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.