Rethinking the Guidelines
Phase 1 public comments now available!
Phase 1 of Rethinking the Guidelines closed on October 31, 2016. Please scroll down to view the submissions we received.
Canada, like many countries, is facing escalating health care costs as payers struggle to reconcile finite drug budgets with patient access to promising new health technologies. Improving affordability and access to prescription drugs is a key Government of Canada commitment and a joint federal, provincial, and territorial priority.
As a first step to framework modernization, the Patented Medicine Prices Review Board (PMPRB) is undertaking major consultations regarding possible reform of its Compendium of Policies, Guidelines and Procedures, commonly referred to as “the Guidelines.”
During Phase 1 of this consultation initiative, the PMPRB asked for your input on how we can rethink the Guidelines in order to improve our performance in ensuring that pharmaceutical patent holders do not charge excessive prices. We are now analyzing the feedback we received. The PMPRB Guidelines Modernization Discussion Paper and discussion questions are still available online for those who wish to consult them.
Phase 2 of the consultation process is expected to consist of a public policy hearing before the Board, where stakeholders who commented on the Discussion Paper will have the opportunity to speak to their written submissions. Timelines for Phase 2 will be announced at a later date.
By Rethinking the Guidelines, the PMPRB seeks to contribute to a sustainable pharmaceutical system where payers have the information they need to make smart reimbursement choices and Canadians can afford the medicines they need to live healthy and productive lives.
The Consultation process
Phase |
Steps |
Proposed Timelines |
Status |
Phase 1: Consult with stakeholders on issues
|
Publish Discussion Paper
Meet with various stakeholder groups across Canada
Obtain written comments from stakeholders and the public on questions in the discussion paper
Gather and analyze all results from Phase 1 of consultation
|
Summer/fall 2016 |
Completed (October 31, 2016)
|
Phase 2: Engage stakeholders and gather expert input
|
Public Policy Hearing – invite stakeholders to appear before the Board and make representations in support of their written submissions
|
To be announced |
|
Phase 3: Presentation of proposed changes
|
Publication of proposed changes to Guidelines for comment through Notice and Comment Process
Strike multi-stakeholder forum(s) on specific issues and proposed changes to the Guidelines
|
To be announced |
|
Phase 1 public submissions
- AbbVie Corporation (PDF – 713 kb)
- Action Hepatitis Canada (PDF – 685 kb)
- Alexion Pharma Canada Corp. (PDF – 4.64 MB)
- American Bar Association (PDF – 314 kb)
- Amgen Canada (PDF – 28 kb)
- AstraZeneca Canada Inc. (PDF – 367 kb)
- Bayer Inc. (PDF – 4.05 MB)
- Best Medicines Coalition (PDF – 95 kb)
- Biogen Canada Inc. (PDF – 171 kb)
- Biosimilars Canada (PDF – 254 kb)
- BIOTECanada (PDF – 1.18 MB kb)
- Blood Ties Four Directions Center (PDF – 354 kb)
- Chris Bonnett, MHSc, PhD (PDF – 147 kb)
- Cameron Institute (PDF – 375 kb)
- Canadian Association of PNH Patients (PDF – 530 kb)
- Canadian Association of Provincial Cancer Agencies (CAPCA) (PDF – 145 kb)
- Canadian Breast Cancer Network (CBCN) (PDF – 206 kb)
- Canadian Cancer Society (PDF – 435 kb)
- Canadian Diabetes Association (PDF – 110 kb)
- Canadian Health Coalition (PDF – 115 kb)
- Canadian Generic Pharmaceutical Association (PDF – 476 kb)
- Canadian Life and Health Insurance Association Inc. (CLHIA) (PDF – 659 kb)
- Canadian Organization for Rare Disorders (PDF – 100 kb)
- Canadian Pharmacists Association (PDF – 526 kb)
- Celgene Inc. (PDF – 1.56 MB)
- CLL Patient Advocacy Group (PDF – 80 kb)
- Consumer Health Products Canada (PDF – 506 kb)
- Eli Lilly Canada Inc. (PDF – 3.09 MB)
- Enerflex Ltd. (PDF – 45 kb)
- Marc-André Gagnon, PhD (available in French only) (PDF – 716 kb)
- Galderma Canada Inc. (PDF – 2.91 MB)
- Great-West Life Assurance Company (PDF – 111 kb)
- GlaxoSmithKline Inc. (PDF – 3.52 MB)
- Health Charities Coalition of Canada (PDF – 255 kb)
- HepCBC Hepatitis C Education and Prevention Society (PDF – 145 kb)
- Anne Holbrook, MD, PharmD, MSc, FRCPC (PDF – 69 kb)
- Institut national d'excellence en santé et en services sociaux Québec (INESSS) (available in French only) (PDF – 183 kb)
- Innovative Medicines Canada (PDF – 781 kb)
- Janssen Inc. (PDF – 430 kb)
- Johnson & Johnson, Family of Companies in Canada (PDF – 168 kb)
- Leo Pharma Inc. (PDF – 516 kb)
- Mario de Lemos, PharmD, MSc (Oncol) (PDF – 45 kb)
- Joel Lexchin, MD (PDF – 43 kb)
- Life Sciences Ontario (PDF – 368 kb)
- Manitoba Ministry of Health, Seniors and Active Living (PDF – 100 kb)
- Manulife (PDF – 88 kb)
- Merck Canada Inc. (PDF – 1.05 MB)
- Multiple Sclerosis Society of Canada (PDF – 382 kb)
- Neighbourhood Pharmacy Association of Canada (PDF – 170 kb)
- Novartis Pharmaceuticals Canada Inc. (PDF – 1.62 MB)
- Network of Rare Blood Disorder Organizations (NRBDO) (PDF – 129 kb)
- Otsuka Canada Pharmaceutical Inc. (OCPI) (PDF – 302 kb)
- pan-Canadian Pharmaceutical Alliance (pCPA) (PDF – 47 kb)
- Patient Coalition (PDF – 327 kb)
- PDCI Market Access Inc. (PDCI) (PDF – 111 kb)
- Nav Persaud, MD, MSc, CCFP (PDF – 239 kb)
- Pfizer Canada Inc. (PDF – 157 kb)
- Roche Canada (PDF – 561 kb)
- Sanofi (PDF – 103 kb)
- Servier Canada Inc. (PDF – 570 kb)
- Sun Life Assurance Company of Canada (PDF – 175 kb)
- Teva Canada Innovation (PDF – 149 kb)
- Unifor (PDF – 3.20 MB)
- Vaccine Industry Committee (PDF – 229 kb)
- Valeant Canada (PDF – 453 kb)
- Gary Walters, FCIA (PDF – 414 kb)
Follow us on Twitter @PMPRB_CEPMB and at the hashtag #RethinkingtheGuidelines for updates and additional announcements, or contact us for more information.