The CAMRT Perspective
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.
Backgrounder: Anticipating a problem, proposing solutions Medical Radioisotope supply – François Couillard
News and Updates
CAMRT Summary Update on the Global Supply Situation for MO-99- August 2018
We were informed by the Canadian Government on August 3, 2018 that the South African NTP Reactor was still shut down due to regulatory issues. We would like to take this opportunity to provide you with an update on the longer-term supply situation and the status of the various projects aimed at securing long-term access to reactor-produced isotopes like Mo-99 and I-133.
Since the first interruption of service of the NTP reactor in late 2017, some nuclear medicine departments in Canada have experienced medical isotope shortages. However, the impact of the issues related to the NTP reactor have been minimized thanks to global collaborative efforts of industry.
It is unclear when the NTP reactor will receive the green light from regulatory authorities in South Africa to resume operations, but industry, through its international association, AIPES, has identified that there could be some future problems concerning I-131 supply.
More long-term, there are several large international projects that aim to replace the capacity lost when reactors like the NRU in Canada and OSIRIS in France were shut down. Most new projects have and will continue to experience delays, making it difficult to assess the long-term supply situation. The following provides updates on some important initiatives:
Nordion announced a few years ago that it was working with General Atomics and the MURR reactor to develop a new source of Mo-99. They have since cancelled this project and are now involved in a new project involving one of Ontario’s power reactors at Darlington. An American company, BWX Technologies, is in the process of acquiring Nordion’s medical isotope division and will be producing its own proprietary Tc-99m generator. Despite a June 2018 press release announcing a start to production by the end of 2019, it is highly unlikely that this project will achieve commercial scale for many more years, given the technical, financial and regulatory hurdles involved.
In Australia, ANSTO’s new Mo-99 processing facility is now scheduled to be fully operational by the end of 2018 or early 2019. This will greatly help in securing the short and long-term global supply chain.
Northstar, an American Tc-99m supplier received FDA approval to commercialize proprietary generators in February 2018. It is selling its product in the USA with no immediate plans no expand into Canada.
Other potential American producers (SHINE, COQUI Pharma, Northwest Medical Isotopes and new International reactors (Korea, Brazil, Argentina, France) are all behind schedule and some are experiencing challenges at securing the investment funding required to move to the next phase of their projects.
None of the Canadian projects (cyclotrons, LINACs) have reached commercial scale yet, and it is unlikely they will be major contributors to Canadian supply equation in the immediate future.
If you or your departments experience any shortage, we encourage you to share this with the CAMRT by contacting Christopher Topham, Director of Advocacy and Communications at email@example.com.
Updates from the Multistakeholder Working Group (Latest November 2018)
Organisation for Economic Co-operation and Development (OECD) News and Forecasts
Update on Isotope Supply: December 2016
The US Department of Energy’s National Nuclear Security Administration (NNSA) has entered into follow-on cooperative agreements with three projects aimed at securing a domestic supply of molybdenum-99 (Mo-99) without using highly enriched uranium (HEU). The latest funding completes the full $25 million NNSA contribution to each project.
Update on Isotope Supply: October 2016
On October 31, 2016 the Canadian NRU reactor will stop regular production of Mo-99, an isotope used to make Tc-99m, itself the most widely nuclear medicine imaging agent.
With the impending production stoppage growing nearer, there has been a number of media reports appearing in newspapers, scientific journals and websites. Many of the reports focused their reporting on the findings of the recent report from the National Academy of Sciences from the US, which suggests that the production stoppage at Chalk River is weakening the supply chain, and will make it more vulnerable to delays in the introduction of new capacity or unplanned failures of existing reactors.
Fortunately, the situation appears much less dramatic than reported these past weeks. In Canada, decisions associated with the stoppage have been monitored for years by the Multi Stakeholder Working Group on Medical Isotopes (MSWG).
Latest update from Canada’s Multi Stakeholder Working Group on Medical Isotopes (MSWG).
The MSWG was created a few years ago to bring together Canadian Federal and Provincial representatives, industry and national associations, like the CAMRT. The aim of the group is to monitor potential supply disruption risks of Tc-99m, develop mitigation strategies and ensure consistent messaging and communication to all stakeholders.
This group last met on October 4th 2016 and the following are a few highlights from the meeting.
There is no new cause for concern with respect to the ongoing supply of Tc-99m worldwide. While the supply chain of Tc-99m has showed its fragility over the past years, industry and governments have been preparing for the production stoppage at the NRU and mitigation strategies are in place. For example:
- The BR-2 reactor in Belgium was shut down for over a year to allow for major refurbishments. It was successfully restarted on July 19, 2016. It has now resumed regular production with increased irradiation capacity. This increased availability of BR2 will significantly alleviate possible future shortages.
- ANSTO in Australia successfully increased processing capacity in its old facility from 1000 to 1800 Ci per week. Their new facility is expected to be up and running in 2017 and provide a much greater capacity (3400 Ci per week)
- The Maria reactor has increased its capacity to irradiate targets from 8 to 12.
- The Canadian government remains committed to resume production of Mo-99 on the NRU reactor should there be a shortage, until the permanent closure of the NRU in March 2018. Officials confirmed that a contingency plan is in place.
The supply and demand forecast report provided by the OECD/NEA in March 2016 predicted that, unless there is a major un-planned production disruption, production capacity should suffice to meet demand for the period 2016-2021. The report’s conclusions are still valid today according to the OECD working group.
Organisation for Economic Co-operation and Development’s Nuclear Energy Agency (OECD-NEA) response
OECD Responds to Questions Raised by the U.S. National Academy of Sciences Report Titled “Molybdenum-99 for Medical Imaging”
NRU contigency and update from the Association of Imaging Producers & Equipment Suppliers (AIPES)
AIPES analysis shows continuous and sufficient capacity from late 2016 and through 2017 for a reliable supply of medical radioisotopes (Mo-99)
This was re-confirmed in a meeting of the AIPES group in January 2017.
Latest updates from industry stakeholders
Lantheus Supply Outlook September 2016
Mallinkrodt Supply Outlook October 2016
Please also check the News section of our website, as updates on the Medical Isotope supply will be posted there (and included in the CAMRT e-news) as news arises.
Stakeholder perspectives and links
Government of Canada
- Health Canada FAQ
- Natural Resources Canada Action on Isotope Supply
- Government of Canada Investment in alternatives to existing isotope production technologies
- NRU facility-specific announcements
For updates on the government’s funded projects;
Canadian Association for Drugs and Technology in Health (CADTH)
Guidance on Medical Isotopes and Alternatives for Diagnostic Imaging
Supply Management Application to Rank Uses of Technetium-99m (The “S.M.A.R.T.” Tool) An interactive and customizable application that helps you to prioritize the use of technetium-99m (99mTc)-based imaging procedures in the event of a disruption in the supply of the isotope.
Visit the isotope supply page or the Isotope Supply Resource Centre for further information about the supply of medical radioisotopes.