SPC Manufacturing Waiver: Good For Generics, But Legal Questions Remain
This article was originally published in SRA
Executive Summary
The European Parliament's backing for a waiver that would allow generics firms in the EU to produce generic and biosimilar drugs for export to non-EU countries during the originator product's EU supplementary protection certificate (SPC) period may have been welcomed by the generics industry, but it poses a set of legal questions that the European Commission will have to deal with before a waiver can be implemented.