Essential Drugs and Their Critical Legacies
Expanding access to pharmaceuticals has become one of the most visible planks of twenty-first-century global health efforts. This is evidenced by the moral urgency of antiretroviral rollout to combat the global HIV/AIDS pandemic, the pressing call for new drugs for neglected diseases in the global South like tuberculosis, malaria and trypanosomiasis, and the increasing interest in long-term pharmaceutical delivery systems to address the rising prevalence of chronic disease in both global North and South (Greene 2010).1 The outsized role prescription drugs now play in international public health is all the more evident when compared to the relatively small role of pharmaceuticals in the framing of international health organizations like the World Health Organization (WHO) in the mid-twentieth century.
The increasing power of pharmacotherapeutics to cure or mitigate disease, from antibiotics to antiretrovirals, has without doubt played an important role in this transformation. Yet the centrality of pharmaceuticals in global health practices today cannot be explained by efficacy alone. Rather, it is as much a consequence of shifts in international politics, multinational capital formations and transnational networks of consumer advocates, pharmacological experts and consumer activists as it is a shift in the overall effectiveness and relevance of medicines. It is perhaps not surprising given these larger scale societal changes that pharmaceutical modalities have come to dominate biomedical imagination over the late twentieth and early twenty-first century. But it is quite important to ask how the field of global public health – which so frequently defines itself as a preventive, upstream alternative to curative, downstream biomedical approaches to disease – has now come to feature pharmaceutical delivery so prominently.
Recent observers of this “pharmaceuticalization of public health,” have depicted this historical process as a relatively recent state change from a prior, nonpharmaceutical mode to a present pharmaceutical one, often linked to one or more fin-du-siècle crises: globalization, neoliberalization or the new materialism of emerging infectious diseases like HIV/AIDS and multidrug-resistant tuberculosis (Biehl 2007; Nguyen 2010; Williams, Martin and Gabe 2011; Koch 2013). Such accounts – like many “-ization” narratives in the sociology of health and medicine – are accounts of rupture which emphasize change over continuity. From the historian’s perspective, however, the critique of the increasing role of pharmaceuticals in global public health is not unique to the twenty-first century, and it is important to pay attention to the threads of continuity and contingency that link both present and past.
The essential drugs concept combined two emergent critical discourses regarding the role of biomedicine in public health – the overuse of biomedical technologies in the global North and their underuse in the global South – in a manner that was highly resonant with changes in the politics of international development and international public health in the 1970s. Critics of pharmaceutical overuse adopted newly available critiques of medicalization – as framed by Ivan Illich (1975), Archie Cochrane (1979) and others – to argue that too many pharmaceuticals were being consumed to combat problems best addressed by preventive, social or economic interventions. Critics of pharmaceutical underuse, in turn, tended to use available critiques of political economy and dependency theory to argue that inequity in the production, distribution, patenting and pricing of pharmaceuticals made a large number of truly effective medicines unavailable to large populations of patients in poor countries unable to afford them. As objects which addressed both questions, essential drugs became an ideal test case of Mahler’s vision of how “appropriate technologies” should be disseminated through the health systems of the developing world: not too many, not too few, but just enough.
Essential drugs were renamed essential medicines at the turn of the twenty-first century, partly to downplay the increasingly negative connotations of the term “drug.” And yet while both terms might ostensibly refer to the same concept, the actors, interests and politics that began to crystallize around essential medicines in twenty-first-century global health practice constituted a very different formation than those that clustered around essential drugs in the 1970s and 1980s. Though one might use the terms essential medicines and essential drugs almost interchangeably, their usage serves to divide historical periods: essential medicines is a twenty-first-century term while essential drugs was largely a twentieth-century term. Viewed in close apposition, these critical engagements old and new offer an opportunity to explore how critiques of the role of pharmaceuticals in public health have grown in resonance and relevance at the same time they have lost their analytic coherence.
Emergence of a Critical Discourse on Global Pharmaceuticals
The concept of essential drugs did not spring fully formed from Halfdan Mahler’s office in Geneva in 1975 like Athena from the head of Zeus. In articulating a concept of essential medicines, Mahler implicitly referenced a much older set of concerns within military medicine, colonial medicine and humanitarian intervention that had developed a logistical language of which drugs were essential to the maintenance of public health in out-of-the-way places and which were not: including the “materia medica minimalis” kits developed by the Red Cross to be able to rapidly deploy needed medical care in the setting of a humanitarian crisis (Evatt 1881; Redfield 2008, 2013). In the rapidly changing landscape of international health and development in the 1970s, the introduction of the essential drugs concept into the WHO mission also sat at the intersection of several critical discourses of health, technology and development. These included a series of critical reassessments of modernization theory by bilateral and multilateral aid organizations, critiques of pharmaceutical pricing and provision in the recently independent Southern nations of Sri Lanka, India, Pakistan and Brazil, and a skepticism of the engines of pharmaceutical promotion in the medicalization of everyday life by prominent academics and consumer advocates.2
The same surge in pharmaceutical research, development and marketing that made the miracle cures of penicillin, cortisone, chlorpromazine and streptomycin widely available in the early postwar era also pushed forward many less-than-miraculous cures that began to glut markets in both the global North and South.3 By the early 1960s – most notably in the wake of the global thalidomide disaster – the pharmaceutical industry became the subject of increased public, professional, journalistic and public critique. An ensuing set of regulatory measures intended to protect drug consumers in the USA and northern Europe swiftly reduced the number of brands on the market, and required stringent proofs of efficacy and safety for the marketing of prescription drugs in these nations (Daemmrich 2003). The deployment of effective state-based regulation among nations of the global North, however, would paradoxically work to augment international disparities in drug quality between North and South.
By the mid-1970s, a number of journalists had written popular exposés of the “dumping” of inferior pharmaceuticals (newly unmarketable due to safety and efficacy concerns in the global North) for sale in relatively unprotected markets in the global South (Mintz 1965; Silverman and Lee 1976; Medawar 1979; Melrose 1982). Ironically, those states that had the least ability to regulate the quality of their drug supply spent the highest proportion of their national health budgets importing pharmaceutical products. For example, by 1976, Thailand spent 30.4 percent of its public health budget on drugs, while Bangladesh spent 63.7 percent of its budget on prescription medicines. Disparities between North and South could also be quantified in terms of the sheer number of potentially useless drugs being marketed in the global South compared to the more highly regulated markets of the global North. By the early 1970s, Norway allowed the sale of only 1,000 drug brands, Brazil and Argentina had 24,000 and 17,000 brand name drugs on the market, and the Egyptian market contained a dizzying array of more than 50,000 brands, most of dubious provenance (Kanji et al. 1992).
Many of these journalists and activists who protested the overuse of worthless and wasteful pharmaceuticals in the global South were located in civil society groups in the global North and were influenced by newly available critiques of medicalization, on the one hand, and a growing critique of the powerful role of multinational corporations on the other. Critical works such as Robert Ledogar’s (1975) Hungry for Profits, and Barnet and Muller’s (1976) Global Reach: The Power of Multinational Corporations cast Northern-based multi-national companies – Pfizer, Merck and Bristol-Myers among them – as rapacious and unaccountable institutions that squeezed money from the poor health budgets of low-income nations and then applied insidious pressure to any national policies which threatened their profitability.4 These critiques of waste and overuse, however, would clash with another set of critiques of inaccessibility and underuse, grounded in the language of political economy and development economics.
The 1970s had also witnessed a period of critical reassessment of development strategies within both United Nations agencies and Bretton Woods institutions such as the World Bank and International Monetary Fund. On some level, the goal of transferring biomedical technologies from North to South had been a part of the larger economic development rhetoric since the end of the Second World War. Yet as Paul Cruickshank (2011) has noted in his recent study of health and international development from 1968 to 1989, the decade of the 1970s witnessed a broadening of the metrics and meanings of development. Following prominent critiques from development economists Gunnar Myrdal (1967) and Dudley Seers (1969), the focus of earlier modernization theorists was critically redesigned to include measures of health and well-being that stretched beyond the gross domestic product (GDP). The result was the approach that World Bank chief Robert McNamara eventually called the “Basic Needs Approach,” which included a series of health indicators in its metrics of economic development (Cruickshank 2011).
McNamara and his circle of modernization engineers in the 1970s were influenced by the teleological theories of demographic and epidemiological transitions developed by postwar population scientists (Teitelbaum 1975; Packard 1997). In one particularly widely cited article in the Milbank Memorial Fund Quarterly, Egyptian-born physician and population scientist Abdel Omran traced the historical evolution of the health profile of a given society as a fixed series of stages proceeding from an “age of pestilence and famine” to an “age of receding pandemics” to an “age of degenerative and man-made disease” (Omran 1971:49). While some countries, like Japan, had passed from stage 1 to stage 3 in an “accelerated transition” through rapid Westernization, Omran singled out countries of the global South – such as Ceylon – as being lodged in a “delayed model.” Omran’s teleology of health and development held out the hope that with proper attention to technology transfer, modernization of the health profiles of the developing world could be “significantly influence[d] by medical technology,” especially “imported medical technologies” like modern pharmaceuticals (Omran 1971:510, 522; Weisz and Olshenko-Gryn 2010).
The vital question of access to new medical technologies was not lost on physicians and pharmacologists in recently decolonized countries. Where Omran had singled out Ceylon as an example of a country whose development was being “delayed,” Senaka Bibile, founder of the first department of pharmacology on Ceylon was at the same time depicting this dependence on imported pharmaceuticals as a problem that could be solved – through the selection of a short list of essential drugs which could be generically obtained through competitive bidding at a price that would be more feasible for the long-term solvency of a postcolonial healthcare sector.5 In October of 1970, Bibile was tasked (along with socialist M.P. and fellow physician S. A. Wickremansinghe) “to look into and correct the needless loss of foreign exchange in the import of drugs” (Associated Newspapers of Ceylon 1978:12). The resulting report, published in March 1971 and picked up by the British Medical Journal later in the year, argued that benefits of modern pharmacotherapy could only be realized in Ceylon by adopting an aggressive policy prioritizing essential over inessential drugs, generic drugs over brand-name versions, and bringing costs down through competitive bidding, local formulation and rational use (Wickremansinghe and Bibile 1971a, 1971b). In 1972, the governing United Front coalition changed the name of the country from Ceylon to Sri Lanka, and created the State Pharmaceuticals Corporation of Sri Lanka (SPC), which implemented Bibile’s plan from 1972 until the collapse of the coalition in 1976.
By that time, a handful of newly independent nations with socialist governments like Sri Lanka had likewise attempted to nationalize their drug industries and create restrictive formularies that would limit their pharmaceutical markets to a small list of generically prescribed essential drugs. But as with Sri Lanka, these unilateral attempts to enact national essential drug policies almost universally succumbed to political and economic pressures attributed to multinational pharmaceutical concerns.6 Ensuing critiques of North–South inequalities in drug quality and pricing became a visible example of a broader critique of multinational corporations by health ministries of the global South (and sympathetic academics and activists within the global North). Pharmaceuticals became a plank in the international politics of the Non-Aligned Movement when the Fifth Non-Aligned Conference in Colombo (1976) adopted Resolution 25, urging all developing countries to cooperate with international organizations to promote the production, procurement and distribution of pharmaceuticals (UNCTAD 1982).
Conflicts over Essential Drugs in the 1970s and 1980s
By the late 1970s, the essential drugs concept had become a powerful and morally salient discourse for recently decolonized nations of the global South to call for action en bloc in multilateral institutions like the United Nations Conference on Trade and Development (UNCTAD), the United Nations Centre on Transnational Corporations (UNCTC) and the WHO. After broaching the issue with his address to the World Health Assembly in 1975, Mahler tasked the pharmaceutical division of the WHO to form an expert committee that would define an “essential drugs philosophy,” create a list of essential drugs and provide technical advice on how such a list could be translated into increased universal access to pharmaceuticals worldwide. The team visited twenty-five countries in four of six WHO regions to interview Ministry of Health officials, doctors, pharmacists and health providers to understand pharmaceutical utilization across all levels of the healthcare systems, and then convened a series of expert panels in Geneva in 1976 and 1977. The committee met to finalize the report in Geneva in October 1977 and circulated the list to regional and national offices for commentary before publication.
The formal definition of essential drugs in the WHO Technical Report 615, “The Selection of Essential Drugs” (1977), privileged prevalent conditions over rare diseases, older drugs of proven efficacy and safety over newer drugs, single agents over combinations and generic names over brand names. As a global reference, the model list of 186 medications was understood to be adaptable by region, country, province, and subdivided by strata of care from primary care clinic to local hospital to tertiary medical center. As a working draft circulated in 1976 noted, the “major objective in the ‘essential drug list philosophy’ is to reach the greatest number of patients/people with acceptable standards of drug treatment, within the limits set by the resources available, at a certain time or under the actual circumstances” (WHO 1976). Assuming some variance in the burden of disease between temperate and tropical zones, the total number of drugs essential to any one region might range from 50 to 250 active substances (WHO 1976).
Although the first WHO model list of essential drugs was almost exclusively comprised of off-patent medicines that posed little immediate threat to world markets for newer brand-name pharmaceuticals, the list was met with immediate protest by the pharmaceutical industry (Egli 1977). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) – a consortium of national drug industry lobbyists that set up offices in Geneva and had by the late 1960s been officially recognized as a WHO-affiliated nongovernmental organization (NGO) – responded that the essential drugs concept was “completely unacceptable to the pharmaceutical industry” (SCRIP 1977). As Michael Peretz, the IFPMA’s permanent vice-president, later explained, “if WHO was recommending a list of essential drugs it would follow that WHO was implicitly arguing that all other drugs not included in the list were non-essential” (Peretz 1983:132). In a formal statement to Mahler in April 1978, the IFPMA outlined their “serious reservations” that the essential drug concept was both “untenable and patently harmful to medical practice and the public health.”7
Subsequent diplomacy between the WHO and the IFPMA sought to fine-tune the essential drugs concept in a manner palatable to industry. When published in 1979, the Second Model List of Essential Drugs made two of these restrictions clear: first, that the concept of essential drugs in no way suggested drugs not on the list were inessential, and, second, that the concept of essential drugs would be restricted to the health needs of developing countries (WHO 1979a, 1979b). With these revisions, the IFPMA dropped its direct opposition to the idea and began to steer its member companies to provide a handful of essential drugs for “favorable prices” for the poorest countries: a set of negotiations that would ultimately lead to the development of tiered pricing policies between developed and developing nations.
By the early 1980s, conflict over essential drugs shifted from the practice of list-making to the challenge of implementation (Hey 1978; IFPMA 1978; Reich 1987). The focus of debate now hinged on the structure and function of a newly created WHO Action Program on Essential Drugs, which reported directly to the office of the Director-General and was tasked with building “national capabilities of developing countries in the selection, supply, and proper use of essential drugs to meet their real health needs and in the local production and quality control, wherever feasible, of such drugs” (WHO 1978). The terms of how the essential drugs concept might be implemented would be contested by stakeholders from the WHO, target nations, industry and a newly formed transnational network of consumer advocacy groups focused on pharmaceutical policy, called Health Action International.
Health Action International (HAI) was founded in Geneva in May 1981 in the wake of the successful bid by International Baby Food Action Network (IBFAN) to pressure the WHO to enact an international code of infant formula marketing.8 Along with IBFAN, HAI represented a more access-oriented stream of international consumer activism that had become the priority of the International Organization of Consumers’ Unions (IOCU) since its presidency and policy headquarters had moved southwards from the Hague to Penang, Malaysia, under the charismatic leadership of Anwar Fazal. In the 1960s the IOCU had largely represented a transatlantic association of consumer-testing organizations in affluent societies (like the American Consumers Union, which produced the consumer products ratings featured in Consumer Reports). By the 1970s, its membership included a greater number of consumer organizations in South and Southeast Asia, sub-Saharan Africa and Latin America. This new global geography of membership forced the IOCU to redirect the emphasis of its policy efforts away from the politics of consumer choice (within a world of excessive marketing) to the politics of consumer access (within a paucity of essential commodities) (Hilton 2009).
The underlying problem is not that there is not enough to go around, nor that in most developing countries, the conspicuously inessential drugs far outnumber the essential ones. As things stand – in the absence of clean water, good nutrition and basic health delivery systems – to supply even the most valuable of drugs can be like putting the proverbial cart before the proverbial horse. (Fazal 1983:265)
HAI’s advocacy and activism walked a fine line between the dialectic of critiquing problems of overuse and underuse. To extend Fazal’s metaphor, HAI was committed to the provenance of both cart and horse. Redefined from the perspective of the global South, Fazal argued, the goal of consumer activists should be a double thrust – both to address nonpharmaceutical solutions to public health problems and, where relevant, to demand access to “the right pharmaceuticals at the right price” (Fazal 1983:265).
To summarize, the policy battles over the definition and implementation of essential drugs in the 1970s and early 1980s were forged along geographical as well as ideological divides. As the IFPMA president Max Tiefembacher would pointedly comment, the international pharmaceutical industry saw the essential drugs concept as antithetical to Western definitions of civil rights, adding that “[i]n a totalitarian regime, this may be enforceable, but in a free society this may be neither feasible nor practicable” (Tiefembacher 1979:212). By 1984, conservative think-tanks in the USA such as the American Enterprise Institute and the Heritage Foundation joined the Pharmaceutical Manufacturers of America (PMA) and later the Reagan administration in citing essential medicine implementation as an overextension of the WHO’s constitutional role.9
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