EU Pharma Package – practical summary related to orphan drugs
Publication date: January 09, 2026
Much of the EU’s pharmaceutical legislation was adopted over 20 years ago. It is clear that much progress has been made in this area since then. Furthermore, due to the nature of European Union legislation, these regulations are fragmented into numerous smaller regulations and directives. To address both of the aforementioned issues, in 2023, the European Commission presented a draft of new legislation in this area. This draft was called the Pharmaceutical Package. After publishing the draft regulation and directive, the European Parliament adopted the draft with amendments at first reading in 2024. Since then, negotiations have been ongoing with the Council of the EU on the final shape of the regulations. However, on December 16, 2025, the Council published the outcome of the negotiations, announcing that both legislative bodies had reached a preliminary agreement on the final shape of the regulations.[1] Now, the draft will be put to a vote by the EU Council, where, probably after introducing the agreed amendments, it will be sent back to the Parliament, which will have to accept the amendments.
