(2001; 96 pages) [French] [Spanish]
1.2 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 prioritizes 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.
Why is a national drug policy needed?
A national drug policy is needed for many reasons. The most important are:
• to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments;
• to define the national goals and objectives for the pharmaceutical sector, and set priorities;
• to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy;
• to create a forum for national discussions on these issues.
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. The guidelines set out here are intended to help countries develop and implement a comprehensive policy framework that is appropriate to their own needs, priorities and resources.
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:
• Access: equitable availability and affordability of essential drugs
• Quality: the quality, safety and efficacy of all medicines
• Rational use: the promotion of therapeutically sound and cost-effective use of drugs by health professionals and consumers.
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 recognize 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.