Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals. These types of medicines contain radioactive forms of chemical elements called radioisotopes and are used to diagnose or treat medical conditions such as cancer. Their use is steadily increasing, while manufacturing capacity in Europe is limited. This has led to occasional shortages in different Member States.

Production of radiopharmaceuticals is reliant on stable isotopes and other materials that are sourced mainly from third countries. In addition, the supply chain of these medicines, including how to transport them safely, is complex. The MSSG recommendations are directed to European and national authorities, as well as to industry with the aim to align efforts to address these issues.

The recommendations to the European Commission emphasise the need to increase the European Union’s domestic capabilities through initiatives such as the European Observatory on the Supply of Medical Radioisotopes, co-chaired by the Euratom Supply Agency (ESA) and Nuclear Medicine Europe (NMEU), the Strategic Agenda for Medical Applications of Ionising Radiation (SAMIRA) and the European Radioisotope Valley Initiative (ERVI). They highlight improving aging infrastructure and enhancing production facilities, such as nuclear reactors. They also consider addressing transport challenges through harmonisation of certification procedures and standards across different countries.

Member States are advised to map their supply chains, coordinate transport solutions and consider the inclusion of new radiopharmaceuticals in horizon scanning activities. EMA will continue to support regulatory activities as necessary and ensure cooperation and coordination, while companies are encouraged to work with regulators and submit any necessary information.

The MSSG, through the Medicine Shortages Single Point of Contact Working Party (SPOC WP), has been monitoring the security of supply of radiopharmaceuticals and managing availability issues by providing regulatory support to prevent or mitigate the impact of shortages on patients. However, regulatory tools cannot address all the vulnerabilities identified in the supply chain, something which will also require long-term industrial policy measures, such as those in the Critical Medicines Act. Enhanced security of supply, especially for medicines included in the Union list of critical medicines, is a priority within the EU. Actions like these recommendations anticipate the implementation of the EU pharmaceutical legislation, in line with the 2023 Commission Communication on Addressing medicine shortages in the EU.