Toronto, September 21, 2017 – The following is a statement by Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA), regarding today’s provisional application of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, which includes extensive changes to Canada’s intellectual property regime for pharmaceuticals.
“Canada had high, internationally-competitive standards for pharmaceuticals intellectual property before the CETA negotiations commenced, with average market protection periods for brand-name drugs that were equal to or longer than in other developed markets.
Unfortunately concessions were made in the CETA negotiations that will delay market entry of cost-saving generic and biosimilar prescription medicines in Canada in the future.
Starting today all new brand-name pharmaceutical products approved will receive two additional years of patent monopoly, meaning cost-saving competition from generic and biosimilar medicines will be delayed by two years.
A new pharmaceutical intellectual property litigation system also comes into effect today. While that system includes several improvements, the CGPA remains concerned that there remains too much business risk and uncertainty and too few incentives for generic and biosimilar medicines companies to invest in litigation to bring new cost-saving medicines to the market.
The CETA pharmaceutical intellectual property concessions will have a long-term negative impact on Canadians, increasing health-care costs for provinces, employers that sponsor drug plans for their employees and Canadians who pay for their prescription medicines out-of-pocket. The changes will also have negative industrial consequences for Canada’s life sciences sector as generic pharmaceutical companies are Canada’s primary pharmaceutical researchers, developers, manufacturers and exporters.
Canada is home to an internationally significant cluster of generic pharmaceutical manufacturing facilities in Toronto and Montreal, which export high quality made-in-Canada generic medicines to 115 countries. Timely access to export markets is critical to the sustainability of its domestic operations and the industry’s 11,000 high quality jobs.
As the generic and biosimilar medicines companies and pharmaceutical payers adapt to the CETA pharmaceutical intellectual property concessions, we are now concerned by reports that the United States plans to table extensive intellectual property provisions in the NAFTA negotiations, including 12-years of data exclusivity for biologic drugs and further extensions of patent terms.
Such pharmaceutical intellectual property measures are not in our domestic interest, and would be devastating to Canada’s healthcare system and generic and biosimilar medicines industries. Such measures must be rejected by the Government of Canada in the NAFTA negotiations should the United States proceed with such proposals.”