The federal government has proposed new regulations that threaten your access to life-saving medicines. These changes mean fewer life-changing medicines available to us. It will force Canadians to leave the country for better medical care—if they can afford it. Act now!
Submission to the PMPRB consultation on the proposed Guideline Monitoring and Evaluation Plan
The Patented Medicine Prices Review Board (PMPRB) has proposed a Guideline Monitoring and Evaluation Plan (GMEP) whose goal is to monitor the impact of the new regulatory framework on the pharmaceutical market. The PMPRB conducted a consultation on the Guideline Monitoring and Evaluation Plan that ended on June 21, 2021. Several patient organizations in Canada are signatories of a joint submission to this consultation. You may read their submission here: Submission to PMPRB and Health Canada on GMEP Consultation.
PMPRB Internal Communications Plan Disclosed
The Patented Medicine Prices Review Board’s (PMPRB) internal communications plan regarding the amended regulations has been disclosed as a result of an Access to Information and Privacy (ATIP) request from MP Tom Kmiec. It paints patient organizations as ‘opponents’ spreading ‘disinformation’, and envisions using $56 000 of taxpayer money to conduct a public relations campaign among whose goals is the discrediting of these organizations.
Read it here: PMPRB ATIP Disclosure – Communications Plan.
More information about the disclosure is available in this article from Cystic Fibrosis Canada.
New Regulations Postponed Until January 1, 2022
The coming-into-force of the new regulations for patented medicines has been delayed by six months. Instead of coming-into-force on July 1, 2021, the new Patented Medicine Prices Review Board (PMPRB) regulations would instead come-into-force on January 1, 2022. The reason given for this delay is, again, the COVID-19 pandemic – in particular, the impact of the third wave. It is supposed to give the industry extra time to prepare for the amended regulations.
The amended regulations will be published in the Canada Gazette, Part II on July 21, 2021.
See below for more background on these regulatory changes and how they threaten to harm Canadians’ access to medicine.
Recent letters to the federal government from the Best Medicines Coalition
The Best Medicines Coalition (BMC) is a national alliance of patient organizations, including the CCSN, whose common goal is to improve Canadians’ access to safe and effective medicines. The upcoming changes to patented medicine regulations touch on key areas of interest for them: lowering drug prices for patients is a key part of improving access, and something that the BMC and all its member organizations want. However, the BMC argues that the proposed regulatory changes would, in part, hinder that goal. Additionally, they have been accused falsely in an internal PMPRB communications plan of spreading misinformation.
- In their submission “Input Regarding PMPRB Proposed Guideline Monitoring and Evaluation Plan”, they outline their position on the proposed regulatory changes. Roughly, this could be summarized as:
- One part of the regulations – the changes to the basket of countries among which drug prices would be compared – should be implemented right away, but another part – the changes to the economic factors (quite technical) – should not.
- There are serious problems with how the PMPRB has been handling input from patient organizations. This should be subjected to a third-party review.
- There needs to be a plan in place – before the regulations are implemented – for a third party to rigorously evaluate the impact of the regulations on patient access to medicine.
- Because of these concerns, the regulations should not be implemented on the scheduled date (which at the time was July 1, 2021).
- Letter to Dr Levine from the BMC regarding PMPRB – part of a chain of correspondence with Dr Mitchell Levine, Chair and Deputy Head of the PMPRB, about their communications plan which alleged that the BMC was spreading misinformation.
- Letter to the Prime Minister from the BMC regarding PMPRB – again regarding the issue of the communications plan and the apparent lack of good faith from the PMPRB when dealing with patient organizations such as the Best Medicines Coaliton.
The BMC website also has a full list of their submissions and letters to the government about the PMPRB regulatory changes.
Put Canadians First by Suspending the Implementation of Harmful Drug Pricing Regulations
Innovative Medicines Canada, a national association of Canada’s pharmaceutical companies, released a statement on June 4th calling on the federal government to suspend the upcoming regulatory changes for the Patented Medicines Prices Review Board (PMPRB).
The PMPRB regulatory changes will have significant unintended consequences on patient access to the newest medicines and treatments, while also diverting R&D and investment away from Canada’s life sciences sector.
If Canada wants a vibrant and competitive life sciences sector that ensures access to innovative medicines, a suspension in the PMPRB’s regulatory changes would provide the appropriate time and process to consider that the price of innovative medicines are not the primary cost drivers for Canadian public and private drug plans.
The Coming-into-force of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) has been delayed until July 1, 2021
As you may recall, these amendments were published in the Canada Gazette, Part II in August 2019 and represent the first substantive update of the Patented Medicine Prices Review Board (PMPRB)’s regulatory framework in more than 30 years. Specifically, the amendments provide the PMPRB with new price assessment factors, a revised schedule of foreign price reference countries and new patentee information reporting obligations. Collectively, the amendments provide the PMPRB with the tools and information needed to protect Canadian consumers from excessive prices for patented medicines.
The Government of Canada is mindful that the COVID-19 pandemic continues to challenge all stakeholders. For this reason, the coming-into-force date of the Amendments to the Patented Medicines Regulations has been delayed by an additional six months, to July 1, 2021. This delay provides industry with additional time to prepare for the new reporting obligations. A delay will also allow industry further time to familiarize themselves with the PMPRB’s final Guidelines, which were published on October 23, 2020.
The amended regulations will be published in the Canada Gazette, Part II on January 20, 2021.
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- The Math of Saving Lives – Canada’s Drug Battle leaves patients caught in the middle
- Health Matters: New federal price controls for new medications have been released and the cystic fibrosis community says
they will prevent access to life-saving treatment.
- Patients, health organizations band together to bring breakthrough treatments to Canada sooner
Patient Group Briefs on PMPRB Guidelines
- ALS Society of Canada
- ALS Action Canada
- The Arthritis Society
- Asthma Canada
- Best Medicines Coalition
- Canadian Arthritis Patient Alliance
- Canadian Association of PNH Patients
- The Canadian Cancer Society
- Canadian Federation of Nurses Unions
- Canadian Health Coalition
- Canadian Labour Congress
- Canadian Organization for Rare Disorders
- Canadian PKU and Allied Disorders Inc.
- Canadian Psoriasis Network
- Canadian Skin Patient Alliance & Canadian Association of Psoriasis
- Cystic Fibrosis Community
- Chronic Lymphocitic Leukemia Patient Advocacy Group
- CONECTed – Oncology Patient Group
- Crohn’s and Colitis Canada
- Canadian Spinal Muscular Atrophy community
- Cystic Fibrosis Canada
- Diabetes Canada
- Eczema Society of Canada
- Gastrointestinal Society
- Health Charities Coalition of Canada
- Health Coalition of Alberta
- Heart & Stroke
- Independent Voices for Safe and Effective Drugs & Breast Cancer Action Quebec
- Muscular Dystrophy Canada
- Lung Health Foundation
- Medicines Access Coalition
- Multiple Sclerosis (MS) Society of Canada
- National Myeloma Canada Advocacy Committee and Myeloma Canada
- Cancer care providers and/or cancer researchers from different regions of the country
- Pulmonary Hypertension Association of Canada
- Women’s Health Coalition of Alberta Society
Briefs to the Federal Standing Committee of Health
The Quebec Cancer Coalition has submitted a brief and a request to appear before the Standing Committee on Health (HESA) of the House of Commons on Patented Medicine Prices Review Board’s (PMPRB) Guidelines. Read the full report
Health Canada New Interim Order – An Important Tool to Address COVID-19 Related Drug Shortages
- Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19
Archive of submissions to PMPRB
- Open Letter to Prime Minister Justin Trudeau regarding PMPRB Regulations (April 2019)
- Canadian Patient Groups Call on Federal Health Minister to Halt the Process Examining Proposed Amendments to the Patented Medicine Regulations Pending Constructive Consultations (February 2018)
- Submission to the Patented Medicines Pricing Review Board (PMRPB) by the Coalition of Concerned Patient Organizations (October 2016)
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.