In what has become an ongoing joke in pharmaceutical circles, the federal government has once again postponed the implementation of new patented drug pricing rules, first introduced in 2019, citing the two-year-old pandemic as an excuse for its inertia .
Federal Health Minister Jean-Yves Duclos announced the latest postponement – the fourth since mid-2020 – on December 23, just under a week before the new rules were due to take effect on January 1. In almost every other area of activity, accidental postponement of a decision affecting the health and livelihoods of millions of Canadians would be tantamount to mistreatment. But in Ottawa, such nonsense has become business as usual.
Instead of simply withdrawing its erroneous proposals, the government continues to maintain the idea that it intends to crack down on “excessive” prices of prescription drugs, although it has become quite clear that its proposed cure for high drug costs would be worse than the disease. At the very least, its proposal runs counter to its priority of rebuilding Canada’s bioproduction capacity to prepare for future pandemics.
Sir. Duclos should perhaps be cut down a bit, having taken over the health portfolio just two months ago. His predecessor in the job, Patty Hajdu, repeatedly turned a deaf ear to concerns from industry and patient associations that the proposed pricing rules would deprive Canadians of access to innovative drugs and discourage pharmaceutical research here. She also refused to tame the anti-industrial bias exerted by the Patented Medicine Prices Review Board (PMPRB), which drafted new rules to significantly expand its mandate, a move that smelled of a grip on power.
In 2019, the idea of taking Big Pharma had a broad political appeal to Justin Trudeau’s liberals. The party’s election platform that year included the promise of a national drug program, a long-standing demand from the New Democratic Party. The pre-election release of a report from an advisory committee chaired by former Ontario Health Secretary Eric Hoskins had set the cost of national medicine at $ 15 billion a year. But that price tag and the sustainability of the program depended on reducing the cost of branded medicine in Canada, which is among the highest in the world.
The PMPRB’s proposal will remove the United States and Switzerland – where prescription drug list prices are the highest – from the basket of comparison countries used by the agency to set maximum permitted prices in Canada. That, and the addition of more low-cost countries, would have the effect of lowering the PMPRB’s threshold for what qualifies as excessive pricing – and depriving the pharmaceutical industry of billions of dollars in potential revenue.
The new rules, which are hopelessly complex, would not stop there. They would force pharmaceutical companies to disclose confidential third-party rebates paid to bulk buyers of prescription drugs, and allow the PMPRB to make decisions about the therapeutic value of new drugs that the industry claims it is ill-equipped to take. Innovative Medicines Canada (IMC), the lobbying group for Big Pharma, says the new rules will lead to “frequent disputes” that would delay the introduction of new drugs in Canada – or completely stop their introduction.
The government thought a bit about the unintended consequences of the new rules – until the pandemic hit. Suddenly, work with Big Pharma to obtain vaccines and rebuild Canada’s decayed bioproduction capacity took precedence over drug policy. Recent court decisions that overturned PMPRB decisions and criticized its harshness also served to put the Agency in a negative light and stress the need for its review. And the new rules risked attracting Washington’s anger after the U.S. Trade Representative put Canada on its “watch list” for the threat the PMPRB rules posed to intellectual property protection under the U.S.-Mexico-Canada trade agreement.
While no one sheds a tear for Big Pharma, whose goal of profit maximization remains all-encompassing, Ottawa has much to gain by building a constructive relationship with the industry. Minister for Innovation François-Philippe Champagne seeks to roll out a new bio-manufacturing and life sciences strategy to attract new investment in this sector. Moderna’s pledge in August to begin manufacturing vaccines in Canada and Merck’s recent announcement that it has given Thermo Fisher Scientific a mandate to manufacture its new COVID-19 drug molnupiravir at a plant in Whitby, Ont., For distribution on the most global markets outside the United States are. early signs that Mr Champagne’s strategy has legs.
Mr. Duclos, who met with Pfizer Canada President and IMC President Cole Pinnow this month to discuss the new rules, must be careful not to interfere with the momentum his cabinet colleague has set in motion. He should pull the plug on the PMPRB’s ill-conceived plan and reform an agency that desperately needs it. A balanced approach is in Canada’s best interest.
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