Compulsory IVD licensing in the EU
This article was originally published in The Gray Sheet
Executive Summary
The European Diagnostics Manufacturers' Association (EDMA) says that some - though not many - options remain for industry to provide input into the legislative process concerning an October 2004 European Commission proposal that would mandate the licensing of patents to manufacturers of generic drugs and - by amendment - diagnostic kits "ex vivo," for export to countries with public health problems. The association lists among its concerns the murky language that blurs the distinction between a pharmaceutical and an in vitro diagnostic - particularly as the two are regulated in the EU under two very different regimes - and stresses that adequate safeguards must be in place to prevent against the reimportation of IVDs back into the EU. The proposal must go to the Council of Ministers for approval before a final draft can be prepared by the Commission, EDMA says...