Question to the Department of Health and Social Care:

To ask Her Majesty's Government what steps they are taking to ensure that (1) patients in the UK benefit from a continued supply of radiopharmaceuticals that meet the CE-marking for technical and safety standards, and (2) UK companies continue to be able to get their own items and equipment CE-marked and sold in Europe, post-Brexit and the UK’s withdrawal from Euratom.

The safety and security of radioactive materials is a top priority for the Government. The United Kingdom already has robust domestic legislation in place to ensure that the keeping, movement and use of radioactive sources is tightly regulated, whether on nuclear sites or in hospitals. The UK’s regulatory regime is based on international regulatory requirements for sources informed by the International Atomic Energy Agency. The UK will continue to meet its international obligations in full and ensure that UK law and regulatory oversight continues to deliver the highest standards of safety, in line with the relevant international frameworks.

Radio pharmaceuticals are also subject to European medicines regulation which establishes a licensing regime and controls on the quality of materials, as well as manufacturing and distribution processes within Europe. In the UK, human medicines are subject to national human medicines legislation which transposes the requirements of the European regulatory regime. This regime is enforced by the Medicines and Healthcare Products Regulatory Agency (MHRA) and MHRA will continue to do so after our withdrawal from the European Union.

The Government's top priority for life sciences during the negotiations is to protect the safety of patients and ensure the integrity of cross-European public health systems. The Government will seek a mutually beneficial future partnership between the UK and EU that is in the interests of both sides, which builds on the convergence between our regulatory systems and gives business the maximum freedom to trade with and operate within European markets.