My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.
As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.
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The Minister’s Amendment 19 makes it very clear that:
“Nothing in this section authorises a disclosure of … information”
that would include patient-identifiable information without the patient’s consent. I warmly welcome that, but Amendment 20 in the name of the noble Lord, Lord Clement-Jones, goes further. It seeks to ensure that such consent is informed. As the noble Lord, Lord Hunt, and others, including the noble Lord, Lord Clement-Jones, said, informed consent is very well recognised within the NHS but sadly not always adhered to. To me, Amendment 20 in the name of the noble Lord, Lord Clement-Jones, is preferable to Amendment 21, which states that
“‘consent’ means that an individual has given notice of their willingness for an appropriate authority to disclose patient information”
by explicitly opting in. That is not good enough.
I fully support Amendment 20, with the proviso that gaining informed consent can never be just a tick-box exercise. The information, of course, pertains to patients and their state of health, the diagnosis they have received, the treatments they have had and the
outcomes from those interventions. That information, rightly, belongs to the patient. The noble Lord, Lord Hunt, mentioned care.data, and we know what a terrible debacle that was, when not enough care was given to the rights of patients over their information.
We know from the reams of evidence that we received during our review that “informed consent”, albeit usually in the context of a patient/clinician consultation, was often anything but informed. However, as I understand it, this debate is not about that; it is about the information that will be passed on through international agreements. I hope I have that right.
If we are to change how the healthcare system manages, interprets and responds to informed consent, we must ensure that it does not just pay lip service. Whenever informed consent matters, we should ensure, through this Bill and elsewhere, that it really does matter and is fully protected.
I support these amendments but ask the Minister to give an assurance that, in relying on informed consent, where disclosure of information can enable a patient to be identified, the relevant authority will have evidence on four issues: first, that consent was indeed properly informed; secondly, that the patient concerned understood how their information might be used; thirdly, that any specific concerns they might have had had been addressed; and, lastly, that the patient was made fully aware that they could withdraw consent at any time. I should perhaps add to that last point that they could withdraw either via an intermediary or directly. There must be a mechanism in place to ensure that the relevant authority is made aware of this change—that the patient has withdrawn consent—and that the authority can be seen to have acted on it.
There is much in all these amendments. It has been a good debate and I look forward to the Minister’s reply.