Canadian Lawyer

November/December 2019

The most widely read magazine for Canadian lawyers

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64 LEGAL REPORT INTELLECTUAL PROPERTY IP practitioners wary of patented medicine pricing amendments Amendments to Canada's Patented Medicines Regulations come into force July 1 — and they have already been met with two court challenges CANADA'S NEW patented medicine pricing regime will come into effect on July 1; and although guidelines have not yet been released, nor the next set of consultations started, it is already controversial. I n A u g u s t , a m e n d m e n t s t o Canada's Patented Medicines Regulations were published — the first since 1987 — and have so far been met with two court challenges. In early September, the patented medicines industry group Innovative Medicines Canada and 16 of its member companies filed a judicial review application in the Federal Court of Canada. The group charges that the new regulations would jeopardize "the industry's rationale to invest in Canada and patient access to new medicines." The other challenge is constitutional, initiated in the Quebec Superior Court on behalf of six pharmaceutical innovator companies. "Canada may be the only country in the world that applies its law so that pricing of patented medicines is controlled," says Daphne Lainson, a partner at Smart & Biggar LLP in Ottawa, who calls the changes to the pricing regime "significant." Related guidance from the Patented Medicine Prices Review Board has not yet been released, although it will be important in how the new amendments will be applied. The PMPRB takes its jurisdiction and mandate from the Patent Act, under the jurisdiction of the minister of industry, although the new amendments were developed in co-operation with input from Health Canada. There are three principal reforms. First, new factors were introduced to enable the PMPRB "to consider the price of a patented medicine in relation to its value and impact on the health care system," according to "The constitutional challenge [to the amendments] is the real threat. . . . Now we're entering a territory where we're going to get U.S.-style drug pricing in this country." Amir Attaran, University of Ottawa

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