Denaturalizing transparency in drug regulation
Health Law and Policy, pharmaceutical drug regulation, transparency
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function – namely, of enabling standard setting through a more participatory, public model of drug regulation. I turn to the history of Canadian drug regulation to demonstrate that such an alternative conception of transparency – transparency qua standard construction – is in fact possible. I document the regulator’s extensive use of publicity practices to develop standards for assessing drug adulteration through the early years of Canadian drug regulation, from 1887 to 1920 when hundreds of analytical bulletins were publicly disseminated. I also show how, from the 1920s onwards, this participatory, public transparency transmogrified into a form of closed, insider transparency as the regulator constituted a collaborative relationship with industry. Given this shift, I suggest that an alternative conception of transparency is not only possible but also increasingly needed, and then begin to sketch how tying transparency to a revitalized concept of fraud in drug research and development might activate that participatory, public regulatory work.
Matthew Herder, “Denaturalizing transparency in drug regulation” 8:2 (2015) MJLH 57-144.