Following Canada's lead from earlier this year, the European Commission has proposed a compulsory patent licensing Regulation that would allow manufacturers of generic pharmaceuticals to produce patented medicines for export to "countries in need."
Most European national laws at present do not allow compulsory licences for export because until recently the WTO TRIPS Agreement provided for compulsory licences only "predominantly for the supply of the domestic market." The Commission's proposal would prohibit re-importation into the EU and provide for customs authorities to take action against goods being re-imported. The patent holder could use existing national procedures to enforce its rights against re-imported goods if they do enter the EU, and the licence could be terminated. The rules also ensure that marketing authorisations do not lapse for reason of non-use in the EU, and set out exemptions from data protection rules which usually require manufacturers of generic medicines to wait for eight years before they can obtain authorisations using data from previous clinical trials conducted by others.