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38 Am. J.L. & Med. 63 (2012)
Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency

handle is hein.journals/amlmed38 and id is 63 raw text is: American Journal of Larv & Medicine, 38 (2012): 63-112 © 2012 American Society of Law, Medicine & Ethics Boston University School of Law Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency Trudo Lemmenst & Candice Telfertt CONTENTS I. INTRODUCTION .................................................................................... 65 II. CLINICAL TRIALS REGISTRATION AND RESULTS REPORTING IN C ONTEXT ....................................................................................... 67 A . Early H istory ............................................................................. 67 B. International Developm ents ....................................................... 69 C. National Implementation ............................................................ 71 D . Rem aining Challenges ................................................................ 72 1. Enforcement and Implementation ......................................... 72 2. Scope of Trial Registration Requirements and Inclusion of Results Reporting ............................................................ 74 3. H alting of Progress? ............................................................ 75 Dr. William M. Scholl Chair in Health Law and Policy, Faculty of Law, University of Toronto. t Counsel, Ministry of the Attorney General of Ontario. The authors thank the organizers and participants of the Conference on Globalization of Medicine: Legal and Ethical Challenges, May 20-21, 2011, at Harvard University's Petrie-Flom Center and of the Central European University's Conference An Enforceable Right to Health in Budapest, June 10-11, 2011, for useful feedback. Special thanks are owed to Kevin Outterson and Saad Abughanm for their insightful comments. The authors are particularly grateful to the latter for further discussions on TRIPS and data secrecy and for providing additional references. We also benefited from comments from an anonymous peer reviewer. Trudo Lemmens developed the concept of this Article and wrote a first draft of Parts I to VI. Candice Telfer wrote a first draft of most of Parts VI.A to VI.C. Both authors further edited this Article. This Article builds on research for a project under supervision of Trudo Lemmens and Sarah Perkins, former director of the International Human Rights Clinic at the Faculty of Law of the University of Toronto. The authors are grateful to Sarah Perkins, and to other students in the program, particularly Hilary Keenan, for research and for drafting a report on TRIPS+ agreements and access to clinical trials data. Special thanks further to colleagues on the Pan American Advisory Committee on Health Research, particularly Luis Gabriel Cuervo, Ludovic Reveiz, and John Lavis; and to Karmela Krle~a-Jeri6 for discussions in the context of related policy work and publications. Finally, Shannon Gibson and Alvin Wong provided excellent help with the references. Research for this Article was supported by a Social Sciences and Humanities Research Council grant on Promoting the Integrity of Biomedical Research: The Janus Face of Regulation and by a grant from Genome Canada. The views expressed in this are those of the authors and do not necessarily represent the views of any of the institutions mentioned in this acknowledgment.

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