On 8 November, the World Health Organization (WHO) announced a shortfall of artemether + lumefantrine, an artemisinin-based combination therapy (ACT) used to treat malaria, for the period between November 2004 and March 2005 (http://mosquito.who.int/malariacontrol).
Based on information provided recently to WHO by Novartis, the shortage is expected to continue beyond March. The reason is a continued lack of raw materials needed to make this medicine. Novartis has informed WHO that production of artemether + lumefantrine is highly dependent on the timely delivery of both artemisinin - a raw material extracted from the plant Artemisia annua - and its derivative artemether by its Chinese suppliers.
ACTs are currently the most effective medicines available to treat falciparum malaria-the deadliest form of the disease; and artemether + lumefantrine is the only such drug currently available in fixed-dose form (the two drugs are combined in a single tablet). The drug is produced by Novartis under the tradename Coartem®. Pursuant to an agreement concluded in 2001, Novartis provides artemether + lumefantrine to WHO at cost for supply to the public sector of malaria-endemic developing countries.
Forty countries (20 of them in Africa) have officially adopted ACTs for the treatment of malaria since 2001. Twenty have adopted artemether + lumefantrine as their first- or second-line treatment.
Novartis has informed WHO that despite the company's investment and rapid scale-up to meet the growing need for artemether + lumefantrine, it is unable to utilize its full production capacity of five million treatment courses per month because of the raw material shortfall.
Novartis has announced that it has secured artemisinin derivatives in quantities sufficient to produce approximately 60 million average treatment courses . However, because most deliveries to Novartis of raw materials will occur in the second half of the year, the company estimates that approximately 30 million treatments will be produced in 2005, and half that quantity will be produced during the last quarter of the year. These 30 million doses represent about half the amount WHO expects will be needed to meet public sector demand in 2005.
The 11 countries that have already started procuring artemether + lumefantrine for 2005 should receive a total of approximately ten million average treatment courses. WHO is advising countries to obtain clear information on timing of planned deliveries, make use of their available stocks accordingly and increase purchases of second-line treatments temporarily, as needed.
The nine countries that have officially adopted artemether + lumefantrine in their antimalarial treatment policies and are planning to procure and use this medicine in 2005, should between them be able to obtain approximately a total of 20 million treatment courses. In the event demand exceeds availability, WHO is establishing a system to prioritize requests from countries based on a number of specific objective criteria, including documented resistance to other antimalarial drugs and the need to implement their new ACT policies.
WHO is providing technical assistance to countries facing the consequences of the shortage of artemether + lumefantrine. It is also informing each country that has placed an order for artemether + lumefantrine about availability and delivery schedules.
Roll Back Malaria partners including WHO have engaged in stepped up malaria prevention, working towards rapid deployment of free or highly subsidized insecticide-treated mosquito nets. Initiatives to encourage wider-scale cultivation of Artemisia annua also are in progress.