SHWREM001 Cape of University

CONCEPTUALISING THE RIGHT TO ENJOY BENEFITS OF SCIENTIFIC PROGRESS AND EXPLORING ITS POTENTIAL TO ENHANCE ACCESS TO EFFECTIVE DIAGNOSIS AND TREATMENT OF DRUG-RESISTANT TUBERCULOSIS IN SOUTH AFRICA.

University of Cape Town

Remmy Malama Shawa SHWREM001

Submitted to the University of Cape Town in fulfilment of the requirements for the degree of

DOCTOR OF PHILOSOPHY School of Public Health and Family Medicine

Faculty of Health Sciences UNIVERSITY OF CAPE TOWN

Date of Submission: Supervisors:

24 January 2020

Professor Leslie London, School of Public Health and Family Medicine, University of Cape Town

Professor Fons Coomans, Faculty of Law, Maastricht University

Associate Professor Helen Cox, Department of Pathology and Institute of Infectious Disease and Molecular Medicine, University of Cape Town

University of Cape Town

The copyright of this thesis vests in the author. No quotation from it or information derived from it is to be published without full acknowledgement of the source. The thesis is to be used for private study or noncommercial research purposes only.

Published by the University of Cape Town (UCT) in terms of the non-exclusive license granted to UCT by the author.

Declaration

I, Remmy Malama Shawa, hereby declare that the work on which this thesis is based is my original work (except where acknowledgements indicate otherwise) and that neither the whole work nor any part of it has been, is being, or is to be submitted for another degree in this or any other university. I empower the University of Cape Town to reproduce for the purpose of research either the whole or any portion of the contents in any manner whatsoever.

Signed:

24 January 2020

Acknowledgements

My deep gratitude first goes to my doctoral supervisors; Professors, Leslie London, Fons Coomans and Helen Cox. I was lucky not to have any `supervisor drama' for the very fact that they seemed to enjoy working together. If at all they fought, I indeed was not privy to that. Secondly, it is only fitting that I thank those who often reply to my WhatsApp statuses... (one must reply to a status, it is rude not to). These friends also have the wisdom not to ask me the touchy question of "when are you finishing your PhD?" Dr Bongiwe Ndebele-Kissi, Ms Chanda MutaleMasengu, Ms Charity Mumba, Dr Choolwe Muzyamba, Dr Dylan Barth, Ms Itumeleng Komanyane, Mr Joshua Kabwe, Mr Kabenuka Munthali, Mr Kakoma Mutenda, Mr Lemani Masengu, Dr Lumbwe Chola, Mr Nkandu Chikonde, Mr Robert Kasenene, Mr Samuel Kwesi Kissi, and Mr Sydney Tete Hushie, I am grateful to them for their encouragement. I also would like to acknowledge the experts in the fields of drug research, TB and human rights that I spoke to, for their valuable insights into this study. I was particularly moved by the spirit of one medical doctor I spoke to, who was diagnosed with MDR-TB in the line of duty, beat the disease and continued to serve her community. Above ground, I am indebted to my family. I acknowledge the inspiration I draw from our two children, Remika-Ela and Lupiya. I also appreciate the support of my parents and elders, my dad Mr Mathias Shawa, and my super moms Ms Joyce Lupiya-Shawa, Ms Agness Kaputo, and Ms Dorothy Sikazwe, and my four amazing young sisters Tina, Adonai, Theresa and Ngoza. And finally, I acknowledge my dear wife Dr Kabaso Kabwe-Shawa, firstly, congratulations on her recent PhD, and many thanks to her for being a supportive wife. Dr. Bae believes in my dreams no matter how far-fetched they are; like the time I told her I will own an international commercial airport.

N.B: To be honest and transparent, I owe much of this PhD to some very strong African coffees, particularly from Ethiopia, Tanzania, Uganda, Kenya, and Malawi.

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Contents

Declaration .......................................................................................................................................................................... ii Acknowledgements ............................................................................................................................................................ iii Contents .............................................................................................................................................................................. iv List of figures.................................................................................................................................................................... viii List of tables ..................................................................................................................................................................... viii Acronyms............................................................................................................................................................................ ix Definitions of key terms...................................................................................................................................................... x Abstract ............................................................................................................................................................................... 1 CHAPTER ONE: GENERAL INTRODUCTION .......................................................................................................... 1 1. 1 Background to the Right to Enjoy Benefits of Scientific Progress (REBSP).............................................................. 1 1. 2 The right to health ....................................................................................................................................................... 2 1. 3 REBSP and the right to health..................................................................................................................................... 4 1. 4 Basic facts about Tuberculosis .................................................................................................................................... 6 1. 5 Drug-resistant Tuberculosis as a neglected disease..................................................................................................... 6 1. 6 Statement of the problem .......................................................................................................................................... 10 1. 7 Overview of the thesis............................................................................................................................................... 10 1. 8 Outline of the thesis .................................................................................................................................................. 12 CHAPTER TWO: LITERATURE REVIEW ................................................................................................................ 13 2.1 Introduction ............................................................................................................................................................... 13 2.2 The conceptual definition of human rights................................................................................................................ 13 2.3 Human rights obligations .......................................................................................................................................... 14 2.4 Enforceability of human rights.................................................................................................................................. 16 2.5 The right to enjoy benefits of scientific progress: a little theorised right .................................................................. 17 2.6 The REBSP and intellectual property rights in access to essential medicines .......................................................... 21 2.7 Access to medicines for neglected diseases .............................................................................................................. 22 2.8 History of TB drug development and diagnosis........................................................................................................ 23 2.9 Low scientific progress and impact on access........................................................................................................... 24 2.10 The co-infection of TB and HIV ............................................................................................................................... 25 2.11 Theoretical frameworks............................................................................................................................................. 26 CHAPTER THREE: RESEARCH DESIGN AND METHODOLOGY ...................................................................... 36

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3.1 Introduction ............................................................................................................................................................... 36 3.2 Aim............................................................................................................................................................................ 39 3.3 Research Question..................................................................................................................................................... 39 3.4 Research Design........................................................................................................................................................ 40 3.5 Legal analysis sub-study ........................................................................................................................................... 40 3.6 Policy analysis sub-study .......................................................................................................................................... 46 3.7 Qualitative sub-study................................................................................................................................................. 54 3.8 Triangulation and interpretation ................................................................................................................................ 57 3.9 Data management ...................................................................................................................................................... 58 3.10 Reflexivity and rigour ............................................................................................................................................... 59 3.11 Ethical considerations ............................................................................................................................................... 60 3.12 Conclusion ................................................................................................................................................................ 61 CHAPTER FOUR: A LEGAL ANALYSIS OF THE RIGHT TO ENJOY BENEFITS OF SCIENTIFIC PROGRESS....................................................................................................................................................................... 62 4.1 Introduction ............................................................................................................................................................... 62 4.2 Basic premises........................................................................................................................................................... 63 4.3 The normative content of article 15, paragraph 1 (b) ................................................................................................ 64 4.4 Elements of article 15, paragraph 1 (b) ..................................................................................................................... 66 4.5 Obligations of states .................................................................................................................................................. 71 4.6 Extraterritorial obligations (ETOs) ........................................................................................................................... 80 4.7 Limitations of the REBSP ......................................................................................................................................... 82 4.8 Violations .................................................................................................................................................................. 84 4.9 Discussion ................................................................................................................................................................. 85 4.10 Summary and conclusion .......................................................................................................................................... 88 CHAPTER FIVE: ANALYSING SOUTH AFRICA'S LAWS AND POLICIES RELATED TO THE RIGHT TO ENJOY BENEFITS OF SCIENTIFIC PROGRESS ..................................................................................................... 91 5.1 Introduction ............................................................................................................................................................... 91 5.2 The South African context ........................................................................................................................................ 92 5.3 Scientific progress in South Africa: a review of national laws ................................................................................. 94 5.4 Scientific progress in South Africa: a review of policies ........................................................................................ 113 5.5 Summary of findings on laws and policies.............................................................................................................. 118 5.6 Court cases concerning scientific progress in South Africa .................................................................................... 121

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5.7 Summary of analysis from court cases ................................................................................................................... 124 5.8 Light budget analysis .............................................................................................................................................. 124 5.9 Conclusion .............................................................................................................................................................. 133 CHAPTER SIX: EXPERIENCES, PERCEPTIONS AND KNOWLEDGE OF THE REBSP AMONG KEY STAKEHOLDERS ......................................................................................................................................................... 137 6.1 Introduction ............................................................................................................................................................. 137 6.2 Findings and discussion .......................................................................................................................................... 138 6.3 Definition of the REBSP ......................................................................................................................................... 140 6.4 Key stakeholders for the REBSP............................................................................................................................. 145 6.5 Core objectives of the REBSP................................................................................................................................. 146 6.6 Duties and responsibilities ...................................................................................................................................... 147 6.7 Private sector responsibilities .................................................................................................................................. 154 6.8 The international community and extraterritorial obligations ................................................................................. 154 6.9 Entitlements............................................................................................................................................................. 155 PART II: PERCEPTIONS ON OPERATIONALISATION OF THE REBSP IN SOUTH AFRICA .................... 157 6.10 Financing................................................................................................................................................................. 157 6.11 Policies and laws ..................................................................................................................................................... 157 6.12 Research dissemination ........................................................................................................................................... 158 PART III: HOW THE REBSP CAN ENHANCE ACCESS TO DR-TB TREATMENT ........................................ 158 6.13 Reducing prices of TB drugs................................................................................................................................... 158 6.14 Fast-tracking prevention and vaccine development ................................................................................................ 159 6.15 Creating a well-informed population....................................................................................................................... 159 6.16 Potential game-changers in the fight against DR-TB .............................................................................................. 160 6.17 Summary of experiences, knowledge and perceptions............................................................................................ 163 6.18 Conclusion .............................................................................................................................................................. 167 CHAPTER SEVEN: CONCEPTUALISING THE REBSP AND DEVELOPING A FRAMEWORK FOR APPLYING IT TO ACCESS TO EFFECTIVE DIAGNOSIS AND TREATMENT OF DR-TB ........................... 168 7.1 Introduction ............................................................................................................................................................. 168 7.2 Current challenges on access to diagnosis and treatment for DR-TB ..................................................................... 170 7.3 Conceptualising the Right to Enjoy Benefits of Scientific Progress ....................................................................... 170 7.4 Minimum essential levels ........................................................................................................................................ 171 7.5 The other elements of the REBSP ........................................................................................................................... 173

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7.6 Applying the elements of availability, accessibility, acceptability, quality (AAAQ) to the REBSP....................... 173 7.7 Obligations of states and responsibilities of non-state actors towards the REBSP ................................................. 178 7.8 Specific legal obligations: obligation to respect, protect and fulfil ......................................................................... 179 7.9 Extraterritorial obligations (ETOs) ......................................................................................................................... 180 7.10 Special topics of broad application ......................................................................................................................... 183 7.11 Responsibilities of non-state actors ......................................................................................................................... 184 7.12 Entitlements of rights-holders ................................................................................................................................. 184 7.13 Relationship with other human rights...................................................................................................................... 186 7.14 Relationship with intellectual property rights ......................................................................................................... 186 7.15 A Framework for applying the REBSP to DR-TB in South Africa......................................................................... 187 7.16 DR-TB and other human rights ............................................................................................................................... 196 CHAPTER EIGHT: FINAL CONCLUSIONS AND RECOMMENDATIONS ....................................................... 198 8.1 Introduction ............................................................................................................................................................. 198 8.2 Reflecting on study aims and objectives ................................................................................................................. 199 8.3 Contribution to the knowledge ................................................................................................................................ 200 8.4 Limitations .............................................................................................................................................................. 200 8.5 Recommendations for future research..................................................................................................................... 202 Bibliography .................................................................................................................................................................... 203 Appendix 1: Ethics approval letter ................................................................................................................................... 213 Appendix 2: Letter to organisations.................................................................................................................................. 214 Appendix 3: Consent form................................................................................................................................................ 215 Appendix 4: Interview Guides .......................................................................................................................................... 219

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