Karin Smyth

As the hon. and learned Gentleman knows—we have spent many long hours in this place discussing the arrangements with regard to our leaving the European Union—there are different regulations, as a result of Brexit, between Great Britain and Northern Ireland. As is currently the case, due to the Windsor framework, that results in Northern Ireland following the EU device regulations. This has been discussed with the Northern Ireland and Windsor framework taskforce in the Cabinet Office, and we are content that the provisions are right, given the framework’s application. I know and understand the point that the hon. and learned Gentleman makes, and I am sure that he will pursue it with the Government in other areas. New clauses 95 and 98 update and clarify the Secretary of State’s information-sharing powers for medicines and medical devices. They provide a clearer legal framework for the Medicines and Healthcare products Regulatory Agency to share information with UK health systems, organisations and trusted international partners. The current legislative framework does not always provide the MHRA with the powers or clarity it needs to share information quickly and effectively, and this creates barriers to collaboration, including with the NHS. The new clauses will address these challenges, providing a clear statutory basis for information sharing. There is currently no explicit statutory domestic information-sharing power for medicines, whereas there is for medical devices. The new clauses bring information-sharing powers about medicines in line with those for medical devices and updates the list of statutory purposes for which the MHRA may share information. Importantly, these reforms do not weaken existing safeguards. Patient information will not be shared internationally without consent, and domestic protections under the Data Protection Act 2018 and the UK General Data Protection Regulation remain unchanged. These new clauses and amendments will act in the interests of patients, and I commend them to the House.