Recommended audience(s):
Health policy professionals, regulatory stakeholders, patient advocacy groups.
Review prepared by:
Jean-François Nepveu, Ph.D
This video provides an overview of Canada’s drug access pathway and its limitations in delivering timely access to new medicines. It describes the Canadian drug approval process as a complex, multi-stage system that makes Canada the slowest among G7 nations in granting patients access to new treatments.
The pathway begins with a Health Canada submission, where a drug’s safety, efficacy, and quality are evaluated over approximately six months. Following approval, the Patent Medicine Prices Review Board (PMPRB) reviews and monitors drug pricing semi-annually throughout the patent period. A standard PMPRB review takes about one year, although Priority Review can shorten this timeline to 180 days, as seen with ALS therapies.
Significant delays arise in subsequent stages. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducts a health technology assessment to inform public reimbursement recommendations. There is typically a three- to four-month waiting period before the next stages begin, meaning that roughly one year elapses before CADTH completes its review. Afterward, the pan-Canadian Pharmaceutical Alliance (pCPA) undertakes price negotiations for provincial, territorial, and federal drug plans, a process that can take one to two years. This stage includes manufacturer negotiations, independent provincial and territorial reviews, product listing agreements, and jurisdiction-specific listings, which add another 51 to 247 days, depending on the province. Conditional approvals can accelerate patient access while larger confirmatory studies are ongoing, but this process is limited to specific treatments.
The video highlights that a systemic reform of the pCPA and provincial listing timelines is essential, considering that Canada’s drug access pathway can take up to two years longer than in peer countries, resulting in reduced life sciences investment, fewer clinical trials in Canada, and greater strain on the healthcare system. It identifies key opportunities to shorten timelines, including broader use of Priority Review, conditional approvals, earlier and parallel engagement between CADTH and Health Canada, and more efficient pCPA negotiations.
The pathway begins with a Health Canada submission, where a drug’s safety, efficacy, and quality are evaluated over approximately six months. Following approval, the Patent Medicine Prices Review Board (PMPRB) reviews and monitors drug pricing semi-annually throughout the patent period. A standard PMPRB review takes about one year, although Priority Review can shorten this timeline to 180 days, as seen with ALS therapies.
Significant delays arise in subsequent stages. The Canadian Agency for Drugs and Technologies in Health (CADTH) conducts a health technology assessment to inform public reimbursement recommendations. There is typically a three- to four-month waiting period before the next stages begin, meaning that roughly one year elapses before CADTH completes its review. Afterward, the pan-Canadian Pharmaceutical Alliance (pCPA) undertakes price negotiations for provincial, territorial, and federal drug plans, a process that can take one to two years. This stage includes manufacturer negotiations, independent provincial and territorial reviews, product listing agreements, and jurisdiction-specific listings, which add another 51 to 247 days, depending on the province. Conditional approvals can accelerate patient access while larger confirmatory studies are ongoing, but this process is limited to specific treatments.
The video highlights that a systemic reform of the pCPA and provincial listing timelines is essential, considering that Canada’s drug access pathway can take up to two years longer than in peer countries, resulting in reduced life sciences investment, fewer clinical trials in Canada, and greater strain on the healthcare system. It identifies key opportunities to shorten timelines, including broader use of Priority Review, conditional approvals, earlier and parallel engagement between CADTH and Health Canada, and more efficient pCPA negotiations.
