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.
As an outcome the European Commission and stakeholders established on 29 June 2012 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
High-Level Group on Medical Radioisotopes (HLG-MR), of which the Commission is a Member,
and focuses on the specificities of their implementation in the
The European Observatory has four general strategic objectives: to support a secure Mo-99/Tc-99m supply across the EU, ensure that the Mo-99/Tc-99m supply issue is given high political visibility, encourage the creation of a sustainable economic structure of the supply chain and establish periodic reviews of the supply chain and capacities.
The Observatory is composed of members from the Euratom Supply Agency (ESA), the European Commission (DG ENER, JRC, RTD, SANCO and ENTR), the European Association of Nuclear Medicine (EANM) and various industry stakeholders most of which grouped within the Association of Imaging Producers & Equipment Suppliers (AIPES).
Communication to the Council of the European Union and the European Parliament on medical applications of ionizing radiation and security of supply of radioisotopes for nuclear medicine COM(210)423 (Working Document to the Communication SEC(2010)974) , 6 August 2010