(2001; 96 pages) [French] [Spanish]
2.1 Overview of 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.
There are various types of plans. The first is probably the strategic plan to develop the policy itself, which should specify the various steps in the development process, and especially plan for the involvement of as many stakeholders as possible. After the policy has been adopted, an implementation plan, or master plan, is needed, which typically covers a 3-5-year period. This details the various activities for each component of the policy. The implementation plan spells out what needs to be done and who is responsible, estimates the budget and proposes a time frame. If resources are insufficient without external input, a set of priority activities should be identified that can be executed within the existing means. The master plan can be broken down into individual annual work plans for the various departments.
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.
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.4,5
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.