Questions and Answers: SAMIRA Action Plan

Source: European Commission (EC) i, published on Friday, February 5 2021.
  • Why do we need an EU Action Plan for medical applications of radiological and nuclear technology?

Radiological and nuclear science and technologies provide a wide range of benefits to EU citizens in many areas beyond the production of nuclear energy, in particular in relation to human health and the fight against cancer. Medical uses of these technologies benefit patients all across Europe. Europe is the leading world supplier of medical radioisotopes and a world leader in developing radiological diagnostics and treatments. We have also led the way in establishing standards and legislation for quality and safety in radiology, radiotherapy and nuclear medicine.

The SAMIRA Action Plan - the Strategic Agenda for Medical Ionising Radiation Applications is our first comprehensive plan for action to support safe, high-quality and equitable use of radiological and nuclear technology in healthcare, which will build upon the above achievements and pave the way for future coordinated EU action.

It responds to the call by the Council of the EU to propose such a plan to ensure that EU citizens have access to high-quality radiological and nuclear technologies in medicine with the highest safety standards. It also aims to improve EU coordination in this area and guide the complementary use of EU Energy, Health and Research programmes and instruments. It seeks to reduce inequalities within and between Member States through improved workforce availability, radiation safety culture, education and training.

  • What measures are included in the Action Plan?

The SAMIRA Action Plan contains measures in three priority areas: (i) securing the supply of medical radioisotopes, (ii) improving radiation quality and safety in medicine, and (iii) facilitating innovation and the technological development of medical ionising radiation applications. Among other actions, it includes:

  • The Commission will establish 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. Over the next few years, the Commission will engage with stakeholders and launch feasibility studies before considering a legal framework for this initiative.
  • Regarding the supply of source materials for radioisotopes production, the Euratom Supply Agency (ESA) will support short- to medium-term supply of High Enriched Uranium (HEU) and explore options for European production of High-Assay Low Enriched Uranium (HALEU). The Commission is examining the EU needs for other source materials and, as part of the ERVI work, will consider EU support for their domestic production.
  • To secure the long-term sustainability of radioisotope production in Europe, the Commission will ensure a continuous monitoring of the supply of medical radioisotopes; support research reactors conversion to HALEU; develop a roadmap for optimised use of research reactors; and guarantee safe long-term operation of research reactors as well as the safe and responsible management of waste resulting from medical applications.
  • The Commission will launch a European Initiative on Quality and Safety of medical applications of ionising radiation. This will also 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 Member States' health systems. It will, in particular, develop high-quality evidence, clinical guidelines and practical tools, and support their implementation in clinical practice across Europe.
  • The Commission will put particular emphasis on monitoring staffing, education and training levels across the EU, and continue to support EU researchers and professionals in radiology, radiotherapy and nuclear medicine through the established EU programmes in the education and training area.
  • The Commission will create synergies between the Euratom Research and Training Programme and the 'Health' cluster of the EU research programme Horizon Europe through the development and implementation of a Research Roadmap for medical applications of nuclear and radiation technology.
  • How does the SAMIRA Action Plan help to reach the objectives of Europe's Beating Cancer Plan?

Radiological and nuclear technologies are indispensable in the fight against cancer. They contribute significantly to all stages of cancer patients' care, including early detection, diagnosis, treatment and palliative care.

The SAMIRA Action Plan will support several of the objectives of Europe's Beating Cancer Plan:

  • The actions on quality and safety will reduce the risks of undesirable effects of the medical uses of radiation and contribute to cancer prevention in the EU.
  • The actions to support stable and resilient supply of radioisotopes will help secure EU citizens' access to high-standard cancer diagnosis and treatment.
  • The coordinated EU actions on research and innovation will contribute to developing more efficient methods and technology for early detection, diagnosis and treatment of cancer.
  • Overall, SAMIRA will help to ensure equitable, affordable and sustainable cancer prevention, early detection and care, and contribute to the quality of life of cancer patients.
  • Which types of medical applications of radiological and nuclear technology are covered?

A variety of nuclear and radiation technologies play a key role in the fight against cancer:

  • Radiological imaging uses x-rays for diagnosis, as well as for planning and guiding treatments. With about 500 million procedures carried out in the EU annually, it is by far the most widespread form of medical application of ionising radiation. Radiological imaging, including mammography and computed tomography, is indispensable in all stages of cancer management.
  • Nuclear medicine uses radioactive substances, mostly for diagnosis of cancer, cardiac and other diseases. In the EU, about 10 million procedures are delivered to patients each year. Nuclear medicine is an important tool for cancer management, contributing to early cancer diagnosis and prognostic assessment, and increasingly available for therapy.
  • Radiotherapy uses high-energy x-rays, charged particles or radioactive sources for cancer therapy. With 1.5 million procedures in Europe annually, it is an indispensable part of modern cancer care, and among the most effective, efficient and widely used cancer treatments available to patients and physicians.
  • Why is the supply of radioisotopes important, and how has the EU secured access for patients?

There is a need to secure the supply of medical radioisotopes in the medium to long term, in order to maintain EU patients' access to vital medical procedures and support the development of new treatments to help in the fight against cancer.

Radioisotope production chains rely on source materials that are not readily available in the EU, and need to be imported from limited stocks or production in third countries. The EU research reactors that used to produce medical radioisotopes are ageing and will need to be replaced by 2030 to avoid radioisotope shortages. This will require significant investment but also creates opportunities for efficiency and sustainability gains through technological innovation in the radioisotopes supply chain.

Following the 2009-2010 radioisotope supply crisis, the EU addressed this issue in a 2010 Commission Communication and Council conclusions, which proposed a set of principles and actions to ensure the sustainable production of radioisotopes in the EU. In response, the Commission and industry stakeholders jointly established a European Observatory on the Supply of Medical Radioisotopes to support the continuity of supply of medical radioisotopes. The EU provided financial assistance for relevant projects, including Euratom research funds for research reactor projects and fuels, and for radioisotope projects by the European Regional Development Fund and the European Investment Bank. The Commission promoted several studies and organised stakeholder meetings to inform about the actions proposed in the SAMIRA Action Plan.

  • How does the EU ensure high standards of quality and safety of medical radiological diagnoses and treatments?

The Euratom Treaty defines the EU competence for health and safety with respect to ionising radiation. The Union has accordingly established an ambitious legal framework in this area, known as the “Basic Safety Standards” (BSS) Directive. The BSS Directive is a key driver for the quality and safety of medical applications of ionising radiation in Member States and in everyday medical practice. The 2013 update of this framework brought several important changes, which benefit EU patients and medical staff. The Commission supports and publishes guidelines for the implementation of the BSS Directive in medicine. Legislative developments on medical devices, as well as EU guidelines on breast cancer screening are also highly relevant to quality and safety of medical radiological applications. The Commission is also co-operating with international organisations, European regulators and professional organisations under various initiatives in this area.

For more information

Press release - IP/21/265

Factsheet - FS/21/268