Rethinking regulation: international harmonisation and local realities

Abstract

The STEPS Rethinking Regulation project is examining the harmonising regulation of two widely available technologies - transgenic cotton seeds and antibiotics - in China and Argentina. We wish to explore how their regulation - in terms of property/access and quality/risk – overlaps, compares and contrasts with the way poorer users experience these properties. What issues, for example, are being raised through the actual use of these artefacts, and that the regulatory view does not reach? Where regulatory reach is absent, what strategies do the users themselves deploy in order to assure themselves of technological benefits and guard against risks? As the initial step in this project, this working paper provides an overview of the project’s objectives and a discussion of two relevant bodies of literature. The first of these concerns the regulation of pharmaceutical drugs and transgenic seeds in a globalising context, and the second concerns the informal reality of drug and seed use in developing country settings. We are interested in the what is known about how international regulatory harmonisation processes influence the development of national regulations, and the ways in which actual patterns of technology use amongst poorer communities have been documented, and in particular how they might differ from the assumptions and expectations of policymakers, regulators and other actors about appropriate technological practices.