Over generic drug authorisations
The European Commission is threatening Italy with legal action at the European Court of Justice (ECJ) over a restriction it imposes on generic drug manufacturers. Italian law prevents them from filing marketing authorisation requests before the penultimate year of a patent’s expiry, which Brussels says breaks EU genetic medicine legislation.
‘As a result of this law, and of the lengthy procedure to secure the authorisation for marketing, manufacturers of generic products are placed at a disadvantage,’ said the Commission.
Brussels has also threatened Greece with legal action at the ECJ if it does not liberalise controls on the parallel import of medicines. Greece imposes fixed prices on these pharmaceuticals, which the Commission says breaches EU rules on the freedom of movement of goods.
‘The national measures in force and/or practices hinder the trade of parallel imported medicine,’ said the Commission.
Both countries have been given two months to promise reforms or potentially face ECJ cases.