چکیده (انگلیسی):

Objectives: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at
reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a
collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive
framework to develop all components of a national pharmaceutical sector. To meet the health needs of the
population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to
the national situation. This review aims to provide a quantitative and qualitative (describing the historical
development) study of the development process and evolution of NMPs.
Methods: The number of NMPs and their current status has been obtained from the results of the assessment of
WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four
countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa.
Results: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase
in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation
plans available and have updated their NMP more recently. The four case studies show that the development of a
NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window
is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a
trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but
should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia
provide indicators for monitoring.
Conclusions: To date, not all countries have a NMP since political pressure by national experts or non-governmental
organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is
just as important as the policy document since the process must create a mechanism by which all stakeholders are
brought together and a sense of collective ownership of the final policy may be achieved.