Position paper - Position on the Supplementary Protection Certificate (SPC) waiver

AmCham EU is concerned about the European Commission’s proposal to introduce a manufacturing exemption (‘waiver’) to the rights of Supplementary Protection Certificate (SPC) holders. This risks sending a negative signal about Europe’s attractiveness as a destination for investment and medical innovation, at a time when other global players like China are strengthening their Intellectual Property (IP) systems. In order to minimise these risks, it is essential that the scope of the proposal is not widened and that the final legislative text provides for additional legal clarity and strengthened safeguards, ensuring that innovators’ rights are not weakened further.