Securing the supply of medical radioisotopes

The use of medical radioisotopes is an important part of modern medical practices. Each year, over 40 million people around the world benefit from nuclear medicine testing. Medical radioisotopes are used in non-invasive nuclear diagnostic imaging techniques to help identify common illnesses such as heart disease and cancer at an early stage. They are used to track disease progression and provide predictive information about the likely success of alternative therapy. This information helps health care professionals to accurately manage diseases and to make informed medical decisions on treatment options such as surgical intervention.

Recent supply shortages

Disruptions in the radioisotope supply chain can interrupt the availability of medical testing for millions of patients around world. Over the last few years there have been a number of supply shortages of the most widely used medical radioisotope, molybdenum-99 (⁹⁹Mo), and its decay product, technetium-99m (^99mTc). With a half-life of 66 hours for ⁹⁹Mo and 6 hours for ^99mTc, these isotopes must be produced continually and used efficiently in order to meet demand. Until recently, five multipurpose research reactors, all over 45 years old, have been producing over 95 percent of the world’s supply of ⁹⁹Mo. These aging facilities face challenges in maintaining a consistent supply to the health community and will likely be retired from service within the next 15 years.

High-level Group on the Security of Supply of Medical Radioisotopes

At the request of its member countries, the NEA became involved in global efforts to ensure a reliable supply of ⁹⁹Mo and ^99mTc. The NEA established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) in 2009. The HLG-MR is comprised of over 20 experts representing the governments of Argentina, Australia, Belgium, Canada, France, Germany, Italy, Japan, Korea, the Netherlands, Poland, the Russian Federation, South Africa, Spain, the United Kingdom and the United States, as well as from the European Commission, the Euratom Supply Agency and the International Atomic Energy Agency (IAEA). Members of the HLG-MR were nominated by governments and included experts from government agencies responsible for medical or nuclear policy, as well as from research and industrial organisations with interests in medical radioisotopes.

First mandate (June 2009-2011)

During the first mandate, the HLG‑MR examined major issues that affected the short-, medium- and long-term reliability of ⁹⁹Mo/^99mTc supply. The HLG‑MR, working with medical isotope stakeholders, completed a comprehensive assessment of the key areas of vulnerability in the supply chain and identified key issues that needed to be addressed. The group examined the supply and demand for ^99mTc , undertook a full economic analysis of the supply chain, and reviewed potential ⁹⁹Mo/^99mTc production technologies. From this analysis, the HLG-MR developed a policy approach to address the issues and ensure the long-term security of supply of these important medical isotopes.

As a result of the work of the first mandate, the NEA released five reports under The Supply of Medical Radioisotopes series. The final report, The Path to Reliability, provides the full findings and analysis of the issues facing the supply chain, and describes the HLG-MR policy approach to encourage long-term supply security of ⁹⁹Mo/^99mTc. The recommendations of the policy approach detail the essential steps to be taken by governments, industry and the health community to address the vulnerabilities within the supply chain, including changing an economic structure that does not support or reinforce reliable supply.

By the end of the first mandate, the supply situation of ^99mTc had stabilised with the return to service of two of the world’s five main supplying research reactors. In addition, members of the HLG-MR and other key stakeholders had implemented changes to address some of the immediate challenges affecting the security of supply. However, the underlying problem – that of an unsustainable economic structure – still remains to be adequately addressed. The market has not completed the necessary restructuring towards sustainably and thus, the long-term supply situation is no more stable or secure than it was during the shortage periods. The full implementation of the policy approach would address this key area of vulnerability.

Second mandate (July 2011-2013)

Recognising that continued action was required on the part of all stakeholders to implement the HLG-MR policy approach in a context of international cooperation, the NEA established the second mandate of the HLG-MR. The objective of the HLG-MR during its second mandate is to work towards increasing the long-term security of supply of ⁹⁹Mo and ^99mTc , especially through the implementation of the HLG-MR policy approach and its associated recommendations. This will entail actions to maintain transparency on global developments, continue communication with the supply chain and end users, evaluate progress toward implementation and provide additional information and analysis where necessary. The broad deliverables of the HLG-MR second mandate are:

Sharing information on the status of the ⁹⁹Mo/^99mTc market.
Communicating the HLG-MR policy approach to governments and other supply chain participants, including working more closely with the health community.
Providing guidance on specific aspects of implementing the HLG-MR policy approach, such as developing a guidance document on full-cost recovery.
Supporting the implementation of all aspects of the HLG-MR policy approach, where appropriate and feasible, including working with the health community to study issues that may help them to accept, adjust or become better informed about the policy approach and its consequences for patients.
Carrying out studies related to security of supply, such as analysing the market and economic impact of converting to using low enriched uranium targets for ⁹⁹Mo production.
Evaluating the progress towards the implementation of the HLG-MR policy approach, including through undertaking a periodic review of the supply chain.
Re-evaluating the policy approach once experience has been obtained.