Key Findings of the Study

The study analyzed data on 45 women’s health products that received approval from the U.S. Food and Drug Administration (FDA) from January 1, 2003, to December 31, 2023. Alarmingly, only 53%—or 24 products—had achieved regulatory approval from Health Canada as of July 2024, with just 13 of these covered by public reimbursement plans.

“These findings highlight a clear need to address inequities in how women’s health is assessed, valued, and prioritized,” said Dany Hallé, Vice President of Commercial Affairs at DPG.

The Delay Dilemma

Additionally, the research indicates that Canadian women face substantial delays in the approval and reimbursement processes for women’s health therapies. On average, these processes take significantly longer—often exceeding three years—compared to general access timelines for medications within the country.

The current Health Technology Assessment (HTA) framework may not adequately reflect the unique benefits of innovative drugs in women’s health, further complicating the reimbursement and market access landscape.

A Call to Action

“This is a call to action,” said Dr. Catherine Beauchemin, a partner at PeriPharm. “This initiative marks an important first step toward improving access to innovations in women’s health. To advance women’s health outcomes in Canada, we must start by understanding their needs and preferences.”

The study aims to lay the groundwork for a comprehensive position paper. Leading experts in the field will collaborate to address the challenges surrounding the assessment of innovative medicines in women’s health. This white paper is expected to be published by the end of the year.

Comparative Approval Stats

In contrast to the findings about women’s health products, data from the 2016 to 2020 period indicates that 67% of all new active substance approvals by the FDA and/or European Medicines Agency (EMA) were submitted to Health Canada.

About PeriPharm

Established in 2003, PeriPharm is a Canadian firm specializing in pharmacoeconomics and outcomes research. Their mission focuses on ensuring optimal market access for healthcare innovations, believing that therapies should be accessible to all who require them.

About Duchesnay

Duchesnay is a specialty pharmaceutical company committed to women’s health. While initially focused on research and educational efforts regarding pregnancy and breastfeeding, the company has since expanded its portfolio to offer a variety of effective therapeutic options tailored to women’s health needs.

About Duchesnay Pharmaceutical Group

Duchesnay Pharmaceutical Group (DPG) is headquartered in Blainville, Quebec, and consists of six pharmaceutical companies dedicated to addressing patient needs in Canada and beyond. DPG was recently recognized with the 2024 Life Sciences Innovation Award by ADRIQ for its commitment to innovation and workplace culture.