Molybdenum-99 (99Mo) and its decay product, technetium-99m (99mTc), the most widely used medical radioisotope, are used in medical diagnostic imaging techniques that enable precise and accurate, early detection and management of diseases such as heart conditions and cancer, all in a non-invasive manner. The imaging can significantly impact medical decisions, for example, by providing predictive information about the likely success of alternative therapy options or whether there is a need for surgical intervention. 99mTc medical imaging techniques account for over 80% of all nuclear medicine procedures, representing over 30 million examinations worldwide every year.
Disruptions in the supply chain of these medical isotopes – which have half-lives of 66 hours (99Mo) and 6 hours (99mTc) respectively and thus must be produced continually – can impact medical diagnostic capabilities. The significant supply shortages faced by the global community over the past few years resulted in many patients having important diagnostic tests cancelled or delayed.
These shortages resulted from the shutdown of two of the five major research reactors, all of which are more than 44 years old and together produce more than 90-95% of the global supply of 99Mo.
In mid-2009, the OECD Nuclear Energy Agency (OECD/NEA) established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) with a two-year mandate. The main objective is to strengthen the reliability of 99Mo/99mTc supply in the short, medium and long term. The HLG-MR has examined the major issues that affect the reliability of 99Mo/99mTc supply and determined that the fundamental issue was the unsustainable economic model behind the provision of 99Mo to the supply chain.
The collective efforts of HLG-MR members and nuclear medicine stakeholders have allowed for a comprehensive assessment of the key areas of vulnerability in the supply chain and an identification of the issues that need to be addressed. Significant progress has already been achieved on improving the supply situation through increased communication, co-ordination of research reactor schedules and a better understanding of demand-management opportunities.
Even though the current supply situation has stabilised, the OECD/NEA Steering Committee for Nuclear Energy stresses that the underlying problem – the unsustainable economic structure – remains to be adequately addressed; the market has not restructured sustainably and supply shortages could become commonplace over the next decade unless actions are taken to ensure long-term security of supply.
The HLG-MR is currently developing a cohesive policy approach to address supply chain issues in order to move towards a long-term, secure supply of 99Mo and 99mTc. At its last meeting, the HLG-MR agreed on the necessary aspects of this approach, including a set of principles that should apply to countries exporting to or influencing the global market. The application of these principles is essential to achieving change and realising secure supply. This policy approach recognises the need for structural reform of the supply chain and includes clear actions by governments to establish the proper environment for the creation and functioning of an economically sustainable supply chain.
The OECD/NEA Steering Committee for Nuclear Energy confirms its support for the policy approach suggested by the HLG-MR, which is based on the following six principles:
Principle 1: All 99mTc supply chain participants should implement full-cost recovery, including costs related to capital replacement.
Principle 2: Reserve capacity should be sourced and paid for by the supply chain. A common approach should be used to determine the amount of reserve capacity required and the price of reserve capacity options.
Principle 3: Recognising and encouraging the role of the market, governments should:
These changes should occur expeditiously, recognising however that time will be required to allow for the market to adjust to the new pricing paradigm.
Principle 4: Given their political commitments to non-proliferation and nuclear security, governments should provide support, as appropriate, to reactors and processors to facilitate the conversion of their facilities to low enriched uranium or to transition away from the use of highly enriched uranium, wherever technically and economically feasible.
Principle 5: International collaboration should be continued through a policy and information sharing forum, recognising the importance of a globally consistent approach to addressing security of supply of 99Mo/99mTc and the value of international consensus in encouraging domestic action.
Principle 6: There is a need for periodic review of the supply chain to verify whether 99Mo/99mTc producers are implementing full-cost recovery and whether essential players are implementing the other approaches agreed by the HLG-MR, and that the co-ordination of operating schedules or other operational activities have no negative effects on market operations.
The OECD/NEA Steering Committee for Nuclear Energy calls on governments and industry to work together to implement these principles in a timely and effective manner, recognising the need for an internationally consistent approach to ensure the long-term secure supply of medical radioisotopes.