Client Alert Series: The New EU “Pharma Package”
Client Alert | 3 min read | 06.30.25
The proposed overhaul of the EU general pharmaceutical legislative framework known as the Pharma Package, has been a long time in the making. The European Commission first published its proposal back in April 2023. One year later, in April 2024, the European Parliament adopted its position. Finally, on June 4, 2025, after intense debate and negotiation between the 27 EU Member States, the Council of the European Union adopted its position.
In the first part of this series of client alerts (Alerts 1-10), we have analyzed and compared the positions of the three EU institutions as they moved into a new phase of negotiations (the “trilogues”). We looked 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.
On March 6, 2026, the "compromise texts" of the EU Pharma Package were published following the political agreement reached on December 11, 2025. Formal adoption by the Council and the European Parliament is expected in fall 2026.
In the second part of this series (Alerts 11–20), we examine the final compromise outcomes on each of the above topics. The table below aligns the two parts of the series, pairing each trilogue-phase alert with its corresponding compromise-text counterpart.
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Insights for the Client Alert Series: The New EU “Pharma Package”
Client Alert | 8 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
