South Africa’s Medicines Control Council (MCC) is set to continue denying compassionate use or pre-approval access to a TB drug that for many drug resistant patients remain their last hope... If the MCC would agree, bedaquiline (TMC207) could be made available with reasonable conditions, to patients with extensively drug-resistant TB, who have limited further treatment options, before the drug is approved by regulatory autorities. In South Africa the obvious mechanism for doing this would be through Section 21 authorisation approved by the MCC.... MSF in South Africa have attempted to access bedaquiline for carefully monitored treatment of a select few patients with pre-XDR and XDR TB. However, several attempts by MSF to gain compassionate access have been declined by the MCC.

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