25 years of the WHO essential medicines lists: progress andchallenges
Richard Laing, Brenda Waning, Andy Gray, Nathan Ford, Ellen ‘t Hoen
The first WHO essential drugs list, published in 1977, was described as a peaceful revolution in international public health. The list helped to establish the principle that some medicines were more useful than others and that essential medicineswere often inaccessible to many populations. Since then, the essential medicines list (EML) has increased in size; definingan essential medicine has moved from an experience to an evidence-based process, including criteria such as public-health relevance, efficacy, safety, and cost-effectiveness. High priced medicines such as antiretrovirals are now included. Differences exist between the WHO model EML and national EMLs since countries face varying challenges relating tocosts, drug effectiveness, morbidity patterns, and rationality of prescribing. Ensuring equitable access to and rational useof essential medicines has been promoted through WHO’s revised drug strategy. This approach has required anengagement by WHO on issues such as the effect of international trade agreements on access to essential medicines andresearch and development to ensure availability of new essential medicines.
In 1977, the birth of the WHO model list of essential drugs
situations; exactly which medicines are regarded as
led the organisation to advocate for the principle that some
essential remains a national responsibility.”3
medicines were more essential than others, pointing out that
In this paper, we review the list’s history, evolution,
many medicines in developing countries were not useful,
application by countries, controversies, and future
whereas others that were did not reach populations at need.
In the past 25 years, 11 revisions of the list have beenpublished and 156 WHO member states have adopted
medicines lists.1 The list has been much debated: the
The 1975 World Health Assembly5 asked WHO to assist
pharmaceutical industry has attacked it for being too
member states in selecting and procuring essential
restrictive, and non-governmental organisations (NGOs)
medicines, assuring good quality and reasonable cost
have been critical, in particular of the scant attention paid to
(panel 1).2,4,5–18 The first list of 205 items (186 medicines)
AIDS. Selection criteria for drugs have evolved, including a
was published 2 years later.2 At the 1978 Alma Ata
change from an experience-based to an evidence-based
conference, provision of essential medicines was identified
approach. The name has also changed, from essential drugs
as one of eight key components of primary health care.6
lists (EDL) to essential medicines lists (EML).
The 1985 Nairobi conference resulted in the development
In 1977, essential medicines were “of utmost importance,
of WHO’s revised drug strategy, in which the model list
basic, indispensable and necessary for the health and needs
was recognised as important mainly for public sectors; the
of the population”2 and criteria relating to safety, quality,
emphasis was moved beyond selection of drugs to their
efficacy, and total cost were defined.2 By 2002 the following
procurement, distribution, rational use, and quality
definition was proposed: “Essential medicines are those that
assurance.9 In 1991, membership of the WHO Expert
satisfy the priority health care needs of the population. They
Committee on the Use of Essential Drugs was balanced by
are selected with due regard to public health relevance,
including “professionals in essential drugs programmes in
evidence on efficacy and safety, and comparative cost-
developing countries”4 and by providing comparative cost
effectiveness. Essential medicines are intended to be
information.4 During this period, many countries and
available within the context of functioning health systems at
NGOs adopted the essential medicines approach,10 and
all times in adequate amounts, in the appropriate dosage
the UN emergency health kit included 55 of the list
forms, with assured quality and adequate information, and
at a price the individual and the community can afford. The
When the 1999 expert committee met to revise the
implementation of the concept of essential medicines is
model list, they expressed concern at the lack of evidence
intended to be flexible and adaptable to many different
provided to justify revisions and asked that “a summary ofthe appropriate evidence be presented for review”.12Around this time, the effect of the World Trade
Organization (WTO) trade-related aspects of intellectualproperty rights (TRIPS) agreement on access to medicines
Boston University School of Public Health, Boston, MA, USA
was being debated by NGOs, the pharmaceutical industry,
(R Laing MD); Massachusetts College of Pharmacy and Health
and governments.13 In a WHO discussion document
Sciences, Boston, MA (B Waning MPH); Department of Experimentaland Clinical Pharmacology, Nelson R Mandela School of Medicine,
University of Natal, Congella, South Africa (A Gray MScPharm);
We did comprehensive literature searches using Medline and
Médecins Sans Frontières, London, UK (N Ford BSc); and MédecinsSans Frontières, Paris, France (E ‘t Hoen
EMBASE. Emphasis was placed on articles published from
1975–2002 containing information on the implementation,
Correspondence to: Dr Richard Laing, Boston University School of
use, effect, and relevance of essential drug lists in developing
Public Health, 715 Albany St, T4W, Boston, MA 02118, USA
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Panel 1: History of the essential medicines concept
1975: Resolution WHA28.66 called on WHO to assist member states to select and procure essential drugs of good quality and at
reasonable cost1977: First list of 205 items published. WHO criticised for attempting to restrict the right of prescribers to prescribe71978: Alma Ata conference identified provision of essential drugs as one of eight key components of primary health care1981: First edition of Managing Drug Supply identified drug selection as an essential management requirement81982: Bangladesh adopted essential drugs list based on the WHO selection and banned 1700 products. World Health Assembly gavelittle support to the essential medicines concept1984: The World Health Assembly resolution known as the Nordic resolution obtained support of all delegations except the USA (WestGermany and Japan abstain)1985: Nairobi conference brought together NGOs, industry, and government representatives, resulting in the WHO Revised Drug Strategy,which put emphasis beyond selection on procurement, distribution, rational use, and quality assurance for the public sector
UK introduced a restricted list of medicines1986: Revised Drugs Strategy received unanimous support by the World Health Assembly1991: Review of changes in the essential drug list highlighted growth of list and increase in the number of substitutable drugs. Inclusion ofcomparative cost information suggested. Many countries and NGOs adopted the essential drugs approach1997: Second edition of Managing Drug Supply included detailed descriptions on how to select medicines based on prevalent morbiditypatterns and existing standard treatment guidelines111999: Concern expressed at lack of evidence provided to justify changes. Change from experience to evidence-based submissionsoccupied most of 2000–01
Increasing attention paid to effect of WTO TRIPS agreement. Suggestion made at Seattle WTO meeting that drugs on the WHO essential
drugs list be subject to automatic compulsory licensing to ensure universal access2001: The WHO discussion document Updating and Disseminating the WHO Model List of Essential Drugs: the Way Forward attacked byUSA in 35-page memorandum. Final version of the revised procedure adopted by the WHO Executive Board in January, 2002
Doha Declaration stated that the TRIPS agreement should be implemented in a manner “supportive of WTO members’ right to protect
public health and, in particular, to promote access to medicines for all”2002: Several antiretroviral drugs under patent added to the list. New list published on the internet within days of the meeting;alphabetical and anatomical therapeutic chemical (ATC) classifications and translations in four languages appeared within months18
WHO developed a web-based Essential Medicines Library.
WHO stated at TRIPS Council meeting that “people of a country which does not have the capacity for domestic production of a needed
product should be no less protected by [TRIPS safeguards than] people who happen to live in countries capable of producing the product.”
published in May, 2001,14 an evidence-based transparent
safe, and cost-effective medicines for priority conditions
process for revising the list was proposed. This document
(selected on the basis of current and estimated future
was generally well received by member states, with the
public-health relevance and potential for safe and cost-
exception of the USA, which attacked every aspect of the
effective treatment); and complementary, defined as
list in a detailed memorandum.15 Areas of dispute included
“medicines for priority diseases which are efficacious, safe
the applicability of the list to developed countries and cost
and cost-effective but not necessarily affordable, or for
considerations. After detailed rebuttals, the final revised
which specialized health care facilities or services may be
procedure was adopted by the WHO Executive Board in
January, 2002.16 In April that year, a meeting of the expert
The process for creating and revising the EML
committee was held under the new procedures, and several
(panel 2) has changed substantially. Selection originally
patented antiretrovirals were added to the list.17
largely involved decisions made by members of the expertcommittee, with sometimes little evidence. Before 1991,
inclusion of medicines in the list was mainly a result of
The structure of the WHO model EML has remained
applications from WHO programme staff and the
largely unchanged since first published; medicines are
divided into two categories: core, defined as efficacious,
communication). In 2002, an evidence-based approachwas adopted, including public-health relevance, efficacy,
A WHO expert committee, appointed by the WHO Director
General, meets to decide which medicines are added or
deleted. The members, ranging between seven and ten in
number, are selected from WHO expert advisory panels; they
are mainly clinical pharmacologists and physicians, although it
is apparent today that pharmacists and public health
professionals should be included. Most members have been
men, although 50% were women in 2002. Despite attempts to
represent all WHO geographic regions, the Western Pacific has
been under-represented with no member present at four expert
committee meetings. The USA is the only country with
consistent representation at all of the expert committee
meetings. The pharmaceutical industry had observer status in
FϩD=number of forms plus dosages. *Multiple salt forms of a drug arecounted as two distinct medicines; combination drugs are not counted as
the expert committee meetings until 2001 when the new
distinct medicines if the single components appear on the EML.
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antidotes and other substances used in poisonings,
antiallergic agents and medicines used in anaphylaxis,
antineoplastics and immunosuppressive medicines used inpalliative care, and disinfectants and antiseptics. Other
The amodiaquine case illustrates the apparent disconnection
therapeutic classes that account for substantial increases
between selection decisions made by WHO expert committees
include anaesthetics, analgesics, anti-infectives, and
and those made by WHO experts creating treatment
guidelines. Amodiaquine was deleted from treatment
Some medicines have been added and deleted many
guidelines by the malaria expert committee in 1990 because
times. Amodiaquine was on the original list, deleted in 1979
of safety concerns and for lack of apparent advantage over
because “of its similarity to choloroquine”,20 re-added in
chloroquine.23 In 1993, however, amodiaquine use was
1982 as a suspension on the complementary list, and
recommended in cases in which benefits outweighed risks
removed by name in 1987 “since the square symbol [which
(WHO 19th Malaria Expert Committee, 1993) and eventually
indicates that there are many possible medicines in a
reinstated in WHO treatment guidelines in 199624 on the basis
therapeutic class that can be used to treat a given condition]
of results of a systematic review. Several countries have
before chloroquine adequately covers use of this drug”.21 In
followed WHO treatment guideline recommendations, which
1995, the expert committee clarified that the square box
has spurred many organisations to request that amodiaquine
next to chloroquine “is retained solely to accommodate
be re-added to the WHO model EML. The 2002 Essential
Medicines Expert Committee deferred a decision to addamodiaquine to the model EML pending evidence on safety
and efficacy in curative treatments. This decision is contrary to
A cross-sectional analysis of 17 national EMLs, shows that
a WHO technical consultation on malaria published in April,
68% contain fewer than 300 medicines (range 108–389),
2001, that recommends the use of amodiaquine in areas
compared with 309 on the WHO EML in 1999 (table 2).
safety, and cost-effectiveness. However, cost-effectiveness
is considered only within WHO therapeutic categories;
WHO can establish the most cost-effective antimalarials to
add to the list, but cost-effectiveness decisions regarding
treating, say, malaria versus HIV/AIDS, are made at
country level. Information and data used to make
evidence-based decisions are supplied by the Cochrane
Collaboration on request. The EML has nearly doubled in
size from 205 items (186 medicines) in the first edition to
325 (320) in the 12th edition published in 2002; 195
medicines have been added, 86 removed, and 11 have
been reinstated (table 1). Although criticised in the past for
revisions, WHO now publishes clear explanations and
Over the past 25 years, some therapeutic classes have
more than tripled in size, including antimigraine drugs,
*Countries were non-randomly chosen based on the following criteria: EML was
revised in the past 5 years; EML formatted in same manner as the WHO model
EML; medicines were listed by generic names. An attempt was made to obtain
EMLs from all WHO geographic regions, with at least two countries from everyregion, and representation from large and small countries. The country EMLs
were quantitatively and qualitatively compared with one another and with the
1999 WHO model EML. †Duplicates excluded.
Table 2: Cross-sectional analysis of national EMLs
Table 3: Medicines not on country lists but on WHO model list
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The ratio of dosage forms to medicines ranged from 1·03 to
been an issue of great concern in the EDL process.
Although the 1998 list mentions an ideal treatment
Some differences between WHO and national lists are
approach for HIV and opportunistic infections, it includes a
expected and justifiable (table 3). Local and regional
warning that the medicines are “very costly and cannot be
morbidity patterns will result in certain medicines, such as
provided on a mass scale by the public health services . . . it
pentamidine and eflornithine, appearing on few national
may only be provided on a limited and selective basis or for
EMLs. Likewise, medicines newly added to the WHO list,
such as nevirapine and zidovudine, might not be included
A new committee is being appointed to revise the list,
on national EMLs because of a time lag. Of especial interest
including people from major programmes such as maternal
are medicines such as quinidine and ephedrine that have
and child health, non-communicable diseases, AIDS,
been on the WHO list for many years, but have been
tuberculosis, and mental health. Nominations have also
deleted from most national EMLs because of lack of use,
been sought from provincial pharmacy and therapeutics
new information, or more cost-effective alternatives. Such
committees. There is also commitment to an evidence-
medicines probably have no evidence base justifying
based approach. Furthermore, the new lists will address
inclusion on the WHO list, but will remain until the list is
allocating prescriber levels, neglected in the 1998 lists,
systematically revised. Similarly, some formulations, such as
reserpine injection, are no longer necessary but have never
However, country-level EMLs face challenges that the
WHO model list does not—they must result in changes in
The following examples from South Africa and Eritrea
the field, save costs, increase rationality of prescribing, and
show how two countries—one large and relatively
improve patients’ outcome. Although some baseline data
developed, the other small and underdeveloped—have used
were collected, follow-up studies are too small to provide
the EML as a key component of their national drug policies
meaningful conclusions. To align procurement processes
with the list is also difficult; around 1600 differentmedicines are still procured by the South African public
sector. The increasing use of evidence-based formularies in
South Africa’s experience in many ways mirrors global
the private sector is, however, promising.30
challenges. In 1994, the country emerged from decades ofisolation and a political system geared to meet the needs of
Revising the Eritrean national list of drugs
an affluent elite. Among the first new health strategies was
The first Eritrean national list of drugs was defined in 1993
the 1996 national drug policy, which was firmly committed
and contained 305 medicines, the second (in 1996)
to the use of an essential medicines list.26 Although a limited
contained 315, and the third (2001) contained 325. All
list had been used in the public sector from the mid-1980s,
three editions underwent exhaustive review involving most
this list had expanded to include some 2600 items. In the
health professionals in the country. The WHO model list
immediate political pre-transition period, the Department
served as the basis for the first edition, which was produced
of Pharmacology at the University of Cape Town put
by about 30 health professionals. For the second and third
forward a list of around 250 active medicines (350
revisions, comments were reviewed at national workshops
formulations) organised in four levels of care ranging from
attended by more than 100 people, including health
professionals and officials of the Ministry of Health,
The South African list was developed by a committee
professional associations, governmental and international
under intense time pressure, much of it from the political
organisations, and international consultants. Immediately
leadership. The first edition of standard treatment
after its publication, the list gained almost universal
guidelines and medicines (about 160) for primary health
acceptance. The formation of hospital drug and therapeutic
care was released within 2 months of publication of the
committees and compilation of individual hospital lists of
national drug policy. Critics immediately claimed the
medicines into a national list assisted this evidence-based
committee lacked input from primary-care providers and
approach and is recommended for future reviews
was pharmacist-dominated, and that the list was overly
(Information provided by Embaye Andom, Ministry of
focused on disease rather than on syndromes or presenting
problems.27 After a review process, membership of thecommittee was expanded. Although the South African
Implementation and advocacy: the role of NGOs
committees still mainly drew on experience and expert
The first director of the WHO Action Programme on
opinion, they sought first to develop standard treatment
Essential Drugs described the essential medicines concept
guidelines, from which necessary medicine lists were
as a peaceful revolution in international public health.
extracted. At the end of 1998, a three-volume set of these
Others characterised the EML as “a brilliant symbolic
lists was released, aimed at primary health care and
strategy on the part of WHO for mobilising opinion and
resources”.31 However, pharmaceutical companies have
Although the lists were widely distributed, implemen-
tation was described as patchy and considerable challenges
remained,28 including the apparent dislocation between the
Manufacturers Associations (IFPMA) called the medical
EDL committee and the structures responsible for design of
and economic arguments for the EML fallacious and
programmes and training material. The committees were,
claimed that adopting it “could result in sub-optimal
in effect, dissolved once the books were published;
medical care and might reduce health standards”.32 The
maintenance of the lists was therefore neglected, and
pharmaceutical industry was concerned that the EML
guidelines produced by national vertical programmes
would become a global concept applicable to public and
increasingly deviated from the selection made by the EDL
private sectors in developing and developed countries, and
committee. A prominent example was the guideline for
were especially opposed to attempts by developed countries
postexposure prophylaxis for rape victims, which in addition
to introduce limited medicines lists. In 1982, a spokesman
to including antiretrovirals suggested the use of
of the US pharmaceutical manufacturers organisation said
azithromycin;29 the drug is not available in state facilities and
“The industry feels strongly that any efforts by the WHO
no tender for its procurement has been issued. HIV has
and national governments to implement this action program
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should not interfere with existing private sector operations”.
and the International Pharmaceutical Federation (FIP) had
The Italian drug industry put it more crudely in response to
adopted essential medicine policies.7 The International
the Italian senate’s attempts to introduce an EML, stating
Federation of Red Cross and Red Crescent Societies has a
“If they want to turn Italy into a third world country, this is
comprehensive essential medicines policy35 and Médecins
Sans Frontières has an essential medicines guide designed
The drug industry’s view that EMLs are only for the
to address practical field needs.36 In 1998, a group of NGOs
public sector of the poorest nations has not changed much
published a guide to encourage NGOs to adopt such
in the past 25 years. The current IFPMA paper about
policies for their own operations or as a condition for
essential medicines repeats that view and says that policies
extending restrictive drug policies to industrialised countries
In 1981, around 50 NGOs met in Geneva to form Health
pose a serious threat to the delivery of effective health care
Action International (HAI) whose aims include “the safe,
rational and economic use of pharmaceuticals world-wide . .
NGOs have advocated for political support for WHO’s
. and full implementation of the WHO Action programme
work on essential medicines and for implementation of
on essential drugs.” HAI has been a strong advocate for
essential medicines policies at the national level (panel 4).
EMLS at the national and international level.
Furthermore, they have a substantial role in the provision of
However, advocacy for the availability of essential
health care in resource-poor settings, and have used the
medicines and removal of non-essential and dangerous
EML for the selection and procurement of medicines. The
medicines from the market was not sufficient to ensure their
importance of this approach is perhaps best illustrated by
rational use. In 1982, HAI put forward a draft code of
the chaos and risks posed by inappropriate drug donations;
practice that addressed the need for international norms on
in Lithuania 11 women went blind as a result of a veterinary
promotion, distribution, trade, and technology in the
drug, donated by a European NGO, being given mistakenly
pharmaceutical sector. Though an international code on the
pharmaceutical sector was never devised, the World Health
By the mid-1980s, international agencies including
Assembly adopted a comprehensive pharmaceutical policy
NGOs such as Médecins Sans Frontières and Oxfam and
within the WHO Medicines Strategy in 1986.38 The strategy
professional bodies such as the British Medical Association
has the aim of ensuring equitable access to essentialmedicines of acceptable quality, promoting rational use ofmedicines, and implementing national medicine policies. In
2001, the WHO Medicines Strategy was expanded to
● Since the publication of the first WHO EDL, Acción
include a mandate for WHO to work on trade-related issues
Internacional para la Salud (AIS) Bolivia has translated and
affecting the availability of medicines.39
distributed the list throughout Bolivia using a network of
15 volunteer groups. AIS also uses the EML as a basis for
consumer education and campaigning to ensure that
The AIDS crisis has highlighted the grave inequity in accessto essential medicines and has drawn attention to the
essential medicines remain in production and are available
potential consequences of WTO agreements on the
availability of medicines. Most AIDS medicines are fairly
● In Malaysia, the National Poison Centre educates the public
new and are produced in what is effectively a monopoly.
about essential medicines by regularly publishing articles in
Once the TRIPS agreement is fully implemented (by 2016
the Malaysian newspaper New Strait Times
for least-developed countries) the cost of all new medicines
● In Latvia, the independent drug bulletin Cito! led campaigns
worldwide will largely depend on price setting by the patent
to stop the sales of inessential medicines such as obsolete
antidiarrhoeals and painkillers using the essential
In 1996, an Assembly resolution requested WHO to
“report on the impact of the work of the World Trade
Organization with respect to national drug policies and
● In 1982, the Dutch parliament adopted a decision that
essential medicines and make recommendations for
development aid could be used only to purchase essential
collaboration between WTO and WHO, as appropriate”.40
medicines. This action followed a campaign by WEMOS
In 1998, WHO published the first guide containing
(Dutch Working Group on Health and Development Issues)
recommendations to member states for implementing
showing that a Dutch company was exporting anabolic
TRIPS while restricting the negative effects of increased
steroids to Bangladesh for use by children to stimulate
patent protection on drug availability.41 At that time,
● Since 1988, BUKO (German Federal Congress of
controversial. The emphasis on public health needs versustrade was seen as a threat in the industrialised world. In
Development Action Groups) Pharma-Kampagne has
1998, the Directorate General for Trade of the European
published an assessment of the product range of German
Commission concluded, referring to “considerable concern
pharmaceutical companies to determine whether it
among the pharmaceutical industry”, “that no priority
addresses the health needs of people in developing
should be given to health over intellectual property
countries. One of the benchmarks used is the WHO EML.
considerations”.42 However, subsequent resolutions of the
The latest study on the marketing of German medicines
World Health Assembly have strengthened WHO’s
Poor Choices for Poor Countries, published in 1999, shows
mandate with respect to trade. In 2001, two resolutions
that more than 40% of the medicines sold in developing
addressed the need to strengthen policies to increase the
countries still do not meet the basic criteria for rational
availability of generic medicines and assess the effect of
medicines. However, there are also improvements: 15 years
TRIPS on access to medicines, local manufacturing
ago two-thirds of German medicines were rated irrational
capacity, and development of new medicines.43,44
● Pakistan Network for Rational Drug Use has successfully
At the 1999 third ministerial conference of WTO in
campaigned for the abolition of sales tax on essential
Seattle, several developing countries proposed adding
medicines in Pakistan leading to increased affordability
medicines on the WHO list to the exceptions to what couldbe patented allowed under TRIPS article 27.3(b).45 A
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developed treatment guidelines as anindependent activity. Now, they will
BNF=British National Formulary. QSM=Quality and Safety of Medicines. WCC=World Council of
Chuches. MSH=Management Sciences for Health. MSF=Médecins Sans Frontières. ATC=Anatomical
in their guidelines on the model list.
and Therapeutic Chemical classification. DDD=Defined Daily Dose. Intern=international.
For example, on May 8, 2002, WHOannounced a new formula for oral
counterproposal led by the European Communities was “to
rehydration solution,53 but the 2002 model list that had
issue . . . compulsory licenses for drugs appearing on the list
been approved the previous month contained the old
of essential drugs of the WHO.”46 But because only around
formulation; the new formulation was included the
15 of the 306 products on the WHO list were patented in
certain countries (at the time drugs such as antiretrovirals
Given that the EU and US delegations to the TRIPS
were excluded because of cost),47 this proposal would have
Council considered WHO’s recent advice54 on how to
greatly limited the scope of compulsory licensing. The
ensure production and export of generic medicines as
Seattle conference collapsed and no conclusion was
being outside WHO’s mandate, WHO will have to insist
on its duty to advocate for health in future trade debates.
2001 saw the WTO Doha Declaration on TRIPS and
This role includes addressing the issue of the lack of
Public Health, which acknowledged the right of countries to
pharmaceutical research and development for health
take measures to protect public health: “. . . while
needs in developing countries. Only 1% of medicines
reiterating our commitments to the TRIPS Agreement, we
developed in the past 25 years have been aimed at these
affirm that the Agreement can and should be interpreted
diseases, despite the substantial burden that they cause.55
and implemented in a manner supportive of WTO
The pharmaceutical industry has engaged in several
Members’ right to protect public health and, in particular,
public-private partnerships, but they are largely still
to promote access to medicines for all.”48 For this statement
focused on diseases where there is an economic incentive
to be of practical use, the issue of the right of countries to
(ie, AIDS, malaria, and tuberculosis) and it is too early to
produce generic medicines for export must be adequately
say whether they will be successful. Where will the new
essential medicines for meeting needs specific todeveloping countries come from?
Although many people in the world still lack effective
The 25-year-old essential medicines concept serves as the
access to essential medicines, the work done by WHO
basis for the WHO medicines strategy in operation today.50
and its partners has done much to bridge this gap. The
It has become a global concept used by governments and
original insight that a restricted list of well chosen
medicines could meet the needs of most of the world
The development of an evidence-based list within WHO
remains as valid now as it did in 1977. However, the
will be mirrored in countries attempting to implement the
fundamental human right to access to these medicines
essential medicines concept, which poses major challenges.
remains a challenge and will require further action at the
Evidence used by WHO to add or remove a drug might
provide some basis for change in country-level decision-making, but in some cases local trials might also be
necessary. WHO’s web-based Medicines Library will
provide information,51 prices,52 and evidence for decisions, toassist national committees (figure). Training committeemembers in the use of evidence-based medicine resources
AcknowledgmentsWork by R Laing and B Waning on the comparative analysis of the essential
medicines lists was made possible through support provided to Boston
Another area that national committees could find
University’s Center for International Health through its subcontract to
challenging is cost-effectiveness analysis. International
Management Sciences for Health by the Office of Health, US Agency for
measures of effectiveness might be locally applicable and
International Development, under the Rational PharmaceuticalManagement Plus Project (contract number HRN-A-00-00-00016-00,
local costs can be incorporated, but local clinical trials might
subcontract RPM-00016-BOS-0003). The WHO EDM programme
be needed to measure effectiveness and international prices
provided country essential drug lists and financial support for the
might have to be used for medicines which are not yet
available in the country. Countries might benefit from
The opinions expressed herein are those of the authors and do not
necessarily reflect the views of the US Agency for International Development
international assistance with these issues, as occurred in
None of the funders had any role in this Review.
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29 Department of Health South Africa. Policy guideline for management of
Executive Board WHO. Revised procedures for updating the WHO
transmission of human immunodeficiency virus (HIV) and sexually
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EB108/INF.DOC./2. Geneva: World Health Organization, 2001.
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for Health Policy, University of the Witwatersrand.
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http://www.hst.org.za/chp/pubs/policy.pdf (accessed Dec 10, 2002).
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Howard NJ, Laing RO. Changes in the World Health Organization
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32 International Federation of Pharmaceutical Manufacturers Association.
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Issue paper: the “Essential Drugs” concept—February, 1997.
http://www.pharmweb.net/pwmirror/pw9/ifpma/pdfifpma/
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___________________________________________________________________________ CLINICAL GUIDELINES for SUBCUTANEOUS INFUSION (HYPODERMOCLYSIS) Clinical Policy Folder Ref No: 16 APPROVED BY: Policy and Guideline Ratification Group (PGRG) Date of Issue: July 2010 Version No: 1.3 Date of review: May 2012 Author: Alison Griffiths. Matron District Nursing NHS South Glouces