1. Access to Antimalarial Medicines
Dr Clive O Ondari
Essential Drugs and Medicines Policy Dept &
Roll Back Malaria Department
World Health Organization
March 2004

2. Malaria in the World
Coding: Red indicates malaria-endemic.

3. Current Situation: Quality of antimalarial drugs has been declining.
The efficacy of (affordable) antimalarial drugs has been declining and high cost of replacement options.
Over 50% of the population does not have regular access to most vital essential drugs.
60-90% of the population seek initial treatment from unqualified sources, i.e. street vendors, kiosks.
Supply of drugs is often inefficient and unreliable.
Use of ineffective drugs leads to inadequate treatment and leads to drug resistance.

4. % of all deaths Rank Malaria 1 20.3 Respiratory inf. 2 17.2 Diarrhoea
Leading causes of death for children under 5 yrs, in the WHO African Region, 2000
% of all deaths
Rank
Malaria 1
20.3
Respiratory inf. 2
17.2
Diarrhoea 3
12.3
HIV/AIDS 4
9.0
Measles 5
8.4
Low birth weight 6
5.8

5. Therapeutic efficacy of SP in Africa: evidence to guide action
THRESHOLD FOR CHANGE 15
West Central East

6. Problems of resistance to antimalarial drugs
Era of availability of cheap and effective drugs has come to an end
Both CQ & SP cost <US$0.2/adult treatment course, but resistance to CQ widespread, and to SP increasing
Alternatives for multi-drug resistant falciparum malaria are x10 expensive

7. Factors leading to development of resistance
Lack of guidelines/poor drug 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. The Abuja Declaration, African Summit on Roll Back Malaria (Abuja, Nigeria), April 2000
Call upon all member states to:
“Make treatment of malaria available as peripherally as possible including home treatment”
“Make appropriate treatment available and accessible to the poorest groups in the community”
Pledge to:
“Reduce or waive taxes and tariffs for …antimalarial drugs”
“Explore and develop traditional medicine in the area of malaria control”

9. Artemether/lumefantrine
Rational Selection
FDC
Artemether/lumefantrine
MDT
Artesunate + amodiaquine
ACTs
Artesunate + SP
Artesunate + mefloquine
Amodiaquine + SP

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

11. Number of countries deploying ACTs for malaria as first-line treatment13 15 9

12. Challenges
Only one fixed dose combination available: artemether- lumefantrine (Coartem®), patented and single-source
All other ACTs: multi-source products, generally off-patent generics, 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
Relatively new products on the international market – limited country experience in regulation and procurement

13. Global negotiation to reduce price of new antimalarials
Expert consensus that co-formulated artemisinin combination best option for use where multi-resistant malaria
Artemether/lumefantrine (Coartem) is only medicine of this type currently licensed
Novartis has agreed to provide drug at cost through WHO for 10 years – US$ 2.40 for adult treatment
Countries to request, direct or through NGOs

14. The GFATM is the largest financial supporter of ACTs in countries.
A total of US$30 million has been committed over the full 5-year life
of GFATM Board-approved proposals from African countries
for the purchase of ACTs in three proposal rounds.
Total annual number
of ACT treatments
(eq. adult doses)
funded by GFATM

15. Total Morbidity estimates
Global Forecasts
Forecasts
for procurement
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

16. Pilot Project on Quality of Antimalarial Products
Project Design :
Country selection criteria: “spot light countries” in AFRO and EMRO
Evaluation of the most widely used antimalarials products in the regions
Sampling from various levels of the distribution chain (household, private sector pharmacy, peripheral health units, district hospital, teaching/referral hospital and district and/or central medical store
Evaluation of samples in a central laboratory (pharmacopeal tests) in CENQAM, South Africa

17. Failure rates (%) - Content

18. Failure Rates (%) - Dissolution

19. Pre-qualification of ACT Manufacturers and Products
Objectives:
To accelerate sustained access to, and use of, good quality ACTs
To ensure that adequate and effective treatment reaches significantly greater numbers of people in need
To assist/support the implementation of ACTs in ways that respond to the specific needs and requests of individual countries
To support drug regulatory agencies in regulating ACTs

20. RBM/EDM Collaborative Activities
Strengthening drug supply, quality assurance and regulatory systems
Develop common guidelines for registration of new antimalarials
Assist countries to evaluate quality and monitor inspection activities (including pre-qualification of sources of products)
Provide support to training in the areas of pharmaceutical inspection (GMP) - manufacturing and distribution channels
Initiate the development of monographs for new AM

21. Making Artemesinin Products Available
Availability
Procurement
Selection
Registration