Pharmaceuticals have made an important contribution to global reductions in mortality and morbidity. Making drugs available to the people is, thus, a priority for every country. Unfortunately, developing countries confront a host of problems in their efforts to ensure the availability and rational use of safe and effective drugs. In trying to overcome these problems many developing countries have formulated national drug policies (NDPs) that specify national pharmaceutical goals and provide a framework of programmes to realise these goals. These policies have often been initiated with assistance and active support from WHO's Action Programme on Essential Drugs, other bilateral and multilateral agencies, nongovernmental organizations and university research groups1.

However, to date there has been no systematic effort to evaluate these policies on either a within-country or a cross-national basis. Studies which have been made suggest that the Action Programme has identified and effectively advocated key elements of a national drug policy. However, the national implementation of new policies and the articulation of how public and private sectors can positively interact in the pharmaceutical sector have encountered difficulties.

A new research project, developed jointly by the Action Programme on Essential Drugs, the Karolinska Institute and the Harvard School of Public Health, seeks to address this lack. Its overall goal is to assess the performance of national pharmaceutical policies in developing countries, to analyse the reasons for their success or failure and to propose strategies for improvement. The principal research question that the project seeks to answer is: have national drug policies (whether they exist as explicit policy documents or are implicit in government actions) in developing countries been successful in achieving the goals of availability, accessibility, good quality and rational use of essential drugs? Why or why not?

The project will combine several disciplines: policy analysis, economics and epidemiology/medicine/pharmacy. It aims specifically to:

- identify strengths, weaknesses and political dimensions of pharmaceutical policy formulation and implementation within each country;

- offer explanations for cross-national variations in performance;

- propose strategies, both national and international, that can improve pharmaceutical policy implementation.

The research will examine key processes of drug policy formulation and implementation in eight developing countries: Colombia, Guinea, India, Philippines, Sri Lanka, Vietnam, Zambia and Zimbabwe. They include some of the world's poorest countries, as well as some middle-income countries; countries with no pharmaceutical manufacturing capacity, as well as some with substantial capacity.

The first step in the implementation of the collaborative project was a workshop, held in Geneva from 6-8 October l994, organized by the Action Programme on Essential Drugs2. The goal was to formally introduce the project to researchers from the participating countries, initiate work on the individual country research protocols and strengthen the research capabilities of the country teams by providing training in the two research methods in the project. These are:

1: Assessment of NDP performance, through the application of a standard set of indicators

These indicators serve two primary purposes: to evaluate the outcomes of pharmaceutical policies in a comparative framework; and to assess pharmaceutical policy formulation and implementation, in other words the policy process.

Outcomes will be measured according to the four common goals of NDPs in developing countries: availability, accessibility, good quality and rational use of drugs. In addition, other country-specific goals may be added to the evaluation. The assessment of success will be based on the extent to which countries have been able to achieve the precise goals and targets (initial or evolving) that they set for themselves. In addition, the evaluation will examine the processes of policy formulation and implementation, and the institutional and political contexts in which the policies were implemented.

The indicators are taken from the recent WHO manual for monitoring national drug policies3 (see Published Lately), and are classified as background information, structural, process and outcome indicators.

The background information provides data on the demographic, health, economic and pharmaceutical contexts in which drug policy is being implemented in a given country. These indicators are quantitative data, at a single point in time, which in most countries are readily available at the national level.

The structural indicators provide qualitative information to assess the pharmaceutical system's capacity to achieve its policy objectives. They are intended to check if the key structures necessary to implement a pharmaceutical policy are present in the country.

The process indicators provide quantitative measurements of the processes by which a national drug policy is implemented. They cover: legislation and regulation: essential drug selection; drug registration; public sector financing policy; pricing policy; drug allocation in the health budget; procurement procedures in the public sector; public sector distribution and logistics; information and continuing education on drug use. These indicators provide a quantitative assessment of the degree to which the pharmaceutical system is "working" and measure the degree of implementation of national drug policy.

The outcome indicators measure the results achieved and the changes that can be attributed to the policy processes. Specifically, they measure the effects of the policy on the overall objectives of national drug policy: availability and affordability of essential drugs, the quality of drugs and the rational use of drugs.

2. Political mapping

The second research methodology that will be used is political mapping (see box), which will provide an analysis of the NDP formulation and implementation process. This methodology has descriptive, explanatory and prescriptive objectives: to describe the consequences, stakeholders, interests, and networks involved in a particular policy; to help explain how and why a particular decision was reached in the past; and to assist decision-makers in managing the politics of formulation or implementation4.

Political mapping, which was developed at the Harvard School of Public Health, has been applied to a series of health policy problems. It has been shown to provide rapid identification of problems, to improve communication among organizations, and to assist policy-makers in identifying effective new strategies for policy implementation.

Six steps of political mapping

Step one: Policy consequences: describes the policy's consequences along four dimensions; the size, identity, intensity and timing of the effects.

Step two: Position map: provides a map of the proponents and opponents of the health policy, according to international sector, political sector, government sector, private sector, nongovernmental sector and social sector.

Step three: Stakeholder analysis: determines the main interests and objectives of each organization and the organizational priority of the interests.

Step four: Policy network analysis: identifies the formal and informal linkages between organizations and individuals.

Step five: Transitions assessment: identifies major transitions underway in the organization responsible for implementing the policy, the general organizational environment and the broader political environment.

Step six: Strategies for change: analyses potential strategies for changing or influencing policy-making processes and outcomes according to symbolic, positive and negative strategies.

end box

Project outputs

There are many anticipated outputs from the project. Firstly, it will provide a basis to explain how different pharmaceutical policies - especially varying public/private mixes - can affect the performance of the pharmaceutical sector. It will also assist policy-makers to identify and substantiate specific strengths and weaknesses of existing policy, from national and cross-national perspectives, and to formulate new strategies.

The project will provide an excellent opportunity for further field testing of the standard indicators and the political mapping technique and their potential development into a method of policy analysis and rapid assessment of pharmaceutical sector performance.

Data collection for WHO's forthcoming World Drug Situation Report will be facilitated.

The project will identify specific policy innovations from cross-national learning that could improve the design and implementation of pharmaceutical policy within each country. It will also propose ways to increase the political feasibility of implementing those innovations within a specific political context.

National health research capacity will be enhanced through the development and application of the methodologies which can be applied to other areas of health policy.

Finally, the project will provide an impetus for international agencies to reconsider their own policies for the pharmaceutical sector. It will also assist in strengthening the policy analysis capabilities of international agencies involved in supporting the development of national pharmaceutical policy.

A significant advance...

The project will use a comparative, cross-national analysis to place each country's experiences within a broader international context, and to explain both the particular features of a country's drug policy and more universal aspects of policy-making. Cross-national studies of health policy in developing countries are relatively few and none specifically focus on pharmaceutical policy. The project will therefore represent a significant advance in the empirical application of comparative policy analysis in developing countries. However, its core goal is to provide data and examples of successful strategies that will assist countries to strengthen their pharmaceutical sector and improve drug supply, safety and use.

References

1. WHO. Guidelines for developing national drug policies, Geneva, World Health Organization, l988

2. Report of a workshop on the research on comparative analysis of national drug policies, Geneva, World Health Organization, Action Programme on Essential Drugs, October 1994

3. Brudon-Jakobowicz P, Rainhorn JD, Reich MR. Indicators for monitoring national drug policies, WHO/DAP/94.12. Geneva, World Health Organization, Action Programme on Essential Drugs, 1994

4. Reich MR, Cooper DM. Political mapping: computer-assisted political analysis, PoliMap, Newton Centre, 1995 (text plus software)

For further information about the project and a copy of the Workshop report write to: Action Programme on Essential Drugs, WHO, l211 Geneva 27, Switzerland.