Pharma industry challenges Canada’s drug pricing plan
Innovative Medicines Canada (IMC), an association that represents drugmakers in Canada, has challenged the overhaul of Canada’s drug-pricing regime.
IMC and 16 of its member companies filed an application for a judicial review of the plan at the Federal Court of Canada on Friday, September 6.
Canada published the final regulations in early August, along with estimations that the amendments are expected to save Canadians approximately $13.2 billion over ten years on patented drug costs.
IMC President Pamela Fralick said: “This is a necessary step given the significant impact these regulations will have on patient access to medicines and the future of Canada’s life sciences sector.”
Fralick added that the pharma industry has tried to work with Health Canada (the Canadian government’s health department) for nearly two years to find policy alternatives that would “make medicines more affordable without jeopardising the industry’s rationale to invest in Canada and patient access to new medicines”.
In its application, IMC claimed that the federal government doesn’t have authority to “fundamentally alter” the role of the Patented Medicine Prices Review Board (PMPRB) through the recent changes to the Patented Medicines Regulations.
The PMPRB is Canada’s federal drug price regulator, which aims to ensure that the prices of patent-protected drugs are not excessive.
The new regulations, which come into force July 1, 2020, change the list of countries with which PMPRB compares domestic prices. PMPRB will also be able to consider whether the price of a drug actually reflects the value it has for patients.
This is the second challenge levelled against the Canadian government’s drug plans. In August, six drug companies filed a constitutional challenge against the new regulations, claiming that price regulation falls within provincial jurisdiction.
‘Insufficient supply’
The challenges come as the government considers the introduction of a national pharmacare programme, which would seek to improve access to lower-cost generics.
In April this year, LSIPR reported that an internal government report obtained by The Canadian Press under access-to-information laws said that the government’s plans to improve access to generics could deter pharmaceutical companies from releasing brand medicine in the country.
According to The Canadian Press, the Department of Finance feasibility report stated that “...brand-name pharmaceutical companies may respond to a broad shift to generic drugs by delaying the introduction of new drugs in the Canadian market or by reducing the R&D activities that they undertake in the country”.
Then, in August, the Trump administration proposed plans to allow the importation of cheaper drugs from Canada and other countries, in a bid to lower drug prices for US patients.
But Canadian organisations were not pleased with the proposals—15 organisations sent a letter to Canada’s Minister of Health Ginette Petitpas Taylor to express concern over US legislation that allows the importation of cheaper drugs.
“The Canadian medicine supply is not sufficient to support both Canadian and US consumers,” said the letter. “The supply simply does not and will not exist within Canada to meet such demands.”
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