The head of the Canadian Generic Pharmaceutical Association (CGPA) has issued a statement criticizing pharmaceutical concessions in the recently inked United States-Mexico-Canada Agreement (USMCA).
“Canada was not at the table when harmful intellectual property provisions were negotiated between the United States and Mexico,” said CGPA President Jim Keon. Noting that biologic medicines represent the fastest-growing cost segment in healthcare spending, Keon said the pharmaceutical provisions in the USMCA will delay access to competition from biosimilar drugs.
Because of a data-exclusivity extension included in the USMCA, the current entry window for cheaper generic alternatives to American biologics will be delayed by two years. That means American drugs will be able to sell their biologics without generic competition in Canada for a full decade.
“[T]hese delays will be costly to patients, businesses that sponsor employee drug plans, private payers and our industry,” he said. He added that the new deal is “disappointing” for the vast majority of Canadians who, according to a recent CGPA poll, feel that access to more affordable prescription medicines is the most important aspect of the negotiations.
The new intellectual property concessions under the UMSCA follow an amendment to Canada’s intellectual property regime for pharmaceuticals in September 2017. Citing estimates from the Parliamentary Budget Officer, Keon said the amendment — a two-year patent term extension under the Comprehensive Economic and Trade Agreement (CETA) with the European Union — will cost Canadians more than $500 million annually.
Speaking to CBC News, McGill University law professor Richard Gold said the two-year delay under the USMCA could cost taxpayers “tens of millions” annually. “The provinces are going to have to pick up this bill," he said, noting that Canada’s public-health system buys about half of the medications used by Canadians.
But Paul Grootendorst, an associate professor at the University of Toronto’s school of pharmacy, said the complexity of making biosimilars — generic equivalents of biologic drugs — has meant there isn’t a lot of competition in biologics right now. That, along with the fact that changes to the Patented Medicine Price Review Board will likely roll out in concert with the USMCA extension, could “take a lot of bite out of this policy change,” he said to CBC News.
“The pharmaceutical intellectual provisions included in the final text are extensive, and other aspects of the text are concerning,” Keon said in his statement. “The CGPA is conducting a comprehensive review of the text to ensure there are no additional negative consequences for the Canadian health-care system.”
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