Radiological and nuclear technologies provide a wide range of benefits to EU citizens beyond the production of nuclear energy. In particular, they are indispensable in the fight against cancer.
The EU is a global leader on supplying medical radioisotopes and for developing radiological diagnostics and treatments.
It has also led the way in establishing legal standards for quality and safety in radiology, radiotherapy and nuclear medicine. The SAMIRA action plan is the EU’s comprehensive plan to support the safe, high quality and reliable use of radiological and nuclear technology in healthcare.
Benefits of radiation medicine
Radiological and nuclear technologies contribute significantly to all stages of patient care, including early disease detection, diagnosis, treatment and palliative care.
Radiological imaging procedures, such as mammography and computer tomography, use x-rays for diagnostics as well as planning and guiding treatments. With about 500 million of these procedures carried out annually in the EU, it is by far the most widespread medical application of radiation.
Nuclear medicine uses radioactive substances, mostly to diagnose cancer, as well as cardiac and other diseases. In the EU, about 10 million of these procedures are delivered to patients each year. It is therefore an important tool in cancer management, contributing to early diagnosis and prognostic assessment, and increasingly for therapy.
Radiotherapy uses high-energy x-rays, charged particles or radioactive sources, mostly for cancer therapy. With 1.5 million procedures carried out in Europe annually, it is a crucial part of modern cancer care and among the most effective, efficient and widely used treatments available to patients and physicians.
Modern radiation-based imaging and therapy are constantly progressing, leading to new and improved approaches to diagnosing and treating cancer and other major diseases. Although private investments help support the technological innovation, it will likely not be enough to meet the needs of public health systems. It is therefore important that the EU identifies specific research needs and keeps a dialogue with national authorities, medical professionals, industry, researchers and other key stakeholders.
Radiation exposure
Despite the many benefits of medical radiation technologies, their growing use has also caused a significant increase in the EU population's overall exposure to radiation.
Medicine is now responsible for up to half of the total radiation exposure of EU citizens and more than 90% of the human-made radiation exposure. It is therefore necessary to ensure that radiological imaging procedures are performed strictly in line with clinical needs, as there is a potential for better adapting radiation doses and image quality to diagnostic needs. The rapid pace of technological innovation requires increased availability of improved staff training, equipment upgrades and greater involvement of manufacturers in its clinical use.
EU legal framework and initiatives for radiation protection in medicine
Under the Euratom Treaty, ensuring health and safety with respect to the harmful effects of radiation exposure is a key role of Euratom. It is therefore responsible for establishing the relevant uniform safety standards across the EU.
In this context, the EU has established an ambitious legal framework for protecting patients, volunteers in medical research and medical staff. It aims to ensure that medical radiation procedures are used only when appropriate and with the minimum clinically needed radiation dose. It also includes strict requirements for staff, procedures and equipment and introduces a number of quality and safety tools, with a particular focus on high radiation doses and/or childhood exposure.
Some aspects of medical applications of radiation are regulated under other legal instruments adopted in line with the Euratom Treaty, such as Directive 2011/70/Euratom on the responsible and safe management of spent fuel and radioactive waste. Relevant aspects are also included under the Treaty on the Functioning of the European Union, for example in Regulation (EU) 2017/745 on medical devices or in Directive 2001/83/EC and in Regulation (EC) 726/20044, both on medicinal products.
Additionally, the Commission has taken a range of legally non-binding initiatives. For instance, in February 2021, the Commission adopted the SAMIRA action plan, which is the first follow-up to Europe’s Beating Cancer Plan and the EU’s first comprehensive plan for action to support the safe, high-quality and reliable use of radiological and nuclear technology in healthcare. Commission Recommendation (2024/1112/Euratom) provides measures for establishing a national framework for clinical audits of medical radiological practices, with the aim of enhancing patient safety and improving radiological procedures across the EU. The Commission also issues regular publications on radiation protection in the medical sector in the ‘radiation protection series’.
Timeline
- 2021
Commission adopted the SAMIRA action plan
- 2017
Regulation (EU) 2017/745 on medical devices
- 2013
Directive 2013/59/Euratom introduced stronger rules particularly on the recording of radiation doses, the role of medical physicists and risk assessments
- 2011
Directive 2011/70/Euratom on the responsible and safe management of spent fuel and radioactive waste
- 1997
Euratom legislation on radiation protection in medicine considerably expanded and strengthened
- 1980's
Euratom legislation on radiation protection in medicine first adopted
- 1950's
Euratom legislation on radiation protection of workers and the general public first adopted
Documents
- 24 SEPTEMBER 2021
Related links
- Medical applications of ionising radiation for better patients’ lives: A European Research Roadmap (2024)
- Europe's Beating Cancer Plan
- SAMIRA Action Plan
- European Observatory on the Supply of Medical Radioisotopes
- Radiation protection publications
- Medical devices in cancer management – World Health Organisation
- Communication from the Commission on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine (COM/2020/423) | Staff working document (SEC/2010/974)
- Nuclear Safety Directive Amendment (2014/87)
- Euratom Basic Safety Standards Directive (2013/59)
- Spent Fuel and Radioactive Waste Directive (2011/70)