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

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
10.34172/ijhpm.9769
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
1.               Tu SS, Nagar S, Kesselheim AS. Recent patent reform bills and their implications for prescription drugs. JAMA. 2023;329(6):459-460. doi:10.1001/jama.2022.24983  
2.               Patented Medicine Prices Review Board. https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html. Published October 23, 2020. Accessed September 5, 2025.
3.               Zhang R, Martin D, Naylor CD. Regulator or regulatory shield? The case for reforming Canada’s Patented Medicine Prices Review Board. CMAJ. 2017;189(14):E515-E516. doi:10.1503/cmaj.161355
4.               Foroutan N, Tarride JE, Xie F, Mills F, Levine M. A comparison of pharmaceutical budget impact analysis (BIA) recommendations amongst the Canadian Patented Medicine Prices Review Board (PMPRB), public and private payers. Pharmacoecon Open. 2019;3(4):437-451. doi:10.1007/s41669-019-0139-y
5.               Crowe K. Canada has found the key to lowering drug prices, but it won’t be used any time soon. CBC News. November 24, 2018.  https://www.cbc.ca/news/health/canada-drug-price-patented-medicine-pharmaceutical-industry-pmprb-1.4919200. Accessed October 27, 2025.
6.               Foroutan N, Tarride JE, Xie F, Jameel B, Mills F, Levine M. Stakeholders’ feedback on the proposed recommendations for updating the Patented Medicine Prices Review Board (PMPRB) budget impact analysis guidelines. J Popul Ther Clin Pharmacol. 2020;27(1):e1-e24. doi:10.15586/jptcp.v27i1.651
7.               pan-Canadian Pharmaceutical Alliance. Submission to the PMPRB Scoping Paper consultation. January 10, 2024. https://www.canada.ca/content/dam/pmprb-cepmb/documents/consultations/scoping-paper/submissions/Scoping%20paper%202023_Written%20submission_pCPA_EN.pdf. 
8.               Patented Medicine Prices Review Board. PMPRB report shows higher-cost medicines driving a 14.1% growth in private plan drug costs in 2023. https://www.newswire.ca/news-releases/pmprb-report-shows-higher-cost-medicines-driving-a-14-1-growth-in-private-plan-drug-costs-in-2023-850940507.html. Published 2023. Accessed June 18, 2026.
9.               Canada Gazette. Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements). https://gazette.gc.ca/rp-pr/p2/2019/2019-08-21/html/sor-dors298-eng.html. Published August 21, 2019. Accessed May 25, 2026.
10.           Torys LLP. Federal Court on amended Patented Medicines Regulations: new pricing factors and new basket of comparison countries are in; rebate reporting is out. Torys LLP website. https://www.torys.com/our-latest-thinking/publications/2020/06/federal-court-on-amended-patented-medicines-regulations. Published June 2020. Accessed May 25, 2026.
11.           Fasken. Quebec Court of Appeal Renders Major Decision on the PMPRB. https://www.fasken.com/en/knowledge/2022/02/decision-on-the-pmprb. 
12.           Patented Medicine Prices Review Board. Draft Guidelines for PMPRB Staff: Administrative Process for Excessive Price Hearing Recommendation. https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines-pmprb-staff.html.  Published December 19, 2024. Accessed September 10, 2026.
13.           Patented Medicine Prices Review Board. Shaping the Future: A Discussion Guide for PMPRB Phase 2 Consultations on New Guidelines.  https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/discussion-guide-phase2.html. Published June 26, 2024. Accessed September 24, 2025.
14.           Patented Medicine Prices Review Board. Guidelines for PMPRB Staff. https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/guidelines.html. Published June 30, 2025. Accessed September 24, 2025.
15.           Balane MA, Palafox B, Palileo-Villanueva LM, McKee M, Balabanova D. Enhancing the use of stakeholder analysis for policy implementation research: towards a novel framing and operationalised measures. BMJ Glob Health. 2020;5(11):e002661. doi:10.1136/bmjgh-2020-002661
16.           Brugha R, Varvasovszky Z. Stakeholder analysis: a review. Health Policy Plan. 2000;15(3):239-246. doi:10.1093/heapol/15.3.239
17.           Koon AD, Hawkins B, Mayhew SH. Framing and the health policy process: a scoping review. Health Policy Plan. 2016;31(6):801-816. doi:10.1093/heapol/czv128
18.           Baicker K, Chandra A. What values and priorities mean for health reform. N Engl J Med. 2020;383(15):e89. doi:10.1056/NEJMp2025966
19.           Gallagher AWA, Evans-Reeves K, Joshi A, Hatchard J, Gilmore AB. Analysis of submissions to the EU’s public consultation on tobacco traceability and security features. Tob Control. 2021;30(e1):e4-e9. doi:10.1136/tobaccocontrol-2020-043875
20.           Glover RE, Petticrew MP, Mays NB, Thompson C. How pharmaceutical and diagnostic stakeholders construct policy solutions to a public health ‘crisis’: an analysis of submissions to a United Kingdom House of Commons inquiry into antimicrobial resistance. Crit Public Health. 2023;33(2):197-206. doi:10.1080/09581596.2022.2026296
21.           Ralston R, Hill SE, Gomes FDS, Collin J. Towards preventing and managing conflict of interest in nutrition policy? An analysis of submissions to a consultation on a draft WHO tool. Int J Health Policy Manag. 2021;10(5):255-265. doi:10.34172/ijhpm.2020.52
22.           Maani Hessari N, Knai C, Gallopel-Morvan K, Petticrew M, Landreat MG. Stakeholder framing of advertising legislation: an analysis of media and parliamentary representations of the Loi Évin in the United Kingdom. J Stud Alcohol Drugs. 2018;79(4):532-538. doi:10.15288/jsad.2018.79.532
23.           Rinaldi C, van Schalkwyk MC, Egan M, Petticrew M. A framing analysis of consultation submissions on the WHO global strategy to reduce the harmful use of alcohol: values and interests. Int J Health Policy Manag. 2022;11(8):1550-1561. doi:10.34172/ijhpm.2021.68
24.           Eisenkraft Klein D, Grundy Q, Hawkins B, Schwartz R. Framing coalitions and the Canadian overdose crisis: the case of opioid marketing. Soc Sci Med. 2025;381:118247. doi:10.1016/j.socscimed.2025.118247
25.           Eisenkraft Klein D, Grundy Q, Hawkins B, Schwartz R. Reframing the overdose crisis: stigma, industry influence, and the politics of abuse-deterrent opioids. Int J Soc Determinants Health Health Serv. 2026;56(1):106-119. doi:10.1177/27551938251378941
26.           Wens I, Claessens Z, Vanneste A, Barbier L, Janssens R, Huys I. Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation. Front Med. 2025;11:1506243. doi:10.3389/fmed.2024.1506243
27.           Hwang TJ, Kesselheim AS, Rome BN. New reforms to prescription drug pricing in the US: opportunities and challenges. JAMA. 2022;328(11):1041-1042. doi:10.1001/jama.2022.15268
28.           Bowen GA. Document analysis as a qualitative research method. Qual Res J. 2009;9(2):27-40. doi:10.3316/QRJ0902027  
29.           Dalglish SL, Khalid H, McMahon SA. Document analysis in health policy research: the READ approach. Health Policy Plan. 2021;35(10):1424-1431. doi:10.1093/heapol/czaa064
30.           Forster M. The analysis of company documentation. In: Cassell C, Symon G, eds. Qualitative Methods in Organizational Research: A Practical Guide. Sage; 1994:147-166.
31.           Humphries B, Xie F. Canada’s amendment to patented drug price regulation: a prescription for global drug cost control? JAMA. 2019;321(16):1565-1566. doi:10.1001/jama.2019.2280
32.           Lexchin J. Reforms to the patented medicine prices review board and the introduction of new drugs in Canada: an observational study. Health Policy. 2022;126(10):1018-1022. doi:10.1016/j.healthpol.2022.08.006
33.           Vondeling GT, Cao Q, Postma MJ, Rozenbaum MH. The impact of patent expiry on drug prices: a systematic literature review. Appl Health Econ Health Policy. 2018;16(5):653-660. doi:10.1007/s40258-018-0406-6
34.           Yulianto A, Supriatnaningsih R. Google Translate vs. DeepL: a quantitative evaluation of close-language pair translation (French to English). AJELP. 2021;9(2):109-127. doi:10.37134/ajelp.vol9.2.9.2021
35.           Hall CM. Quantitative and qualitative content analysis. In: Nunkoo R, ed.  Handbook of Research Methods for Tourism and Hospitality Management. Edward Elgar Publishing;  2018:395-406.
36.           Zhang W, Sun H, Guh DP, Grootendorst P, Hollis A, Anis AH. The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study. CMAJ. 2024;196(20):E691-E701. doi:10.1503/cmaj.231485
37.           Boothe K. “Getting to the table”: changing ideas about public and patient involvement in Canadian drug assessment. J Health Polit Policy Law. 2019;44(4):631-663. doi:10.1215/03616878-7530825
38.           Gagnon MP, Tantchou Dipankui M, Poder TG, Payne-Gagnon J, Mbemba G, Beretta V. Patient and public involvement in health technology assessment: update of a systematic review of international experiences. Int J Technol Assess Health Care. 2021;37(1):e36. doi:10.1017/S0266462321000064
39.           Morgan SG, Boothe K. Universal prescription drug coverage in Canada: long-promised yet undelivered. Healthc Manage Forum. 2016;29(6):247-254. doi:10.1177/0840470416658907
40.           Rand LZ, Mooney H, Hong D, Eisenkraft Klein D, Kesselheim AS, Rome BN. Characteristics of speakers at US FDA Advisory Committee meetings on drug approval. JAMA Intern Med. 2026;186(1):139-141. doi:10.1001/jamainternmed.2025.6107
41.           Rand LZ, Eisenkraft Klein D. What can we learn from patient input at FDA Advisory Committee meetings? J Law Med Ethics. 2025;53(1):145-146. doi:10.1017/jme.2025.52
42.           Hansen MB, Nørgaard LS, Hallgreen CE. How and why to involve patients in drug development: perspectives from the pharmaceutical industry, regulatory authorities, and patient organizations. Ther Innov Regul Sci. 2020;54(3):577-585. doi:10.1007/s43441-019-00090-6
43.           Executive Office of the President. Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. Federal Register website.  https://www.federalregister.gov/documents/2025/05/15/2025-08876/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients. Published May 15, 2025. Accessed May 25, 2026.
44.           Centers for Medicare & Medicaid Services. GLOBE (Global Benchmark for Efficient Drug Pricing) Model. https://www.cms.gov/priorities/innovation/innovation-models/globe. Published 2026. Accessed June 18, 2026.
45.           The White House. Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States. The White House. https://www.whitehouse.gov/presidential-actions/2026/04/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states/. Published April 2, 2026. Accessed June 18, 2026.
International Journal of Health Policy and Management
Volume 15, Issue 1
2026
Pages 1-13

  • Received Date 28 January 2026
  • Revised Date 07 August 2026
  • Accepted Date 14 October 2026
  • First Published Date 14 October 2026
  • Published Date 01 December 2026