Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

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

[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.

[Lord O'Shaughnessy (Con)]

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

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

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

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

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[Lord O'Shaughnessy (Con)]

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

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

[Baroness Walmsley (LD) [V]]

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

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

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

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

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

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

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

[Lord Kakkar (CB) [V]]

My Lords, I support Amendments 5 and 70 in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I seek further clarification on the Government’s purpose regarding the amendments proposed by the Minister.

First, what is the rationale for moving away from the current basis on which regulations in this regard exist, which states the purpose of safeguarding public health? Why do the Government not think that appropriate as the basis for legislation for medicines and medical devices? It has been the basis on which regulations have previously existed in domestic legislation and it seems counterintuitive to move away from that purpose, as so clearly explained by the noble Lord, Lord Lansley.

Secondly, there is this question of whether there should be an objective or a subjective test attending the purpose of legislation, all parties having agreed that it is of benefit to move away from simply having a power to clearly defining a purpose. There has been considerable debate and discussion about what is considered the frequent use of judicial review now and how in some way it undermines the position of Parliament and is less than helpful more generally in our country. It seems therefore intuitive for a Government who have concerns about what is sometimes considered excessive use of judicial review to try to provide legislation that would make it less necessary and less frequently turned to.

The noble and learned Lord, Lord Woolf, made the point that clarity is essential. Surely an element of clarity would be to have in place an objective test—to safeguard public health—rather than, as currently, merely being “satisfied”. The need that the Secretary of State can make regulations if he is satisfied, as we have heard in this debate, is much more subjective and therefore must be open to much more frequent challenge.

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[Lord O’Shaughnessy (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

[Baroness Walmsley (LD) [V]]

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

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

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

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

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

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

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

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.