In Apotex Inc. v Canada (Minister of Health) (“Apotex”), the Federal Court (the “Court”) provided some guidance with respect to the procedure pharmaceutical companies should undertake to obtain a Notice of Compliance (“NOC”). Overall, the Court’s findings suggest that pharmaceutical companies should put their best foot forward in their application or on appeal in front of expert panels considering or reconsidering their applications because overturning an expert panel’s decision is often difficult with Courts showing deference to expert panels.
Background of the Case
On September 8, 2015, Apotex Inc. (“Apotex”) applied for judicial review of the Director General’s July 16, 2015 decision (the “Final SLS Decision”), denying Apotex’s Abbreviated New Drug Submission (“ANDS”) for 100 mg capsules of Apo-Progesterone. The Final SLS Decision was issued after a four-person internal panel of toxicological experts recommended upholding the Minister of Health’s decision to issue a notice of non-compliance (“NON”) on April 17, 2014 and a notice of non-compliance/withdrawal (“NON-W”) on December 29, 2014, citing concerns that the proposed formulation contained “unusually high levels” of Sodium Lauryl Sulfate (“SLS”), a non-medical ingredient used as an excipient.
Federal Court’s Response and Implications
Justice Phelan dismissed Apotex’s application for judicial review finding there was no reason to interfere with the Minister of Health’s decision. The decision raises several implications for stakeholders in the pharmaceutical and biochemical industry.
(a) Limits of Judicial Review
Courts are typically cautious to interfere with decisions made by an expert panel. This Court made several comments with respect to the panel affirming and supporting this deferential approach:
This deferential approach is in line with the other, albeit few judicial review decisions regarding NONs and NON-Ws, such as in Apotex Inc. v Canada (Minister of Health) (2009 FC 452), where Justice Phelan upheld the Minister of Health’s decision and noted that it was “sufficient that the Minister’s opinion or lack of satisfaction [be] rationally and adequately explained.” This deference may also be a result of the Minister of Health’s important task of ensuring that drugs that are on the market are safe and effective.
What has emerged, then, is a situation in which judicial review has become a tool of last resort and, even then, rarely results in a different decision. As a result, prospective ANDS applicants should consult counsel early and submit a fulsome ANDS in the first instance, as obtaining a favourable result after a request for reconsideration is often challenging.
(b) Evidence Relied On
The Court based its decision partly on the reasoning that Apotex put forward evidence that suffered from numerous shortcomings:
This highlights the importance of presenting comprehensive and persuasive studies to withstand detailed, technical and expert review. Submitting a few studies and stating that another jurisdiction approved a related drug is not, in other words, always sufficient.
The Court considered Apotex’s late application. It reasoned that, while Apotex filed its application late in the honest but mistaken belief that the Director General’s communications with Apotex after the Final SLS Decision meant that the Director General would reconsider Apotex’s request, the Court could still consider Apotex’s application because Apotex had a reasonable explanation for the delay: if it filed for judicial review, any reconsideration would be terminated. As a result, pharmaceutical companies may, depending on the circumstances, still apply for judicial review after the deadline if they have a compelling explanation.