Canada’s generic drug makers argue that the ban could prevent customers’ access to cheaper generic drugs and be costly for Canada’s healthcare system.
“Canada’s Parliament approved legislation allowing the government to make regulations necessary to comply with Canada’s international trade obligations,” said Jim Keon, president of the Canadian Generic Pharmaceutical Association.
“But by imposing eight years of data exclusivity, the new rules vastly exceed what is necessary for Canada to comply with the North American Free Trade Agreement and the Agreement on Trade Related Aspects of International Property Rights.”
The government has provided brand-name drug companies with an eight-year ban on generic competition, regardless of whether there are relevant patents on their products.
The new rules are the government’s response to lobbying from brand-name drug companies to strengthen data exclusivity provisions. Large pharmaceuticals have been facing increasing competition from generic copycats that can reduce their profits and shares.
The Canadian Generic Pharmaceutical Association estimates that the new regulations could cost consumers $600 million in drug costs over a five year period.