E-DRUG: Shortage of ACT for malaria (4)
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Medecins Sans Frontieres responds to shortages of Novartis malaria drug Coartem announced by the World Health Organization
November 10th 2004
On November 8th the World Health Organization communicated mis-information regarding reasons for current shortages of the malaria drug artemether-lumefantrine (sole supplier Novartis, under the trade name Coartem). In addition, the WHO failed to point out that there are alternatives to Coartem available that are already being procured by both WHO and UNICEF. (footnote 1)
The current demand for Coartem is not a surprise, as WHO suggests in their communication of November 8th. WHO makes quarterly forecasts to Novartis, as stipulated in their 2001 agreement, and Novartis has known about this year's demand since spring. Novartis needs to take responsibility for its failure to produce product according to WHO forecasts. It is in breach of its 2001 agreement with WHO to make "all reasonable efforts" to produce quantities forecasted by WHO and should be held accountable.
Novartis has failed to effectively organize its suppliers for this product, which has left the company vulnerable to capacity problems. Novartis' own estimate of current global raw material availability is 50 tons. Yet the company is failing to produce monthly quantities of Coartem that would require only 5 tons of raw material.
This Novartis/WHO failure has serious consequences for people in African countries. For example, Novartis will only be able to supply one million out of the three million doses needed by Ethiopia. The rest of the patients will be forced to take a complex seven-day regimen, which is often not completed, leading to treatment failure.
The good news is that three other companies have been validated by WHO/UNICEF to sell other WHO-recommended artemisinin-based combination therapies ("ACT"). The three other suppliers are Sanofi of France, and IPCA and Cipla of India. WHO/UNICEF should also be working with these producers to ensure that all ACT capacity is mobilized.
For next year, there is a global shortage of ACTs looming and the only way to avoid this is for the international community to make advance purchases from multiple suppliers. Advance purchases will increase quantities of Artemisia annua that will be planted in December 2004/January 2005. This is the only way to ensure dramatically increased supplies for next year. Although WHO/UNICEF and the Global Fund agree that advance purchases are necessary, no actions have yet been taken.
1 "Surge in Demand Leads to Shortage of Artemisinin-Based Combination Therapy for Malaria," WHO press release, 8 November 2004.
Sean Healy
Information Officer
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
Geneva, Switzerland
tel ++41-22-8498 401
fax ++41-22-8498 404
mobile tel ++41-79-239 9271
sean.healy@geneva.msf.org
www.accessmed-msf.org
[moderator’s comment: MSF speaks about “validation” of malaria drugs in the above message. “Validation” by WHO (for procurement?) is however not the same as “pre-qualification” (of quality) by WHO. So far, only lumefantrine+artemether (Novartis) and artesunate (Sanofi) are pre-qualified (see http://mednet3.who.int/prequal/mal/mal_suppliers.doc)
The “validated” suppliers of ACT (IPCA and Cipla) can be found in http://www.rbm.who.int/docs/mmss/procuringACTpreferentialprices.pdf
Finally, a complete review of all available malaria-related products and their registration status can be found at http://www.rbm.who.int/docs/mmss/SP-Malaria-May2004.pdf The May 2004 document carries a footer with “draft – September 2004”.
The confusion and shortage needs to be sorted out! Millions of Africans now face largely useless chloroquine or near-toxic oral quinine regimes, and need effective ACT! WB]