Submission to the Patented Medicine Prices Review Board

Posted: 06-28-2017

Executive Summary

The Health Charities Coalition of Canada is pleased to provide patient-focused input into the proposed amendments to the Patented Medicines Regulations. Access to medicines is an important issue for our members and to the Canadians that they serve. Prescription drugs can manage conditions, cure disease(s), improve quality of life, shorten or prevent time spent in hospitals and reduce the demand for health care services, potentially leading to positive health outcomes and decreased costs to the healthcare system. Effective and sustainable regulation of pharmaceuticals is key in being able to provide timely access to medicines for Canadians. It is understood that this consultation is specific to the issue of pricing however, pricing is one piece of a large system that must be addressed in concert with other factors. One cannot address affordability of medicines without also examining availability and accessibility. 

HCCC is looking for sustainable change to the regulation of pharmaceuticals in Canada. As this is the first time in twenty years that the Regulations will be updated, we want to ensure that the Regulations are revised in a manner that allows for the further evolution of access to prescription medicines in Canada. For example, ensuring that the Regulations allow for modifications to account for the inclusion of real world evidence and are supportive of the shifts in the health environment. A major change in the healthcare environment has been the move to integrate patient partnerships as a key component of healthcare reforms. HCCC recommends that the PMPRB establish a formal mechanism for meaningfully and continuously engaging patient representatives in their decision making and regulatory processes through patient voice, patient choice, and representation. Additionally, HCCC recommends that any updates to the Regulations be undertaken in a fully transparent mannerthat; clearly details the nature of the changes, provides all relevant information publicly, includes patients, provides sufficient time for stakeholder input and ensures the continuity of the regulatory approach for patients during the next twenty years. With respect to the current consultation, HCCC provides comment on the following sections:

  • With regards to the proposed pharmacoeconomic factors, the QALY evaluation does not include some metrics that are important to patients, the lived experience. HCCC recommends a system in which patient outcomes and quality of life are included as an integral part of any assessment that determines the ceiling price on medications. Additionally, the proposed factors should only be used if they arecomplementaryto the HTA evaluation conducted by CADTH, INESSS or other provincial HTA evaluators, not in addition to those processes.
  • HCCC is concerned about the limited focus on the size of market use in determining whether or not a drug is priced excessively. The size of market is an important consideration for those launching a new active substance (NAS) in Canada. However, the needs of patients should also be considered, given that they are the primary consumers of the product. Patients’ needs and choice must be considered in addition to the analysis of the market in this consultation.
  • The proposed list of countries used for international price comparisons, should be evaluated in advance to ensure that their inclusion will not delay launch times in Canada, does not affect Canada’s launch standing internationally, and the selected comparator countries should have comparable health systems overall to Canada’s (i.e. language, price lists, etc.).

Canadians deserve high-quality therapies and services that are appropriate for patient needs, respect an individual’s choice, and are delivered in a manner that is timely, safe and effective according to the most current evidence available. The review of the PMPRB regulations is an important part of updating Canada’s healthcare system. The PMPRB is encouraged to conduct this review in a transparent manner and the Government of Canada is encouraged to communicate to Canadians a greater understanding of how these changes will play into a larger federal government roadmap for making prescription medications more affordable, accessible, and appropriately prescribed. 

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