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e-2546 (Health)

E-petition
Initiated by Jocelyn James from Chiliwack, British Columbia

Original language of petition: English

Petition to the House of Commons in Parliament assembled

Whereas:
  • New medicines and vaccines help save and improve the lives of Canadians;
  • New therapeutics are revolutionizing medical care by, inter alia, targeting specific genes to address severe rare diseases like cystic fibrosis;
  • Medicine and vaccine developers already negotiate competitive discounts and rebates with governments and private benefit drug programs, and are already subject to federal and provincial regulations regarding prices;
  • Canadian patients and families desperately need medicines that keep them out of hospitals and vaccines and therapeutics to combat COVID-19;
  • Regulation and guideline changes to the Patented Medicine Prices Review Board scheduled to come into effect on July 1, 2020, are so unclear, uncertain and unreasonable with respect to the regulated price ceilings of new medicines in Canada that developers have chosen to not introduce new medicines to the Canadian market and have reduced clinical research in this country; and
  • As a result of the changes to the federal price regulations, many Canadians with cancer, cystic fibrosis and other life-threatening diseases do not have access to medicines and clinical trials that could save, prolong or improve their lives.
We, the undersigned, citizens of Canada, call upon the Government of Canada to repeal the changes to the Patented Medicines Regulations that were adopted in August 2019; engage in substantive, transparent and evidence-based consultations with stakeholders on any changes to the Patented Medicine Prices Review Board; and work with patients, clinicians, provincial health systems, researchers and medicine developers to inform the federal price review regime so that the Patented Medicine Prices Review Board does not obstruct access to new medicines and clinical trials.

Response by the Minister of Health

Signed by (Minister or Parliamentary Secretary): Darren Fisher

The Government is committed to strengthening Canada’s health care system and to supporting the health of Canadians. Prescription medicine prices in Canada are among the highest in the developed world. This adversely impacts the ability of Canadians to access needed medications and challenges the sustainability of Canada’s health care system. Current high prices in Canada place an added financial burden on public and private insurers, as well as on individuals who pay out of pocket for medications. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision.

That is why the Government of Canada is committed to working with provinces, territories and stakeholders to continue to implement national universal pharmacare so that Canadians have the drug coverage they need. As stated in the Speech from the Throne in September 2020, we will accelerate steps to achieve this system including developing a rare-disease strategy, establishing a national formulary and working with provinces and territories that are willing to move forward without delay.

As a foundational step towards national pharmacare, the Government of Canada recently modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with the tools and information needed to protect Canadians from excessive patented medicine prices. This was the first substantive update to the regulations since 1987 and it is expected that these amendments will save Canadians $13.2 billion in drug spending over the next 10 years. The amendments were published in Canada Gazette, Part II on August 21, 2019 and are available at: http://www.gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html 

 

The amendments are the result of an extensive, multi-year stakeholder consultation process which included the establishment by the PMPRB of a multi-stakeholder Steering Committee and Technical Working Group. On November 21, 2019, the PMPRB launched its stakeholder consultations on a draft of its Guidelines, which operationalize the amendments. After publishing revised draft Guidelines on June 19, 2020, the PMPRB undertook a second consultation process that was concluded on August 4, 2020. The PMPRB released its final  Guidelines on October 23, 2020.

Due to the COVID-19 pandemic, the Government of Canada has delayed the coming-into-force of the regulatory amendments by six months to January 1, 2021, to minimize the imposition of new administrative burden on the pharmaceutical industry as patented drug manufacturers faced increased demands related to supply chains and shortages of existing products. It also provided stakeholders with additional time to engage with the PMPRB’s Guidelines consultation process, which had been impacted by the onset of COVID-19. More information on the delay is available in the Regulatory Impact Assessment Statement (RIAS), published in the Canada Gazette Part II and accessible at the following link: http://gazette.gc.ca/rp-pr/p2/2020/2020-06-10/html/sor-dors126-eng.html

On September 17, 2020, the PMPRB issued a policy notice of the special consideration afforded to specified patented medicines authorized for use in COVID-19. This policy notice was adopted as part of a government wide effort to provisionally ease the regulatory pathway for drugs and medical devices urgently needed for COVID-19 diagnosis, treatment, mitigation or prevention. This policy notice is accessible at the following link:  https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines.html.

Even with lower prices, Canada will remain an important pharmaceutical market and revenues from patented drug sales are expected to continue growing over the next ten years. Drug companies are expected to launch their products in Canada at the same rate as they do today. In fact, industry sponsored studies have found that many countries with lower prices than Canada have faster access to new medicines, including the Netherlands, Sweden, the United Kingdom and Norway. In general, new medicines are launched in all major markets within the same general timeframe, regardless of price.

The Government of Canada understands the importance of the pharmaceutical sector and in supporting research and development in Canada. However, a balance between supporting innovation and improving the affordability and accessibility of patented drugs for Canadians is essential.

The Government of Canada will continue to work with provinces, territories, and other partners to improve the accessibility and affordability of medications.

Open for signature
April 20, 2020, at 4:36 p.m. (EDT)
Closed for signature
May 20, 2020, at 4:36 p.m. (EDT)
Presented to the House of Commons
Mark Strahl (Chilliwack—Hope)
September 30, 2020 (Petition No. 432-00044)
Government response tabled
November 16, 2020
Photo - Mark Strahl
Chilliwack—Hope
Conservative Caucus
British Columbia
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