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 financière d’Afrique) franc, or the collapse of the Union of Soviet Socialist Republics, which created the need to harmonize 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.6
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 policy-makers 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 finalized.
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.