Medicines and Medical Devices Bill

Debate between Lord Clement-Jones and Lord O'Shaughnessy

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

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

My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.

In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.

The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.

The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.

I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.

[Lord Clement-Jones (LD)]

My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.

I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?

Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?

I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.