Medicines and Medical Devices Bill

Debate between Baroness Watkins of Tavistock and Lord O'Shaughnessy

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Lord O'Shaughnessy (Con)]

My Lords, I thank the noble Lord, Lord Patel, for moving this amendment. I also pay tribute to my noble friend Lord Lansley for laying the amendment and for creating the template for the innovative medicines fund—the Cancer Drugs Fund—in the first place. The noble Lord, Lord Patel, described the tens of thousands of patients who have benefited from that scheme. It has been a fantastic innovation and something I am sure we all want to build on.

It also seems entirely appropriate that I am following the noble Lord, Lord Hunt, who gave a powerful speech. When I was a Minister, he was unrelenting in pointing out the weaknesses in the PPRS when it came to supporting innovation. He was right then and he is right now. That is why I needed no persuading to support this idea and this amendment. It was something that I tried and failed to introduce in the VPAS when I was a Minister, but perhaps a seed was planted then. It was fantastic to see the commitment made in the Conservative party manifesto in 2019 to create an innovative medicines fund.

As the noble Lord, Lord Patel, said, there are many areas, particularly, but not exclusively, rare diseases—and I have a daughter with a rare genetic condition—where experimental drugs seem to offer great hope, whether that is cannabinoids for epilepsy in children, or gene therapies for children with spinal muscular atrophy, or the many other conditions where the promise seems huge but the data does not yet convince. It feels to me that if we accept circumstances in which it is right to give cancer patients access to those kinds of therapies, it should also be right to give all other patients access to those kinds of therapies too. That is really what the innovative medicines fund is about.

I think that we have seen the shape of the future innovative medicines fund and what it would look like. The VPAS allows for confidential, complex deals for the first time. We have seen CAR-T therapies come through that route. We have also seen a deal signed for Inclisiran—originally from the Medicines Company, now Novartis—with testing of that in a real-world situation following a very successful large-scale clinical trial that was largely focused in the UK. This provides a template for how we might go about doing business for common conditions, as well as for rare ones.

I am sure my noble friend the Minister will agree with everything she has heard today, so I want to ask her what the timetable is for introducing the scheme. Questions have been raised by the BIA and ABPI and others, and I very much agree with them that an ambitious definition of innovation is required. The noble Lord, Lord Hunt, made an excellent point when he forcefully said that we must make sure that the rebate is recycled into innovative medicines, rather than just going back to the Treasury—there does not need to be an additional expenditure control mechanism. I will be grateful for my noble friend’s guidance on that.

One other thing that has come up in our debate in Committee so far—and of course this is more difficult because it takes it outside medicines and into other areas—is the exciting potential in devices, digital and diagnostics. There is no rebate scheme or automatic source of third-party funding that could provide for that. Is the Minister prepared to entertain exploring the potential for expanding the innovative medicines fund into something broader, and beyond medicines, perhaps not in its first iteration but in the future? I look forward to hearing what she has to say.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I call the noble Baroness, Lady Finlay of Llandaff. Lady Finlay? I think we had better move on and we can come back. I call the noble Baroness, Lady Jolly.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have also received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

I apologise for my email ineptitude.

I am grateful to my noble friend for her response. I was not planning to do so, but I have to again underline the points made by the noble Lord, Lord Hunt. We have trapped ourselves in a vicious, rather than a virtuous, circle that could well be undone. That may not be a discussion for now, but I want to underline its importance.

I want to ask my noble friend a very practical question. What did she mean by engagement? That could mean anything; it could mean pre-consultation discussion or a formal consultation. She will have garnered the strength of feeling on the topic, even in this small debate, and I am sure that will not dissipate as move forward to Report. The more detail and specificity she can give us on that process, the better.

Medicines and Medical Devices Bill

Debate between Baroness Watkins of Tavistock 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 have spent far too much time with patients harmed by medicines and medical devices going wrong—valproate, mesh and Primodos—and many people affected adversely by other treatments in which they had vested so much hope to be unconcerned about the issue of patient safety. I applaud all noble Lords who have tabled amendments on this topic, and especially pay tribute to my noble friend Lady Cumberlege, whose exemplary work on this issue through her review has given the issue, and the women—because it is mainly women who have been affected—the profile that they should always have had.

I certainly agree with all noble Lords that safety should be considered of greater importance than the attractiveness of the UK. There is and should be no trade-off necessary between attractiveness and high regulatory standards. I also agree with the point made by the noble Lord, Lord Hunt—that there is so much more to patient safety than the regulatory regime for medicines and devices that we are discussing today, but that is what we are discussing.

Having said all that, I have something nagging slightly at me about the topic, which I want to explore in my comments. I wonder whether there is some tension between availability of medicines and devices on the one hand and their safety on the other. As the Bill stands, it fails to elucidate this tension properly. The question that we need to solve is whether it is always right that safety should trump availability and access to medicines.

I start by looking at the purpose of our regulatory regime. The homepage of the MHRA says that it is to

“maintain the safety, quality and effectiveness of our medicines, devices and diagnostic tools”.

Of course, its reputation stands on its ability to make judgments against those criteria, which can sometimes be in tension: a drug can be safe but not efficacious, and it can be effective but not acceptably safe. If there are shortages, which sometimes happens, quality variation might be needed to access necessary medicines and devices. Striking a balance between all those factors and getting the right balance between risk and reward is where the hard task of regulating occurs.

We have heard many examples already on Second Reading and in Committee today of the tragedies that have happened when there have been regulatory and other failures of medicines and medical devices. However, it is also true that some of the greatest success stories in medicines have come about through a more pro-risk approach. I mentioned the HPV vaccine last time, which of course has been extended to boys, even though there continues to be some concern about the level of adverse events. The early access to medicines scheme allows patients to be treated with unlicensed medicines that have not yet had regulatory approval but where there might be a transformative opportunity for patients. Of course, in considering these issues, the words of the noble Lord, Lord Saatchi, and Baroness Jowell in the debate that they so wonderfully led, inspiring us all, also ring true. Creating more access to experimental therapies for ordinary patients can often be the right thing to do for them. It is not that we want unsafe medicines—of course not. But what matters ultimately is the safety of the patient, and sometimes that might mean—or their health and best interests might mean—better access to riskier medicines for some patients that would be unacceptably risky for most patients. Indeed, it is quite possible that the move to personalised medicine will make this more and more likely.

I am strongly supportive of the patient safety agenda, and encourage my noble friend the Minister to commit the Government to taking forward the recommendations made in my noble friend Lady Cumberlege’s review. However, I am a little worried, perhaps wrongly, about the potential impact of these amendments on patients’ ability to access experimental medicines and devices, or even the availability of standard medicines that are experiencing a shortage that might improve people’s lives. In a spirit of this being Committee, though not quite as iterative as it usually is, I wondered whether a different approach would be to amend the Bill so that Clause 1(2)(a) instead reads,

“the safety, quality and effectiveness of human medicines”,

which could then unambiguously be made the overarching priority of the legislation, involving as it would recognition of the trade-offs and tensions in the standard to which regulators are currently held, then applying this approach to medical devices. Whether this is the right way forward is up to noble Lords, but I hope that my noble friend the Minister is open minded on this issue and will consider very carefully the various arguments being made.

[Baroness Watkins of Tavistock (CB) [V]]

My Lords, it is a pleasure to follow other noble Lords, the majority of whom I completely agree with. I put my name down to speak to this group as I wish strongly to support the amendments tabled by the noble Baroness, Lady Cumberlege, Amendments 10, 12, 74 and 75.

Last year, I was on the pre-legislative scrutiny committee for the Health Service Safety Investigations Bill, which did not proceed as a result of the election. Therefore, I believe that putting patient safety at the heart of this Bill and making it a safety Bill as other noble Lords have outlined makes complete sense. It would protect our population and make our country far more attractive for medical research, because we would be seen internationally as a leader in safety in that work and in any licences we gave to medicines and medical devices.

As well as medical devices inserted in the way that was so eloquently outlined by the noble Baroness, Lady Cumberlege, and my noble friend Lord Patel, there are other pieces of equipment used regularly in intensive care and other care settings, including the community settings, where safety is paramount, particularly for the safe delivery of very small amounts of medication. Engineers in our country are developing far safer equipment for that kind of healthcare, which is largely delivered by nurses and other community health- care workers. Therefore, if we can make these issues clear in the Bill, we will be an extremely attractive country to sell such pieces of equipment internationally. For that reason, the priority of the Bill must be for patient safety, because it will result in much-increased attractiveness for us as an exporting nation in this field.