Protect Our Access

The federal government has proposed new regulations that threaten your access to life-saving medicines. These changes mean fewer life-changing medicines available to us. It will force Canadians to leave the country for better medical care—if they can afford it. Act now! Visit the website to learn how you can make a difference!

The Coming-into-force of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) has been delayed until July 1, 2021

As you may recall, these amendments were published in the Canada Gazette, Part II in August 2019 and represent the first substantive update of the Patented Medicine Prices Review Board (PMPRB)’s regulatory framework in more than 30 years. Specifically, the amendments provide the PMPRB with new price assessment factors, a revised schedule of foreign price reference countries and new patentee information reporting obligations. Collectively, the amendments provide the PMPRB with the tools and information needed to protect Canadian consumers from excessive prices for patented medicines.

The Government of Canada is mindful that the COVID-19 pandemic continues to challenge all stakeholders. For this reason, the coming-into-force date of the Amendments to the Patented Medicines Regulations has been delayed by an additional six months, to July 1, 2021. This delay provides industry with additional time to prepare for the new reporting obligations. A delay will also allow industry further time to familiarize themselves with the PMPRB’s final Guidelines, which were published on October 23, 2020.

The amended regulations will be published in the Canada Gazette, Part II on January 20, 2021.

PMPRB Articles

Patient Group Briefs on PMPRB Guidelines

CCSN is highlighting submissions from patient organizations for the June 2020 PMPRB consultations. To read additional letters and briefs please click here.

Briefs to the Federal Standing Committee of Health

  • The Quebec Cancer Coalition has submitted a brief and a request to appear before the Standing Committee on Health (HESA) of the House of Commons on Patented Medicine Prices Review Board’s (PMPRB) Guidelines. Read the full report

Health Canada New Interim Order – An Important Tool to Address COVID-19 Related Drug Shortages

Archive of submissions to PMPRB

Canada, like many countries, is facing escalating health care costs as payers struggle to reconcile finite drug budgets with patient access to promising new health technologies. Improving affordability and access to prescription drugs is a key Government of Canada commitment and a joint federal, provincial, and territorial priority.

As a first step to framework modernization, the Patented Medicine Prices Review Board (PMPRB) is undertaking major consultations regarding possible reform of its Compendium of Policies, Guidelines and Procedures, commonly referred to as “the Guidelines.”

During Phase 1 of this consultation initiative, the PMPRB asked for your input on how we can rethink the Guidelines in order to improve our performance in ensuring that pharmaceutical patent holders do not charge excessive prices. We are now analyzing the feedback we received. The PMPRB Guidelines Modernization Discussion Paper and discussion questions are still available online for those who wish to consult them.

Phase 2 of the consultation process is expected to consist of a public policy hearing before the Board, where stakeholders who commented on the Discussion Paper will have the opportunity to speak to their written submissions. Timelines for Phase 2 will be announced at a later date.

By Rethinking the Guidelines, the PMPRB seeks to contribute to a sustainable pharmaceutical system where payers have the information they need to make smart reimbursement choices and Canadians can afford the medicines they need to live healthy and productive lives.