Thoughts on PMPRB’s role in Canada’s complex system

Posted on November 1, 2016

There is no doubt that Canadians want and demand the best when it comes to our country’s healthcare system and that access to innovative medicines and vaccines is a key component to a quality health system. Innovative Medicines Canada and its member companies believe that all Canadians should have access to the medicines they need, without affordability as a barrier.

Created in 1987, the Patented Medicines Prices Review Board (PMPRB) was developed as a result of bold and visionary changes to Canada’s patent regime and the elimination of domestic compulsory licensing. There were dramatic health and industrial policy objectives and the changes resulted in significant improvements in both health research infrastructure in Canada as well as the availability of innovative medicines for Canadians and the resulting improvements in health outcomes.

At the time, PMPRB was the only mechanism that provided Canadians an assessment of the “reasonableness” of the price of a patented medicine in Canada. Today, the prices of patented medicines in Canada remain below the median of the prices in the PMPRB comparator countries (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the USA). However, after three decades other changes have taken place that have also altered the pharmaceutical landscape in Canada. New tools, mechanisms and agencies have been established to refine and enhance our understanding of the value of medicines and the role they play in our healthcare system.

Because of this, the PMPRB has initiated a broad-based consultation document to modernize and simplify its regulatory framework in order to remain relevant in a “dynamic and evolving pharmaceutical market.” Innovative Medicines Canada has taken part in this consultation and submitted our thoughts on how best the PMPRB can operate in our new reality.

The environment has shifted; the way we do business in this country has evolved and new medicines are changing the lives of Canadians every day. In order for the PMPRB to remain relevant it must look at the system holistically and identify where it can operate alongside the mechanisms and systems currently in place and not duplicate processes that could further delay Canadians getting access to the treatments they need.

While recognizing fiscal constraints, we should collectively aspire to goals more ambitious than minimizing expenditures. We should aspire to create a marketplace that encourages market entry of novel medicines. This approach will benefit both payers and patients. Payers will benefit from greater levels of competition, and patients will benefit from having more options available to them and their healthcare practitioners.

Innovative Medicines Canada is prepared to work with governments in Canada to build a predictable, stable and sustainable role for the innovative pharmaceutical industry and ensuring Canadians continue to get value for their healthcare dollars. We are keen to engage with public and private payers, Health Canada, CADTH and INESSS to help evolve the drug review mechanisms to address issues of clinical value and value for money, with the objective of improving timely and affordable access of innovative medicines to Canadians.

We are committed to working as a strategic partner with government and other healthcare stakeholders to bring forward solutions to address the affordability and access gaps in the system. However, we do not believe that changing the PMPRB guidelines to reduce pricing thresholds for patented medicines will solve the problem of individuals facing affordability challenges due to lack of or insufficient drug coverage in Canada. Solving this problem will require innovative collaboration between the federal, provincial and territorial governments, the pharmaceutical industry, and private insurers – and we are ready.

Read the Executive Summary.
Read the full submission.

Keith McIntosh is the Executive Director, Scientific & Regulatory Affairs at Innovative Medicines Canada.

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