The European Council adopted on 4 June 2025 its position on the new rules for the EU’s pharmaceutical sector. The mandate will allow the negotiation phase to begin in order to reach a final agreement on the reform. According to the approved text, regulatory data protection should last eight years, while regulatory market protection will add a further year (extendable to two years upon achieving pre-defined key objectives). The Council also introduced an obligation to supply, giving member states the power to require the marketing authorisation holder make a medicinal product available in sufficient quantities to cover the needs of patients in the member state.
As for the transferrable exclusivity vouchers, the Council’s position states that they can only be used in the fifth year of the regulatory data protection period, if the MA holder can demonstrate that the annual gross EU sales of the product were not greater than €490 million in any of the preceding four years. The Council has addresses access to market for generics and biosimilars by clarifying the scope of the Bolar exemption and expanding it to include submissions for procurement tenders.