Expert Review Panel on Medical Isotope Production Terms of Reference

Mandate

The Expert Review Panel on Medical Isotope Production (the Panel) will report to the Minister of Natural Resources Canada on its assessment of the most viable options for securing supplies of technetium-99m to the Canadian health system over the medium and long term, and the actions that may be required by governments and others to facilitate realization of the options.

The Panel will receive and review submissions from public or private-sector organizations in response to a Call for Expressions of Interest (EOI) for alternative production of molybdenum-99/technetium-99m. The Panel will assess the EOIs, in a fair and transparent manner, against specified criteria.

Context

Technetium-99m (Tc-99m) is widely used in medical imaging and accounts for the largest proportion of nuclear medicine diagnostic procedures. Canada’s supply of Tc-99m generators is largely met by two U.S.-based manufacturers that, in turn, source the parent isotope, molybdenum-99 (moly-99), principally from five research reactors, including Atomic Energy of Canada Limited’s (AECL) National Research Universal (NRU) reactor in Chalk River, and four other reactors located in Europe and South Africa. Production of moly-99 at AECL’s Chalk River facility is part of a complex supply chain that originates with the import of highly-enriched uranium (HEU) “targets” that are irradiated in the NRU reactor and processed on site for moly-99 extraction. Moly-99 is then shipped to the facilities of MDS Nordion in Kanata, Ontario, for purification, before being exported to Tc-99m manufacturers in the U.S. and offshore. All steps in this process are overseen by national and foreign nuclear and medical regulatory authorities to ensure health, safety, and security.

Since the November 2007 outage of AECL’s National Research Universal (NRU) reactor, a number of proposals have been advanced by private and public sector organizations for alternative production sources of molybdenum-99/technetium-99m. With a view to understanding the options available and how they may be integrated into the existing supply chain for medical isotopes, the Minister of Natural Resources announced on May 28 that the Government would establish an Expert Review Panel on Medical Isotope Production to review alternative supply options and provide advice to the Minister on the most promising options for further development.

Composition of Panel

The Panel will be composed of four individuals with health sciences, technology and public policy background and experience. One of the members will be designated as Chair.

Assessment Criteria

The Panel will assess options for long-term security of supply of medical isotopes according to the following criteria:

Technical Feasibility: The Panel will assess the scientific and technical merits of projects taking into account risks associated with the introduction of new technologies and the likelihood that technologies could be realized on a commercial scale.
Business Implementation: The Panel will assess the business merits of the projects, taking into account the partnerships established by the proponents; funding requirements and secured resources; access to existing or new physical infrastructure required; the ability of the proponents to integrate their proposal within a supply chain; and cost structure and required revenue from market or other sources. The Panel will take into account business risks associated with these elements.
Timeliness of Proposal: The Panel will assess the schedule for implementing proposed options, including the risks of delays.
Regulatory Issues: The Panel will assess EOIs with regard to the capacity of proponents and the project to meet nuclear and medical safety standards and provide an assessment of potential issues, including nuclear and medical regulatory issues that could affect implementation. The EOI should provide information about how facilities would be sited, how controlled nuclear materials would be handled, facility safety and security would be ensured, and waste management or transportation issues would be addressed.
Benefits to Canadians: The Panel will provide an assessment of the benefits of implementation to Canadians. While this assessment will focus on the overall ability of the project to assure supplies of technetium-99m generators to the Canadian health care system, it will also consider concomitant scientific and technological benefits, economic benefits, or any other benefits to Canadians.

Soliciting Expert Review And Advice

In the pursuit of its work, the Panel will consult and engage actively with domestic and international experts, including the Canadian nuclear medicine and broader medical community and their national associations, to better understand the many considerations that have bearing on the determination of a long-term strategy for Canada given its position in the North American and global markets for medical isotopes. Additional resources may also be engaged to review Expression of Interests, or parts thereof.

Secretariat Resources and Budget

In order to provide support to the Panel members and to assist with preparation of a final report, a secretariat will be constituted with personnel seconded from Natural Resources Canada and Health Canada, and will be housed in Natural Resources Canada.

In addition to seconded personnel, the secretariat will manage a budget of approximately $1 million, which will be used to fund panel members’ per diems and expenses, to cover costs of ancillary research ordered by the Panel, and to support the operations of the secretariat and the production of a final report to the Minister.

Schedule

By June 19, the secretariat will finalize a public call for expressions of interest. This call will be posted on the Natural Resources Canada website and communications efforts will be undertaken to ensure appropriate dissemination of the information for potential proponents.

The proposals will be submitted to Natural Resources Canada by July 31, 2009. The Panel will have the opportunity to engage with proponents and solicit additional information in a manner and form to be established by the panel. The panel will submit a final report to the Minister of Natural Resources Canada by November 30, 2009.