Medicines and Medical Devices Bill

Debate between Baroness Walmsley and Lord O'Shaughnessy

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

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

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

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

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

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

[Baroness Walmsley (LD) [V]]

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

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

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

Medicines and Medical Devices Bill

Debate between Baroness Walmsley and Lord O'Shaughnessy

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

[Baroness Walmsley (LD) [V]]

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

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

[Lord O'Shaughnessy (Con)]

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

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

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

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

--- Later in debate ---

[Lord O'Shaughnessy (Con)]

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

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

[Baroness Walmsley (LD) [V]]

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

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

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

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

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

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

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

--- Later in debate ---

[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.