SPC waiver may be altered on stockpiling and disclosure

European generics and biosimilars manufacturers should be allowed to stockpile within the European Union (EU) for day-one launch ahead of supplementary protection certificate (SPC) expiry, under proposed amendments to a draft SPC manufacturing waiver. Moreover, according to the amendments put forward in an opinion by a rapporteur for the European Parliament’s committee on environment, public health and food safety (ENVI), limits will also be put on the extent to which commercially-sensitive manufacturing information provided by the generics industry must be published and shared by national authorities.

The draft opinion eases industry concerns over the SPC waiver, which has been an industry goal for years but which...