Exemption from SPC Protection for Medicines (Regulation)


By way of an exemption from protection certificates, the EU wants to permit the manufacture of generics and so-called biosimilars for export, even where the original medicine is still protected by a certificate in the EU. Using this exemption, it wants to remedy competitive disadvantages for EU manufacturers and strengthen its generics and biosimilars industry.


In cep’s view, the exemption actually reduces competitive disadvantages for European manufacturers of generics and biosimilars which, like many SMEs, are unable to relocate their manufacturing to third countries. It also increases the attractiveness of the EU for manufacturers of generics and biosimilars. Nevertheless, its advantages are limited because it does not permit manufacturing for stockpiling purposes for protected EU markets and thus it is still impossible for manufacturers to gain immediate market access in the EU after expiry of a protection certificate. The Regulation should therefore make such manufacturing for stockpiling purposes (“stockpiling waiver”) possible.