Drug Pricing Process in Canada
An opportunity to present the patient’s view on proposed changes
In the spring of 2017, Health Canada issued a call for input from all stakeholders interested to comment on their proposed changes to the Patented Medicine Prices Review Board (PMPRB) regulations. The role of the PMPRB is to protect and inform Canadians by ensuring that the price of patented medicines sold in Canada is not excessive and by reporting on pharmaceutical trends. These regulations are governed by the laws under the Patent Act which has been in place since 1987.
 
Drug manufacturers are required to comply with the Patent Act to ensure that the price of patented medicines sold in Canada is not excessive. If the Board finds that the price is excessive, it may order the manufacturer to reduce it and take measures to offset any excess revenues it may have received.
 
Since the regulations have been in place for over twenty years, Health Canada has taken the opportunity to review and update them. If approved through the government review process, these changes would take place in January 2019.
A summary of the proposed changes that will have the most impact on access to medicines are:
 
  • Including three additional evaluation factors for consideration when determining if a drug price is excessive:

  • A pharma-economic analysis
  • An impact assessment budget
  • An assessment of the Canadian Gross Domestic Product (GDP) as a benchmark
 
  • The PMPRB currently uses a list of 7 countries as a reference for pricing. Canada’s listed price cannot exceed the median price of these 7 countries. It was proposed to change the current list of 7 countries (United States, Switzerland, United Kingdom, Sweden, Germany, Italy and France) to a list of 12. In the new list, the United States and Switzerland would be removed given they are the highest-priced countries in the list. In the new proposed list, the other five current international reference countries (United Kingdom, Sweden, Germany, Italy and France) would remain and seven new countries (Australia, Belgium, Japan, Netherlands, Norway, South Korea, and Spain) would be added to bring the list to 12.
 
The 2 other proposed changes pertain to generic versus branded medicines:
 
  • Eliminating the Patented Medicine Prices Review Board (PMPRB) filing requirements for generic medicines covered by Canadian patents, except upon receipt of a complaint, or at the request of the PMPRB.

  • Requiring patentees to report to PMPRB all third-party discounts and other benefits. Currently, only rebates and benefits accruing to direct, factory-gate customers are reported to the PMPRB.
Martine Elias, Myeloma Canada’s Director of Access, Advocacy and Community Relations, co-authored with Louise Binder, Policy Consultant from Save Your Skin Foundation, the response to the proposed regulatory changes that was endorsed by 17 other patient organizations.

A copy of this submission can be found here:
* Please note this document is only available in English.
In short, we questioned why the PMPRB should duplicate the work with respect to the pharma-economic analysis of a new drug already undertaken by the Canadian Agency for Drug Technology in Health (CADTH). The analysis already performed by CADTH is of the utmost quality, extremely thorough and, paid for by our tax dollars. We recommend that the PMPRB use CADTH’s pharma-economic analysis.
 
Additionally, we suggest other relevant factors be included. Considering the proposed list of 12 reference countries, the federal government should ensure that all factors are considered and compared and that these be made transparent. Amongst the most important suggestions:

  • private/public insurance drug split
  • health care delivery mix in each country
  • whether they have a robust Health Technology Assessment (HTA) process
  • demographics of the reference country
  • price control tools e.g. cost per QALY, cost-plus /cost calculation, cost comparison, tendering or pricing negotiations
  • monitoring and evaluation
  • time-to-market
  • access to research and clinical trials and commitment to innovation
  • a measure of health outcomes (perhaps that from the WHO) in these countries need to be used in selecting reference countries.

To conclude, we emphasize that the changes in the list of reference countries considered by the PMPRB must not delay the timing or entry of new drugs into Canada even with new factors coming into play.
 
From June to December 2017, Health Canada reviewed the input provided by many stakeholders from the initial consultation phase. On December 1, 2017, Health Canada published in the Canada Gazette, Part I, the “Proposed Changes to the Patented Medicines Regulations”. This is a process by which they seek input from the Canadian population at large.
 
This consultation period is until February 14 , 2018. For more information, visit the following link: Notice on Proposed Amendments to the Patented Medicines Regulations

In this recommendation, none of the comments made by Myeloma Canada from the June 2017 submission were included and neither were those of many other stakeholders who had submitted suggestions.
 
Myeloma Canada will be commenting on the recent recommendations relating to the regulation changes under the Gazette Part I. If you are interested in providing us with your input or comments please do so by emailing Martine at melias@myeloma.ca.