Government of Canada Proposes Regulatory Changes to Lower the Cost of Patented Drugs
December 1, 2017 - Ottawa, ON - Health Canada
Prescription drugs are an important part of Canada’s health care system and can help to enhance the well-being of Canadians. The Government of Canada is taking action to improve the affordability, accessibility and appropriate use of prescription drugs through regulatory improvements, enhanced partnerships and better integration of drug review processes.
Today, the Government of Canada published in the Canada Gazette, Part I, proposed changes to the Patented Medicines Regulations, representing the first major update to the regulations in more than 20 years. These proposed amendments to the Regulations are intended to provide the Patented Medicine Prices Review Board (PMPRB) with the tools it needs to better protect Canadian consumers from the high prices of patented drugs. Interested parties are invited to provide comments on the proposal within 75 days of publication (February 14).
The proposed regulations include a revised list of countries against which Canada’s patented drug prices would be compared, and the introduction of new regulatory factors that the PMPRB would take into consideration when assessing whether a patented drug price is excessive. Changes to these regulations will lower prices for public drug plans and, ultimately, for Canadians.
For example, under the current Regulations, drug companies are required to report on only the direct price reductions they offer to Canadian customers at the first point of sale such as wholesalers and pharmacy chains. The amendments would require reporting on all price reductions, so that the PMPRB can take all reductions into consideration when setting price ceilings and monitoring compliance.
Through these amendments the Government of Canada is taking steps to ensure that Canadians will have access to and be able to afford medicines that are necessary for their health and well-being.
“Our government is committed to improving the affordability of patented prescription drugs that Canadians rely upon for their health and well-being. The proposed regulations published today advance our work with our provincial and territorial partners to ensure Canadians have access to the medicines they need.”
The Honourable Ginette Petitpas Taylor
Minister of Health
The PMPRB is a federal agency created in 1987 under the Patent Act to ensure that drug companies do not abuse their patent rights by charging consumers excessive prices.
The Patent Act and Patented Medicines Regulations set out the factors and information to be considered by the PMPRB when determining whether the price of a patented drug is excessive.
Budget 2017 allocated $140.3 million over 5 years, starting in 2017-18, with a further $18.2 million per year ongoing, for Health Canada, the PMPRB and the Canadian Agency for Drugs and Technologies in Health to improve access to prescription medications, lower drug prices and support appropriate prescribing.
Office of Ginette Petitpas Taylor
Minister of Health
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