Amendment 17

Part of Medicines and Medical Devices Bill - Report (2nd Day) – in the House of Lords at 2:15 pm on 14th January 2021.

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Photo of Lord Patel Lord Patel Chair, Science and Technology Committee (Lords), Chair, Science and Technology Committee (Lords) 2:15 pm, 14th January 2021

My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.

I will start by saying that I support the amendments tabled by the noble Baroness, Lady Thornton, which address the broadly drafted government amendments that were introduced in Committee. Those amendments allow information held in connection with medicines and medical devices to be shared with relevant persons outside the UK, to give effect to international agreements in relation to the regulation of medicines and medical devices.

The original wording of these clauses was worrying due to the use of vague terms. It was not clear, for example, whether any information held by the relevant authority could cover all information contained in patient records relating to medicines and medical devices, including any information in medical records relating to the use of medicines for patients. As highlighted in Committee debates, there was also no definition of

“persons outside the United Kingdom”,

which left it open to broad interpretation, placing no limits on the category of persons to whom information may be disclosed.

The purposes of information disclosure are also broad, relating to the fulfilment of the requirements of any potential international agreement concerning the regulation of medicines and medical devices. In fact, a letter which the Minister sent to us all explaining these amendments in Committee argued that any such information disclosure would be related to the purposes of promoting public safety. There was and still is no mention of public safety in the purposes of information disclosure in the Government’s amendments, although I accept that, in presenting his amendments, the Minister did mention it in his introductory remarks.

The purposes are left to be determined by any international agreement, and thus this power is exceptionally broad. The Government’s own amendments to these clauses are welcome. They narrow the powers slightly by providing a definition of “relevant persons” to whom such information may be disclosed, and add new subsections requiring that no patient information be disclosed without consent. However, it is not clear to me what mechanism or form of consent is required.

Some may well remember that the scandal evolved from the lack of a requirement for opt-in consent to the use of medical and healthcare data. The amendment tabled by the noble Baroness, Lady Thornton, addresses this issue by requiring that consent be “opt-in” in these situations. This is a sensible addition to ensure greater safeguards for patients. It is also worth highlighting that patient information is defined in government Amendment 22, in a new subsection relating to

“physical and mental … diagnosis … care or treatment”,

and information that

“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.

This means that information pertaining to patients can be shared where it has been rendered non-identifiable. This is in line with current data protection principles.

The amendment tabled by the noble Baroness, Lady Thornton, strengthens this protection further, through the addition of the word “could”, so that any information which might lead to reidentification is also captured in this definition. These protections are necessary as aggregate data can reveal patterns which may allow for reidentification, especially for small patient clusters, such as in rare diseases and conditions, and even in cancers, and where patients with common diseases are stratified for particular medicines.

Regardless of the need for consent to disclose patient data, consent is not required where data has been anonymised. Decisions on the use of public health data represent a substantive area of policy that should be subject to scrutiny and debate, and not relegated to the discretion of the Government alone. Data can be of high commercial value, so this power would essentially be used to allow the sharing of such data with interested parties as part of their trade deals. It has “international agreements” within the meaning of this clause, and the Minister may wish to comment on whether trade deals are included in international agreements.

This comes back to the issue of scrutiny at the heart of the Bill. It may be that information sharing and disclosure is necessary to allow smooth functioning and support internationally on pharmacovigilance and medical device monitoring, but there is an issue that patient/NHS data could also be bought as part of commercial interests in trade deals which the operation of information disclosure clauses may still allow for. The clauses as they stand, and as the Government now intend to amend them, still potentially allow for sharing of anonymised data with commercial partners for undefined—and therefore unknown—purposes, to be settled as part of an international agreement or trade deal that would probably not be scrutinised by Parliament.

While it may be conceded that international agreements may require the sharing of information to allow for proper international co-operation for pharmacovigilance and monitoring of safety, as the Minister himself mentioned, in their current form the government amendments may allow sharing for broader purposes that we are currently unable to scrutinise. The amendment tabled by the noble Baroness, Lady Thornton, requiring that any information disclosure to relevant persons outside the UK be permissible only to aid pharmacovigilance and device safety, and for purposes that are in the public interest, represents an acceptable compromise in narrowing the purposes for which information can be shared. The public interest principle at least requires consideration by the Government of substantial ethical issues in sharing information, yet it still allows significant flexibility when contemplating future agreements post Brexit.

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.