EU Committees Amend SPC Manufacturing Waiver, Push Access To Generics, Biosimilars

The European Parliamentary Committees on Health and Trade have each voted in recent weeks to adopt amendments to the proposed Special Protection Certificate (SPC) manufacturing waiver, an intellectual property exception for the EU generic and biosimilar industry. The amendments include provisions that push the waiver toward increasing EU generic and biosimilar industry competitiveness in EU markets, and improving access for EU patients to affordable medicines. The waiver and amendments still have several hurdles to go, including a vote by the Legal Affairs Committee planned for January.






