The steady danger of stock-outs: - MSF's experience accessing TDF in South Africa

Lack of registration in South Africa has been the single biggest hurdle to accessing the drug. Despite promises from Gilead that it had filed the application for registration in late 2003, the company later struck a deal with Aspen Pharmacare, which led to further delays.

"Completing all the steps to access TDF in South Africa takes MSF over two months. About half that time is usually due to unexpected delivery delays. The other half is spent getting the special authorisations from the Medicines Control Council (MCC) required to import the drug. These authorisations allow use of TDF for specific patients and only for a period of six months.

"Delays left us with only two bottles of TDF in the Khayelitsha programme in late 2005, when 13 patients at the time were receiving the drug. After considerable time spent chasing up the order, it finally arrived at the beginning of December.

"We were confronted with the same situation in March 2006, when some patients were forced to share their monthly supply of TDF, so as to avoid treatment interruption while we awaited a new order. At that time, the lives of 26 patients depended on TDF. And I had to start working on the order for August all the way back in May - that's three months for a shipment of less than 100 bottles!

"Lack of registration in South Africa has been the single biggest hurdle to accessing the drug. Despite promises from Gilead that it had filed the application for registration in late 2003, the company later struck a deal with Aspen Pharmacare, which led to further delays.

"The whole registration process had to start from scratch in November 2005, when finally Aspen finalized the application. We have wasted two years that the companies have failed to justify - a time during which many lives have been lost.

"In Khayelitsha, the number of patients relying on TDF has today risen to nearly 40. These patients are extremely privileged: as an international organisation, MSF is able to manage considerable bureaucratic and logistical challenges of shipping medicines directly from California, as well as high freight costs.

"Nevertheless, we're increasingly concerned that after nearly three years of experience importing TDF, we have still not been able to establish a reliable importation system, nor is the drug registered here yet. Since there is no way to assure stock, this seriously inhibits us from starting new patients on the drug who need it as a matter of life or death."