- New! Read our feedback to the PMPRB on the Change to the Definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions sent on 2021-08-31
- Read the letter we sent to the Prime Minister of Canada and other government officials on 2021-06-16
- Read our feedback to the PMPRB Guideline Monitoring and Evaluation Plan (GMEP) 2021 sent on 2021-06-21
- Read our feedback to the PMPRB 2020 Draft Guidelines sent on 2020-08-04
- Read our feedback to the PMPRB 2019 Draft Guidelines, co-authored with the Alliance for Safe Biologic Medicines, sent on 2020-02-14
Want to know the basics about what the PMPRB is and how it affects medication regulation and access in Canada?
Watch These Short Videos
What is the PMPRB?
Price vs. Value
Patient Input and Drug Reviews
Drug Price Reviews in Canada
PMPRB and Lower Prices
PMPRB Impact on the Global Market
Basket of Comparator Countries
Changes to Medicine Access in 2021
The Gastrointestinal Society released the Patented Medicine Prices Review Board: Report on the Changes and Their Impact on Canadians, the (“PMPRB Impact Report”) detailing how our access to medicines are changing as of January 1, 2021.
Update: On June 29, 2021, Health Canada has, again, postponed the implementation date of the new PMPRB changes from July 1, 2021 to January 1, 2022 in recognition of the ongoing challenges brought by the COVID-19 pandemic. Details will be published in the Canada Gazette, Part II on July 21, 2021. Contact the federal government now to share how important access to new and lifesaving medicines are for you, your loved ones, and fellow Canadians at www.fightforourlives.ca.
Canada is the only country in the world with a regulator that caps patented medicine prices but it claims to adopt best practices used in other developed countries by considering value and affordability and it does so under the Patented Medicine Prices Review Board (PMPRB). After the PMPRB sets a maximum price, Canada and its provinces and territories also have other bodies that further negotiate the price of a medicine lower.
Why does this matter to Canadians now?
The PMPRB has been around since 1987, with guidelines as to how it calculates a maximum price. However, release of the final PMPRB Modernization Guidelines on October 23, 2020 has not given Canadians enough time to respond to the changes before the January 1, 2021 implementation date.
Experts in the Canadian healthcare system, including patient groups, say this “modernization” could seriously affect access to lifesaving and life-altering drugs. When the amount paid to the manufacturer for publicly-funded medications becomes so low, it might no longer be viable for the companies to sell their medicines in Canada. This includes both new drugs and existing drugs, which could be pulled from the Canadian market.
In the full report we explore the changes to the guidelines, provide background, and explain the potential effects of these changes. We hope you take the time to read about them now, before it’s too late. We identify the ways in which healthcare systems interact with our lives, as we use prescription medicines, medical devices, participate in clinical trials, and access patient support programs. We also provide real world examples to show the effects of these policies on Canadians today.
The PMPRB guideline changes are generating a high level of uncertainty, which could jeopardize the launch of new medicines by significantly decreasing Canada’s attractiveness as a priority jurisdiction in which to seek regulatory approval to sell their new medicines. The changes can also affect existing medications for which prices go so low that, suddenly, they are no longer available to Canadians. Pricing uncertainty will impact drug manufacturers, but this concern reaches right down to the end user of medications. We foresee significant delays for Canadians to access important new therapies that are lifesaving or life-altering. A decision not to launch a product in Canada would eliminate access for all patients, even those who have private insurance for drugs.
The PMPRB is also executing this regulatory overhaul as our healthcare systems continue to prioritize responding to the challenges of the COVID-19 pandemic. This is not the time!
What can you do?
The Canadian Organization for Rare Disorders (CORD), of which we are a member, has launched a movement, www.fightforourlives.ca, to call on the federal government to stop the PMPRB guidelines coming into effect.
Individuals across Canada have taken part in their letter-writing campaign, and you can too. Share your story on the importance of access to medicines for you, your loved ones, and fellow Canadians. You do not need to have a rare disease or disorder, or chronic health conditions to participate. You can also contact us at the Gastrointestinal Society to learn more of how we can ensure the right people hear your voice.
Join us in our advocacy. It is crucial that we raise awareness of these impending changes that will limit our access to innovative and lifesaving medicines.
Breaking News
On October 1, 2020, the US released the Final Rule and guidance documents on how the country will import prescription drugs from Canada.1 However, on November 27, 2020, the federal Minister of Health blocked US President Trump’s executive order by signing the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply).2
According to PDCI Market Access, the pharmaceutical industry estimates that the impact of the PMPRB changes will result to $19.8 billion in savings over a 10-year period from the new basket of comparator countries alone. This is a difference of $13.6 billion from PMPRB’s claims of $6.2 billion in savings.
Furthermore, on November 16, 2020 the House of Commons Standing Committee on Health (HESA) initiated a series of meetings with stakeholders, including PMPRB staff and Board, to investigate the new PMPRB guidelines.3
As we near the implementation deadline on January 1, 2021, Canadians and stakeholders in the healthcare systems continue to express their concerns to the federal government. More updates from the GI Society will follow as additional changes will likely develop.
