International Journal of Health Policy and Management

International Journal of Health Policy and Management

How Do Stakeholders Perceive Canada’s Drug Pricing Reforms? An Analysis of Submissions to Canada’s Patented Medicine Prices Review Board

Articles in Press

Document Type : Original Article

Authors
Daniel Eisenkraft Klein
Samantha Nicolson
Aaron S. Kesselheim
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Abstract
Background
Canada’s Patented Medicine Prices Review Board (PMPRB) regulates pharmaceutical prices to prevent excessive pricing. In June 2024, the PMPRB proposed major reforms including international price comparison (IPC) screening, annual re-benchmarking of existing medicines, and new complaint processes. Understanding how stakeholders responded to these proposals reveals the competing interests and strategic positioning that shape pharmaceutical price regulation.

Methods
We conducted a systematic qualitative content analysis of all 54 public consultation submissions to the PMPRB’s 2024-2025 consultation on its Draft Guidelines. Using NVivo software, we coded submissions according to stakeholder type, main concerns, policy recommendations, and positions on specific regulatory mechanisms. We coded concerns and recommendations separately to compare them across stakeholder groups. Thematic analysis identified patterns within and across stakeholder groups.

Results
Pharmaceutical companies and patient advocacy organizations raised different concerns yet converged on several of the same recommendations. Industry submissions described the proposals in constitutional and economic terms, characterizing annual re-benchmarking as jurisdictional overreach and warning of market exit. Patient organizations described the same proposals in terms of access and health equity, emphasizing delayed drug launches and impacts on vulnerable populations. Despite raising different concerns, some organizations in both groups recommended greater transparency in the review process and restricted, validated complaint eligibility, and complaint validation. Five concerns were dominant, raised primarily by pharmaceutical organizations: retroactive application of guidelines to existing medicines (21 of 34), expanded complaint eligibility risking strategic misuse (21 of 34), unclear compliance guidance (18 of 34), limited transparency in in-depth reviews (17 of 34), and insufficient transition periods (13 of 34). Patient organizations primarily sought inclusion in the PMPRB’s review processes, recommending patient participation in both therapeutic class comparison (TCC) and the complaint process.

Conclusion
Pharmaceutical stakeholders positioned the proposed PMPRB guidelines as fundamental regulatory problems rather than technical refinements. Industry and patient organizations converged on a number of similar recommendations, highlighting the need for policy-makers to assess the evidence underlying shared recommendations.
Keywords
Pharmaceutical Pricing
Canada
Drug Price Regulation
Stakeholder Engagement
Qualitative Research
PMPRB
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International Journal of Health Policy and Management

Articles in Press, Accepted Manuscript
Available Online from 14 October 2026

  • Received Date 28 January 2026
  • Revised Date 07 August 2026
  • Accepted Date 14 October 2026
  • First Published Date 14 October 2026
  • Published Date 14 October 2026