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Annual Report 2002 - Essential Drugs and Medicines Policy: Supporting Countries to Close the Access Gap
(2003; 20 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentDeveloping a monitoring culture to improve impact
View the documentTraditional and complementary medicine: putting policy into action
View the documentKey country support in Africa and Eastern Mediterranean
View the documentWHO Collaborating Centres: supplying active support for medicines work
View the documentHow is TRIPS affecting access to medicines?
View the documentDevelopment of the essential drugs concept over the past 25 years
View the documentMeasuring access to antimalarials
View the documentStrengthening regional and national bulk procurement
View the documentLearning from successful supply systems
View the documentWorking out the cost of medicines
View the documentSupporting MDG target on access to essential medicines
View the documentCommon guideline for evaluating new medicines in Baltic countries
View the documentNGO toolkit for improving access to HIV/AIDS treatment
View the documentHarmonizing medicines regulation in the Americas
View the documentGood manufacturing practice in China: rapid progress
View the documentPharmacovigilance: detecting and reporting adverse drug reactions
View the documentVariations in prescribing information in 26 countries
View the document10th ICDRA: an international basis for medicines regulation
View the documentFighting poor-quality drugs
View the documentImproving medicines use in hospitals in Cambodia and Lao PDR
View the documentWHO-India Essential Drugs Programme: multiplying impact
View the documentOman: improving antibiotic use in primary health care

Development of the essential drugs concept over the past 25 years

Before and into the 1960s




21st century

Pharmaceutical promise and dangers

The concept of essential drugs emerges

Operationalizing the essential drugs concept

New global challenges

The essential drugs concept is more valid than ever before

New and powerful drugs emerge
• Aspirin first marketed

• Penicillin isolated - first clinical use

• Chloroquine trial against malaria

• Streptomycin first effective TB drug

• Antiobiotics tetracyline and chloramphenicol introduced

• Isoniazid introduced against TB

• Erythromycin introduced for patients with penicillin allergy

• Sulfonylureas introduced as first oral antidiabetic and nystatin as first antifungal agent

• Field trials of oral contraceptives

A powerful pharmaceutical industry develops
• Automated high-volume manufacturing processes create large profits
• Patent protection creates long periods of market exclusivity
• Mergers create large companies

Significantly increased and widespread concern about safety: thalidomide

• Thalidomide withdrawn from US and European markets after association with serious birth defects observed, leading to global recognition of need for drug regulation and safety assessment

Growing recognition that medicines can bring dangers as well as great promise

General picture
• Few countries have essential drugs lists
• Very little independent information on drugs and prices publicly available
• Few countries allow generic substitution
• No systematic teaching on prescribing
• No regulation of drug promotion
• Early start of safety monitoring

Early 1970s
• Developing countries complain that up to 40% of health budgets is spent on drugs
• Public protest at promotional practices of pharmaceutical industry

1975 First definition of essential drugs
• WHO Director-General Dr Halfden Mahler puts drugs issues on international development agenda by defining essential drugs as “those considered to be of utmost importance and hence basic, indispensable and necessary for the health needs of the population”

• WHO collects drug lists from Member States, prepares criteria for drug selection and produces first draft list of essential drugs

1977 WHO Model List of Essential Drugs
• First Model List includes 206 active substances - Model List revised every two years thereafter

• 31st World Health Assembly urges Member States to establish essential drugs lists and demands creation of Action Programme on Essential Drugs

1978 WHO/UNICEF Conference in Alma Ata
• Adopts essential drugs concept as 8th component of primary health care

Late 1970s: economic crisis starts

• Reduced health budgets and limited availability of convertible currency result in drug shortages, leading to renewed discussion about need for national drug policies

Early 1980s
• Developing countries - with 75% of the world’s population - produce less than 10% of the world’s drugs and account for less than 25% of global expenditure on drugs
• First medicines kit-based programme in Kenya
• Some stakeholders strongly oppose essential drugs concept

1981 WHO and NGOs get started
• Establishment of Action Programme on Essential Drugs (DAP) formalizes WHO’s involvement in essential drugs
• Health Action International founded by 50 nongovernmental organizations to promote “the safe, rational and economic use of pharmaceuticals worldwide”
Managing Drug Supply, with comprehensive information on selection, procurement, distribution and use, published by Management Sciences for Health

• Operational national essential drugs programmes established in Bhutan, Tanzania, Uganda, Yemen and Zimbabwe, but little success in larger countries

• WHO Conference of Experts in Nairobi, Kenya brings all stakeholders together and they define Revised Drug Strategy as basis for future collaboration
• WHO Essential Drugs Monitor launched to advocate for essential drugs

• World Health Assembly endorses Revised Drugs Strategy

• WHO publishes Guidelines for Developing National Drug Policies and Ethical Criteria for Drug Promotion

• International Network for Rational Use of Drugs (INRUD) established, with six interdisciplinary developing country teams in Africa and Asia, to develop and test interventions to promote rational drug use

Burden of TB, HIV/AIDS and malaria soars even though appropriate drugs exist
• HIV/AIDS, TB and resistant malaria rise rapidly in many developing countries
• New drugs available but very expensive - triple therapy for AIDS costs US$ 10 000-12 000 per person per year, while drugs for multidrug-resistant TB cost US$ 2000-3000 per year

• UNDP Human Development Report: “Many countries recorded major reverses in human progress, with rising rates of child malnutrition and infant mortality, particularly in sub-Saharan Africa and Latin America”
• World Bank World Development Report promotes basic social services and primary health care as essential strategy for alleviating poverty
• Break up of Soviet Union creates challenges for drug regulation and supply, but in following years, Newly Independent States develop essential drugs lists and national drug policies

• Australia develops national policy on quality use of drugs
• Delhi State implements essential drugs policy, which later expands to most of India

• First International Conference on Improving Use of Medicines (ICIUM) in Chiang Mai, Thailand defines agenda for research into rational use of drugs

• WHO Action Programme on Essential Drugs and Division of Drug Management and Policies merge to form Department of Essential Drugs and Medicines Policy

WHO’s mission in essential drugs and medicines policy defined as “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”

At the turn of the century
• 100 countries have national drug policies
• 156 countries have national essential drugs lists but face increasing numbers of patients and restrained public budgets
• New essential medicines are expensive
• In industrialized countries, medicines expenditure shows unsustainable growth of 12-18% per year, underscoring need for prioritization and rational selection

Increasing profile for essential drugs2000
• UN Committee on Economic, Social and Cultural Rights states: “Functioning public health and health-care facilities, goods and services have to be available in sufficient quantity within the State party…[and] include essential drugs”
• UN defines “access to affordable essential drugs” as one of 17 health-related Millennium Development Goals

• UN Commission on Human Rights recognizes that access to drugs is, “one fundamental element for achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of health”
• Doha WTO Ministerial Declaration stresses importance of implementing and interpreting TRIPS Agreement in a manner supportive of public health, by promoting access to existing therapies and research into new medicines
• Global Fund to Fight AIDS, Tuberculosis and Malaria generates substantial new funds to procure essential medicines

• Rejuvenating the concept and modernizing the methods
• Evidence-based methods introduced to process for updating WHO Model List
• First WHO Model Formulary issued
• WHO Essential Medicines Library established as web-based resource

2002: Essential Medicines is celebrated worldwide as a global concept


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