The new proprietary pricing system for medication in Canada will come into effect on July 1; and although recommendations have not yet been released, nor the next round of consultations has begun, it is already contentious.
Amendments to the Patented Medicines Regulations of Canada were issued in August — the first since 1987 — and two court challenges have been faced so far.
In early September, Innovative Medicines Canada as well as 16 of its member companies filed a request for judicial review at the Federal Court of Canada by the patented medicines industry group. The group claims that the new rules would jeopardize “the rationale for the industry to invest in Canada as well as access new medicines for patients.”
The other hurdle is constitutional, initiated by six pharmaceutical innovator companies in the Quebec Superior Court on behalf of them.
The Patented Medicine Price Review Board’s guidance has not yet been published, although how the new amendments will be applied will be important. The PMPRB derives its authority and mandate under the control of the Minister of Industry from the Patent Act, although the latest reforms have been implemented in conjunction with Health Canada’s feedback.
Other factors to consider will be the size of the market and the per capita gross domestic product in Canada, which boils down to whether Canadians can afford to pay for a particular drug.
Second, alterations in reporting requirements will involve patentees to report all of their net sales information, Lainson states.
Amir Attaran, Canada’s Chair of Pop Health and a cross-appointed professor at the law and medicine faculties of the University of Ottawa, sees these changes as being in line with other jurisdictions.
Noel Courage, a partner at Bereskin & Parr LLP in Toronto, says the way the rules were set years ago had an effect on whether some firms would operate at all in Canada.