Regulatory Anatomy: How ‘‘Safety Logics’’ Structure European Transplant Medicine

TY - JOUR

T1 - Regulatory Anatomy

T2 - How ‘‘Safety Logics’’ Structure European Transplant Medicine

AU - Hoeyer, Klaus

PY - 2015/7/12

Y1 - 2015/7/12

N2 - 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.

AB - 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.

U2 - 10.1177/0162243915570947

DO - 10.1177/0162243915570947

M3 - Journal article

C2 - 26139952

SN - 0162-2439

VL - 40

SP - 516

EP - 538

JO - Science, Technology & Human Values

JF - Science, Technology & Human Values

IS - 4

ER -