AN increasing number of pharmaceutical products are available in the world market, and there has been rapid growth in both drug consumption and expenditure. However, many people throughout the world cannot obtain the drugs they need, either because they are not available or too expensive, or because there are no adequate facilities or trained professionals to prescribe them. Although hard data are unavailable, WHO has estimated that at least one-third of the world's population lacks access to essential drugs; in poorer areas of Asia and Africa this figure may be as high as one-half. Millions of children and adults die each year from diseases that could have been prevented or treated with cost-effective and inexpensive essential drugs.

Even people who have access to drugs may not receive the right medicine in the right dosage when they need it. Many people buy, or are prescribed and dispensed, drugs that are not appropriate for their needs. Some use several drugs when one would do. Others use drugs that carry unnecessary risks. The irrational use of drugs may unnecessarily prolong or even cause ill-health and suffering, and results in a waste of limited resources. In many countries drug quality assurance systems are inadequate because they lack the necessary components. These include adequate drug legislation and regulations, and a functioning drug regulatory authority with adequate resources and infrastructure for enforcement. All these factors may have serious health and economic consequences.

These problems persist despite much work to improve access to essential drugs, to ensure drug quality and to promote rational drug use. The reasons are complex and go beyond simple financial constraints. To understand them it is necessary to look at the characteristics of the drug market, and to study the attitudes and behaviour of governments, prescribers, dispensers, consumers and the drug industry. Health sector development, economic reform, structural adjustment policies, trends towards liberalisation, and new global trade agreements all have a potential impact on the pharmaceutical situation in many countries. They may also affect the ultimate goal of achieving equity in health.

Changes in the patterns of disease and drug demand also represent major challenges. The rise of new diseases, such as acquired immunodeficiency syndrome (AIDS), the re-emergence of other diseases and increasing drug resistance of potentially fatal diseases, such as malaria and tuberculosis, all contribute to increased spending on drugs and growing pressure on health resources. Changes in life expectancy and in lifestyles have led to an increase in chronic diseases and diseases of the elderly, and an increase in the need for drugs to treat these.

A common framework to solve problems

Experience in many countries has shown that these complicated and interdependent problems can best be addressed within a common framework. Piecemeal approaches can leave important problems unsolved and often fail. In addition, the different policy objectives are sometimes contradictory, and so are the interests of some of the stakeholders. On the basis of this experience, WHO therefore recommends that all countries formulate and implement a comprehensive national drug policy (NDP).

Its new publication, How to Develop and Implement a National Drug Policy¹, discusses key policy components. They include selection of essential drugs, affordability, finance and supply, regulation and quality assurance, rational use, research, human resources, monitoring and evaluation. These practical guidelines examine both ongoing problems and new challenges. Each chapter presents strategies and approaches that can be used to improve the situation. Each chapter also includes advice and references to other sources of more detailed technical information.

A valuable resource for health professionals, policy-makers and researchers, the publication takes readers through the process of planning, developing, implementing and monitoring a comprehensive policy framework based on a country's unique needs, priorities and resources. Here we reproduce part of the text, which analyses the value of a national drug policy and sets out the policy development process.

WHAT IS A NATIONAL DRUG POLICY?

A commitment to a goal and a guide for action

A national drug policy is a commitment to a goal and a guide for action. It expresses and prioritises the medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the main strategies for attaining them. It provides a framework within which the activities of the pharmaceutical sector can be coordinated. It covers both the public and the private sectors, and involves all the main actors in the pharmaceutical field.

A national drug policy, presented and printed as an official government statement, is important because it acts as a formal record of aspirations, aims, decisions and commitments. Without such a formal policy document there may be no general overview of what is needed; as a result, some government measures may conflict with others, because the various goals and responsibilities are not clearly defined and understood.

The policy document should be developed through a systematic process of consultation with all interested parties. In this process the objectives must be defined, priorities must be set, strategies must be developed and commitment must be built. The importance of the process is discussed further in relation to policy development in Australia, Lao People's Democratic Republic, Thailand, and the Philippines (see p 26).

The consultations and national discussions preceding the drug policy document are very important, as they create a mechanism to bring all parties together and achieve a sense of collective ownership of the final policy. This is crucial in view of the national effort that will later be necessary to implement the policy. The policy process is just as important as the policy document.

The main objectives of ensuring equitable access, good quality and rational use are usually found in all national drug policies, but clearly not all of these policies are the same. The final definition of objectives and strategies depends on the level of economic development and resources, on cultural and historical factors, and on political values and choices.

A national drug policy is an essential part of health policy

A national drug policy cannot be developed in a vacuum - it must fit within the framework of a particular health care system, a national health policy and, perhaps, a programme of health sector reform. The goals of the national drug policy should always be consistent with broader health objectives, and policy implementation should help to achieve those broader objectives.

The health policy and the level of service provision in a particular country are important determinants of drug policy and define the range of choices and options. On the other hand, the drug situation also affects the way in which health services are regarded. Services lose their credibility if there is no adequate supply of good quality drugs, or if these are badly prescribed. Thus the implementation of an effective drug policy promotes confidence in and use of health services.

There are also economic arguments. In many countries a large proportion of health care spending is on drugs. Health care financing is therefore closely related to drug financing. It is very difficult to implement a health policy without a drug policy.

Objectives of a national drug policy

In the broadest sense a national drug policy should promote equity and sustainability of the pharmaceutical sector.

The general objectives of a national drug policy are to ensure:

The more specific goals and objectives of a national policy will depend upon the country situation, the national health policy, and political priorities set by the government. In addition to health-related goals there may be others, such as economic goals. For example, an additional objective may be to increase national pharmaceutical production capacity.

It is critical that all the drug policy's objectives are explicit, so that the roles of the public and private sectors and of the various ministries (health, finance, trade and industry) and government bodies (such as the drug regulatory authority) can be specified.

Importance of the essential drugs concept

The essential drugs concept is central to a national drug policy because it promotes equity and helps to set priorities for the health care system. The core of the concept is that use of a limited number of carefully selected drugs based on agreed clinical guidelines leads to a better supply of drugs, to more rational prescribing and to lower costs.

The reasons are clear. Essential drugs, which are selected on the basis of safe and cost-effective clinical guidelines, give better quality of care and better value for money. The procurement of fewer items in larger quantities results in more price competition and economies of scale. Quality assurance, procurement, storage, distribution and dispensing are all easier with a reduced number of drugs. Training of health workers and drug information in general can be more focused, and prescribers gain more experience with fewer drugs and are more likely to recognise drug interactions and adverse reactions.

By the end of 1999, 156 developed and developing countries had national or institutional lists of essential drugs for different levels of care, in both the private and public sectors; 127 of these lists had been updated in the previous five years, and 94 were divided into levels of care. There is substantial evidence that the use of national lists of essential drugs has contributed to an improvement in the quality of care and to a considerable saving in drug costs.

THE NATIONAL DRUG POLICY PROCESS

A national drug policy involves a complex process of development, implementation and monitoring. First, the policy development process results in the formulation of the national drug policy. Second, strategies and activities aimed at achieving policy objectives are implemented by the various parties. Finally, the effect of these activities is monitored and the programme adjusted if necessary. Throughout the process careful planning and the involvement of all parties are needed, and the political dynamics have to be considered at all times.

A drug policy without an implementation plan remains a dead document. Careful planning of the implementation steps and activities necessary to arrive at the expected outcome is important throughout the process.

Involving all parties

Throughout the policy process (and not only in the development phase) there should be consultation, dialogue and negotiations with all interested groups and stakeholders. These include other ministries (higher education, trade, industry), doctors, pharmacists and nurses, local and international pharmaceutical industries, drug sellers, academia, nongovernmental organizations (NGOs), professional associations and consumer groups. It is also important to consult with provincial and district medical and administrative personnel, and to make an effort to include traditional and herbal medicine practitioners. Other government agencies (such as the drug regulatory agency), insurance companies and groups paying for health care must be involved. The media can be helpful, and support from international organizations is important. It is recommended that the national drug policy committee meets regularly to review the implementation of the policy with all interested parties in a national drug policy forum.

There is likely to be some disagreement among the various stakeholders. For example, drug manufacturers may feel that their commercial interests are threatened, and doctors may fear the loss of clinical freedom. Any party that benefits from the existing situation will be worried about change. It is a real challenge to create and maintain a process that delivers the broad consensus essential to implementing the policy. In general it can be said that the more the existing pharmaceutical system needs to be improved, the more important it is to involve all interested parties in discussing the necessary reforms.

Political dynamics

Formulating and implementing a national drug policy are highly political processes. This is because such a policy usually seeks to achieve equity of access to basic health care, primarily by making the pharmaceutical sector more efficient, cost-effective and responsive to health needs. Such responsiveness may include redistribution of goods and power, leading to increased competition among the groups affected by reform. Given the diverse interests and the economic importance of the issues involved, opposition to the new policy and attempts to change it during implementation can be expected, as happened in Bangladesh and the Philippines.

For this reason it is important to identify political allies, and to maintain their support throughout the process. Strategies to deal with opponents should be developed and ways of working with them must be identified. Decisions and priorities touching on the interests of these stakeholders must be balanced on the basis of estimated gains and losses. Strong political leadership and sustained commitment are vital for the formulation and implementation of a national drug policy.

Formulating a national drug policy

By the end of 1999, 66 countries had formulated or updated their national drug policy within the previous 10 years. Very often an acute emergency or an important political change created a window of opportunity to start the policy formulation process. In some countries this was a change to a government committed to reform; in other countries it was an economic or political change, such as the sudden devaluation of the CFA (Communauté financiére d'Afrique) franc, or the collapse of the Union of Soviet Socialist Republics, which created the need to harmonise and improve certain aspects of the pharmaceutical system. Other factors could be a political drive towards expansion of the local industry or the implementation of global trade agreements.

Step 1: Organize the policy process

The ministry of health is the most appropriate national authority to take the lead role in formulating a national drug policy. The first step is to decide how to organize the development process that will identify the structure of the policy, its major objectives and its priority components.

At this stage it is important to identify all the interested parties that need to be involved, the necessary resources, and how these can be obtained. The need for assistance from WHO, donors or countries with relevant experience should also be assessed. This stage can be carried out within the ministry of health with support from a small committee of selected experts.

Step 2: Identify the main problems

In order to set realistic objectives a thorough analysis and understanding of the main problems in the pharmaceutical sector are needed. There are various ways of carrying out an initial situation analysis.

One successful approach has been to bring together a small team of experts, some of whom should have performed similar analyses in other countries. These experts should come not only from the ministry of health but also from other disciplines and backgrounds. They should be asked to examine the situation systematically, to identify the main problems, to make recommendations about what needs to be done and what can be done, and to identify possible approaches. They should act as impartial advisers. Once they have formulated their recommendations, these can be discussed at one or more multidisciplinary workshops, in order to formulate consolidated advice to the government. Examples of such reports are available from the WHO Department of Essential Drugs and Medicines Policy.

Step 3: Make a detailed situation analysis

A more detailed situation analysis of the pharmaceutical sector and its components may be needed. This should further analyse the source of the problems, in order to identify potential solutions, choose the most appropriate strategies, set priorities, and serve as a baseline for future systems of monitoring and evaluation.

Step 4: Set goals and objectives for a national drug policy

Once the main problems have been defined, goals can be set and priority objectives identified. For instance, if one of the priority problems is lack of access to essential drugs, one of the priority objectives should be to improve the selection, affordability and distribution of essential drugs.

The selection of appropriate strategies to achieve the objective is more complex, since it may involve choosing from among very different approaches. A workshop involving a small number of key policymakers may be helpful. The situation analysis should justify the choices and serve as the basis for decisions.

Once the main objectives and strategies have been outlined, they should be discussed with all interested parties. Broad consultation and careful consideration of conflicting interests and structural constraints are necessary to set achievable objectives and to formulate appropriate strategies to attain them.

Step 5: Draft the text of the policy

Once a thorough analysis of the situation and an outline of the main goals, objectives and approaches have been completed, a draft text of the national drug policy should be prepared. It should set out the general objectives of the policy. In most countries this will be to ensure that essential drugs are accessible to the entire population; that the drugs are safe, efficacious and of good quality; and that they are used rationally by health professionals and consumers. The specific objectives should also be described, followed in each case by the strategy to be adopted. Drafting of the policy can be done by a small group of experts who have been involved in the earlier stages of the process. Examples of national drug policy documents from other countries may be consulted.

Step 6: Circulate and revise the draft policy

The draft document should be widely circulated for comments, first within the ministry of health, then in other government ministries and departments, and finally to relevant institutions and organizations outside the government, including the private and academic sectors. Endorsement by government sectors responsible for planning, finance and education is important, since the successful implementation of many elements of the policy will depend on their support as well. Once this wide consultation is complete, the draft document should be revised in the light of the comments received, and finalised.

Step 7: Secure formal endorsement of the policy

In some countries the document can then go to the cabinet or parliament for endorsement. In others it will remain an administrative document that serves as a basis for implementation plans and changes in the law and regulations. In some countries the entire national drug policy document has become law. This is a powerful demonstration of political commitment but it can also cause problems, as future adjustments to the policy may become difficult. It is therefore recommended that only certain enabling components of the policy are incorporated into law, without too many operational details.

Step 8: Launch the national drug policy

Introducing a national drug policy is much more than a technical task. To a large extent the policy's success will depend on the level of understanding of different sectors of society, and on their support for its objectives. The implications and benefits for all interested parties should therefore be stressed.

The policy should be promoted through a clear and well-designed information campaign. Public endorsement by respected experts and opinion leaders can be very useful. Information should be disseminated through a variety of channels to reach different target groups. The media can play a major role in ensuring public understanding and support for the policy. Some countries have organized high profile launches.

Implementing a national drug policy

A policy, however carefully formulated, is worthless if it is not implemented. Every drug policy needs an overall implementation plan or "master plan"; each component of the policy needs a detailed strategy and specific action plans (see Box 2).

Priorities for implementation

For each country the priorities for implementation will be different. For example, when health care coverage is broad and access to drugs is not a problem, rational use and the cost of drugs are likely to be of concern. In such a situation, implementation of a drug policy will focus on regulating the market and on containing costs without decreasing sustainable access and equity. In least developed countries total spending on health and pharmaceuticals may be very low, and the private sector not geared to meeting the needs of the majority of the population. In this situation the focus of the policy will be more on increasing access to essential drugs.

Priorities for implementation should be based on the severity of the problems, and on the potential for success in achieving the objective and making an impact with available resources.

Monitoring national drug policies

Monitoring is a form of continuous review which gives a picture of the implementation of planned activities and indicates whether targets are being met. A variety of methods can be used, but it is essential to:

• Identify the right questions: focus on questions with answers that are relevant for management decisions.

• Limit data collection to data that are relevant and are likely to be used. If too many data are collected the process will become expensive, and data analysis will become too complicated and probably less accurate.

• Establish a reliable data collection system; remember that the data will be reliable only if they are also of relevance to the people who collect them. Wherever possible, build on and strengthen existing systems; data collection should as much as possible be built into the routine functioning of the system. This requires staff to be trained and resources to be allocated. Rapid feed-back of results is important.

• Report the aggregated results to the central policy and management level, to be used for management decisions, as well as being used by district or provincial health managers. If the data are used to prepare a monitoring report, the report should be shared with all those who contributed to it, including those who collected the data.

Periodic evaluations

The national drug policy should be evaluated periodically, for example, every four years. Independent consultants or professionals from other countries or from WHO may be invited to complement a national evaluation team. Such evaluations should be an integral part of the pharmaceutical master plan, with the necessary resources allocated from the start.

A vital framework

In summary, national drug policies are crucial because they promote equity and sustainability in the pharmaceutical sector and provide a framework to identify national goals and commitments. The WHO guidelines described here help countries to develop and implement a comprehensive policy, appropriate to their own needs and resources. They are already proving an invaluable resource for health professionals, policy-makers and researchers.

(Copies are available from: World Health Organization, Marketing and Dissemination, 1211 Geneva 27, Switzerland. Price: Sw.fr.26, US$23.40, and in developing countries Sw.fr.18.20. Single copies are available free of charge to those in developing countries).

Reference

1. WHO. How to develop and implement a national drug policy. Geneva: World Health Organization; 2001.

Box 2