The European Parliament has strongly approved the proposed manufacturing and stockpiling exemptions (waiver) to the SPC Regulation for pharmaceuticals – a ruling paving way for considerable changes for European pharma industries. There is likelihood the Council will adopt the proposal so the SPC waiver will enter into force before the autumn.
As Setterwalls flagged for last week, the SPC Waiver was this week scheduled for the Parliament’s first reading. Moreover, yesterday, the Parliament clearly approved the proposal (572 votes in favour, 36 against, 22 abstentions). Based on the text related to here last week (thus the preliminarily agreed inter-institutional trilogue’s text dated 20 February), editorial amendments had been made. The provisional text the Parliament approved is here.
Hence, the Council is now in a position to adopt the text, with an entry into force 20 days following its publication in the EU’s Official Journal. Subject to political priorities, the Council is expected to do so prior to Brussels’ August leave. If so, the SPC Waiver will be operational before the end of summer.
Setterwalls has ample experience on SPC matters and we are following developments closely, standing ready to assist. You are welcome to contact us.