Canada’s medical isotope supply the focus of reports and legal action

Ottawa, ON – This week, two reports have been published in the wake of the extended outage of Atomic Energy of Canada Limited (AECL)’s National Research Universal (NRU) reactor in Chalk River last November and December.

An ad hoc advisory group of health specialists has released a report that looks at ways to minimize potential future disruptions of medical imaging services related to the isotope supply.

The group of health specialists, including experts from the field of nuclear medicine, was convened by Health Canada in December 2007 during the reactor’s shutdown. Once the reactor was restarted and the supply of medical isotopes returned to normal, the group began work on lessons learned from the situation.

The report notes that the supply system for medical isotopes is complex, and the panels’ recommendations go beyond areas solely under federal jurisdiction to suggest actions that could be taken by the many different players involved. It recommends that the key players minimize the potential for future shortages, mitigate patient care consequences should shortages occur, and establish a nationwide plan to coordinate the supply, distribution and management of medical isotopes.

The full report can be viewed on Health Canada’s website at www.hc-sc.gc.ca/hcs-sss/pubs/qual/2008-med-isotope/index-eng.php.

The other report released this week was produced by Washington DC-based consulting firm Talisman International for the Canadian Nuclear Safety Commission (CNSC) and AECL. The independent review consisted of document reviews and interviews, and was focused on renewal of the NRU license in 2005 and 2006, and the extended outage in late 2007. As part of its mandate, Talisman was asked to identify the underlying causes of the outage and to make recommendations for improvements in both organizations that would prevent a repeat occurrence of similar situations.

The report outlines 15 specific recommendations, which have been accepted by both the CNSC and AECL. The report also includes responses by both organizations to the recommendations and outlines the actions that will be taken to address each one. The full report can be viewed at www.aecl.ca/Assets/Publications/Reports/Talisman.pdf.

Meanwhile, in May, AECL announced that it was cancelling work on a project in the works since 1996 to replace the aging NRU reactor. The project, called MAPLE, involved the design, development and construction of two new nuclear reactors and a processing facility.

On July 9, MDS Inc announced that it has served AECL with notice of arbitration proceedings over the cancellation. As part of long-standing agreements, AECL supplies isotopes to MDS subsidiary, MDS Nordion, which in turn processes them into medical isotopes that are then distributed to radiopharmaceutical companies.

MDS says it is seeking an order to compel AECL to fulfil a 40-year medical isotope supply contract signed in 2006, and if not granted, to seek significant monetary damages. It also filed a court claim for $1.6 billion in damages against AECL, for negligence and breach of contract, and against the federal government for inducing breach of contract and for interference with economic relations.

AECL says it believes it has met its obligations under its agreements with MDS and will vigorously defend itself against both actions.

When it announced the project cancellation in May, AECL’s president and CEO, Hugh MacDiarmid said the organization had decided that terminating the project was the “right business decision given the circumstances,” and that it would not impact the current supply of medical isotopes.

This view was disputed by the Canadian Society of Nuclear Medicine (CSNM), which issued a statement shortly after emphasizing Canada’s need for a long-term essential medical isotope backup contingency.

Currently, the NRU’s operating license has been extended to October 2011, assuring a short-term supply, but the CSNM called on AECL and the federal government to reassure Canadians that alternative solutions are in the works for medium- and long-term supplies.