Luxembourg, 17 June 2024
Today the Council approved conclusions to ensure the supply of medical radioisotopes, as part of the priorities of the Belgian presidency. Medical radioisotopes play a vital role in diagnosing cancer, cardiac conditions and other diseases, and are increasingly used for cancer treatments. The Council’s conclusions aim to maintain Europe’s autonomy as well as global leadership in this field.
Recalling the commitment of the European Union, the Euratom Community, and the member states to provide citizens with a high level of healthcare, this set of conclusions highlights the role of radioisotopes for medical diagnostic and therapy, stressing in particular the increasing need for therapeutic radiopharmaceuticals.
The transport of radioisotopes across the EU is vital for ensuring access for patients, taking into account that some of them must be used within a few hours or days after being produced, as well as the fact that production is mainly concentrated in only a few member states.
In order to ensure that medical practitioners can dispose of the relevant medical isotopes when and where they need them, it is important that all involved have a clear understanding of future demand and supply.
The Council calls on the Commission, the Euratom Supply Agency, and the member states, as well as industry and relevant stakeholders to continue efforts to secure a reliable supply of source materials for radioisotope production.
The Council furthermore underlines the important contribution of European nuclear research reactors and other nuclear facilities able to produce medical radioisotopes at the levels required for the long-term needs in the European Union.
Each year, around 10 million diagnosis or treatment procedures in Europe, including for cardiac, neurological and cancerous diseases, are based on radioisotopes. The need for autonomy is crucial for all raw materials, but in nuclear medicine, it is a matter of human lives. Today we approved conclusions to ensure their secure supply and access to them across the EU, while sustaining research and innovation in the field to meet the increasing need for radiopharmaceuticals.
Tinne Van der Straeten, Belgian Minister for Energy
The Council conclusions urge the Commission to act on five key pillars:
- Europe’s global leadership role in the supply of medical radioisotopes
- monitoring and forecast of demand and supply for all relevant medical radioisotopes based on the experience of the European Observatory on the Supply of Medical Radioisotopes
- research and innovation on topics related to medical radioisotopes
- assessment and development of critical skills
- assessment of the framework for transporting radioisotopes for medical use in order to contribute to ensure access for patients in all member states
They also urge the European Medicines Regulatory Network to assess, according to existing methodology, the criticality of the radiopharmaceuticals authorised in Europe.
Background
Member states have consistently supported EU actions to secure the supply of medical radioisotopes and approved already in 2009, 2010 and 2012 conclusions on it following the severe supply crisis of that time.
More recently, in 2019, the Council called upon the Commission to develop an action plan on non-power nuclear and radiological technologies and medical radioisotopes also in the Council conclusions of 2021 on strengthening the European Health Union.
In 2021, the Commission adopted the Strategic Agenda for Medical Ionising Radiation applications (SAMIRA) as a comprehensive action plan to support a safe, high quality and reliable use of radiological and nuclear technology in healthcare, contributing to Europe’s beating cancer plan.
- Council conclusions on the security of supply of radioisotopes for medical use
- EU health policy (background information)