I am grateful to the noble Baroness, Lady McIntosh, for bringing this discussion before the Committee. I also thank the noble Lord, Lord Clement-Jones, for his contribution. The information collected by the future medicine information systems has the potential to be used appropriately to support relevant research and improve the way in which we monitor medicines across the UK. However, once again, referring to the previous debate, we must be quite clear about whose data that is and the right to opt out.
Exchanging information with both national and international institutions is already integral to the MHRA’s post-market surveillance activities. Appropriate sharing of data from medicine information systems and medicine registries could also help support wider research to directly inform regulatory decision-making and to further support patient safety. Once again, we must respect patients’ concerns and their right to opt out.
The clause already provides the necessary power, by inserting new subsection (7A)(2)(c), enabling regulations to be made about the use and disclosure of information held within medicine information systems.
In regard to the noble Baroness’s admirable desire to ensure international co-operation with other bodies for post-market surveillance, medicines information systems will be established to support the MHRA developing medicine registries. As the regulatory authority, it is the MHRA’s international collaboration, rather than the information centres’, that will be key to supporting post-market surveillance. To ensure that this can continue, there are already specific powers in the Medicines and Medical Devices Act which enable
the Secretary of State, and by extension the MHRA, to appropriately share information with international partners. Once again, going back to a previous debate, it is about what is an appropriate sharing of data.
As with medicines information systems, we already have sufficient legal powers to appropriately share. On the second element of this amendment, the existing provisions in Section 19, specifically Section 19(2)(c), enable regulations to address the use and disclosure of information held within medical devices information systems, providing an ability to appropriately share information within a future system. There will need to be careful consideration and consultation on the sharing and use of information, as we have previously said. However, there is a beneficial impact that the system could have in research and post-market surveillance.
In response to the specific question, I recognise the desire to see a system set up under the regulation-making powers in place, but given the importance of this matter, it is crucial—I hope that the noble Baroness reflects on the previous debate—that we take the time to get this right. Any regulations made under Section 19 and the wider system will need to be informed by extensive engagement and consultation, working closely with our partners in the devolved Administrations, so that they can deliver their full potential for patients and clinicians across the UK, taking account of the very real concerns raised about patient data. Once again, we are trying to get that balance right: better healthcare and better research feeding into health, but at the same time patients having the right to opt out.
NHS Digital is well placed to deliver and operate the medical devices information system. Alongside key partners, such as the devolved Administrations, we will consider how we can establish this system in a controlled, staged manner that builds on the confidence and momentum behind this issue.
Finally, I will be moving Amendment 306AA in my name. The amendment is supported by the Scottish Government; it is simply a clarification in wording. It makes clear that any powers or duties conferred on Scottish Ministers in relation to their role in collecting information for medicines information systems can be treated in the same way as other NHS powers or duties in Scotland and be delegated to health boards in Scotland. It is my sincere intent not only to respect the devolved settlement but to create the best possible system, one that will work UK-wide. This amendment supports that aim. It is for that reason that I ask noble Lords to support this amendment and invite my noble friend to withdraw hers.