Workshop on Security of Supply of Medical Radioisotopes
Chair's Summary

The OECD Nuclear Energy Agency (NEA) convened a workshop on the Security of Supply of Medical Radioisotopes in Paris on 29-30 January 2009. The workshop was initiated at the request of the Government of Canada to address present and future challenges to the reliable supply of Technetium‑99m (Tc-99m), a key medical isotope derived from Molybdenum-99 (Mo-99), and to identify measures that should be taken to help ensure supplies in the short, medium and long term. The workshop, organised with the assistance of the International Atomic Energy Agency (IAEA), brought together over 80 participants from 13 OECD countries and 3 non-OECD countries and from international organisations, including government policy and regulation officials, specialists in nuclear medicine, health industry professionals and nuclear research reactors operators.

Participants recognised the vulnerability of the global medical isotope supply chain, which depends on a limited number of ageing nuclear research reactors for isotope production and a complex processing and distribution chain for delivery of short-lived isotope products to the health system. The vulnerability of the chain has manifested itself in several regional and global supply disruptions over the last decade, which were due to reactor outages and various complications in the processing and distribution system. Participants noted that, due to the age and increasing maintenance requirements of the major production reactors, the vulnerability of the isotope supply chain is likely to persist, if not to increase, for several years.

In light of the foregoing, participants identified measures to enhance short-term supply security:

  • reactor owners and operators should continue to share information and to enhance co-ordination of reactor maintenance schedules, with a view to ensuring an uninterrupted global supply of isotopes;
  • options for increasing production from existing reactors in times of global shortage should be further explored and encouraged;
  • current economic conditions for irradiation services should be reviewed to provide better incentives to reactors operators, including where the main mission is research in support of national nuclear energy or scientific programmes;
  • unnecessary impediments to the distribution of medical isotopes, such as restrictions in transport capabilities and denial of shipment by airline companies, should be removed;
  • anticipative actions to avoid the dilemma between meeting nuclear safety requirements or meeting health care needs should be encouraged; in this regard, participants were pleased to be informed of the outcome of the nuclear regulators meeting held in Paris three weeks earlier;
  • radio-pharmacies, hospitals, health product regulators and the medical community should explore options for more efficient patient scheduling and utilisation of Mo-99/Tc-99m generators to make best use of currently available supplies of Mo-99 and/or other potential alternatives.

Participants underscored the need to develop, deepen and share, as appropriate, contingency plans for future supply disruptions. They urged industry efforts to improve the flexibility and efficiency of the distribution chain, as these could make a significant contribution towards increasing the supply of Tc‑99m ultimately delivered to patients.

There was broad agreement that increased transparency among reactor operators, isotope processors and distributors, government regulators, and health care professionals would facilitate all efforts. In particular, it is important that the health care community obtains early information from all participants in the supply chain concerning potential and real disruptions, including estimates of the timing, duration and severity.

Participants expressed a wide range of views on the best means of ensuring adequate Tc‑99m supplies over the longer term. Replacing or supplementing the ageing reactors that are used to produce Mo-99 would help to reduce supply disruptions arising from unplanned reactor outages. It was recognised that the uncertainties regarding the long-term global demand due to competing, although more expensive, techniques in the medical sector make the decision to invest in capital-intensive additional nuclear capacities, which are designed for around 50 years, difficult. A greater involvement of health authorities is needed to reduce these uncertainties. In addition, questions were raised regarding the long-term validity of the current economic model where the security of supply relies mainly on government-run reactors which typically charge only marginal costs for their irradiation services.

There was agreement, however, that governments have a responsibility for establishing an environment conducive to the private and/or public sector investments that may be required. There was recognition that it could take 5 to 10 years for significant additional capacity to be developed. Participants also recognised that long-term supply presents a global challenge that will require a global response. At the same time, it was noted that regional co-operation has proved effective in some cases and should be explored as a complementary vehicle.

A range of views was expressed on the feasibility and time required to eliminate the use of highly enriched uranium in targets for Mo-99 production. The presentation of the recent report from the US National Academy of Sciences provided an informed background, notably on the use of low enriched uranium targets already occurring on a regional scale. While reducing the proliferation and security risks is a common goal, views differ strongly regarding the feasibility and timing of the conversion from highly enriched uranium to low enriched uranium at global scale at affordable costs without increasing the vulnerability of the global supply chain.

Participants requested the NEA to consider establishing a working group, also involving the IAEA, to carry forward the agenda of the workshop and to review additional practical measures that could be taken. Special attention should be given to the economics of the supply chain, and to means of increasing its flexibility, for instance through improved standardisation.

The NEA wishes to thank all those who participated in the workshop. NEA officials noted that the NEA Steering Committee for Nuclear Energy has scheduled a policy discussion on medical isotope supply at its next meeting on 28-29 April 2009, and that this meeting would provide an opportunity for continuing this productive international dialogue, advancing solutions and fostering decision making for future actions.