How much is too much? New guidelines released for determining excessive drug pricing

For years, PHA Canada has been working to ensure that the drug approval process in Canada meets the needs of our pulmonary hypertension community and other rare disease communities—early and ongoing access to new and innovative medicines is essential for improving health outcomes for all patients. The patient voice must be heard and respected throughout our healthcare system. To ensure this, when systemic changes might affect our community, we (and other like-minded patient groups) provide submissions to and consult with policymaking bodies such as Health Canada (HC), the Canadian Drug Agency (CDA), the pan-Canadian Pharmaceutical Alliance (pCPA), and the Patented Medicines Prices Review Board (PMPRB).

In Canada, the PMPRB monitors and reviews the prices of patented medicines to ensure they are not excessive. In the past, there has been much room for improvement regarding when and how patients’ interests were considered in the process and the degree to which the PMPRB guidelines focused on improving patient health outcomes.

PHA Canada closely followed the PMPRB as it created new guidelines for its staff to follow when making decisions about excessive pricing, making numerous submissions on behalf of the PH community. After six years of stakeholder consultations, major rewrites, significant senior staff turnover, and two lost court cases, the final PMPRB guidelines reflect a shift toward more patient-centred decision-making and recognizing that previous proposals risked negatively impacting drug access. We are happy that the new guidelines, published on June 30, 2025 (and which come into effect January 1, 2026), align with the recommendations that PHA Canada supported. You can read PHA Canada’s submissions to the PMPRB on our website.

While challenges in ensuring swift and affordable access to innovation remain, PHA Canada is proud to have played a role in this advancement and will continue to advocate for policies that uphold the needs and voices of our patient community.

“It was a long process, but we are pleased with what we were able to accomplish. We stood up for the interests of patients—who, of course, need drugs to be both accessible and affordable—and the new Guidelines will hopefully do that. But I think the thing that I am most proud of is that, going forward, patient communities will now have a more equal seat at the table when future changes at the PMPRB are initiated.” – Joan Paulin, PHA Canada Board Chair