How to develop and implement a national drug policy

1 WHO 6. policy Perspectives on Medicines How to develop and implement a national drug policy January 2003. World Health Organization Geneva T he world pharmaceuticals market has witnessed an increase in the number of pharmaceutical productsa circulating worldwide, leading to a rapid is needed; as a result, some government measures may conflict with others, because the various goals and responsibilities are not clearly defined and un- growth in both medicines consumption and expendi- derstood. The policy document should be developed ture. However WHO estimates that, as of 1997, at least through a systematic process of consultation with all one-third of the world's population still lacks access interested parties. In this process the objectives must to essential medicines, either because these are be defined, priorities must be set, strategies must be not available or are too expensive, or because there developed and commitment built.

2 Are no adequate facilities or trained professionals Progress in developing and implementing national to prescribe them. In poorer areas of Asia and Africa drug policies has been impressive since the con- this figure may be as high as one-half. As a result, cept was launched in the mid-seventies. By 1999, 66. millions of children and adults die or suffer needlessly, countries had formulated or updated a national drug although their disease could have been prevented policy within the previous 10 years, compared with or treated with cost-effective and inexpensive essential 14 countries in 1989. A further 41 countries were in the medicines. process of developing a policy or had developed one Experience in many countries has shown that these more than 10 years ago. complicated and interdependent problems can best be addressed within a common framework, as piece- meal approaches can leave important problems unsolved and often fail.

3 In addition, the different policy Box 1 Why is a national drug policy objectives are sometimes contradictory, and so are needed? the interests of some of the stakeholders. On the To present a formal record of values, aspirations, aims, basis of this experience, WHO recommends that all decisions and medium- to long-term government countries formulate and implement a comprehen- commitments;. sive national drug policy (NDP). A policy is not static To define the national goals and objectives for the and will usually evolve over time. Most countries will pharmaceutical sector, and set priorities;. need to revise their policies within five years. To identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy ;. What is a national drug policy ? To create a forum for national discussions on these issues.

4 A national drug policy is a commitment to a goal and The consultations and national discussions that lead to the a guide for action. It expresses and prioritizes the production of the drug policy document are very important, medium- to long-term goals set by the government as they create a mechanism to bring all parties together for the pharmaceutical sector, and identifies the main and achieve a sense of collective ownership of the final strategies for attaining them. It provides a framework policy . This is crucial in view of the national effort that will later be necessary to implement the policy . The policy within which the activities of the pharmaceutical sec- process is just as important as the policy document. tor can be coordinated. It covers both the public and the private sectors, and involves all the main actors in the pharmaceutical field. Objectives of a national drug policy A national drug policy , presented and printed as an official government statement, is important because In the broadest sense a national drug policy should pro- it acts as a formal record of aspirations, aims, deci- mote equity and sustainability of the pharmaceutical sions and commitments.

5 Without such a formal policy sector. The general objectives of a national drug policy document there may be no general overview of what are to ensure: a Throughout this document, the words drug ', medicine' and pharmaceutical product' are used interchangeably. Page 1: WHO policy Perspectives on Medicines How to develop and implement a national drug policy Figure 1 By the end of 1999 over 100 countries had a national drug policy national drug policy status Official national drug policy less than 10 years old (66). Official national drug policy more than 10 years old (5). Draft national drug policy (36). No national drug policy (43). Status unknown (41). Access: equitable availability and affordability of essential medicines: (1) appropriate selection and use essential medicines, including traditional medi- of generic drugs, and (2) improved drug procurement cine; and management through training, central medical Quality: the quality, safety and efficacy of all medi- store, and regional bulk procurement.

6 In six years, the cines; policy has had a significant impact (see Figure 2). Rational use: the promotion of therapeutically sound and cost-effective use of medicines by health professionals and consumers. Figure 2 Impact of national drug policy in Chad, 1995 2001. The more specific goals and objectives of a national policy will depend upon the country situation, the 100 ($ ) national health policy and political priorities set by the government. In addition to health-related goals 80 there may be others, such as economic goals. For 60 Percent example, an additional objective may be to increase US$. national pharmaceutical production capacity. It 40 is critical that all the drug policy objectives are 20 ($ ) explicit, so that the roles of the public and private sectors and of the various ministries (health, finance, 0 1995 2001. trade and industry) and government bodies (such as the drug regulatory authority) can be specified.

7 Percentage of population with access to essential medicines A drug policy can have a rapidly noticeable impact. Public per capita expenditure on medicines For example, Chad adopted its drug policy and devel- Availability (cost to treat pneumonia/food basket): public oped an implementation plan in 1995. Based on pharmacies the results of the baseline survey carried out at that Affordability (cost to treat pneumonia/food basket): private pharmacies time, the national drug policy and its implementation plan focused on two strategies to improve access to Page 2: WHO policy Perspectives on Medicines How to develop and implement a national drug policy The essential medicine concept the programme adjusted if necessary. Throughout the process careful planning and the involvement of is central to a national drug policy all parties are needed, and the political dynamics The essential medicines concept is a global concept have to be considered at all times.

8 That can be applied in any country, in the private and Throughout the policy process there should be con- public sectors and at different levels of the health care sultation, dialogue and negotiations with all interested system. It promotes equity and helps to set priorities groups and stakeholders. These include other minis- for the health care system. The core of the concept is tries (education, trade, industry), doctors, pharmacists that the use of a limited number of carefully selected and nurses, local and international pharmaceutical medicines based on agreed clinical guidelines industries, drug sellers, academia, nongovernmental leads to a better supply of medicines, to more rational organizations, professional associations and consumer prescribing and to lower costs. There is substantial groups. It is also important to consult with provincial evidence that the use of national lists of essential and district personnel, and traditional and herbal medicines has contributed to an improvement in medicine practitioners.

9 Other government agencies, the quality of care and to a considerable saving in such as the drug regulatory agency, government medicine costs. sponsored health care schemes and insurance companies, must be involved. The national drug policy process A national drug policy involves a complex process of development, implementation and monitoring. Box 3 The national drug policy First, the policy development process results in the of South Africa formulation of the national drug policy . Second, strategies and activities aimed at achieving policy The national drug policy of South Africa was developed by the Department of Health over a two-year period through objectives are implemented by the various parties. a large number of consultative meetings involving political Finally, the effect of these activities is monitored and parties, other ministries, academia, provincial and district representatives, professional bodies, the pharmaceutical industry and consumer representatives.

10 The final document was adopted by Cabinet and presented to Parliament in Box 2 The policy process June 1996; this formed the basis for a comprehensive five- (check list for policy makers) year implementation Plan. Part of its success was due to the political window of opportunity immediately after Steps in formulation the end of apartheid in 1994. Organize the policy process Identify the main problems and stakeholders Make a detailed situation analysis Set goals and objectives Draft the text of the policy Key components of a national drug Circulate and revise the draft policy policy Secure formal endorsement of the policy Launch the national drug policy A national drug policy is a comprehensive framework in which each component plays an important role in implementation achieving one or more of the general objectives of Define priorities for implementation the policy (access, quality and rational use).