A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry Daniel J
Total Page:16
File Type:pdf, Size:1020Kb
Duquesne University Duquesne Scholarship Collection Electronic Theses and Dissertations Fall 1-1-2017 A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry Daniel J. Hurst Duquesne University Follow this and additional works at: https://dsc.duq.edu/etd Part of the Bioethics and Medical Ethics Commons Recommended Citation Hurst, D. J. (2017). A Bioethics Tool for the Implementation of Global Principles by the Pharmaceutical Industry (Doctoral dissertation, Duquesne University). Retrieved from https://dsc.duq.edu/etd/193 This One-year Embargo is brought to you for free and open access by Duquesne Scholarship Collection. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of Duquesne Scholarship Collection. For more information, please contact [email protected]. A BIOETHICS TOOL FOR THE IMPLEMENTATION OF GLOBAL PRINCIPLES BY THE PHARMACEUTICAL INDUSTRY A Dissertation Submitted to the McAnulty College and Graduate School of Liberal Arts Duquesne University In partial fulfillment of the requirements for the degree of Doctor of Philosophy By Daniel J. Hurst, ThM, MDiv December 2017 Copyright by Daniel J. Hurst 2017 A BIOETHICS TOOL FOR THE IMPLEMENTATION OF GLOBAL PRINCIPLES BY THE PHARMACEUTICAL INDUSTRY By Daniel J. Hurst Approved August 31, 2017 ________________________________ ________________________________ Henk ten Have, MD, PhD Gerard Magill, PhD Director, Center for Healthcare Ethics The Vernon F. Gallagher Chair Professor of Healthcare Ethics Professor of Healthcare Ethics (Committee Chair) (Committee Member) ________________________________ ________________________________ Joris Gielen, PhD Henk ten Have, MD, PhD Assistant Professor of Healthcare Ethics Assistant Professor of History (Committee Member) Director, Center for Healthcare Ethics Professor of Healthcare Ethics ________________________________ James Swindal, PhD Dean, McAnulty College and Graduate School of Liberal Arts iii ABSTRACT A BIOETHICS TOOL FOR THE IMPLEMENTATION OF GLOBAL PRINCIPLES BY THE PHARMACEUTICAL INDUSTRY By Daniel J. Hurst December 2017 Dissertation supervised by Henk ten Have, MD, PhD Due to scandals of scientific misconduct, a climate of mistrust of science exists amongst the general public. This becomes of concern when we acknowledge that it is difficult for science and technology to flourish without broad societal trust. The pharmaceutical industry has often felt the brunt of such mistrust and has suffered many reputational setbacks over the past several years. Such reputational decline has a strong moral dimension, as it stems from issues such as the questionable conduct of clinical trials, pricing schemas, and access to medicines for low- or middle-income countries. The end product of such issues is the public not viewing pharmaceutical and biotechnology companies favorably. Since pharmaceutical and biotechnology companies are intrinsically tied to health and human flourishing, an ethical framework to aid in resolving both the ethical issues facing the industry and the resulting iv reputation it yields on both the industry as a whole and individual companies, could certainly be valuable. The central supposition of this dissertation is that additional work needs to be done in the area of pharmaceutical ethics and corporate social responsibility. Currently, no specifically global bioethics tool exists to implement ethics principles into the business practices of pharmaceutical and biotechnology companies, which constitutes a glaring gap in the implementation of ethics principles. This dissertation thus aims to do the following: (i) clarify the ethical grounding of pharmaceutical corporate social responsibility, and (ii) develop a global bioethics tool that can be utilized by the pharmaceutical industry as a manner to aid in implementing global ethics principles. The global bioethics tool seeks to implement a global ethical framework on the basis of performance indicators and best practices, with a long-term goal of helping society regain its trust in the pharmaceutical industry. While there are numerous bioethical guidelines available, it is argued that the UNESCO Universal Declaration on Bioethics and Human Rights, as a global ethics document with the backing of the global community, can be utilized to create such a tool by which to measure the ethical practices of pharmaceutical and biotechnology companies. v DEDICATION To my bride, Rachel. Your constant love, encouragement, and selflessness knows no bounds. And our son, Justus. May you exemplify your name. vi ACKNOWLEDGEMENT I would like to begin by thanking my dissertation director, Dr. Henk ten Have. You have believed in this project, and me, since its inception. You provided me with opportunities and insights that I will remember for a lifetime. Thank you for your mentorship, and in many ways, friendship. Your love of global bioethics is now deeply shared by me. Because of you, my thinking has been shaped in ways that I can only begin to understand. Dr. Lise Holst, you tried to get the global bioethics tool off the ground. We share the vision of what pharmaceutical bioethics and corporate social responsibility could be, and I hope one day that will be realized. Thank you for giving this project a fighting chance. Thanks also to Dr. Joris Gielen and Dr. Gerard Magill. Dr. Gielen, you provided me with numerous opportunities during the two years I worked for you that I would never have had otherwise. My qualitative research interests were spurred because of you. Rachel and I talk often and fondly about our trip to Leuven. Thank you for letting us be part of it. Dr. Magill, you challenged me to think deeply and provocatively. You always showed great interest in my work. Thank you for your guidance. To Glory, you constantly pour yourself out for the sake of the Center and its students. Countless times I came to you for answers, and you were always there. You celebrated with Rachel and I in the good times, and cried with us in the tough. Your friendship has been cherished. Mom and Dad, thank you for always supporting me to follow my interests, my academic pursuits, and instilling in me many of the values this work hopes to express. You have supported Rachel and I in countless ways along this journey. And finally, words fail to express the gratitude I have for my beautiful bride, Rachel. Your encouragement throughout this degree has sustained me. You have unconditionally stood by me and allowed me to chase my dreams. Being your husband is the joy of a lifetime. It is not hyperbole to say that this work would scarcely have been possible without the above people, as well as numerous others I have failed to mention. These words offer only a glimpse of your role. My sentiments echo those of Sebastian towards his friend Antonio in Shakespeare’s Twelfth Night, which I first read in an undergraduate course nearly a decade ago: I can no other answer make but thanks, And thanks; and ever thanks. (Act III, Scene 3) Soli Deo Gloria vii TABLE OF CONTENTS Page Abstract .......................................................................................................................................... iv Dedication ...................................................................................................................................... vi Acknowledgement ........................................................................................................................ vii Chapter 1: Introduction ....................................................................................................................1 Chapter 2: Global Bioethics and Human Rights ............................................................................34 2.1: Global Bioethics .........................................................................................................34 2.2: Human Rights .............................................................................................................53 2.3: Symbiotic Relationship ...............................................................................................67 Chapter 3: Corporate Social Responsibility and the Pharmaceutical and Biotechnology Industry ...........................................................................................................87 3.1: Social Responsibility in Global Health and Bioethics ................................................87 3.2: CSR and the Pharmaceutical and Biotechnology Industry ......................................100 Chapter 4: Analysis of Current Bioethics Guidelines ..................................................................140 4.1: Ethics Guidelines: 1947—Present ............................................................................140 4.2: UNESCO Universal Declaration on Bioethics and Human Rights ..........................160 4.3: Bioethics Governance and the Differing Models of Accreditation, Certification, and Rating ...............................................................................................................................169 Chapter 5: Global Bioethics Tool: Methodology and the Development of Indicators ................193 5.1: Rationale, Methodology, and Benchmarking ...........................................................194 5.2: Development of Indicators ........................................................................................211 Chapter 6: Global Bioethics Tool: Application ...........................................................................250