Civil society clear way for generic version of critical HIV medicine into Argentine health system
Fundación Grupo Efecto Positivo (FGEP) celebrates an important victory – the recent acquisition by the Argentinan government of the generic version of an HIV drug. The recent acquisition of TDF+FTC+EFV, brand name Atripla®, is an important step in guaranteeing the sustainability of the publicly funded HIV treatment program in Argentina. During a meeting of people living with HIV and other members of civil society, the Head of the National AIDS Program (NAP), Dr Carlos Falistocco, confirmed the purchase of the generic version of TDF+FTC+EFV from Indian company CIPLA. The purchase means a reduction of the price of the medicine, from US$9.78 per pill offered by Gilead to 38 cents per pill. This improved saving will increase the sustainability of the public program that offers free medicines to people living with HIV.
The decision about purchasing the generic version from India took place after several interventions from FGEP over the last few years. FGEP held meetings with the National AIDS Program officials, and released statements highlighting exorbitant prices charged by Gilead for their equivalent drug, and the savings that could be made by purchasing Indian generic medicines. These interventions were supported by a pre-grant opposition that FGEP filed in December 2013, against the patent application on TDF+FTC+EFV which was sought by Gilead Sciences and Bristol Myers Squibb (see article in Spanish) at the Argentine patent office. FGEP proved that the application filed by these companies did not meet patentability requirements of novelty, inventive step and industrial application. The three active ingredients included in this key first line one-per-day-pill combination of drugs is in public domain and, according to the Argentine patent law, it cannot be claimed in a patent application.
The patent application is currently pending of examination at the National Institute of Industrial Property (INPI). FGEP has warned repeatedly about the urgency in resolving the case due to the current relevance to public health of these drugs.
According to the Ministry of Health, the purchase of the generic version of TDF+FTC+EFV means public savings of almost US$20 million. The savings could be used so by the government to treat more people living with HIV, and address other urgent health needs. The head of the NAP confirmed that the purchase intends to guarantee the sustainability of the program for 2016. The decision is an important example showing the way forward to guarantee treatment for all who need it in Argentina.