The Federal Court is tasked with hearing a wide variety of judicial review applications that can have a substantial impact on Canadian industry and technology sectors. For example, the Federal Court is the first instance review for decisions of Health Canada for prescription drugs, non-prescription drugs and natural health products; the Office of Patented Medicines Liaison; the Patented Medicines Pricing Review Board; the Commissioner of Patents; and the Registrar of Trade-Marks.
While decisions of these federal bodies often directly involve only one or two discrete parties, the issues raised can be significantly broader, and impact the industry as a whole. Consequently, industry groups may wish to intervene on any judicial review of the decision to speak to the unique impact of the government's decision on the industry as a whole.
Despite these potential benefits, few industry groups have sought to intervene at the Federal Court in such judicial reviews. However, a recent decision of the Federal Court provides useful guidance on the benefits that industry groups can bring to the proceeding in light of their unique perspectives.
Novo Nordisk Canada Inc v The Minister of Health and Teva Canada Limited
In a recent decision of the Federal Court, Madam Prothonotary Tabib granted BIOTECanada leave to intervene on a judicial review application brought by Novo Nordisk Canada Inc. (Novo Nordisk) regarding a pharmaceutical submission filed by Teva Canada Limited (Teva).
The underlying judicial review involved the Minister of Health's (the Minister) decision to accept an Abbreviated New Drug Submission for a generic version of Novo Nordisk's biologic medicine VICTOZA® (liraglutide), in contrast to the requirements established in Health Canada Guidance Documents that generic versions of biologic drugs (termed "biosimilars") be submitted as a biosimilar New Drug Submission. Both Teva and the Minister challenged Novo Nordisk's ability to seek judicial review of the Minister's decision. BIOTECanada sought to intervene on the basis that it could have a unique perspective on the significant public policy implications that arose from the Minister's decision.
In seeking to intervene, BIOTECanada highlighted that as a national, non-governmental organization, it advocates on behalf of its broad membership base across a variety of sectors of Canada's biotechnology industry. Notably, while BIOTECanada's membership includes several large pharmaceutical companies, the majority are companies with fewer than 25 employees whose interests lie in the broader policy aspects of consistency and predictability. Consistency and predictability in the regulatory sphere permits BIOTECanada's smaller members to develop new innovations, attract investments and partnerships, and create jobs in Canada's biotechnology industry.
The Court agreed with BIOTECanada's submissions, permitting BIOTECanada to intervene and provide its unique perspective to the policy considerations at play. Notably, the Court found BIOTECanada was uniquely positioned to speak to the public policy impacts of the Minister's decision on the Canadian biotechnology industry as a whole, which the existing parties were not as well positioned to address.
The Unique Perspective Brought to the Proceeding by Industry Groups
On a motion to intervene, the proposed intervener must show the Court that they will bring a further, different and valuable insight and perspective to assist the Court in determining the matter, and that the issue is not adequately defended by the existing parties. This is often a difficult burden to meet, with leave to intervene often denied if the intervener's position simply duplicates that of the existing parties.
The Federal Court's decision granting BIOTECanada intervener status highlights some of the distinct and valuable insights and perspectives that an industry group can bring before the Court. These include:
- a broad membership base, covering all aspects of the relevant industry and companies of various sizes;
- a unique viewpoint on the potential impact of the government's decision on the industry as a whole, including the impact on smaller companies' ability to attract investment and partnerships to develop new technologies in Canada;
- the overall impact of any deviation from existing regulatory procedures or expectations, especially in situations where the industry group was directly involved in the consultation process surrounding the existing regulatory procedure; and
- a position which seeks to balance, or contrast, the policy considerations put forward by the Attorney General (representing the federal decision maker) in regards to the policy impacts on the industry as a whole.
As noted by the Court, these factors are often difficult for individual companies, particularly large, international companies, to fully canvas and adequately address. As a result, the Court benefits from the intervener's submissions to permit review of the underlying decision in its full and proper context, including the impact on the industry as a whole.
These factors would also benefit industry groups seeking to intervene at the Federal Court of Appeal either in the appeal of a judicial review, or for those tribunals who bypass the Federal Court and provide a direct right of appeal to the Federal Court of Appeal.