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SAMIRA Action Plan

The SAMIRA action plan is the EU’s first comprehensive plan for action to support a safe, high quality and reliable use of radiological and nuclear technology in healthcare.

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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 for action to support a safe, high quality and reliable use of radiological and nuclear technology in healthcare. It builds upon previous achievements and paves the way for future coordinated EU action. The action plan defines EU actions in 3 priority areas: securing the supply of medical radioisotopes, improving radiation quality and safety in medicine and facilitating innovation and the technological development of medical ionising radiation applications.

Securing the supply of medical radioisotopes

The Commission has started a process towards establishing a European Radioisotope Valley Initiative (ERVI) to maintain Europe's global leadership in the supply of medical radioisotopes and help accelerate the development and introduction of new radioisotopes and production methods.

In August 2022, the Commission launched a consultation to gather the positions of stakeholders on the ERVI objectives and the specific issues concerning the supply chain of medical radioisotopes in order to define a concrete roadmap for the ERVI initiative, focusing on actions in which the EU can have decisive added value (end date of the consultation: 14 October 2022). Over the next few years, the Commission will engage with stakeholders and launch feasibility studies before considering a legal framework for this initiative.

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 the radioisotopes production. The Commission is examining the EU 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 radiation quality and safety in medicine

The Commission launched in 2021 a European Initiative on Quality and Safety of medical applications of ionising radiation aiming to ensure that diagnostic and therapeutic uses of ionising radiation in EU countries are in line with high standards for quality and safety, in the interest of patients.

To achieve the coordination and complementarity required in this area, the Commission has created the Steering Group on Quality and Safety (SGQS) of medical applications of ionising radiation, a group with representatives of EU countries from both the health and the radiation protection authorities. The SGQS will provide a common European platform to support the implementation and integration of European requirements for radiation protection and other quality and safety standards into the EU countries' health systems. It will develop in particular high-quality evidence, clinical guidelines and practical tools, and support their implementation in clinical practice across Europe.

Specific actions aim to coordinate the implementation of the Euratom requirements for radiation protection in medicine with the relevant elements of EU health legislation and policy. Another key aspect concerns education and training of researchers and professionals in radiology, radiotherapy and nuclear medicine, where the SAMIRA Action Plan foresees further support through EU programmes in this area. Finally, the initiative seeks to reduce inequalities within and between EU countries by supporting access to modern technology and interventions.

Facilitating innovation and the technological development

A coordinated European approach to research and innovation in medical applications of ionising radiation aims to support 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 the development and implementation of a Strategic Research Agenda and Roadmap for medical applications of nuclear and radiation technology.

SAMIRA's initiative is supported by several EU programmes. The Directorate-General for Energy provides implementation support for the Euratom legal requirements in EU countries. The EU4Health programme supports the quality and safety of radiation technology in diagnosis and cancer treatment. The 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 building synergies with Horizon Europe in the future.

Studies and projects

Studies and projects conducted under SAMIRA and other projects related to SAMIRA topics are listed below.

Supply of medical radioisotopes

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 on future growth potential of the use of therapeutic radionuclides of more than 200 professionals in the field of nuclear medicine and radiopharmacy. 

Two Commission’s projects have been launched on 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) aims to evaluate the current and future needs for research reactors and neutron sources in Europe (October 2020 - September 2023, Euratom R&T programme).

In January 2022, the Directorate-General for Energy launched a study on ‘Safe, sustainable operation of research reactor facilities in the EU’ (duration: 18 months).

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 (expected start: October 2022; duration: 36 months, Euratom R&T programme).

PRISMAP (Production of high purity medical radionuclides by mass separation) is a project whose main goal is to provide a sustainable source of high-purity grade new radionuclides for medicine, involving from the onset upcoming major European infrastructures to provide a single-entry point for all researchers active in this field, including SMEs, global pharma, nuclear centres, hospitals and universities, using standardised access procedures (May 2021 - April 2025, Horizon 2020).

Two 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

Quality and safety of medical applications of ionising radiation

The EU-funded QuADRANT project promotes constant improvement in 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 EU-JUST-CT project aims to improve the justification of computed tomography in the EU through the development and implementation of common approach and coordinated action in this area among EU countries (start date: April 2021; duration: 36 months).

SAMIRA Simplerad (study on 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 aims 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 (expected start: September 2022, EU4Health).

A study on workforce availability, education and training needs for the quality and safety of medical applications involving ionising radiation in the EU will also start in autumn 2022 (duration: 24 months, EU4Health).

The Commission has recently launched a call for tenders for a SAMIRA study on Reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and diagnostic radiology. The call will close on 15 September 2022.

Innovation and technological development

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, will develop 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 an 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 up-to-date 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 European Union’s reference programme for doctoral education and postdoctoral training. 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

The SAMIRA initiative started with an evidence gathering and consultation phase in 2017. An international conference was organised by the Commission in March 2018, highlighting how societal challenges can be addressed by advancing SAMIRA.

The Commission also hosted a technical workshop on 'Medical radioisotopes in the future' in 2019 to investigate the challenges and opportunities in this area and discuss them with relevant stakeholders.

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' in 2019. The workshop results contributed to the preparation of the Council conclusions from December 2019 on this subject area.

The Commission, together with the Dutch Ministry of Health, held a meeting on the security of EU supply of medical radioisotopes for beating cancer and the role of the Pallas project (new medical isotopes reactor that should replace the old High Flux Reactor in Petten, Netherlands) in May 2021. The aim was to better understand what is needed to secure the future supply of medical radioisotopes in the EU for diagnostics and the development of innovative treatments of cancer, and to discuss how EU countries and the Commission can cooperate on specific radioisotope supply projects and initiatives.

Documents

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