Question to the Department of Health and Social Care:

To ask Her Majesty's Government what arrangements are currently in place for ensuring (1) the safety and quality of medical isotopes used by the NHS when they leave production centres in mainland Europe, and (2) the safe handling of such isotopes following arrival in the UK; and what role Euratom plays in delivering those arrangements.

Radio pharmaceuticals (medical isotopes) used for diagnostic procedures are human medicines and are the subject of European medicines regulations which sets out a licensing regime and includes controls on the quality of materials used and processes followed during manufacture and the way they are distributed within Europe.

In the United Kingdom, human medicines are subject to national human medicines legislation which transposes the requirements of the European regulatory regime.

As a form of radioactive material, medical radioisotopes are covered by the European atomic energy community (Euratom) Treaty framework. However, they are not classified as special fissile material so they are not covered by the safeguards provisions of that Treaty.

The use and disposal of medical radioisotopes are governed by a set of standards established in domestic legislation (and regulated by domestic regulators) that have in some cases been informed by Euratom standards.

The UK already has robust, domestic regimes in place for the safety, security, transport, use and disposal of nuclear and radioactive materials – including medical radioisotopes – throughout their lifecycle. These regimes will remain in place as the UK leaves Euratom, ensuring we exit with certainty, clarity and control.

In addition, relevant Euratom and European Union safety and transport legislation Directives have already been, or are in the process of being, transposed into UK law before the UK’s withdrawal. The EU Withdrawal Bill will convert all European law, including that made under the Euratom Treaty, as it stands at the moment of exit into UK law.