The Media Room

2009/67 (a)

Backgrounder

GOVERNMENT OF CANADA ACTIONS TO ADDRESS THE MEDICAL ISOTOPE SHORTAGE

Canada and the world are experiencing a shortage of medical isotopes, given that the production of Molybdenum-99 (Moly-99) and its derivative Technetium-99m (Tc-99m) currently depends on a handful of aging nuclear reactors. Tc-99m is currently used in approximately 80 percent of nuclear medicine scans.

Our Government is dedicated to ensuring Canadians have a predictable and reliable supply of medical isotopes. Canada’s Ministers of Natural Resources and Health are currently working with provinces, territories, the medical community and international partners to address Canadian needs during the current shortage.

Current efforts are focused on:

  • repairing the Chalk River reactor as quickly as possible in a safe and reliable manner;
  • maximizing the use of existing medical isotopes supplies;
  • working with international producers to increase production and co-ordinate reactor operations — including downtimes;
  • developing, assessing and reviewing alternatives to the current supply of TC-99m; and
  • identifying and assessing possible alternatives to medical isotopes currently in use.

To better inform its actions in these five areas, the Government has enlisted the help of a number of medical and nuclear experts from across the country and around the world. These include: a Special Advisor on Medical Isotopes to the Minister of Health appointed on June 14, 2009; an Expert Review Panel, announced on June 19, 2009, that will assess options to secure a sufficient and reliable isotopes supply for Canada in the medium to long term; Health Canada’s Ad Hoc Group of Experts on Medical Isotopes, which was struck in 2007; and the first face-to-face meeting — chaired by Canada — of the High Level Group established by the Nuclear Energy Agency of the OECD to coordinate international efforts on isotope production.

1. Repairing the Chalk River Reactor

Why is this important?

When it is operational, the Chalk River nuclear reactor produces approximately 80–85 percent of the Canadian supply of Moly-99 and about 30–40 percent of the global supply.

Government Action:

To help ensure that the Chalk River reactor is repaired as quickly as possible in a safe and reliable manner, the Government has:

  • instructed Atomic Energy of Canada Limited (AECL) to give utmost priority to bringing the Chalk River reactor back into service safely and reliably.
  • asked AECL to determine the requirements for extending the Chalk River reactor’s operating license past 2011.

2. Maximizing the Use of Existing Isotope Supplies:

Why is this important?

During a medical isotope shortage, it is essential that the Government work closely with distributors, provinces and territories, and the medical community to ensure that existing supplies are used as effectively as possible where they are needed most. The necessity for coordination in a shortage situation is heightened by the fact that medical isotopes have a very short shelf life.

Government Action:

To ensure that existing medical isotope supplies are being used effectively the Government of Canada:

  • has worked with provinces, territories and medical experts to produce guidelines for health care professionals during a medical isotopes shortage. These include recommendations on how to make better use of available isotopes, assessing where need is greatest, and shifting to viable alternatives where safe and effective to do so;
  • is communicating regularly with medical isotopes distributors Covidien and Lantheus Medical Imaging on short-and long-term supply issues. This includes ensuring that up-to-date, forward-looking supply information is being communicated to provinces, territories and the Canadian medical community; and,
  • is working closely with the Federal/Provincial/Territorial Working Group on Medical Isotopes, formed in fall 2008, which is playing a key role in contingency planning and managing the shortage.

3. Working with International Producers to Increase Production and Co-ordinate Reactor Operations

Why is this important?

The medical isotopes shortage is a global problem requiring a global solution. The world’s current supply of Moly-99 comes from five large aging reactors in Belgium, Canada, France, The Netherlands and South Africa. Two-thirds of the world’s supply is normally provided by Canada and the Netherlands. Frequent maintenance requirements — both planned and unplanned — regularly impact on global supply.

Government Action:

This year the Government, led by Natural Resources Canada, has been instrumental in drawing attention to the fragility and security of the global medical isotopes supply and mobilizing a more international approach to the problem. This was accomplished by requesting and hosting a number of international meetings with key global stakeholders. Further to these meetings:

  • Both the Netherlands and South Africa are temporarily increasing production in order to contribute to global supply;
  • Australia is accelerating efforts to ramp up production at its new isotopes-production facility to contribute to global supply; and,
  • There is better coordination among the five major international producers to coordinate operations — including shutdowns.

Canada was named chair of the OECD’s High Level Group on the Security of Supply of Medical Isotopes, which met for the first time in Toronto in June.

4. Developing, Assessing and Reviewing Alternatives to the Current Supply of Tc-99m.

Why is this important?

The supply shortage currently being experienced is a global problem, given that the production of medical isotopes currently depends on a handful of aging nuclear reactors. The Government recognizes that the Canadian public and the medical community need alternative supply options for Moly-99/Tc-99m when one or more of the world’s major Moly-99 producing reactors is down for maintenance.

Government Action on Regulations:

The Government of Canada has put in place regulations to ensure that alternatives to the current production of Moly99/Tc-99m, deemed safe and effective, can be provided to the medical community and the public quickly.

Facilitating research and soliciting ideas:

  • On June 19, the Minister of Natural Resources launched a process to solicit ideas for the alternative production of Moly-99/Tc-99m for the Canadian market in the medium to long term. An Expert Review Panel was named to assess these options. The Panel will complete its final report by November 30, 2009.

Finding Alternative suppliers:

  • On June 15, Health Canada approved radioisotopes produced in Australia’s OPAL reactor as an alternative supply of the Moly-99 isotopes for Canada.
  • On July 3, Health Canada approved radioisotopes produced in South Africa’s Safari reactor as an alternative supply of the isotope Iodine 131 to treat thyroid cancer in Canada.

5. Identifying and assessing possible alternatives to medical isotopes currently in use.

Why is this important?

The Government of Canada is pursuing a number of safe and effective options for alternatives to isotopes currently being used by the health care community for medical and diagnostic purposes. Not only is it important to have alternative plans to supply traditional isotopes like Moly-99, the Canadian public and medical community need options to substitute entirely different isotopes and procedures in times of shortage.

Government Action on Regulations:

The Government of Canada has put in place regulations to ensure that alternatives to the use of Moly99/Tc-99m, deemed safe and effective, can be provided to the medical community and the public quickly. This includes providing rapid access to products not available in Canada through the Special Access Program on a case-by-case basis (24-hour review); conducting clinical trials and accumulating clinical data at the same time through open clinical trials; shortening review times for specific submissions through expedited reviews; and enabling a Minister to issue interim orders for immediate action when a situation presents a significant risk to human health, public safety, security or the environment.

Facilitating research and soliciting ideas:

  • On June 16, the Minister of Health with the Canadian Institutes of Health Research and the Natural Sciences and Engineering Research Council of Canada announced $6 million in funding to find alternatives to nuclear-produced Technetium-99m, the principal medical isotope affected by the current shutdown at the Chalk River nuclear reactor.

Accelerating review and assessment processes:

  • Since the outset of the shortage, Health Canada has reviewed regulatory requests for approvals of alternate isotopes on an urgent basis to provide health care providers with options as quickly as possible. Fast approval of sodium fluoride for bone scans has made it available through the University of Sherbrooke Hospital in Quebec, McMaster University in Ontario and the Cross Cancer Institute in Alberta.

       

The Government of Canada will continue working around the clock with partners across the country and around the globe to address the current medical isotopes shortage and address the future needs of Canadians in this area.

Media may contact:

Jocelyn Turner

Press Secretary

Office of the Minister

Natural Resources Canada

Ottawa

613-996-2007

Or

Media Relations

Natural Resources Canada

Ottawa

613-992-4447

NRCan's news releases and backgrounders are available at www.nrcan.gc.ca/media/index-eng.php.