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68 www.canadianlawyermag.com T he cons titutional challenge from Quebec charges that the amendments to pricing regulations are ultra vires federal authority in the constitution; but this matter has been litigated before, and unsuccessfully, he says. "The courts have said because the federal government has constitutional authority in s. 9.1 . . . to make laws in relation to patents, that includes laws in relation to the pricing of patent medicine." Nor is the contention LEGAL REPORT INTELLECTUAL PROPERTY contains a fair degree of unpredictability," says Alan West, a partner in Gowling WLG's Toronto office, who practises primarily in the pharmaceutical and health-care sectors. "The new changes will only exacerbate that and inject more unpredictability," he says. One thing that won't change is the provision that says the guidelines are not binding on the PMPRB, West says. This creates uncertainty for a company or manufacturer that may adhere to the guidelines only to lose out in a dispute with the PMPRB. West also points to two of the new factors that will be considered by the PMPRB in determining whether the price of a medicine is excessive: the GDP of a country and the per capita GDP. "If the price of a drug is set in Year One, and the . . . price of oil plummets — and Canada is a petrol-exporting country — if our GDP dips, how does that affect the price of medicine in Year Two?" This takes pricing control away from manufacturers, says Alex Camenzind, who practises with Gowling WLG in Ottawa, as pricing becomes tied to the vagaries of the market. For now, the guidelines have not been released nor new consultations started, and they won't likely be released until after the federal election dust clears. As for the two court challenges, Attaran says that neither is likely to succeed. "Canadians pay among the highest prices for patented medicines in the world, after only the United States and Switzerland." Anna Maddison, Health Canada valid that the cost effectiveness of a drug is a new criterion that distinguishes this case from all previous ones, Attaran says. The challenge in Federal Court, filed by the mainstream of the industry, "turns on the supposition that when Parliament legislated the Patent Act and gave the PMPRB jurisdiction to set prices, which that power was communicated to PMPRB through regulations" but that the new regulations are ultra vires the Patent Act. "Canadians pay among the highest prices for patented medicines in the world, after only the United States and Switzerland. Canadians pay close to 25 per cent more than the median price that people in other developed countries pay for the same medicines. This influences Canadians' access to important medications and the sustainability of Canada's health-care system." Health Canada CANADIANS AMONG HIGHEST PAYERS FOR PATENTED MEDICINES