Lawmakers in a EU parliamentary committee on Tuesday voted to extend the exclusivity period for new medicines compared to an initial draft, seeking to address concerns expressed across the bloc’s pharma industry as part of a wider regulatory overhaul.
Committee members adopted the draft position published earlier this month before a final plenary vote scheduled for April 11 by a large majority.
The EU Parliament aims to set baseline data protection to 7.5 years with one extra year of incentives if the medication meets “unmet medical needs”, and if clinical trials are held in the EU.
This is softer than the EU Commission’s initial proposal to reduce the period to six years, from eight currently, to boost competition as European pharmaceutical research and development is falling behind non-European rivals according to critics.
via Reuters
