Paris, 17 December 2014
Eleven countries have formally adhered to the Joint Declaration on the Security of Supply of Medical Radioisotopes which seeks to ensure the security of supply of the most widely used medical radioisotope, molybdenum-99 (99Mo). Additional countries may adhere going forward and are being encouraged to do so by the Council of the Organisation for Economic Co-operation and Development (OECD).
The Joint Declaration provides a co-ordinated political commitment by countries involved in the production and use of medical radioisotopes to help bring about the necessary changes across the supply chain. It sends a clear signal to the actors in the medical radioisotope supply chain that the governments have the resolute intention to take co-ordinated action to ensure the long-term security of supply of this important medical radioisotope. This effort, which was co-ordinated through the Nuclear Energy Agency (NEA) High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR), promotes, among other steps, full-cost recovery of isotope production and the availability of reserve capacity. The Joint Declaration also provides a platform for ongoing discussions among participating countries on their current or potential future involvement in the supply chain for molybdenum-99 (99Mo).
The Joint Declaration, to which the governments of Australia, Canada, Germany, Japan, the Netherlands, Poland, the Republic of Korea, the Russian Federation, Spain, the United Kingdom and the United States have formally adhered, was presented today to the OECD Council and can be found at www.oecd-nea.org/med-radio/jointdeclaration.html. It remains open to adhesion by the remaining countries participating in the HLG-MR as well as by any other country that wishes to do so.
The NEA will continue to support global efforts to ensure a long-term, secure and reliable supply of medical radioisotopes by providing relevant information, economic analyses and policy recommendations on the market situation.
Background notes to editors
Molybdenum-99 (99Mo) is the most widely used medical isotope in the world, used approximately 40 million times worldwide every year in advanced, highly accurate medical diagnoses. 99Mo is produced through irradiation of uranium targets in various research reactor facilities around the world. This material, which has a rather short, 66-hour half-life, decays to another radioisotope – technetium-99m (99mTc) – as it is packaged and shipped for use by physicians. It is the 99mTc which is injected into patients to enable sophisticated imaging techniques needed to diagnose cancer, heart disease and other ailments. 99mTc has a very short half-life – only 6 hours – and it decays to nonradioactive materials and thus limits patient exposure.
Because these materials have such short half-lives, they must be produced continuously. Disruptions in the supply chain of these medical isotopes can lead to cancellations or delays in important medical testing services. Unfortunately, supply reliability has declined over the past decade due to unexpected or extended shutdowns at a few of the ageing, 99Mo-producing research reactors and processing facilities. These shutdowns have created conditions for global supply shortages.
At the request of its member countries, the Nuclear Energy Agency (NEA) became involved in global efforts to ensure a secure supply of 99Mo/99mTc. Since June 2009, the NEA and its High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) have examined the causes of supply shortages and developed a policy approach, including principles and supporting recommendations to address those causes. The NEA has also reviewed the global 99Mo supply situation periodically, using the most recent data from supply chain participants, to draw attention to potential periods of reduced supply and to underscore the case for implementing the HLG-MR policy approach in a timely and globally consistent manner.
Governments are involved in the global 99Mo/99mTc supply chain primarily at each end, at the reactor and end-use levels. The vast majority of 99Mo producers represented in-between are commercial, for-profit entities. Although governments have been reducing their support for 99Mo irradiations at reactors, much remains to be done to achieve universal implementation of full-cost recovery. Despite real progress since the adoption of the HLG-MR policy principles (see www.oecd-nea.org/med-radio/statement.html), some governments continue to subsidise 99Mo production, thus supporting healthcare systems both nationally and in other countries. While it is their prerogative to fund basic research at reactors, any commercial 99Mo production as part of the global supply chain should comply with the principle of full-cost recovery to avoid distorting the global market.
The HLG-MR, whose main objective is to strengthen the reliability of 99Mo and 99mTc supply in the short, medium and long term, is comprised of more than 40 experts representing the governments of Argentina, Australia, Belgium, Brazil, Canada, the Czech Republic, France, Germany, Japan, the Netherlands, Poland, the Republic of Korea, the Russian Federation, South Africa, Spain, the United Kingdom and the United States, as well as the European Commission (Euratom Supply Agency) and the International Atomic Energy Agency (IAEA). Members of the HLG-MR are nominated by governments and include experts from government agencies responsible for medical or nuclear policy, as well as from research and industry organisations with interests in medical radioisotopes.