Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations
Title of Regulatory Initiative
Regulations Amending the Patented Medicines Regulations
The objective of this amendment is to modernize the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations. The Regulations, together with the Patent Act, provide the Patented Medicine Prices Review Board (PMPRB) with a framework to protect consumers from excessive drug prices. The amendments include revising the list of countries used for comparison when assessing whether a patented drug price is excessive and adding new price regulatory factors so value for money and affordability can be taken into consideration. The amendments will equip the PMPRB to be a more effective price regulator. This will be the first time in more than 20 years that the Patented Medicines Regulations have been substantially updated.
Regulatory cooperation efforts (domestic and international)
Regulatory cooperation does not extend to drug pricing considerations. Each country is responsible for maintaining its own health care system, including decisions related to which treatments, procedures, drugs and devices will be eligible for coverage and under what conditions.
Potential impacts on Canadians, including businesses
The amendments would reduce the prices of patented drugs in Canada so that they are better aligned with prices paid in other countries and the value of the health benefit that is produced by the drug. This will alleviate financial pressure on Canada’s health care system and reduce financial barriers to Canadians’ accessing needed drugs. Total 10-year savings to Canadian patients, public and private drug plans of $13.2B are estimated to be associated with the amendments. These savings are also a cost to business that result from lower prices for patented drugs.
Impacts on investment are not anticipated, since other countries receive higher drug industry investments than Canada despite benefiting from lower drug prices than Canada.
On December 2, 2017, proposed amendments to the Patented Medicines Regulations were published in Canada Gazette, Part I for a 75-day comment period. The comment period closed on February 14, 2018. A media briefing was held on December 1, 2017, to announce the Canada Gazette, Part I publication and provide an overview of the main features of the proposal.
To support informed stakeholder participation, Health Canada hosted public and targeted stakeholder information sessions, which were held December 13 and 14, 2017. Health Canada also hosted a January 10, 2018, information session specifically on the cost benefit analysis that accompanies the regulatory proposal. Health Canada also expressed willingness to meet with stakeholder associations upon request.
The Canada Gazette, Part I proposal reflected several adjustments to the original proposal that was the subject of a 45-day public consultation that was launched by the federal Minister of Health in spring 2017. During that consultation period, Health Canada held nine engagement sessions with external stakeholders, including representatives from public and private drug plans, patient organizations, the pharmaceutical industry, the health professions and academia.
Based on some of the concerns raised by industry stakeholders during the Canada Gazette Part I consultation, Health Canada commissioned Dr. David Dodge and Dr Åke Blomqvist to perform an Independent Assessment of the regulatory proposals features and accompanying Cost-Benefit Analysis. The Independent Assessment was completed on August 23rd, 2018, and found that “…there is no good economic or conceptual reason not to proceed with the proposed regulatory changes.”
The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in the Spring 2019 session. It is anticipated that the amended regulations would come into force 12 months following their publication in Canada Gazette Part II.
The following additional documentation is available upon request:
- Government of Canada’s complete Cost-Benefit Analysis of the regulatory proposal; and,
- Independent Assessment of the regulatory proposal by Dr. David Dodge and Dr. Åke Blomqvist.
Requests for these documents should be directed to Karen Reynolds.
Departmental contact information
Office of Pharmaceuticals Management Strategies
Strategic Policy Branch
Email address: email@example.com
Date the regulatory initiative was first included in the Forward Regulatory Plan
October 1, 2017
Consult Health Canada’s acts and regulations web page for:
- a list of acts and regulations administered by Health Canada
- further information on Health Canada’s implementation of government-wide regulatory management initiatives
Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:
To learn about upcoming or ongoing consultations on proposed federal regulations, visit:
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