Raison d'être, mandate and role: who we are and what we do

Raison d'être

The PMPRB contributes to sustainable spending on pharmaceuticals in Canada by:

• acting as an effective check on the prices of patented medicines and intervening where the board determines a price to be excessive; and
• reporting annually on trends in pharmaceutical sales and pricing and on research and development spending by pharmaceutical rights holders.

Mandate and role

The PMPRB is an independent, quasi-judicial body with the mandate to monitor the price at which rights holders sell their patented medicines in Canada to ensure that this price is not excessive. The PMPRB is also responsible for reporting annually to Parliament through the Minister of Health on its activities for the previous year, pricing trends of all patented medicines, and research and development expenditures reported to the PMPRB by pharmaceutical rights holders.

In addition, at the request of the Minister of Health under section 90 of the Patent Act, the PMPRB conducts analysis of price, utilization, and cost trends for patented and non-patented medicines under the National Drug Utilization Information System (NPDUIS) research initiative. The reports prepared through this initiative provide pharmaceutical payers and policy makers with information to support evidence-based reimbursement and pricing decisions.

The PMPRB is part of the Health Portfolio, which includes Health Canada, the Public Health Agency of Canada, the Canadian Institutes of Health Research, and the Canadian Food Inspection Agency. The Health Portfolio supports the Minister of Health in maintaining and improving the health of Canadians.

Because of its quasi-judicial responsibilities, the PMPRB carries out its mandate at arm’s length from the Minister, who is responsible for the sections of the Patent Act pertaining to the PMPRB.

Where does the PMPRB fit in Canada’s healthcare ecosystem?

The PMPRB’s mandate is an independent piece of a complex ecosystem that manages the medicines approved in Canada. This includes healthcare-related bodies, such as:

• Health Canada, which approves medicines for marketing in Canada based on their safety, efficacy, and quality;
• Canada’s Drug Agency (CDA, formerly the Canadian Agency for Drugs and Technologies in Health), which performs health technology assessment and assembles expert committees to make recommendations on which medicines should qualify for reimbursement under publicly funded drug programs, as well as the Institut national d’excellence en santé et en services sociaux (INESSS), which evaluates medicines to make recommendations on reimbursement by public plans in Quebec;
• The pan-Canadian Pharmaceutical Alliance (pCPA), which negotiates the list prices on behalf of the publicly funded drug programs across Canada (both federal and provincial, including Quebec); and
• Federal, provincial, and territorial (F/P/T) public drug plans and private drug plans, which approve the listing of medicines on their respective formularies for reimbursement purposes.

Operating context

The regulatory landscape and policy environment for pharmaceuticals in Canada is a complex and evolving ecosystem, in which the PMPRB has a specific role. Canadians face increased costs of living and mounting prescription medicine costs, exacerbated by socioeconomic inequities. Recent analysis of pharmaceutical spending and innovation in Canada characterizes a public payer market driven by the use of newer and higher-cost drugs, as well as an expanding drug pipeline defined by specialized orphan-designated medicines and novel gene and cell therapies that are broadening to larger patient groups.

Most relevant to the PMPRB, amendments to the Patented Medicines Regulations (“Regulations”) in July 2022 set out a new, and larger, basket of comparator countries as context for the monitoring of patented medicine prices. As a result, rights holders have been filing new foreign pricing information with the PMPRB since 2022. The amendment also acknowledged the PMPRB’s important and limited jurisdiction, as set out by the Patent Act and as clarified in recent determinations by the Quebec Court of Appeal^{Footnote 1} and the Federal Court of Appeal^{Footnote 2}.

The PMPRB continues to monitor changes in the geopolitical and economic context in which it operates. As the market for pharmaceuticals is complex, international, and interdependent, changes in trading relationships could have an impact on the prices of medicines in Canada. The PMPRB actively monitors the prices of medicines based on factors laid out in the Patent Act and associated Regulations and is empowered to take action in the event of a sudden rise in prices.

The PMPRB also operates in a decision-making environment that has a need for high-quality analytic information on pharmaceutical spending, and that emphasizes the importance of transparency and engagement with the Canadian public. These values form a pivotal piece of the PMPRB’s continued commitment to the responsible and efficient execution of its mandate.