Insights

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the “Bolar” exemption.

In our first alert in this weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In the second alert, we discussed the proposed changes to regulatory data protection. Our third alert delved into the different proposals of the European Commission, Parliament, and the Council regarding the transferable exclusivity voucher (TEV) for priority antimicrobials.

On June 25, 2025, the European Commission adopted a new framework that simplifies EU State aid rules to make it easier for Member States to support the development of clean energy, industrial decarbonization and clean technology. This Clean Industrial Deal State Aid Framework (CISAF) will be in place until December 31, 2030 and replaces the Temporary Crisis and Transition Framework (TCTF), which was introduced in March 2023 to address the economic impact of the war in Ukraine and reduce the EU’s dependence on imported fossil fuels.