Question to the Department for Business, Energy and Industrial Strategy:

To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 January (HL4659), which body will discharge the framework-setting role currently performed by Euratom with regard to the safe manufacture, transport, use and disposal of medical isotopes.

The safety and security of radioactive materials is a top priority for the Government. The UK 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 (IAEA). 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.

Medical radioisotopes 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 will continue to do so after our withdrawal from the EU.