GlaxoSmithKline challenges Argentina court ruling

UK pharma giant GlaxoSmithKline (LSE: GSK) says it disagrees with the recent court ruling in favor of ANMAT (the Argentinean National Administration of Medicines, Food and Medical Technology) on the fine issued to GSK regarding the administrative conduct of the COMPAS (Clinical Otitis Media and PneumoniA Study) study in Mendoza, Argentina.

The 400,000 Argentinean peso ($90,000) fine issued by the ANMAT relates to administrative procedures in place for the COMPAS study in 2007 and 2008. It does not question the safety of the study vaccine, Synflorix, for the prevention of pneumonia. GSK is initiating an appeal against this ruling to the Supreme Court of Argentina.

GSK failed to get proper consent from the children’s parents before injecting Synflorix, one of its bestselling vaccines, according to a judge in Buenos Aires. The company was also criticized for keeping inadequate records of the children’s ages, medical histories and previous jabs.