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.

Healthcare (International Arrangements) Bill

Debate between Lord Clement-Jones and Lord O'Shaughnessy

Report stage (Hansard): House of Lords
Tuesday 12th March 2019 Lords Chamber

[Lord Clement-Jones]

My Lords, I beg to move Amendment 14, and your Lordships will be pleased to hear that I will be brief.

During the passage of the Bill, considerable concerns have been raised by a number of noble Lords about the use and sharing of data within the NHS. It is a hotly contested subject, and one of the best briefings on it is from our Library, prior to a debate on 6 September initiated by the noble Lord, Lord Freyberg. It unpacks a number of the concerns and issues about data within the NHS, and I am sorry that I have been unable to be at Second Reading or in Committee to expand on some of those issues.

During our Select Committee inquiry into artificial intelligence, there were a number of witnesses who talked about the use of data in the NHS, and we drew a number of conclusions, namely that the data was not in good shape to be utilised for beneficial purposes such as research, diagnosis and screening. That is another issue, however; what concerns noble Lords is the question of sharing. Now that we have seen Amendment 1 pass, maybe we will deal only with countries where there is a level of data adequacy which gives us an assurance about the use of NHS data. As the King’s Fund said last year in its report, Using Data in the NHS:

“National policy has to keep a balance between responding to legitimate public concern about the security and confidentiality of data and enabling data to be shared and used by NHS organisations and third parties. It is also essential that NHS national bodies are transparent with the public about how patient data is used”.


It went on to suggest that the level of opt-outs for patients would be key to the quality and validity of future research, and that NHS England and NHS Digital should keep this under review. One of the issues in the NHS is that there are several organisations responsible for NHS data. It is not just NHS England, NHS Digital, the National Information Board and Public Health England. The Caldicott Guardian—the national guardian for health and care—has a responsibility as well. It is quite a disparate, rather balkanised issue.

I was reassured on reading what the noble Baroness, Lady Manzoor, had to say when she responded, as the Minister, to this set of amendments in Committee:

“Under the Bill, personal data can be processed only in accordance with UK data protection law, namely the Data Protection Act 2018 and the general data protection regulation, which will form part of UK domestic law under the EU withdrawal Act 2018 from exit day”.


I am not going to go into all the questions about data adequacy and so on. I take what she said as quite reassuring, but it was less so when she later responded to what was then Amendment 23—this amendment is identical. She said:

“I assure the Committee that the Government are committed to the safe, lawful and responsible processing of people’s data”.


However, she then said:

“As the noble Baroness, Lady Jolly, and my noble friend Lord O’Shaughnessy noted, the Caldicott principles and the Government’s Data Ethics Framework are admirable standards to apply to the handling of patient data. Both of these non-legislative frameworks are in line with the Data Protection Act and the GDPR, which are enshrined in the Bill”.—[Official Report, 19/2/19; cols. 2261-63.]


That is not unequivocal in terms of those standards applying. As the Minister knows, we discussed this between Committee and Report. I had hoped to receive correspondence from her, but sadly I have not done so. She may need to repeat whatever text of the letter she may be able to find in her outbox. I hope she can give the House reassurance that the national data ethics framework and the Caldicott principles will apply to any sharing of data. The data ethics framework is a cross-government standard, of course, but the Caldicott principles are specific to the NHS. It is important to make sure they apply both domestically and internationally.

[Lord O'Shaughnessy]

My Lords, I am grateful to the noble Lord, Lord Clement-Jones, for giving the House the opportunity to talk about this issue again. He has been deeply involved in this topic and, as he said, I spoke on it in Committee. Compliance with this country’s very robust data protection rules is critical in general and particularly important in healthcare. This was discussed in the debate instigated by the noble Lord, Lord Freyberg; it has been a topic of conversation in this House, both in and out of the Chamber, on many occasions.

The noble Lord talked about the number of bodies that have some responsibility: he called it balkanised. It is important that we do not create a balkanisation in the law, even if a small one is in operation. One set of law should take precedence over all data protection, security and connected issues. That is, and should be, the Data Protection Act 2018. This means that there are operational guidelines, frameworks, principles and so on about how these ought to operate within individual contexts. That is precisely where the Caldicott principles come in. They take a general piece of legislation and translate what good practice in interpreting it ought to mean in a health setting. In that sense, it is important to say that we should not put those principles in a legislative setting. They are interpretive of the core, primary legislation and may need to change over time. They may need to adapt; there may be an eighth principle as we get into interesting questions about the value of data and so on.

It is important to recognise that the Caldicott principles bring to life what the Data Protection Act ought to mean in health settings. It would be a mistake to create competing law. Of course the Government agree with the noble Lord about the importance of giving force to the principles. That is one reason why we supported the Private Member’s Bill brought into this House by my noble friend Lady Chisholm to put the national data guardian on a statutory basis. I hope that that gives him the strength of reassurance about the way that the framework is constructed, which is not to create an opportunity to do funny stuff at the edges, but rather to make sure that there is primacy of one set of legislation.