Regulation of the Pharmaceutical Industry

“John Abraham’s unique collection brings together the work of social scientists, ethicists, lawyers, and policy analysts on regulation, ethics, and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe and developing countries are discussed, including case studies of Norplant, interferon, and anti-fertility vaccines. The contributors analyse several key dimensions of the debate: national political culture; the Europeanization of regulatory decision-making; the globalization of scientific standard-setting and intellectual property rights in drug development; the impact of industrial innovation strategies on regulatory practices; secrecy and public accountability of regulatory agencies; the regulatory influence of users on medical technology; the ethics of drug development and research; and the oligopolization of the industry. This book will be of great interest to all those concerned about how pharmaceuticals and medical technologies should be developed and controlled.”

“This book provides useful new insights into regulation and the development of pharmaceuticals.”