Data Protection Bill [HL]

Lord Stevenson of Balmacara Excerpts

Committee: 1st sitting (Hansard - continued): House of Lords
Monday 30th October 2017 Lords Chamber

[Baroness Manningham-Buller (CB)]

My Lords, it is late and I have little to add to what my noble friend Lord Patel said. I declare an interest as chair of the Wellcome Trust, and I was also closely involved with Imperial until conflicts of interest preventing my going on. I have a lot of sympathy with those who spoke earlier on the issue of fundraising for universities. I speak tonight briefly about the concern I raised on Second Reading: the Bill as drafted just does not offer the clarity we need for people dealing with medical research in universities and other institutions, such as the Crick Institute.

The noble Lord, Lord Patel, amply illustrated the value of such research in understanding fundamental disease, the efficacy of treatment, and following on and learning from big datasets which give us the power to do things in medical research that were once not possible. We are not looking for medical researchers to be given particularly special treatment—there are quite a lot of exceptions here anyway—but to clarify what they are doing and how, so they can do it safely and with confidence.

I come back to where the noble Lord, Lord Patel, started. Researchers need to be able to do this work to improve global health—the health of everyone. Health does not stop at boundaries. Results are shared and we all learn from each other. We heard examples from the noble Lord. In a more parochial sense, this is a critical part of the industrial strategy we need to implement to deal with the economy post-Brexit. That document said that we have to streamline our legal and ethical approvals for medical research. This is one of the ways to get economic growth, so over and above the health aspects, there are strong economic reasons for being sure we can provide absolute clarity for people doing this sort of work. The consent issues are not straightforward but provided there are other safeguards—proper ethical committees and proper supervision—I think we can get there. However, we need to say a bit more in the Bill so that people are confident that they can do this.

[Lord Stevenson of Balmacara (Lab)]

I am conscious that we have had had a full and interesting introduction to this group of amendments from the noble Lord, Lord Patel, which builds on earlier discussions. It was difficult to get into this debate without having a little more than he was able to give us—and I do not want to push him too hard on this, but it would be helpful to hear a bit more about ethical committees.

As I understand it, the argument is a three-pronged one. An additional point was made about the need to think about the industrial strategy and not to hold back the research that will be influential in driving forward our brilliant life sciences. But the issue here is whether we could have a parallel system, changing the nature of the public interest test as described by the noble Lord, Lord Patel, and relying on an agency basis. We are calling that an ethics committee, which will basically take on the burden of determining what is appropriately done outside the narrow scope of the Bill as drafted. It would provide the measures of assurance that the Bill seeks, because it deals with a particular type of operation that would not fit naturally into the GDPR more generally. That is the main burden of the argument. I need a bit more information on how the noble Lord sees ethics committees more generally taking on that burden; perhaps he could share that with us.

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[Lord Patel]

I shall respond to some of the points raised. First, on the research ethics committee, we established through legislation—and I remember the debates that we had—a national Research Ethics Committee to deal with all applications for biomedical research, but particularly research involving patient data and transfer of data. If I as a clinician want to do a trial, I have to apply to that committee with a full protocol as to what consent procedures and actual research there will be, and what will be the closing time of that consent. If I subsequently found the information that I had could lead to further research, or that the research that I had carried out had suddenly thrown up a next phase of research, I would have to go back to the committee and it would have to say, “Yes, that’s part of the original consent, which is satisfactory to progress with the further research”. It is a robust, nationally driven, independently chaired national ethics committee, apart from the local ethics committee that each trust will run. So the national ethics committee is the guardian.

Furthermore, there is a separate ethics committee for the 500,000 genomes project, run by the Wellcome Trust and other researchers; it is specifically for that project, for the consent issues that it obtains, the information given at the time when the subject gives the consent and how the data can be used in future. The genomes project aims to sequence all the 500,000 genomes, and to link that genome sequence data with the lifestyles that people had and diseases that they developed to identify the genes that we can subsequently use for future diagnosis and treatment—and to develop diagnostic tests that will provide early diagnosis of cancers, for instance. The future is in the diagnostic tests. Eventually we will find them for diseases which have not developed but which have a likelihood of developing. Those diagnostic tests will identify the early expression of a protein from a gene and then find a treatment to suppress that expression well before the diseases develop, rather than waiting until the cancer develops and then treating it.

All this is based on the data originally collected. At this stage, it is impossible to know where that research will lead—that is the history—apart from the clinical trials which are much more specific and you get consent for them. I realise that there is a limit to how much the text of the Bill can deviate from the GDPR, unless it is dealing with specific issues which the GDPR permits member states to provide derogations for. I realise that, post exit, the UK will need an adequacy agreement and some equivalent, neutral recognition of data protection regimes between the UK and the EU. We need that for the transfer of data. For instance, the noble Baroness, Lady Neville-Jones, has talked about extremely rare diseases, which require the exchange of data across many countries because their incidence is low and no one country could possibly have enough information on that group of patients.

The research exemption does not undermine agreement on Clause 7—which is what the noble Lord, Lord Clement-Jones, was leading up to when he asked about the ethics committee. The noble Baroness, Lady Neville-Rolfe, suggested that medical research should be possible through the research exemption, but that has to be wide enough yet not specific enough to encompass wider exemptions. I hope that the Minister will come up with that trick in an amendment which he might bring forward. It will not be restrictive, yet protect the patient’s personal interest.

There is a research exemption for processing specific categories of data, including health data. The legal basis for this is through article 9 of the GDPR, referred to in Part 1 of Schedule 1 to the Bill. However, all processing of personal data also needs an article 6 legal basis: research is not exempt from needing this. I am arguing today that research needs that exemption, defined in wide enough terms. For processing special categories, you need both an article 6 and an article 9 legal basis. We need to have provision for both in the Bill. One of the article 6 legal bases is consent and I have explained why this is not suitable for much research. The other feasible route for universities and other public bodies processing personal data for research is public interest. This is why it is so important to be clear on what processes can use this legal basis.

There was serious concern about the likely impact of the GDPR on research as it was being drafted. However, this was successfully resolved and it provides the necessary flexibility for the UK to create a data protection regime that is supportive of research in the public interest. The Government, and other UK organisations, worked hard to make sure that this was the case. The provision is there: it is now for the Government to act on it. It is also important to seek an adequacy agreement post Brexit: we will have to have one. It will be vital to consider the need to retain, post Brexit, cross-border transfers of data for research. I give the same example of rare diseases as the noble Baroness, Lady Neville-Jones, used. The Government have recognised the value of retaining a data protection regime consistent with the EU, but the research community would welcome knowing whether it will seek a status of adequacy as a third country or an equivalent agreement.

The plea I make is that unless we include a provision, and there are exemptions which can be written in the Bill in the format that is required, we will not be able to carry out much of the research. A question was asked about the life sciences industrial strategy. It is the key pillar of the Government’s industrial strategy Green Paper. It relies on data that the NHS collects and the data that the science community collects and marrying up the two to produce, and lead the world in, treatments and developing technologies. If we are not able to do this, the whole thing will be unworkable.

[Lord Stevenson of Balmacara]

I am very grateful to the noble Lord for a very full response. It was quite a narrow question. I did not need all of that response but I have learned a lot more in the last few minutes—

[Lord Patel]

I thought that it might have been leading up to more.

[Lord Stevenson of Balmacara]

It might have been. The noble Lord has exposed a much greater issue than we thought we were grappling with. The case has now been well made that there are four pillars rather than the three that I adumbrated before. We seem to have a case for special treatment. I am sure that the noble Lord, Lord Patel, with his assiduous workload and high work rate will have made this point several times to officials and Ministers. However, if he is not getting the answers he needs, we have a bit of a problem here, so I hope that the Minister will be able to help us on that.

This goes back to an earlier debate about the public interest. It again worries me—I think the noble Lord, Lord Clement-Jones, touched on this—that “public interest” is becoming an overworked term for rather too many issues. In other words, the argument here is not about the public interest at all; it is about the public good that would come from a differential approach, safeguarded by the ethics approach—I said that was new to me and I am grateful to hear about it—and about reinforcing the contribution that would make to an industrial strategy covering a much broader range of understanding about what we are doing, thus making this country a world centre for all that. So there is a power behind this that I had not appreciated and I am grateful to the noble Lord for explaining it. It is easy to analyse it in this way and come up with the answer that he might want, but is it the right way forward on this?

The noble Lord was wise to point out that there are constraints within the GDPR and limits on what the Government can do, but it must be possible to think more creatively about the problem that has come forward. If, as the noble Lord said, the GDPR opens up the question of not requiring consent in that very formal sense, and we are looking for an evidence-led policy initiative which addresses the public good, it behoves Ministers to think very carefully about how one might take it forward.

This may or may not be the only issue that requires this sort of approach, but the case has been made on its merits that more needs to be done. Listing existing bodies that are not included, to put it in the positive, in a list of issues—for example, the administration of justice is a function of the Houses of Parliament—is not the way into this issue. I appeal to the Minister to think creatively about this because it seems to me that we need a new approach here. I am very convinced by that and look forward to hearing what the Minister says.

[The Parliamentary Under-Secretary of State, Department for Digital, Culture, Media and Sport (Lord Ashton of Hyde) (Con)]

My Lords, first, I thank the noble Lord, Lord Patel, for his insightful remarks and for providing us with evidence of his knowledge of this subject, and of the Bill’s potential implications for pioneering medical research. I am grateful to him for sharing his expertise on these issues. I am also grateful to the noble Baroness, Lady Manningham-Buller, who speaks on behalf of the Wellcome Trust. Other reputable medical research organisations and universities have also expressed concern about this issue. I understand about the issue of consent and whether it is GDPR-compliant.

On the concerns the noble Lord raised in relation to Clause 7, I mentioned at Second Reading, and on a previous group of amendments, that the list of tasks in Clause 7 is deliberately designed to be indicative and non-exhaustive. When I wrote to noble Lords after that debate, I committed to make this clearer in the Explanatory Notes and the Government will honour that commitment.

The noble Lord, Lord Stevenson, mentioned that we might have to have a new approach to this problem. We are happy to think about these issues. At the moment we find that it is difficult to expand Clause 7 to cover every scenario where personal data has been processed in the public interest. Each addition to the list, however justified on its own merits, would cast greater uncertainty on the public interest tasks that continue to be omitted. However, I can reassure universities and research groups carrying out legitimate medical research, that, in the Government’s view, such tasks are in the public interest for these purposes. I will come later to how we take this forward.

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[Lord Ashton of Hyde]

I believe also that even when consent is obtained, the worry is that it may not be subject to GDPR compliance, even if consent was acceptable before.

[Lord Stevenson of Balmacara]

I think we have already made the point and we do not need to come back to it. What I took from the noble Lord’s earlier contribution was that one way in which medical research is developed and carried out involves a consent process, and we would not want to change anything in that sense. However, for lots of reasons—the noble Lord gave three or four—you cannot always use consent. You may not want to go to the patient, or perhaps you cannot go to or find the patient. Alternatively, the noble Lord made the more general point that you often collect data without any real sense of where it might go in the future. We are not saying that any of that is good, bad or indifferent—one is no better than the other—but they all need to be considered in a broader understanding of the public good being best served by having the least restrictive system concomitant with appropriate procedures being in place. That is the line, with the ethics committee sitting at the top, that gets you to the point where that would be a fruitful conversation to have with Ministers.

[Lord Patel]

I must make the issue absolutely clear. If I did not do so before, I will set it out again slowly and carefully. Medical researchers are not asking to be allowed to do research without consent. They are asking for consent to be interpreted not in a narrow sense but in a sense that will allow research to continue with consent having been obtained. I shall give an example. When I chaired the UK Stem Cell Bank, we made it clear that consent would have to be obtained from those who donated stem cell material, including embryonic stem cells. Consent was given on the basis that the embryonic stem cells would be used for research to improve healthcare, but at that time it was not possible to say which healthcare.

Embryonic stem cells, properly kept, are immortal: they can survive for generations. There is a classic example of this. Most of your Lordships are familiar with the lady whose tissue was taken in 1950. Her name was Henrietta Lacks—hence the cells are called HeLa cells. These aggressive cervical cancer cells were taken from her in the United States without consent, but they still exist in every laboratory in the world. A billion dollars-worth of drugs have been developed and marketed using HeLa cells. If consent had been obtained, what would that consent have been for? Exactly the same applies to consent for stem cells—it is for the development of drugs.

Researchers are not saying that we should not have consent. They are saying that there ought to be an authority like the ethics committee that gives consent and to which you can go back and say, “By the way, I have that material and I have found more. I am still developing drugs but this is not the same”. I hope I have been clear about that. We are looking for exemptions that are wide enough.

Perhaps I may come back to the matters raised by the Minister and refer, first, to the public interest issues. I understand that the Government do not intend the functions listed in Clause 7 to be exhaustive and to allow, for example, research conducted by universities or NHS trusts to use the public interest legal basis. It would provide much needed clarity and assurance for the research community if that could be made explicit in the Bill. That, basically, is all we are saying on the public interest. There is currently a highly risk-averse culture in data protection, driven in part because people are unclear about the rules and about what they can or cannot do with that data and for what purposes. If it is made clear what they can do or where they have to go to make it clear, that will be helpful. This is why the public interest legal basis matters so much for research. The Data Protection Bill is an opportunity to set out very clearly the legitimate basis for processing personal data, setting out a clear public interest function for research that will give researchers the confidence to know when they are operating within the law.

I will now make a comment about what the Minister said about the safeguards. My Amendment 111 is to Clause 18, which prohibits the processing of personal data to support measures or decisions with respect to particular individuals. This is clearly problematic for any research that involves an intervention for an individual, which forms the bedrock of our understanding of a vast range of treatment of diseases. The range of law covering the use of personal data for research is complex, governed both by data protection law and common law, where duties of confidentiality toward the data subject exist. In my view, the implementation of GDPR through the Bill is an opportunity to provide clear information to researchers about the legal basis for processing personal data and the requirements of accountability, transparency and safeguards.

It is therefore essential that authoritative, comprehensive and unambiguous guidance is created to assist with this transition to a new data protection law. The Health Research Authority is working on guidance for health research, but researchers are urgently in need of this advice to ensure they are compliant by May 2018.

Those are my comments in response to the Minister. I am labouring these points today because this is the only opportunity I will have in Committee to debate these issues at length. I do not wish to rehearse this at Third Reading if we can resolve these issues by communication and find a way out.

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[Lord Arbuthnot of Edrom (Con)]

My Lords, I shall speak only to Amendment 188, and I do so because, as so often, I am confused. In Scotland, a person aged 12 is presumed to have capacity to exercise rights under the Data Protection Act 1998, and that position is perpetuated in the Bill. How does that mesh with the general data protection regulations, which provide that consent to process personal data is lawful below the age of 13 only if given by a parent? I think that is the position and that is why I have tabled my probing amendment. Perhaps my noble friend could explain why Scottish children are so much more mature than English children.

I was persuaded by the view expressed by the noble Baroness, Lady Lane-Fox, at Second Reading when she said that we do not want to bring in lots of new and different laws for 13 year-olds and we need to recognise the reality that children will wish to do what their peers are doing. We do not want to incentivise them to tell lies online. So I am perfectly happy with the Government’s position on the age of 13 and just a bit bewildered about Scotland.

[Lord Stevenson of Balmacara]

As a Scot I can hardly complain, and I am always bewildered, too—not only about this but about many other things. Our Amendment 17 in this group is also one of bewilderment. Clause 8 is headed:

“Child’s consent in relation to information society services”,


and refers to “preventive or counselling services” not being included. This goes back to an earlier amendment, when we established that these references are actually recitals and not part of the substantive GDPR, so we are back in what is not normative language and issues that we cannot possibly talk about in relation to the wider context because we are talking about the law that will apply.

There are three points that need to be made and I would be grateful if the noble Lord would either respond today or write to me about them. The first is to be clear that the reference to “information society services”, which is defined, has nothing in it that would suggest that it is a problem in relation to the lack of inclusion of preventive or counselling services. The answer is probably a straightforward yes. Secondly, what are the preventive or counselling services that we are talking about? I think the context is that these are meant to exclude any data processing relating to a data subject if the data subject concerned—with parental consent if the subject is younger than 13 and on their own if they are older than 13—who is taking a form of counselling that may be related to health or sexual issues would not be allowed to be included. Is my understanding of that right? I am sure that it is.

Thirdly, could we have a better definition of preventive or counselling services because those are very wide-ranging terms? Yes, they come from a recital and perhaps in that sense they can be tracked back to earlier discussions around the formation of the GDPR, but they have to be applied in this country to situations in real life. I am not sure what a preventive service is and I should like to have it explained. Counselling services I probably do get, but do they include face-to-face counselling or is this about only online counselling services? Is it the same if the child is being accompanied by a parent or guardian? There are other issues that come into this and there is a need for clarity on the point.

While I am on my feet I should like to respond to the amendment moved by the noble Baroness, Lady Howe, who has campaigned long and hard on these issues. We would be bereft if she did not enter into this Bill with all its implications for children, given the wisdom and experience that she brings to the table. The point she makes is one of simple clarity. There is a need to be very careful about the evidence gathering on this issue and it is probably not appropriate for it to be left to Ministers in regulations. There needs to be a wider discussion and debate on the matter, perhaps involving the Children’s Commissioner and other persons with expertise. She has made her point very well and I should like to support it.

[Lord McNally (LD)]

My Lords, I associate myself with the amendment in the name of the noble Baroness, Lady Howe. We are in Committee and it is a probing amendment. When we discussed it with colleagues the feeling was that 13 might be the right age but, as the noble Baroness indicated, it needs probing and some thinking about.

There is a danger, particularly in a House with our age group, that we assume these technologies are understood by the young—even the very young. We all hear anecdotes of parents or grandparents who have to consult their eight year-olds on how to make various gadgets work, but that misses the point. A frightening amount of information is being freely given. I mentioned at Second Reading that my generation and my parents’ generation had thoughts of personal privacy that my daughter and her contemporaries seem to have no thought of. They are very happy to exchange information about themselves, what they do and where they are with gay abandon.

When we get to the very young it is very important to make sure—we will discuss this in later amendments, if not tonight—that there is sufficient understanding and information to make informed choices, otherwise we get into very dangerous territory indeed. Therefore we are, not for the first time, in the noble Baroness’s debt for raising these questions. Late as it is, it is right that we put on record that these things, along with the amendments that will follow in the next couple of groupings, need to be taken as a whole before we make a final judgment as to the right age.