Ensuring Access to Antimalarial DrugsRoll Back Malaria (RBM) Department
World Health Organization
Started UN Agencies movement – UNICEF, UNDP, WB (founding partners)
Initiated Global Movement "doing things differently": Regional Dev. Bank; major partners: USAID, DfID, NGOs, private sector
Regional Initiatives (OAU →African Union)
Country movement: MOH (Nat. Malaria Control Programmes) + country-level partners: NGOs, community-based organizations, large private-sector employers (estates, mining and petroleum companies, etc.)
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HOW?
working together – globally, regionally, nationally
raising awareness
Strategies:
Right medicines, right place, right time
Addressing emergencies and epidemics
Quality of antimalarial medicines has been declining
Efficacy of (affordable) antimalarial medicines has been declining and high cost of replacement treatment options
>50% of population does not have regular access to most vital essential medicines
60 - 90% of the population seek initial treatment from unqualified sources, i.e. street vendors, kiosks (private informal sector)
Supply of medicines is often inefficient and unreliable
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Lack of treatment guidelines / poor treatment policies
Irrational prescribing
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Country selection criteria: “spot light countries” in AFRO and EMRO
Evaluation of most widely used antimalarials in these regions
Samples from various levels of distribution chain (household, peripheral health unit, district, private sector pharmacy, district hospital, teaching/referral hospital and gvt. medical stores
Quality testing of samples in central QC laboratory (CENQAM), South Africa
Evaluation of results and publication
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What is required to include ACTs in the WHO Model List?
Submission to the Expert Committee on Essential Drugs by:
RBM Department
Pharmaceutical Manufacturers
Review by the relevant WHO Department(s) and Expert Committee(s) - comparison with other drugs on:
efficacy
safety
cost-effectiveness
Registration
Selection
Procurement
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Antimalarial drug quality survey in 7 African countries
Training (DRA and manufacturers) in GMP and QA: focus on antimalarials
Clinical screening of traditional medicines for antimalarial activity (TRM support)
Development of treatment guidelines for malaria
Development of Malaria Medicines and Supplies Service (MMSS)
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for procurement
Adult treatments
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Only one fixed dose combination (FDC) available: artemether-lumefantrine (Coartem®), patented and single-source
All other ACTs: multi-source products, available as individual products to be co-administered (preferably in course-of-therapy blister packs)
Market not primed: few manufacturers, limited experience with manufacturing and packaging of artemisinin derivatives (highly hygroscopic), API linked to natural plant production – shortages?
Relatively new products on the international market – limited country experience in regulation and procurement
In Jan. 2005: GFATM will support ONLY prequalified medicines!
Challenges – Access to ACTs
accelerate access to, and use of, assured quality ACTs
ensure adequate and effective treatment reaches greater numbers of people in need
support implementation of ACTs in ways that respond to specific needs of individual countries
support drug regulatory agencies in regulating ACTs
Progress:
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What it MMSS?
Mechanism for assisting countries to scale-up access to medicines and other products
What will MMSS do?
How will MMSS operate?
sources and prices
mechanism for providing support to national programmes and producers)
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AwardCummulative
0
20
40
60
80
100
Gabon
Ghana
Mali
Kenya
Mozambique
Zimbabwe
Sudan