1. 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

2. 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?

3. 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.)

4. 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%
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

5. 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

6. 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
% 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

7. 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

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

9. 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)

10. 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

11. Failure rates (%) - Content

12. Failure Rates (%) - Dissolution

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

14. Global Forecasts/Estimates
for procurement
Adult treatments
Total Morbidity estimates
2004
30,007,678
50,012,796
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

15. GFATM grants for ACTs

16. 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!

17. 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

18. 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)