not yet set up—

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

and

“to allow for greater transparency and scrutiny.”

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

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

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

Medicines and Medical Devices Bill

Lord Lansley Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Lord Freyberg (CB)]

My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.

The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.

Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.

I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.

The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.

[Lord Lansley (Con) [V]]

My Lords, I am very glad to follow the noble Lord, Lord Freyberg, who has made some very cogent points, both in that speech and when we discussed these clauses in Grand Committee.

I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.

My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:

“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.


Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.

In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.

My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.

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

My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.

At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.

I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?

I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?

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The amendments in the name of my noble friend Lady Wheeler seek to create greater certainty by substituting “must” for “may”. Surely that is right, and I certainly support her on that.

[Lord Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a very welcome move on the Government’s part. The analogy with the Commission on Human Medicines is helpful. As regards translating the Devices Expert Advisory Committee into a statutory role, in effect, in the process, as the noble Lord, Lord Hunt, suggested, there is considerable scope to think about how the Government’s new and expanded roles in the regulation of medical devices can be supported by the advisory committee.

I have a number of points. The first reflects the point made by the noble Lord, Lord Hunt, which is that the MHRA has an enviable reputation as a regulatory authority for the approval of medical devices. If I recall correctly, among the European regulatory bodies something like 40% of the most important or significant medical devices were authorised by the MHRA. Other regulatory authorities in other countries will seek to supplant that. However, our reputation should enable us to establish an international position, and I hope that the advisory committee will not be confined to expertise from within the United Kingdom. There is a lot to be said for positioning the MHRA as a body providing internationally recognised authorisations for medical devices, and its scientific evaluation in that respect should be something that others look to. I therefore hope that that will assist if we have some international participation in the advisory committee structure.

Secondly, I recall, not least in the context of the vexed experience of the PIP breast implant issues back in 2010-11, that the role of notified bodies is very important. Hitherto they have, in essence, been regulated by the European Commission, not by the UK Government, but they fall to be UK-regulated in future. There are not many of them, but there is considerable benefit in there being an advisory committee sub-committee which is focused on the work of the notified bodies. That was the weak link that probably led to the PIP breast implant problems. The regulation is all very well but we have to have bodies that we are confident are able to deliver on these things. The few notified bodies we have in this country are highly respected but we want to make sure that that is maintained even as further notified bodies are authorised.

Thirdly, I recognise that the Devices Expert Advisory Committee has leading clinicians from Scotland and Wales in its membership. However, this must be a UK advisory function, as the MHRA is. I wonder whether it would be appropriate for there to be in addition a Northern Ireland representative on the committee and for there to be perhaps some specific mechanisms to ensure that Scotland, Wales and Northern Ireland are represented in the regulations that establish the advisory committee.

I have one further point, which is that I hope that the various categories of medical devices are very carefully examined and the relevant expertise is available in relation to those. So, for example, on digital devices it is important that we have not only the clinical expertise to deal with the safety of medical devices we have at the moment but the technical expertise in the advisory committee to understand how digital devices will work in the future. That must also be the case in the special interests section related to in vitro diagnostic devices. I hope that that also will have its own special advisory committee function.

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

My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can be optional and makes the regulations weaker, and people might miss important aspects of care. There is no doubt that clear, correct information is the way to better patient safety. In many ways, communication within the National Health Service should be improved.

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

My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.

I am very happy to support Amendment 66 in the name of the noble Lord, Lord Hunt of King’s Heath. The availability of medicines and medical devices is top of my priority list. In fact, antibiotics have saved my life on several occasions. It is important that NICE adheres to health equality: everyone who needs medicines or medical devices should be treated equally and there should be no delay. Unfortunately, with this devious coronavirus, this has not happened, but we hope for better days.

Having experienced a member of my family dying, I know that sometimes it seems worth trying anything that might help and that is in the research process. There are many really rare diseases which need orphan drugs; they can be a lifeline to the individual. I hope that NICE will consider them without delay and realise their importance and value to these small patient groups. It is so frustrating when patients in Scotland and other European countries can get medicines and medical devices, when those in England cannot; patients here have to wait—unless the public come to their rescue by crowd funding.

Many users of devices also need instruction on their use, and staff and patients need training. Personal medicine is so important and patient safety is absolutely paramount.

[Lord Lansley (Con) [V]]

My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.

I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.

In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.

What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.

What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.

Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.

Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.

There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.

We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.

[Baroness Jolly (LD) [V]]

My Lords, these amendments relate to NHS access to medical devices, and Amendment 46 from the noble Baroness, Lady Finlay, would ensure early access for NHS patients to medical devices and allow monitoring of safety and efficacy in real-time use. This amendment is pre-empted rather by the Government’s amendment, which removes the concept of attractiveness.

Amendment 66 from the noble Lord, Lord Hunt of Kings Heath, would require NICE to ensure that its recommendations support the NHS in the ways outlined in subsection (1) of the proposed new clause. This includes ensuring access to new medicines and medical devices for patients with rare diseases. Those of us who have been involved in rare diseases will be all too well aware of the problems of access to appropriate treatments for so few patients.

The interesting thing about this debate is that two of the House’s big health thinkers have been speaking, and both the noble Lord, Lord Hunt of Kings Heath, and the noble Lord, Lord Lansley, have given us a really good big-picture look which takes us slightly above legislation.

The noble Lord, Lord Lansley, spoke of social and innovation benefits and the need to value innovation, but with innovation does not always come success: we may have to try again. He spoke about the innovative medicines fund and the necessity for NICE and NHS England to work together. When it is put like that, it sounds very straightforward: why is that not normally happening? He talked about the importance of value-based pricing and getting the best value from the drugs budget—which, after all, is finite. He also talked about the health technology assessment, which is of course qualitative, not quantitative. I valued the contribution of this debate on the fourth group of amendments, and I will read it again with great interest.

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[Lord Lansley (Con) [V]]

My Lords, I am very glad to follow the noble Baroness, Lady Bennett of Manor Castle, and prior to her the movers of Amendment 67. I welcome the fact that we have this opportunity to say something about redress. Amendment 68 is to follow in the next group, and I think it important to distinguish between the need to establish a scheme of redress where the NHS or government have been responsible for something which subsequently turns out to have damaged or harmed people, and the need to establish a scheme to provide proper support to those who have been harmed. That has been done on an ex gratia basis but, if the Government sought to do so, I think it would be possible to commence the NHS Redress Act 2006 and to establish such redress schemes under a statutory footing. It is not necessary to pass legislation to make that happen.

Those are different and distinct from the process of recognising that those harmed as a result of clinical negligence or failures in treatment processes should be able to secure a remedy and redress. I say remedy advisedly because often, in my experience of talking to people who have been harmed as a result of clinical negligence—these are often cases involving harm to babies during birth—it is as important to understand what happened, to accept where responsibility lies and to understand that others will not suffer in the same way, as it is to secure redress, compensation and support, which is often support for the child throughout their life. We need to understand that that is what we are talking about, not just the question of compensation.

I am slightly surprised by Amendment 67. I wonder what we think NHS Resolution is, if not an agency within the NHS with responsibility for securing redress for those who have been harmed as a result of clinical negligence. We need to recognise the need for, and I hope the Minister will tell us that the Government have not abandoned thought of, further reform. Certainly, when we were in opposition, we argued during the passage of the NHS Redress Bill that there should be a fact-finding phase. We argued that, rather than having an adversarial process with expert witnesses and all the associated costs, we should have a phase during which a claim is brought and the facts are established on an independent basis. That could lead to arbitration procedures and a settlement, rather than court-based proceedings, and we might escape some of the burden of cost. We should remember that nearly half the total cost of compensation in the clinical negligence process through NHS Resolution is actually legal fees. If we can escape some of that through an independent fact-finding phase, an arbitration process and financial settlements which recognise the support that the NHS and taxpayers give to those who have been harmed and have enduring problems and disabilities as a result, we might escape some of the burden of cost.

As the noble Lord, Lord Hunt, said, the potential contingent liability—not on an annual basis, but in the future—has risen to £83 billion. It is an enormous sum. The amounts paid by way of premiums to NHS Resolution are a significant aspect of the cost of NHS providers. There continues to be a good argument that the Government should consider this area still in need of reform.