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. In this section some general observations on implementation are made. More detailed technical recommendations for each component of a national drug policy are made in subsequent chapters (see also Box 1).
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.
Master plan and work plans
The national drug policy leads to an implementation plan or master plan, which may cover a 3-5-year period. This implementation plan spells out for each component of the policy what needs to be done and who is responsible, estimates the budget requirement and proposes a rough time frame. If resources are insufficient without external input, a set of priority activities should be identified that can be executed within existing means. Potential donor inputs should also be included, and gaps in funding can be identified as a guide for future donor support. The master plan facilitates monitoring and follow-up, and it is important that it is communicated to all parties involved.
The master plan should be broken down into annual action plans and work plans, which should be carefully developed with the various agencies involved in implementation. These plans should outline the approaches and activities for each component, specifying in detail who is responsible, listing the major tasks, and describing the target output, the detailed time frame and the exact budget.
Responsibilities in implementation
As lead agency, the ministry of health should oversee and coordinate all activities, and monitor the extent of implementation and the achievement of targets. In some countries a separate unit within the ministry, with its own budget and personnel, acts as the coordinating body.
Apart from the coordinating body, it is recommended that a national consultative forum is created to oversee policy implementation. This is essential to create and maintain countrywide support for the policy, and to ensure that the major stakeholders remain informed and involved. The same could be done for some specific policy components, for example, all activities dealing with quality assurance or rational drug use.
National institutions, such as the drug regulatory agency, the pharmacy department in the ministry of health, the central medical stores, and district or provincial health offices, are key players in drug policy implementation. So too are other agencies dealing with finance, trade, economic planning and education. Given the multisectoral nature of pharmaceutical issues it is important not only to obtain but also to maintain consensus on the policy objectives. This can be achieved by agreement on implementation plans and through regular progress reports.
It is important to match the strategies and action plans with available financial resources. Allocations from government funds and revenue from drug registrations and fees are the usual funding sources. The responsible agencies should have a mechanism for actively seeking funds and be able to secure regular funding from the government. Contributions from international and local donors are also possible sources. However, there should be no conflict of interest in accepting donor contributions, for example, when donors are interested in funding activities that are of low priority in the national drug policy.
Practical aspects of policy implementation
A drug policy can be successfully implemented only if the government is committed and proactive. Some successful strategies are:
• At an early stage, prepare the relevant legislative structure to enable the development and implementation of the national drug policy.
• Seize a window of political opportunity, such as a specific political change or developments in neighbouring countries, to advance policy development or implementation.
• Start implementing the policy in relatively easy subject areas, in order to ensure initial high visibility and success, and support for the policy at the critical early stage.
• Adopt a flexible approach; be prepared to postpone an activity if more time is needed to prepare for it, to explain it and to build consensus for it.
• Have national experts and respected political figures publicly express support for the policy and vouch for its technical soundness. It is important that the public feels confident about the policy.
• Mobilize key groups in society to support the policy. Consumer organizations, trade unions, religious organizations and the media, for example, can be important in building such support.
• Anticipate shifts in opponents’ positions, and identify strategies to involve them and to win their support. For example, the pharmaceutical industry may oppose drug pricing policies and the introduction of an essential drugs list, but will usually support strategies to strengthen drug regulation and improve drug quality assurance.
• Create constituencies that support the policy both inside and outside the government. This is crucial to the policy’s long-term success and sustainability.
Regional cooperation can be useful in implementing drug policies. Countries, institutions and organizations can share information, expertise, skills and facilities. Exchanging experiences helps to ensure that best practices are promoted, that mistakes are not repeated and that limited resources are used effectively.
Increasingly, countries cooperate on a regional basis on a wide variety of economic and policy issues. The Association of South-East Asian Nations (ASEAN), the European Union (EU) and the Organization of African Unity (OAU) are just three examples of regional partnerships.
ASEAN cooperation in pharmaceuticals
For more than a decade, the ASEAN countries have collaborated in various aspects of the pharmaceutical sector. The following factors have contributed to success:
• Similarity in language and cultural affinity of most of the cooperating countries.
• Consultative and participatory planning by all countries from an early stage.
• Technical, financial and organizational support from international organizations such as WHO and the United Nations Development Programme.
• Careful selection of priority areas for cooperation with an immediate and visible impact.
• Continuing and sustained activities over a period of time, with one lead country coordinating each project and other countries actively participating.
• Dissemination of outputs and relevant information from each project to all participating countries at annual meetings.
• A political climate in the region conducive to cooperation in many areas.
• Absence of significant opposition from any sector or vested interest in any of the participating countries.
Sharing information and technical expertise can be particularly effective if the policies and strategies are mutually relevant and easy to adapt. Harmonization of drug regulatory standards can be one outcome of successful technical and regulatory cooperation among countries. Harmonization in these areas could lead to a more economical use of human, animal and material resources, and to the development of regionally or internationally agreed standards. However, the issue of sovereignty has to be considered. During the process of harmonization each country must ensure that the areas being harmonized can be implemented and are relevant to national interests.
Technical cooperation with WHO
WHO can provide a forum for exchange of information, and can promote cooperation through regional and international training courses and through inter-country research projects. WHO collaborating centres and other centres of excellence are also involved in training and research, forming professional networks and exchanging information among cooperating countries.
New information technologies present a wealth of opportunities for efficient and low-cost exchange of information, consultation, collaboration and technical cooperation. WHO’s Medicines web site contains most of the technical information and key documents relevant for developing national drug policies.7 Another key reference is Managing drug supply, a textbook developed by Management Sciences for Health (MSH) in close collaboration with WHO.8
A training course on drug policy issues is conducted regularly for key officials involved in pharmaceuticals,a and the International Conference of Drug Regulatory Authorities (ICDRA) meets every two years to discuss drug regulatory matters.
a Detailed information on these and other courses and conferences is available from the WHO Department of Essential Drugs and Medicine Policy, Geneva; or from national WHO offices.