Regulatory Anatomy

This article proposes the term ‘‘safety logics’’ to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of ‘‘safety’’ produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. Department of Public Health, University of Copenhagen, Copenhagen, Denmark Corresponding Author: Klaus Hoeyer, Centre for Medical Science and Technology Studies, Øster Farimagsgade 5, Building 10, Ground Floor, DK 1014 Copenhagen K, Denmark. Email: [email protected] Science, Technology, & Human Values 2015, Vol. 40(4) 516-538 a The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0162243915570947 sthv.sagepub.com