Client Alert Series: The New EU “Pharma Package”
Client Alert | 1 min read | 06.30.25
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: The Interaction Between B2B Legislation and Book 6 on the Belgian quasi-immunity rule
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).
Contacts
Insights for the Client Alert Series: The New EU “Pharma Package”
Client Alert | 9 min read | 07.09.25
In our first alert in our new 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 this second alert, we will 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).
Client Alert | 3 min read | 06.30.25
