The study, Access Delayed, Access Denied: Waiting for New Medicines in Canada, by the Fraser Institute, found that the regulatory agency, Health Canada, takes around 14 months to approve new drugs as safe and effective. Although private insurers will then cover these medicines immediately, it can take the provincial governments up to a year to decide whether they will cover them. The findings of the study then state that, in many cases, the drugs are then not given coverage at all.
The report found that Health Canada took an average of 453 days to approve new drugs in 2007, and the provinces then took a further 314 days to approve them under their drug plans. However, this is a marked improvement from 2004, when Health Canada took an average of 839 days and the provinces took around 552 days to approve new medicines, totalling 1,391 days or almost four years.
Furthermore, only 10.1% of new drugs approved by Health Canada in 2007 were being fully or partially reimbursed under provincial drug plans by the end of 2008.
The report proposed three policy changes which could speed up the approval process to ensure Canadians have access to new medicines:
- Regulatory co-operation with other countries - Canada should enter into mutual recognition agreements with other countries, introducing new medicines onto the Canadian market far more rapidly.
- Performance-based user fees - the government should establish, and strictly enforce, targets that Health Canada must meet before it receives user fees from drug companies, as is the case in the US.
- Replace government drug programmes with subsidized access to private insurance - introduce means-tested, publicly standardized access to private insurance for prescription drugs, to ensure that everyone has adequate drug insurance coverage, without delaying access to new medicines.
Further reading - An in-depth analysis of the Canadian pharmaceutical market, including some background information on drug approval processes, is available from Espicom: The Pharmaceutical Market: Canada (published June 2009)