October 20, 2016
The Organisation for Economic Co-operation and Development’s Nuclear Energy Agency (OECD-NEA) has convened the High-Level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) since 2009. SNMMI participates in the OECD meetings and is represented by Sally Schwarz, MS, RPh, BCNP, FAPhA, currently SNMMI’s president. This international working group focuses on the reliability of supply of the medical isotope molybdenum-99 (Mo-99).
The OECD-NEA regularly reviews the global Mo-99 market demand and available production capacity. It issued its most recent report in June 2016 titled 2016 Medical Isotope Supply Review: 99Mo/99mTc Market Demand and Production Capacity Projection 2016-2021. This report concluded, "Overall, the current irradiator and processor supply chain capacity should be sufficient and, if well maintained, planned and scheduled, be able to manage an unplanned outage of a reactor, or a processor throughout the whole period to 2021."
Without the supply historically provided by Canada, the other current producers have sufficient production capacity available to meet patient needs and also cover limited, unscheduled maintenance outages. This is due, in part, to the recent increase in current production capacity from the facilities located in Australia, Belgium, the Czech Republic and the Netherlands. Production capacity is expected to be further bolstered in the coming years through the introduction of new production facilities located in Australia, Europe, the United States and elsewhere.
On September 12, 2016, the U.S. National Academies of Sciences, Engineering, and Medicine published a separate, independent report titled Molybdenum-99 for Medical Imaging. The report, among other findings, states, “The committee judges that there is a substantial (>50 percent) likelihood of severe molybdenum-99/technetium-99m supply shortages after October 2016, lasting at least until current global suppliers complete their planned capacity expansions.” The findings of the National Academies also indicate a similar period of increased risk to the Mo-99 supply, which is consistent with the findings of the 2016 OECD-NEA report.
While the cessation of production at the NRU reactor in Canada after October 2016 will lead to a period of increased risk to the Mo-99 supply chain, neither report indicates that Mo-99 shortages will occur. The HLG-MR is of the opinion that the industry will not be subjected to additional risks not previously identified.
Of Note: Mallinckrodt Pharmaceuticals and Lantheus Medical Imaging have both sent letters to nuclear medicine professionals stating that they don’t anticipate an increased risk of isotope supply shortage and explaining the steps taken to secure the supply of Mo-99. Read the Mallinckrodt letter and the Lantheus letter.
In addition, the Council on Radionuclides and Radiopharmaceuticals (CORAR) issued a press release affirming that "the risk of a substantial shortage of Mo-99 in the next five years is overstated."