The national drug policy process brings together all interested partners in the pharmaceutical sector, encouraging them to focus political commitment, financing and human resources on improving access to drugs, improving drug quality and promoting rational drug use. The essential drugs concept is key to this process. In practical terms it means focusing on a number of carefully selected drugs and an agreed standard treatment guideline. A better supply of drugs, assured drug quality, more rational prescribing, lower costs and better health outcomes can then be assured.
The national drug policy itself provides a framework for action relating to pharmaceuticals within the overall national health policy. The goals of a national drug policy should therefore be consistent with broader health objectives, and its implementation should help attain those objectives.
Component 1: Implementation and monitoring of national drug policies:
Help countries to formulate and implement their national drug policy, and to monitor key components of national drug policy implementation
Table 2 WHO Medicines Strategy 2000 - 2003 objectives, components and expected outcomes
Objectives |
Components |
Expected outcomes |
Policy: Ensure commitment of all stakeholders to national drug policies, to coordinated implementation, and to monitoring policy impact |
1. Implementation and monitoring of national drug policies
Help countries to formulate and implement their national drug policy, and to monitor key components of national drug policy implementation
|
1.1 National drug policies developed and updated
1.2 National drug policies implemented
1.3 Global national drug policy progress monitored and impact evaluated
1.4 Poverty perspective introduced into national drug policies
1.5 Gender perspective introduced into national drug policies |
|
2. Health system development supported by essential drugs policies and programmes
Work with countries to integrate their work in essential drugs and medicines policy into their national health system, in support of health system development
|
2.1 Essential drugs concept integrated into national health programmes
2.2 Development of sustainable management capacity in pharmaceuticals
2.3 Traditional medicine integrated into national health care systems |
Access: Ensure equitable availability and affordability of essential drugs, with an emphasis on diseases of poverty |
3. Access strategy and monitoring for essential drugs
Help countries to ensure and monitor access to essential drugs, focusing on diseases of poverty, such as malaria, HIV/AIDS, tuberculosis and childhood illnesses
|
3.1 Increased access to essential drugs for priority health problems
3.2 Increased access to newly developed and abandoned essential drugs
3.3 Standard indicators to measure equitable access to essential drugs
3.4 Access to drugs promoted within international trade agreements |
|
4. Financing mechanisms and affordability of essential drugs
Ensure the implementation of national strategies to finance the supply and increase the affordability of essential drugs, in both the public and the private sectors
|
4.1 Planning and advocacy for public sector drug financing
4.2 New drug-financing strategies
4.3 Increased affordability of essential drugs in public and private sectors
4.4 Expanded coverage and improved drug benefits within health insurance
4.5 Increased drug price information and guidance on drug price policies |
|
5. National and local public sector drug supply systems and supply capacity
Support countries to run efficient public sector drug supply systems, ensuring the availability of essential drugs at all levels of the distribution chain
|
5.1 Enhanced drug supply management capacity
5.2 Improved drug supply management as part of health sector reform
5.3 Adherence to good pharmaceutical procurement practices
5.4 Cost-effective and reliable local drug production promoted
5.5 Adherence to good drug donation practices among donors and recipients |
Quality and Safety: Ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards |
6. Norms, standards and guidance for pharmaceuticals
Strengthen global norms, standards and guidelines for the quality, safety and efficacy of drugs, including traditional medicine, and provide guidance for global harmonization efforts
|
6.1 Norms, standards, and guidelines developed or updated
6.2 Quality control specifications, basic tests, screening tests and international chemical reference materials for pharmaceuticals developed
6.3 Drug nomenclature and classification efforts continued
6.4 Promotion of WHO norms, standards, guidelines, nomenclature and WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
6.5 Coordination of regional and international harmonization of norms |
|
7. Drug regulation and quality assurance systems
Support countries to establish and maintain effective drug regulation and quality assurance systems
|
7.1 Drug regulation effectively implemented and monitored
7.2 Drug manufacturing, distribution and inspection practices improved
7.3 Substandard and counterfeit drugs combated
7.4 Regulatory Situation of Herbal Medicines: Worldwide Review updated |
|
8. Information support for pharmaceutical regulation
Improve the access of national regulatory and pharmaceutical control authorities to reliable information management systems, and to mechanisms for exchange of independent information on drug quality, safety and efficacy
|
8.1 Increased exchange of information on quality, safety and efficacy of medicines
8.2 Reliable information management systems created
8.3 Access to international adverse drug reaction monitoring system extended |
|
9. Guidance for control and use of psychotropics and narcotics
Provide advice and guidance on psychotropic and narcotic substances in accordance with WHO’s mandate under international treaties
|
9.1 Psychoactive substances assessed for international control
9.2 Rational use of controlled medicines promoted |
Rational use: Ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers |
10. Rational drug use strategy and monitoring
Support countries in implementing and monitoring a national strategy to promote rational use of drugs by health professionals and consumers
|
10.1 Advocacy of rational drug use
10.2 Identification and promotion of successful rational drug use strategies
10.3 Responsible drug promotion encouraged
10.4 Information support on use of traditional medicine
10.5 Antimicrobial resistance contained |
|
11. Rational drug use by health professionals
Develop national standard treatment guidelines, essential drugs lists, educational programmes and other effective mechanisms to promote rational drug use by all health professionals
|
11.1 Development of national standard treatment guidelines and essential drugs lists supported
11.2 Support for problem-based and skill-based in-service training programmes
11.3 Drugs and therapeutics committees established and operating effectively
11.4 International technical guidelines and standards on traditional medicine expanded |
|
12. Rational drug use by consumers
Establish effective systems to provide independent and unbiased drug information including on traditional medicine to the general public and to improve drug use by consumers
|
12.1 Effective systems of drug information
12.2 Public education in rational drug use and consumer empowerment |
Progress
Progress in developing and implementing national drug policies since publication in 1988 of Guidelines for Developing National Drug Policies 28 has been impressive:
• At the end of 1999, 66 countries had introduced official national drug policies within the last 10 years. A further 41 countries were developing national drug policies or had developed such a policy more than 10 years ago. In 1998 - 1999 alone, 23 countries adopted or substantially revised their national drug policies, most of them with WHO assistance, and including countries as diverse as Australia, India, Jordan, the Maldives and Yemen.
• More and more countries are now moving directly from policy to action by creating a master plan for policy implementation; recent examples include Brazil, Chad and India.
• For countries with an active national drug policy process such as Australia, Bolivia and South Africa, significant pharmaceutical sector improvements have been observed.
• A small but growing number of countries routinely monitor their progress, including Cambodia, Indonesia and Zimbabwe.
Monitoring is very important. It helps to ensure that development and implementation of drug policies is effective, and, if not, that the necessary adjustments are made. Two different levels of routine indicator-based monitoring for use at country level have been developed and are being put in place. Level 1 monitoring uses core structural and process indicators that can be easily collected without a survey. Level 2 monitoring uses outcome indicators that can be easily collected using data samples during simple surveys. WHO is working with an increasing number of countries to monitor the implementation and evaluate the impact of their national drug policies. (Chapter 6 explains in more detail how these indicators will be used to monitor implementation of the WHO Medicines Strategy 2000 - 2003.)
Figure 8: By the end of 1999 over 100 countries had national drug policies in place or under development
Figure 9: Core indicators are used to monitor and refine national drug policies to ensure maximum health impact
Challenges
Scores of countries have developed national drug policies. 29 All too often, though, a policy exists on paper while in practice drugs are unavailable at health facilities, large quantities of dangerously substandard drugs circulate on the market, and prescribing practices are unsafe and wasteful.
The challenges are to encourage countries without national drug policies to develop and officially adopt them and to ensure that countries with such policies implement them effectively. At the same time, a “culture of monitoring” which uses the results of monitoring to inform policy action, is needed.
In terms of policy content WHO is committed to ensuring that national drug policies tackle not just pharmaceutical but also broader development issues such as poverty and gender. 2, 11 Poverty is often a result of ill health and, conversely, poor populations are most vulnerable to ill health and have less access to health care. This is reflected in morbidity and mortality statistics. Communicable diseases remain the leading cause of death and disability among impoverished populations worldwide even though cost-effective treatments exist for most of them. So by prioritizing treatment for communicable diseases, policy-makers can do much to improve the health of poor populations, to improve their life expectancy and to reduce the differences in health status between rich and poor. 30
Gender is an equally important development issue given that 70% of the 1.3 billion people living in poverty are women, twice as many women as men are illiterate (600 versus 300 million), and women's access to health care often considerably more limited than that of men. 31 Even finding data on women's access to and use of drugs can be difficult. Thus while studies on the world population's access to drugs abound, sex-disaggregated data on this topic are very scarce.
Expected outcomes for 2000 - 2003
1.1: National drug policies developed and updated following needs assessment and wide consultation at national level with policy-makers, health professionals and key partners.
• WHO will provide technical assistance on national drug policy development to countries, facilitate national drug policy meetings involving all partners, organize training courses on drug policy issues and publish a revised edition of Guidelines for Developing National Drug Policies.
1.2: National drug policies implemented through national pharmaceutical master plans and routinely monitored at national level.
• Through provision of technical assistance to countries and facilitation of national and regional workshops, WHO will support the elaboration of national pharmaceutical master plans and strategies, and implementation of national drug policy components.
1.3: Global national drug policy progress monitored and impact evaluated through yearly updating of global and country information and data in WHO’s global computerized database.
• WHO will monitor global national drug policy progress, help countries to monitor their own progress in implementing their national drug policies and collect additional data on pharmaceutical sector development from other sources, such as international organizations and industry.
1.4: Poverty perspective introduced into national drug policies during elaboration and implementation of national drug policies.
• WHO will raise awareness among national policy-makers and international organizations of the positive impacts of strategies that aim to improve the health of impoverished populations.
Specifically, WHO will encourage development of national drug policies that prioritize treatment for the major communicable diseases.
1.5: Gender perspective introduced into national drug policies during the elaboration and implementation of national drug policies.
• Following operational research in several countries, and in consultation with gender experts, WHO will develop a standard protocol on introducing a gender perspective into national drugpolicies. It will also promote the collection of sex-disaggregated data on access to drugs and drug use for use during the development and modification of national drug policies.
Figure 10: 36% of countries with a national drug policy have no implementation plan
Component 2: Health system development supported by essential drugs policies and programmes
Work with countries to integrate their work in essential drugs and medicines policy into their national health system, in support of health system development
|
1999 Status |
2003 Target |
Country progress indicators |
No./No. reporting |
% |
|
Countries with an official national drug policy document - new or updated within the last 10 years |
(66/151) |
44% |
55% |
Countries with a national drug policy implementation plan - new or updated within the last 5 years |
(39/107) |
36% |
43% |
Progress
After much debate and research both within and outside the Organization, WHO recently established 23 that the fundamental goals of any country's health system are:
• improving the health of the population it serves
• ensuring fairness in financial contribution to health care
• responding to people's non-health expectations. a
a This includes respecting people’s dignity, autonomy and confidentiality of information. “Responsiveness” is not a measure of how a health system responds to health needs, which is reflected in health outcomes, but of how the system performs relative to non-health aspects, meeting or not meeting a population’s expectations of how it should be treated by providers of prevention, care or non-personal services. 23
These goals are fully supported by those of national drug policies (see Table 3). Available, affordable, good quality, and rationally used medicines improve population health, while public drug financing, health insurance schemes and generic policies help make drugs affordable, thereby contributing to fair health financing. Last but definitely not least, efforts to ensure, for example, adequate dispensing and prescribing time, and equal access to treatment for men and women, help ensure that a health system respects the individual, and pays due heed to client needs.
As well as clarifying the goals of health systems WHO has strived continually to show that contributing to health system effectiveness has positive impacts on educational levels, economic growth and political participation.
Two-thirds of all WHO resources for essential drugs and medicines policy are now invested directly in country work aimed at implementing national drug policies and essential drugs programmes. As a result, considerable progress has been achieved in increasing the contribution of the pharmaceutical sector to health system development, particularly in the Newly Independent States, Latin America and, albeit to a lesser extent, in Africa.
“If we do not design health programmes and policies with a gender perspective, we may reach only half of the population.”
Director-General Dr Gro Harlem Brundtland, address to UN Commission on the Status of Women, New York, 3 March 1999. 31
Table 3 National drug policies help health systems achieve their goals
Health system goals |
National drug policy features |
Improved population health |
• Efficient and sustainable drug supply systems |
|
• New essential drugs for priority health problems |
|
• Quality assurance through good manufacturing, distribution and inspection practices |
|
• Reliable drug information |
|
• Evidenced-based standard treatment guidelines, essential drugs lists and national formularies |
|
• Public education and consumer empowerment |
Fair financing |
• Equitable public sector drug financing strategies, with focus on impoverished populations |
|
• Social health insurance schemes covering essential drugs |
|
• Affordable drugs through generic competition, bulk purchasing, and reduced import duties, taxes and distribution costs |
|
• Use of lowest cost equivalent drug in therapeutic category through therapeutic competition |
|
• Free drugs from public and private providers for priority health problems |
Reponsiveness to non-health expectations |
• Policy and legal framework for defining roles and responsibilities of prescribers and dispensers |
|
• Human resource development and management strategies |
|
• Ethical criteria for medicinal drug promotion |
Box 4 The increasing interest in and application of traditional, and complementary and alternative medicine
|
Traditional medicine
Traditional medicine existed long before the development and spread of modern Western medicine. Knowledge of traditional medicine - frequently intertwined with and reflecting a country’s culture, history and beliefs - is often passed on orally from generation to generation and often incorporates sophisticated theory and system. 23
Traditional medicine practices include medication and non-medication therapies. Medication therapies use raw materials or extracts from medicinal plants, animals and mineral materials. Non-medication therapies may include acupuncture, manual therapy, spiritual healing, diets and traditional exercises. Traditional medicine practices have been used by local communities for a considerable time and are therefore trusted and accepted.
Complementary or alternative Medicine (CAM)
The term “complementary or alternative medicine” is used in some countries to refer to a broad set of health care practices that even though they may be of a country’s own traditions are not integrated into its dominant health care system. Thus in countries where national health care is based on modern Western medicine, traditional medicine and other therapies are usually considered to be complementary or alternative systems of medicine.
Complementary or alternative medicine practices include systems of traditional and folk medicine and other natural therapies such as herbal medicines, chiropractic and homeopathy.
|
WHO has also moved ahead to help ensure that traditional medicine systems reach their full potential for improving health care. Experience is showing that although the specific focus may vary, many of the basic questions regarding traditional medicine in relation to health systems are similar from region to region and from country to country. For example, the Chinese and Indian Governments are each concerned with how best to use traditional medicine to strengthen health care in remote areas. Similarly, in Africa, the emphasis is on use of local resources and making traditional medicine an integrated component of minimal health care packages. Meanwhile, in developed countries, the growing interest in and application of traditional medicine have created a common need for governments to both regulate its use and ensure that demand for treatment involving traditional medicine is met safely.
Challenges
A national drug policy cannot be successfully developed in a vacuum. Rather, it must be developed within the framework of a national health policy and health care system. Only then are the two types of policy likely to be mutually supportive. All too often, however, a national drug policy is developed without reference to the national health policy, and in isolation from ongoing health sector development. It may even be developed before the national health policy is in place. If so, essential drugs programmes are likely to be run in parallel to rather than in collaboration with other health programmes. Precious human and technical resources will then be wasted. At the same time, many health professionals will be unaware of the essential drugs concept, and procurement, prescribing and use of drugs less than optimal.
Traditional medicine policy is another area of concern. More and more countries have a traditional medicine policy and are integrating traditional medicine into their national health care systems. In many others, though, traditional medicine and its practitioners are not officially recognized. Opportunities for improving and providing health care are therefore lost, particularly in those developing countries where up to 80% of the population uses plant-based traditional medicines to help meet health care needs.
Figure 11: The pharmacy service gap nearly a 100-fold variation in pharmacists per million population
Source: World Health Organization 1994.33
|
1999 Status |
2003 Target |
Country progress indicators |
No./No. reporting |
% |
|
Countries with a national drug policy included in the national health plan |
n.a.* |
n.a. |
n.a. |
Countries with a national policy on traditional medicine |
(31/46) |
n.a. |
n.a. |
* Data will be collected in 2000. |
|
|
|
Many of the problems described here can be fully resolved only if a country's pharmaceutical sector is strengthened. This will in turn call for a greater number of well-trained pharmacists and greater understanding of the potential role of the pharmacist in population health care. Unfortunately, many developing countries continue to suffer severe shortages of pharmaceutical staff. Indeed, there is a huge gap between lower and higher-income countries in terms of pharmacy training and pharmacy service provision (Figure 11). A weak pharmaceutical sector has many unwanted repercussions. For example, at local level, dispensing of pharmaceutical products, including prescription-only drugs may well be by untrained drug sellers. 32 At national planning level, health policy-makers may fail to develop sustainable management capacity in pharmaceuticals or ensure that national drug policy, national health policy and health system development complement and fully support each other. (See also Component 11).
Expected outcomes for 2000 - 2003
2.1: Essential drugs concept integrated into national health programmes following advocacy activities aimed at health policy-makers and health professionals working in health systems development at national level.
• WHO will continue to advocate for application of the essential drugs concept during national drugs policy and health system development, and to ensure that national drug policy objectives fit in with the broader objectives of national health policies. This will include advocacy via all types of country support activities, including expert consultant and national drug policy meetings.
2.2: Development of sustainable management capacity in pharmaceuticals by strengthening country capacity to manage and implement sustainable national essential drugs programmes.
• WHO will focus primarily on strengthening national pharmaceutical resources through training of ministry of health officials and WHO national staff, and whenever possible increasing human resources in WHO country offices for carrying out activities relating to the pharmaceutical sector.
2.3: Traditional medicine integrated into national health care systems through development and implementation of national policies on traditional medicine.
• Work will include providing information on traditional medicine policies and regulation of traditional medicine activities and products to national health policy-makers and national drug regulatory authorities. Additionally, workshops will be organized on how to develop a national traditional medicine policy. A worldwide review of the legal status of traditional and complementary/alternative medicine will also be carried out.
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