Access to prescription drugs in Canada is delayed by pharmaceutical company submissions to Health Canada rather than by the regulator taking a longer time to approve their applications, according to new research.

The submission of new drugs to Health Canada is substantially delayed compared with those to the US Food and Drug Administration (FDA) and in the European Union (EU), say the researchers, reporting their findings this week in the Canadian Medical Association Journal (CMAJ).

“New drugs reached the market much later in Canada than in the US and the EU because of long delays before their submission to Health Canada,” according to authors Ali Shajarizadeh and Aidan Hollis of the Department of Economics at the University of Calgary in Alberta.

“For drugs that were ultimately approved in Canada and in at least one of the other jurisdictions, the mean delay from first submission in either foreign jurisdiction to submission was 540 days,” they report.

Looking at the reasons for the timing of approval submissions, the authors conclude that these are mainly due to the capacity of pharmaceutical companies to navigate the regulatory process in less-profitable markets such as Canada; smaller firms may lack the resources and expertise, they say, and point out that larger drugmakers operating in Canada achieve much faster approval times. 

Another important factor is companies’ desire to obtain approval of first-in-class drugs with higher potential sales, they add.

“We found that corporate capacity and priority status of new drugs are important determinants of submission delays,” say the researchers, and they suggest that harmonisation of the regulatory processes of the US FDA and Health Canada would accelerate the approval process in Canada – although they acknowledge that the situation can vary for each drug.

- Last year, the Canadian free-market think tank The Fraser Institute reported that, if Canada had accepted EU and US approvals instead of duplicating their processes, Canadian patients could have gained access to 152 new drugs an average of 494 days earlier from 2005 to 2011/12.

The Institute also found that most of the delay resulted from drugmakers submitting their applications for approval significantly later in Canada than in the EU and US. It suggested that the reasons for this may include Canada’s relatively weaker intellectual property protections, small market size and drug pricing controls, plus the extra financial burden associated with additional regulatory hurdles.