It was supposed to be simple. 

In 2017, the federal government released a plan to reduce medicine prices in Canada by changing how Canada’s drug price regulator—the Patented Medicine Prices Review Board (PMPRB)—reviews medicines for excessive prices. The plan was designed by the PMPRB itself and foisted onto Health Canada to update regulations.

The PMPRB’s approach included layer upon layer of price-cutting mechanisms that would have ultimately resulted in up to 90 per cent price reductions for some treatments, including for cancer and other critical illnesses. Although this may sound promising, it would have prevented many medicines from coming to Canada. 

Federal and provincial courts of appeal have since ruled that key elements of the PMPRB’s proposal were unlawful. In a related decision, the Federal Court of Appeal even accused the PMPRB of helping itself to powers “it does not lawfully have” and putting itself “in a position where they are not accountable.”

Given these developments, in 2022 federal Health Minister Jean-Yves Duclos decided to move forward with the aspect of the reform not struck down by the courts: a change to the countries to which Canada compares its medicine prices. This change alone would have led to a 20 per cent reduction in medicine prices across Canada. 

With legal clarity from the courts and clear direction from the health minister, the PMPRB had the straightforward task of implementing this change while keeping everything else the same. Canada would benefit from lower drug prices. Drug developers would have clear rules. But that’s not what happened.

Instead, last fall, the PMPRB proposed new guidelines that further reduced regulatory certainty for drug makers who want to bring their medicines to Canada. The new guidelines were directly opposed to the Cabinet Directive on Regulations, which requires federal regulations to be evidence-based and supported by a clear rationale that protects “the health, safety, security, social, and economic well-being of Canadians.” 

How would it work? Kind of like a highway with no posted speed limit. At any point in time, a police officer (the PMPRB in this case) could pull over a driver (a drug company) and say, “I believe you were speeding, let’s negotiate your fine.” Would you take that highway or look for other highways (countries) with more transparent rules? The answer is obvious.  

Numerous stakeholders—including patients, researchers, provincial governments, Health Canada, and others—poured in to warn against the PMPRB’s approach. Stakeholders expressed several concerns ranging from the PMPRB’s lack of extensive consultation to the inconsistency between the proposed guidelines and federal government priorities, such as the Biomanufacturing and Life Sciences Strategy.

Fortunately, the PMPRB’s proposed guidelines were suspended before the Jan. 1, 2023, deadline. The suspension came just weeks after the last-minute resignation and refusal from PMPRB acting chair Mélanie Bourassa Forcier to sign off on the board’s approach. According to Bourassa Forcier, the PMPRB’s approach posed legal, ethical, and medicine-access risks she was not willing to take. She also expressed concern over the PMPRB’s failure to consult the health minister, as required. Her resignation was followed by resignations from other PMPRB leaders, including board member Matthew Herder and executive director Doug Clark. 

Over the past few weeks, a number of accusations—from Herder, via reporting by journalist Kelly Crowe, and from others—have been levelled against Duclos after he submitted a letter asking the PMPRB to consider pausing its consultation to better understand the impacts of its proposal. Critics accused Duclos of intervening in the PMPRB’s work and capitulating to the pharmaceutical industry. 

The Patent Act, which governs the PMPRB’s mandate, does not support these claims. In fact, Section 96 of the Patent Act requires the health minister to be consulted on the PMPRB’s proposed changes to guidelines. Since the PMPRB refused to consult him directly, he proactively reached out to fulfill the Act’s requirements. He was also acting in the best interest of Canadians. With emerging health threats, including rapidly increasing rates of cancer and the threat of antimicrobial resistance, preserving Canada’s access to new medicines will be more important than ever in the coming years.

For some time now, it has been glaringly obvious that some PMPRB staff and board members have advanced an anti-industry agenda and worked against the very sector they are responsible for regulating in an impartial manner. The PMPRB can no longer pretend to be impartial.

The recent vacancies created by the resignation of PMPRB board members and the appointment of a new chairperson represent an opportunity for change. While it hasn’t been simple, it doesn’t need to be hard. The PMPRB just needs to stop trying to push an agenda and go back to doing its job: to be an impartial regulator that implements clear and predictable rules that will ensure pharmaceutical prices are not excessive while also ensuring Canadians can access new cures and treatments. 

Dr. Jason Field is a former government official, scientist, and current president and CEO of Life Sciences Ontario.

The Hill Times