Approving new drugs in Canada—a 30-year review

This is the first installment of a three-part blog series examining issues around the time required to review and approve new medicines in Canada. Read part 2.

Coming to Canada more than 30 years ago, I quickly noticed that several of the drugs whose safety issues I had studied in England in the 1980s received marketing authorization in Canada much later than in the United Kingdom. For example, Enalapril, an angiotensin-converting enzyme inhibitor used to treat hypertension and other cardiovascular conditions, was first marketed in the U.K. in April 1985 but was only approved in Canada in July 1987.

It was also apparent that the time elapsing between marketing authorization in Canada and inclusion in the Saskatchewan government drug plan formulary could be extensive. For example, the period for Ranitidine, a gastrointestinal drug, received marketing approval in November 1981 but was included in the formulary in July 1987.

Canada was not unique in approving new drugs later than the U.K. In the 1970s and 1980s, North America’s drug approval focus was more prolonged premarketing trials leading to later applications for authorization and consequently later approval than in the U.K. where greater effort was made to get beneficial medicines to patients in a timely manner followed by a robust post-marketing surveillance system. This led to therapeutics in North America being several years behind that in the U.K.

Indeed, the slow approval of new medicines in Canada was well known. Several independent reviews of the drug approval system from the mid-1980s, including the Eastman Commission of Inquiry on the Pharmaceutical Industry, had criticized the slowness with which new medicines were authorized by Health Canada. Patient advocacy groups were also concerned about delayed access to new drugs.

In 1994, I responded to an article titled “Who needs faster approval times in Canada: the public or the industry?” with an analysis demonstrating Canadians needed earlier approval. The author’s assertion at that time was (and has continued to be) that few new drugs can be considered breakthroughs or truly innovative.

This view is based in part on the fact that, for the last 35 years, the Patented Medicine Prices Review Board, a little-known quasi-judicial tribunal, which regulates prices for patented medicines in Canada, has categorized few patented medicines as breakthroughs each year. This classification discounts factors important to patients including fewer doses per day, ease of taking the medicine and fewer side effects, as being a therapeutic advance. Enalapril, for example, was the second angiotensin-converting enzyme inhibitor, so was not considered to be a breakthrough, but it went on to be much more commonly used and accepted by patients and health-care providers than its predecessor.

The interaction around the article led me to evaluate the time required to review new drugs approved for marketing between 1992 and 1995 in Canada, the United States, Australia, the U.K and Sweden. The time required to review an application for regulatory approval is usually measured as the number of days or months between the date of submission of the application and the date of its approval.

Approval times in Canada were significantly longer between 1992 and 1995 than in the other countries, with a median approval time of 30 months compared with 20 months in Australia and the U.S, almost 18 months in the U.K. and only 12 months in Sweden. The maximum review times ranged from three years in Sweden to 14 years in Canada.

A further evaluation of the same countries covering the period 1996 to 1998 demonstrated that the gap between approval times in Canada and Australia had closed so that they were similar (median times in both countries were 17 months). However, approval times in Canada and Australia were significantly longer than in the U.S. and Sweden (both with a median time of approximately 12 months) and the U.K. with a median time of 10 months. With the exception of Sweden, where review times remained stable, those in the other four countries had decreased substantially, including maximum approval times though they remained extensive. Despite approval times in Canada being shortened due to the implementation of some of the recommendations from a review of the Canadian drug approval system published in 1992, the median approval time in Canada was still more than six months longer than Health Canada’s performance target at that time.

A third evaluation of the five countries covering the period 1999 to 2001 showed the same kind of result. Approval times were similar in Canada and Australia (median times of approximately 21 and 18 months, respectively) but significantly longer than in the U.S., the U.K. and Sweden (median times of approximately 17, 16 and 15 months, respectively). Again, maximum review times had generally decreased, but the Canadian maximum review time was over five years. Furthermore, there was a trend in the annual median approval time in Canada from 19 months in 1999 to 23 months in 2001.

More prolonged approval times in Canada would be of less concern if drugs with an important therapeutic potential were approved in a similar timeframe to those in other countries, even if reviews of other drugs take longer. However, this was not the case. Regardless of their potential impact on patient health, approval times in Canada were longer than in other countries.

Other analyses showed similar results. An annual series of reports from the Fraser Institute evaluating approval times of drugs approved in Canada, the U.S. and the European Union between 2001 and 2010 showed that, although review times in Canada were longer than in the U.S. and EU, they were closer than in previous years.

In 2018, I evaluated approval times of new drugs approved in Canada, the U.S. and the EU between 2002 and 2016. At this time, most drugs were approved through the centralized process of the European Medicines Agency for all EU countries including the U.K. and Sweden. The results demonstrated that, after much longer approval times in Canada between 2002 and 2005, median approval times of the three agencies over the following decade were quite similar at 10 to 12 months.

More recently, Fraser Institute authors evaluated new drugs approved in Canada, the U.S. and the EU between 2012/2013 and 2018/2019 and showed that the time taken to review and approve new drugs in Canada is consistent with that in the U.S. and EU.

In the next blog post, we’ll discuss reasons for lengthy review times and delays in approval in Canada.