The New EU “Pharma Package”: Preparing for the Trilogues

The New EU “Pharma Package” Series

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.

In this alert we will provide some important background and general information about the status of the Pharma Package and how the trilogues work.

Alert 1: Preparing for the Trilogues

What is the new EU Pharma Package?

The Pharma Package consists of a Directive and a Regulation that will replace the current legislative framework (Directive 2001/83 and Regulation 726/2004), which is over two decades old. It will also incorporate the currently separate Regulations on orphan and paediatric medicines (Regulations 141/2000 and 1901/2006, respectively). The Pharma Package is designed to modernize the EU’s approach to medicines for human use, and it aims to improve timely, fair access to, and the availability and affordability of, safe and effective medicines for patients throughout the EU. It also seeks to support innovation and competitiveness in the pharmaceutical sector and promote higher environmental standards.

What stage has the new legislation reached?

The Council’s recent adoption of its position on the Pharma Package marks a new milestone in the reform of the EU pharmaceutical legislation. The European Commission first published its proposal back in April 2023. One year later, in April 2024, the European Parliament adopted its position, pushing back on some of the Commission's suggestions and raising some additional points of its own.

All three EU institutions now have their negotiation mandates to conduct the "trilogue" discussions and interinstitutional technical meetings (ITMs) to reach an agreement on the Pharma Package, particularly on contentious issues such as the regulatory data protection framework and the access and supply obligations. These meetings take place behind closed doors until a final compromise is reached. The ITMs will seek agreement on the more technical aspects of the text, while the aim of the trilogues is to reach general political agreement on the core principles. Several ITMs take place prior to each trilogue meeting. The first trilogue took place on June 17, 2025. During the negotiations, the institutions are, in principle, bound by their mandates, i.e., they are not allowed to propose a compromise that falls outside the scope of the three proposals that are already on the table.

Once a provisional compromise text has been informally agreed in the trilogues, both the Parliament and the Council must vote again to formally approve the new legislation in accordance with the EU’s ordinary legislative procedure, also known as the co-decision procedure.

Once agreed, the Directive and Regulation will enter into force 20 days after publication in the Official Journal of the EU. The transitional period will then begin, during which the EU Member States must transpose the Directive into their national laws. The Council has proposed a transitional period of 36 months. This is double the 18 months previously proposed by the Commission and the Parliament. Assuming an interinstitutional agreement is reached by the beginning of 2026 (though this timing is thought to be quite ambitious), the earliest possible effective start date for the Pharma Package would be the middle of 2027 if there is an 18-month transitional period, or the beginning of 2029 if there is a 36-month transitional period. The proposals contain an extensive list of transitional provisions for products that are approved or applied for prior to the entry into application of the Pharma Package. Notably, the Council has added a transitional provision stating that medicinal products placed on the market prior to the new legislation entering into application, and which do not comply with its requirements, may be marketed until stocks are exhausted.