Canadians access newly patented medicines later than other countries do—a situation that can be remedied if Canada accepts American and European Union drug approvals instead of waiting to duplicate them, according to a study by the Fraser Institute.
The report notes that almost all new prescription drugs approved by Health Canada were also approved by the United States and the EU—but about a year earlier. Thirty out of 31 drugs approved by Health Canada in 2011 and 2012 were approved by a median of 386 days earlier in the U.S. In Europe, all 31 were approved by a median of 267 days earlier.
This group of medications includes important cancer drugs such as Avastin and Jevtana, says Nadeem Esmail, the Fraser Institute’s director of health policy studies and co-author of the study. “Such needless delay unquestionably had a negative effect on those patients whose lives could have been extended by these drugs.”
Canada’s delayed access to new drugs happens mainly due to the fact that pharmaceutical companies submit their applications for approval much later in Canada than they do in the U.S. and Europe, the study notes. The difference in submission happens because of Canada’s relatively weaker intellectual property protections, small market size, drug pricing controls and the extra financial burden associated with additional regulatory hurdles, according to the report.
The EU reviews and approves new medicines through the European Medicines Agency or through a method where individual EU nations give their okay to a drug and the other EU nations are expected to recognize the approval.
In the United States, drug approval is carried out by the Food and Drug Administration.
In Canada, new drugs are federally approved after review by Health Canada. The approval process in Canada is not significantly different from the process in Europe or the U.S. so it’s inefficient to make Canadian patients wait for access to medication already approved, the report argues.
“If Canada accepted European and American approvals instead of duplicating their processes, patients in Canada could have received access to 152 new pharmaceutical therapies a median of 494 days earlier between 2005 and 2011/12,” states the report.
If Health Canada abandons its mandatory drug regulation function, it will still be able to provide safety warnings or require the withdrawal of a medicine from the Canadian market, Esmail says. He points out that Canadian approvals could still be carried out on a non-mandatory basis.
This approach would allow the federal agency to monitor drugs that have already been approved, the study says. It also argues that this approach would free up resources for better communication with both patients and physicians about prescription drugs and their side effects.
Related articles: