Serious illness is a major reason why poor populations remain trapped in poverty. Either they cannot afford health care or else its cost is so high that they are pushed into debt and dependency. The knock-on effects are many and long lasting. Parents cannot afford to send their children to school, working days are lost and economic productivity declines. In countries hit hardest by diseases such as malaria and HIV/AIDS, development has ceased altogether.

Yet cost-effective tools for fighting ill health do exist. Essential drugs are one of those tools. By increasing access to essential drugs, their safety and their rational use, we could make the most of pharmaceutical potential to improve health status and secure development gains.

The impacts of essential drugs

As their name implies, essential drugs:

... have a profound health impact -

Effective drug treatment now exists for most leading infectious diseases, including acute respiratory infections, HIV/AIDS, malaria, diarrhoeal diseases, tuberculosis and the complications of measles. Essential life-saving drugs have also been developed for leading noncommunicable diseases such as ischaemic heart disease and cerebrovascular disease. Every one of these diseases impinges on poor populations disproportionately, detracting from health gains and delaying progress in other areas such as education and economic development.

... increase health system effectiveness -

Essential drugs are high-value commodities. Their availability draws patients to health facilities, where they can also benefit from preventive services. Moreover, if drug procurement is efficient and transparent, the confidence of governments, ministries of finance and donors in a country's health system is increased, and provision of financial and other resources for health system development encouraged. Conversely, lack of essential drugs means that attendance at health facilities drops and that health workers cannot perform effectively. Health status then stagnates or declines.

... increase the cost-effectiveness of pharmaceutical expenditure -

In many developing countries, medicines represent the largest household health expenditure. And in terms of total health expenditure, for both developing and transitional economies, public pharmaceutical expenditure is second only to spending on staff costs. So by focusing pharmaceutical expenditure on essential drugs, the cost-effectiveness of government and out-of-pocket drug expenditure can be enhanced and pharmaceutical health impact heightened.

Progress and challenges

Much has been achieved in pharmaceuticals in the 50 years since WHO began establishing international pharmaceutical standards and guidelines, and since the introduction 25 years ago of the essential drugs and national drug policy concepts. Nearly 160 countries now have national essential drugs lists, while over 100 countries have national drug policies in place or under development. Similarly, rational drug use concepts and teaching are spreading in all regions. Most importantly of all, though, access to essential drugs grew from 2.1 billion people in 1977 to 3.8 billion people in 1997.

Yet at the beginning of the 21^st century essential drugs remain unavailable, unaffordable, unsafe, or improperly used in many parts of the world. An estimated one-third of the world population lacks regular access to essential drugs, with this figure rising to over 50% in the poorest parts of Africa and Asia. And even if drugs are available, weak drug regulation may mean that they are substandard or counterfeit, rather than safe and effective. Irrational use - for example, high rates of antibiotic prescription, overuse of injections, very short dispensing times and incorrect drug use by patients - is of great public health concern too. Inappropriate spending on medicines is often a major source of impoverishment for already disadvantaged populations.

Policy guidance, management tools and training materials, derived from successful essential drugs initiatives, do exist. But they remain insufficiently known and inadequately applied.

WHO Medicines Strategy: 2000 - 2003

This strategy is WHO's response to these problems. Moreover, it directly supports WHO's corporate strategy and, within this, the overall strategic plan for health technology and pharmaceuticals. The Medicines Strategy 2000 - 2003 seeks to:

• create a One-WHO approach to essential drugs and medicines policy

• provide a common policy and technical framework for WHO's pharmaceuticals work with countries

• strengthen and expand operational linkages among WHO activities involving medicines, health systems, communicable diseases and noncommunicable diseases

• provide a clear framework for pharmaceuticals work with development partners, be they UN agencies, governments, nongovernmental organizations (NGOs) or professional associations.

Strategic directions

The Medicines Strategy takes WHO's mission in essential drugs and medicines policy as its starting point: To help save lives and improve health by closing the huge gap between the potential that essential drugs have to offer and the reality that for millions of people - particularly the poor and disadvantaged - medicines are unavailable, unaffordable, unsafe or improperly used.

WHO is already working with a wide range of partners to achieve this aim by providing global guidance on essential drugs and medicines, and by working with countries to implement national drug policies to ensure equity of access to essential drugs, drug quality and safety, and rational use of drugs. Traditional medicine activities are an integral part of this work.

These activities are in turn contributing to all four WHO strategic directions to:

• reduce the excess mortality of poor and marginalized populations
• reduce the leading risk factors to human health
• develop sustainable health systems
• develop an enabling policy and institutional environment for securing health gains.

The greatest impact, however, of WHO medicines activities is and will continue to be on reducing excess mortality and morbidity from diseases of poverty, and on developing sustainable health systems. This strategy aims to extend and increase that impact. Understandably, in view of the many demands on health systems, its emphasis is on integrated solutions, which are both equitable and sustainable.

Core functions: improving health through knowledge, advocacy and partnerships

As the world's leading international public health agency, WHO's fundamental role is to create, synthesize and disseminate practical knowledge by: articulating policy and advocacy positions; working in partnership; producing guidelines and practical tools; developing norms and standards; stimulating strategic and operational research; developing human resources; and managing information.

The Medicines Strategy pays considerable attention to each of these core functions since they provide a solid basis for ethical, needs-driven, evidence-based action in pharmaceuticals. Tensions often exist, however, between public health, national development and economic interests, and sometimes constrain progress in the pharmaceutical sector. The experience, expertise, authority and financial resources of a number of partners will therefore be vital to successfully carrying out the activities described in this strategy. So even greater efforts will be made to enhance partnerships within WHO, with UNICEF and other UN agencies, with the World Bank, with NGOs, with universities, with industry, and with all other members of the WHO “extended medicines family”.

Country work: why and how?

WHO has always had a strong country presence in medicines. Technical support has been provided in response to countries' determination to develop their pharmaceutical sector to help improve the health of their populations. At the same time, many donors have been keen to use WHO's health and pharmaceutical expertise when providing their own country support. This wealth of experience will help greatly in effectively implementing this strategy where it is most needed - in countries.

The need is great. Combined factors such as globalization, shifting demographics and patterns of disease, and a rapidly changing economic environment are vastly increasing the complexity of decisions concerning how best to improve and maintain health.

The need is also reciprocal. Country work is a fundamental resource for WHO. Only by undertaking such work can WHO expand its evidence and knowledge base. This is crucial if the Organization is to maintain its position as the world's leading authority on public health issues and its capacity to serve Member States.

Over the next four years, WHO will increase the impact of its country work by:

• strengthening pharmaceutical programmes in priority countries, according to identified criteria

 

• integrating medicines work into overall WHO country cooperation strategies

• expanding its network of country programme advisors and establishing essential drugs access advisors in priority countries, especially in Africa and Asia

• increasing support to regional and subregional networks and to working groups focusing on pharmaceutical issues

• further integration of planning, implementation, and information-sharing among WHO country, regional and headquarters staff working in pharmaceuticals

• expanding direct country support relationships with key development partners such as the World Bank and bilateral donors.

Framework for action

The WHO Medicines Strategy 2000 - 2003 addresses policy, access, quality and safety, and rational use. Among these four objectives, the greatest emphasis for the next four years will be on securing access to essential drugs for priority health problems. Priority health problems include malaria, tuberculosis, HIV/AIDS and childhood illnesses, the burden of which falls most heavily on impoverished populations.

Objective 1. Policy - Ensure commitment of all stakeholders to national drug policies, to coordinated implementation, and to monitoring policy impact

The national drug policy process brings all interested parties together to focus political commitment, financing and human resources on pharmaceutical sector improvements. A national drug policy therefore provides a framework for action relating to pharmaceuticals within an overall national health policy. Its goals should therefore be consistent with broader health system objectives, and its implementation should support those objectives. Additionally, every national drug policy should be accompanied by an implementation plan.

WHO will help countries to actively implement national drug policies and monitor their impact. The policy objective has two main components:

• 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.

• 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.

Objective 2. Access - Ensure equitable availability and affordability of essential drugs, with an emphasis on diseases of poverty

Access to essential drugs is a key priority for WHO. From the patient's or consumer's point of view, access to essential drugs means that such drugs can be obtained within reasonable travelling distance (i.e. are geographically accessible), they are readily available in health facilities (i.e. are physically available), and affordable (i.e. are financially available). But meeting these three conditions remains a difficult challenge and will require an integrated, sustainable approach. Such an approach is incorporated in this objective's three main components:

• 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.

• Financing mechanisms and afford-ability 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.

• 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.

Objective 3. Quality and safety - Ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards

Global standards for drug quality are becoming increasingly rigorous. Yet the quality of drugs on the market in many countries remains a major public health concern. Similarly, major efforts to improve drug regulation at national and international levels have been instigated, such as the development of norms and standards, but enforcement of regulatory standards remains a challenge for every country. The quality and safety objective includes four components:

• 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.

• Drug regulation and quality assurance systems - support countries to establish and maintain effective drug regulation and quality assurance systems.

• 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.

• Guidance for control and use of psychotropic and narcotics - provide advice and guidance on psychotropic and narcotic substances in accordance with WHO's mandate under international treaties.

Objective 4. Rational Use - Ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers

Improving drug use by prescribers, dispensers and the general public helps to reduce morbidity and mortality, and to contain drug expenditure. The challenge is how best to ensure therapeutically sound and cost-effective use of drugs, at all levels of the health system, in both the public and private sectors, by both health professionals and consumers. WHO will work to support three components:

• 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.

• 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.

• Rational drug use by consumers - establish effective systems to provide independent and unbiased drug information to the general public - including on traditional medicine - and to improve drug use by consumers.

Monitoring and evaluation

Monitoring and evaluation are crucial to achieving the pharmaceutical objectives of access and rational use of quality drugs. The WHO Medicines Strategy: 2000 - 2003 incorporates 26 country progress indicators corresponding to the strategy's target outcomes, and representing pharmaceutical components and strategies that are key to the delivery of effective health services. The indicators will be used to monitor and evaluate country, regional and global pharmaceutical situations and progress. Results of this monitoring and evaluation will contribute to ongoing modification and refinement of WHO work in essential drugs and medicines policy. They will also be reported to policymakers and other players responsible for decisions relating to health systems planning, national drug policy implementation and allocation of technical, human and financial resources.