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Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November 2009 - Geneva Silvia Schwarte Global Malaria Programme
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WHO/UNICEF TBS | 19 November 2009 2 | Outline WHO Guidelines and Prequalification Malaria diagnosis Artemisinin market situation Resistance and oral artemisinin-based monotherapies
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WHO/UNICEF TBS | 19 November 2009 3 | WHO Guidelines for the Treatment of Malaria Malaria diagnosis - Prompt parasitological confirmation by microscopy or alternatively by RDTs is recommended in all patients suspected of malaria before treatment is started. - Treatment solely on the basis of clinical suspicion should only be considered when a parasitological diagnosis is not accessible. Malaria treatment: - artemether – lumefantrine (AL) - artesunate – amodiaquine (AS+AQ) - artesunate + mefloquine (AS+MQ) * - artesunate + sulfadoxine-pyrimethamine (AS+SP) - dihydroartemisinin–piperaquine (DHA-PPQ) * not for wide-scale public sector use in Africa Update
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WHO/UNICEF TBS | 19 November 2009 4 | Co-blisters Fixed-dose combinations
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WHO/UNICEF TBS | 19 November 2009 5 | Product testing 2008 Pre-qualification 2010 Lot testing 2007 Malaria Rapid Diagnostic Tests (RDTs): International Quality Assurance Systems Dossier review and manufacturer inspections 2009
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WHO/UNICEF TBS | 19 November 2009 6 | WHO/FIND RDT performance testing
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WHO/UNICEF TBS | 19 November 2009 7 | WHO/FIND RDT performance testing
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WHO/UNICEF TBS | 19 November 2009 8 | ACTs: policy adoption, deployment, past procurement and 2009/10 forecast ACT treatment courses (Mio) Cumulative number of countries Forecast 6-24 months from policy adoption to ACT deployment 6-24 months from policy adoption to ACT deployment ? AMFm
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WHO/UNICEF TBS | 19 November 2009 9 | Complex ACT Supply Chain Management Example of artemether-lumefantrine Seedling, nursery, plantation, growth and harvest (7 months) Extraction (1 month) Extraction (1 month) Derivatisation (2 months) Derivatisation (2 months) Co-formulation, tabletting, packaging and shipping (4 months) Co-formulation, tabletting, packaging and shipping (4 months) Growers Manufacturers Extractors API suppliers
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WHO/UNICEF TBS | 19 November 2009 10 | Artemisinin price evolution (2002-2009) Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI) Global shortage Relative over-supply Cost of production
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WHO/UNICEF TBS | 19 November 2009 11 | Artemisinin market situation Assured Artemisinin Supply System (A2S2) Confirmed artemisinin production gap Variable market forecasts, low available stocks or raw material, low profit and low incentives for growers resulting in low plantings, low extraction efficiency May 2009: UNITAID approves A2S2 Project Loan facility for artemisinin extractors and API suppliers Urgent action required to meet 2010-2012 forecasts High approval rates GF R7/R8, ongoing R9 and upcoming AMFm launch
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WHO/UNICEF TBS | 19 November 2009 12 | Artemisinin resistance
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WHO/UNICEF TBS | 19 November 2009 13 | Oral artemisinin-based monotherapy Slow progress National Drug Regulatory Authorities 45/78 (58%) in line with WHO recommendations 2006 2007 2008 2009 Pharmaceutical manufacturers 24/73 (33%) withdrew their products 11/73 (15%) intend to comply with WHO ban Last updated on 17.11.2009
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WHO/UNICEF TBS | 19 November 2009 14 | Thank you
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