Aula 13 - Greene

Original Article
Making medicines essential:

The emergent centrality of
pharmaceuticals in global health
Jeremy A. Greenea,b
a
Department of the History of Science, Harvard University, Cambridge, MA, USA.
b
Division of Pharmacoepidemiology, Brigham & Womens Hospital, Boston, MA, USA.
Abstract Expanding access to pharmaceuticals has become one of the most visible aspects of
twenty-first century global health practices, as evidenced by the moral urgency of antiretroviral rollout
and the pressing call for new drugs for neglected diseases. However, the role of prescription drugs in
public health was far less obvious to the framers of international health organizations only a half-
century ago. This article examines the evolving role of pharmaceuticals in global health practices by
charting the emergence of the category of essential medicines: initially a list of 186 drugs first
defined by the World Health Organization (WHO) in 1977 to be basic, indispensable, and necessary
for the health of the population, and subsequently expanded by actors beyond the WHO including
NGOs, pharmaceutical companies and the broader financial community. This apparently simple act of
list-making worked to transport a set of commodities from the private, commercial sphere into a
public health commons, and sparked a series of methodological, logistical and political controversies
over the winnowing of essential from inessential that collapsed evidentiary, regulatory, participatory
and market terms into a single process. To ask what practices render a medicine essential? is
therefore to address the shifting ecology of knowledge governing global health today.
BioSocieties (2011) 6, 1033. doi:10.1057/biosoc.2010.39
Keywords: global pharmaceuticals; global health; international health; essential medicines;

pharmaceutical industry; essential drugs
Introduction
Expanding access to pharmaceuticals has become one of the most visible planks of twenty-
first century global health efforts, evidenced by the moral urgency of antiretroviral rollout to
combat the global HIV/AIDS pandemic, the pressing call for new drugs for neglected
diseases 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.1 However, the role of prescription drugs in international
1 On the emerging ethnography of antiretroviral rollout, see Fassin (2007), Biehl (2009), Nguyen (2010) and
Mahajan (2010). On neglected diseases see Light (2010). On pharmaceuticals for chronic disease see Yach
et al (2004).
r 2011 The London School of Economics and Political Science 1745-8552 BioSocieties Vol. 6, 1, 1033
www.palgrave-journals.com/biosoc/
Making medicines essential
public health was far less obvious to the framers of international health organizations only
a half-century ago. The 1946 constitution of the World Health Organization (WHO) barely
mentioned pharmaceuticals, and for decades its systematic drug policies were largely limited
to the standardization of nomenclature. How did access to pharmaceuticals, once a
negligible concern of public health practice, come to assume such prominence in global
health practices today?
The answer is not simply that the drugs of today work better than those of the mid-
twentieth century, although the increasing power of drugs to help or harm is clearly one
factor in the developing biopolitics of pharmaceutical access. Rather, the centrality of
pharmaceuticals in contemporary global health projects must be understood as a product
of simultaneous biological, technical and social changes, 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 was a shift in
the overall effectiveness and relevance of medicines. It is perhaps not surprising that
pharmaceutical modalities have come to dominate the general 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 defined itself in opposition to
biomedical approaches to disease has now come to feature pharmaceutical delivery so
prominently.
This article sketches a historical narrative of pharmaceutical ascendance within global
public health by narrating the late twentieth century emergence of a discourse of essential
drugs, renamed essential medicines at the turn of the twenty-first century to downplay the
perceived negative connotations of the term drug.2 This concept gained global visibility
when it became a central tenet of WHO policy under the leadership of Director-General
Halfdan Mahler, when he warned the 1975 World Health Assembly of an urgent need to
ensure that most essential drugs are available at a reasonable price, and to stimulate research
and development to produce new drugs adapted to the real health requirements of
developing countries (Mahler, 1975). Mahlers speech hinted at an impending double shift
in the role of pharmaceuticals in world health. On the one hand, the speech presaged
Mahlers efforts to redirect WHO priorities away from disease-specific vertical programs
and toward more horizontal efforts to support comprehensive primary health care (PHC)
systems, most visibly reflected in the 1978 Declaration of Alma Ata. On the other hand,
Mahlers speech delineated a more activist move for the WHO in the medicines arena,
extending beyond the normative setting of pharmaceutical standards toward the broader
project that AIDS activists of later decades would call getting drugs into bodies (Gould,
2009).
The essential drugs concept sought to carve out a core subset of therapeutic substances
from the broader universe of commercial pharmaceutical products, and appropriate them
into a public health commons. On paper, essential medicines joined clean water, adequate
housing and a safe food supply in a short list of things whose absence constituted a basic
humanitarian failure within the language of universal human rights. This move to recast a
2 Though I use the terms essential medicines and essential drugs almost interchangeably, they serve to divide
historical periods: essential medicines is a twenty-first-century term whereas essential drugs was largely a
twentieth-century term.
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Greene
set of profitable and privately produced commodities in terms of global public utility
provoked a series of political skirmishes over the definition and implementation of the
essential drugs concept and the conduct of the sub-agency the Action Program on
Essential Drugs that Mahler had created to promote its uptake and that reported
directly to his office. As I will soon describe, these conflicts mirrored NorthSouth and
EastWest tensions in the Cold War politics of international health in the 1970s and
1980s.3
Although public debates over essential drugs would fade after the end of Mahlers third
and final term in 1988, the essential medicines concept would resurface in reinvigorated
form in the late 1990s and 2000s through the agency of a number of other actors
outside the WHO including NGOs, philanthropies, pharmaceutical companies and the
broader financial community. Prompted partly by limited access to antiretrovirals and
diminished pipelines of drugs for neglected diseases, this diffuse network of public and
private actors often worked laterally rather than through national and international
channels in their efforts to bring relevant drugs to needy populations. This novel
assemblage is in turn emblematic of the recent shift from international to global health
governance.
Separating essential medicines from inessential medicines is conceptually easy at the
fringes: today, it seems strikingly inhumane for any person anywhere to die from an
illness treatable with a shot of penicillin, whereas any argument for the essentiality of
Botox injections or Viagra appears laughable if not simply macabre. But the middle
terrain has been harder to define with any bright line. How many classes of antibiotics
are necessary to cover for potentially resistant strains? How many variations of drugs
within the same therapeutic class are necessary to present alternatives for patients with
adverse or insufficient responses? In turn, the taxonomy of therapeutics required in
order to prepare a pharmaceutical Noahs Ark in which each kind of medicine is
represented by one generic form has itself been highly contested. A closer look at the
essential medicines concept reveals long-standing technical, logistical and political
conflicts over who determines and how one determines which drugs are essential to the
health of the public.
This article, an early report from an ongoing research project on the history of
essential medicines, narrates three moments in the evolution of the essential medicines
concept as a means of exploring continuity and change within global health practices.
First, it situates the genealogy of essential drugs within older projects of choosing key
medical supplies for global health efforts as structured by colonial health practices and
the early postwar formation of the WHO. Second, it explores the formal articulation
of the essential drugs concept as a form of critical discourse and site of contestation
within the Cold War politics of international health in the 1970s and 1980s. Third, it
briefly discusses the renewal of a discourse of essential medicines in the 1990s and
2000s, before concluding with a description of how contemporary global health
practices have been structured around the increasingly visible need to facilitate access to
pharmaceuticals.
3 On the politics of international health agencies in the Cold War, see Douglas (1987), Mingst (1990), Siddiqi
(1995), Brown, Cueto and Fee (2006).
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Essential Drugs Before the Fact

Most histories of essential medicines take as a starting point Mahlers 1975 address to
the World Health Assembly,4 or the formal definition of essential drugs 2 years later in the
WHO Technical Report No. 615, Selection of Essential Drugs, which designated a list of
186 pharmaceuticals known to be of the utmost importance and y basic, indispensable,
and necessary for the health needs of the population (WHO, 1977, p. 9). Two years later, an
Action Program on Essential Drugs was created, and by the end of the twentieth century
some 156 countries had developed functional essential medicines programs. The short
history of essential medicines can therefore be narrated as an institutional history of one of
the more successful and long-lasting programs within the WHO.
Yet, the concept of essential drugs did not spring fully formed from Mahlers mind in
1975, like Athena from the head of Zeus. To understand the role of essential medicines in
contemporary global health practices, it is crucial to situate the 30-odd-year history of this
policy instrument within a broader genealogy of commonsensical and institutional practices
that sought to distinguish those therapeutic substances vital to the health of the public from
others vital only to the survival of their manufacturing firms. In global context, it is
especially important to attend to the institutions of imperial therapeutic supply that would
inform the assemblage of international health agencies in the 1940s, and continue to
structure medical care during and after the decolonization movements of the 1950s through
the 1970s.
Colonial medicine was closely (often explicitly) related to military medicine, and the
importance of key therapeutic objects to global colonial ventures has been an object of
historical discussion since Headricks (1981) controversial claim that quinine prophylaxis
for malaria represented the single most important tool for European imperial expansion
into the African interior.5 Even if quinines material significance was over-estimated in
Headricks account, the perceived importance of maintaining supplies of quinine and
plantations of the cinchona tree from whose bark it was derived had been understood by
European powers to be essential to maintaining military control of occupied tropical
regions well into the twentieth century (Slater, 2009). This vital intersection of materia
medica and Empire still rang clear to the author of an editorial in the Lancet during the
Second World War:
The entry of Japan into the war will interfere with our future supplies of such drugs
as menthol, camphor, agar-agar, and quinine, and we must look more to the Empire
as a source of them than we have done in the past. Can the Empire supply them and
why do we not produce all the drugs we need within it? (Drug supplies from the
empire, 1942, p. 21)
To rationalize therapeutic restrictions during the wartime economy, the British Empire
created a list dividing drugs which are regarded as essential from drugs which are not
4 Though Kanji et al (1992) provide a broad synthetic account and Chowdhury (1995) a detailed case-study
of essential drugs in Bangladesh, most histories of essential drugs to date have been actors narratives, for
example, Quick et al (2002), Quick (2003), Helling-Borda (2003), Laing et al (2003), with the exception of
Robertson and Hill (2007).
5 For critique of these claims, see Cohen (1983), Arnold (1988), Worboys (2000).
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essential and do not justify importation or manufacture in war-time.6 This list-making

project of selecting essential drugs was grounded within a much longer military medical
tradition of selecting which therapeutic supplies were essential to carry on the person of all
enlisted men, which should be carried by the combat medic, which items needed to be carted
in supply chains to the battalions tent infirmary and so on.7 In spite of the remarkable
developments in alkaloid pharmaceutical chemistry in the late nineteenth century, medics
kits in World War I contained mostly antipyretics, analgesics and topical antiseptics.8 By
the Second World War, the field medics kit had expanded to include cocaine injection for
topical anesthesia, the self-dosing morphine syrette, infusible blood plasma, ammonia
inhalants, atropine (as antidote to nerve gas and therapy for cardiac and respiratory
depression), laxative pills, mercurochrome and iodine antiseptics, sulfanilamide powder
(to sprinkle over wounds), sulfadiazine tablets for systemic infections, atabrine (a synthetic
antimalarial) and by the end of the war penicillin.
As Redfield (2008a) has demonstrated, the interwar development of materia medica
minima kits by the International Red Cross transported the logic of deployable therapeutic
supplies from military to humanitarian institutions. As with the military medics kits, the
Red Cross kits had expanded by the Second World War from basic first-aid supplies, such as
bandages and gauze, to standardized formularies of pharmaceutical products. Military
models of supply were likewise central to the work of the United Nations Relief and
Rehabilitation Agency (UNRRA) an important precursor to the WHO in distributing
supplies of key drugs like penicillin to war-devastated areas of Europe and Asia (Bud, 2007).
The UNRRAs pharmaceutical actions are best memorialized, perhaps, in Carole Reeds
1949 classic film noir The Third Man, which featured Orson Welles as the arch-villain Harry
Lime, who disrupted UNRRA shipments of penicillin to refugee hospitals in Eastern Europe
for personal profit. Limes action is clearly depicted as a crime against humanity in a
sequence of images that juxtaposes adulterated penicillin vials with children dying of
meningitis in makeshift wards for lack of proper penicillin. This cinematic portrait provides
an early and powerful expression of the emerging role that pharmaceuticals would play in
the maintenance of humanitarian standards during the late twentieth century.
As the UNRRAs activities were folded into the newly formed World Health Organization,
Brock Chisholm, the architect and first director-general of the early WHO, noted with
some concern an early divide in the international politics over pharmaceuticals at the first
World Health Assembly in 1948. Though pharmaceuticals were only discussed briefly,
6 At present there is something like a vicious circle. Because there is no immediate shortage of them, drugs
which are not essential continue to be used, and as they are used further supplies are imported to keep up
the stock. Quotations are from Non-essential drugs: Hints to prescribers (1940, p. 603); see also
Economy in essential drugs: more hints to prescribers (1940).
7 For example, Evatt (1881, p. 603): I take it that a formulary of prescriptions for our army hospitals is
absolutely essential. It need not be too elaborate, but should contain a very full list of pills and powders.
These two modes of administering drugs will be always important in the field; and by having such
formularies one could telegraph for the drug wanted, and get it by field-post, and not by the slower
transport train. See also the reply by Woodward (1881, p. 799): I think I may safely estimate that a pair of
ordinary sized saddle-bags would contain a fully equipped dispensary, sufficient to meet the medical
requirements of a thousand men for a three-months campaign even including anesthetics, to be carried in
metallic flasks, fitted with close-fitting screwed tops, instead of the glass bottles at present in use.
8 An online index of contents of medics kits in WWI and WWII can be found at David Steinerts WWII
Combat Medic (http://home.att.net/Bsteinert/).
Chisholm noted, some delegations felt that it was a function of the WHO in the present
situation to provide essential medical supplies, such as DDT, penicillin and streptomycin, to
countries that do not produce these commodities and that, because of the lack of necessary
currencies, are unable to import them in the quantities required for carrying out national
health projects. On the other hand, an opposing set of delegations complained that the
amount of assistance which the WHO could furnish in that field was infinitesimal compared
with world needs, and held that medical supplies, like other commodities, should now be
obtained through the normal peacetime economic machinery (Chisholm, 1950, p. 1025).
This debate over essential medical supplies in the foundational moment of institutions
of world health reflected an international divide over whether the WHO was to act as
standard-bearer or as advocate in the international distribution of medical supplies. This
question invoked a dilemma at the core of the WHO. On the one hand, the framers of the
early WHO took pains to emphasize that the organization was not a supranational
regulatory agency, but instead represented a site for expediting the normative harmonization
of its constituent sovereign regulatory agencies through an iterative process of convening
expert conferences and publishing consensus standards. At the same time, the WHO
was also understood to have an explicitly activist set of responsibilities in the field of
international epidemiological intelligence and the international coordination of responses
to epidemic disease threats.
Each distinct program at the WHO could be positioned somewhere along this normative/
activist dipole: tuberculosis control, yaws eradication, malaria eradication and then
smallpox eradication rapidly assumed more activist roles (Cueto, 2007), whereas the
international unification of pharmacopoeia emphasized the more normative side of the
institution. Ironically, at the first meeting of the Expert Committee on the Unification of
Pharmacopoeia in 1947, the Committee had first framed their agenda within the broader,
activist role of winnowing out essential drugs from less important compounds. Our goal,
they wrote, is:
to present to medical men a comprehensive list of the drugs considered to have

outstanding value in medical practice. Such a list might be divided into two sections:
a primary list of the essential drugs, and a secondary list of the less important but
useful drugs. It was decided that, for the present, monographs should be prepared only
of the essential drugs. (WHOIC, 1947, p. 1; emphasis mine)
Yet the Pharmacopoeia Internationalis and the generic nomenclature system soon dropped
the task of distinguishing essential from less important drugs (Kopp and Rago, 2007).9
Although the WHO archives are silent as to the reasons why, WHO policy from the 1940s
9 Such an approach was grounded in wartime declarations of therapeutic essentiality and in interwar
professional practices of medical and pharmaceutical education. The Council on Drugs of the American
Medical Association (AMA) had by that point published several editions of a textbook of Useful Drugs: A
Selected List of Essential Drugs intended to encourage to rationalize medical pedagogy. By the mid-
twentieth century, however, the AMA Council on Drugs had proven unable to function as arbiter of
therapeutic necessity largely due to institutional convergence between the AMA and the Pharmaceutical
Manufacturers Association and instead published compendia that merely reflected the totality of Food
and Drug Administration (FDA)-approved therapeutic agents without comment on their relative relevance
to public health or clinical practice. The history of the Pharmacopoeia Internationalis illustrates a similar
trajectory of moving away from the project of discriminating essential from inessential drugs.
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through the 1970s suggests that a compromise was struck: the organization pursued an
activist policy of technology transfer for a small number of drugs such as chloroquine,
penicillin and streptomycin that were linked to vertical campaigns against malaria, yaws
and tuberculosis (Bud, 2007). But for the majority of drugs relevant to PHC, questions of
drug quality and supply were left to the private sector.
Essential Drugs and the Politics of International Health,

1970s1980s
The emergence of a critical discourse on essential drugs must be understood within the
world-historical context of the 1970s, as debates over world health became a central site for
articulating the increased political presence of recently decolonized nations of the global
South within United Nations institutions. As novel organs of South-South solidarity, such
as the Group of 77 and the Non-Aligned movement, articulated a common critique of
multinational corporations housed in the global North, they also examined the global public
health relevance of the loss of patent protection for a wave of post-WWII blockbuster
drugs that had increasingly been viewed as central to providing a basic standard of patient
care within a biomedical framework.
The same wave of pharmaceutical developments that brought the miracle cures of
penicillin, cortisone, chlorpromazine and streptomycin 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,10 reaching a critical level of public, professional, journalistic
and political outcry in the global North by the early 1960s particularly in the wake
of the global thalidomide disaster (Mintz, 1965; Silverman, 1974).11 An ensuing set of
regulatory measures intended to protect drug consumers in the United States 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.
Journalistic exposes began to document the practice of drug-dumping whereby multi-
national pharmaceutical firms willingly sold drugs newly unmarketable in the North to
Southern states with weaker regulatory regimes, and pursued varying claims of safety and
efficacy in different locales (Silverman, 1976; Medawar, 1979; Silverman et al, 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. By 1976, Thailand spent 30.4 per cent of public health budget on drugs, whereas
Bangladesh spent 63.7 per cent of its budget on prescription medicines. The private sector
market in pharmaceuticals, meanwhile, contained a staggering number of brand names: by
the early 1970s, Brazil and Argentina had 24 000 and 17 000 brand name drugs on the
10 On the postwar drug explosion in the global North and the ensuing difficulties of distinguishing
therapeutic innovation from innovative repackaging, see Bud (2007), Greene (2007), Lesch (2007),
Rasmussen (2007), Watkins (2007), Strasser (2008), Greene and Podolsky (2009) and Herzberg (2009).
11 For example, Mintz (1965), Silverman (1974).
market, whereas Egypt had over 50 000 brands. Norway, by contrast which had enacted
the earliest national drug safety legislation allowed a market of only 1000 drug brands
(Kanji et al, 1992, pp. 23).
By the mid-1970s, a few newly independent nations with socialist governments
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. As Muller (1982), Medawar (1984) and Kanji et al (1992) have demonstrated,
these unilateral attempts to enact national essential drug policies almost universally
succumbed to political and economic pressures attributed to multinational pharmaceu-
tical concerns.12 Ensuing critiques of North-South inequalities in drug quality and pricing
became a concrete example of the broader critique of multinational corporations by
the member nations of the Group of 77. Critical works such as Ledogars (1975) Hungry
for Profits, and Barnet and Mullers (1976) Global Reach: The Power of the Multi-
national Corporation cast Northern-based multinational companies Pfizer, Merck and
Bristol-Myers among them as rapacious and unaccountable institutions who squeezed
money from the poor health budgets of low-income nations and then applied insidious
pressure to any national policies that threatened their profitability. 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.13 By the late 1970s, a
language of essential drugs had become a powerful and morally salient discourse for
Non-Aligned nations to act en bloc and articulate their new position of electoral plurality
within the World Health Assembly.
The 1970s also witnessed a period of critical re-assessment of development strategies
within both United Nations agencies and Bretton Woods institutions. Under the
leadership of Robert McNamara, the World Bank moved away from initial infrastructural
models of development, and shifted toward a more human centered, basic needs
approach to international economic development (Cruickshank, 2009). Similarly, the
WHO, roundly criticized for the perceived failure of the disease-specific vertical Malaria
Eradication Program, began to focus on more comprehensive horizontal investments
in primary health systems (Litsios, 2002). The concept of PHC received increased
international attention with the entry of China to the WHO in 1973, prompting
widespread discussion of the efficacy of rural cadres of Maoist barefoot doctors who
managed health in village life with the use of an iconic kit of Western and traditional
Chinese medicines.14
12 By the early 1970s, Pakistan, Mozambique and Sri Lanka had each attempted to establish restricted
formularies of generic drugs with tight controls on pharmaceutical imports. Each nation was subsequently
subjected to highly unfavorable positions within international trade and either swiftly abandoned these
efforts, like Pakistan, or gave up such strategies after the outbreak of war (as in Mozambique) or a series of
government collapses and, ultimately, civil war (as in Sri Lanka) (see Muller, 1982; Medawar, 1984; Kanji
et al, 1992).
13 See UNCTAD (1982), also described in Kanji et al (1992).
14 As mentioned earlier, the primary health-care concept was already strongly supported by Mahler, who was
influenced by works such as John Bryants Health and the Developing World (1969) and Kenneth Newells
Health by the People (1975).
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Essential drugs therefore entered WHO policy at a moment when access to pharma-
ceuticals had become symbolic of the most pressing and visible international health concerns
of the day. 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 25 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 health-care 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 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 and 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, pp. 67). 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.
The means of selecting such drugs were thematic rather than systematic, and leaned
heavily on a set of unpublished guidelines drafted by the American member of the Expert
Committee Daniel Azarnoff, a professor of medicine and pharmacology at the University of
Kansas and member of the AMAs Council on Drugs. Azarnoffs preparatory text coupled
a thinly veiled anticommercialism with a utilitarian vision for using the model list of
essential drugs to raise the floor of available drugs for basic medical care throughout the
developing world. Azarnoff noted that though a number of truly effective therapeutic agents
had only become available in the last quarter century, their public health impact had been
muted because
[P]harmaceutical companies have undertaken extensive advertising activities in an

attempt to coerce physicians to prescribe their generally more expensive brand name
products. y In order to provide the best health care feasible at the lowest cost it is
necessary to restrict the availability of all drug products to those essential for the
health of the Public y A select list may not provide for the needs of every person, but
certainly will for the vast majority although the choices in most therapeutic categories
will be minimal. (Azarnoff, 1977)
Of great concern to the pharmaceutical industry members present (but not voting) in the
Expert Committee meetings, this language did not differentiate between developing and
developed nations.15 Worse still from the industry perspective, the first three selection
criteria linked the essential drugs project with a broader project of rational prescribing in
the global North, including the use of generic names, evidence of proven safety and efficacy
via randomized, controlled, trials and cost-effectiveness (Greene and Podolsky, 2009).
Although the first WHO Model List of Essential Medicines almost exclusively comprised
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.16
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 NGO responded that the
essential drugs concept was completely unacceptable to the pharmaceutical industry (SCRIP,
1977). As Michael Peretz, the IFPMAs permanent vice-president, later explained, if the WHO
was recommending a list of essential drugs it would follow that the WHO was implicitly
arguing that all other drugs not included in the list were non-essential (Peretz, 1983).
In a formal statement to Mahler in April 1978, the IFPMA outlined their serious
reservations about the promotion of such policies by the WHO, noting concern that the
essential medicines concept was fundamentally untenable and patently harmful to medical
practice and the public health (Egli, 1978, p. 1). The IFPMA objected that in promoting
generic drugs over brand-name drugs, the WHO was not only taking on an inappropriately
activist role, but was exceeding its own technical capacity to monitor drug standards.17 The
IFPMA also protested the anticommercial tone of the essential drugs concept, and suggested
that the existence of any essential drugs list would ultimately restrict all access to medicines,
depriving those dependent on public sector health care of the drugs which they might
individually need and lending impetus to similar measures affecting the private sector (Egli
and Mahler, 1978, p. 3).
Richard Crout, the head of the Bureau of Drugs at the US FDA, had written a letter in
support of the essential drugs concept to the head of the WHO pharmaceuticals section,
15 Azarnoffs draft (which would later circulate as a document intended to help nations develop their own
essential medicine lists) listed 10 thematic criteria for circulation (i) use of generic names only, (ii) proven
efficacy and safety in Randomized Controlled Trials, (iii) inexpensive, (iv) stable substance, (v) minimal
degree of medical expertise (diagnostic and therapeutic) necessary to use drug properly, (vi) minimal
degree of specialized technology needed to use drugs properly, (vii) local disease states that complicate
utilization of drug (for example, malnutrition), (viii) local prevalence of specific diseases (for example,
resistant strains), (ix) pharmacokinetic parameters, and (x) local manufacturing capabilities (Azarnoff and
Nakajima (1977, p. 2), see also Helling-Borda (2003)).
16 To deflect anticipated critique from industry the WHO had included five IFPMA members, including the
IFPMA president, in the consultations in 1976 and 1977 that led to the formation of the first essential
drugs list (see Egli, 1977).
17 The pharmaceutical industry is not aware of any developed nation where regulatory authorities can
provide assurance of the bioequivalence or interchangeability of the drug supply within their jurisdiction;
and the state of regulatory effectiveness in most developing countries is substantially less advanced.
Because of this reality, governments, the medical profession, and the patient must rely upon the
reputations of companies with consistent histories of producing high quality products as the best assurance
of safety and therapeutic effectiveness y To discourage [the use of brand names] as the WHO Report does
would have grave repercussions for the quality of pharmaceutical supplies and health care, whether in
developed or developing nations Egli and Mahler (1978, p. 2). On the problem of equivalence in generic
drugs, see Hayden (2007), Greene (forthcoming), Tobbell (forthcoming) and Carpenter and Tobbell
(forthcoming).
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noting that [t]he next step, and a much harder one is to try to find those public policies
which would encourage the international drug industry to supply these drugs at cost to
developing countries.18 Subsequent diplomacy between the WHO and the IFPMA focused
on the boundary work required to contain the essential drugs concept to a point where it
would be 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
medicines would be restricted to the health needs of developing countries (WHO, 1979a, b).
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 favourable prices for the
poorest countries: a set of negotiations that would lead to the development of tiered-pricing
policies between developed and developing nations.
By the early 1980s, conflict over the list itself had waned as the focus of debate over
essential drugs shifted from the practice of list-making to the challenge of implementation.19
The focus of debate now hinged on the structure and function of a newly created WHO
Action Program on Essential Drugs that 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, 1978b).
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 to pressure the WHO to
enact an international code of infant formula marketing.20 Patterning itself after this model
of international consumer activism, HAI included a coalition of consumer advocacy groups
from 27 countries, and its membership of anthropologists, physicians, pharmacists and
organizers was explicitly inclusive across global North and South. Its founding mission
18 Crout had suggested that the name of the list be changed from essential drugs to basic drugs, noting that
the idea that most drugs are non-essential is obviously bothersome to the industry, whereas they can
accept the idea that most are non-basic (J. Richard Crout to V. Fattorusso, 9 February 1978, E 19 81 1,
folder 1. WHO Archives, Geneva).
19 At the 1978 World Health Assembly, the WHOs pharmaceuticals group presented a technical report
calling for an action program where the WHO would work directly with national governments to
strengthen their capacity to select and supply essential drugs to their full populations, and announced that
the WHO had initiated a dialogue with interested research-based pharmaceutical industries and there are
good prospects for future collaboration, whereas Max Tiefenbacher claimed that the industry has a vital
role to play in the WHO action program. We stand ready to continue the dialogue with new visions and
initiatives (Hey, 1978). The IFPMAs annual report for 1978 mentioned lists of essential drugs, a concept
which IFPMA has rejected in its statement to the Director General as being against the interests of the
WHOs prior stated objectives. Nevertheless, IFPMA has responded positively with the WHOs request to
improve the dialogue with the pharmaceutical industry and is sympathetic [to the principles of Primary
Health Care laid out at Alma Ata] (IFPMA, 1978). For a contemporary analysis of the shift from list-
making to implementation, see Reich (1987).
20 The foundational International NGO Seminar on Pharmaceuticals in Geneva took place immediately
following the 1981 World Health Assembly in Geneva, and included over 50 organizations from 26
countries (see Fazal, 2006).
concerned the implementation of the essential drugs concept to further the safe, rational,
and economic uses of pharmaceuticals worldwide, to promote the full implementation of the
WHOs Actions Programme on Essential Drugs, and to look for non-drug solutions to
the problems created by impure water and poor sanitation and nutrition (Fazal, 2006).
Alongside more technical NGOs such as Management Sciences for Health (who published
Managing Drugs Supply, known as the yellow bible for national medicines programs),
HAI supported critical studies of the pharmaceutical industry, such as Mullers (1982) The
Health of Nations: A NorthSouth Investigation and Diane Melroses (1982) Bitter Pills.
HAIs announced itself as an international antibody against the ill-treatment of
consumers by multinational drug companies (HAI, 1981). This transnational alliance of
consumer activists opposed itself directly against the transnational alliance of industry
lobbyists represented by the IFPMA, yet their battles were fought by groupings of
sympathetic nation-states within the World Health Assembly. HAIs policies were typically
introduced by a coalition of Non-Aligned countries and social-democratic states from
northern Europe (the Nordic bloc), whereas the IFPMA could reliably mobilize Western
nations which housed major multinational pharmaceutical companies. For example,
at the 1982 World Health Assembly, the HAI agenda for stronger standards on the
international marketing of pharmaceuticals was proposed by the Netherlands and
supported by Chile, Cuba, Romania, Sudan and Ghana, but was defeated by a coalition
led by the United States, Britain, France, and Germany. A subsequent HAI push to encourage
the rational use of drugs at the 1984 World Health Assembly was more successful, and
involved a team of 13 lobbyists that coached the Netherlands and the Nordic bloc to
demand an international conference on the subject. When this conference opened in Nairobi
in November 1985 it began with a somewhat weary appeal from Mahler that the assembly
not serve as yet another international battleground for the pharmaceutical industry and
consumers to vent their interests. (Kanji et al, 1992, p. 55). The consensus at the Nairobi
conference granted a legitimate role to the WHO in providing expert assistance in helping
countries develop rational essential drugs programs but with the crucial concession to
industry that the role of the essential medicines concept would be formally limited to the
public sector.21 Even this compromise, however, was fragile.
These contests over the definition and implementation of the essential drugs concept
help to demonstrate key limitations of world health as an organizing concept in the Cold
War era. While the problem of access to essential drugs entered the WHO as a form of
NorthSouth critique, the precise bounding of essential drugs was by the early 1980s caught
in a charged field between a broad socialist definition of health in terms of social rights
which demanded an expanded activist role for the WHO, versus a Western definition of
health and civil rights in narrower individualist terms, with a correspondingly stricter vision
of role of the WHO. As IFPMA president Max Tiefembacher (1979, p. 212) 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 not practicable.
Newly emboldened by the US withdrawal from UNESCO in 1984, conservative think-
tanks in the United States, such as the American Enterprise Institute and the Heritage
21 WHO (1987), see also Laing et al (2003).
Greene
Foundation, began to complain vocally about the politicization of other international

bodies, and joined the Pharmaceutical Manufacturers Association (PMA) and later the Reagan
administration in citing essential medicine implementation as an over-extension of the WHOs
constitutional role.22 As Hardon (1992) recollects, by the 1986 World Health Assembly, the
US delegate protested the alarming prospects of politicizing health and called for a
resolution for reaffirmation to restrict WHO activities to a conservative reading of the
1946 charter that is, to focus on infectious disease surveillance and normative roles
regarding international drug nomenclature and not attempts to regulate commercial
products. Though this resolution did not pass, it took on further significance when the
United States failed to make its contribution to the WHO representing 25 per cent of the
WHOs regular budget in 1986 and again in 1987. By the time the United States reinstated
payments in 1988, Hiroshi Nakajima had replaced Mahler as Director-General, the Action
Program on Essential Drugs had been shifted from its prominent position in the Director-
Generals Office back to a subdivision of the pharmaceuticals sector, and the WHO had
begun a period of policy drift that presaged increasing concerns about its role in
international health and its ability to visibly push forward controversial policy initiatives
such as the essential drugs concept.23
Essential Medicines as Global Health Discourse, 1990s2000s

The late 1980s and early 1990s are frequently called the country years by the WHO EDP
staffers, a time in which the visibility of international debate over essential drugs diminished
and the WHO medicines program worked methodically in partnership with individual
nations to build essential drugs lists and enhance the procurement, distribution, rational
use and quality assurance of materials on these lists. Brown et al (2006) have further
characterized these years as a period of marginalization of the WHO in international health
agenda-setting, due in part to the decline of its budgetary independence at the same time that
the World Bank began to make significant inroads into funding health-related projects. In turn,
the re-emergence of essential medicines as a critical discourse in the late 1990s and 2000s
would largely be driven by forces outside of the WHO, which placed pharmaceuticals at the
center of a headless assemblage of actors and institutions all claiming to work in the new
field of global health. In place of a central monolithic bureaucracy of world health, the new
field of global health involves the competition of multiple overlapping private, public and
publicprivate hybrid institutions within a marketplace of global health delivery.
The new urgency of global access to pharmaceuticals is often attributed to a set of material
changes, either the dynamic epidemiology of the HIV/AIDS pandemic with devastatingly
22 For example, Brooks (1985), PMA (1985). See also Mingst (1990), Siddiqi (1995). As Siddiqi cites (p. 8),
this claim of politicization had earlier been made by US Ambassador William Scranton that the absence of
balance, the lack of perspective and the introduction by the WHO of political issues irrelevant to the
responsibilities of the WHO do no credit to the United Nations. Indeed, this is precisely the sort of
politicized action which decreases respect for the United Nations system.
23 After much debate on the subject, the mid-to-late 1980s also saw a concerted move away in WHO policy
from an emphasis on broad horizontal programs (such as the Alma Ata-PHC concept and the essential
drugs movement) and toward more operational programs such as selective primary health care; Kenneth
Newell described these linked phenomena as a counter revolution against the spirit of Alma Ata (Newell,
1988).
disproportionate burdens in sub-Saharan Africa, the Caribbean and Southeast Asia or

the development and widespread adoption of novel antiretrovirals that, deployed in
combinations, could transform an AIDS diagnosis from death sentence into a manageable
condition. But as a growing group of activists were quick to point out in the late 1990s,
the availability of highly active antiretroviral therapies transformed the cartography of
HIV/AIDS mortality to match the contours of access to medicines an access that was as
determined by global intellectual property regimes as by any material difficulty or necessary
cost in drug manufacturing. Advocacy groups protested the moral unacceptability of
preventable deaths due to the flawed geography of pharmaceutical access. NGOs from
ACT-UP to Medecins Sans Frontiers (MSF) clamored that the WHO Model Essential
Medicines List which did not contain any antiretroviral drugs due to their cost, novelty and
patent status was at risk of becoming farcical in any country with significant HIV/AIDS
burden.
The means of winnowing essential from non-essential drugs had been methodologically
and politically challenged since the publication of the first list in 1977. While the selection
criteria for the first list of essential drugs invoked commonsensical notions of safety,
efficacy, relevance and cost, the exact method for defining the list had been left mostly
to the expertise of an elite group of pharmacologists, and the formal inclusion of on
the ground practitioners into the list-making process was not established until 1991
(Howard and Laing, 1991). Value-laden choices regarding the inclusion or exclusion of
contraceptives, abortifacients, palliative medications, cancer chemotherapeutic agents,
drugs for rare diseases and drugs for risk-factor reduction had simmered continuously
throughout the programs operation.24
But the general exclusion of innovative, patent protected drugs from the list of essential
drugs had been uniquely troublesome. Observing the publication of the second essential
drugs list in 1979, the prominent American clinical pharmacologist Louis Lasagna (1980)
archly observed that by promoting the explosive liquid ether as an anesthetic while barring
the reportedly new life-saving anti-ulcer drug cimetidine on the basis of its lack of broad
base of experience, the list conflated geography with history: old drugs for poor countries,
new drugs for rich countries. Lasagna suggested that the essential medicines list would
continue to limit the accessibility of promising new drugs from reaching the public sector in
the developing world:
[I]f most countries do not pay for a new drug, how will it ever be used widely enough
for health providers to find out if the drug is essential? As of today, the WHO list is
largely a theoretical threat. Tomorrow? (Lasagna, 1980, p. 369)
As John Horton would later allege, extending Lasagnas critique to the beginning of the
twenty-first century:
[M]uch of the list comprises products that were old even in 1977. One could
therefore argue that the EDL encourages the provision of outmoded medicines for
the people of the developing world, and essentially excludes them from advances in
medical science. (Horton, 2003, p. 12)
24 For example, Stolk et al (2006), Lancet (2006), De Lima (2007), Robertson and Hill (2007).
Greene
Hortons argument was made in support of a 2001 motion for the Royal Society of Tropical
Medicine and Hygiene to officially condemn the essential drugs concept (Breckenridge,
2003). He was answered by Pierre Chirac, a representative of MSF, who argued that it was
the WHO essential drugs list and not the essential drugs concept that had failed to live
up to its operational, didactic, and symbolic functions. Declaring itself a major supporter
of the essential drugs concept, MSF was nonetheless worried that the most recent list is
already outdated and does not reflect the essential drug concept as increasingly common
medical situations fail to be addressed.25 In distinguishing the ideal (essential drugs concept)
from the real (WHO Model List of Essential Drugs List), MSF presented itself a trans-
national NGO engaged with the challenge of getting drugs into bodies as the new torch-
bearer of the philosophy of essential medicines.
MSF was founded in the 1970s by a group of French physicians frustrated with
the limits of formal internationalism in humanitarian relief efforts in response to
complex humanitarian emergencies. Subsequent years saw the emergence of local MSF
chapters worldwide. Their philosophy of speed saves lives, and rejection of the priority
of national sovereignty and due process of international institutions in situations of
humanitarian crisis,26 would become the archetype for a group of subsequent professional
sans-frontierisme groups that positioned networks of NGOs, rather than the WHO,
as the key site for emergent forms of global health.27 By the late 1990s, a small group
within MSF had begun to reframe the scale of preventable deaths from global HIV and
neglected tropical diseases as a morally urgent crisis, and began a globally prominent
Campaign for Access to Essential Medicines (Pecoul, 1999). Receipt of the 1999
Nobel Prize added visibility and further moral weight to their campaign, which swiftly
progressed from petitioning the WHO Essential Medicines List to include newer
medications for HIV/AIDS and trypanosomiasis, to leaning on the World Trade
Organization in the Doha round of TRIPS to leverage space for public health patent
exemptions for essential medicines, to working with specific countries to encourage
TRIPS to promote compulsory licensing and parallel importing of generic HIV medications
(tHoen, 2002). Where these efforts failed, the transnational organization simply acquired
relevant drugs and brought them across national borders on their own, with attendant
publicity.
The flexibility and speed with which groups such as MSF and the Boston-based Partners in
Health could transport complex regimens for the treatment of HIV and multiple drug-
resistant tuberculosis into collaborating health organizations in resource-poor settings in
sub-Saharan Africa, the Caribbean and South America worked to set the glacial pace of
international bureaucratic process in sharp relief. International health bureaucracies such
as the WHO, UNICEF and UNITAID were now ironically cast as pathogenic factors
in the spread of AIDS itself (Farmer, 2001; Farmer et al, 2001). If time lost meant further
25 Chirac (2003, p. 12) (see also Chirac and Laing, 2001).

26 For recent ethnography positioning MSF as a case study in the novel articulation of global
humanitarianism, see the recent publications of Redfield (2006, 2008a, b, c) which builds on the earlier
work of Fox (1995).
27 Sans-frontierisme has extended beyond MSF/Doctors Without Borders to include professional
associations of nurses, teachers, pharmacists, plumbers, astronomers and other groups who claim to
operate beyond rather than within the borders of the nation-state.
preventable deaths, then the 3-year delay between the request to include combination
antiretrovirals in 1999 and their appearance on the list in 2002 was seen to be simply
unconscionable.28 NGO-based forms of lateral delivery circumvented not only the
international agency but the role of the nation-state in determining medicines policy,
as evidenced by the role of transnational NGOs in funneling antiretrovirals into South
Africa during a period marked by Thabo Mbekis official denial of HIV as the causative
agent of AIDS (Fassin, 2007).
The role of NGOs and other publicprivate partnerships in health delivery was buoyed
by widespread enthusiasm from the mid-1990s onwards (Economist, 1999, 2000) and
supported by visual demonstrations of the symbolic efficacy of new pharmaceutical forms:
maps of HIV mortality that equated the geography of access with death, images of patients
in resource-poor settings before and after combination antiretroviral or antituberculosis
chemotherapy, production of visual metaphors for international patent law and EDL list-
making processes that indicted corruption in health ministries and bureaucratic inertia forms
as pathogenic processes themselves (Farmer, 2001). As Mahajan (2010) has argued in the
case of India, and Nguyen (2010) in the case of Francophone West Africa, in the ensuing
decade, the focus on pharmaceutical provision through nongovernmental networks has
subsequently shifted the population health responsibilities of HIV/AIDS care from the
nation-state to a diffuse network of NGOs, American universities and European hospitals.
The rise in prominence of global health NGOs and university programs has supported
and been supported by a confluence of individual and institutional philanthropic giving in
the early 2000s that increased available funding by orders of magnitude through the
sequential establishment of the UN Global Fund to Fight AIDS, Tuberculosis and Malaria;
George W. Bushs Presidents Emergency Plan for AIDS Relief; and the unprecedented
generosity of the Bill & Melinda Gates Foundation into the arena of global health (Garrett,
2007). All of these philanthropic ventures, and others that followed, hinged on existing or
anticipated pharmaceutical solutions to globally neglected diseases that in turn became
configured as priority problems within the global health field. Of the 14 Grand Challenges
in Global Health, which Gates introduced at the World Economic Forum in Davos in
January 2003, 9 relate directly to improving access to novel or existing pharmaceutical
technologies (Varmus et al, 2003).
If the redefinition of the essential medicines concept was central to articulating the
new role of NGOs and philanthropies in emergent forms of global health, the term was
equally useful to the multinational pharmaceutical industry as it sought to reform its public
image from global robber-baron to a more Promethean stature. As with MSF and Gates, the
re-purposing of essential medicines was itself essential to the pharmaceutical industrys
positioning as a central player in new structures of global health. By the early twenty-first
century, most pharmaceutical firms could point to their own public-minded global health
initiatives as evidence of the industrys capacity to support access to essential medicines as
long as the concept of essential medicines was configured in ways that did not threaten
pharmaceutical IP prerogatives. These self-defined programs expressly resisted the notion
of essential medicines as a public commons, recasting them instead as private goods that
could be donated by altruistically minded corporations. Most prominent among these
28 On the delay of the WHO EDL reforms and the role of US resistance in particular see Steiger (2001).
Greene
initiatives, perhaps, was the Accelerating Access Initiative, formed in 2000 by seven large
pharmaceutical corporations (Boehringer-Engelheim, Bristol Myers Squibb, GlaxoSmith
Kline, Merck, Hoffmann-La Roche, Abbott Laboratories and Gilead Sciences) in
cooperation with UNAIDS, the WHO, UNICEF and the World Bank, expressly to
strengthen access to antiretroviral medications in Least Developed Countries (LDCs) and
sub-Saharan Africa (Sturchio, 2006).
The Accelerating Access Initiative was conceptualized as a more systematic and focused
extension of earlier forms of pharmacophilanthropy, a defining principle of the globally
social-conscious pharmaceutical corporation that took as its ur-example the successful and
widely celebrated Merck program for the donation of Mectizan (ivermectin) for African
river blindness (Collins, 2004). Mectizans lack of profitability in human applications
could be offset by its extraordinarily profitable veterinary applications, and the program
produced both publicity and sense of moral purpose for Merck employees. During the 1980s
and early 1990s Merck was commonly depicted as the white knight of the pharmaceutical
industry, as the Mectizan program became emblematic of the civic-mindedness of Mercks
charismatic CEO Roy Vagelos.
In turn, the Accelerating Access Initiative proposed a number of company-specific
initiatives whereby each corporation could specify the degree and means of access it was
willing to grant to resource-poor settings, ranging from sustainable preferential pricing,
to donation of drugs at cost, to donation of drugs at loss, to the granting of generic
licenses in specific countries, to the declaration (by Hoffmann-La Roche) that it would
seek no further patents and offer no protest to generic manufacture of its proprietary
medications in LDCs and sub-Saharan Africa.29 In addition to their impact on the lives of
recipients of pharmaceutical aid, these programs could provide a much-needed boost for
the public profile of the pharmaceutical industry and the morale of its employees, both of
which had suffered from a series of prominent scandals over pharmaceutical marketing
and drug safety in the first decade of the twenty-first century (Avorn, 2004). Among the
many vehicles for converting pharmacophilanthropy to motivational and promotional
goals, an outfit called PharmaCorps was celebrated in 2007 for its innovative use of
motivational seminars among industry employees to build morale and consciously
mobilize them into an army of 450 000 global public relations advocates. A central goal of
the PharmaCorps motivational curriculum was to catalog and promote company-specific
essential medicines access programs. Even though our companies improve life for
patients here and around the world every day, it is relatively easy for employees to lose
29 Noting the diversity of offerings in pharmacophilanthropic programs, Sturchio (2006) describes that
Abbott had launched Abbott Access in 2001, and offered Kaletra and Norvir as well as a rapid HIV
test branded Determines HIV; Boerhinger Ingelheim had made the Virammunes Donation
Programme available free of charge for the prevention of mother to child transmission of HIV
(PMTCT), though much of the other programs were dependent on sustainable preferential pricing;
and Bristol-Myers Squibb, GSK and Boehringer Ingelheim have granted licenses to generic
manufacturers in South Africa. Mercks own contribution, titled the African Comprehensive HIV/
AIDS Partnership, established in partnership with the Bill & Melinda Gates Foundation, involved a
direct donation program to the Botswana national ARV therapy program. Hoffmann-La Roche,
moreover, had shifted its patent policy to (a) not file any patents for any Roche medicines in low-
income nations and sub-Saharan Africa, and (b) promise not to take action in these countries against
the sale or manufacture of generic HIV medicines.
sight of the tremendous value our companies deliver to society noted PhRMA head Billy
Tauzin, [t]he program is designed to harness employees pride in what they do and give
them the tools they need to start changing the conversation about biopharmaceutical
companies and the medicines we make (Ross, 2007, p. 82).
The intersection of public relations, marketing and the essential medicines concept is not
entirely novel to twenty-first century, but the extent and visibility of this intersection is
widening.30 More recently this premise has been harnessed by the Access to Medicines
Foundation a coalition of investors, companies and NGOs largely cobbled together in
2004 by the efforts of Wim Leerveld, an energetic former pharmaceutical marketer who
suggested that the extent to which a company invested in access to essential medicines
could itself be a marketable trait.31 Leervelds group published a report in 2008 that
ranked all major multinational pharmaceutical companies by eight criteria of commitment
to expanding access to essential medicines (Access to Medicines Foundation (ATMF),
2008). GlaxoSmithKline, ranked No. 1 in the 2008 Access to Medicine Index (ATMI)
rankings, has made consistent mention of this in their public relations and in crafting the
public persona of their CEO Andrew Witty as the embodiment of a corporation concerned
with the advancement of global health (McNeil, 2010). Lower-ranked companies such as
Merck and Pfizer, in turn, issued statements regarding their plans to position for a better
ranking in the second set of ATMI rankings that were published in June 2010.32 The group
has received endorsement from a subset of socially responsible investment firms, who seek
to differentiate their own financial products by marketing to individual investors the
opportunity to invest only in those segments of industry that support essential medicines
policies. Bill Gates recently cited the initiative as an example of a sustainable market-based
solution to problems of pharmaceutical access, noting: [w]hen I talk to executives
from pharmaceutical companies they tell me that they want to do more for neglected
diseases, but they at least need to get credit for it. The Access to Medicine Index does
exactly that.33
30 Even in 1978, as the IFPMA was actively denying the possibility of a list of essential drugs, a few
pharmaceutical firms had approached the WHO unilaterally to lobby for admission to the essential
drugs list, leading the WHO to censure companies on more than one occasion for the use of the
essential drugs logo for promotional purposes. Eaton Laboratories lobbied the WHO for inclusion of
nitrofurantoin macrocrystals as a primary drug in the management of urinary tract infections in the
WHO Essential Drug List. American Cyanamid sent a similar list of four of their own products
(leucovorin, minocycline, chlortetracycline and traimcinolone) that they suggested to be added to the
list. Each of the companies met with some success both nitrofurantoin and chlortetracycline were
included in the 1979 revision of the essential drugs list (see Keenan, 1978); Affleck, 1978);WHO,
1979a, b).
31 http://www.atmindex.org/, accessed 10 April 2010.
32 Pfizer responded to their low ranking on the 2008 ATM Index, We recognize that we have yet to meet our
full potential, as reflected in pharmaceutical company rankings such as the Access to Medicines Index
ranking, and value the feedback and insights provided by the many stakeholders we engage and partner
with on access to medicine issues, http://www.pfizer.com/responsibility/cr_report/access.jsp; Merck has
posted a similar report: http://www.merck.com/corporate-responsibility/summary-data-resources/kpis-gri-
atmi-mdgs/atmi-2008-index.html, accessed 10 April 2010.
33 As cited on the ATMF website: http://www.atmindex.org/index/what_leaders_are_saying, accessed
10 April 2010.
Greene
Conclusions: Essentiality and Pharmaceutical Centrality

The success of a program such as the ATMI inconceivable as it might have seemed to the
framers of the first WHO Model Essential Drugs List now illustrates the flexibility of
the essential medicines concept within increasingly plastic conceptualizations of global
health. The essential medicines concept, like global health itself, has taken on somewhat of a
moral universality, as a thing that has acquired enough stakeholders and commonsensical
status that it is increasingly difficult to argue against and even more difficult to define. The
classic dipoles of prior international politics of essential drugs in the 1970s and 1980s
producers versus consumers, North versus South, East versus West are now softened and
entangled in a more diffuse acceptance of the centrality of pharmaceuticals in contemporary
global health practices. New conflicts, in turn, break out along new seams: the applicability
of TRIPS provisions, the feasibility of patent pools, the ability of a university to determine
the licensing of patents built off of its own innovations in LDC, or the definition of the
borderline between LDCs and the middle-ground occupied by the destitute segments of
middle-income and rich countries. The politics of essential medicines play out in microcosm
the problem of defining global health politics in macrocosm: much as the meaning of
essential medicines has shifted from a tightly contested term to an open variable meaning
different things to different actors, the term global health itself can simultaneously serve
several discordant objectives, meaning very different things in the hands of humanitarian
aid groups, counter-bioterrorist units and pharmaceutical companies such as Abbott
Laboratories who have recently renamed themselves global health companies.34
And yet at core there remains a kind of moral clarity regarding the importance of naming
a set of pharmaceuticals as essential to public health, a project that itself is both necessary
and fragile, laudable in the general but difficult to define in the particular. Situating the
critical discourse of essential drugs in the politics of world health of the 1970s and the 1980s
helps to explain why its enduring relevance nonetheless has led to complex and unexpected
political formations after its broad resurrection in the late 1990s and early 2000s. Thus
reinvigorated, the essential medicines concept has since rejoined clean water, adequate
housing and a safe food supply as part of a short list of things necessary for basic human-
itarian conditions, and added the right to medicines to the broader rights discourse of
UN organizations. At the same time, the potential of the essential medicines concept (as
initially articulated by consumer advocates within HAI) to uphold pharmaceuticals as a
basic necessity rather than a de facto commodity is countered by its paradoxical potential
(as currently articulated in pharmacophilanthropic programs) to stabilize an otherwise
maligned regime of intellectual property instruments.
In recent years, too, the careful boundary work performed by the IFPMA in the 1970s
and 1980s to limit the essential drugs concept to the public sector in the developing world
also appears to be coming undone. The past decade has seen several calls to directly apply
the essential medicines concept beyond low-income countries to create policies for pri-
oritizing medicines of broad population value to middle- and high-income countries as well
(Hogerzeil, 2004), and such principles have taken on practical weight in the decisions of
national medicines review commissions in rich nations, such as the United Kingdoms NICE
34 As proclaimed on the Abbott website: http://www.abbott.com/global/url/content/en_US/10:10/general_

content/General_Content_00004.htm, accessed 10 April 2010.
and Germanys IQWiG. Even in the United States, which has historically provided the most
consistent objection to the application of essential medicines programs, one can find a
functional large-scale deployment of essential medicines concept within the private sector,
from the use of formularies by Health Maintenance Organizations to the announcement by
Wal-Mart, in 2004, that it would offer a list of 300 basic prescription drugs for guaranteed
US$4 each.35
Placing essential medicines at the center of global health priorities is not without its risks.
On the one hand, critics have noted the risks entailed in reducing the broader goals of global
health advocacy to the simple technological challenge of drug delivery (Birn, 2005). For
medicines to be helpful, and not harmful, they must not merely be available, but come wrapped
in effective standards of quality and appropriate utilization within durable structures of health-
care delivery. Moreover, the social geography of accessibility of essential medicines tracks
closely with other structural determinants of health inequalities, few of which will be fixed
merely by providing a pipeline of pharmaceuticals. As most careful advocates of the essential
medicines concept argued from 1977 onwards, access to essential medicines is therefore a
necessary but not sufficient condition for the amelioration of broad health disparities in global
health. On the other hand, to truly engage the social factors that determine the development,
production, regulation, distribution, utilization and consumption of essential medicines is to
engage with the project of understanding health disparities and the challenges of strengthening
complex health systems at the most detailed level. To ask what renders a medicine essential? is
therefore to continue to address a key set of frictions defining the field of global health in the
many sites where it is conceived and practiced today.
Acknowledgements
The author gratefully acknowledges the time and historical insight provided by several former
and current actors within the Essential Medicines Programme of the WHO, especially
Margaretha Helling-Borda, Hans Hogerzeil, Richard Laing and Jonathan Quick. The archival
work supporting this project would not have been possible without the generous assistance of
Marie Villemin at the archives of the WHO, and the manuscript benefitted from discussions
with Paul Cruickshank, Dennis Ross-Degnan, David Jones, Stephen Pemberton and Anita
Wagner. Earlier versions of this article were presented at a Global Health Histories Seminar at
the WHO in December 2009, the November 2010 meetings of the American Anthropological
Association and a December 2010 conference on Drugs, Standards and the Practices of
Globalization supported by the European Science Foundation, the Centre de Recherches
Medecine, Sciences, Sante et Societe and the Ecole des Hautes Etudes en Sciences Sociales.
About the Author
Jeremy A. Greene, MD, PhD, is a physician-historian whose first book Prescribing by

Numbers: Drugs and the Definition of Disease (Johns Hopkins University Press, 2007)
35 http://www.walmart.com/cp/4-Prescriptions-Program/546834, accessed 10 April 2010.
Greene
narrated the convergence of pharmaceutical marketing and chronic disease categories. His
current work focuses on the evolving role of pharmaceuticals in public health.
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Original Article

Making medicines essential:

Keywords: global pharmaceuticals; global health; international health; essential medicines;

Essential Drugs Before the Fact

essential and do not justify importation or manufacture in war-time.6 This list-making

to present to medical men a comprehensive list of the drugs considered to have

Essential Drugs and the Politics of International Health,

[P]harmaceutical companies have undertaken extensive advertising activities in an

21 WHO (1987), see also Laing et al (2003).

Foundation, began to complain vocally about the politicization of other international

Essential Medicines as Global Health Discourse, 1990s2000s

disproportionate burdens in sub-Saharan Africa, the Caribbean and Southeast Asia or

25 Chirac (2003, p. 12) (see also Chirac and Laing, 2001).

Conclusions: Essentiality and Pharmaceutical Centrality

34 As proclaimed on the Abbott website: http://www.abbott.com/global/url/content/en_US/10:10/general_

About the Author

Jeremy A. Greene, MD, PhD, is a physician-historian whose first book Prescribing by

35 http://www.walmart.com/cp/4-Prescriptions-Program/546834, accessed 10 April 2010.

Steiger, W. (2001) Letter. 13 August 2001, http://dcc2.bumc.bu.edu/richardl/WHO_Select_docs/back

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