Patented Medicine Prices Review Board

Patented Medicine Prices Review Board (PMPRB) is an independent quasi-judicial body established by the Government of Canada in 1987 following amendments to the Patent Act. Its primary role is to ensure that prices charged by manufacturers for patented medicines sold in Canada are not excessive. The PMPRB operates within the context of the Canadian healthcare system, which is characterized by a commitment to universal coverage for medically necessary hospital and physician services. The Board's mandate and activities are a critical component of the broader strategy to manage healthcare costs while ensuring that Canadians have access to new and innovative medicines.

Mandate and Jurisdiction

The PMPRB's mandate is to ensure that prices of patented medicines sold in Canada are not excessive. It does this by reviewing the prices that patentees charge for each patented medicine sold in Canada to wholesalers, hospitals, or pharmacies. The Board has the authority to hold public hearings and potentially order price reductions or the offset of excess revenues through additional price reductions or payments to the Government of Canada if it finds that the price of a patented medicine is excessive. The jurisdiction of the PMPRB covers all patented medicines, including those sold on prescription and over-the-counter, as well as patented medicines used in hospitals.

Regulatory Framework

The regulatory framework guiding the PMPRB's operations includes the Patent Act, the Patented Medicines Regulations, and the Board's own Compendium of Policies, Guidelines, and Procedures. This framework sets out the criteria and factors the Board must consider when assessing whether a patented medicine's price is excessive, including the prices of the medicine in other countries, changes in the Consumer Price Index, and the medicine's therapeutic benefits.

Price Review Process

The price review process involves a series of steps, starting with the submission of information by patentees about the medicine, including its price. The PMPRB then conducts an initial review to determine if the price is within its guidelines. If a price is found to potentially exceed these guidelines, the PMPRB may commence an investigation, which could lead to a public hearing. The outcome of a hearing could include orders to reduce the price of the medicine and/or to offset excess revenues.

Challenges and Criticisms

The PMPRB has faced challenges and criticisms related to its effectiveness and its impact on the availability of new medicines in Canada. Some stakeholders argue that the Board's regulations may discourage pharmaceutical companies from introducing new medicines in Canada due to concerns about price restrictions. Others contend that the PMPRB plays a vital role in controlling drug costs and ensuring that Canadians have access to affordable medicines.

Recent Developments

In recent years, the PMPRB has undertaken initiatives to modernize its regulatory framework to better address the challenges posed by the high cost of new and innovative medicines. These initiatives aim to enhance the Board's ability to protect consumers from excessive drug prices while encouraging the availability of new treatments.

Conclusion

The Patented Medicine Prices Review Board plays a crucial role in the Canadian healthcare system by ensuring that the prices of patented medicines are not excessive. Through its regulatory framework and price review process, the PMPRB seeks to balance the need for affordable access to medicines with the incentives for pharmaceutical companies to bring new and innovative treatments to the Canadian market.