Accordingly, by resolution WHA 28.66 the Health Assembly requested the Director

General of WHO '. . . to develop means by which the organization can be of greater

direct assistance to member states in advising on the selection and procurement, at

reasonable cost, of essential drugs of established quality, corresponding to the

national health needs'. Subsequently, the resolution from the UNCTAD Conference

in Colombo, August 1976 also gave strong support to such a prograrnme, by inviting

the organizations ofthe United Nations' System to collaborate 'in the preparation of

a list of priority pharmaceutical needs of each developing country and the formulation of the basic model list of such needs as a general guideline for action by the

developing countries'.

Procedures

Accordingly WHO developed its programme on the selection of essential drugs as

outlined in technical reports (TRS) 615 (WHO Expert Committee, 1977) and 641

(WHO Expert Committee, 1979) and elsewhere (Lunde, 1980; Tognoni, Colombo,

Franzosi & Garattini, 1980). Key notes on the procedure are given in Table land the

Action Programme is summarized in Table 2.

Table 1 Working procedure when establishing WHO Programme on the selection of essential

drugs.

I) WHA resolution May, 1975,to the Director-General ofWHO.

2) Reorganization, including the establishment of 'The Drug Policy and Management

Division' of WHO HQ, collection of material from member states, Autumn 1975-Spring

1976.

3) First working documents prepared May-June 1976 (background and criteria for drug

selection, administrative aspects).

4) Working documents circulated to WHO Regional Office for comments , Summer 1976.

5) Internal revision before the first informal expert consultation, October 1976. Informal

report DPM176.1 prepared containing background and a mode/list of essential drugs.

6) DPM176.1 circulated to all member states for comments, Winter-Spring 1977. Drug

industry informed and reacts by initial protests (Tiefenbacher, 1977).

7) Additional internal revision upon the comments. The ftrst/orma/ expert consultation held

in Geneva, October 1977. WHO Technical Report Series No. 615 printed and distributed

from December 1977.

8) Drug industry goes into dialogue with WHO; increasingly positive comments from

professionals within or outside health authorities. Many countries start or continue work on

drug selection, and ask WHO for assistance.

9) WHO Executive Board passes resolution EB 611SR/17 on essential drugs, January 1978.

The 31stWHA approves 'Action Programme on Essential Drugs', May 1978(seebelow).

10) Revisions and follow up: The model list is to be updated annually , and an informal

consultation was held in November 1978 as followed by a formal one in October 1979.

Special attention was paid to the establishment ofunbiased model information on the drugs

on the model list (and their alternat ives), and to guidelines on the pharmaceutical dosage

forms, strengths, and so on.

THE WHO ESSENTIAL DR UG CONCEPT

Table 2 WHOAction Programme on essentialdrugs; as summarized by the author.

531

I) The member states should establish national drug lists according to the criteria given in

Technical Report Series No.615, including the distributional and legal (registration)

apparatus necessary. Independent drug information should be provided, and international

collaboration on drug price policy, production and other strategic aspects should be

strengthened. As a rule, generic drug namesshould be preferred.

2) The Director General of WHO should continue elTorts to identify the scientifically bestdocumented drugs and to collaborate with the member states according to their conditions:

a) to ensure a supply of knowhow and resources through collaboration with UNICEF,

UNIDO, The World Bank and other Development Banks and Funds; b) to stimulate

reasonable local production of drugs; c) to study price-setting for drugs and mechanisms for

their marketing; d) exchange information and experience and to give feedback to WHO,

amongothers.

The concept ofdrug seIection is twofold:

I) To ensure the accessab ility of the most necessary drugs - of appropriate efTtcacy,

safety, product quality and acceptab ility - as adjusted to the local needs and

circumstance s, and

2) to implement a comprehensive strategy for the establ ishm ent of a more rational

drug utilization , con sidering all levels of the therapeutic chain (drug producers,

control authorit ies, distributors, prescribers and takers).

Criteria and guidel ines for the selection ofdrugs and pharmaceutical products were

developed in the first report, in which a model list was also presented. In the second

report the model list is revised, and includes guidelines for administration, proposed

dosage forms and strengths. Th is revised and somewhat completed mod el list of

essential drug s contains about 250 substances/items, including vaccines, antidotes,

minerals, vitamins and diagnostic agent s. Of the 175 therapeutic drugs left when

subtracting those mentioned, some 55 are anti-infectives for systemic purpose, 20

cardiovascular and only six are, stric tly speaking, psychotropic drugs. Fixed drug

combination s are onl y accepted if clin ical documentation just ifies the concomitant

use ofmore than one dru g; ifthe therapeutic effect is greater that the sum ofthe effect

of each , if the cost of the combination product is less than the sum of the individual

products, if compliance is improved, and if sufTtc ient drug ratios are prov ided to

allow dosage adjustments satisfactory for the majority ofthe population .

Immediate reactions and implementation

It should be recalled th at despite the strong political force beh ind the WHO

Programme on essenti al drugs, the whole procedure has been based upo n

experiences and widely accepted criteria for drug regulations and the establishment

of therapeutic formul ar ies in several deveIoped countries (Controlling the use 01

therapeutic drugs, 197 8; Togn on i, 1978a). In a number of Afro-Asian and Latin

American countries restricted national Iists of basic drugs had also been prepared

before WHO entered the scene. Several obstacl es were faced in the se countries,

however. Despite the fact that man y lists ofbasic dru gs were rellecting a high professiona l standa rd in the work of selection, insufTtcient professional promotion, acti ve

and passive resistance by the dru g producers, the profession als and the public, mostly

hampered the implementation. Thi s is not surprising, considering the lack, in most

countries, of an overall drug strategy on the side of the health authorities (and

politician s) and the direct economic interest, not only on the side of the dru g

industry , but also among dom inant parts of the medical and pharmaceutical

profess ions. The profe ssion al prestige and the personal polyph armacotherapeutic

image ofthe prescriber on the on e hand and the distributor (pharmacist) on the oth er

adds to these difTtculties (Tognoni, 1980).

532 P. K . M . LUNDE

The immediate reaction by the drug industry, especially during the first half of

1977 was quite harsh, as reflected in Tiefenbacher's (1977) statement saying that the

WHO concept on essential drugs is 'completely unacceptable by the pharmaceutical

industry' and further that the programme is 'in fact strongly advocated by left wing

radicals in developed countries because it strengthens the request for reduction in the

number ofproducts in their countries'(l),

The term 'essential' does indicate that the drugs to be selected 'are of utmost

importance, and are basic, indispensable and necessary for the health needs of the

population'. lt is further stressed that the drugs to be included would difTer from

country to country, depending on morbidity patterns, available resources (personnel

and fmances), as weil as genetic, demographic and environmental factors. Adoption

of a list of essential drugs is part of anational health policy aiming at achieving the

widest possible coverage of the population with drugs of proven efficacy and safety.

Only drugs meeting with adequate standards of quality and subject to appropriate

clinical pharmacological documentation of the rationale for their use are accepted.

Concise, accurate and comprehensive drug information drawn from unbiased sources

should accompany each list of essential drugs as adjusted to the educational standard

and the level of health service in question. Detailed guidelines for the selection

procedure, including the medical, pharmaceutical, legal and educational aspects are

included in TRS 615 (WHO Expert Cornmittee, 1977), in which the need for

establishing appropriate systems for drug utilization studies is also underlined

During the preparation of the model list the safety aspects were thoroughly

discussed for a number of drugs, such as chloramphenicol, clioquinol(s), phenylbutazone and aminopyrine-like drugs. These considerations have, among others, led

to the design of a large epidemiological project "The international study of agranulocytosis and aplastic anemia' (Levy, 1980).

However, after an intensive campaign in the European mass media by the drug

industry, as assisted by some professionals who were also reluctant or hesitant as to

the concept, the visible opposition gradually faded ofT. Despite the highly sensitive

medical, cultural, economical and political implications, an increasing understanding and acceptance became apparent as illustrated by the publication of two

editorials (Lancet, 1978; Journal ofthe World Medical Association, 1978). During the

period 1977-1980 the author and others were acting as short term consultants in

order to assist in drug selection and drug utilization studies in a number of AfroAsian countries (Lunde, 1977a , 1977b, 1979, 1980; Tognoni, 1978b). The general

acceptance ofthe concept in the selection of essential drugs is perhaps best illustrated

by the unanimous approval ofthe programme by all member states at WHA 31/78,

that is, only three years after the initial resolution .

When considering the last years of development and the present state ofthe WHO

Action Programme on essential drugs the results may in many ways be encouraging,

but there are also disturbing features on the scene. Since May 1978 a number of

countries and WHO regions have discussed the strategy for the implementation ofthe

programme and a number of modified lists have been adopted (WHO Regional

Expert Cornrnittee, 1977; The Alma Ata Conference, 1978; WHO Regional Expert

Committee, 1979; National Drug Policies, WHO/EURO, 1979; Report from the

WHO Regional Committee for South-East Asia, 1979; Report on Technical Co -

operation among Asean countries, 1979). This reflects the awareness at the level of

the health authorities and the drug regulatory bodies with regard to the identification

ofbasic needs and for providing drug quality products either by improved planning

in the supply from the outside or by establishing local production according to

existing professional facilities. After some initial misunderstanding that the work was

done as soon as a list of essential drugs was prepared, most key officials have now

recognized that this is a continous activity with numerous implications not only for

the health services, but also for the cultural and social situation in each country. The

THE WHO ESSENTIAL DRUG CONCEPT 533

major obstacle faced at the moment is that the key professions and the public have

not been sufficiently informed about the gains in terms of enhanced therapeutic

efficacy and safety by implementing such a programme, as based upon the best of

what medicine, pharmacology and pharmacy can provide.

The drug industry has, at least through its international organizations, seen the

challenge in assisting in the present programme, and also in discussing new priorities

in drug research and development with relevant international organizations inside

and outside the network of the United Nations. However, on a local level the

representatives from the international, as weil as from national, drug industry pay

little or no attention to these new ideas, unless directly guided or requested by the

authorities in charge.

Despite the fact that the Action Programme on Essential drugs is approved by all

member states of WHO, few countries have taken steps for full implementation. As

an impressive example, attention should be paid to what is going on in

Indonesia, which is the fifth most populated country in the world and with great

problems in their health delivery system (Darmanshah, 1978). Since the formal

degree of February 1980 intensive activity has been going on in order to

implement a national programme for essential drugs, as briefly shown on Table 3 and

further described in arecent assignment report (Lunde, 1980).

Table3 Simplified scheme for the implementation of an essential drug programme

in Indonesia aimed at hospital levels (A, B, C, D), health centres and primary health

care.

1977-1979

Preliminary

discussions,

drafted

lists.

(A list was

also prepared

in October 1979

by WHO, Geneva)

June (13-18)

Second draft

evaluated by a

loeal drug

committee +a

WHO eonsultant

- third

draft

1980: February

Decree by H. E.

the Minister

ofHealth to

start the work,

adopting the

criteria given

in TRS 615as

extended in TRS 641

June (18-21)

Evaluation of

third draft at

anational

plenary meeting

including physieians

(specialists+GP's)

and pharmaeists

from all parts of

thecountry

- agreed

draft for most

therapeutic c1asses

April/May

First draft

prepared

and evaluated

by key professionals

(physieians and

pharmacists) in

Jakarta

- second draft

July

Final draft"

to be implemented

* To be implemented gradually from August/September 1980, by taking action for

procuring the drugs recommended for the various levels of the health services, for

establishing drug information services, monitoring of adverse drug reactions and

designing drug utilization studies for future evaluation ofthe programme.

534 P. K. M . LUNDE

Comments and prospectives

The development within the frame of WHO, of a model strategy for the selection of

essential drugs has probably proceeded faster than could be expected, when

considering that this a quite unique and comprehensive approach, as compared to

previous technical matters handled within the field of drugs and health services.

Surprisingly few objections have appeared as to the technical side ofthe programme,

although several alterations were necessar y when the revision ofthe Irrst model list in

TRS 615 (WHO Expert Committee, 1977) took place in 1978-1979.

The implementation of this strategy for national purposes obviously must take

time . Subsequently, continuous evaluation in terms of drug utilization studies (for

rnethodology see, Studies in Drug Utilization, 1979; Lunde et al., 1979) and

appropriate drug information as adjusted to the result s of the evaluations, and the

level of the hea1th service (Herxheimer & Lionel , 1978; Herman, Herxheimer &

Lionel, 1978) is necessary. Such drug information programmes, especially

when facing the public, must be part of a broader information and education on

problems related to health and disease, however.

The idea behind the concept of essential drugs was not to deprive the health

professionals and the public of important drugs and remedies. On the contrary, the

guidelines have always been to provide the best possible quality of drug treatment for

a maximal part of the population, limiting the cost to the minimum necessary . The

priorities must be set by the health services, but collaboration must be sought by the

drug indu stry and independent academic institutions, and whene ver necessary, with

the assistance of appropriate international organizations. In the long run this may

increase the rate in the already ongoing change s in the existing market mechanisms

for the development and sales ofdrugs.

The future implementation ofthe WHO Programme on essential drugs does indeed

also represent a great challenge for clin ical pharmacology, not onl y in develop ing

countries. Although we should also see the great potential for a future development of

clin ical pharmacology that lies in the developing countries, when looking at the

numerous, exciting and mostly unexploited problems present.

Finally, the concept of drug selection could also repre sent a future model for a

more extensi ve scrutiny of the wide variety of products and procedures related to

diagno stic, preventative and therapeutic measures in medicine, as weil as elsewhere

in our societies.

References

Controlling the Use 0/ Therapeutic Drugs: An International Comparison (1 978). Ed. Wardell,

W. M. Washington D.C. : Enterprise Institute for Public Polic y Research .

Darmanshah , I. (1978). Various drug problems in Indonesia' s health deli very system. Presented

at: Lokaharya Penelitian dan Pengernabangan, Kesehatan, April 24-27.