In line with its strategic objective, ESA leads the actions towards securing the supply of source materials for the radioisotopes production, thus actively contributing to the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA).
The Agency undertakes measures to ensure security of supply of high-enriched uranium (HEU) and high-assay low-enriched uranium (HALEU), required to feed the production of medical radioisotopes and to fuel research reactors. These strategic materials are currently not produced in the Community and must be imported from the US or the Russian Federation.
In cooperation with the Member States concerned, ESA facilitates the supply of HEU to users who still need it until their conversion to HALEU, in line with international nuclear security and non-proliferation commitments. A dedicated Working Group on HALEU explores possible specific industrial and commercial options for building a European capacity for producing HALEU metal responding to the EU needs for the research reactors fuel and medial radioisotopes production
ESA also monitors the production chain of medical radioisotopes through the European Observatory on the Supply of Medical Radioisotopes.
Radioisotopes are used in medicine for the diagnosis and treatment of various diseases, including some of the most important ones, like cancers, cardiovascular and brain disorders. Over 10000 hospitals worldwide use radioisotopes for the in vivo diagnosis or treatment of about 35 million patients every year, of which 9 million in Europe.
Technetium-99m (Tc-99m) is the most widely used (diagnostic) isotope.
Europe is the second largest consumer of Tc-99m, accounting for more than 20% of the global market.
The production of Tc-99m is a complex process which includes irradiation of uranium targets in nuclear research reactors to produce Molybdenum-99 (Mo-99), extraction of Mo-99 from targets in specialised processing facilities, production of Tc-99m generators and shipment to hospitals. Unfortunately, the current Tc-99m supply relies on an unsustainably low number of production reactors. As those reactors were constructed in the 1950s and 1960s, they are approaching the end of their lifespan, which causes an increasing need for planned maintenance shutdowns and a growing frequency of unplanned production interruptions. As a result, the global supply of radioisotopes has become more fragile, particularly in recent years.
A severe supply crisis in 2008-2010 of Mo-99 and its decay product, Tc-99m, has resulted in many patients having important diagnostic tests cancelled or delayed and has exposed the fragility of the current production chain. Without change the supply of Mo-99/Tc-99m will continue to be unreliable, jeopardising key medical imaging services for millions of patients.
The European Union already undertook several initiatives to respond to the critical situation regarding the supply of radioisotopes for medicine. The issue has been discussed by the EU Health Security Committee and by the Council of the European Union, who came with conclusions calling for further actions by the European Commission and Member States.
The European Medicines Agency and the European Commission took several initiatives to identify possible medium- and long-term solutions to the current situation, including the organization of a Workshop on Current Use and Future Needs of Radiopharmaceuticals Labelled with Radionuclides Produced in Reactors and Possible Alternatives (February 2010) and the organization of a series of stakeholders meetings (2010 – 2012) to define a European solution.
On 29 June 2012, the European Commission and stakeholders established a European Observatory on the Supply of Medical Radioisotopes, aimed at bringing together all relevant information to the decision makers in the EU institutions and national governments in order to assist them in defining strategies and policies for their implementation. The Observatory follows the OECD/NEA principles established by the , of which the Commission is a Member, and focuses on the specificities of their implementation in the EU.
The European Observatory has four general strategic objectives:
- to support a secure Mo-99/Tc-99m supply across the EU,
- to ensure that the Mo-99/Tc-99m supply issue is given high political visibility,
- to encourage the creation of a sustainable economic structure of the supply chain, and
- to establish periodic reviews of the supply chain and capacities.
The Observatory is composed of members from the Euratom Supply Agency, the European Commission (DG ENER, JRC, RTD, SANTE and GROW), (EANM) and various industry stakeholders most of which grouped within the industry association (NMEu).
Mission Statement of the European Observatory on the Supply of Medical Radioisotopes, 30 March 2021
The Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) is the energy sector's contribution to the Europe's Beating Cancer Plan, and a response to the EU Council's conclusion on non-power nuclear and radiological technologies and applications, from 24 May 2019.
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 will pave the way for future coordinated EU action.
ESA has contributed to the preparation of the action plan and is actively involved in its implementation. It leads the actions towards securing the supply of source materials for the radioisotopes production, namely :
- to support High Enriched Uranium supply until full radioisotope supply chain conversion to High Assay Low Enriched Uranium;
- to explore options for the European supply of High Assai Low Enriched Uranium.
In addition, ESA will perform the EU monitoring of supply of most relevant medical radioisotopes and participates to the European Radioisotope Valley Initiative action.
- Updated Mission Statement of the European Observatory on the Supply of Medical Radioisotopes of 30 March 2021
- Council Conclusions on “Non-power nuclear and radiological technologies and applications”, Council of the European Union, 06 June 2019
- European Research Reactor Position Paper by CEA, NCBJ, NRG, PALLAS, RCR, SCK•CEN and TUM, 15 June 2018
- Nuclear and Radiation Studies Board; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine, "Opportunities and Approaches for Supplying Molybdenum-99 and Associated Medical Isotopes to Global Markets: Proceedings of a Symposium", 20 February 2018
- Mission statement of the European Observatory on the Supply of Medical Radioisotopes, 28 July 2017 (currently under review)
- Committee on State of Molybdenum-99 Production and Utilization and Progress Toward Eliminating Use of Highly Enriched Uranium; Nuclear and Radiation Studies Board; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine - , 20 September 2016
- The Netherlands Presidency Paper on the security of supply of medical radioisotopes,
25 May 2016
- Capacity and Infrastructure Development - report of the Working Group of the European Observatory on the Supply of Medical Radioisotopes, July 2014
- Management of conversion from HEU to LEU and Target Production - report of the Working Group of the European Observatory on the Supply of Medical Radioisotopes, December 2013
Creation of the European Observatory on the Supply of Medical Radioisotopes – press release, 29 June 2012