The NEA established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) in April 2009 to examine the underlying reasons for the global 2009-10 supply shortage and to develop a policy approach to ensure the long-term security of supply of molybdenum-99 (⁹⁹Mo) and technetium-99m (^99mTc). To achieve its objectives, the HLG-MR reviewed the ⁹⁹Mo/^99mTc supply chain and identified the key areas of vulnerability, the issues that need to be addressed and proposed mechanisms that could be used to address those issues. The HLG-MR agreed on a policy approach to ensure the long-term reliability of supply, but recognised that governments have the ultimate responsibility for establishing an environment conducive to investment and for regulations related to the ⁹⁹Mo/^99mTc supply chain.

In 2014, a Joint Declaration on the Security of Supply of Medical Radioisotopes was agreed and published by a number of NEA countries.

The HLG-MR mandates were performed during the following periods:

Fourth Mandate (2015-2017)

The fourth mandate of the HLG-MR allowed for an extension of its work in the field of security of supply of medical radioisotopes. The work addressed specific issues affecting the full implementation of the HLG-MR policy approach, such as full-cost recovery and isotope reimbursement. The HLG-MR continued to work towards increasing the long-term security of supply by maintaining transparency on global developments, communicating with the supply chain and end-users, evaluating progress towards implementation and providing additional information and analysis where necessary. The group met twice a year to share information and discuss ongoing policy issues.

The broad deliverables of the group during its fourth mandate were to:

• carry out studies related to the security of supply, e.g. updating the global ⁹⁹Mo/^99mTc medium- and long-term demand and capacity forecast.
• evaluate progress towards the implementation of the HLG-MR policy approach through a fourth self-assessment by the global supply chain.
• have closer engagement with downstream supply chain participants (e.g. ^99mTc generator manufacturers, nuclear pharmacy operators, nuclear medicine and other associated healthcare professionals and healthcare policy makers) to understand the impact of economic forces throughout the entire supply chain.
• re-examine the six HLG-MR policy principles, in particular, those where market participants have reported having significant implementation challenges and consider if adjustment is required and additional policy principles appropriate.
• share information on the status of the ⁹⁹Mo/^99mTc market and regular reporting on developments within the market, to increase transparency and encourage consistency in approach, implementation and communication.
• communicate the need to implement the HLG-MR policy approach to governments and supply chain participants, including working more closely with nuclear medicine and associated healthcare professionals and healthcare policy makers.
• provide ctions to support the implementation approach, where appropriate and feasible
• report regularly on HLG-MR actions to governments and other major stakeholders
  
  

Third Mandate (2013-2015)

The third mandate of the HLG-MR allowed for an extension of its work in the field of security of supply of medical radioisotopes. The work addressed specific issues affecting the full implementation of the HLG-MR policy approach, such as full-cost recovery and isotope reimbursement. The HLG-MR continued to work towards increasing the long-term security of supply by maintaining transparency on global developments, communicating with the supply chain and end-users, evaluating progress towards implementation and providing additional information and analysis where necessary. The group will met twice a year to share information and discuss ongoing policy issues.

The broad deliverables of the group during its third mandate were to:

• carry out studies related to the security of supply, e.g. updating the global ⁹⁹Mo/^99mTc supply and demand forecast and examining waste management costs from ⁹⁹Mo production.
• evaluate progress towards the implementation of the HLG-MR policy approach through a second self-assessment by the global supply chain.
• have closer engagement with downstream supply chain participants (^99mTc generator manufacturers, health policy makers and nuclear medicine professionals) to explore issues related to full-cost recovery and isotope reimbursement.
• re-examine the six HLG-MR policy principles, in particular, those reported by market participants to be challenging to implement.
• share information on the status of the ⁹⁹Mo/^99mTc market and provide regular reports on technical developments within the market, to increase transparency and encourage consistency in approaches.
• communicate the need to implement the HLG-MR policy approach to governments and other supply chain participants, including working more closely with health policy makers and nuclear medicine professionals.
• provide actions to support the implementation of the policy approach, where appropriate and feasible.
• prepare regular reports to governments and other major stakeholders.
  
  

Second Mandate (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 was to work towards increasing the long-term security of supply of ⁹⁹Mo and ^99mTc, especially by implementation of the HLG-MR policy approach and its associated recommendations. This entailed 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 were to:

• share information on the status of the ⁹⁹Mo/^99mTc market
• communicate the HLG-MR policy approach to governments and other supply chain participants, including working more closely with the health community
• provide guidance on specific aspects of implementing the HLG-MR policy approach, such as developing a guidance document on full-cost recovery.
• support the implementation of all aspects of the HLG-MR policy approach, where appropriate and feasible, including work 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
• carry out studies related to security of supply, such as analysing the market and economic impact of conversion to the use of low enriched uranium targets for ⁹⁹Mo production.
• evaluate the progress towards the implementation of the HLG-MR policy approach, by undertaking a periodic review of the supply chain
• re-evaluate the policy approach once experience has been obtained
  
  

First Mandate (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. A full implementation of the policy approach would address this key area of vulnerability.