Medicines and Medical Devices Bill

Lord Bethell Excerpts

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

[Baroness Thornton (Lab)]

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”


That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”


drugs

“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.

The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.

Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.

This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:

“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]


I could not have put it better myself.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.

I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.

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[Lord Alton of Liverpool (CB)]

My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.

My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?

[Lord Bethell (Con)]

I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.

[Baroness Sheehan (LD) [V]]

My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.

I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.

At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.

The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.

My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.

I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?

I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.

On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.

In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.

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[Baroness Thornton (Lab)]

This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.

I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.

All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.

[Lord Bethell (Con)]

My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.

The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.

I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.

I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.

By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.

However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.

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[Baroness Cumberlege (Con) [V]]

My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.

I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.

I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.

The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.

I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.

I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.

[Lord Bethell (Con)]

I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.

I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.