NEA Mandates and Structures

Expert Group on Medical Radioisotopes (EG-MR)

Mandate (Document reference):

• High-level Group on the Security of Supply of Medical Radioisotopes-Second Mandate [NEA/NDC(2011)22]
• The Supply of Medical Radioisotopes Progress and Future Challenges in Implementing the HLG-MR Policy Principles: Final Report of the Second Mandate (2011-2013) of the HLG-MR [NEA/SEN/HLGMR(2013)7]
• High-level Group on the Security of Supply of Medical Radioisotopes - Third Mandate [NEA/NDC(2013)25]
• High-level Group on the Security of Supply of Medical Radioisotopes - The Supply of Medical Radioisotopes - Final Report of the Third Mandate of the High-level Group on the Security of Supply of Medical Radioisotopes (2013-2015) [NEA/SEN/HLGMR(2016)4]
• High-level Group on the Security of Supply of Medical Radioisotopes Fourth Mandate [NEA/NDC(2015)15]
• High-level Group on the Security of Supply of Medical Radioisotopes - Fourth Mandate Extension [NEA/NDC(2017)14]
• Final Report of the Fourth Mandate of the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) [NEA/SEN/HLGMR(2019)2]
• Background Note for The Policy Briefing on The Supply of Medical Radioisotopes [NEA/SEN(2025)1]
• NDC Programme of Work for 2025-2026 [NEA/NDC(2024)9]
• Mandate of the Expert Group on Medical Radioisotopes (EG-MR) [NEA/NDC(2025)7]

Mandate (Document extract):

Extract of document NEA/NDC(2025)7

Background

The NEA’s support for global efforts to ensure a reliable supply of medical radioisotopes dates to 2009 during substantial shortages for molybdenum-99 (Mo-99) and its decay product technetium-99m (Tc-99m). This led to the establishment of the High-Level Group on the Security of Supply of Medical Radioisotopes (HLG-MR), comprised of experts representing 18 countries (including some non-NEA member countries), the Euratom Supply Agency (ESA) and the International Atomic Energy Agency (IAEA).  Significant progress had been achieved in response to the 2009 crisis, which included important policy advancements, such as improved coordination among Mo-99 producers, greater transparency in reactor scheduling, and stronger regulatory frameworks. The HLG-MR ran for four consecutive mandates and formally concluded its activities at the end of 2018, given substantial improvement to the security of supply conditions.

NEA’s Reengagement on Medical Radioisotopes Supply

In October 2023, due to the reappearance of periodic disruptions to global supplies of Mo-99, NEA held an International Workshop on Medical Radioisotopes Supply, bringing together more than 200 international experts including over 70 in-person attendees for a two-day event to review the security of supply and identify priorities for cooperation moving forward. Participants displayed general enthusiasm and consensus on the need for continued attention to the security of supply, as well as for additional collaboration in new areas such as market forecasting for emerging radioisotopes, e.g., lutetium-177 (Lu-177) for current therapeutic applications and actinium-255 (Ac-225) in early-stage development. Discussions also evidenced continued concerns about periodic supply disruptions and significant optimism about the medical impacts of a new generation of medical radioisotopes. This was followed by a 2^nd International Workshop on Medical Radioisotopes Supply in October 2024, co-hosted with the U.S. Department of Energy (DOE) and the European Commission’s Joint Research Centre (JRC), which generated even more interest from experts from the medical radioisotope community and healthcare system providers.

Policy Briefing to the Steering Committee

In April 2025, a Policy Briefing on Supply of Medical Radioisotopes was held as part of the 149^th session of the Steering Committee for Nuclear Energy highlighting current security of supply challenges and the advent of therapeutic applications in the field of nuclear medicine. The Policy briefing concluded that the supply of Mo-99 continues to face challenges amid increasing demand, notwithstanding successful resilience strategies and improvements in international coordination. Presentations highlighted the rapid emergence of radioligand therapy (RLT), which uses novel therapeutic radioisotopes and shows significant promise in cancer treatment. As RLT is expected to expand quickly, ensuring reliable supply chains for these isotopes is essential. The briefing also pointed out barriers to broader adoption, including the need for infrastructure investment, workforce training, and harmonised regulatory and reimbursement systems.

Proposed Establishment of the EG-MR and Activities Moving Forward

NEA members demonstrated significant interest in the policy briefing and voiced clear support for continued work in this area. Therefore, building on the legacy of the HLG-MR, NDC members agree to create an Expert Group on Medical Radioisotopes (EG-MR) to directly contribute to NDC’s Programme of Work for 2025-2026, particularly in support of the Intermediate Output Result on the “Supply of radioisotopes for new and innovative medical applications.” Plans for the EG-MR include a continued focus on the security of supply of Mo-99 and new analysis on supply and demand projections for RLT, including healthcare system preparedness. The EG-MR would report to the Committee for Technical and Economic Studies on Nuclear Energy Development and the Fuel Cycle (NDC), and its activities will be included in the NDC programme of work.

Scope and Objectives

The EG-MR will provide advice and support to the NDC in carrying out its Programme of Work related to medical radioisotopes. In particular, the group will:

• Promote secure and sustainable supply of both conventional and novel medical radioisotopes;
• Support technical and policy analysis related to production, demand, and delivery systems;
• Identify key challenges and opportunities related to innovation, health system integration, and international coordination;
• Facilitate dialogue and strengthen collaboration among stakeholders in the medical, nuclear, regulatory, and policy fields

Working Methods

• The EG-MR would operate through plenary meetings — in person or virtually — as often as needed to advance its activities under the NDC Programme of Work. A Chair and a Vice-Chair will be appointed to lead the group’s work.
• The EG-MR would identify resources and schedules for its activities. All reports, publications, and products of the EG-MR will be submitted to the NDC for approval prior to release.
• The EG-MR would report to the NDC on its progress and activities as requested, which includes a minimum of an annual basis. The EG-MR will incorporate the feedback received from NDC to refine the scope and objectives.
• The NDC may also identify and task the EG-MR with other activities related to medical radioisotopes.

Membership

The membership of EG-MR is to be comprised of government and private sector experts from NEA member countries in the areas of medical radioisotope production, regulation, and clinical application. This would include representatives from government agencies, industry, research institutions, and the healthcare sector, ensuring a multidisciplinary perspective across established and novel radioisotopes.

Interactions

The EG-MR will:

• coordinate and undertake joint activities with the Committee on Radiological Protection and Public Health (CRPPH) and the Radioactive Waste Management Committee (RWMC) to assess opportunities for harmonisation of standards for patient schedules and disposal of treatment waste across NEA member countries;
• establish strong collaboration with the European Commission’s Joint Research Centre (JRC), Nuclear Medicine Europe (NMEU), and the World Council on Isotopes (WCI) to align data collection efforts, share best practices on production capacity forecasting, and explore joint initiatives to address global challenges in the radioisotope supply chain;
• engage with pharmaceutical companies and medical isotope producers, both directly and through industry associations such as NMEU and WCI, to exchange insights on supply chain challenges, production innovations, and clinical deployment of radioligand therapies;
• coordinate with professional societies and associations, such as the European Association of Nuclear Medicine (EANM) and the European Society for Medical Oncology (ESMO), to ensure alignment with clinical practices and patient care standards;
• collaborate with policy-focused organisations, including the forthcoming Strategy for European Life Sciences led by the European Commission’s Directorate-General Research and Innovation (DG RTD), and relevant health policy actions overseen by the Directorate-General for Health & Food Safety  (DG SANTE) to support coordinated policy actions;
• coordinate and undertake joint activities with the U.S. Department of Energy (DOE) and the JRC to contribute scientific and technical expertise to EG-MR’s work;
• coordinate with IAEA on initiatives on nuclear medicine, radiological protection, and global supply of medical radioisotopes;
• liaise with the Health Division of OECD’s Directorate for Employment, Labour and Social Affairs  (ELS/HD) for broad outreach to healthcare system stakeholders across OECD members.

Deliverables

The EG-MR would directly support NDC in delivering activities on the Supply of Radioisotopes for New and Innovative Medical Applications and Policy Measures to Ensure Adequate and Resilient Capacity for Medical Radioisotope Production. Proposed deliverables would include: 

1. Flagship publications on market economics related to developing a new generation of medical radioisotopes for RLT in cancer treatment.
2. Assessments of healthcare system readiness and policy measures to support the adoption of RLT (in collaboration with OECD ELS/HD).
3. Workshops and briefings focused on full cost recovery system designs and enforcement mechanisms across countries, to ensure coherence in current and future markets for medical radioisotopes.