‘Embedded Regulation’: The Migration of Objects, Scripts and Governance

This paper examines the way in which regulation can become embedded in material objects and ‘black-boxed’ to the point where it becomes invisible to everyday analysis, while maintaining its effects in action. It uses a case study of the supply of
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   Published version available in Regulation and Governance (2013)  1 ‘Embedded Regulation’: The Migration of Objects, Scripts and GovernanceEmilie Cloatre * and Robert Dingwall †  Abstract: This paper examines the way in which regulation can become embedded in materialobjects and ‘black-boxed’ to the point where it becomes invisible to everydayanalysis, while maintaining its effects in action. It uses a case study of the supply of  pharmaceuticals to a least developed country, Djibouti, to explore what Actor- Network Theory can bring to the understanding of regulation, by allowing us toconceptualise materials as able to enrol complex networks of other actors, rules,values and practices. It argues that this approach strengthens understandings of regulatory mechanisms as part of the heterogeneous ordering of society.  Key words:Regulation; actor-network theory; intellectual property; pharmaceuticals;development.Introduction This paper examines the way in which regulation can become embedded in materialobjects and practices and ‘black-boxed’ to the point of invisibility in everydayanalysis, while maintaining its effects in action. We explore what Actor-Network Theory (ANT) can bring to the understanding of regulation, by conceptualisingmaterials as able to enrol complex networks of other actors, rules, values and practices. Latour (1992) observed that everyday objects, like seat belts or speedhumps in roads, can be made to act as regulatory instruments, shaping human behaviour in predetermined ways. The ‘official graffiti’ of Hermer and Hunt (1996)are another well-known form of action at a distance by regulators through thedeployment of purpose-built materials (see also Hunt 1996; Lessig 1999; Lippert2009).The ability of materials to enrol other actors can result in regulatory effects being produced in ways that may be unexpected, unintentional, or invisible to humanregulators. The materials considered here are not artefacts explicitly designed or builtto act as regulatory agents or ‘regulatory tools’. Observing their workings allows usto reflect on the definition of ‘regulatory space’, or ‘regulations’. This paper, then,also responds to the recent recognition within regulation studies of the need to * Lecturer, Kent Law School † Dingwall Enterprises and Nottingham Trent University † Dingwall Enterprises and Nottingham Trent University   Published version available in Regulation and Governance (2013)  2understand regulatory entities and activities beyond those represented by theinstitutions and work of official national or supranational agencies.Our case study, of the supply of pharmaceuticals to a least-developed country,Djibouti, shows how ANT can assist in understanding the embedding of regulatoryforces within materials, and their consequent influence in new, unexpected, networks.The regulations embedded in pharmaceuticals by governance networks in France, andother developed countries, have travelled to Djibouti, where the pharmaceuticalmarket is officially open, but is in practice limited to a small range of patented, branded, and expensive, medications. An analysis of local networks demonstrateshow these embedded regulations have met little resistance and how medicines havesuccessfully enrolled key actors to create a de facto regulated market. We conclude byreflecting on what ANT can add to the study of regulation more generally through itsestablished tradition of exploring the heterogeneous ordering of society. Silentregulations, embedded in technologies, can be identified, described and analysed, inways that blur the limits and boundaries of ‘regulatory space’. ‘Legal’ space becomessimilarly uncertain. Djibouti: market, drugs and regulatory scripts Djibouti is one of the world’s smallest and poorest countries. Its population is about820,000 and GDP per capita about $1,250 (World Bank 2010). While the state isreasonably effective, its capacity is limited by the population’s size and relatively lowlevel of education. In particular, Djibouti lacks the specialist scientific, technologicaland cultural activities which generate a demand for the legislative and regulatoryinterventions that constitute and structure markets, including those for  pharmaceuticals, in more developed countries. Intellectual property has onlydeveloped as a field in Djibouti since its adoption of the TRIPS agreement, and the passage of implementing legislation in 2009, which is still not in effect. Stateintervention in the pharmaceutical market has historically been very limited and therewas no statutory protection for pharmaceutical patents prior to 2009.EC carried out fieldwork was carried out in Djibouti from January to April 2004. Thisincluded interviews with twenty-five local actors and observation around interviewsand in key settings such as pharmacies and local markets. Snowballing was animportant part of the process of recruiting informants: it is difficult to identifyrelevant actors from documents in Djibouti. Informants included staff within theministries of health, and trade and industry; health professionals (doctors, and hospitaland community pharmacists); a WHO representative; the leaders of the World Bank  programmes on access to medicines then being implemented; legal professionals; andother policy actors with general knowledge and experience of the political and juridical context. They included both Djiboutian and French nationals (present in policy and political institutions, and in the health field). Most informants wereinterviewed several times over the period of fieldwork, allowing statements to be   Published version available in Regulation and Governance (2013)  3interrogated and refined. Further, shorter, visits have been carried out in subsequentyears allowing developments to be observed.Policy documents were used when available, but a significant amount of informationwas simply not published – due both to the predominant oral tradition in the country,highlighted by many informants, and to the limited availability of informationtechnologies common in developed countries. Observational visits were made to private pharmacies, to one hospital pharmacy, to the ‘pharmacies communautaires’introduced by the World Bank (described later in this paper), and to the site where thedrugs distributed in these last were centrally collected and stored. The visits allowedstatements in interviews to be followed up in a practice context, prompting further questions focussed on the history and properties of selected drugs.The sensitive political climate in Djibouti placed a particular stress on protectinginformants’ anonymity. Although it had srcinally been intended to recordinterviews, informants were reluctant to agree and most data are extensive hand notes,reviewed after the event. Some stories remained incomplete and could not be clearlyspelt out or elaborated by informants: those limitations are noted as appropriate. Nevertheless, given the relatively small size of the networks under scrutiny, andsignificant support from participants, a detailed picture of the pharmaceutical fieldcould be gained within the three months of data collection.The project was srcinally designed to explore the impact of the TRIPS agreement onthe availability of patented drugs in Djibouti. The introduction of ANT’s emphasis onthe modes of action of ‘things’, unearthing the role of materials in social networks,generated broader questions about the deployment of drugs, how these acted in particular ways, and how their action related to ordering and regulating processes,such as those of patenting. Accepting that materials are also the gathering of scriptsand forces brought us to explore the constant interaction between levels, actors andnetworks, and the part that drugs, and patents, played in these multi-directionalinfluences. The analysis came to focus on the mechanisms for the procurement anddistribution of pharmaceuticals, which, in turn, required a more general understandingof the health system.The situation in Djibouti has evolved since 2004. This paper reflects a well-stabilizedmoment that allows us to investigate the role of medicines in regulating and orderinglocal pharmaceutical markets. We are describing the situation prior to itsentanglement with the networks of global institutions that have since imposedliberalisation and transformed the systems. References are made to the currentsituation as appropriate, but the focus is on the market as it functioned for many years.Current developments can be understood fully only if we recognise what they are laidupon, and interacting with, through continuing, and complex, processes of entanglement and disentanglement between local and international actors.   Published version available in Regulation and Governance (2013)  4 The pharmaceutical market in Djibouti This section describes the dynamics of Djibouti’s apparently unregulated pharmaceutical market in 2004, which drugs are, in practice, allowed to enter it, andhow this selection takes place. Officially, very few regulations limited the availabilityof drugs, beyond basic rules aimed at preventing counterfeiting. There were nointellectual property rules and no regulations specifying conditions under whichgeneric medicines might enter the country. The implementation of the TRIPSagreement was progressively bringing changes, but their practical impact was stilluncertain (on the implementation of TRIPS in general, see Deere 2009).During fieldwork, however, it emerged that this market was more constrained, and far less flexible, than its apparently unregulated nature had led us to expect. Only specificranges of drugs managed to enter the networks of supply, distribution and prescriptionor sale. These were often the branded and patented, and the most expensive, versionsof medication (on the links between patents and prices, see, for example,Balasubramanian 2002). There are obvious practical implications for a very poor country and it was puzzling that the cheaper generic versions of key medications produced in countries like India, South Africa and Brazil had failed to enter thismarket.The pharmaceutical market of Djibouti is not homogenous, and we will focus on its‘dominant’ part. However the exceptions are also interesting for what they tell usabout other influences and how these manage to enter parts of the market or sub-systems linked to particular diseases.In 2004, the most substantial part of the Djiboutian pharmaceutical market (‘two-thirds’ was the consensus estimate among informants, who generally considered localstatistics to be unreliable) consisted of drugs sourced and distributed by the country’stwo private pharmacists. They supplied most individual patients, and most of thedrugs used by public hospitals. The medicines purchased and distributed through this private system fell within a narrow range, purchased from a small set of multinationalcompanies. Most were under patent, or were the srcinal version of a drug whose patent had expired elsewhere and which now faced generic competition in other markets. Generic medications, from any source, were almost completely absent. The pharmacists affirmed that they did not purchase generic drugs, and EC’s visits to private pharmacies and public hospitals found that the observable drugs were branded; some “branded generics” sourced from large multinational companies werefound, but in limited supplies. When asked, the pharmacists agreed that these wereexceptions. Whilst largely unregulated in terms of proprietary rights, this part of themarket appeared both narrow and constrained.   Published version available in Regulation and Governance (2013)  5Smaller, isolated, networks enrolled generics more extensively. The OPS (Organismede Protection Social) runs a hospital targeted to Djiboutian employees, funded partlythrough public funds and partly through private employers’ contributions. Thoseentitled to treatment there would tend to choose it over public hospitals, and benefitfrom free medication distributed by the OPS pharmacy – out-patients in other hospitals needed to purchase their drugs from private pharmacies. The reputation of this hospital was also generally good, explaining why it was a preferred choice for those with entitlement. The OPS pharmacy depended largely on generic drugs, purchased through a specialised Dutch international wholesaler. A notable exceptionwas anti-retroviral drugs: the pharmacist stated that their regular supplier did not provide them, and they had not yet investigated alternative sources. In effect, the listof drugs supplied to this pharmacy (which was made available to us) was a list of out-of-patent generic drugs, whilst the patented drugs that were used in the hospital(ARVs) were purchased in their branded version. The OPS system remainedcompatible with European patenting rules.Donations had traditionally played a part in Djibouti’s pharmaceutical system,although this has been diminishing. Through these, a number of generic drugs enteredthe country and were redistributed to hospitals. Public health officials, and the pharmacists in charge of managing donations, all emphasised that this source had become highly problematic; quality control was an issue, and the poor fit between thedrugs donated and the needs of local hospitals meant that a substantial part of directdonations could not be used. The lack of ability to test or verify drugs in Djibouti alsomeant that any uncertainty about drugs, which was prevalent when dealing withgenerics, meant that they would not be used.Finally, some generic drugs entered Djibouti through World Bank interventions. In particular, one project, implemented while this research was in progress, aimed atdeveloping new points of entry for cheap basic medication targeted at the poorest partof the population that currently had no access (World Bank 2002). It created small‘pharmacies communautaires’ based in the poor neighbourhoods of the capital andother cities. They stocked a very limited range of drugs (including paracetamol andaspirin; antibiotics; anti-diarrheals); these were in generic form and made available ata symbolic cost. All drugs distributed through these pharmacies were out-of-patent.These exceptions were only a small part of the pharmaceutical market of Djibouti.They do, however, reflect some relevant social considerations. Djibouti ischaracterised by a significant gap between the ‘very rich’ and the ‘very poor’(common in many developing countries), and a relatively small ‘middle class’. Asignificant part of the resident population is French expatriates – from a large military base or working through different elements of a cooperation system. These foreignresidents, together with the richer layers of the Djiboutian population, constitute alarge part of the market served by the private pharmacists. For others, treatment isavailable either through public hospitals, as in-patients, or, for those with employment
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