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

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 % 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

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

Malaria distribution and reported case of resistance or treatment failure

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

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

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. Procurement of ACT's WHO/UNICEF Interim solution

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)

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

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

66 countries have adopted ACTs Continen t CountriesDrugLine AFRICA Burundi, Cameroon, Congo, Côte d'Ivoire, Democratic Republic of Congo, Eq. Guinea, Gabon, Ghana, Guinea, Liberia, Madagascar, Mauritania, Senegal, Sao Tomé & Principe (ST&P), Sierra Leone, Sudan (S), Zanzibar AS + AQ 1 st Angola, Benin, Burkina Faso, Central African Republic, Comoros, Ethiopia, Gambia, Guinea Bissau, Kenya, Mali, Namibia, Niger, Nigeria, Rwanda, Uganda, S. Africa, Tanzania, Tchad, Togo, Zambia, Zimbabwe AL1 st Côte d'Ivoire, Djibouti, Gabon, Mozambique, Sudan (N), ST&P, Zanzibar AL2 nd Mozambique, Djibouti, Somalia, South Africa (Mpumalanga), Sudan (N) AS + SP1 st ASIA Cambodia, Malaysia, Myanmar, Thailand AS + MQ 1 st Bangladesh, Bhutan, Laos, Saudi Arabia AL1 st Indonesia AS + AQ 1 st Afghanistan, India (5 Provinces), Iran, Tajikistan, Yemen AS + SP1 st Viet Nam DP1 st Papua New Guinea AS + SP2 nd Iran, Philippines, Solomon Islands AL2 nd SOUTH AMERICA Ecuador, Peru AS + SP1 st Bolivia, Peru, Venezuela AS + MQ 1 st Brazil, Guyana, Suriname AL1 st 39 are deploying ACTs Updated September 2006 AQ=amodiaquine; AL=artemether/lumefantrine; AS=artesunate; DP=dihydroartemisinin/piperaquine; MQ=mefloquine; SP=sulfadoxine/pyrimethamine; 75% deploying 72% deploying 56% deploying

Procurement of ACTs (2001–2006) Millions of treatment courses Year 2006 as of

After a slow start, orders are picking up Treatments delivered from the 1 st of January to the 30 th of June 2005 Treatments delivered from the 1 st of January to the 30 th of June 2006 AS+AQ3,239,8307,585,652 AL1,250,08037,311,150

2007 ACT forecast ACT forecast Millions of treatment courses Cumulative No. of countries adopting ACT as 1st-line Rx Cumulative No.of countries adoptingACT as 1st-line Rx CumulativeNo. of countriesimplementing ACT 150

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

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