The soap opera drama that has been unfolding over at the Patented Medicines Prices Review Board (PMPRB) seems to have taken another wild plot twist in what may, in fact, turn out to be the season cliffhanger.
The day after a dramatic resignation announcement from board member Matthew Herder, the PMPRB today announced that Douglas Clark would be “stepping down” after nearly a decade at its helm as Executive Director.
Created under the Patent Act, 1985, the PMRPB was established as a counter-balance to the temporary monopoly granted (i.e. a patent) to an innovative pharmaceutical company for a new drug product. In this way, Parliament acted to ensure that drug prices of a patent-protective product aren’t “excessive” by establishing the PMPRB as an independent arm’s length agency of Health Canada, reporting directly to Parliament. Within the parameters set out in the Patent Act and Canada’s drug pricing regulations, the PMPRB’s can make rulings and issue orders that are on par with the Federal Court in terms of enforceability. For nearly forty years, it has represented an important cornerstone in Canada’s attempts to strike a balance between the need to reward and incent innovation and the desire to protect consumers and payors.
Clark’s departure comes amidst a whirlwind of change and controversy, particularly at the board level. After having the chair and then acting chair resign, earlier this year, Vice Chair Mélanie Boruassa Forcier confirmed her own resignation by Twitter, leaving the board with just three members. The open letter to Duclos that accompanied yesterday’s resignation announcement could easily have been interpreted as an act of open rebellion against the government’s decision to back off the most challenging aspects of reform.
These reforms — intended to further reduce the price innovative companies could charge for patented medicines — had been the subject of what some have described as an active advocacy “campaign” by the PMRPB and its head, Mr. Clark — a campaign dating back to as early as 2015. Such advocacy by a regulatory body is certainly unusual, if not questionable. The aggressive role played by the PMPRB, a quasi-judicial agency in trying to pressure government policy even earned it the moniker “rogue regulator” by CHPI’S Dr. Brett Skinner. In his book by the same name, he also accused the agency of using “a false narrative to drive dangerous changes to drug price controls in Canada.”
The regulatory changes, first put forward by former health minister Jane Philpott were indeed controversial and, in the end, key components of it were found to be outside the authority of the federal government in a seminal court ruling. This, along with concerns expressed by industry and patients alike, meant that Duclos had little choice but to back off from the most extreme aspects of the proposals. While the changes that government DID move forward with would put downward pressure on drug prices, the speculation is that board members were not happy with the direction the government was now taking.
The instability and uncertainty around Canada’s drug pricing regulatory regime – and the agency responsible for enforcing it – served no one. And while recent dramatic events, including today’s announcement, might appear on the surface as more chaos, they might also signal a turning of the page to a quieter time to come.
Whatever one thinks of the battle over Canada’s drug policy changes and the role the PMPRB itself played, it should also be said that Douglas Clark has had a distinguished career as a public servant. Before taking on the role as Executive Director of the PMPRB, he served as Assistant Deputy Commissioner with the Competition Bureau, as well as the Director of the Patent Policy Directorate at Industry Canada (ISED). By all accounts, including my own, Mr. Clark was always generous with his time and was a strong advocate for the PMPRB. He clearly earned the respect and loyalty of his team, as well as past chairs of the PMPRB with whom he served. I wish him all the best.