All countries have a national pharmaceutical policy. Such a policy may exist in the form of a policy document, in which case it is explicit. Alternatively, it may be indicated in certain government procedures and actions, in which case it is implicit. Often these policies reflect the many changes in the pharmaceutical sector which most countries, particularly developing and transitional ones, have experienced in recent years.

Overall, the main objectives of these national drug policies are:

• to make effective, safe, low-cost drugs available and affordable to meet the needs of the entire population (essential drugs); and

• ensure that drugs are of good quality and used rationally.

However, no effective and accepted tools exist at the global or country level to evaluate the performance of pharmaceutical sectors, to monitor progress in the implementation of national drug policies or to assess the effects of changes on drug policy objectives.

This manual has been developed to meet this need. It contains a comprehensive set of simple, objective and reliable indicators which can be adapted to fit national contexts. It will allow countries and international agencies to do the following:

• assess a country's capacity to implement the various elements of a national drug policy;

• monitor the processes by which a national drug policy is implemented and the changes over a period of time;

• measure the policy's progress towards the achievement of objectives, allowing decision-makers to adjust strategies accordingly.

An effective national drug policy requires: clear and mutually consistent objectives; appropriate strategies (policy measures) adapted to national resources; and the necessary technical means to achieve objectives. Although strategies for drug policy may differ from country to country - depending on the specific political, economic and social situations and the health status - the overall policy objectives and the key strategies are basically the same for all nations. A logical method was therefore sought to identify the major problems faced by countries in achieving the overall objectives of drug policy and selecting key strategies of universal importance for achieving objectives on the basis of which to develop indicators. The method is described in detail in Chapter II.

The manual focuses on relatively low-cost and non-complex methods that can be used with limited specialist input and integrated into routine monitoring systems. It derives from the belief that in many countries, much of the necessary data exist but are often not organized to address specific policy concerns. This manual therefore suggests ways to organize, analyse and present data for such purposes.

It is hoped that these indicators will be used widely for monitoring drug policies and will facilitate the systematic monitoring of national drug policy implementation. In 1996, the indicators were applied in 12 countries using a systematic research-based approach, and the experience acquired in these countries has been incorporated in this new version¹. The manual’s indicators and methods will continue to be reviewed and improved. New experience gained will be incorporated by the Department of Essential Drugs and Medicines Policy in future editions.

¹Comparative analysis of national drug policies: second workshop (WHO/DAP/97.6).