Anticipating a problem, proposing solutions

Medical Radioisotope Supply

Submitted by François Couillard, CAMRT CEO

The Canadian Association of Medical Radiation Technologists (CAMRT) has identified the potential of a global shortage of medical radioisotopes as an emerging issue of concern in the near to medium term, particularly for the international community of nuclear medicine specialists and their patients. Technetium-99m (99mTc)is used in over 80% of nuclear medicine procedures- more than 30-40 million examinations worldwide yearly. This is the “bread and butter” of nuclear medicine. Ongoing reliable supply of this critical isotope is under threat. According to a recent OECD report , “Current global irradiation and processing capacity is predicted to be insufficient over the period analysed for reliable 99Mo/99mTc supply, even with all producers operating under normal conditions…”

CAMRT is working with a number of stakeholders to define the issue more specifically and propose solutions that mitigate the impact of a diminished supply of medical isotopes , to provide decision makers with the details they need to make an informed decision.

Defining the issue

In order to understand the issue, it is necessary to understand the current supply chain:

Uranium targets are irradiated in a nuclear reactor. They are then processed to extract 99Mo. This product is shipped to facilities where “generators” are assembled. These generators are then sent to hospitals all over the world. The two most critical steps in the process are the irradiation of uranium target in reactors and the processing of these targets to produce 99Mo. Any disruption can hurt the supply chain downstream.

There are several issues that threaten the supply of this critical isotope:

• Demand is expected to continue to grow at a rate of about 2% per year worldwide until at least 2020 (ref. NEA-OECD report).
• 2 of the 9 reactors used in this supply chain are scheduled to stop production in 2016 (the Canadian NRU and French OSIRIS reactors). Together, they account for over 25% of the potential annual production capacity. The Canadian government has indicated that it will not extend NRU production beyond 2016.
• All other major existing producing reactors, except for OPAL in Australia, are aging and scheduled to shut down by 2030.
• OECD countries have agreed to substitute the use of High Enriched Uranium (HEU) in reactors with Low Enriched Uranium (LEU) (HEU can be used to make nuclear bombs). The transformation is proving technically challenging and expensive in light of the short expected life of existing reactors.
• The 99Mo processing capacity in the world is predicted to be insufficient to meet demand. One of the largest processor, Nordion, will cease 99Mo processing after NRU stops production, creating a gap until new projects like Australia’s ANSTO new facility are fully operational.
• The future price of 99mTc is likely to rise due to the above challenges and the exit of Nordion.

Possible solutions

There are 3 ways to address these issues:

1. Increase production capacity
2. Optimize distribution and utilization
3. Substitute tests with other tracers or modalities

The last major disruption in supply forced health providers to collaborate to find creative ways to share limited 99mTc supplies. It also encouraged substitution to other modalities, often at higher cost and/or with compromised quality. Most health jurisdictions in Canada now have contingency plans in place.

The ideal situation would be to have new irradiation and processing capacity in place by 2016 to ensure a seamless transition away from the NRU and OSIRIS reactors and associated processing facilities. There are over 11 new irradiator projects underway (mainly reactors) and almost as many new processing facility projects. Canada is also experimenting with 3 cyclotron/linear accelerator schemes to replace reactor supplied 99mTc. These Canadian projects are promising but they are still years away from full approval by Health Canada and pricing and distribution scenarios remain uncertain.

At this point we have been unable to get industry reassurance that a sufficient number of these projects will be fully operational on time to ensure a steady and reliable supply of 99mTc. Getting a clear picture of the situation post-NRU is proving very challenging. The best information available is from the April 2014 OECD report which concludes that “clearly, insufficient processing capacity will be a major risk for secure supply in the next 5 years”. Capacity should stabilize after 2020, provided additional capacity is added to replace the 6 reactors scheduled for shutdown between 2024 and 2030.

Progress to date

The CAMRT is monitoring the situation closely, and coordinating ongoing investigation of the situation through dialogue and information sharing with CAMRT members, international colleagues and other national healthcare associations.

We are currently engaged in discussions with Health Canada, with provincial and territorial government representatives, and various industry players. Our goal is to stimulate the emergence of mitigation strategies through constant engagement with our members, producers, governments and other stakeholders.

We welcome partners, questions, suggestions and any new information you would like to share with us.