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 for human health, including the fight against cancer.
Medical uses of radiological and nuclear technologies benefit patients all across Europe. The EU is a global leader for supplying medical radioisotopes and for developing radiological diagnostics and treatments. In addition, it has also led the way in establishing legal standards for quality and safety in radiology, radiotherapy and nuclear medicine.
Ionising radiation and cancer management
The 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.
Radiological imaging, like mammography and computer tomography, is of key importance, as it uses x-rays for diagnosis, 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.
Nuclear medicine uses radioactive substances, mostly to diagnose cancer, as well as cardiac and other diseases. In the EU, about 10 million procedures are delivered to patients each year. Nuclear medicine is therefore 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 a crucial part of modern cancer care and among the most effective, efficient and widely used cancer treatments available to patients and physicians.
Despite the many benefits that medical radiation technologies bring to patients across the EU, the growing use of these technologies have also caused a significant increase in the radiation exposure of the European population.
Medicine is now responsible for up to half of the total radiation exposure of EU citizens and more than 90% of the man-made radiation exposure. At the same time, it is 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 and improved staff training, as well as equipment upgrades and greater involvement of manufacturers in its clinical use.
There is a need to secure the European supply of medical radioisotopes in the long term to maintain EU patients’ access to vital medical procedures and support the development of new cancer treatments. This will require significant investments in the supply chain for radioisotopes, particularly in securing source materials and new irradiation capacity. Many of the source materials in the production chain are not readily available in the EU, but are rather imported from limited stocks or production in third countries. In addition, the EU research reactors used to produce medical radioisotopes are on average 40 years old and experiencing ageing issues and will need to undergo major refurbishments, or be replaced with new reactors or by other production facilities by 2030 to avoid radioisotope shortages.
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.
EU legal framework and initiatives for radiation protection in medicine
The Euratom Treaty defines a key Euratom competence for health and safety with respect to establishing uniform safety standards for protection against the dangers arising from exposure to ionising radiation. The EU has established an ambitious legal framework for protecting patients, volunteers in medical research and medical staff from ionising radiation. This framework aims to ensure that medical ionising radiation procedures are used only when appropriate and with the minimum clinically needed radiation dose. It also includes requirements with respect to staff, procedures and equipment in use, and mandates a number of quality and safety tools, with particular attention to applications involving high radiation doses and/or childhood exposures to ionising radiation.
Euratom legislation on radiation protection in medicine was first adopted in the 1980s, followed in 1997 by new legislation which considerably expanded and strengthened the rules in this area. Directive 2013/59/Euratom on basic safety standards brought important changes to radiation protection in medicine, particularly regarding the recording of radiation doses, the role of medical physicist and risk assessments.
Besides this directive, some aspects of medical applications of ionising radiation are regulated under other legal instruments adopted pursuant to 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) No 726/20044 on medicinal products.
In addition, the Commission has taken legally non-binding initiatives to support EU countries. For instance, it adopted in 2010 the Communication on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine. 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 a safe, high-quality and reliable use of radiological and nuclear technology in healthcare. The Commission also issues regular publications on radiation protection in the medical sector in the ‘radiation protection series’.
- Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) (SWD (2021) 14 final)
- 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)