“We have just received the amended Regulations and will require time to analyze them fully,” stated Pamela Fralick, President of IMC. “However, given what we have heard to date, our fear is that patients will be worse off.”
The PMPRB’s own case studies indicate the amended Regulations will drop drug ceiling prices by up to 70 per cent, severely weakening the business case to launch new medicines in Canada. A recent EY study confirms that there is indeed a correlation between market conditions when it comes to global drug launch decisions, contrary to Health Canada’ statements.
The amended Regulations will also have significant impacts on the future of Canada’s life sciences sector, including a decline in investments and the loss of highly skilled jobs across the country. IMC notes that the outdated and narrow definition of research and development used by Health Canada does not reflect the current investments by this industry. According to a recent EY analysis, 10 per cent of industry revenues are invested into R&D.
“These regulatory changes have jeopardized our industry’s incentive to invest in innovation in Canada,” continued Ms. Fralick.” The Regulations will also impact global decision making with respect to the launch of clinical trials in Canada, which are high-value health research activities that enable Canadian patients to benefit from early access to new and promising medicines free of charge.”
The innovative pharmaceutical industry is currently the third largest R&D funder in Canada and contributes to a strong economy by supporting over 30,000 jobs and driving over $19-billion in annual economic activity.
IMC and its member companies, along with dozens of stakeholders – including some provincial governments, patient advocacy organizations, pharmacists, chambers of commerce, researchers and life sciences organizations – repeatedly urged the government to reconsider its approach. Recognizing the need for more affordable medicines, the industry offered to work collaboratively with government on an alternative solution that would balance the need for more affordable medicines with a competitive regulatory environment for health research. However, Health Canada did not meet with industry in a meaningful way on this issue, despite repeated requests.
“This is a disappointing day for those of us in the life sciences community, as well as for the many patients who will be worse off under these regulatory changes,” stated Ms. Fralick. “As we evaluate the next steps for our industry, we remain committed to advocating for patient-centric solutions and a regulatory environment that fosters Canadian competitiveness.”
About Innovative Medicines Canada
Innovative Medicines Canada is the national voice of Canada’s innovative pharmaceutical industry. We advocate for policies that enable the discovery, development and commercialization of innovative medicines and vaccines that improve the lives of all Canadians. We support our members’ commitment to being valued partners in the Canadian healthcare system.
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SOURCE: Innovative Medicines Canada