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 Bethell Lord Bethell The Parliamentary Under-Secretary for Health and Social Care 2:15 pm, 14th January 2021

My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.

I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.

It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.

As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.

Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.

We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.

In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.

Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.

I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.