Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

There can surely be no objection to this minimal protection being required when contemplating the broad power being taken by the Government in decisions on the international sharing of valuable public data.

[Lord Clement-Jones (LD) [V]]

My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.

We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on 7 December. There was no debate or discussion about the new Clauses 7 and 12 and the new subsection in Clause 37 when they were introduced in Grand Committee. On both counts it is therefore vital that we get to grips with them today. I welcome the Minister’s new amendments, which he has spoken to and which take us a step further in terms of patient consent, definition of information and relevant persons. But I have signed, and these Benches support, the additional amendments to those clauses and subsection put forward by the noble Baroness, Lady Thornton, to ensure that we further tighten these provisions. Specifically, we want to tie this to international co-operation on pharmacovigilance or in monitoring the performance and safety of medical devices, and a public interest test put around the disclosure of health data, for all the reasons put forward by the noble Lord, Lord Patel.

As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the

“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”

I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.

Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.

At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.

There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.

On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.

I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. I look forward to the Minister’s reply.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.

I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.

My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.

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[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Lord, Lord Clement-Jones, wish to move Amendment 20, as an amendment to Amendment 19?

[Lord Clement-Jones (LD) [V]]

[Inaudible]—very much about informed consent, but, nevertheless, I will not move the amendment.

Amendment 20 (to Amendment 19) not moved.