A national drug agency

Like the editors of CMAJ,1 we strongly support the Romanow Commission's recommendation for a national drug agency.2 Our recent study3 showed that the current system of listing drugs for reimbursement on the basis of estimates of how well they will work in routine medical practice is seriously flawed. We found considerable differences between provinces in their drug review processes. Furthermore, reviewers were making decisions (to list or not list new drugs in their formularies) without having the information they considered “necessary” for such decisions. Probably in direct relation to these 2 factors, we identified wide differences between provinces regarding drug acceptances and refusals. We also found that not all provinces have the resources to do adequate evaluations of new drugs.

There is a need to replace the present flawed system with a national drug agency that would evaluate premarketing data and, eventually, postmarketing use of new drugs, according to scientifically appropriate methods and documented policies and procedures.3

With the agreement of federal and provincial ministers of health, the Canadian Coordinating Office on Health Technology Assessment is setting up a Common Drug Review initiative4 to carry out such evaluations of new drugs. But is this the best choice for developing and overseeing this extremely important function? The placement and oversight of a national drug agency needs to be debated now.

We believe that a national drug agency must be publicly responsible, free-standing, credible and capable of attracting an expert leader in this highly specialized assessment field.

Roy West Professor Memorial University of Newfoundland St. John's, Nfld. E. Keith Borden Pharmacoepidemiology Consultant Toronto, Ont. Jean-Paul Collet Associate Professor McGill University Montréal, Que. Nigel S.B. Rawson Senior Researcher Center for Health Care Policy and Evaluation Minneapolis, Minn. Robert S. Tonks Professor Dalhousie University Halifax, NS