Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

Country ATV RLPV/rLPV/r(HS)TDFArgentina Y Y YFTCBelize Y YCameroonCambodiaChina Y Y/N YDominican Republic Y Y Y/N YIndia Y YYTDF/FTCMalawi Y Y*MoroccoYPhilippines Y YRussia Y YUganda Y Y Y* Y*TDF/FTC/EFVZambia Y Y Y Y* YZimbabwe Y Y* This registration information comes from the Gilead website.Although innovator companies complain of slow and complicated processes tojustify their delay, these same companies will register their bigger-selling productsmuch more quickly. The fact that drug companies suffer no adverse consequencesof delaying or staggering registration of lifesaving medicines is deeply problematicand must be addressed both through international norms and national law.Paradoxically, some of the same companies that issue big publicity announcementson their developing-country access programs thereafter drag their heels in terms ofactually registering their medicines in-country. Gilead is one of the most infamouscompanies in this regard, having announced a large-scale access program fortenofovir (TDF), emtricitabine (FTC), and Truvada (TDF + FTC) in 2005, but havingdone little to actually register their product until 2007. 3In a more egregious case, Abbott has used registration as a cudgel by withdrawinga registration application for heat stable lopinavir/ritonavir (LPV/r) from the ThaiFood and Drug Administration in retaliation for Thailand having issued a lawfulcompulsory license. Although Abbott is acting relatively expeditiously in registering3 Part of this problem was caused by Aspen Pharmacare which undertook to register Gilead’sproducts in Access Countries but made no serious effort to do so.51