Patented Medicine Prices Review Board

Patented Medicine Prices Review Board. The Patented Medicine Prices Review Board is an independent, quasi-judicial body established by the Government of Canada under the Patent Act. Its primary role is to ensure that prices charged by manufacturers for patented medicines sold in Canada are not excessive, protecting consumers and contributing to the sustainability of the Canadian health care system. The Board operates at arm's length from Health Canada and reports to Parliament through the Minister of Health.

Mandate and functions

The core mandate of the Board is to protect consumers by reviewing the prices of patented drug products sold in Canada to prevent excessive pricing. This function is enshrined in amendments to the Patent Act made in the late 1980s. Key functions include conducting price reviews for new patented medicines and existing products, investigating potential cases of excessive pricing, and ordering price reductions or monetary penalties if violations are found. The Board also reports annually on pharmaceutical trends, including research and development spending by patentees, and its analyses inform broader discussions on drug policy and pharmacare.

History and establishment

The Board was created in 1987 following significant amendments to the Patent Act. These changes, part of a compromise to extend patent protection for pharmaceutical innovations, were influenced by the recommendations of the Eastman Commission. The establishment balanced the interests of the pharmaceutical industry with public concern over drug prices, creating a regulatory mechanism unique among OECD nations. Its formation coincided with broader national debates on intellectual property and the role of generic drugs within the medicare system.

Price review process

The Board's review process begins when a manufacturer files a price for a new patented medicine. Prices are assessed against defined regulatory factors, including comparison to prices in other countries like France, Germany, Italy, Sweden, the United Kingdom, and the United States. The Board also considers the price of existing therapies for the same disease and the median price of all drugs in the relevant therapeutic class. If an introductory price is deemed excessive, the Board can issue a Notice of Hearing, potentially leading to an order to reduce the price and repay excess revenues to the Crown.

Regulatory impact and controversies

The Board's regulatory actions have significantly influenced the Canadian pharmaceutical landscape, often keeping prices lower than those in the United States. However, its role and methodologies have been subject to ongoing controversy and legal challenges from members of Innovative Medicines Canada. Critics argue the Board's processes stifle innovation and delay market access for new medicines, while public health advocates and provinces like Quebec and Ontario have called for stronger powers to further control costs. Debates often center on its international price comparison list and its authority in the context of proposed national pharmacare programs.

Governance and structure

The Board is led by a Chairperson and up to four Vice-Chairpersons, who are appointed by the Governor in Council. Members typically have expertise in fields such as health economics, law, and medicine. The Board's secretariat, based in Ottawa, includes staff who conduct economic analysis, legal review, and policy development. While it operates independently, it coordinates with other agencies including Health Canada, the Canadian Agency for Drugs and Technologies in Health, and provincial drug plans like those in British Columbia and Alberta.

Category:Government agencies of Canada Category:Healthcare in Canada Category:Pharmaceutical industry in Canada