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Medicines policy
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WHO supports Member States in country/intercountry, regional efforts to develop, implement and monitor the effectiveness of national medicines policies, guidelines, strategies and plans that ensure the availability, affordability and rational use of essential medicines and traditional, complementary and alternative medicines that are safe, effective and of good quality.
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How to Develop and Implement a National Drug Policy
How to Develop and Implement a National Drug Policy (Second Edition)
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Download full version [pdf 353kb]
In 1975, the World Health Assembly in resolution WHA28.66 requested WHO to develop means to assist Member States in formulating national drug policies. It also urged WHO to assist countries in implementing strategies, such as the selection of essential drugs and appropriate procurement of quality drugs based on health needs, and in providing education and training in various elements of pharmaceutical programmes. This resolution was followed by a series of events that marked the evolution of country drug programmes with the assistance of WHO.
The first WHO Model List of Essential Drugs was published in 1977. A year later he WHO/UNICEF Conference on Primary Health Care at Alma-Ata included access to essential drugs as one of the eight elements of primary health care. In 1979, he WHO Action Programme on Essential Drugs was established. Another landmark in promoting strategies to improve the pharmaceutical situation in countries was he 1985 Conference of Experts on Rational Use of Drugs in Nairobi. The following year’s World Health Assembly adopted resolutions that reflected the Conference recommendations on promoting rational use. Also in 1986, a WHO Expert Committee on National Drug Policies met to develop practical guidance for Member States, published as Guidelines for developing national drug policies.1 This publication has proved very useful over the years.
The efforts of countries, WHO and other agencies have had a considerable impact. The number of people with access to essential drugs has grown from roughly 2,100 million in 1977 to an estimated 3,800 million in 1999. By 1999, 66 countries had formulated or updated a national drug policy within the previous 10 years, compared with 14 countries in 1989. By the end of 1999, 156 WHO Member States had a national essential drugs list; 127 of the lists had been revised within the previous five years.
Nevertheless, problems of access to quality drugs and rational use persist. Although few hard data are available, it is likely that in the poorest parts of Africa and Asia more than half the population still lacks access to essential drugs. And there are new challenges that may have an impact on access, such as the expansion of the private sector’s role in pharmaceuticals, health sector reforms and the effects of globalization. The changing pattern of diseases, antimicrobial resistance and emerging new diseases are other factors. Particularly important is the current trend of governments to reduce health care spending because of inadequate resources, despite increasing health needs.
After a decade, and with new problems to be addressed, there was a clear need to revise the 1988 guidelines. The Expert Committee on National Drug Policies met in 1995 to review the current pharmaceutical situation and to start the updating process. Their deliberations resulted in a report that became the basis of the present guidelines.
These updated guidelines focus on the national drug policy process, strategies and options which can be used by Member States and organizations active in the pharmaceutical sector. Each policy component is discussed, with a focus on current problems and new challenges. And each chapter presents strategies and practical approaches that can be used to improve the situation. All chapters include references to publications that provide additional technical and practical details.
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How to Develop and Implement a National Drug Policy (Second Edition)
WHO Medicines strategy 2004-2007: Countries at the Core
Download full version [pdf 4mb]
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Download short edition [pdf 276kb]
Medicines policy is a fundamental component of the WHO Medicines Strategy. The WHO Medicines strategy 2004-2007: Countries at the core", acknowledges the fact that all the activities should benefit countries, which remain at the core of WHO's work. The WHO Medicines Strategy expresses the current wider vision of WHO as well as acknowledging the fact that over the past 30 years activities in the area of Medicines have been focused on countries.
WHO Medicines policy activities focus on ensuring the implementation and monitoring of national medicines policies, with a focus on:
- Continued support to ensure that all countries develop a national medicines policy and that these are implemented, monitored, and regularly updated in line with broader health and development objectives.
- Supporting countries in their efforts to use public health safeguards in international, regional, and bilateral trade agreements to improve access to priority medicines.
- Promoting and monitoring: access to essential medicines as a fundamental human right; public investment in medicines R&D, especially for neglected diseases; and ethical practices in the pharmaceutical sector.
- Implementation of WHO’s strategy for traditional medicine to ensure affordable access, protection of intellectual property rights, and guidance on safety.
WHO’s goal in medicines is to help save lives and improve health by ensuring the quality, efficacy, safety and rational use of medicines, including traditional medicines, particularly for the poor and disadvantaged. The challenge for WHO in is to continue to interpret the concept of essential medicines via a strategy and activities that reflect both the ongoing issues and the current high profile issues around access to, financing, and quality of medicines.
WHO’s current priority in medicines is to expand access to essential medicines, particularly for low-income and disadvantaged populations and for the priority diseases of HIV/AIDS, TB, and malaria. Considerable progress is being made on drug selection and drug pricing. Greater focus is being put on financing, supply systems, and quality assurance, areas in which effective work with countries and partnerships with other international organizations, aid agencies, and NGOs are crucial for achieving sound, sustainable results.
OTHER LINKS
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The Interagency Pharmaceutical Coordination group (IPC)
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Monitoring and Evaluation
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Training materials for NDPs
Examples of National Medicines Policy
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Australia
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South Africa
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Sri Lanka [pdf 31kb]
Policy Reports and Meetings
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Priority Medicines for Europe and the World Project Web Site
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