PMPRB court case outcome great news for cystic fibrosis
TORONTO 4 March, 2022 - The Quebec Court of Appeal has issued a much-anticipated decision in the court case brought forward by a number of pharmaceutical companies, led by Merck Canada, Inc, and on which Cystic Fibrosis Canada intervened. In a unanimous decision the three judges struck down two key proposed changes to the Patented Medicine Prices Review Board (PMPRB) guidelines, opening the way to improved access to medicines for patients living with cystic fibrosis. Cystic Fibrosis Canada intervened in the original court case to speak to the impact that delays in accessing new medicines, caused by PMPRB’s new guidelines, would have on the lives of people living with cystic fibrosis.
As the body responsible for setting the maximum price a drug can be sold for in Canada, the changes proposed to the PMPRB guidelines could have required companies to reduce the prices of patented medicines by up to 90% in Canada. Such a drastic requirement would make Canada an outlier when compared to other developed nations, and risk companies delaying introducing innovative and lifesaving medicines to Canada. Cystic Fibrosis Canada, the Canadian cystic fibrosis (CF) community and other rare disease patient groups have long advocated against the over-reach of the proposed changes, fearing that it would negatively impact patients.
“Cystic Fibrosis Canada, along with the CF community and other patient groups including the Cystic Fibrosis Treatment Society and CF Get Loud, have raised red flags about the proposed changes to the PMPRB since they were first brought forward in 2017.” said Kelly Grover, President and CEO of Cystic Fibrosis Canada. “We are happy to see the Quebec Court of Appeal strike down two of the more concerning requirements of the proposed changes. This will have a real impact on the ability of people living with cystic fibrosis to access the medicines they need to survive.”
At the heart of Cystic Fibrosis Canada’s fight against the proposed changes was access to the new CF modulator drug, Trikafta.
“Access to Trikafta in Canada was delayed by nearly two years because of the proposed changes to the PMPRB guidelines. We are hoping this verdict will mean future cystic fibrosis medicines will not face a similar delay.” said Kim Steele, Director of Government and Community Relations at Cystic Fibrosis Canada.
The Court of Appeal found the requirements for companies to disclose confidential information regarding negotiated rebates and the implementation of arbitrary pharmacoeconomic criteria to be unconstitutional. Both changes would make Canada an unattractive market to introduce new medicines, resulting in potential delays in new drugs coming to the Canadian market.
However, not all changes to the PMPRB guidelines were rejected by The Court of Appeal. The suggested changes to the way the PMPRB uses comparator countries to set a maximum price were upheld. By comparing to a new basket of countries, Canada could see a reduction in the price of patented medicines by up to 20%. In two submissions to PMPRB consultations in 2020, Cystic Fibrosis Canada endorsed this change as a way to immediately lower the price of drugs in Canada.
Cystic Fibrosis Canada hopes the outcome from the appeal will result in the PMPRB revising the guidelines. We hope the final guidelines will work to reduce the costs of patented medicines in Canada, while not impacting access to new and innovative future therapies.
Cystic Fibrosis Canada thanks the thousands of members of the CF community who raised their voices in opposition to the changes to the PMPRB guidelines to help get Trikafta into the country. We also thank the donors who have made this work possible. Without the support of our community, we would not be able to continue this vital work on behalf of Canadians living with CF.
