Adopted in February 2021, the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) is the energy sector's contribution to Europe's Beating Cancer Plan, and a response to the EU Council's conclusion from 24 May 2019 on non-power nuclear and radiological technologies and applications.
The SAMIRA action plan is the EU’s first comprehensive plan to support the safe, high quality and reliable use of radiological and nuclear technology in healthcare. It defines 3 priority areas for EU action
- securing the supply of medical radioisotopes
- improving radiation quality and safety in medicine
- facilitating innovation and the technological development of medical ionising radiation applications
It is supported by several EU programmes. The Directorate-General for Energy provides support for the implementation of Euratom legal requirements in EU countries. The EU4Health programme supports the quality and safety of radiation technology in diagnostics and cancer treatment. Euratom’s research and training programme supports radiation protection in medicine as well as the safe use and reliable supply of medical radioisotopes, with a potential for involvement with other EU funding and research programmes in the future.
Securing the supply of medical radioisotopes
Securing the long-term supply of medical radioisotopes is essential to maintaining EU patients’ access to vital medical procedures and supporting the development of new cancer treatments.
This requires significant investments across the entire supply chain, particularly in securing source materials and new production capacity. Many of the source materials are not readily available in the EU and are imported from limited stocks or production elsewhere.
In addition, the production of many medical radioisotopes takes place in research reactors, which are already experiencing ageing issues. To avoid potential shortages of radioisotopes, research reactors will need major refurbishments or to be replaced either with new ones or by other production technologies by 2030.
In order to help overcome these issues and maintain Europe's global leadership in the supply of medical radioisotopes, the Commission has started a process towards establishing the so-called European Radioisotope Valley Initiative (ERVI).
Stakeholders provided their views on the objectives and challenges of ERVI during a consultation in 2022, the results of which are published in a report and extended analysis. Following this, the feasibility of different projects proposed to be developed under ERVI is under assessment, maintaining the strong involvement of all interested stakeholders.
The Euratom Supply Agency plays a key role in monitoring the supply of major medical radioisotopes and securing the supply of nuclear fuels and materials for radioisotopes production. The Commission is examining the EU's needs for other source materials and will consider EU support for their domestic production.
The Commission also supports the long-term safety and security of the European research reactor fleet, as well as the safe and responsible management of waste from medical applications.
Improving quality and safety in radiation medicine
The Commission launched in 2021 a European Initiative on Quality and Safety of medical applications of ionising radiation aiming to ensure that its diagnostic and therapeutic uses are in line with the highest standards for quality and safety across the EU.
To achieve the necessary coordination and collaboration in this area, the Commission created the Steering Group on Quality and Safety (SGQS) of medical applications of ionising radiation, composed of representatives from both the health and the radiation protection authorities of EU countries.
The SGQS offers a common platform to support the implementation of European requirements for radiation protection and other quality and safety standards into the EU national health systems. It develops in particular high-quality evidence, clinical guidelines and practical tools, and support their implementation in clinical practice across Europe.
Another key aspect of SAMIRA is the education and training of researchers and professionals in radiology, radiotherapy and nuclear medicine. The initiative also seeks to reduce inequalities within and between EU countries by supporting access to modern technology and interventions.
A Commission Recommendation on clinical audits of medical radiological practices (2024/1112/Euratom) was adopted in April 2024, building upon the SGQS Position Paper of June 2023. It provides recommendations for establishing a national framework for clinical audits, with the aim of enhancing patient safety and improving radiological procedures across the EU.
Published by the Commission in September 2024, the Radiation Protection Publication RP 205 documents the EU JUST CT study carried out between 2021-2023. It includes the results of structured clinical audits of about 7 000 computed tomography (CT) referrals submitted to radiologic institutions in 7 EU countries, to identify whether a certain percentage of CTs are conducted without justification.
In the context of the Commission Recommendation on clinical audits of medical radiological practices, which advises EU countries to regularly audit, on a risk-based approach, the medical applications of ionising radiation in their healthcare institutions, this project provides a good practical example of implementation of clinical audit.
Besides the outcomes of the EU JUST CT clinical audits, the Radiation Protection Publication contains an overview of the systems for justification of CT in each EU country, discussion on how to bring systemic improvements in this area, and practical guidance for imaging departments. Therefore, it also reflects the December 2015 Council Conclusions on 'Justification of medical imaging involving exposure to ionising radiation', which call upon EU countries to strengthen the justification of CT including the application of clinical audits in relation to justification.
Facilitating innovation and the technological development
A coordinated EU approach to research and innovation in medical radiation applications aims to support acheiving a stable and resilient supply of medical radioisotopes, guarantee the quality and safety of applications and facilitate innovation in medical radiation therapies and imaging. The Commission aims to create synergies between the Euratom Research and Training Programme and the 'Health' cluster of Horizon Europe through implementation of a European Research Roadmap for medical applications of nuclear and radiation technology, developed after the Euramed Rocc-n-Roll strategic agenda
Studies and projects
Studies and projects conducted under SAMIRA and other projects related to SAMIRA topics are listed below.
The Directorate-General for Energy launched in 2020 a study to collect additional information on the radioisotope supply chains in Europe, laying the ground for long-term European cooperation in this area. The final report ‘Co-ordinated approach to the development and supply of radionuclides in the EU’ was issued in October 2021.
In January 2022, the European Commission’s Joint Research Centre issued the latest edition of ‘Study on sustainable and resilient supply of medical radioisotopes in the EU’, which presents an overview of the current use of radionuclides for medical therapy in Europe, as well as an estimate on the amounts being used. It also provides the expert opinion of more than 200 professionals on the future growth potential of the use of therapeutic radionuclides in the field of nuclear medicine and radiopharmacy.
2 Commission projects addressed the conversion of research reactors from high-enriched uranium (HEU) to low-enriched uranium (LEU)
- LEU FOREvER - Low Enriched Uranium Fuels fOR REsEarch Reactors (October 2017 - September 2022, Horizon 2020)
- EU-QUALIFY - EUropean QUalification Approach for Low EnrIched Fuel sYstems for secure production supply of medical isotopes (October 2020 - September 2024, Horizon 2020)
The TOURR project (Towards optimized use of research reactors in Europe) aimed to evaluate the current and future needs for research reactors and neutron sources in Europe (October 2020 - September 2023, Euratom R&T programme). For more information, see the TOURR platform.
In September 2023, the Directorate-General for Energy published a study on ‘Safe, sustainable operation of research reactor facilities in the EU’. The study highlights that, despite having achieved high safety levels, research reactors in the EU are still facing challenges (ageing, need for safety improvements funds and uncertainties regarding long term operation).
SECURE (Strengthening the European chain of supply for next-generation medical radionuclides) will focus on promising developments in the design of irradiation targets, production routes for existing and new isotopes in nuclear therapy and diagnostics (start: October 2022; duration: 36 months, Euratom R&T programme).
PRISMAP (Production of high-purity medical radionuclides by mass separation) is a project which aims to provide a single-entry point for researchers active in the field of medical radioisotopes, including SMEs, global pharma, nuclear centres, hospitals and universities, using standardised access procedures and involving from the onset, upcoming major European infrastructures (May 2021 - April 2025, Horizon 2020).
2 initiatives will contribute to ensure a safe and responsible management of waste resulting from medical application
- The ENSREG WG2 sub-group on radioactive waste from non-power applications
- The NuBaFA group of experts on financial aspects of nuclear decommissioning and spent fuel and radioactive waste management, created in June 2021
The EU-funded QuADRANT project promoted constant improvement in the quality and safety of radiology, radiotherapy and nuclear medicine through the implementation of clinical audit as part of EU countries’ healthcare systems (end date: July 2022). The results of the project were published in the Radiation Protection publication 198.
The EU-JUST-CT project aimed to improve the justification of computed tomography in the EU through the development and implementation of a common approach and coordinated action in this area among EU countries (start date: April 2021; duration: 36 months). The results and methodology of the project were published in the Radiation Protection publication 205.
SAMIRA Simplerad (study on the implementation of Euratom and EU legal bases with respect to the therapeutic uses of radiopharmaceuticals) aims to improve the understanding of the links and interdependencies between the European pharmaceutical legislations and Euratom radiation protection requirements (start date: May 2022; duration: 24 months).
SAMIRA ‘Equipment’ study aimed to improve the implementation of Directive 2013/59/Euratom on basic safety standard requirements for medical equipment with respect to monitoring and control of patient’s radiation exposures (start date: January 2022; duration: 24 months).
The i-Violin project aims to disseminate the image quality assessment tool developed in MEDIRAD for chest computed tomography in hospitals throughout Europe and adjust it for imaging procedures in the abdominal and pelvic regions (start date: September 2022, EU4Health).
The EU REST study aims to provide an analysis of workforce availability, education, and training needs to ensure quality and safety aspects of medical applications involving ionising radiation in the EU (start date: September 2022, 24 months, EU4Health).
A study aiming to improve reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and diagnostic radiology, was launched under the acronym MARLIN in January 2023 and lasts until December 2024.
MEDIRAD (Recommendations on implications of medical low dose radiation exposure) was designed to have direct implications for the radiological safety of European patients undergoing medical imaging and therapy procedures involving ionising radiation, and of exposed medical professionals. For this purpose, MEDIRAD established evidence-based consensus policy recommendations to enhance the effective protection of patients and medical professionals and to identify further research priorities (end date: February 2022).
EURAMED Rocc-n-roll (European medical application and radiation protection concept) developed a Strategic Research Agenda and Roadmap Interlinking Health and Digitisation Aspects (September 2020 - August 2023, Euratom R&T programme).
PIANOFORTE (Towards a safer use of ionising radiation and improved protection of the environment and human health), is a European partnership for research in radiation protection and detection of ionising radiation (start date: June 2022; duration: 60 months, Euratom R&T programme).
HARMONIC (Health effects of cardiac fluoroscopy and modern radiotherapy in paediatrics) aims at better understanding the long-term health effects of medical exposure to ionising radiation in children treated for cancer or cardiac defects (June 2019 - November 2024, Horizon 2020).
SINFONIA will develop novel methodologies and tools that will provide a comprehensive risk appraisal for detrimental effects of radiation exposure on patients, workers, carers and comforters, the public and the environment during the management of patients suspected or diagnosed with lymphoma and brain tumours (September 2020 - August 2024, Horizon 2020).
In 2019, the Commission published a Study on medical, industrial and research applications of nuclear and radiation technology. This report provides information on the non-power applications of nuclear and radiation technology in the EU with the view of identifying their key societal benefits and development perspectives.
The Marie Skłodowska Curie actions are the EU’s reference programme for doctoral education and postdoctoral training. The Euratom Programme 2021-2025 provides for synergies with Horizon Europe in this area by making Marie Skłodowska Curie actions fellowships available to researchers in radiation protection.
Events
- 28/2/2024
A workshop on medical radioisotopes was organised by the Belgian Presidency and DG Energy was invited to speak about how to unlock the opportunities of SAMIRA.
- 27/4/2023
The Commission organised a high-level workshop on the security of supply of medical radioisotopes, which focused on EU dependencies in the context of the Russian aggression in Ukraine.
- 19/5/2021
Together with the Dutch Ministry of Health, the Commission held a meeting on the security of EU supply of medical radioisotopes for beating cancer and the role of the Pallas project
- 13/11/2019
The Commission and the Finnish presidency of the Council of the EU hosted a workshop on 'Management of spent fuel and radioactive waste arising from non-energy uses of nuclear and radiation technologies'.
- 7/2/2019
The Commission hosted a technical workshop on 'Medical radioisotopes in the future' to investigate the challenges and opportunities in this area and discuss them with relevant stakeholders
- 20-21/3/2018
An international conference was organised by the Commission, highlighting how societal challenges can be addressed by advancing SAMIRA.
- 2017
The SAMIRA initiative started with an evidence-gathering and consultation phase in 2017.
Documents
Related links
- Commission adopts recommendation on clinical audits of medical radiological practices (18/4/2024)
- Press material on SAMIRA Action Plan (5/2/2021): Press release, factsheet, Q&A