Nicolas Dodier

The periodic creation of frameworks designed to organize medicine in ways that cross national boundaries has long been observed, particularly in relation to efforts to combat epidemics (Biraben, 1976). Since the twentieth century, however, these frameworks have increased significantly and become more stable. Transnational medicine expresses the now long-term and established nature of these frameworks, which go beyond the occasional international mobilizations that can occur in response to a particular crisis situation (Delvecchio Good, 1995). Several factors have contributed to the emergence and development of transnational medicine: the rise and subsequent fall of colonial medicine (McLeod & Lewis, 1988; Van Dormael, 1997); the activities of international agencies, such as the World Health Organization (WHO), and various private foundations (such as the Rockefeller Foundation) (Löwy, 2001); and the gradual development of evidence-based medicine at an international level, based on the dissemination of a reference standard for treatment testing and approval (Dodier, 2005). The emergence of humanitarian medicine promoted by non-governmental organizations has played a significant role in the recent changes in transnational medicine in many ways. On the one hand, NGOs (and MSF in particular) have carried out a significant amount of critical evaluation designed to further the development of this kind of medicine. On the other, they have opted to fit into pre-existing frameworks to use the tools they provide, or to have their voices heard. These two aspects now need to be brought together.

Research on humanitarian medicine has so far yielded relatively little information. As far as MSF is concerned, attention has been focused on other issues. Many studies have examined the more overtly political aspect of the work carried out by the organization, which aims to defi the place of humanitarian action in armed confl The past thirty years have seen a whole series of debates, with which MSF has been very directly associated, proving the great diffi involved in reaching a clear conclusion on the status of humanitarian NGOs in armed confl (Fox, 1995; Vallaeys, 2004; Fassin, 2006). Other studies have questioned the kind of militantism developed by members of MSF, particularly in a context of fundamental changes in collective forms of mobilization (Dauvin & Siméant, 2002; Siméant, 2001). Little attention has been paidExcept for recent research by Peter Redfield (2008a, 2008b).to the specifically medical aspect of MSF and the organization’s contribution, in this respect, to potential new developments. Publications produced individually or collectively by members of MSF only occasionally question the kind of medicine practiced by the organization, and the place it occupies in transnational medicine.The compilation of articles by Rony Brauman (2000) is, to my knowledge, in terms of publications, the most ambitious attempt.The contributions included in this publication have come at the right time. Based on examples of medical innovations produced by MSF, they provide an opportunity to approach the question from a dynamic point of view. How and to what extent has an organization that claims to represent humanitarian medicine turned the desire for change into a tangible reality within transnational medicine? In what ways has the organization itself been changed? In this chapter, I intend to follow some of the lines of this collective history by referring to the contributions in this publication and putting them in perspective with other publications about MSF, in order to gain a better understanding of where each example of innovation described here fits into an overall dynamic.This chapter therefore needs to be read from an exploratory point of view, and not as the result of research.

The history of the organization can be divided into four major sequences, which in turn represent four major periods of innovation for MSF. For each of these sequences, I will show what factors drove the change (what members of MSF used as a basis for identifying failings in transnational medicine and outlining possible improvements) and the targets of the change (what they were committed to changing). By focusing on the connections between these sequences over a period of forty years, I aim to show both MSF’s contributions to changes in transnational medicine and the shifts in the organization itself in its approach to innovation.

“Ordinary Doctors” Without Borders

The creation of MSF in 1971 in itself showed a clear determination to innovate in transnational medicine—particularly, in the early days, in relation to the systems in place within the Red Cross, which at the time organized a significant proportion of international assistance in response to armed conflicts. The process involved three main tasks.

The first was to change the rules for emergency workers so they could have their voices heard. The episode is well known and the story has been told many times, attracting many comments, some of which have become part of the founding mythology of the group, but it is worth retelling it here to understand the foundations it laid for future innovations. It all began when doctors were sent by the Red Cross to help people in the Biafra conflict (1967). The scale of the suffering was such that the doctors found it intolerable to maintain the principle of neutrality, which normally governed the relationship between the Red Cross and the various stakeholders involved, by remaining silent about who was responsible. They spoke in public, both on television and in the press. Their transgression was striking because it combined the roles of two different figures as witness. On the one hand, it was based on the figure of the “moral spectator” as it has been construed since the eighteenth century, which urges someone who has witnessed suffering to alert public opinion. This figure came back to the fore in the 1960s, through the new possibilities (and formats) for remote reporting thanks to new media, particularly television (Boltanski, 1993). On the other hand, media reporting also relied on the figure of the doctor, as someone who had both specialist knowledge, which was supposed to ensure objectivity, and embraced professional ethics (i.e., was sworn to protect the health and life of patients), particularly in the face of authority. The future founders of MSF stood out because they were at the crossroads where these two figures—the doctor and the moral spectator—met. They thus gave the ordinary moral spectator the tools and legitimacy of the doctor, and reinterpreted the professional defense of their patients as a duty to alert public opinion, reporting on their fate in the role of moral spectator.The link between these two scenarios is not uncommon in medicine. One example from recent years is the small groups of company medical officers who are heavily involved in regular reporting on the suffering of staff working in companies (Dodier, 1993). The originality of MSF is that it has carried both scenarios onto the international stage and made them the group’s raison d’être.

The next task was to think of humanitarian assistance in medical terms. In the late 1960s, non-governmental humanitarian organizations were not primarily medical: medicine just served their main objective, which was humanitarian intervention. They therefore used doctors on an ad hoc basis and in limited numbers compared with other volunteers. MSF’s view of itself, however, was as an organization run by doctors and designed to assist people first and foremost on a medical basis. Although MSF’s primary focus from the outset was intervening in crisis situations, the doctors it recruited were not specialists in emergency medicine. They were doctors who provided healthcare in other countries to people in urgent need of intervention as the result of a crisis situation.

Finally, MSF took on the task of reassessing the scope and range of sovereign powers in situations of humanitarian crisis, in particular vis-à-vis the caution with which the existing international agencies usually tackled such issues. They felt that it was legitimate not only to report on such situations, but also to care for people without feeling that they were constrained by national agreements. MSF sought to establish an unconditional and legitimate right for doctors to go out and find their patients wherever there was an urgent need (Fox, 1995). There were obviously negotiations with the countries concerned, but MSF believed, as part of its reassessment of sovereign powers, that it was entitled to enter these countries—much more so than the Red Cross— and make a point of doing so if deemed necessary. In certain circumstances, clandestine operations were undertaken.One such example is the missions in Afghanistan in the early 1980s, after the Soviet invasion.

A Reaction to Amateurism: Kits and an Epidemiological Statistics CenterIn this first phase, innovation lay not so much in products, equipment, or rules as in promoting the profile of someone who had appropriated a specific kind of knowledge and set of ethics: ordinary doctors determined to intervene in other countries when a crisis situation arose, and ready to criticize what was taking place—in the media, if necessary. The organization struggled at the beginning and reports highlight a glaring problem of a lack of resources in disaster areas. Doctors acknowledged that they were overwhelmed by the scale of the catastrophes with which they had to deal. Archive footage showing an interview in the field with a young doctor sent on a mission by MSF to help people hit by Hurricane Fifi in Honduras in 1974, and reused in a film directed by Patrick Benquet and Anne Vallaeys (L’aventure MSF, 2006) proves this point. The success of the advertising campaigns of the 1970s and 1980s marked a turning point. Resources began to arrive, including both people and equipment. The questions these “ordinary doctors” had to face began to change. The issue was no longer the scarcity of resources, but the kind of resources available: it meant defining and developing the necessary skills, and identifying and organizing the various stages of the assistance process. MSF was confronted with the problem of its own amateurism.Criticism of its amateurism took several forms. First of all, there was a growing awareness of their own amateurism amongst doctors sent on missions. Certainly doctors who were sent out on missions had no hesitation in highlighting in their reports their understanding of the reality in the field and their ability to innovate by improvising with what they had available—and this would be a constant, both for MSF and for all those who saw themselves as practitioners. But their accounts also lapsed into an often severe degree of self-criticism on the limited range of things they really knew how to do in light of the problems they encountered. MSF doctors then found themselves facing criticism from the outside (Baron, ch. 3)References to studies published in this book are indicated by the name of the author, followed by the chapter.or from new arrivals as they began to understand how MSF operated in practice. The paradigmatic episode was the view expressed by Jacques Pinel, a pharmacist, when he was sent to work in the Khmer refugee camps (Redfield, 2008b, p.158). Tension was finally beginning to mount in the organization around the professionalism of its actions. It crystallized around the “Ile de Lumière” operation in 1979 (Vallaeys, 2004). A first group began to emerge, made up of people who supported a significant investment in much-needed improvements in the professionalism of MSF. This group felt that the organization’s main priority should be to overcome amateurism. A second group formed around Bernard Kouchner, made up of those who were primarily focused on putting out powerful public messages and who were therefore willing to live with or even keen to maintain a degree of flexibility in how missions were organized. The first accused the second of being poorly organized, unrealistic, and not taking seriously enough the imperatives of efficient healthcare in individual missions. They criticized them for being satisfied with symbolic actions, and even of taking personal advantage of the benefits associated with media coverage of their activities. The second group, meanwhile, accused the first of wanting to tie the hands of a group of militants through bureaucratic organization, or of soulless professionalization. They prided themselves on being romantics, in the positive sense of the term (i.e., people who were ready to defend a cause and take the risk of speaking out in public whenever it became necessary). As we know, the first group was to win the day, in 1979, when a vote put Bernard Kouchner in the minority.Tangible progress towards overcoming amateurism first came in the form of innovation at a local level, at each site. Jacques Pinel, for example, a pharmacist and as such someone with a detailed knowledge that doctors generally lack, of all the issues around the transport, packaging, storage, presentation, and availability of drugs, began to organize the site and equipment in the Khmer refugee camps.See the interviews with Dominique Angotti and Jacques Pinel in the film L’aventure MSF. MSF sought to capitalize on these innovations, starting with defining and testing new treatment protocols, and then turning them into real “investments in form” (Thévenot, 1986). This work was developed and made an autonomous activity as part of the first “satellite,” MSF-Logistique (Vidal and Pinel, ch. 2). MSF used this structure to develop one of the basic specialist emergency assistance tools: the kit.

A kit is a set of related items (with specific instructions for use), prepared and packaged in such a way that they can be easily transported and used in a given type of situation in varying and often unpredictable locations. The kit principle predates the existence of MSF by some time; armies have long given them to their soldiers. The Red Cross used the same principle to prepare for and provide emergency assistance, starting with the famous Materia Medica Minimalis, developed in 1944 following a wide-ranging survey designed to assess the essential needs of people rescued from bomb-stricken cities in Europe (Redfield, 2008b). A kit designed for use in crisis situations must be able to be stored easily in a central warehouse so that it can then be transported quickly to where assistance is being provided. MSF’s work in this area has been innovative in two respects. On the one hand, as part of its efforts to overcome its own amateurism, MSF developed a whole series of new kits designed for the specific situations its staff were encountering. The innovation here was the extensive range of kits available. Some of them were to be adopted and authorized for use by other organizations, such as the Red Cross and the WHO. But there was another innovative aspect as well, namely the way that MSF kits addressed the relationship between standardization and specific uses. In general terms, any kit must comply with a high level of standardization. They are designed to be mass-produced according to strictly regulated procedures. But the designers do not see the use of kits and their future development in the same way. There are two possible scenarios. The “traditional” kit can be seen as a set package that imposes a sacrosanct set of standards on users. Adjustments are only barely tolerated.This is typically the status of technical items in “planned” organizations (Dodier, 1995).The kit is a rigid concept and all examples of the same kit are identical. As P. Redfield (2008b) shows, MSF developed much more “flexible” kits. The flexible kit, unlike the traditional one, is designed to be adaptable to the way it is used. The adjustments to which standards are subjected are to some extent encouraged. Changes are even meant to be recorded, retained, and worked on further so that new versions and even new kits can be developed in turn. These are “adjustable” (based on the user’s own view of the situation in the field) and “evolutive” (some adaptations may in turn result in changes to the kit).Here MSF is clearly part of a wider movement of transforming design methods in the industry (cf. Akrich, 1993), with implications for the production of kits (Akrich, 1992). It would be useful to carry out further research to examine how work related to kits is organised within MSF.The move away from amateurism was also seen in another area: being able to produce objective reports based on statistics. Initially, MSF relied on simple factors to defend the objectivity of its reports: the clinical competence of each ordinary doctor and the common sense of the moral spectator. The limitations of this policy quickly became apparent, particularly when, in the context of sometimes harsh debates with other extremely well-resourced parties (the WHO, local health authorities, and political powers), it became necessary to be able to push the introduction of evidence further. This prompted the need to invest in statistical skills and systems, such as those designed and taught by the Centers for Disease Control and Prevention in Atlanta around the epidemiology of intervention. MSF thus became part of the movement of NGOs that were made up of professionals, and equipped themselves with resources in terms of independent expertise (particularly in relation to epidemiology) in order to be able to infl public health issues when dealing with the other parties involved, in particular dedicated institutions.See for example F. Chateauraynaud and D. Torny (1999). A good example would be the Commission de Recherche et d’Information Indépendante sur la Radioactivité on the risks associated with the nuclear sector.An examination of the policy on statistics adopted by MSF reveals two ways of approaching innovation, in the same way as with their kits. First of all, as with the kits, MSF’s epidemiological statistics center was an autonomous internal unit, which was a way both of encouraging specialization in the areas concerned (and therefore strengthening the move away from amateurism) and of consolidating its independence. This led to the development of the statistics center known as Epicentre. On the one hand, as with the kits, there was evidence of seeking a balance between the contribution made by codifi and the pertinence of the judgments made by practitioners on the ground. Codifi serves to provide guidelines quickly, particularly in emergency situations, but a degree of trust in the local judgments made by doctors (sometimes in opposition to national or international authorities) also seems to be defended by the organization. At the same time, it frequently seeks a balance between the imperatives of codifi and attention to the observations made by clinicians outside the standard formats. It all relates to what C. Vidal and J. Pinel identify as a “culture of risk” (Vidal and Pinel, ch. 2).See also F. Chateauraynaud and D. Torny (1999) on how public health measures try to incorporate vigilance in relation to emerging risks that cannot simply be reduced to standard risk-calculation procedures (by attempting primarily to define a place for “whistleblowers”).Biomedical Research Rooted in Humanitarian ActionMSF’s first major investments in biomedical research (developing testing protocols relating to treatments or diagnostic techniques) followed close on the heels of the development of its epidemiological statistics center. Its research activities have continued uninterrupted right up to the present day.The following are mentioned in the publication in terms of biomedical research: meningitis: 1988 to 2005; malaria Artemisinin-based Combination Therapies (ACTs): 1994 in Thailand, up to 2004; meningitis vaccine 1996 in Nigeria, up to 2000; human African trypanosomiasis (sleeping sickness) 2000–2003; malnutrition, Niger 2005).They were made possible by previous events, but also led MSF into new debates and alliances. There were three main aspects to therapeutic and diagnostic innovation over this period. First of all, innovation within MSF was driven primarily by its desire to simplify treatments by drawing on a store of existing products. This was not so much about “reusing the old,” because the scale of the change required to simplify something was sometimes enormous. That said, it often involved making use of drugs that had previously been ignored, because they were of no interest to the pharmaceutical industry, at any rate in that particular market, which was not seen as sufficiently profitable.See, for example, among the cases covered by this publication: on malaria, research into a simple, fast diagnostic method and trials on derivatives of artemisinin (Balkan, Corty, ch. 8); another example is the revival of research into eflornithine to combat sleeping sickness (Corty, ch. 7).The fact that products were available allowed MSF to engage in research without discovering or developing new drugs as such. The focus on innovating by simplifying or adapting treatments that already existed to some extent reflects an ethical and political stance. It is about giving the disadvantaged the opportunity to benefit from scientific progress on the basis of the principle of equality of treatment for both rich and poor. As disadvantaged people are unable, in many cases, to take advantage of the most expensive, cutting-edge treatments as they stand, humanitarian biomedical research uses high-cost developments as a basis for identifying and testing those that could be made less complex and turned into a “realistic cutting-edge treatment.” It must be “cutting edge” (otherwise it would simply be a cheap version of a standard treatment), but it must also be “realistic” (otherwise it would simply be an illusion). The window of opportunity between a lack of realism and discrimination is certainly a narrow one. But it is also where one of the driving forces of humanitarian innovation can be found.

The second is the exploration by MSF of so-called alternative treatments. This is not in the sense of traditional treatments, but in the sense that people judge, based on clinical observations, that they have suffi conclusive information to try to have such treatments approved (by the national authorities, or by international agencies like the WHO), when they have not previously been through the standard approval process, often as the result of a lack of investment or, again, in markets that offer limited potential for profi (Baron, ch. 3; Le Pape and Defourny, ch. 4). Finally, the third driving force for biomedical innovation at MSF is the fact that the organization has to deal with specifi situations on the ground as a direct result of the work it does. Refugee camps are a good example. As confi spaces with large numbers of people in one area, they offer entirely new opportunities for observation (Corty, ch. 5; Balkan and Corty, ch. 8).

The 1990s and first few years of the twenty-first century were a good time for MSF to develop humanitarian biomedical research as the result of a historic conjunction of a number of factors. The first was an internal factor, namely the opportunity to use Epicentre for treatment trials. This was a necessary investment in a context where evidence-based medicine was becoming increasingly important at a transnational level. Against this background, MSF was able to take advantage of its well-established transnational position (operating in locations all over the world, sometimes affected by the same illnesses), which gave it the opportunity to set up multi-center trials or to move from one location to another in a series of trials that could then be subjected to meta-analyses. Finally, a large number of the illnesses studied during their research had already been the subject of scientific work in the context of colonial or military medicine. Many biomedical innovations of the 1990s were based on this body of knowledge and experience. Work was done on existing products that had previously been abandoned either to develop and test new protocols or, conversely, to prove that they were of no interest, primarily by providing objective evidence of the development of resistance, thus acting as an incentive to turn over a new leaf with respect to treatments that had finally been recognized as outmoded.Some of these drugs pending approval or rejection came from the post-colonial wars, particularly the Vietnam War. See on malaria: Balkan and Corty, ch. 8.

MSF has occupied an ambivalent position in relation to transnational evidence-based medicine (or TEBM). On the one hand, the organization has worked within the framework defined by TEBM, particularly in making use of Epicentre’s research and statistics capabilities. At the same time, however, members of the organization have expressed the gap between themselves and this framework on several occasions. They have done so either by indicating the purely instrumental nature of the relationship, which for them consisted of “resigning themselves” to TEBM as a way of persuading other parties based on a standard format, and giving themselves more influence in the often polemical debates between those involved, but still being conscious of the artificial or opportunistic nature of this stance, and publicizing this in various arenas (Balkan and Corty, ch. 8; Bradol and Szumilin, ch. 9). Alternatively, they explicitly showed a marked interest in treatments that had not been approved by TEBM: treatments that were supported by clinicians and particularly by local carers, but which had not been the subject of any standard studies (Biberson, 2000, p. 81).A more detailed study would help to explain MSF’s internal stance in relation to TEBM: are there real, long-term tensions within the organization, according to the proximity/distance of TEBM? Do the same people vary their position depending on which arena they are addressing? Is it possible to identify a trend within MSF, for example towards a closer relationship vis-à-vis TEBM, as we saw, for example, in the context of AIDS in France, including from those players who were initially opposed to it (Barbot, 2002; Dodier, 2003)?

Within TEBM, MSF’s position in relation to its direct contacts (national governments, international agencies, and pharmaceutical companies) has been built around three political factors, which have structured the debate for some fifteen years.For a discussion of the two political factors (the form of objectivity valued and the degree of autonomy given to patients) that have structured the controversies around AIDS treatments for twenty years, see Dodier and Barbot, 2008.The first political factor relates to the kind of objectivity valued by those involved. As we have seen, there were two opposing approaches to clinical trials for AIDS treatments in France (Dodier and Barbot, 2000). The strict approach to trials is infl xible in terms of compliance with randomized controlled trial standards. It imposes stringent constraints in the way evidence is managed before reaching a decision on the effectiveness of treatments. The “flexible” approach to trials still relies on TEBM systems but assigns value, within this framework, to the relevance of observations based on clinical competences or on knowledge of the reality in the field that cannot simply be reduced to the mechanisms of randomized controlled evaluations. Until now, MSF has largely positioned itself on the side of a flexible approach to trials both in debate and in its day-to-day practice. This is also the position that has tended to be adopted by contributors to this book, and based on their accounts it is often their starting point for judging the other players involved. It is clear that there are some important nuances within MSF in terms of the approach to trials. There are several references in this book to “internal resistance” to an overly flexible philosophy (demanding more rigorous constraints in relation to evidence) (Corty, ch. 5; Baron, ch. 3). Conversely, some contributions also raise criticisms about the excessively “strict” stance adopted by researchers (Baron, ch. 3).Compared with MSF, other players generally support a stricter approach to trials. This is the case when laboratories get involved in comparative studies (Bradol and Le Pape, ch. 1). They are therefore considered to have a “wait and see” attitude. The WHO generally appears as a defender of a strict approach to trials, which at the same time revives the more traditional criticisms made by MSF: its “bureaucratic” nature, the fact that it “stands firm on its recommendations” or is “slow” to react. The position of the national authorities is more variable. They are more likely to adopt a strict position within TEBM when they are examining a proposed innovation and conversely a more lax approach, compared with TEBM standards, for the management of routine medical practices. This was the case, for example, in relation to the position on malaria adopted by the authorities in Burundi in the controversy over ACTs (Le Pape and Defourny, ch. 4). In certain cases, however, this strict offi position sits alongside a certain degree of tolerance for practices and arrangements that could prove benefi (Balkan and Corty, ch. 8, on the Thai authorities in relation to malaria treatments; idem, ch. 8, on the Kenyan authorities). This more flexible approach by national governments (and sometimes MSF’s own work “on the fringe”) is often necessary for MSF to be able to carry out trials on treatments whose scope is necessarily uncertain.The second political factor concerns the emphasis placed on the diplomatic relationship between nations (and therefore the extent of national sovereignty desired) in supervising and promoting transnational biomedical research. All the contributions in this book tend to position MSF as a player that stands outside the diplomatic sphere, compared with others (such as the WHO and national governments) who are closely involved in it (on malaria in particular, see Balkan and Corty, ch. 8). For MSF, the influence exerted by diplomacy brings with it a whole series of negative consequences: less concern for the health of populations, less regard for the requirement of objectivity, more time taken to set up research projects, and a preference for silent diplomacy rather than speaking out publicly (on nutrition in Niger, see Le Pape and Defourny, ch. 4; and on malaria in Burundi, idem, ch. 4).On the necessity of democratizing medical research ethics, see for example Bradol and Le Pape, ch.1.Similarly, on several occasions MSF has distanced itself from national ethics committees (more so than the position adopted by the WHO), within the framework of a general approach that has aimed, again since the creation of MSF, and in a way that is highlighted here, to put the scope of national sovereignty into a more relative perspective (Bradol and Le Pape, ch. 1).It would be useful to examine to what extent it is possible for an NGO to be “adiplomatic” in negotiations designed to make biomedical research possible in the countries of the South. And conversely, to gain a better understanding of the reasons given by national and international authorities why MSF, and the authors of this book, sometimes rally quickly to criticise a kind of diplomacy that has clearly seems to have drifted.The polarized positions of the various players around the legitimacy of diplomatic-type arguments clearly converge with the fault lines created by the different approaches to trials discussed above. A more diplomatic approach often means a “slower” approach, which at the same time goes hand-in-hand with a stricter approach to trials (d’Alessandro, ch. 6).The third political factor that tends to oppose the various players involved in the transnational research carried out by MSF concerns the supposed capacity among resource limited countries to integrate biomedicine. MSF has a clear tendency, in various scenarios, to have more faith than other players in the ability of resource limited countries to integrate biomedicine. To reuse the terms I adopted in an analysis of the controversies surrounding therapeutic trials developed as part of the efforts to combat AIDS in resource limited countries (Dodier, 2003), MSF stands in the “rapid universalism” camp, while other parties oppose it from a position of “moderate universalism.” Several contrasting aspects are involved in assessing the ability of countries in need to “adopt” biomedical products: their ability to overcome operational or economic constraints, the ability of patients or their families to comply with treatment regimes, the data available, opportunities for access to treatment, the existence of specialist staff and their ability to provide training, and the level of stock available. In addition, there is the degree of “medicalization” of problems. In the sphere described here, MSF tends to attribute problems to the absence of biomedical products and to target solutions on delivering such products, compared with players who tend to “socialize” problems and who therefore attribute them to socio-economic factors and, as a result, are inclined to focus efforts in crisis resolution on development assistance. A typical case is the whole set of controversies surrounding malnutrition in Niger (Le Pape and Defourny, ch. 4). With this third political factor, we find in the various controversies reciprocal examples of rhetoric that are closely linked to the previous factors (the criticism of “slowness” in the name of “speed,” for example, corresponds to the criticism of the “simplicity” of MSF in the name of taking into account the issue of “complexity” [Bradol and Le Pape, ch. 1]).

Transnational medical research has thus been clearly structured, since the late 1980s, around a small number of political factors that come up regularly in controversial issues and that play a part in differentiating the players in transnational medicine along fairly well-established fault lines. MSF has occupied a fairly consistent position in this area and thus driven, through its investments in various diseases, a fairly well-defined style of “humanitarian research” that is rooted in TEBM but approaches it from an ethical and political position that combines an approach to trials, a relationship to diplomacy, and a relationship to the ability of countries to integrate biomedicine, all of which differentiate the organization both in relation to international agencies (primarily the WHO) and local authorities, and to a lesser extent to companies (which, in practice, have a limited presence in treatment trials). Alongside the innovative work in medical research that pits players against each other despite the fact that they are all working within TEBM, there was another, more radical push towards innovation that developed in the late 1990s, which aimed to transform the fundamental rules governing the production and availability of drugs on an international level. I shall attempt to describe the role played by MSF in this most recent phase of innovation.

 

Changing the Rules on Drug Production and Distribution at an International Level

It is worth taking a step back and reviewing how a system emerged in the 1980s which linked public health and changes in capitalism at an international level in a new way. A number of key players began to come together at that time around the idea that the pharmaceutical industry were not interested in diseases, that people were suffering or dying as a result of their lack of interest, and that combating diseases meant developing a new legal and economic framework designed to reawaken the industry’s interest in them. In the United States initially, and later in Europe, these diseases were known by the generic term “orphan diseases” and were subject to specifi regulations (Huyard, 2009). A little later other players, partially inspired by this new cause, came to reclassify as “neglected diseases” a number of tropical diseases which, although they affected large numbers of people, were also ignored by pharmaceutical innovation. Concerns about the fate of these diseases and the populations affected by them increased in the 1990s as a result of the fundamental changes that occurred in capitalism in general, and the pharmaceutical industry in particular, over the course of the decade. There was alarm over the increasing power of shareholders and the ensuing risks for diseases that were not suffi profi (Trouiller, 2000). The creation of the WTO in 1994, with the prospect of a consolidation of the ownership rights of pharmaceutical laboratories over drugs, and a radical reshaping of the whole economic structure of the pharmaceutical industry, also led to a great deal of comment and uncertainty amongst all those who were interested in the availability of treatments in poor countries.For further discussion of these questions, see Chirac, Dumoulin, and Kaddar in Brauman (2000).It was in the early 1990s that the WHO began to take specifi steps to organize efforts to combat neglected diseases on an international level (Dodier 2003, ch. 9).During the 1990s MSF found itself facing sudden, sporadic stoppages in the production of drugs that pharmaceutical companies deemed to be insufficiently profitable, but without linking these cases to the general cause of “neglected” diseases as such.Aventis, for example, stopped production of eflornithine, a medication used to combat sleeping sickness, in 1995 (Redfield, 2008a). In spite of promising results, in 1996, from the first trials on quick tests for malaria in Burma, the parent company stopped production (Balkan and Corty, ch. 8).In 1996 an MSF–Epicentre symposium began to develop the idea of neglected diseases as a cross-cutting problem (Vidal and Pinel, p. 28). Work on this cause began in 1999 with the launch by MSF of the Campaign for Access to Essential Medicines, known as the Access Campaign. At the time, the Access Campaign’s proposals for action focused on changes to the international rules governing the ownership, production, and distribution of drugs. These were an important development both in terms of transnational medicine at the time and MSF’s earlier areas of innovation, on three fronts.

First, because the lever for change was one that had not been used previously: international trade regulations. This was the supposed starting point for major changes in access to effective treatments for disadvantaged people. This new lever within transnational medicine went hand-in-hand with the shift in MSF’s activities towards economic questions and mobilizing new skills. The Access Campaign brought together not only pharmacists, but also lawyers, and economists.

Second, because in addition to MSF’s work on shifting legal mechanisms in relation to intellectual property (international regulations and action on national rights), it became involved in the whole of the production chain of generic drugs. Given the decisive stance taken in this new context by (public-or private-sector) organizations producing generics, the development of international regulations designed to control production of these quickly became a crucial issue (Bradol and Szumilin, ch. 9). MSF, however, was also determined to carry out its own checks on production conditions and the nature of quality control, and to negotiate selling prices (Bradol and Szumilin, ch. 9).

Finally, this new phase of innovation was accompanied by a significant shift in the organization’s approach to producers of pharmaceutical compounds. I have noted that, as far as medical research was concerned, MSF was working on trialing treatments downstream of producers of pharmaceutical drugs. This involved MSF both lobbying the companies and leaving them to take care of production.See for example Corty, ch. 7, and Redfield (2008b) on MSF’s repeated lobbying of Aventis to restart production of eflornithine to combat sleeping sickness.Hence, from this point on, there was a twofold relationship with the companies: the organization was both critical of them and at the same time sometimes worked in close cooperation with them. This ambivalence has tended to be further accentuated over recent years. On the one hand, criticism of the companies by MSF is now expressed in public to a much larger extent and in multiple arenas where MSF operates (Bradol and Le Pape, ch. 1). At the same time, however, MSF is more involved than previously in the upstream stages of pharmaceutical drugs through its participation in collaborative bodies bringing together international agencies, industries, and NGOs with the aim of reinvesting in the development of drugs for neglected diseases at an early stage. Thus MSF was behind the launch of the Drugs for Neglected Diseases Initiative (DNDi) (Vidal and Pinel, ch. 2; Redfield, 2008b, p.135) and acts as an intermediary with Glaxo, in the context of the development of vaccines by the International Coordinating Group (ICG ) (d’Alessandro, ch. 6).

 

Conclusion: Four Possible Histories

When we look back over all of these various phases and the connections between them, several histories seem possible. The first is a linear progression of humanitarian innovation for the last forty years, which has slowly brought MSF closer to cutting-edge medical research. In the beginning there was just an ordinary doctor. The doctor learned specialist skills, innovating in terms of logistics, and going on in a third phase to explore true biomedical research, although generally working on compounds that had already been developed. In the most recent phase, through its participation in collaborative bodies such as the DNDi or the ICG, MSF has become a quasi-developer of drugs and vaccines in conjunction with international bodies and companies. The next step would be for MSF to develop its own drugs.

The second history has just as many sequences and just as many different forms of innovation. The linearity of the previous account of MSF’s history hides the degree of variety. One cannot help but be struck by the ability of this protean organization constantly to renew the fronts on which it works to introduce new developments. Each sequence of its history thus equates to a break in the drive towards innovation. Targets change, as do the foundations on which innovation is based, as does the list of players involved. The group of doctors who founded the organization had a twofold target. Mainstream medicine in the first place, with its massive shifts (a form of medicine judged, in its different segments, as commercial, bureaucratic, or dogmatic), which prompts these doctors to try to develop another kind of medicine elsewhere. Then there is the silent neutrality of the Red Cross. What, then, drives change? Basic medicine and a willingness to speak out about the suffering in this world. The result is the creation of an entirely new kind of doctor. In a second phase, basic medicine itself becomes the target. It is too “amateur.” The organization begins to rely on more specialist areas of medicine (pharmacists and their understanding of packaging, the kit tradition, the epidemiology of intervention) to produce new kits designed to meet the specific requirements of the situations it encounters, and to set up the statistics center needed for independent humanitarian epidemiology. In a third sequence, the target moves again: this time it is standard, routine, “official” treatments, often approved by the WHO or national authorities and used in countries with disadvantaged populations. Investing in the methods used by TEBM becomes a way of demonstrating the limitations of these treatments and gaining approval for entirely new treatments, dealing with many controversial issues along the way. Lastly, in the most recent phase, MSF attacks the pharmaceutical firms in Western countries and their responsibility for the enormous difficulties of access to treatment faced by disadvantaged populations in resource limited countries. It can then draw on the significant reorganization, during the 1990s, of the list of players involved in the drug distribution business: the rise of a generics industry in these countries and the emergence of an alterglobalist battle against new laws on international trade. In fighting economic and legal battles, the organization contributes to the emergence of new international trade legislation, to a better deployment of the generic drugs chain (from the producer to the patient), and to the emergence of collaborative consortia structured in different ways to develop new products.

While this version of its history highlights the significant new areas of innovation MSF has tackled within transnational medicine, it has one important limitation: it does not identify what is “structural” in this series of phases. At a certain level, in fact, MSF has always approached humanitarian innovation in the same way. On to the third version of its history, then: the repetition of an underlying pattern of innovation. The same basic pattern is repeated in each sequence, and always consists of two parts. First comes innovation within an existing framework. At each stage, MSF will seek specialist tools which, added to an existing base, enable the development of new entities. Initially there was transnational medicine that supplanted humanitarian organizations with a limited medical focus (e.g., the Red Cross).

This was followed by humanitarian medicine with specialized logistic support and an epidemiological statistics center. Next, again building on this body of knowledge and experience, came humanitarian medicine able to carry out scientific testing of innovative treatments that were becoming increasingly important in relation to standard treatments. Finally, there was the development of an entire production chain that used generics to give the world’s poorest people access to cutting-edge treatments derived from research in Western countries. But in addition to innovating within an existing framework, MSF always adds a change of framework alongside it. The organization in fact always seeks to identify the problems in an established framework. This is, in some sense, the political dimension that MSF adds to each of these stages. In the first stage, for example, MSF added something extra to the idea of the “ordinary doctor”: a commitment to speaking out in public, against the notion of neutrality as instituted by the Red Cross as the dominant model for humanitarian action. In the second stage, that of producing kits, MSF added a commitment to take into account the views of practitioners who actually used the kits. MSF did not simply produce new kits, but was committed to designing a new kind of kit. It differentiated itself from the technicist view of innovation advocated by designers who believed they held the key to the truth about new items and their uses. In the third stage, in addition to discovering new treatments, MSF adopted a slightly critical stance towards evidence-based medicine and advocated a flexible approach to trials that should take into account, once again, the skills of practitioners in the face of the dogma of a stricter approach. In the final stage, innovation within an existing framework was represented by the establishment of well-equipped distribution channels for generics. Changing the framework involved mobilizing people to change intellectual property law, primarily by significantly extending the scope of the argument for exceptions for healthcare products. In this systematic approach of starting with innovations within a framework and then moving on to developing the framework itself, MSF reveals a fundamentally political tendency, which should no doubt be better understood in terms of how and why it has persisted through the various historical sequences.

I would like to conclude on a fourth version of the organization’s history: the changing relationship with transnational standards. Transnational medicine faces two requirements on an ongoing basis. On the one hand, it develops transnational standards designed to apply to the whole of the planet. On the other hand, it must necessarily adjust to the specific local characteristics where operations are underway. Tensions, going back and forth, compromises, and seeking balance between, on the one hand, the extreme of a radical standardization of practices, and, on the other, an openness that is endlessly reconstructed to deal with the situations encountered during the course of operations, are at the heart of all the frictions seen in transnational medicine, whatever form it takes. By taking a stance, MSF has proved it is no exception to the rule. The consequences of its medical innovations can be seen as a series of different positions on the question of standards. In the initial stage, one would be tempted to refer to standards overwhelmed by reality. The “ordinary doctor” has a basis of knowledge and tools but also a set of core ethics that any properly trained doctor is supposed to have. Such a basis, however, seems insignificant in light of the great barrage of people and issues faced, and the doctor struggles to find a response, particularly in a crisis situation. During stages two and three, what was dominant within MSF, whether in the use of kits or drug trials, was the search for balance: operating in line with standards that themselves incorporated a practice-based critique of standards, one which took note of the pertinence of clinical judgments that cannot simply be reduced to an approach based on standard procedures, and tried to find an appropriate relationship between standards and practice.

In the final stage, the emphasis was on strong standards that were legally enforceable at an international level and intended to be imposed across the world. An adjustment in the law is only envisaged at a very far remove from practices on the ground: at the level of national laws, over which legal battles are waged, and which take account of specific national characteristics on a case-by-case basis. In this instance, MSF has moved away from the concerns of practitioners to act at a more decontextualized level. There is one major element missing from this history: an anthropological criticism of standards, one which takes cultural or societal diversity as its starting point and opens up the debate on the possibilities of thinking in broad terms about the conditions under which transnational standards can be combined with the specific characteristics of each society concerned. MSF’s publications are nonetheless full of reflection (and even self-criticism) on the conditions for incorporating cultural diversity in transnational medicine.22 As a number of anthropologists and sociologists have shown (Christakis, 1992; Delvecchio Good, 1995), biomedicine is always confronted, including in its most advanced sectors in terms of cutting-edge biomedical research, with the real core of evidence-based medicine and with the necessity of thinking about its relationship with other ways of dealing with people, their bodies, and the world in which they live. Will this current blind spot in MSF’s reflection on medical innovations continue in the next wave of innovation on which the organization embarks?

This is one of the main contributions of the book edited by Rony Brauman (2000). See in particular on this point contributions by Philippe Biberson, based on the MSF mission in Guinea between 1985 and 1990, and by Eric Goemaere, based on the mission in Chad between 1983 and 1987.

 

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