Actor-Network Theory and Socio-Legal Objects: Analysing TRIPS and Pharmaceutical Patents in the Republic of Djibouti By Emilie Cloatre, LLM, MA. Thesis submitted to the University of Nottingham For the degree of Doctor of Philosophy, November 2005 1 ABSTRACT This research analyses the role and action of the Trade Related Intellectual Property Agreements (TRIPS) and pharmaceutical patents in the public health network of Djibouti, by using an approach largely inspired by actor-network theory (ANT). In doing so, it addresses issues that run beyond the specificities of this case study and relate more broadly to the relevance of ANT to socio- legal analysis. The relation between TRIPS, pharmaceutical patents and public health in developing countries has been a widely debated issue in the past decade. However, the field remains limited by a relative uniformity in the range of approaches and case studies chosen in existing research. This project aims to address some of these limits, by looking at the role of TRIPS and pharmaceutical patents in a small country with no local pharmaceutical industry, no pre-existing official system of intellectual property, and with a largely undocumented public health system. Using ANT in this project allowed for the complexity of the mechanisms of both TRIPS and pharmaceutical patents to be highlighted. It participated in emphasising that they need to be understood as made of multiple, co-existing dimensions. By demonstrating how specific connections and associations have shaped what TRIPS and pharmaceutical patents are and do in the networks of 2 Djibouti, this research emphasises the artificiality of the dichotomy between social and legal, and proposes an understanding of social connections as symmetrical and co-dependent. It discusses the more general relevance of this approach to socio-legal research. The example of Djibouti also allows for new questions to be raised in relation to the actual impact of TRIPS and pharmaceutical patents in “developing countries”. In particular, it emphasises the need to return to a more balanced approach to the relation between pharmaceutical patents and health in poor countries. 3 Acknowledgements I would like to thank my supervisors, Prof. Robert Dingwall, Prof. Tamara Hervey and Dr. Paul Street for all their help, advice and support during my PhD. I am also most grateful to all those who helped me by reading and discussing aspects of my work, and those who introduced me to new, much needed vocabulary and helped me correct the most clumsy of my sentences. The past three years – and even more so the last few months – would never have been as manageable without the great support that I enjoyed from my friends, in England and in France. Although I cannot thank everyone individually, I want to put a special note to Jemima Agyare and Juliette Salabert who have been the most efficient answer to any stress attack I might have had in the last few months. In the same way, and as always, I am very grateful to my family for simply caring and being there, and for always encouraging and supporting me. I also need to thank everyone in Djibouti for making my fieldwork not only possible and instructive, but a highly enjoyable experience. 4 Finally, I need to give the biggest thanks to my partner, Pritesh Shah, for all his patience, care and support, which made the last three years not only possible, but also very happy times. 5 TABLE OF CONTENTS INTRODUCTION p.1 CHAPTER 1 - TRIPS, PHARMACEUTICAL PATENTS AND PUBLIC HEALTH IN “DEVELOPING COUNTRIES” p. 18 SECTION 1: PATENTS BEFORE TRIPS – A VARIETY OF APPROACHES JUSTIFIED ON ECONOMIC GROUNDS p. 20 SECTION 2: TRIPS AND THE FRAMING OF PHARMACEUTICAL PATENTS AS A PUBLIC HEALTH ISSUE p. 53 CHAPTER 2 - INTRODUCING ACTOR-NETWORK THEORY p. 77 SECTION 1: SOCIOLOGICAL RESEARCH AND MOBILITY OF ORDERINGS p. 79 SECTION 2: UNDERSTANDING TRIPS AND PHARMACEUTICAL PATENTS THROUGH ANT p. 105 CHAPTER 3 - METHODOLOGY p. 116 SECTION 1: HOW TO BE A “CONSTRUCTIVIST” AND A “SCIENTIST”? p. 118 SECTION 2: NARROWING DOWN THE FOCUS OF ANALYSIS p. 130 SECTION 3: METHODS FOR DATA COLLECTION p. 138 SECTION 4: ETHICS p. 158 6 SECTION 5: APPROACH TO DATA ANALYSIS p. 163 SECTION 6: ASSESSING THE VALIDITY OF RESEARCH METHODS AND FINDINGS p. 166 CHAPTER 4 - FINDING TRIPS AND PATENTS: AN INTRODUCTION TO THE VIEWPOINTS CHOSEN p. 174 SECTION 1: INTRODUCING DJIBOUTI p. 176 SECTION 2. DJIBOUTI AND IPR LAW – PRE-TRIPS “IPR SYSTEM” p.183 SECTION 3: PUBLIC HEALTH IN DJIBOUTI: DEFINING SOME TERMS AND NETWORKS p. 188 SECTION 4: DEVELOPMENT OF A LOCAL PHARMACEUTICAL INDUSTRY IN DJIBOUTI – IS IT A TRIPS ISSUE? p. 203 CHAPTER 5 - TRIPS AND “LEGAL” ASSOCIATIONS- UNDERSTANDINGTHE ROLE OF TRIPS AS PRESCRIPTION p. 210 SECTION 1: TRIPS IS CHANGING WRITTEN, NATIONAL LAW… p. 212 SECTION 2: … BUT DOES IT REALLY MATTER? p. 219 SECTION 3: ACTION AND CIRCULATION IN DJIBOUTI p. 230 CHAPTER 6 - EMBEDMENT OF PHARMACEUTICAL PATENTS IN THE DRUGS USED IN DJIBOUTI p. 249 7 SECTION 1: PHARMACEUTICAL PATENTS AS DETERMINANT TO THE LOCAL PHARMACEUTICAL MARKET p. 251 SECTION 2: ENROLMENT AND ACTION OF PATENTS IN THE PHARMACEUTICAL MARKET OF DJIBOUTI – HOW DO THEY GET THERE? p. 262 CHAPTER 7 - TRIPS, PHARMACEUTICAL PATENTS AND HEALTH IN DJIBOUTI - UNDERSTANDING TRIPS IN ITS NETWORKED EFFECTS p. 287 SECTION 1: UNDERSTANDING THE LINKS BETWEEN TRIPS, PATENTS AND HEALTH p. 289 SECTION 2: RE-ORDERING OF HEALTH NETWORKS AND DISLOCATED EFFECTS OF TRIPS p. 298 CHAPTER 8 - CONCLUSION p.329 SECTION 1: EXPECTATIONS AND DISRUPTIONS: TRIPS AND PHARMACEUTICAL PATENTS IN ACTION IN DJIBOUTI p. 331 SECTION 2: UNDERSTANDING SOCIO-LEGAL OBJECTS THROUGH ANT: STRENGTHS AND LIMITS OF THE METHOD p. 346 BIBLIOGRAPHY p. 354 APPENDIX I: LIST OF INFORMANTS 8 INTRODUCTION This research discusses the role and impact of pharmaceutical patents and the Trade Related Intellectual Property Agreement (TRIPS) on health networks in Djibouti. Based on actor-network theory (ANT), it provides an understanding of these two instruments as multi-dimensional and fragile systems, enrolled in a multiplicity of mobile and changing social networks. It emphasises their nature as “socio-legal objects”1. Overall, this research explains how the complexity of the links between TRIPS, pharmaceutical patents and health can best be understood by looking at the different roles and mechanisms of each instrument within the several networks of which they are part. The impact of these instruments on health can then be explained while acknowledging the complexity of the changes generated, as the result of the multiple actions and shapes of both TRIPS and pharmaceutical patents as complex actor-networks. 1 Although the term will become clearer throughout the following chapters, the notion of “socio-legal objects” needs to be briefly explained. First, the term “socio-legal” is used throughout when designating TRIPS and pharmaceutical patents, as a way to emphasise the absence of dichotomy between what is sometimes understood as two “fields” or “dimensions”, but is considered throughout this project as series of fluid and interrelated associations. Second, it should be emphasised that the term “object” should not be understood as pre-determining any form of “passivity” – partly because ANT puts forward the idea that any entity is always both acting and acted upon. Although the term “actant” used in some ANT writings could have more explicitly emphasised this idea, it was decided that the less “cryptic” notion of “socio- legal object” would be used throughout, while emphasising early in this project that this should not preclude their active role. 9 TRIPS and pharmaceutical patents in a least developed country Although intellectual property has been a matter of national law and policy for a long time, the adoption of the TRIPS agreement in 1995 has created new international standards and requirements in the field. The adoption of TRIPS has generated important debates and disagreements amongst actors. Opposition to the text focused in particular on the potential risks and benefits that these new intellectual property (IP) standards would have for poorer countries. Within TRIPS, pharmaceutical patents has been one of the most controversial areas, and has been taken up as a key ethical problem in a wide range of arenas. They have generated oppositional discourses and positions, in which TRIPS and pharmaceutical patents have been framed and understood in a fundamentally different way by different groups. Broadly, the relation between TRIPS, pharmaceutical patents and health in poor countries has been fitted within two main sets of discourses. On the one hand, many have expressed the view that pharmaceutical patents in the form required by the TRIPS agreement would create obstacles to access to health. Based on the idea that stronger patents would have a negative effect on the availability of generic drugs, and therefore on the cost of medical treatment worldwide, this position explained how strengthening patents would make modern drugs unaffordable for people already in a critical health situation. This idea has been reframed in similar terms in the media, and has resulted in a 10
Description: