Monday,30 September 2002  
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Government - Gazette

Sunday Observer

Budusarana On-line Edition

The neglected solution

Prof. Senake Bibile

by Dr. K Balasubramaniam

This article is an attempt to do justice to the revolutionary people-oriented drug policy which Sri Lanka successfully implemented during the period 1972 to 1976.

The policy was abandoned when a more industry oriented government came to power and not because it was a failure as critics argue. The analysis of the Sri Lankan experience in rationalizing the structure of importation, production, distribution and use of pharmaceuticals during that period will provide valuable guidelines to policymakers in other Third World Countries who wish to reform their own drug supply systems.

This article is published to mark the 25th death anniversary of Prof. Senaka Bibile, respected all over the world as a father and Prophet of modern medicine and the founder Chairman of the State Pharmaceutical Corporation.

In the 1970s Sri Lanka demonstrated that a state buying agency lined to a national formulary was a viable and powerful instrument for reducing drug costs without compromising quality, for saving foreign exchange, for rationalizing drug usage and for supplying essential drugs at reasonable prices to the whole community. The formulation and implementation of an integrated national pharmaceutical policy made it possible.

A careful selection of drugs was the first essential component of the national policy. A National Formulary Committee (NFC) consisting of representatives from the public and private health sectors and the University Medical Schools, prepared a national formulary of about 630 drugs under their generic names, which covered the same therapeutic needs as the countless brand name drugs previously imported without restriction. The support of the medical profession was crucial for the successful implementation. So leaflets to inform prescribers of the proper use of the reduced list and to convince them of the quality and efficacy of generic named drugs were provided.

A state trading institution, the State Pharmaceutical Corporation (SPC), was established to channel all imports of pharmaceuticals. Imports were limited to the approved drugs listed in the national formulary. The public and private health sectors obtained all their requirements from the SPC.

Brand names for drugs were replaced by generic names in the sale and prescribing of medicines. Promotion of drugs by manufacturers was stopped to remove the dangers and costs inherent in the extravagant promotional practices of the industry. Drug information was provided from official sources. The Prescriber, a quarterly publication edited by the NFC, was published by the SPC and distributed to all medical personnel. The journal provided them with objective information on drugs and therapeutics.


While the above measures were implemented, a policy for local production was being evolved, outlining the manufacture of pharmaceuticals consistent with the overall programme. Local manufacturers would produce according to the rationalized drug list, use materials imported by the SPC and leave promotion and distribution to the State.

The entire pharmaceutical programme was conceived, formulated, developed and implemented by the late Senake Bibile, Professor of Pharmacology at the University of Sri Lanka. His contribution to development in the drug area was acknowledged publicly during the 35th World Health Assembly, in Geneva in May 1982.

The interventions of delegates from 47 different countries during the discussion on the rationalization of the pharmaceutical supply system in developing countries showed how important this subject was throughout the Third World. A WHO official said, referring to WHO's Action Programme on Essential Drugs, that "the philosophy guiding action was based on that recommended by the late Professor Bibile of Sri Lanka". He underscored the impact of the Sri Lankan reforms on the evolution of the WHO Programme.

During the early seventies health planners in developing countries were calling for innovative changes in the pharmaceutical supply system in their countries.

The existing arrangements did not meet the needs of the majority of their people, although a considerable portion of their health budgets went to the procurement of pharmaceuticals. The call led to the establishment of a Group of Experts on Pharmaceuticals within the United Nations Action Programme for Cooperation among Non-Aligned and other Developing Countries (UNAPEC) to work out proposals for reforming the pharmaceutical sector.

The final recommendations presented by the Expert Group drew heavily upon the experience of Sri Lanka and recommended it as a model for others. They were endorsed by the Fifth Non-Aligned Summit Conference, Colombo, Sri Lanka, August 1976, which meant that the Heads of State and Governments of Non-Aligned and other Developing Countries exhorted the Third World countries to follow the example of Sri Lanka in rationalizing the importation, production and distribution of pharmaceuticals.

Countries were advised to prepare national drug formularies with a limited number of drugs, abolish brand names in favour of generic names, establish an institution for the centralized bulk purchase of drugs, abolish drug promotion by the private sector and provide object information on drugs and therapeutics, revise the existing legislation on patents to suit their economic and development needs, set up local production of drugs as appropriate and establish regional cooperative mechanisms for joint action to develop the pharmaceutical sector.

Following this move, a special task force on pharmaceuticals was established by six international agencies: UNAPEC, UNCTAD, UNDP, UNDTCD (United Nations Department of Technical Cooperation for Development), UNIDO and WHO. This task force jointly organized an inter-regional mission which visited several developing countries. Their report contained recommendations addressed to developing countries for rationalizing their pharmaceutical supply system.

The pharmaceutical reforms initiated in Sri Lanka in the early seventies have apparently snowballed and been transformed into a global action programme.

While the six UN Agencies were carrying out joint activities, the UNCTAD Secretariat examined in depth the Sri Lankan experience and concluded that an analysis of the Sri Lankan model could give other developing countries much insight into ways of formulating, developing and implementing integrated national pharmaceutical policies. Accordingly, with the assistance of the late Professor Bibile, the Secretariat published a document entitled "Case Studies in the Transfer of Technology: Pharmaceutical Policies in Sri Lanka". This document has proved to be a very valuable guideline for developing countries intending to initiate pharmaceutical reforms. Translated into other UN languages, copies of it could be found with health planners of almost every Third World country.

Crucial lesson

In an issue of 'World Health Forum', WHO, of 1981 an article focused on an especially significant feature of the Sri Lankan drug policy. The writer argued that promotion and sale of pharmaceuticals in the Third World should be regulated and suggested that an analysis of the innovations introduced by Sri Lanka could give developing countries guidelines for formulating and implementing regulatory procedures.

A unique phenomenon about Sri Lanka's pharmaceutical reforms was that the entire programme was conceived, formulated, developed and implemented by Sri Lankan nationals without any form of external aid or assistance. This in my view, should be the most important lesson other developing countries should draw from the Sri Lankan example. Reliance on experts and advisers from advanced industrialized countries, copying their technology and accepting various types of capital transfers from these countries has resulted in pockets of economic and industrial development being established in the major cities of many developing countries. These pockets have more linkages with the developed world than with the rest of the country in which they are located.

An urban elite in the capital cities of these countries has easy access to the most recent and sophisticated medical technology at prices heavily subsidized by their governments, whereas the majority of the people living in the rural areas cannot obtain even the basic drugs for their common ailments which make their lives a misery. These countries now realize that their economies cannot sustain the systems they have developed and are looking for innovative changes. The Sri Lankan model may be their answer.

Bangladesh is a least developed country which has confirmed and reiterated that it is within the capabilities of developing countries with limited resources to successfully introduce an integrated national pharmaceutical policy. The successful implementation of pharmaceutical reforms in Sri Lanka, and Bangladesh was due to the presence of the vital ingredient of political will without which real progress will be impossible.

As Dr Halfdan Mahler, Director General of WHO, put it in speaking before the World Health Assembly in May 1979; "we must not delude ourselves.. The vested interests are far too great for technical action alone to succeed. It has to be accompanied by political and economic action to ensure drug availability at reasonable cost, by social action to ensure the concept's acceptability by all and by managerial action to ensure that the drugs reach all in need at the right time".

(The writer is a former Senior Lecturer in Pharmacology and now Asia-Pacific Consultant/Cordinator for Health Action International)

HNB-Pathum Udanaya2002

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