Emilie Cloatre

International law, public health, and the meanings of pharmaceuticalization

Recent social science scholarship has employed the term “pharmaceuticalization” in analyses of the production, circulation and use of drugs. In this paper, we seek to open up further discussion of the scope, limits and potential of this as an analytical device through consideration of the role of law and legal processes in directing pharmaceutical flows. To do so, we synthesize a range of empirical and conceptual work concerned with the relationships between access to medicines and intellectual property law. This paper suggests that alongside documenting the expansion or reduction in demand for particular drugs, analysts of pharmaceuticalization attend to the ways in which socio-legal developments change (or not) the identities of drugs, and the means through which they circulate and come to be used by states and citizens. Such scholarship has the potential to more precisely locate the biopolitical processes that shape international agendas and targets, form markets, and produce health.

Regulating Alternative Healing in France, and the Problem of ‘Non-Medicine’

Abstract This article explores the ambiguities of the legal system that, in France, regulates ‘alternative healing’, and determines the boundaries of legitimate medical care. While the law suggests that the delivery of therapeutic care should be the monopoly of biomedically-trained professionals, alternative healers operate very widely, and very openly, in France. They practice, however, on the verge of (il)legality, often organising their activities, individually and collectively, so as to limit the likelihood of state intervention. This creates a high degree of precarity for both practitioners and, crucially, for patients. Efforts to change the system are being deployed, but while healers themselves have increasingly organised to seek recognition by the state, alternative healing occupies an uncertain policy space: they are not fully constituted as a social and policy matter by the state, and occupy a liminal position between medicine and spirituality that “unsettles” republican ideals of scientific rationality, and of secularism. This article explores some of those tensions, at the crossroad between law, science, and medicine. It reflects on why tensions seem to persist around the regulatory questions at stake, and suggests that ways forward may depend on moving away from science as a sole arbiter in drawing boundaries of legitimate and illegitimate care in regulation.

‘On the Perimeter of the Lawful’: Enduring Illegality in the Irish Family Planning Movement, 1972-1985

Between 1935 and 1985, Irish law criminalized the sale and importation of condoms. Activists established illegal markets to challenge the law and alleviate its social consequences. They distributed condoms through postal services, shops, stalls, clinics, and machines. Though they largely operated in the open, their activities attracted little direct punishment from the state, and they were able to build a stable network of medical and commercial family planning services. We use 30 interviews conducted with former activists to explore this history. In doing so, we also examine the limits of ‘illegality’ in describing acts of everyday resistance to law, arguing that the boundaries between legal and illegal, in the discourses and practices of those who sought to challenge the state, were shifting and uncertain. In turn, we revisit ‘illegality’, characterizing it as an assemblage of varying selectively-performed political practices, shaped by complex choreographies of negotiation between state and non-state actors.

Book review: Sociological Reflections on the Neurosciences

In recent years, the neurosciences (i.e. biomedical studies of the brain, including its structure and functioning through imaging techniques) have attracted significant interest among lawyers. This is evident within academia, through frequent conferences and funded projects (especially in the United States), and in practice, where brain imaging has come to be discussed and used in the courts, for example. Both the ethical questions that this fast-developing field of knowledge may raise, and their potential contribution to some of the difficult issues faced by legal systems, mean that neuroscience is deemed uniquely important for the law. At the same time, the complexity of science in its engagement with law has progressively come to the fore of scholarly analysis. (Neuro)Science and technologies have been unpacked in analyses which aimed to demonstrate that, rather than being a fixed system of knowledge on which the law could ‘rest’, they were productive of new realities, new identities and new social practices. In turn, such analyses have demonstrated that any potential relationship between law and science is necessarily complex and co-productive. For legal scholarship that seeks to engage with neurosciences, it is important to take these insights on board and conceptualize neuroscience as a complex social field. Sociological Reflections on the Neurosciences provides a rare and much needed starting point for lawyers keen to achieve this deeper engagement with and understanding of both the neurosciences as social phenomena and their broader implications.

Global Movements, Changing Markets and the Reshaping of Health and Disease

The role of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, within the public health landscape of African states cannot be understood as a static image. Rather, TRIPS is about transformations. In the previous chapters, I have introduced some of these transformations as enacted through the movements generated by the implementation of TRIPS – or at times, their unexpected lack of movement. I have then questioned how the influence of pharmaceutical patents can be explored aside from their role as legal regulation, through their action within markets, and in particular in markets that are still heavily influenced by past and current forms of imperialism. Here, I reflect on the changes, innovations and transformations that have occurred within the public health context of Djibouti and Ghana in recent years, and in particular those that can be viewed as a reflection of the broader movements generated by TRIPS at the global level. My starting point here is that TRIPS can only be explored fully if we also engage with the various global movements that is has produced or been entangled with. The analysis provided in Chapter 2 is built upon in this chapter, and I start from the understanding of TRIPS as a complex assemblage that has come to produce and become entangled into the access to medicines campaign and its different effects. I explore two main issues here: first, I look at some of ways in which medicines and diseases have become reshaped in Ghana and Djibouti following the new global emphasis on access to affordable medicines. I then turn specifically to AIDS, as a site in which the complexity of the coproductive processes linking TRIPS and disease can be explored in more specific depth. I argue throughout that these movements and transformations need to be considered carefully if we wish to understand the full extent of the relationship between public health and intellectual property (IP). This approach is both informed by my theoretical conceptualization of TRIPS and by the entanglement of TRIPS, IP and recent global programmes in the discourses of participants to this research. In their views, discussions of IP were inherently linked to a broader questioning of the movements that animate the landscape of disease and treatment that they engaged with on a day-to-day basis. TRIPS is an event that happens in many places, that generates changes in many networks, that is embedded in multiple actions and practices, and, in order to understand what it ‘does’ in Djibouti or in Ghana, it is essential to have a clearer idea of the effects it has in these many other places, and the indirect repercussions this has on these localized contexts.

Ghana, Pharmaceutical Patents and the Ambivalence of Generic Medicines

The pharmaceutical market of Ghana highlights further aspects of thecomplexity of the relationship between access to medicines and pharmaceuticalpatents. In this chapter, I attempt to unpack the actions of pharmaceuticalpatents in Ghana, starting from the point of view of the pharmaceuticalmarket and health system, rather than from the letter of the law. I focus hereon the main system of distribution of medicines, to the exclusion of thedistribution of antiretrovirals (ARVs). This is because this particular systemis organized alongside an alternative model that does not directly link tothe rest of the market in terms of procurement, or in terms of distribution(and I turn to exploring it specifically in the next chapter). Here, I thereforefocus on other medicines, many of which are out of patent, but thatnonetheless, as was the case in Djibouti, remain entangled in networks thatemerge through and around patents. In contrast to happenings in Djibouti,however, the Ghanaian government has actively tried to facilitate the enrolmentof generic medicines in its healthcare networks, and by comparisontried to avoid seeing innovator brands dominate a market in which accessfor the poor is still difficult. These efforts are challenged time and again,however, by practices, habits, discourses and attitudes that repeatedly resistgeneric medicines. In this chapter, I explore those efforts and the continuedprocesses of inclusion/exclusion that are at play in the Ghanaian healthsystem and question the various possibilities and limitations that are createdand encountered when trying to bring good quality and cost-effective drugsto patients in Ghana. The story told here is one of constant tension betweenthe need to keep prices under control and to promote the most fundamentalinstrument for doing so (generic medicines) and the difficulties encounteredby these generic medicines in stabilizing their role beyond policy documentsand government offices. Generics become an essential yet fragile object ofpublic health. The chapter can be read as echoing some of the issues seenin Djibouti: for example, the struggle of generic medicines to become establishedand stable actors and the strength used by patented drugs to opposetheir enrolment and stabilization. Throughout, I deliberately avoid reducingthe strength of patented/branded drugs to merely the expression of thepower of multinational companies. Instead, I hope that exploring the variousways in which branded drugs are stabilized will contribute to explaininghow this power is constituted through a set of localized practices and heterogeneousconnections and disconnections.

From IP to Public Health in Djibouti and Ghana

The legal implementation of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement (and the challenges it raised in terms of expertise and process of translation) is only a small aspect of what needs to be looked at in order to understand the effects of TRIPS and of patents as a source of formal regulation in Djibouti and Ghana. If understanding legal regulations as part of broader processes of social ordering, and as having ordering as one of the very aims of legal regulations, the next level of inquiry should question how TRIPS has transformed or is transforming local relationships and how pharmaceutical patents influence behaviour and practices. The significance of TRIPS on healthcare in specific localities is dependent on its ability, and of the ability of intellectual property (IP) regulations more broadly, to shape specific networks; in particular, the effect of pharmaceutical patents in general is codependent on their ability to ensure that drugs in breach of international standards of patents remain excluded from the territory concerned. And this implies that those importing drugs are aware of the rules and made to obey them. In order to understand the potential and actual effect of rules relating to pharmaceutical patents on social ordering in Ghana and Djibouti, it is thus essential to move away from the networks of IP stricto sensu and explore how TRIPS affects practices and behaviour in other offices. In both case studies, the picture emerging from this further investigation is one in which the limits and weaknesses of IP as a set of legal prescriptions are apparent and are a constitutive part of the system.

Introduction: Global IP and Pills for the Poorest

The desperate need for a vast part of the global population to access better medicines in more reliable ways is a persistent social concern. Since the mid-1990s, it has also evolved into one of the most cynical and disheartening aspects of international politics, as we have seen the interests of a few conflict with the needs of the many. The conflicts between the rise of global intellectual property (IP) rights and the deployment of cheap medication for the poor have been extensively discussed since shortly after the adoption of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement in 1995. A plethora of academic writings on the topic has been produced and the media have extensively commented (sometimes accurately, sometimes less so) on a subject that has now become familiar to many. However, since starting the research leading to this book in 2002, I have remained convinced that there are too many dimensions of the debate that have been left unexplored. Whilst this book does not claim by any means to provide an exhaustive story of TRIPS, it aims to unpack some of these unexplored aspects, but also to bring together bodies of analyses and questions that have not been confronted with each other in this context. I do this by bringing together qualitative data collected in two states of sub-Saharan Africa (Djibouti and Ghana) and the conceptual insights of actor-network theory (ANT) to propose a socio-legal exploration of the links between IP and access to medicines. I explore TRIPS as a multiple actor, flowing along networks that bring it from the World Trade Organization (WTO) to Djibouti and Ghana, through offices, into drugs, encountering AIDS, malaria, patients and activists on its way. I explore pharmaceutical patents as part of TRIPS, but also as part of materials, including medicines, and as part of the daily lives and practices of many other human and non-human actors, and question the co-constitutional roles of diseases and regulatory politics in the context of IP. I am primarily interested in the ‘small’ and in localized connections, while understanding those as always entangled in events and linkages happening elsewhere. In this process, ANT provides a useful toolbox to analyse the multidimensional interactions between the wide range of actors that is relevant to TRIPS. I have chosen to use ANT in an open and flexible way, and hope not to have betrayed any of its fundamental claims in doing so. Instead, I hope that this book provides an opportunity to question the possibilities and limitations of engaging with ANT in socio-legal studies, and in the study of global legal instruments. Reciprocally, using ANT to explore a particular set of legal tools enables me to question the processes of ordering and production that surround their deployment into new networks, offering an analysis of the law that opens questions beyond these particular case studies.

Pharmaceutical Patents as Silent Regulatory Tools: Escaping Branded Drugs in Djibouti

In this chapter, I question the links between the existence (or absence) of pharmaceutical patents in written national law and the role of pharmaceutical patents in ordering the local pharmaceutical market of Djibouti. I explain why the set of regulatory forces that shape the market cannot be deduced fully from the absence of intellectual property (IP) in the legal landscape of Djibouti until very recently, and why the absence of engagement of public health actors with patents cannot be interpreted as meaning that they are fully irrelevant to the way in which the market for drugs is shaped. I argue throughout that patents in Djibouti have in fact always been highly influential and can be conceptualized as silent regulatory tools with fluid jurisdictional boundaries. In this analysis, I position my understanding of regulation at the crossroads between actor-network theory’s (ANT) approach to analysing processes of social ordering (Latour, 2005; 2010) and recent approaches in regulation theory that have emphasized the increasingly fluid and decentred nature of regulatory forces (Black, 2001; 2002; Scott, 2004). The discreet but influential modes of action of patents in Djibouti invite one to reflect carefully on the role that patents may play in public health systems aside from their official role, and what this may mean for the ways in which the markets of states that do not or did not protect pharmaceutical patents may have been shaped.

TRIPS as Assemblage

In this chapter, I explore some of the conceptual ideas that guided this research. In particular, I question the significance of its grounding in actor-network theory (ANT), and what this means for the way the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, intellectual property (IP) and pharmaceutical patents are conceptualized in this research. I start by explaining in some detail the key ideas of ANT, focusing on the elements that are particularly relevant to this research, and on some of its controversies. I then turn more specifically to TRIPS and question its historical constitution as an assemblage, and how it has become shaped over the years into the complex multidimensional entity that now travels the globe. I conclude by summarizing the way in which this conceptualization of TRIPS and patents is played out in the following chapters.