EU SPC Waiver: Originators May Need To Act Soon
A new EU regulation relaxing the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period will take effect on 1 July. Originator companies wanting to benefit from a three-year transition period should consider taking action now.
You may also be interested in...
PhRMA wants the UK to be placed on the US Trade Representative’s “Watch List” over issues such as the supplementary protection certificate waiver and delays in access to new drugs caused by “overlapping” cost-containment measures.
In its 2022 “Special 301” submission, US pharmaceutical industry group PhRMA says that EU data protections and other incentives for innovative R&D are under threat, echoing concerns already expressed by European industry bodies.
Changes to how the UK plans to implement the supplementary protection certificate manufacturing waiver after it separates itself fully from the EU following the current Brexit transition period have been criticized by the generics industry, while originators have welcomed the move.