Toronto, October 18, 2013 – Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA), issued the following statement regarding today’s announcement by Prime Minister Harper and President Barroso of an Agreement in Principle in the negotiations for a Comprehensive Economic and Trade Agreement (CETA):.
“The Pharmaceutical intellectual property provisions announced in today’s Agreement in Principle fall short of the European Commission’s original unnecessary demands on behalf of brand-name drug companies but will still delay market entry of cost-saving generic prescription medicines in Canada in the future, increasing health-care costs for provinces, employers that sponsor drug plans for their employess and Canadians who pay for their prescription medicines out-of-pocket.
The full cost to Canadians of the actual delays in generic drug competition resulting from the new measures will depend on the specific manner in which they are implemented by the Government of Canada.
The Canadian Generic Pharmaceutical Association is, however, pleased that the Government of Canada has also made commitments for additional safeguards and reforms to Canada’s pharmaceutical intellectual property regime to provide greater business certainty for Canadian generic pharmaceutical manufacturers. These commitments are outlined by International Trade Minister Ed Fast in a letter to CGPA.
CGPA has received written assurances from the Government of Canada that its implementation of the “Right of Appeal” treaty commitment will also address excessive and duplicative litigation by ending the practice of dual litigation. CGPA has advocated for such reforms to Canada’s pharmaceutical patent linkage system for several years.
Currently, Canada is the only country that allows brand-name pharmaceutical companies to sue generic pharmaceutical companies multiple times on the same patents, adding to the costs and risks of bringing generic drug competition to the Canadian market. While the specific implementation details will be crucial to the success of these critical reforms, CGPA welcomes the Government of Canada’s commitment to reduce the burden on the courts, bring earlier finality to pharmaceutical patent disputes and deliver greater business certainty for generic pharmaceutical companies in Canada.
If implemented correctly, the reforms to end dual litigation will help protect Canadian consumers by ensuring invalid or non-infringed patents do not prevent cost-saving competition from coming to market.
CGPA is disappointed by the inclusion of a patent term extension in CETA, but welcomes the Government of Canada’s commitment to cap the maximum length of extension at two years and include other essential safeguards.
CETA also sets an international precedent as the first trade agreement that permits an exception under the period of patent extension for the production and other activities related to the export of generic medicines.
CGPA commends the Government of Canada for recognizing the importance of generic pharmaceutical manufacturing to the domestic economy. 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 around the globe.
The generic pharmaceutical industry operates most of the pharmaceutical manufacturing in Canada, and timely access to export markets is critical to the sustainability of its domestic operations and the industry’s 12,000 high quality jobs.
CGPA is also pleased that CETA will not impose changes to the domestic data protection regime, but is disappointed that Canada’s treaty obligations have been extended by three years to reflect current levels.
CGPA looks forward to continuing to work with the Government of Canada for the successful conclusion of the CETA agreement and for the implementation of the reforms the Government of Canada has committed to in support of the continued international competitiveness of the domestic generic pharmaceutical industry.”
About the Canadian Generic Pharmaceutical Association
The Canadian Generic Pharmaceutical Association (CGPA) represents Canada’s generic pharmaceutical industry. The industry plays an important role in controlling health-care costs in Canada. Generic drugs are dispensed to fill 65 per cent of all prescriptions but account for account for only 24 per cent of the $22-billion Canadians spend annually on prescription medicines.
For more information, please contact:
Vice President, Corporate Affairs
Canadian Generic Pharmaceutical Association (CGPA)
Tel: (416) 223-2333
Mobile: (647) 274-3379