Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November 2009 - Geneva Silvia Schwarte Global Malaria Programme.

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Presentation transcript:

Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November Geneva Silvia Schwarte Global Malaria Programme

WHO/UNICEF TBS | 19 November | Outline WHO Guidelines and Prequalification Malaria diagnosis Artemisinin market situation Resistance and oral artemisinin-based monotherapies

WHO/UNICEF TBS | 19 November | 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

WHO/UNICEF TBS | 19 November | Co-blisters Fixed-dose combinations

WHO/UNICEF TBS | 19 November | Product testing 2008 Pre-qualification 2010 Lot testing 2007 Malaria Rapid Diagnostic Tests (RDTs): International Quality Assurance Systems Dossier review and manufacturer inspections 2009

WHO/UNICEF TBS | 19 November | WHO/FIND RDT performance testing

WHO/UNICEF TBS | 19 November | WHO/FIND RDT performance testing

WHO/UNICEF TBS | 19 November | 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

WHO/UNICEF TBS | 19 November | 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

WHO/UNICEF TBS | 19 November | Artemisinin price evolution ( ) Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI) Global shortage Relative over-supply Cost of production

WHO/UNICEF TBS | 19 November | 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 forecasts High approval rates GF R7/R8, ongoing R9 and upcoming AMFm launch

WHO/UNICEF TBS | 19 November | Artemisinin resistance

WHO/UNICEF TBS | 19 November | Oral artemisinin-based monotherapy Slow progress National Drug Regulatory Authorities 45/78 (58%) in line with WHO recommendations Pharmaceutical manufacturers 24/73 (33%) withdrew their products 11/73 (15%) intend to comply with WHO ban Last updated on

WHO/UNICEF TBS | 19 November | Thank you