This appeal arose in the context of a February 15, 2017 decision of the Minister of Health and Social Services (the "Minister") to halt coverage of Janssen's REMICADE (with certain exceptions, including patients who had previously been receiving REMICADE), and to require that Quebec only pay for the less expensive biosimilar version of infliximab. On January 16, 2019, the Quebec Court of Appeal found the Minister's decision to delist REMICADE from Quebec's Liste des médicaments (the "List") (the Quebec equivalent to a formulary) to be invalid and ordered the Minister to reinstate the drug on the List: Janssen Inc c Ministre de la Santé et des Services sociaux, 2019 QCCA 39. In allowing the appeal, the Court did not comment on the merits of delisting REMICADE, instead holding that (1) the Minister's decisions to list or delist individual drugs are administrative and not regulatory in nature; and (2) a decision to delist a drug may require the Minister to respect certain minimum standards of procedural fairness. The Court concluded that the Minister had violated procedural fairness and should have given Janssen formal notice and an opportunity to respond before making the change. On February 11, 2019, the Minister published an amendment to the List, reinstating full coverage of REMICADE.
Related Publications & Articles
-
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training
TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal to overturn the refusal of the Minister of Mental Health and Addictions...Read More -
2025 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories.Read More