Mandate and Jurisdiction
The PMPRB has a dual mandate: in its regulatory role, it protects consumers by ensuring that the prices of patented medicines are not excessive; in its reporting role, it provides information on pricing trends in the pharmaceutical industry via its Annual Reports.
Further to a directive from the Minister of Health under section 90 of the Act, the PMPRB also supports informed and evidence-based health policy by reporting on medicine price, utilization and cost trends under the National Prescription Drug Utilization Information System (NPDUIS) initiative.
What you need to know
More about the PMRPB
- The PMPRB is a drug price watchdog
- The PMPRB reviews patented medicine prices to ensure they are not excessive.
- Patents in Canada typically last 20 years. If a rights holder takes advantage of that exclusivity by charging an excessive price, the PMPRB has the legal authority to order a price reduction.
- The PMPRB does not set drug prices
- The PMPRB ensures that drug prices set by manufacturers are not excessive.
- “Excessive” is not a one-size-fits-all approach. One drug that costs $50,000 may be considered excessive in one hypothetical example, while a different drug that costs $500,000 could be considered non-excessive.
- The PMPRB Guidelines outline the process staff uses to identify cases which could benefit from a hearing to determine if excessive pricing is present.
- Only once a hearing panel determines that a price is indeed excessive, can a price reduction be ordered.
- The PMPRB is not a barrier to market entry
- The PMRPB only reviews the price of a drug after it is first sold in Canada; The PMRPB is not involved in the approval process for a drug in Canada, nor whether it is reimbursed by the public health systems in different provinces or territories.
- Companies are free to decide the pricing level of their drugs as the PMPRB only intervenes when the price may be excessive.
Canada’s biopharmaceutical ecosystem is complex. To know more about where the PMPRB fits in the ecosystem, how we review prices and how the PMPRB staff recommend a hearing to the chairperson, visit our website.