Canadian Firms Unite Over Drug Approvals

In Canada, a coalition of five organizations representing the drug industry, including the Pharmaceutical Manufacturers Association of Canada and the Canadian Drug manufacturers Association, has called for a separate government agency to be set up for the licensing of new drugs, along the lines of the UK's Medicines Control Agency, as a way of speeding up the drug approval system.

This work is now done by the Department of Health drugs directorate, which the coalition says takes almost three years on average to approve a new branded drug and up to four years for a generic. This is twice as long as countries with separate approval agencies, and six government reports in the last 10 years have noted the slowness and inefficiency of the system. "As a result, Canadian patients experience delays in receiving access to important therapies" and R&D is inhibited, claims the coalition, which is also offering to pay user fees for such a new agency.

Dann Michols, executive director of the drugs directorate, replied that while the coalition plan was not being ruled out, it had not yet been made clearly evident that it would offer "such tremendous advantages that we can't afford to be without it." While there had been delays, a two-year improvement plan launched in mid-1993 had made significant progress in streamlining and the elimination of backlogs, he said. The coalition's estimates of approval delays were based on outdated figures, Mr Michols added, and blamed much of the delays on companies themselves, which he said had submitted applications for approval which were incomplete, or not particularly well researched.