USCMA Revision Worsens Innovator Woes In Canada
News Comes As Consultation On New Pricing Guidelines Is Extended
Executive SummaryStripping the revised USMCA deal of provisions to strengthen IP rights for biologics will worsen market difficulties in Canada caused by changes to the drug pricing regime, says industry.
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Revised North American trade deal touted as enabling Congress to address crisis of high drug prices; requirement for 10 years biologic exclusivity is removed and language to allow incentives for generics added.
Long awaited changes to Canada’s Patented Medicines Regulations have been announced, but companies will have to wait for new guidelines from the pricing watchdog to better understand how they will be implemented.
USA's 12-year-plus scheme won't change, but Canada and Mexico must offer sponsors more than previously; biosimilar industry bemoans lack of incentives for competition. Trade pact also specifies damages award options and links regulatory review to patent disputes.