In 2010, Canada’s drug regulator took 527 days, on average, to certify new drugs as safe and effective, while the nation’s provinces added another 358 days to approve them for coverage under public drug plans, says a new study.
“This bureaucratic layering creates unnecessary delays and deprives many Canadians access to new medicines,” according to the report, which is entitled Access Delayed, Access Denied, and is published by free-market think tank The Fraser Institute.
There are two stages to Canada’s drug approval process. First the regulator, Health Canada, must certify a drug as safe and effective, then the provinces have to decide whether or not the product will be eligible for reimbursement under provincial drug programmes.
As of January 1, 2012, only 22 (62.9%) of the new medicines which were certified by Health Canada in 2006 had been covered by provincial drug plans, compared to 31 (88.6%) which had been covered by at least one private insurer, according to the report.
Nevertheless, it adds that the nearly two-and-a-half year wait in 2010 still represents a significant improvement over the waits recorded in 2004, when Health Canada took an average of 839 days and the provinces 648 days to approve new prescription drugs, representing a total of 1,487 days or more than four years.
But Health Canada is continuing to take longer than its international counterparts to certify new drugs, the study adds. From 2006 to 2010, the regulator’s performance was worse than that of the European Medicines Agency (EMA), and it was also worse than that of the US Food and Drug Administration (FDA) for six of the last seven years studied (2004-2010).
The report’s authors suggest two specific policy changes which they say could improve the drug approval process in Canada and speed up access to new medicines.
First, they call on Canada to take advantage of the regulatory knowledge and capacity of other jurisdictions, rather than attempting to duplicate the drug approval process.
International safety standards are similar, so Canada’s federal government could speed up access to new drugs by harmonising with European and US regulatory processes trough mutual recognition of drug approval decisions.
Second, they point out that private drug insurers in Canada tend to cover a wider range of new medicines and approve their coverage at a much faster rate than public drug programmes. Therefore, they suggest that the provincial governments could both improve access for patients and save money by replacing existing public drug programmes by introducing a means-tested subsidy for people on low incomes, which they would use to purchase a drug insurance plan of their choice in a competitive private market.
“This policy would allow low-income patients to choose the drug plan that’s best for them, thus reducing government-imposed restrictions on consumer choice,” said Mark Rovere, associate director of health policy research at The Fraser Institute and co-author of the report.
“Allowing the private insurance market to compete through price and service is the best policy choice for improving access to new medicines, while also cutting costs for patients and taxpayers,” he added.
