Access to Antimalarial Medicines EDM-RBM Collaboration Dr Clive O Ondari Essential Drugs and Medicines Policy Dept & Roll Back Malaria (RBM) Department World Health Organization

Scope of presentation What is RBM? What have we done together? What has worked well within the partnership RBM-EDM? What have been the challenges in working together?

What is RBM? RBM = Roll Back Malaria Initiated as a WHO/Cabinet project in 1998 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.)

What is RBM? HOW? GOAL? Strategies: WHY? mechanism for coordinated international approach to fighting malaria HOW? an assembly of expertise, infrastructure, funding working together – globally, regionally, nationally raising awareness GOAL? burden of malaria reduced by 50% - 2010 Strategies: Protecting most vulnerable groups (pregnant women, <5's) Preventing measures: insecticide-treated bednets (ITNs), in-door residual spraying (IRS) Right medicines, right place, right time Addressing emergencies and epidemics

Abuja Declaration, African Summit on Roll Back Malaria (Abuja, Nigeria), April 2000 Call upon all member states to: Make treatments available as peripherally as possible including home-based treatments Make appropriate treatments available and accessible to poorest groups in community   Pledge to: Reduce or waive taxes and tariffs for … anti-malarial medicines Explore and develop traditional medicines in area of malaria control

What environment are we working in? 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 Use of ineffective medicines leads to inadequate treatment and leads to drug resistance

Factors leading to development of resistance Lack of treatment guidelines / poor treatment policies Irrational prescribing Irrational drug use Drug concentration “tail” Liberalized, uncontrolled drug market leading to poor quality products circulating in international and domestic markets

Cost implications of combination therapy (ACT) Average cost per adult treatment (US$)

What have we done together? Development of monographs for: artemether (tabs, caps, inj); artemisinin (caps); artemotil (arteether) (inj); artenimol (DHA) (tabs); artesunate (tabs) + mefloquine, proguanil 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)

Pilot Project on Quality of Antimalarial Products Project Design: 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

Failure rates (%) - Content

Failure Rates (%) - Dissolution

Selection of anti-malarials Moving towards ACTs FDC Artemether/lumefantrine MDT Artesunate + amodiaquine ACTs Artesunate + SP Artesunate + mefloquine Amodiaquine + SP

Global Forecasts/Estimates for procurement Adult treatments Total Morbidity estimates 2004 30,007,678 50,012,796 2005 - 2006 131,583098 219,305,163 These are conservative (cautious) estimates of the countries that have changed, that are changing, and that are expected to change, and which will be deploying ACTs in 2004 and 2005

GFATM grants for ACTs

Challenges – Access to ACTs 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!

Pre-qualification of ACT Manufacturers and Products Objectives: 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: Limited: Coartem® and 1 Artesunate 50mg tab. prequalified

Malaria Medicines and Supplies Services (MMSS) What it MMSS? Mechanism for assisting countries to scale-up access to medicines and other products What will MMSS do? Link NMCP with suppliers and other products How will MMSS operate? Creating procurement platform: depository of information on: sources and prices prequalified suppliers and products national quantification of requirements → global estimates mechanism for providing support to national programmes and producers)