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.