EU lawmakers vote to extend exclusivity period for new medicines, softening Commission proposal
A company would also receive three years of market protection from generics
(Reuters) – 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.
Lawmakers will then need to strike a deal with member states which have not yet agreed on a joint stance.
The EU Parliament aims to set baseline data protection to 7.5 years with one extra year of incentives if the medication meets unmet 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.
The new legislation aims to slash the time it takes to approve new medicine, incentivise production of medicines for antibiotic-resistant bacteria, improve patient access and "future-proof" the rules to account for technological leaps like artificial intelligence.
But Europe's pharmaceutical industry has been critical of the proposal. At issue is the new linking of a medicine's exclusivity period to access across all 27 member states, where the length of approval can vary by years.
According to the draft voted by lawmakers on Tuesday, a company would also receive three years of market protection from generics, taking the total exclusivity period to a maximum 11.5 years, down slightly from 12 years initially proposed by the Commission.
