WHO Model List of Essential Medicines

WHO Model List of Essential Medicines
Name	WHO Model List of Essential Medicines
Established	1977
Publisher	World Health Organization
Location	Geneva, Switzerland

WHO Model List of Essential Medicines

The WHO Model List of Essential Medicines is a catalog maintained by the World Health Organization that identifies medicines considered priority for public health needs. First published in 1977, it guides procurement, reimbursement, and national selection by organizations such as the United Nations, World Bank, Gavi, and national ministries of health. The list interfaces with agencies including the World Trade Organization, UNAIDS, UNICEF, and regional bodies like the European Commission and African Union.

History and development

The list was initiated under the leadership of the World Health Organization amid global discussions influenced by actors such as Jimmy Carter's administration, the Alma-Ata Declaration, and post-colonial health reforms in countries like India and Brazil. Early contributors included experts from institutions such as the CDC, the Rockefeller Foundation, and the London School of Hygiene & Tropical Medicine. Debates in the 1980s and 1990s engaged stakeholders including the World Bank and non-governmental organizations like Médecins Sans Frontières and Oxfam International, especially around access to antiretroviral therapy during the HIV/AIDS pandemic. Legal and trade dimensions involved the World Trade Organization's TRIPS Agreement and patent discussions in venues such as the Doha Declaration. Revisions have been periodic, informed by panels including members linked to the Royal Society, the Institute of Medicine, and national drug regulatory authorities such as the European Medicines Agency and the United States Food and Drug Administration.

Criteria and selection process

Selection criteria are deliberated by expert committees convened by the World Health Organization and draw on evidence from randomized controlled trials published in outlets such as The Lancet, New England Journal of Medicine, and BMJ. Committees consider disease burden metrics from the Global Burden of Disease Study and guidance from entities like the Global Fund to Fight AIDS, Tuberculosis and Malaria and the Bill & Melinda Gates Foundation. The process incorporates inputs from agencies such as UNICEF, UNAIDS, and national regulators including Health Canada and the Therapeutic Goods Administration (Australia). Ethical and economic analyses reference institutions like the Nuffield Council on Bioethics and the World Bank. Technical appraisals involve advisory groups with expertise from universities such as Harvard University, University of Oxford, and Johns Hopkins University.

Structure and content of the list

The list is organized into sections reflecting therapeutic categories used by clinical services in settings exemplified by hospitals in Geneva, clinics in Nairobi, and primary care in São Paulo. It contains medicines for conditions prioritized by global agendas including the Sustainable Development Goals and targets from WHO programs on malaria, tuberculosis, and HIV/AIDS. The content spans formulations endorsed in formularies published by organizations like the American Medical Association and compendia such as the British National Formulary. The list distinguishes core medicines suited for basic health systems, drawing parallels with procurement lists used by UNICEF Supply Division and national essential medicines lists in countries such as South Africa, China, and Bangladesh.

Implementation and national adaptation

National ministries of health adapt the model list to local contexts, as seen with adaptations by the ministries in India, Brazil, and Rwanda. Implementation involves procurement agencies such as UNOPS and payers influenced by systems like those in Germany and Japan. Integration with insurance schemes references models from Medicare and social health insurance in France. Training and stewardship occur through collaborations with institutions such as the International Committee of the Red Cross and academic centers including the London School of Economics and University of Cape Town. Donor programs run by Gavi and the Global Fund often use the list to inform supply chains managed by logistics partners like DHL and Crown Agents.

Impact on global health and access to medicines

The list has influenced procurement practices across multilateral agencies including UNICEF, PAHO, and the Global Fund to Fight AIDS, Tuberculosis and Malaria, shaping access to treatments for conditions highlighted by the World Health Organization's campaigns against polio and measles. It has been cited in policy decisions by national regulators such as the European Medicines Agency and courts addressing compulsory licensing issues under the TRIPS Agreement and precedents in cases involving pharmaceutical companies like GlaxoSmithKline and Pfizer. The list has guided donors such as the Bill & Melinda Gates Foundation and programs run by Médecins Sans Frontières, improving availability of vaccines procured through initiatives like the PAHO Revolving Fund.

Criticisms and controversies

Criticisms have centered on perceived tensions between public health priorities and intellectual property regimes represented by the World Trade Organization and multinational pharmaceutical firms such as Novartis and Roche. Advocacy groups including Health Action International and Médecins Sans Frontières have contested decisions on inclusion of high-cost biologics and orphan therapies, while academic critics from institutions like University of Toronto and Yale University have questioned evidence thresholds and transparency. Debates over essential medicines for noncommunicable diseases, cancer therapies, and precision medicines have involved policymakers from the European Commission and national agencies such as the National Institutes of Health.

Category:World Health Organization