September brought many developments on open files. The opinion of the Advocate General of the European Court of Justice, still subject to the Court’s final judgement, represents the first position against the current EPR scheme. The JURI Committee of the Parliament approved its position on the SPC extension, supporting the possibility of manufacturing and stockpiling biosimilars in Eu-rope to be ready for day-1 launch. The proposal for a Public Procurement Act introduces quality criteria alongside the sole price criteria.