Client Alert Series: The New EU “Pharma Package”

On June 4, 2025, after nearly two years of intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework known as the new Pharma Package.

In this series of client alerts, we will analyze and compare the positions of the three EU institutions as they move into a new phase of negotiations (the “trilogues”). We will look at some of the most contentious issues, including the regulatory data protection framework, the transferable exclusivity voucher, the "Bolar" exemption, launch obligations and shortages mitigation, and other key issues affecting the pharmaceutical industry.

Alert 1: Preparing for the Trilogues

06.30.25
The first alert provides some important background and general information about the status of the Pharma Package and how the trilogues work.

Alert 2: Regulatory data protection

07.09.25
In the second alert, we discuss the respective positions of the European Commission, the European Parliament and the Council of the European Union with respect to one of the most debated and anxiously anticipated topics on the table, the regulatory data protection (RDP).

Alert 3: The transferable exclusivity voucher

07.16.25
The third alert compares the proposals for the grant, use and transfer of TEVs that have been put forward by the European Commission, the European Parliament, and the Council of the European Union, and we consider to what extent these proposals are likely to achieve their stated aim.

Alert 4: The Debate on Fiscal Import in the Supply Chain

07.23.25
The fourth alert addresses a longstanding but increasingly debated issue in the pharmaceutical supply chain: the alignment of physical and financial flows, specifically the question of “fiscal import”.

Alert 5: Global (Orphan) Marketing Authorization

07.30.25
The fifth alert delves into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal – aside from an important introduction of the notion of a GMA for orphan medicinal products.

Alert 6: The "Bolar" exemption

08.06.25
The sixth alert focuses 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.

Alert 7: Access conditionalities and Shortage measures

08.13.25
In the seventh alert, we discuss the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the European Commission, the European Parliament and the Council of the EU.

Alert 8: Interplay with the Critical Medicines Act and other shortage initiatives

08.20.25
In the eighth alert, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. We discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act, and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.