(1997; 175 pages)
II. The Problem
Effective, safe, affordable, and good quality drugs are an essential element of comprehensive health care (WHO, 1988; Hamrell et al., 1985; Sterky, et al., 1988: London School, 1989; Reich, 1987; Kanji, et al., 1992). There is increasing recognition that serious problems exist in many current pharmaceutical systems, especially in Third World countries (see the Background Paper). The WHO has designed guidelines for the development of national drug policies (WHO, 1988) to include legislation/regulation, regulatory control, pricing, distribution, drug selection, drug prescribing, dispensing, quality assurance, and manpower aspects. The WHO guidelines are based on the concept of essential drugs - that a model list of about 250 drugs could serve about 90 per cent of the morbidity within a country (WHO, 1977). These guidelines, however, provide little information about the processes of policy development and implementation. In addition, the WHO is just beginning to develop methods to assess the performance of pharmaceutical policy.
In the past 20 years, numerous initiatives have been taken in formulating and implementing pharmaceutical policies in developing countries. During the 1980s, the leadership provided in this field by the Action Program on Essential Drugs (APED) at the World Health Organization was actively supported by bilateral aid agencies, nongovernmental organizations, industry associations, and university research groups. Furthermore, many bilateral and multilateral agencies also became involved in promoting and supporting pharmaceutical policy development. In the late 1980s, attention turned to issues of health financing and drugs (through UNICEF's Bamako Initiative) and to issues of drug utilization (illustrated by the International Network on the Rational Use of Drugs). In the 1990s, improving the pharmaceutical sector in developing countries was cited as a priority by the World Bank in its 1993 World Development Report.
Various groups have studied national drug policies (NDPs), based on the concept of essential drugs (Chowdhury, 1992; Goonaratne, 1989; Kanji, et al., 1989; Kanji, et al., 1992; Kiatying-Angsulee, et al., 1992; Reich, 1994; Tomson, 1990; WHO, 1992). The global policy analysis of the WHO Action Program on Essential Drugs (APED) in 1989 (London School, 1989) assessed these efforts at pharmaceutical policy development and emphasized the spread of Essential Drug Lists as an achievement and the limited adoption of National Drug Policies as a problem. Others identified weaknesses in the Information-Education-Communication component together with a lack of focus on the rational use of drugs (Finer, et al., 1992). A third group stressed the supply orientation of many essential drug programs (Kanji, et al., 1989), and criticized the tendency for national drug policy to be reduced to a drug supply system. As pointed out in the Background Paper, however, there have been few systematic reviews and analyses of the national and international efforts at pharmaceutical policy development and their accomplishments.
The above reports suggest that while the WHO program has effectively identified key elements of a national drug policy and has disseminated information on these ideas, APED has encountered difficulties in promoting the national implementation of new policies and in articulating how the public and private sectors can positively interact in the pharmaceutical sector. In addition, the existing studies have suffered from two main problems: first, they have lacked systematic comparisons of in-depth national studies; and second, they have, therefore, been unable to provide innovative ideas for improving the formulation and implementation of national drug policies. This research project seeks to address both of these deficiencies.