Question Period Note: Medical Isotope Supply Disruption

N/A

• Disruptions in the global supply of the medical isotopes Molydenum-99 and Iodine-131 in November 2022.
KEY MESSAGES
• Our Government is well aware of the importance of maintaining a sufficient supply of medical isotopes used for diagnostic procedures, such as cancer screening.
• On December 7th Canada received confirmation that, due to the early restart of 2 different reactors in Europe, the supply situation for both I-131 and Mo-99 had returned to normal.
• The Government of Canada monitors the global supply of medical isotopes and is in close communication with all partners, including international suppliers.
IF PRESSED ON ACCESS TO MEDICAL ISOTOPES …
• The Government works closely with stakeholders, including suppliers, to mitigate the impact any shortage of medical isotopes has on patients.

Molydenum-99 (Mo-99), and its decaying isotope Technetium-99m, is used in 80% of all nuclear imaging procedures worldwide. Iodine -131 (I-131) is most routinely used to treat thyroid cancer.

Prior to 2009, the world experienced several major supply interruptions of medical isotopes when reactors were stopped for unplanned maintenance and repairs. Since 2009:
• The supply chain diversified extensively, enabling better management of planned and unplanned outages of ageing reactor facilities;
• Canada led the creation of the OECD High Level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) with the mandate to monitor the global medical isotope supply system; and
• An international scheduling system has been put in place that has successfully addressed several unplanned outages and prevented shortages from occurring.

In March 2010, the previous government formally announced its plan to exit from reactor based production of Mo-99 and to cease production of medical isotopes at the NRU at the end of October 2016.

On October 31, 2016 the NRU ceased the routine production of medical isotopes and officially transitioned into ‘Standby Mode”. In March 2018 isotope production at the NRU ceased permanently. This transition was conducted smoothly and without incident.

To help prepare Canada for the post-NRU environment the Multi Stakeholder Working Group (MSWG) on Medical Isotopes was created in September 2014. The MSWG is comprised of representatives from the F/P/T governments, professional associations and industry. It is mandated to coordinate efforts to identify, prepare for, prevent, mitigate and resolve potential medical isotope disruptions in Canada.

The MSWG has established a Medical Isotope Shortage Communications Protocol, which allows for the rapid exchange of information in the event of a shortage of medical isotopes. Early notification of a shortage allows P/Ts and the health care community to implement measures to mitigate risks and minimize any negative impact upon health care delivery in Canada.

Current Disruption
On October 21st, Health Canada was advised by Nuclear Medicine Europe (NME) (the industry association that coordinates the global supply of medical isotopes) of possible disruptions in the global supply of the medical isotopes Molydenum-99 and Iodine-131.

The disruptions are connected to delays in the resumption of isotope production at two reactors (The SAFARI research reactor in South Africa and the BR2 reactor in Belgium), after some routine maintenance. These delays would not normally impact global supply, however it happened to overlap with scheduled maintenance programs at other reactors.

On October 21st, the Government of Canada activated its Medical Isotope Shortage Communications Protocol, and a first notice was sent to stakeholders informing them of the potential disruption in the supply of medical isotopes. This communication also included advice to stakeholders and practitioners in the event of a shortage and asked stakeholders to notify Health Canada if they learned of any potential supply disruptions.

The Government remained in close communication with stakeholders during the shortage and received a number of reports of medical isotope supply disruptions from both industry and PT stakeholders.

On December 7th the Government received confirmation that, due to the early restart of the LVR-15 Reactor (Czech Republic) and the HFR Reactor (Netherlands), the supply situation for both I-131 and Mo-99 had returned to normal.

The Government continues to closely monitor the supply of these medical isotopes.

• On October 21st, Health Canada was advised by Nuclear Medicine Europe (NME) (the industry association that coordinates the global supply of medical isotopes) of possible disruptions in the global supply of the medical isotopes Molydenum-99 and Iodine-131 in late October and early November:
o Molydenum-99 (Mo-99) is used in 80% of all nuclear imaging procedures worldwide.
o Iodine -131 (I-131) is most routinely used to treat thyroid cancer.
• The disruptions were connected to delays in the resumption of isotope production at two reactors (The SAFARI research reactor in South Africa and the BR2 reactor in Belgium), after some routine maintenance.
• On October 31st Health Canada received the first reports of supply disruptions in Canada with Alberta reporting that their supplier had informed them that their next shipment of Mo-99 would be short some supply. Additional reports of shortages were received from both industry and P/T contacts throughout November.
• On December 7th Health Canada received confirmation that, due to the early restart of 2 different reactors in Europe, the supply situation for both I-131 and Mo-99 had returned to normal.