The Ontario Superior Court of Justice (Divisional Court), on October 16, 2008, decided a case involving a challenge to the Canadian Agency for Drugs and Technologies in Health (CADTH), the non-profit corporation that reviews medicines and technologies and makes recommendations to provincial governments and agencies as to which drugs should be listed (ie., paid for) by provincial government drug plans.
In this case, Boehringer Ingelheim (Canada) Ltd. (Boehringer Ingelheim) and Bayer Inc. (Bayer), an intervener in the case, were each seeking Health Canada regulatory approval for competing drugs directed to the treatment of blood clotting after knee and hip replacement surgery. Bayer volunteered to participate in a pilot project run by CADTH which permitted regulatory approval for its product, and the CADTH review process, to run concurrently. This allowed Bayer's product to be approved at the same time as Boehringer Ingelheim's product, despite Boehringer Ingelheim having filed its regulatory submission to Health Canada earlier in time.
CADTH was challenged by Boehringer Ingelheim on the basis that CADTH arbitrarily breached a duty of fairness owed to it by failing to publish and follow draft rules of its own pilot project. It also alleged breach on the basis that Bayer had been provided a copy of the draft rules before they were posted. The Court disagreed and concluded there was no obligation for CADTH to publish the draft rules, that the decision by Bayer to participate in the pilot project preceded the existence of the draft rules (and, therefore, was not relevant to Bayer's decision to participate in the pilot project), and that Bayer learned of the pilot project through publicly-disseminated information that was also available to Boehringer Ingelheim. The Court concluded that there was no evidence of any preferential treatment by CADTH in Bayer's favor, and indeed, that there had been no guarantees that the pilot approval process would in fact be faster, more efficient or less costly.
While the case was ultimately dismissed, it did establish the principle that CADTH is part of the machinery of both the federal and provincial governments and hence its conduct, including its recommendations, is subject to judicial review – at least in the courts of Ontario. The Divisional Court noted that while CADTH has no specific defined decision-making power, it was nonetheless subject to a duty of procedural fairness. This finding permits manufacturers to seek judicial review of certain CADTH recommendations where the applicant can show a lack of due process.
A copy of the decision can be found at: http://www.gowlings.com/resources/pdfs/2008canlii55998.pdf