My Lords, I rise to move the amendment standing in my name and to speak to my other amendments in this group. I am grateful to the noble Baroness, Lady Kidron and the noble Lord, Lord Clement-Jones, for signing a number of those amendments, and I am also very grateful to Foxglove Legal and other bodies that have briefed me in preparation for this.
My amendments are in a separate group, and I make no apology for that because although some of these points have indeed been covered in other amendments, my focus is entirely on NHS patient data, partly because it is the subject of a wider debate going on elsewhere about whether value can be obtained for it to help finance the National Health Service and our health in future years. This changes the nature of the relationship between research and the data it is using, and I think it is important that we focus hard on this and get some of the points that have already been made into a form where we can get reasonable answers to the questions that it leaves.
If my amendments are accepted or agreed—a faint hope—they would make it clear beyond peradventure that the consent protections in the Bill apply to the processing of data for scientific research, that a consistent definition of consent is applied and that that consistent definition is the one with which researchers and the public are already familiar and can trust going forward.
The Minister said at the end of Second Reading, in response to concerns I and others raised about research data in general and NHS data in particular, that the provisions in this Bill
“do not alter the legal obligations that apply in relation to decisions about whether to share data”.—[Official Report, 19/11/24; col. 196.]
I accept that that may be the intention, and I have discussed this with officials, who make the same point very strongly. However, Clause 68 introduces a novel and, I suggest, significantly watered-down definition of consent in the case of scientific research. Clause 71 deploys this watered-down definition of consent to winnow down the “purpose limitation” where the processing is for the purposes of scientific research in the public interest. Taken together, this means that there has been a change in the legal obligations that apply to the need to obtain consent before data is shared.
Clause 68 amends the pivotal definition of consent in Article 4(11). Instead of consent requiring something express—freely given, specific, informed, and unambiguous through clear affirmative action—consent can now be imputed. A data subject’s consent is deemed to meet these strict requirements even when it does not, as long as the consent is given to the processing of personal data for the purposes of an area of scientific research; at the time the consent is sought, it is not possible to identify fully the purposes for which the personal data is to be processed; seeking consent in relation to the area of scientific research is consistent with generally recognised ethical standards relevant to the area of research; and, so far as the intended purposes of the processing allow, the data subject is given the opportunity to consent to processing for only part of the research. These all sound very laudable, but I believe they cut down the very strict existing standards of consent.
Proposed new paragraph 7, in Clause 68, then extends the application of this definition across the regulation:
“References in this Regulation to consent given for a specific purpose (however expressed) include consent described in paragraph 6.”
Thus, wherever you read “consent” in the regulation you can also have imputed consent as set out in proposed new paragraph 6 of Article 4. This means that “consent” within the meaning of proposed new paragraph 6(a)—i.e. the basis for lawful processing—can be imputed consent in the new way introduced by the Bill, so there is a new type of lawful basis for processing.
The Minister is entitled to disagree, of course; I expect him to say that when he comes to respond. I hope that, when he does, he will agree that we share a concern on the importance of giving researchers a clear framework, as it is this uncertainty about the legal framework that could inadvertently act as a barrier to the good research we all need. So my first argument today is that, as drafted, the Bill leaves too much room for different interpretations, which will lead to exactly the kind of uncertainty that the Minister—indeed, all of us—wish to avoid.
As we have heard already, as well as the risk of uncertainty among researchers, there is also the risk of distrust among the general public. The public rightly want and expect to have a say in what uses their data is put to. Past efforts to modernise how the NHS uses data, such as care.data, have been expensive failures, in part because they have failed to win the public’s trust. More than 3.3 million people have already opted out of NHS data sharing under the national data opt-out; that is nearly 8% of the adults who could have been part of surveys. We have talked about the value of our data and being the gold standard or gold attractor for researchers but, if we do not have all the people who could contribute, we are definitely devaluing and debasing that research. Although we want to respect people’s choice as to whether to participate, of course, this enormous vote against research reflects a pretty spectacular failure to win public trust—one that undermines the value and quality of the data, as I said.
So my second point is that watering down the rights of those whose data is held by the NHS will not put that data for research purposes on a sustainable, long-term footing. Surely, we want a different outcome this time. We cannot afford more opt-outs; we want people opting back in. I argue that this requires a different approach—one that wins the public’s trust and gains public consent. The Secretary of State for Health is correct to say that most of the public want to see the better use of health data to help the NHS and to improve the health of the nation. I agree, but he must accept that the figures show that the general public also have concerns about privacy and about private companies exploiting their data without them having a say in the matter. The way forward must be to build trust by genuinely addressing those concerns. There must not be even a whiff of watering down legal protections, so that those concerns can instead be turned into support.
This is also important because NHS healthcare includes some of the most intimate personal data. It cannot make sense for that data to have a lower standard of consent protection going forward if it is being used for research. Having a different definition of consent and a lower standard of consent will inevitably lead to confusion, uncertainty and mistrust. Taken together, these amendments seek to avoid uncertainty and distrust, as well as the risk of backlash, by making it abundantly clear that Article 4 GDPR consent protections apply despite the new wording introduced by this Bill. Further, these are the same protections that apply to other uses of data; they are identical to the protections already understood by researchers and by the public.
I turn now to a couple of the amendments in this group. Amendment 71 seeks to address the question of consent, but in a rather narrow way. I have argued that Clause 68 introduces a novel and significantly watered-down definition of consent in the case of scientific research; proposed new paragraph 7 deploys this watered-down definition to winnow down the purpose limitation. There are broader questions about the wisdom of this, which Amendments 70, 79 and 81 seek to address, but Amendment 71 focuses on the important case of NHS health data.
If the public are worried that their health data might be shared with private companies without their consent, we need an answer to that. We see from the large number of opt-outs that there is already a problem; we have also seen it recently in NHS England’s research on public attitudes to health data. This amendment would ensure that the Bill does not increase uncertainty or fuel patient distrust of plans for NHS data. It would help to build the trust that data-enabled transformation of the NHS requires.
The Government may well retort that they are not planning to share NHS patient data with commercial bodies without patient consent. That is fine, but it would be helpful if, when he comes to respond, the Minister could say that clearly and unambiguously at the Dispatch Box. However, I put it to him that, if he could accept these amendments, the law would in fact reflect that assurance and ensure that any future Government would need to come back to Parliament if they wanted to take a different approach.
It is becoming obvious that whether research is in the public interest will be the key issue that we need to resolve in this Bill, and Amendment 72 provides a proposal. The Bill makes welcome references to health research being in the public interest, but it does not explain how on earth we decide or how that requirement would actually bite. Who makes the assessment? Do we trust a rogue operator to make its own assessment of how its research is in the public interest? What would be examples of the kind of research that the Government expect this requirement to prevent? I look forward to hearing the answer to that, but perhaps it would be more helpful if the Minister responded in a letter. In the interim, this amendment seeks to introduce some procedural clarity about how research will be certified as being in the public interest. This would provide clarity and reassurance, and I commend it to the Minister.
Finally, Amendment 131 seeks to improve the appropriate safeguards that would apply to processing for research, archiving and scientific purposes, including a requirement that the data subject has given consent. This has already been touched on in another amendment, but it is a way of seeking to address the issues that Amendments 70, 79 and 81 are also trying to address. Perhaps the Government will continue to insist that this is addressing a non-existent problem because nothing in Clauses 69 or 71 waters down the consent or purpose limitation protections and therefore the safeguards themselves add nothing. However, as I have said, informed readers of the Bill are interpreting it differently, so spelling out this safeguard would add clarity and avoid uncertainty. Surely such clarity on such an important matter is worth a couple of lines of additional length in a 250-page Bill. If the Government are going to argue that our Amendment 131 adds something objectionable, let them explain what is objectionable about consent protections applying to data processing for these purposes. I beg to move.