As previously reported, the 2018 Federal Budget announced the creation of an Advisory Council on the Implementation of National Pharmacare. On March 6, 2019, the Advisory Council delivered an interim report, with three initial recommendations:

• Creating a national drug agency to oversee national pharmacare;
• Developing a comprehensive, evidence-based list of prescribed drugs - a national formulary - to harmonize coverage across Canada; and
• Investing in data on prescription drugs and information technology systems.

The Advisory Council indicated that the final report should be issued in the coming months.

On March 19, 2019, the Federal government delivered the 2019 Federal Budget, which reflects these recommendations. In particular, the government plans to create a new Canadian Drug Agency, a national formulary, and a national strategy for high-cost drugs for rare diseases “to help Canadians get better access to the effective treatments they need…. an important first step in expanding drug coverage through federal support.” While the mandate for the Canadian Drug Agency is still in development, it will “be able to provide impartial and independent advice so that drug evaluation and price negotiation could be carried out by a single, coordinated entity.”

Quebec Court of Appeal overturns Minister's decision to delist REMICADE from Quebec's List of Medications

By Tierney GB Deluzio

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.