Trading risks for markets: the international harmonisation of pharmaceuticals regulation

Drawing on interviews and documentary research, this paper explores the nature of international harmonisation of pharmaceutical regulation. The relationships between international harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial interests. This is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.