Insights

In our first alert in this 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 the second alert, we discussed the proposed changes to regulatory data protection. Our third alert delved into the different proposals of the European Commission, Parliament, and the Council regarding the transferable exclusivity voucher (TEV) for priority antimicrobials.

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.

The Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands, repackaged and rebranded them, and placed them on the Belgian market alleging they were a Novartis’ originator product.

At the beginning of the year, we brought to your attention that a number of important Belgian and EU legislative changes are likely to have an impact in 2024: there are new laws that have been adopted and proposals that are expected to firm up into law.

A number of important Belgian and EU legislative changes are likely to have an impact in 2024. On the one hand, there are new laws that have been adopted and will start to bite, and, on the other, there are proposals that are expected to firm up into law.

On April 26, 2023, the European Commission finally published its long-awaited EU Pharmaceutical Package. This Package introduces new draft legislation that would revise and replace existing EU pharmaceutical legislation in line with the Pharmaceutical Strategy for Europe, which was adopted by the EU on November 25, 2020.

On November 17, 2022, the European Court of Justice (ECJ) issued four important decisions (here) relating to parallel imports of branded products within the internal market of the European Union (EU). This is a complex topic at the crossroads of free movement of goods and trademark enforcement in the EU.

The Belgian regulatory framework for medical devices is highly complex, and the already dense legal landscape was recently added to by the adoption of two new Belgian royal decrees: the Royal Decree of 25 September 2022 relating to performance studies involving in vitro diagnostic medical devices and the Royal Decree of 13 September 2022 amending and repealing various provisions regarding in vitro diagnostic medical devices.

On May 3, 2022, the European Commission published a proposed regulation (the “EHDS Proposal”) for the establishment of a European Health Data Space (or “EHDS”). This is the first proposal for establishing domain-specific common European data spaces following the European strategy for data and an important step in building a European “Health Union”.

Crowell & Moring's series of alerts provides practical information and professional comment on all the ramifications regarding the introduction of the Unified Patent Court (UPC). For further information, please see our UPC leaflet PDF or contact the lawyers listed near the bottom of each alert. To view other alerts in this series, please click here.

The 2006 European Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) imposes requirements on the use of chemicals in the European Union (EU) to improve the protection of human health and the environment.

REACH is the Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals. It entered into force on June 1, 2007 and established a system for generating, documenting and disseminating information for chemicals sold on the European market.