Intellectual Property, Competition and Regulatory Aspects of Medicines: International Determinants and Public Policy

Intellectual property, competition and regulatory aspects of medicines: International determinants and public policy examines the most recent generation of international norms that impact on pharmaceutical products and the corresponding challenges they raise in terms of domestic implementation. The book’s fourteen chapters offer a comprehensive overview of the legal aspects of the pharmaceutical chain, which are key to the development of new drugs and access to medicines. All these questions have important economic, legal and ethical, underpinnings that are closely intertwined with intellectual property rights, competition law, consumer law and human rights.
The first part of the book focuses on regulatory aspects and examines the link between patent protection and pharmaceutical marketing authorisation, regulatory test data protection and the relevance of technical standards. The second part of the book addresses intellectual property law, and pays particular attention to issues such as the implementation of the Bolar exception, patentability criteria, enforcement issues, competition law and access to knowledge.
Against the background of growing global pharmaceutical harmonization, two-core threads are the main focus of attention in the book. First, the importance of developing national legal orders that enshrine a level of intellectual property protection that matches the social and economic needs. Second, the corresponding need for careful negotiation of new international commitments, appropriate domestic implementation and proper interpretation of international economic agreements that interrelate closely with competition and intellectual property law. It is from this double perspective that the various authors of this compilation provide a detailed analysis of key legal institutions, put forward several policy proposals, and identify a number of instances of potential litigation.
Intellectual property, competition and regulatory aspects of medicines: international determinants and public policy, is edited by Xavier Seuba (Senior Research Associate and Lecturer at Centre for International Intellectual Property Studies, University of Strasbourg, and Universitat Pompeu Fabra, Barcelona). The publication was presented recently, in Colombia, to a specialized audience of judicial authorities, public health officials and academics.
The authors (Mariano Genovesi, Aurelio López-Tarruella, Juan Camilo Pérez, Pedro Roffe, Xavier Seuba, Miguel Vidal-Quadras and David Vivas), drawing on their comparative and international experience, offer a practical piece of work that could provide guidance to legislators, public officials, legal practitioners and judicial authorities.
The electronic version of the book will be made available by ICTSD at the beginning of 2014.