Doug Clark, former executive director of Canada’s Patented Medicine Prices Review Board (PMPRB), has been on this change-making mission for many years. He argues for radical reforms to the country’s drug approval system. After a decade at the helm of the PMPRB, he now speaks openly about the difficulties both the industry and government faced while he was in office. He has been particularly rabid about the challenges of the COVID-19 pandemic.
With Clark’s departure from the PMPRB in 2023, a dark chapter in Canadian drug regulation has come to a welcome close. He moved on to be the inaugural chief executive officer of the pan-Canadian Pharmaceutical Alliance (pCPA). After less than a year in that post, he surprised many people by announcing his retirement from public service. His unique perspective on Canada’s drug approval process has prompted him to call for immediate changes to enhance efficiency and effectiveness.
Having led the PMPRB during tumultuous times, including legal challenges from the pharmaceutical industry, Clark possesses firsthand knowledge of the lengthy approval process for new medications. He remarked on the real numbers associated with these delays, stating, “The numbers on how long it takes in Canada are real numbers.”
Clark’s tenure at the PMPRB occurred during great upheaval. In response to the rising drug prices, the government was eager to pass new legislation to control drug prices. However, with the system’s complexity making it difficult to quickly get the medications people need most, he highlighted this key gap. “The Canadian system is fragmented, cumbersome, onerous,” he pointed out, emphasizing the need for a streamlined approach.
The former executive director didn’t shy away from fiery rhetoric when targeting the drug lobby. They claim that Canada’s attempts to rein in costs are responsible for long wait times. He also seemed to dismiss this idea too, calling it a “red herring.” He made the case that the numerous pathways through the approval process are a major factor in causing long delays. “There’s too many steps. It’s like a relay race, right?” he explained.
Before leaving the PMPRB, Clark acknowledged it was time to resign. This important decision followed the government’s announcement of yet another series of public consultations on a new set of regulations. He reflected on his experience within a consensus-driven organization comprising 14 members, stating, “I did see from the inside how difficult it is when you are a consensus-driven organization with 14 members.”
Clark’s perspectives are particularly timely as conversations about the drug approval process are at a peak right now. Recent global health crises have exposed flaws in health care and pharmaceutical policy, raising new concerns over access and equity. It is our hope that his observations beget much needed and substantial reform to the regulatory environment.
The challenges experienced in the PMPRB during Clark’s tenure have revealed major missteps that must be addressed. Stakeholders across the industry will likely take note of his calls for reform, as they seek to balance the need for cost control with timely access to innovative therapies.
