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The Ethical, Legal and Social Implications of Pharmacogenomics in Developing Countries

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The Ethical, Legal and Social Implications of Pharmacogenomics in Developing Countries The Ethical, Legal and Social Implications of Pharmacogenomics in Developing Countries Report of an International Group of Experts Human Genetics Chronic Diseases and Health Promotion WHO Library CataloguinginPublication Data The ethical, legal and social implications of pharmacogenomics in developing countries : report of an international group of experts. "Preparation of this report was undertaken by Human Genetics, headed by Victor Boulyjenkov. Cathy Schapper (Monash University) had principal responsibility for researching, writing and editing the report ..."Acknowledgements. 1.Pharmacogenetics ethics. 2.Pharmacogenetics legislation. 3.Ethics, Pharmacy. 4.Patient rights. 5.Socioeconomic factors. 6.Legislation, Drug. 7.Developing countries. I.Boulyjenkov, Victor. II.Schapper, Cathy. III.World Health Organization. ISBN 978 92 4 159546 9 (NLM classification: QV 38) © World Health Organization 2007 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization. Cover by D. Meissner WHO/GRA Printed by the WHO Document Production Services, Geneva, Switzerland ELSI of Pharmacogenomics in Developing Countries Contents ACKNOWLEDGEMENTS 1 1. INTRODUCTION 2 2. SCIENTIFIC BACKGROUND 3 2.1. BACKGROUND 3 2.2. CHARACTERIZING HUMAN GENOMIC VARIATION 5 2.3. DRUG METABOLIZING PHENOTYPES AND CLINICAL APPLICATIONS OF PHARMACOGENOMICS 6 2.4. CLINICAL TRIALS 7 2.5. RELEVANCE OF PHARMACOGENOMICS TO DEVELOPING COUNTRIES 8 2.6. "E THNICITY " IN PHARMACOGENOMIC RESEARCH 11 2.7. BARRIERS TO IMPLEMENTATION OF PHARMACOGENOMICS IN DEVELOPING COUNTRIES 12 2.8. CONCLUSION 13 3. ETHICAL ISSUES OF PHARMACOGENOMICS 14 3.1. ETHICAL PRINCIPLES 14 3.2. ETHICAL ISSUES IN PHARMACOGENOMICS 14 3.2.1. FAIR TREATMENT OF HUMAN BEINGS - JUSTICE 14 3.2.2. RESPECT FOR PERSONS -AUTONOMY 16 3.2.3. DOING GOOD AND PREVENTING HARM - BENEFICENCE AND NON -MALEFICENCE 17 3.3. ETHICAL ISSUES IN PHARMACOGENOMIC RESEARCH AND IMPLEMENTATION 18 3.3.1. PHARMACOGENOMIC RESEARCH - CONSENT 18 3.3.2. HANDLING OF GENETIC INFORMATION 22 3.3.3. FURTHER USE AND STORAGE OF GENETIC INFORMATION 25 3.3.5. CLINICAL ISSUES 25 3.3.6. CONCLUSION 27 3.4. IMPLEMENTATION OF PHARMACOGENOMICS : BENEFIT -SHARING , DRUG RESUSCITATION , TECHNOLOGY TRANSFER AND CAPACITY BUILDING 28 3.4.1. BENEFIT SHARING 28 3.4.2. DRUG RESUSCITATION AND PHARMACOGENOMICS 30 3.4.3. TECHNOLOGY TRANSFER AND CAPACITY BUILDING 32 3.4.4 CONCLUSIONS 34 4. LEGAL AND SOCIAL ISSUES OF PHARMACOGENOMICS 36 4.1. PATENTS AND PHARMACOGENOMICS 36 4.1.1. WHAT COULD BE PATENTED IN PHARMACOGENOMICS? 36 4.1.2. PATENTS , RESEARCH AND DEVELOPMENT 36 4.1.3. PATENTS , DELIVERY AND ACCESS 37 4.2. LIABILITY AND PHARMACOGENOMICS 38 4.2.1. LIABILITY AND PHARMACOGENOMIC PRODUCERS 39 4.2.2. DEVELOPING COUNTRIES AND LIABILITY 41 4.3 TREATING PHYSICIAN 41 4.3.1. PHARMACIST 42 4.3.2. CONCLUSIONS 41 iii ELSI of Pharmacogenomics in Developing Countries 4.4 INEQUALITY AND AVAILABILITY - SOCIO -ECONOMIC FACTORS AND PHARMACOGENOMICS 43 4.4.1. FINANCIAL LIMITATIONS AND PHARMACOGENOMICS 43 4.4.2. FINANCIAL BARRIERS TO IMPLEMENTATION 44 4.4.3. PROFIT MOTIVES AND PHARMACOGENOMICS 45 4.4.4. ORPHAN DISEASES 46 4.5. STRATIFICATION , STIGMATIZATION AND DISCRIMINATION 46 4.5.1. ETHNICITY 47 4.5.2. CONCLUSIONS 50 4.6. EDUCATION 50 4.6.1. EDUCATION FOR HEALTH CARE INFRASTRUCTURE 50 4.6.2. PHARMACOGENOMIC EDUCATION OF HEALTH CARE PROFESSIONALS IN DEVELOPING COUNTRIES 51 4.6.3. PUBLIC ENGAGEMENT AND EDUCATION 52 4.6.4. CONCLUSIONS 53 5. CONCLUSIONS 54 6. GLOSSARY 55 7. REFERENCES 56 iv ELSI of Pharmacogenomics in Developing Countries Acknowledgements WHO’s Human Genetics initiated a series of ELSI reports covering different aspects of genetic services and technologies. The first report Genetics, genomics and the patenting of DNA: review of potential implications for health in developing countries was published in 2005. The second report Medical genetic services in developing countries: the Ethical, Social and Legal Implications of genetic testing and screening was also published in 2006. This report is the third in the series. The Human Genetics would like to thank the Monash University (Australia), for its support for this and other ethics-related initiatives of the programme. Preparation of this report was undertaken by Human Genetics, headed by Victor Boulyjenkov. Cathy Schapper (Monash University) had principal responsibility for researching, writing and editing the report, assisted by Adam Henschke (Monash University). This report benefited from the input of numerous individuals. A range of international experts contributed significantly to different sections of the report. We are particularly grateful to Abdallah Daar, Anna Dabu and Beatrice Seguin from the Program on Genomics and Global Health, University of Toronto Joint Centre for Bioethics, for preparing the technical section of the report. We would also like to extend our special thanks to the expert review panel who undertook two rounds of review of the report Expert Review Panel 1. Dr Shaikha Al-Arrayed (Salmaniya Medical Complex, Kingdom of Bahrain) 2. Dr Nikola Biller-Andorno (Universitaet Zurich, Switzerland) 3. Dr Ruth Chadwick (Cardiff University, Wales) 4. Dr Nadine Cohen (J&J Pharmaceuticals, United States of America) 5. Dr Abdallah Daar (University of Toronto Joint Centre for Bioethics, Canada) 6. Dr Bartha Maria Knoppers (Université de Montréal, Canada) 7. Dr Darryl Macer (UNESCO Bangkok, Thailand) 8. Dr Peter Ndumbe (University of Yaounde 1, Cameroon) 9. Dr G. Padmanaban (Indian Institute of Science, India) 10. Dr Vicharn Panich (Thailand Research Fund, Thailand) 11. Dr Victor Penchaszadeh (Columbia University, United States of America) 12. Dr Raj Ramesar (University of Cape Town, South Africa) 13. Dr Godfrey Tangwa (University of Yaounde 1, Cameroon) 14. Dr Ishwar Verma (Sir Ganga Ram Hospital, India) 15. Dr Wanchai Wanachiwanawin (Mahidol University, Thailand) 16. Dr Huanming Yang (Beijing Genomics Institute, People's Republic of China) 1 ELSI of Pharmacogenomics in Developing Countries 1. Introduction The completion of the Human Genome Project in 2003 (1) together with developments in information technology opened up new areas of research in human genetics and genomics. While it is important to implement and maintain the conventional medical and health practices that are crucial to improving and sustaining health (2), applications of new genomic knowledge may also offer health benefits and alleviate the burden of disease around the world. One area in which this new knowledge of the human genome has great potential is in the field of pharmacogenomics, which involves "the use of genomic technologies in assessing differential response to pharmaceuticals."(3) Pharmacogenomics may offer considerable advantages in the development and prescription of drugs to effectively treat disease, and may also prevent the prescribing of drugs that will have little or no clinical effect or produce adverse reactions in certain people. It has been estimated that in the United States alone, adverse drug reactions (ADRs) may cause over 100,000 deaths a year (4). Pharmacogenomics may therefore enable safer and more cost- effective use of pharmaceuticals. Pharmacogenomic information may also contribute to the more effective diagnosis of a variety of genetic conditions. Thus pharmacogenomics may provide new diagnostic and treatment information that, if handled effectively, could be a useful tool within an integrated health care system. The World Health Organization’s (WHO) report on Genomics and World Health , released in 2002, considered the development of genetics and genomics and the implications it might have for world health. In that report, the Advisory Committee on Health Research recognized that a number of ethical, legal and social implications
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