Patented Medicine Prices Review Board on:
[Wikipedia]
[Google]
[Amazon]
The Patented Medicine Prices Review Board (PMPRB; ) is a federal quasi-judicial regulatory and reporting agency in Canada.
The mandate of the agency is to protect consumers by ensuring that the prices of patented medication charged by pharma companies are not excessive. The board also reports on trends, research and development in the Canadian pharmaceutical industry.
The PMRPB investigates, reviews and negotiates the price of drugs that are still under
Bill C-22, which was passed in 1987, established a compulsory licensing system under which drug patent holders were required to allow competing drug manufacturers to import their patented drug in exchange for a very modest 4% royalty, which resulted in an increase in the
Road Map for the Next Decade
Ottawa, Ontario. 36pp. Patented medicines represented 61.5% of the total medicine sales in Canada in 2017 up from 60.8% in 2016.
patent
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...
and which have no generic substitutes. It establishes the maximum prices that can be charged in Canada. Prescription drug prices in the United States
Accountability
The board is accountable to theParliament of Canada
The Parliament of Canada () is the Canadian federalism, federal legislature of Canada. The Monarchy of Canada, Crown, along with two chambers: the Senate of Canada, Senate and the House of Commons of Canada, House of Commons, form the Bicameral ...
through the Minister of Health, the elected official responsible for the health portfolio. Under sections 89 and 100 of the '' Patent Act'', the board produces an annual report submitted to the minister, who tables it in the House of Commons
The House of Commons is the name for the elected lower house of the Bicameralism, bicameral parliaments of the United Kingdom and Canada. In both of these countries, the Commons holds much more legislative power than the nominally upper house of ...
.
Background
Bill C-22, which was passed in 1987, established a compulsory licensing system under which drug patent holders were required to allow competing drug manufacturers to import their patented drug in exchange for a very modest 4% royalty, which resulted in an increase in the market share
Market share is the percentage of the total revenue or sales in a Market (economics), market that a company's business makes up. For example, if there are 50,000 units sold per year in a given industry, a company whose sales were 5,000 of those ...
of generic drugs
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
. At the same time, it established the federal Patented Medicine Prices Review Board. The board determines a maximum price for individual drugs through a review process, and negotiates "voluntary compliance agreements" with drug companies to ensure that "manufacturer prices are within justification, and renot excessive".
The PMPRB is an independent federal quasi-judicial body established through Section 91 of the '' Patent Act''. Sections 79 through to 103 of the Act set out the mandate, structure, appointment process, and jurisdiction of the Board. The objective of the board is to preventing manufacturers of patented medicines from charging excessive prices.
Annual reports
According to their annual report for the fiscal year 2017, there were 1,391 patented medicines for human use that were reported, which included 80 new medicines. By December 31, 2017, there were 14 voluntary compliance undertakings accepted.1998. Report of the Patented Medicine Prices Review BoardRoad Map for the Next Decade
Ottawa, Ontario. 36pp. Patented medicines represented 61.5% of the total medicine sales in Canada in 2017 up from 60.8% in 2016.
Recent PMPRB reforms
Since 2017, the federal government has been working on passing regulatory changes to how the Patented Medicine Prices Review Board (PMPRB) regulates the excessive pricing of patented medicines in Canada. The Federal Court andQuebec Court of Appeal
The Court of Appeal of Quebec (sometimes referred to as Quebec Court of Appeal or QCA; ) is the highest judicial court in Quebec, Canada. It hears cases in Quebec City and Montreal.
History
The court was created on May 30, 1849, as the Court ...
decisions in ''Innovative Medicines Canada v. Canada'' (2022) and ''Merck Canada inc. v Procureur général du Canada'' (2022) rebuked the federal government's initially-proposed changes to the PMPRB as ultra vires
('beyond the powers') is a Latin phrase used in law to describe an act that requires legal authority but is done without it. Its opposite, an act done under proper authority, is ('within the powers'). Acts that are may equivalently be termed ...
the ''Patent Act''. The Trudeau Liberal government has proceeded with subsequent regulatory changes designed to reduce the prices Canadian drug insurers pay for patented medicines. The government has been criticized for their use of the Patent Act and the Patented Medicine Prices Review Board to drive cost savings for drug insurers and for the potential cooling effect this may have in bringing innovative medicines to Canada 22.
References
External links
* * * {{Authority control Independent government agencies of Canada Pharmacy organizations in Canada