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EDITORIALS

WHO’s essential drugs conceptFifteen years after the World Health Organisationdeveloped the essential drugs concept, a team from theLondon School of Hygiene and Tropical Medicineand the Royal Tropical Institute, Amsterdam,commissioned by several donor governments, hasconducted an external evaluation of the Action

Programme on Essential Drugs.!The evaluation covers WHO’s work on essential

drugs between 1975 and 1989 and concludes that theProgramme has succeeded in communicating andadvocating understanding, acceptance, and

implementation of the essential drugs concept and inproviding technical support to countries. For

methodological reasons the impact of implementationon health or health care at grassroots level was not

assessed, other than by using limited evidence on drugavailability for primary health care. However, severalof the thirteen country case-studies illustrated thedifficulties of integrating donor essential drugsprogrammes and the ministries of health and primaryhealth care services. The authors’ of the report believethat WHO’s leadership is crucial to the developmentof policies and implementation of strategies that willensure availability, accessibility, and rational use ofessential drugs in primary health care into the 1990s.The essential drugs concept originated in the 1970s,

when a changing climate of opinion emphasised amore equitable distribution of resources for health.The concept, which was identified as one of the

eight pillars of primary health care in the Alma Atadeclaration in 1978, owed much to the then newDirector of WHO, Dr Halfdan Mahler, who had anenduring interest both in its principles and in itssuccessful translation into national policies and

programmes.The first model essential drugs list appeared in

1977, and was accompanied by an importantintroductory exposition of the concept.2 The list

provided a scientifically rigorous framework for

governments that enabled them to rationalise their

requirements for drugs by selecting a limited numberwhich could be matched to assessed national healthneeds. By emphasising generic agents the liststimulated international competition and broughtdown prices-an important consideration, since some

countries were spending 40% of their slender healthbudgets on drugs. It also provided governments witha blueprint for regulation and, by reducing the totalnumber of drugs, simplified all the elements thatcontribute to effective supply and use at a nationallevel.

However, publication of the WHO list was notfollowed by implementation of similar lists at a

national level, and the Action Programme on EssentialDrugs was established in 1981 to promote the conceptand to provide technical support to countries. From1983 it reported directly to the Director General’soffice, setting as its objectives: "to ensure availabilityto all people of a regular supply of a selected number ofsafe, effective drugs of acceptable quality at lowestcost".The essential drugs concept engendered

considerable friction. Not surprisingly, the

pharmaceutical industry was initially reluctant to

endorse the concept but subsequently accepted itsapplication in the public sector of the poorestcountries. Essential drugs policies for the privatesector, and for other developing countries, metresistance. There were fears that a global applicationwould affect private enterprise in drug supply in thedeveloped world.A painful period in the 1980s brought to light

examples of double standards applied by industry inits dealings with developing countries, and saw theemergence of some highly critical non-governmentalorganisations and consumer groups. The question of aWHO international code on pharmaceuticalmarketing contributed to turbulence at World HealthAssemblies in Geneva. WHO managed to containcontroversy and a landmark conference in Nairobi in1985 usefully broadened the essential drug concept toinclude a strong emphasis on the rational use of drugs.A more cooperative atmosphere was achieved byallocation of specific responsibilities for further

development to the various actors, including non-governmental organisations and industry. In 1986 theupdated concept was endorsed by all member states atthe Assembly. Funding followed, with donor

governments adding$20 million as extra-budgetaryresources to the regular budget of$1 3 million in thelast biennium. Developing countries increasinglyapplied for help.

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WHO’s achievements in this area can besummarised as the establishment of equitable accessto essential drugs as a key principle, linked to asimple conceptual framework--easy to understandif not to implement. The model essential drugs listhas been a powerful tool for advocacy, providingscientific justification for the concept in workshopsand training in the third world. Support for theconcept has spread to encompass the developmentof lists and formularies in industrialised countries.In addition, the Action Programme has providedhigh quality technical support to governments ofdeveloping countries, few of which have function-ing registration systems or quality control schemes.By the end of the period under study in the evalu-ation document, 90 countries had a partly or fullydeveloped national essential drugs policy. Never-theless, trained personnel and resources for selec-tion, quantification, procurement, storage,distribution, and training are lacking, and there arevirtually no unbiased and objective informationservices.

The Action Programme has first and foremostaddressed the need of between 1-3 and 25 billion ofthe world’s population who are still without regularaccess to the most basic drugs at primary health carelevel.3 3 The economic predicament of so many

developing countries as a result of declining healthbudgets and lack of foreign exchange has led to seriousshortages of drugs. Africa, heavily dependent onimported drugs, has suffered unduly, since rising debtrepayments, falling commodity prices, and repeateddevaluation of currencies have had a dramatic effect in

many countries. In view of these economic realities,dogmatic wrangling over the universality of theessential drugs concept and demagogy in internationalforums must be forgotten. In the interest of

strengthening national health services, the wayforward lies in action in and by individual countrieswith maximum external support.

WHO’s skills and leadership on essential drugs arestill needed. Recent publicity about managementdifficulties within the Organisation is therefore of

specific concern to the future of the Action

Programme on Essential Drugs. Whilst the removal ofthe Programme from the new Director General’soffice into the reorganised Division of Drug Policyand Management is understandable on managerialgrounds, lack of a permanent head of the division,vacancies in three key posts, and inability to spendmore than half the last budget allocation are notreassuring. At the most recent Management AdvisoryCommittee in March government donors agreed to abudget of$22 million for the biennium 1990/91. Theywill be listening attentively to the Director General’sprogress report to the World Health Assembly nextmonth and will expect an affirmation of existingessential drugs policies and concrete action to followtheir gesture of good faith.

1. An Evalution of WHO’s Action Programme on Essential Drugs, LondonSchool of Hygiene and Tropical Medicine, United Kingdom, andRoyal Tropical Institute, Amsterdam, the Netherlands. December,1989. (The report may be obtained from the Health Policy Unit,LSHTM, Keppel Street, London WC1E 7HT.)

2. The Selection of Essential Drugs. Report of a WHO Expert Committee.WHO Tech Rep Ser 1977; 615.

3. World Health Organisation. The world drug situation. Geneva, WHO:1988.

Legislated clinical medicineThe concept of legislated clinical medicine may seemalien to most phsyicians in Western Europe, but it is agrowing reality in the United States and New Zealandand, to a lesser extent, in the United Kingdom.1 Thisnotion began rather innocently in the USA with

hospital tissue committees. Then, gradually, the

scrutiny of physicians by physicians began to be usedby third-party payers as a management tool. Eddy2lately described the essential elements of this process:"What is going on is that one of the basic assumptionsunderlying the practice of medicine is beingchallenged ... This assumption concerns theintellectual foundation of medical care. Simply put,the assumption is that whatever a physician decides is,by definition, correct. The challenge says that whilemany decisions no doubt are correct, many are not,and elaborate mechanisms are needed to determinewhich are which. Physicians are slowly being strippedof their decision-making power".As long ago as 1972, Alford had identified the

developing conflict between the "corporaterationalizers" of health care on the one hand and the

profession on the other, with the interests of theconsumer in play between the two.3 In the USA, themomentum in this struggle for the trust of theconsumer appears to be shifting away from the

profession towards the rationalisers, who represent analliance of business and government under the guise ofcost containment. Light and Levine4 observed that"the center of power in American health care is now

shifting from the profession to buyers". This changehas been manifested in legislative efforts that

challenge the integrity of the medical profession andappear potentially to hasten the decline in professionalautonomy foreseen nearly a decade ago by Starr. 5Three recent developments illustrate this trend.

The first began in 1972, when the US Congresscreated Professional Standards Review Organizations(PSROs) to review the quality and appropriateness ofcare provided to Medicare patients in hospital. In1983 Congress abolished the PSROs and replacedthem with Professional Review Organizations (PROs)to oversee quality and utilisation review in theMedicare programme. There are now 54 physician-controlled PROs and the federal government hasinvested nearly a billion dollars in these peer reviewactivities, which are intended to assess the medicalnecessity of services and the quality of care provided toMedicare beneficiaries. PROs are linked to Medicare