WHO's mission in essential drugs and medicines policy, country work that flows from that mission, the pharmaceutical needs of WHO's diverse Member States, and World Health Assembly Resolutions concerning implementation of the Revised Drug Strategy, all served as key reference points during development of this strategy.
WHO’s mission in essential drugs and medicines policy
WHO's mission in essential drugs and medicines policy is to help save lives and improve help 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.
The Organization works to fulfil this mission by providing global guidance on essential drugs and medicines, and working with countries - at their request - to implement national drug policies to ensure equity of access to essential drugs, drug quality and safety, and rational use of drugs. Development and implementation of national drug policies are carried out within the overall national health policy context, with care taken to ensure that their goals are consistent with broader health objectives. Work in traditional medicine forms an integral part of this work.

Figure 2: Essential drugs and medicines policy activities contribute to all four WHO strategic directions
Revised Drug Strategy
The World Health Assembly and the WHO Executive Board have been guiding WHO's work in the pharmaceutical sector since the Organization's inception in 1948. Resolutions adopted by the World Health Assembly cover many areas of responsibility, such as publication of the International Pharmacopoiea, selection and approval of international nonproprietary names (INNs), promotion of the essential drugs concept and ensuring rational drug use.
Currently, most of WHO's work in pharmaceuticals is guided by the Revised Drug Strategy. This consists of a series of resolutions that have expanded and updated this work in the light of new and continued challenges. In May 1999 the World Health Assembly adopted resolution WHA52.19 on the Revised Drug Strategy 20 requesting WHO to intensify its activities in six areas (see Box 2).
WHO’s objectives in medicines for 2000 - 2003
WHO's strategy in medicines for 2000 - 2003, presented in its entirety in Chapter 5, covers four main objectives, to guide pharmaceutical work at country, regional and global levels.
Policy: ensure commitment of all stakeholders to national drug policies, to coordinated implementation, and to monitoring policy impact.
Access: ensure equitable availability and affordability of essential drugs, with an emphasis on diseases of poverty.
Quality and safety: ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards.
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Box 2 The 1999 World Health Assembly Resolution on the Revised Drug Strategy requested WHO to intensify work in six areas
National drug policies
• strengthen support to Member States in developing, implementing and monitoring national drug policies
Pharmaceuticals and trade agreements
• monitor and analyse the pharmaceutical and public health implications of international trade agreements, such as the WTO TRIPS Agreement
• advise Member States on international trade issues, within the framework of national drug policies and regulatory measures
Drug information and drug promotion
• help Member States strengthen their own independent drug information capacity
• provide information on counterfeit drugs and medicines
• develop tools to help stakeholders actively apply the WHO Ethical Criteria for Medicinal Drug Promotion
• monitor new forms of promotional activity
Drug quality
• support mechanisms to extend the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce to cover control of starting materials
• establish guidelines on drug quality issues relating to export, import and transit of pharmaceutical products
• promote implementation of good manufacturing practices
Drug donations
• promote improved implementation of good drug donation practices
Partnerships
• encourage continuing dialogue and collaborative partnerships between Member States, other UN agencies, nongovernmental organizations and the private sector on issues relating to access to essential drugs.
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“Health is in itself opportunity - for each individual and the community we live in. In a world torn by economic, ethnic, religious and cultural divisions, health remains as one of the few truly universal values.”
Director-General Dr Gro Harlem Brundtland, Statement to the Executive Board at its 105th Session, January 2000. 22
Rational use: ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers.
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Box 3 Access: priority area for 2000 - 2003
Among this strategy’s four objectives, access to essential drugs is a key priority area for 2000 - 2003. WHO is working with all partners to ensure that access continues to increase, and will continue to ensure that this issue remains high on the world’s health agenda during the next four years. The focus will be on increasing access to essential drugs for treating the major diseases of poverty, including malaria, HIV/AIDS, tuberculosis and childhood illnesses.
Four factors are critical for securing and increasing access:
• rational selection of essential drugs and drug development • affordable prices for governments and consumers • sustainable financing, through general government revenues and social health insurance • reliable supply systems, with a mix of public and private services.
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Ethical values
Activities for pursuing the attainment of each strategy objective were planned with careful attention to broad ethical considerations. This was essential. WHO sets normative standards for medical products, provides guidance on regulatory standards, defines and classifies diseases, provides therapeutic advice (such as treatment guidelines), produces a model list of essential drugs (which is widely used by countries and development agencies), and actively advises countries on such areas as the development of national drug policy. The actual and potential economic impact of these activities is considerable.
So WHO must act and must be perceived to act independently, according to the best scientific evidence, and free of any possible commercial or political influence. This is especially important in light of the wealth of experience demonstrating that scientific and economic achievements alone cannot guarantee that health goals are met. Rather, health development must be guided by basic key values to ensure that health improvements benefit everyone, but particularly those most in need.
Accordingly, The Health For All vision 21 recognized that:
• access to health care is a fundamental human right
• ethical approaches must be applied to health policy, research and service provision
• equity-oriented policies and strategies that emphasise solidarity should be implemented
• a gender perspective should be incorporated into health policies and strategies.
Each of the activities that form part of this Medicines Strategy can be justified on the grounds of contributing to the upholding and furthering of each of the above values.
Integration and sustainability
The WHO Medicines Strategy was also developed primarily with a long-term view. That is, activities have been planned that will contribute to the integration and sustainability of health systems.
Currently, the health care systems of many developing and transitional countries are overstretched, underfunded and faced with multiple problems such as the HIV/AIDS epidemic, resistant malaria and multidrugresistant tuberculosis. At the same time, poor communities continue to witness the death of hundreds upon hundreds of children from diarrhoea and respiratory infections, even though effective treatments have long existed for these illnesses.
Given the urgency of these health problems and the suffering they inflict, development of vertical drug management and supply systems may achieve some rapid gains, especially for poor and disadvantaged populations. But they can only ever be short-term solutions. Long-term solutions to long-standing problems demand a more comprehensive approach. This means that ministries of health, development agencies, and the private and voluntary sectors must work together to ensure that medicines and medicines policies help build health systems that are not only equitable, but also integrated. An integrated health system promotes health, seeks to prevent ill health and provides health care without overlap, duplication or gaps. Additionally, the human, technical and financial resources to ensure its continuity are available.
“Combating disease epidemics, striving to reduce infant mortality, and fighting for safer pregnancy are all WHO priorities. But the Organization will have very little impact on these and other battlegrounds unless it is equally concerned to strengthen the health systems through which the ammunition of life-saving and life-enhancing interventions are delivered to the front line.”
The World Health Report 2000.23
By prioritizing access, quality and safety, and rational use of medicines for diseases of poverty, this strategy will help reduce the world's disease burden, improve health and accelerate development where it is needed most (Figure 3). And by focusing on drug financing, affordability, regulatory control and overall pharmaceutical sector development, the strategy will help strengthen the performance of health system functions. These consist primarily of: stewardship (or oversight); creating resources (through investment and training); delivering services (that is, provision); and financing (including collecting funds, pooling those funds and purchasing medical supplies and services).23

Figure 3: The WHO 2000-2003 Medicines Strategy provides the pharmaceutical foundation for improved health outcomes and stronger health systems