Long-delayed drug-pricing changes are being postponed again by the federal government, which cited the need for the industry to have more time to adjust in the midst of a pandemic.
The lobby group for pharmaceutical giants has strongly opposed the changes and on Tuesday called for more talks to look at alternative options. The new rules were initially supposed to take effect on July 1, 2020, but after this third delay, they are now scheduled to come into force on Jan. 1, 2022. At a virtual news conference on Tuesday, Health Minister Patty Hajdu said she was open to more talks but said any changes cannot alter the end game: making medications more affordable.
“Pharmaceutical companies have been working flat out to help the world break free of COVID-19, including by developing vaccines and other therapeutics. We’ve been working closely with the industry and other stakeholders, as you know, on making sure that whatever we impose in Canada, in terms of changes to these regulatory frameworks, will result in a reduction of costs,” Ms. Hajdu said.
However, the repeated delay to acting on the government’s stated mission brought charges from the NDP that the governing Liberals are in cahoots with the industry, while the Conservatives said it was a tacit acknowledgement that their changes are a mistake.
The latest delay was made official through an order in council on June 24 – just days before they were to take effect on July 1. The government did not issue a news release about the move but notified stakeholders Tuesday.
The changes to the Patented Medicines Prices Review Board, or PMPRB, seek to lower the price of drugs by allowing the regulator to adjust which countries it uses to set a benchmark on prices and to take into account the drug’s cost-effectiveness for patients. Under the new rules, the PMPRB would compare Canadian list prices to those in Australia, Belgium, Japan, Netherlands, Norway, Spain, Britain, Sweden, France and Italy.
“It is not anticipated that further delaying these amendments will be needed,” Health Canada said in a statement provided to The Globe and Mail on Tuesday.
When the regulations were first published in August, 2019, Health Canada said changes would result in more than $8-billion in lost profit for the pharmaceutical industry over 10 years. At the time, an industry-funded report pegged the cost to companies at $26.1-billion. Health Canada commissioned David Dodge and Ake Blomqvist to compare the cost estimates. The PMPRB said the additional report found Health Canada’s assessment was “carefully done” and based on recent data.
Innovative Medicines Canada is the lobby group representing major drug makers, including the majority of the manufacturers of COVID-19 vaccines that Canada has purchased. On Tuesday, it urged the government to use the time granted in the extension “to examine the potential impact of these reforms, as well as affording time to generate more effective alternative solutions.”
The group’s statement said it and its member companies believe going ahead with the current changes would have a “significant negative impact.” Its member companies include AstraZeneca, Pfizer, Sanofi, and Janssen (part of Johnson & Johnson). Most companies did not have anything else to say Tuesday, but Janssen said it wants to work with Ottawa on the “shared public policy objectives of affordability and patient access.”
The most strongly worded statement came from AstraZeneca, which said the current changes risk quality of care in Canada.
“The proposed PMPRB reforms would see Canada shift from a 1st to a 2nd tier health care system, with the risk that Canadian patients would wait much longer to gain access to new medicines,” AstraZeneca spokesperson Carlo Mastrangelo said.
Innovative Medicines Canada has previously told The Globe and Mail that if “the amended regulations come into force, there is no question that companies will be required to evaluate their impact on all new medicines and vaccines, which could in turn lead to more drugs not launching, or delaying their launch in Canada.”
The Official Opposition Conservatives are against the proposed changes from the government. “We need to rebuild and grow our life-sciences sector and foster R&D domestically. The Liberals’ new regulations don’t do that, and need to be rethought,” MP Michelle Rempel Garner said in a statement to The Globe on Tuesday.
New Democrat MP Don Davies noted that Prime Minister Justin Trudeau has repeatedly made cutting drug costs a signature policy, but the stated goals have been met with little real action and further delay. “The bottom line is the Liberals are putting pharmaceutical industry profits ahead of the interests of Canadians,” Mr. Davies said.
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