Access to medicines: antimalarials

1. Access to medicines: antimalarials Dr Maryse Dugué Malaria Medicines and Supplies Service

2. Situation analysis: the challenges • Quality of antimalarial drugs has been declining. • "Disease of the South": not much investment in the North, or export-only productions • The efficacy of (affordable) antimalarial drugs has been declining (drug resistance) and high cost of replacement options. • 60-90% of the population seek initial treatment from non- public sector, i.e. street vendors, kiosks. • Supply of drugs is often inefficient and unreliable. • Pharmacovigilance very weak in most affected countries

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

4. Malaria distribution and reported case of resistance or treatment failure

5. FDC WHO recommandation:Artemisinin-based Combination Therapies (ACTs) • Artemether/lumefantrine Artesunate + amodiaquine ACTs • Artesunate + SP • Artesunate + mefloquine

6. Still many challenges! • Relatively high price of ACTs (average of UNICEF/WHO price $1.21/treatment): critical aspects of external financial support • Slow process of changing drug policy at country level • Artemisinin monotherapies have to be banned! • Only one ACT prequalified yet

7. Procurement of ACT's WHO/UNICEF Interim solution In April 2003, tripartite meeting to discuss possible solutions and actions until a sufficient number of products are pre-qualified WHO/UNICEF cooperation on selection and procurement.

8. WHO/UNICEF joint tender 2003, 2004, 2005, 2006 Evaluation based on the UNICEF product quality questionnaire (similar to WHO's) Criteria included GMP certification, registration information (countries), API, stability reports, shelf-life and storage conditions Quality assurance based on a review of the documentation submitted jointly by UNICEF Pharmaceutical Team and WHO (EDM and Procurement with assistance from QSM when necessary)

9. Availability of ACTs There is NO SHORTAGE of recommended ACTs There are GOOD QUALITY manufacturers for all the recommended combinations

10. 12–18 month lag time between ACT adoption & implementation Cumulative No. of countries adopting ACT as 1st-line Rx Cumulative No. of countries implementing ACT Cumulative No. of countries adopting ACT as 1st-line Rx

11. 39 are deploying ACTs Updated September 2006 66 countries have adopted ACTs 56% deploying 72% deploying 75% deploying AQ=amodiaquine; AL=artemether/lumefantrine; AS=artesunate; DP=dihydroartemisinin/piperaquine; MQ=mefloquine; SP=sulfadoxine/pyrimethamine;

12. Millions of treatment courses 65 70 60 50 40 31.3 30 20 5 2.1 10 0.5 0.6 0 2001 2003 2005 2004 2006 as of 31.08.2006 2002 Year Procurement of ACTs (2001–2006)

13. After a slow start, orders are picking up

14. Cumulative No. of countries adopting ACT as 1st-line Rx Cumulative No. of countries implementing ACT 2007 ACT forecast ACT forecast 150 Millions of treatment courses Cumulative No. of countries adopting ACT as 1st-line Rx

15. What will influence access/demand/market size • FDCs/new combinations manufacturers/research • Price manufacturers/procurement/competition • Paediatric formulations manufacturers/research • Private sector market penetration (up to 80%) manufacturers/donors/countries • Global subsidy donors

16. What else will influence ACCESS? Timely procurement, logistics and distribution systems!