Times Colonist columnist Lawrie McFarlane and CBC’s reporter Kelly Crowe wrongly claim that the federal Liberals sold out Canadians to Big Pharma when Health Minister Jean-Yves Duclos announced the government’s decision to cancel most of its revisions for the Patented Medicine Prices Review Board (PMPRB).
McFarlane and Crowe, together with anyone else who believes the government conceded to the industry, should read recent decisions from the Quebec Court of Appeal and the Federal Court of Appeal that dissected fact from fiction. In addition, they should reflect on the fact that Canadians got relatively speedy access to COVID vaccines and drugs because Ottawa exempted them from PMPRB scrutiny.
McFarlane is also incorrect when claiming the revisions to the PMPRB’s regulations were to establish a process “to determine how much benefit a new drug actually conferred.” This is not the PMPRB’s role, which is simply to prevent time-limited drug patents from being abused.
The changes were actually intended to drastically reduce list prices of new medicines that the PMPRB and the government thought were unreasonable to a level unsustainable for drug developers. This would have drastically diminished Canada’s attractiveness as a market for new medicines.
Drug developers would have delayed launching new medicines or not launched them here at all, leading to denial of timely or no access to new ground-breaking therapies for an increasing number of Canadians with unmet or poorly met health needs. As the PMPRB’s 2020 annual report shows, uncertainty during the five years in which Ottawa tried to force through its ill-advised regulations already impacted the number of new medicines launched in Canada.
Analyses from several countries have repeatedly demonstrated that regulating, instead of negotiating, drug prices leads to delays in access. Delayed access harms patients and reduces life expectancy. People dying from ALS or Duchenne muscular dystrophy, for example, don’t have time to wait for a system that prevents access to life-saving/life-altering drugs.
McFarlane suggests, without evidence, that the government’s cancellation of the changes is related to the Prime Minister’s and Mr. Duclos’ parliamentary seats being in Quebec. The truth is that the scale-back marks a victory for the rule of law over purveyors of policy spin and federal overreach.
Legal challenges in two Canadian Courts of Appeal led to senior judges rebuking false claims of the PMPRB, its supporters and the federal Cabinet. They struck down the use of health technology assessments and other economic factors to regulate prices and the requirement for drug developers to divulge confidential business secrets about rebates negotiated with public and private insurers. The Supreme Court of Canada saw no merit in reviewing the unanimous Federal Court of Appeal’s decision that the PMPRB had abused its existing powers.
Revisions will now be limited to an adjustment in countries in the PMPRB’s international list price comparison. France, Germany, Italy, Sweden and the United Kingdom will be retained, but Switzerland and the United States, which have higher drug prices, will be replaced by Australia, Belgium, Japan, Netherlands, Norway and Spain, which have lower drug prices.
Some drug developers may accept this change. However, the risk of reduced prices from changing countries, together with shorter patent life, narrowly-focused health technology assessments relying unduly on clinical trial results and not real-world evidence or patient perspectives, and the likelihood of a further price reduction in negotiations with drug plans may cause other developers to decide that just too many barriers exist in Canada to bring their medicines here.
McFarlane, Crowe and others see the cut back in PMPRB changes as a triumph for Big Pharma. Not so. A success for the industry would be federal and provincial governments changing their decades-old antagonism to a collaborative relationship in which patent life for pharmaceuticals is extended to the international standard and Canada stepping up to pay its fair share towards the development of medicines, instead of freeloading on the United States or other countries.
It’s also not a win for patients if drug developers regard Canada as a less attractive country in which to undertake research and clinical trials and launch new medicines. Canadians need their politicians to encourage faster and easier access to new life-changing and life-saving medicines, not create more obstructions.
Ottawa and provincial governments should rethink policies and processes so that Canadians get rapid access to new drugs and vaccines without delays. The success or failure for patients of comprehensive universal pharmacare (not a skimpy version covering only inexpensive “essential drugs”) and a national strategy for rare disorders hangs on the results of this rethink.
Nigel Rawson is an independent researcher and a Senior Fellow at the Macdonald-Laurier Institute. John Adams is cofounder and CEO of Canadian PKU and Allied Disorders Inc., a Senior Fellow at the Macdonald-Laurier Institute, and volunteer board chair of Best Medicines Coalition. The views expressed are the authors’ own and do not necessarily represent those of organizations with which they collaborate.