EU Council seeks to further justify SPC “Manufacturing Waiver” on grounds already rejected by WTO
As discussed in our blog of 30 May 2018, the EU Commission has proposed an amendment to Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (“SPC Regulation”) aimed at introducing a “manufacturing for export exception.” The purpose of the amendment is to allow the manufacture of generic and biosimilar medicines within the…