The WHO Essential Drugs Strategy
Narrowing the Gap
Modern drugs save lives and improve health. Yet there are millions of people with common, treatable illnesses such as pneumonia, diarrhoea, malaria, tuberculosis, and hypertension to whom treatment is not available, who cannot afford treatment, who receive the wrong drug or wrong dose, who fail to take the drug correctly, or who receive a poor quality drug. More than twenty years ago - 21 October 1977 to be precise - the WHO Expert Committee on the Selection of Essential Drugs concluded the meeting that produced the first Model List of Essential Drugs. The small blue booklet that resulted from this meeting, containing the Model List and describing the use of essential drugs, has been one of the most influential WHO documents of the last quarter of the century.
The motivating force behind the 1977 meeting of the WHO Expert Committee on the Selection of Essential Drugs and the recommendations that it produced was the desire to narrow the immense gap between the health benefits which pharmaceuticals could bring to the world's populations and the much smaller benefit which was actually being realized.
WHO's mission in essential drugs has remained in essence what it was when the Action Programme on Essential Drugs was formed in 1981: To contribute to reduced morbidity and mortality from common illnesses by collaborating with countries to develop and implement national drug policies and programmes which ensure equity of access to essential drugs, rational use of drugs, and drug quality.
Today, some twenty years after the first WHO Model List, the essential drugs concept is widely accepted as a pragmatic approach for providing the best of modern, evidence-based, cost-effective health care. The essential drugs concept does not exclude all other drugs, but it does focus therapeutic decisions, professional training, public information, and financial resources on those drugs which represent the best balance of safety, efficacy, quality, and cost for a given health care setting. Health systems of all types, from basic health systems in the poorest countries to highly developed national health insurance schemes, have recognized the therapeutic and economic benefits of an essential drugs approach.
The concept of essential drugs is forward-looking. It incorporates the need to regularly update drug selections to reflect new therapeutic options and changing therapeutic needs; the need to ensure drug quality; and the need for continued development of better drugs, drugs for emerging diseases, and drugs to meet changing resistance patterns.
WHO Action Programme on Essential Drugs: Present and future challenges
Although the mission has not changed in the 17 years since the Action Programme was formed, the world has changed. Present and future challenges include
- equity of access,
- health sector reform (changes in organization and financing of health services and drug supply systems),
- changing pharmaceutical and global markets,
- continued irrational prescribing, dispensing, and patient use of drugs,
- new therapeutic needs (emerging diseases, ageing populations, growing drug resistance), and
- the need to implement rules, regulations and standards to guide pharmaceutical markets and ensure drug quality.
Primary health care, including essential drugs, remains a basic component in the WHO renewing health-for-all strategy. Therefore, national drug policies and programmes must be formulated within overall national health policies and health development strategies.
WHO's role in promoting essential drugs strategies is defined in terms of policy and technical development, country programme development, key approaches, and assessment of progress and achievements.
Priorities for action
A core function of WHO is to develop and disseminate new knowledge about strategies and mechanisms to improve access to essential drugs, rational use of drugs, and drug quality. To better focus WHO efforts and, in particular, the work of the Action Programme on Essential Drugs (DAP), the following six policy and technical areas and priorities for action have been defined.
(1) National drug policy. WHO will continue to work with countries to formulate national drug policies, but with much greater emphasis on policy implementation and monitoring. In addition, relatively more emphasis will be placed on factors for successful implementation and on involvement of all key actors in a consultative policy process.
(2) Health economics and drug financing. In many parts of the world economic and financing factors are a major, and often increasing, barrier to equitable access to drugs. Therefore, greater attention will be given to the role of essential drugs in health sector reform, practical aspects of drug financing, application of health economics to improving efficiency, mechanisms for improving access to drugs in the private sector, implications of changing models of socioeconomic development, and globalization in trade.
(3) Access, drug management and national supply strategies. Closely related to health economics and drug financing are issues of national drug supply strategies, public and private roles in drug distribution, and local production. Previously centralized supply systems are giving way to a variety of alternative approaches. More strategic and operational research on access to drugs is needed, along with continued emphasis on capacity-building for drug management at the national and local levels.
(4) Rational drug use. Work to promote better prescribing, medical training, and in-service training for all categories of health workers will continue. In addition, much greater emphasis will be placed on public and patient education and on involving key stakeholders, including the government, professional associations, consumer organizations and the media.
(5) Traditional medicines. Priorities will be to disseminate up-to-date information on traditional medicines; establish regulatory guidelines; promote proper use of traditional medicines; improve research methodologies for studying efficacy, safety, quality and use of traditional medicines; and increase efforts to integrate traditional medicines into national policies and programmes.
(6) Regulation and quality assurance capacity. Unregulated pharmaceutical markets do not ensure drug quality, safety, efficacy, or information accuracy. WHO norms and standards provide an essential foundation for regulation. The remaining challenge is to find practical, innovative approaches to fully implement existing regulations and guidelines. DAP and the Division of Drug Management and Policies (DMP) will focus work in this area to strengthen regulatory effectiveness in countries through human resources development, development of the regulatory infrastructure, and improved regulatory management.
The approach in each of these six areas will be need-driven, evidence-based, and action-oriented. It will focus on unsolved problems and respond to the changing environment.
Country programme development
Country-level implementation of national drug policies and essential drugs programmes has been the largest area of WHO activity in the field of essential drugs. Country programme development will remain a priority, but the Programme will work closely with regional offices and country programmes to strengthen the coordination and to increase the impact of WHO support through:
- focus on specific programme development objectives (not simply ongoing support);
- integrated planning and monitoring between DAP and regional offices;
- careful selection of countries and activities;
- standard guidelines for country programme development;
- flexibility and responsiveness to local needs;
- enhanced country level coordination with all parties;
- increased support to intercountry and subregional activities; and
- guidelines and technical advice for donors.
WHO's work in essential drugs depends on effective use of five key approaches which are the building blocks for country programme development, and policy and technical development:
(1) Partnerships and collaboration -In today's complex world progress depends on combining the experience, expertise, authority and financial resources of a number of partners. Thus, renewed efforts will be made to ensure productive, mutually-beneficial relationships within WHO; with UNICEF, The World Bank, and other UN agencies; with NGOs; with universities; with industry; and with all other members of the WHO "essential drugs extended family".
(2) Strategic and operational research. Research is necessary to develop new knowledge and innovative solutions to unsolved problems. In each of the six policy and technical areas, strategic and operational research will receive increased attention, with an emphasis on multicountry and comparative studies; on intervention research; and on analytical, but action-oriented literature reviews and reviews of experience. WHO will carry out this work through increased networking and north-south collaboration.
(3) Advocacy and information. Advocacy and information activities will continue to provide stakeholders with information, guidelines, and available tools to support the formulation and implementation of national drug policies and programmes.
(4) Guidelines and practical tools. To provide policy makers, essential drugs managers, NGOs, and other stakeholders with practical assistance, WHO will continue the development of policy guidelines, technical guidelines, how-to manuals, training materials, drug control and drug management software, and pharmaceutical sector databases.
(5) Human resources development. Human resources development builds capacity in countries to effectively implement national drug policies within the context of national health policies. Efforts will be focused on human resources requirements in this area; undergraduate and postgraduate curricula for medicine, pharmacy, and all other health professions; and methods for in-service training and supervision.
Assessment of progress and achievements
Progress toward achieving the objectives of greater access to drugs, more rational use, and acceptable drug quality will be assessed regularly at country and global levels. In addition, WHO activities will be carefully monitored. Existing methods for monitoring and evaluation of national drug policies and essential drugs programmes will be strengthened. WHO will support countries to set up or improve their monitoring systems.
*For further information, please contact: WHO Action Programme on Essential Drugs (DAP), Action Programme on Essential Drugs, World Health Organization, 20, avenue Appia, CH-1211 Geneva 27, Switzerland, internet: http://www.who.int/medicines// The Essential Drugs Monitor published by DAP carries news of developments in national drug policies, current pharmaceutical issues and concerns, information and education, and operational research. The journal, which is free of charge and published twice a year in English, French and Spanish and Russian, is distributed widely to both developed and developing countries. It has a readership of some 200,000. Order the Essential Drugs Monitor, at: The Editor, Essential Drugs Monitor, c/o DAP (as above)