The European Commission has proposed a Regulation to allow manufacturers of generic pharmaceuticals to produce patented medicines for export to “countries in need” without sufficient capacity to produce them.
The Regulation would implement within the EU the WTO decision of 30th August 2003 under which national authorities can grant “compulsory licences” for such production if certain conditions are fulfilled. One requirement is that the destination country must have notified the WTO that it is seeking the medicine covered by the licence.
To help ensure that medicines get to the patients who need them and to protect patent holders, customs authorities will be able to prevent the re-importation into the EU of medicines produced under the system.
The proposed Regulation would set up a system for companies who wish to manufacture medicines for export to apply to national authorities for the grant of a “compulsory licence” from a patent holder who has exclusive rights over the manufacture and sale of the products concerned. Most 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 Doha declaration on trade and health adopted in November 2001 agreed to address the difficulties raised by this restriction for developing countries with no manufacturing capacity. After long negotiations, on 30 August 2003 WTO members agreed on a waiver giving these countries access to much needed generics.
More information:
EUROPA Press Release
DG Internal Market website
DG Trade website
