Lawmakers Finally Kick Off Debate On EU Pharma Overhaul
The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.
You may also be interested in...
The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.
The European pharma industry group fears planned cuts in regulatory data protection and orphan drug exclusivity periods will hit innovation but says it is ready to work with legislators to close what it sees as an R&D gap between the EU on the one hand and the US and Asia on the other.
The controversial nature of some of the plans in the EU medicines legislative overhaul suggests a long road ahead for negotiations at the European Parliament and Council, with some “substantial amendments” likely along the way.