The Power of Pills

Patricia Illingworth and Udo Schuklenk, Edited by Jillian Clare Cohen

Description

Why does one-third of the global population not have access to essential medicines? What drives new drug research priorities? How do we manage the ethical, legal and social challenges associated with improving drug access? Answering these questions and more, this book is one of the first comprehensive and critical guides to global pharmaceutical policy issues.



This multidisciplinary book covers core issues in clear, short chapters. It is a one-stop resource for students, policy makers and academics. Bringing together the insights of over thirty different specialists from around the world, this book discusses:



- current regulation of the industry

- ethical issues in developing and distributing drugs

- how it prices and markets drugs

- recommendations on how to improve pharmaceutical policy

- the importance of pharmaceuticals

- the structure of the pharmaceutical industry

- what drugs are needed on a world wide scale
Part 1: Pharmaceutical Industry, Profits and Obligations

1. The Pharmaceutical Industry and the Pursuit of Profits by Joel Lexchin

2. Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing Policies: ‘Setting Priorities: Pharmaceuticals as Private Organizations and the Duty to Make Money/Maximize Profits’ by Kristina M. Lybecker

3. The Pharmaceutical Industry and its Obligations in the Developing World by Ann Mills, Patricia Werhane, and Michael Gorman

4. Drug Companies as Organizational Hybrids by Warren Kaplan

5. Physicians and the Pharmaceutical Industry: A Symbiotic Relationship? by Ian E Marshall

6. Industry Perspectives on Equity, Access and Corporate Social Responsibility: A View from the Inside by Robert A Freeman

Part 2: Justice – Medicines as Global Public Goods

1. Pharmaceuticals, Public Health and the Law: A Public Health Perspective by W.E. Parmet

2. Access to Medications and Global Justice by David. Resnik

3. Pharmacogenetics and Global (In)Justice by Soren Holm

Part 3: The Social, Ethical and Political Challenge: Neglected Diseases

1. The Enduring Crisis in Neglected Diseases by Nathan Ford

2. Moving Beyond Charity for R&D for Neglected Diseases by J. Orbinski and B. Burciul

3. Neglected Disease Research: Health Needs and New Models for R&D by Aidan Hollis

4. Advance Purchase Commitments: Moral and Practical Problems by Donald W. Light

5. Harnessing the Power of Pharmaceutical Innovation by Thomas Pogge

Part 4: Patents and Access to Medicines

1. Patents, Profits, and the Price of Pills: Implications for Access and Availability by Michael J Selgelid and Eline M. Sepers

2. Fair Followers Expanding Access to Generic Pharmaceuticals for Low-Income Populations by Kevin Outterson

3. Abolishing the Product Patent: A Step Forward for Global Access to Drugs by Adam Mannan and Alan Story

4. Trading Health for Profit: Bilateral and Regional Free Trade Agreements Affecting Domestic Intellectual Property Rules on Pharmaceuticals by Lisa Forman

Part 5: Research Ethics å

1. Human Genomic Research Ethics: Changing the Rules by Steven H. Miles

2. Assumptions in the Standard of Care Debate by Florencia Luna

Part 6: Political Activism and Treatment Access

1. Medicines for All? Commitment and Compromise in the Fight for

Canada’s Law on Compulsory Licensing for Export by Richard Elliot

2. Placing Access to Essential Medicine on the Human Rights Agenda by Brook K. Baker

Part 7: National Responsibilities

1. Producing Affordable Medicines in South Africa by Joao L. Carapinha

2. National Responsibility in the Provision of Basic Medicine by Kinsley Wilson, Laura Esmail and Jillian Clare Cohen

3. Pharmaceutical Cost-Effectiveness Pricing: Developing and Protecting a Global Ideal Form by Thomas A. Faunce

Index

Sujets

• Droit et juridique
• Medical law
• Legislation
• Law

Informations

• Publié par: Pluto Press
• Date de parution: 20 octobre 2006
• Nombre de lectures: 0
• EAN13: 9781849642712
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

The Power of Pills

Social, Ethical and Legal Issues in Drug Development, Marketing, and Pricing

Edited by Jillian Clare Cohen, Patricia Illingworth, and Udo Schüklenk

P Pluto Press LONDON • ANN ARBOR, MI

First published 2006 by Pluto Press 345 Archway Road, London N6 5AA and 839 Greene Street, Ann Arbor, MI 48106

www.plutobooks.com

Copyright © Jillian Clare Cohen, Patricia Illingworth, and Udo Schklenk 2006

The right of the individual contributors to be identified as the author of this work has been asserted by them in accordance with the Copyright, Designs and Patents Act 1988.

British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library

hardback ISBN10 0 7453 2403 7 ISBN13 978 0 7453 2403 6 paperback ISBN10 0 7453 2402 9 ISBN13 978 0 7453 2402 9

Library of Congress Cataloging in Publication Data applied for

10

9

8

7

6

5

4

3

2

1

Designed and produced for Pluto Press by Chase Publishing Services Ltd, Fortescue, Sidmouth, EX10 9QG, England Typeset from disk by Stanford DTP Services, Northampton, England Printed and bound in India

Contents

List of abbreviations

Introduction

Part I: Pharmaceutical industry, profits and obligations  1. The pharmaceutical industry and the pursuit of profit  Joel Lexchin

 2. Social, ethical, and legal issues in drug development, marketing, and pricing policies: setting priorities: pharmaceuticals as private organizations and the duty to make money/maximize profits Kristina M. Lybecker

 3. The pharmaceutical industry and its obligations in the developing world  Ann Mills, Patricia Werhane, and Michael Gorman

 4. Drug companies as organizational hybrids  Warren Kaplan

 5. Physicians and the pharmaceutical industry: a symbiotic relationship?  Ian E. Marshall

 6. Industry perspectives on equity, access, and corporate social responsibility: a view from the inside  Robert A. Freeman

Part II: Justice – medicines as global public goods

 7. Pharmaceuticals, public health, and the law: a public health perspective  Wendy E. Parmet

 8. Access to medications and global justice  David B. Resnik

 9. Pharmacogenetics and global (in)justice  Søren Holm

ix

1

11

25

32

41

57

65

77

88

98

vi

Part III: The social, ethical, and political challenge: neglected diseases

10. The enduring crisis in neglected diseases  Nathan Ford

11. Moving beyond charity for R&D for neglected diseases  James Orbinski and Barry Burciul

12. Neglected disease research: health needs and new models for R&D  Aidan Hollis

13. Advanced purchase commitments: moral and practical problems  Donald W. Light

14. Harnessing the power of pharmaceutical innovation  Thomas Pogge

Part IV: Patents and access to medicines

15. Patents, profits, and the price of pills: implications for access and availability  Michael J. Selgelid and Eline M. Sepers

16. Fair followers: expanding access to generic pharmaceuticals for low and middleincome populations  Kevin Outterson

17. Abolishing the product patent: a step forward for global access to drugs  Adam Mannan and Alan Story

18. Trading health for profit: the impact of bilateral and regional free trade agreements on domestic intellectual property rules on pharmaceuticals  Lisa Forman

Part V: Research ethics

19. Human genomic research ethics: changing the rules  Steven H. Miles

20. Assumptions in the “standard of care” debate  Florencia Luna

Part VI: Political activism and treatment access 21. Medicines for all? Commitment and compromise in the fight for Canada’s Law on compulsory licensing for export  Richard Elliot

The power of pills

109

117

125

134

142

153

164

179

190

203

215

227

22. Placing access to essential medicines on the human rights agenda  Brook K. Baker

Part VII: National responsibilities

23. Producing affordable medicines in South Africa  Joo L. Carapinha

24. National responsibility in the provision of basic medicines  Kinsley Wilson, Laura Esmail, and Jillian Clare Cohen

25. Pharmaceutical costeffectiveness pricing: developing and protecting a global ideal form  Thomas A. Faunce

Notes on the contributors Index

239

251

260

272

283 289

Contents

vii

List of abbreviations

AARP ABC ACM ACP ADAA ADE AGAO AGDFAT AHRQ AMA AMC ANC ANDAs APC API ARC ART ARV AUSFTA AZT BC BCG BOP BUMED CAFTA CBD CBO CCIC CCOHTA CEDAC CEP CESCR CfA CGD CHAI

American Association of Retired Persons Abstinence, Be Faithful, Use Condoms Advanced Market Commitments American College of Physicians Anxiety Disorders Association of America Adverse Drug Event African Growth and Opportunity Act Australian Government Department for Foreign Affairs and Trade Agency for Healthcare Research and Quality American Medical Association Advanced Market Commitments African National Congress (South Africa) Abbreviated New Drug Applications Advanced Purchase Commitment Active Pharmaceutical Ingredients Australian Research Council Grant Antiretroviral Therapy Antiretroviral Australia–US Free Trade Agreement Azidothymidine (first retroviral approved for treatment of HIV) British Columbia Boston Consulting Group BuyOut Price Bureau of Medicine and Surgery Central American Free Trade Agreement Convention on Biological Diversity Congressional Budget Office Canadian Council for International Cooperation Canadian Coordinating Office for Health Technology Assessment Canadian Expert Drug Advisory Committee Clinical Evaluation Packages Committee on Economic, Social and Cultural Rights Commission for Africa Center for Global Development Clinton Foundation HIV/AIDS Initiative

List of abbreviations

ix

x

CH(A)LN CHR CIA CIGB

CIOMS CIPIH CIPR CLASS CMA COO COX2 CPA CPI CPIX CRBPC CSPL CSR DBSA ddI DEFEND DFAIT DFID DMD DMF DNA DNDI DNDWG DoC DoH DOTS DPCO DQT DRA DTC(A) DTI DUR EC ECDS ED EDL EFTA EMA

Canadian HIV/AIDS Legal Network Commission on Human Rights Central Intelligence Agency Centro de Ingeniería GenÉtica y Biotecnología (Cuba: Center for Genetic Engineering and Biotechnology) Council for International Organization of Medical Sciences Commission on Intellectual Property, Innovation and Public Health Commission on Intellectual Property Rights Celecoxib LongTerm Arthritis Safety Study Canadian Medical Association Chief Operating Officer Cyclooxygenase 2 Central Procurement Agency Consumer Price Index Consumer Price Index – excluding certain interest rates Canada’s ResearchBased Pharmaceutical Companies Committee on Standards in Public Life Corporate Social Responsibility Development Bank of South Africa didanosine Developing Economies’ Fund for Essential New Drugs Department of Foreign Affairs and International Trade Department for International Development Doha Ministerial Declaration Drug Master File Deoxyribonucleic Acid Drugs for Neglected Diseases Initiative Drugs for Neglected Diseases Working Group Department of Commerce Department of Health Directly Observed Treatment, Shortcourse Drug Price Control Authority (India) Drug Quality and Therapeutics Committee Drug Registration Authority Direct to Consumer (Advertising) Department of Trade and Industry Drug Utilization Review European Community Eastern Caribbean Drug Service Erectile Dysfunction Essential Drugs List European Free Trade Agreement European Medicines Agency

The power of pills

EU European Union FDA Food and Drug Administration FDCs FixedDoseCombination/Fixed Dose Combination Medicines FHC Female Health Company FMSAE French Ministries of Social Affairs and Economy FTA Free Trade Agreement FTAA Free Trade of the Americas Agreement G8 Group of Eight: Canada, France, Germany, Italy, Japan, UK, USA, Russian Federation GATB Global Alliance for TB Drug Development GB Great Britain GDF Global TB Drug Facility GDP Gross Domestic Product GFATM Global Fund to Fight HIV, TB, and Malaria GFHR Global Forum for Health Research GMP Good Manufacturing Practices GRRF Genetic Recognition Resources Fund GTAG Global Treatment Access Group (Canada) HALE Healthy Life Expectancy (WHO) HDI Human Development Index Health GAP Health Global Access Project HIV Human Immunodeficiency Virus HoC House of Commons HSPH Harvard School of Public Health HUGO Human Genome Organization IAVI International Aids Vaccine Initiative ICC International Criminal Court ICESCR International Covenant on Economic, Social & Cultural Rights ICTSD International Center for Trade and Sustainable Development IFPMA International Federation of Pharmaceutical Manufacturers Associations IFRC&RCS International Federation of Red Cross and Red Crescent Societies IHR Institutes of Health Research ILO International Labour Organization IMS IMS Health, Inc. IoM Institute of Medicine IOWH Institute for OneWorld Health IP Intellectual Property IPR Intellectual Property Rights IRB Institutional Review Board IRC International Red Cross JAMA Journal of the American Medical Association LDC Least Developed Country LDL Lowdensitylipoprotein

List of abbreviations

xi

xii

LP MCP MCSRTA MDG MDR MINEFI MLJ MMAS MMV MoH MoI MPDIMA MRDT MSA MSF MSH NBAC NCB NCE NDA NDP NGO NHS NIC NICE NIEHS NIH NIHCM NME NPV NRTI NSAID NTE NVNB OCGPDT OECD OIG OPV OTA PBAC PBPA PBS PEC

Liberal Party (of Canada) Marginal Cost of Production Mubarak City for Scientific Research and Technology Applications Millennium Development Goals MultiDrug Resistant Ministry of Economy, Finance and Industry Ministry of Law and Justice Massachusetts Male Aging Study Medicines for Malaria Venture Minister/Ministry of Health Ministry of the Interior Medicare Prescription Drug Improvement and Modernization Act Medical Research and Development Treaty Ministry of Social Affairs MÉdecins Sans FrontiÈres Management Sciences for Health National Bioethics Advisory Commission Nuffield Council on Bioethics New Chemical Entity New Drug Application National Drug Policy Non Governmental Organization National Health Service National Intelligence Council National Institute of Clinical Excellence National Institute of Environmental Health Sciences (NIH, DHHS) National Institutes of Health National Institute for Health Care Management New Molecular Entity Net Present Value Nucleoside Reverse Transcriptase Inhibitor NonStereoidal AntiInflammatory Drug National Trade Estimate NonViolation Nullification of Benefits Office of the Controller General of Patents, Designs and Trademarks Organization for Economic Cooperation and Development Office of Inspector General (Department of Health & Human Services) Oral Polio Vaccine Office of Technology Assessment Pharmaceutical Benefits Advisory Committee Pharmaceutical Benefits Pricing Authority Pharmaceutical Benefits Scheme President of the European Commission

The power of pills

PEDFAR President’s Emergency Plan for AIDS Relief PhRMA Pharmaceutical Research and Manufacturers of America PMPRB Patented Medicines Prices Review Board PNGIMR Papua New Guinea Institute of Medical Research PoC Parliament of Canada PPH Primary Pulmonary Hypertension PPP Public–Private Partnership PPRS Pharmaceutical Price Regulation Scheme QALYs Quality Adjusted Life Years RCT Research on Clinical Trials R&D Research and Development RDS Respiratory Distress Syndrome RTAM Round Table on Access to Medicines Rx&D Canada’s ResearchBased Pharmaceutical Companies Association SA South Africa SACU Southern African Customs Union SARS/SRS Severe Acute Respiratory Syndrome SC Supreme Court SCRP (KFPE) Swiss Commission of Research Partnership with Developing Countries (Kommission des CASS fr Forschungspartnerschaften mit Entwicklungsländern) SSRI Selective Serotonin Reuptake Inhibitor TAC Treatment Action Campaign (South Africa) TAC/ALP Treatment Action Campaign and the AIDS Law Project TAM Treatment Access Movement (PanAfrican) TB Tuberculosis TDR The Special Program for Research and Training in Tropical Diseases TGA Therapeutic Goods Administration TRIPS TradeRelated Aspects of Intellectual Property Rights UDHR Universal Declaration of Human Rights UKP United Kingdom Parliament UNAID The Joint United Nations Program on HIV/AIDS UNCESCR United Nations Committee on Economic, Social and Cultural Rights UNCHR United Nations Commission on Human Rights UNCTAD United Nations Commission for Trade and Development UNDP United Nations Development Program UNESCO United Nations Education, Scientific and Cultural Organization UNICEF United Nations International Children’s Emergency Fund UNIDO United Nations Industrial Development Organization UNIFEM United Nations Development Fund for Women UNRISD United Nations Research Institute for Social Development USAID United States Agency for International Development USC United States Congress

List of abbreviations

xiii