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In this blog post, experts from across our pharma regulatory, IP and competition teams provide a brief snapshot of some of the key European developments which companies in the pharma sector should be aware of.
Pharma regulation
After many months of intense negotiations, in December 2025, the European Parliament and the Council of the EU reached an agreement on a proposed draft of the EU pharmaceutical reform package - the most extensive revision of EU pharma regulations in twenty years. It is designed - at least on paper - to make Europe a more competitive and innovative jurisdiction for pharma, while at the same time ensuring greater security of supply and fairer access to medicines.
Whilst only a provisional draft at this stage, the key elements agreed between the Council of the EU and the European Parliament are:
- restructured regulatory data and marketing protection incentives, setting a 8 + 1 year baseline period of data and marketing protection, with up to 2 additional years available through targeted, policy-driven incentives – totalling a maximum of 11 years;
- revised incentives for orphan medicines;
- a broader Bolar provision (although with some uncertainties);
- antibiotics and antimicrobial resistance: new incentives (a potential transferable +1) but new responsibilities also; and
- clearer obligations for marketing authorisation (MA) holders related to supply continuity and shortage prevention.
The Council must now formally adopt the text, after which it will return to the European Parliament for the final vote. Once approved, there will be a transitional period, to allow businesses time to adjust their development, regulatory and portfolio strategies. For Europe's pharmaceutical sector, this marks the beginning of a new phase. Read more about this development here.
Intellectual property
The patent litigation landscape for life sciences has continued to be dynamic in Europe throughout 2025, with a number of notable cases with important implications being decided.
A major theme was patentees seeking cross-border injunctions in both the UPC and national courts, following the CJEU's landmark decision in BSH Hausgeräte v Electrolux (handed down in February 2025). In a key decision in September 2025, the Munich Regional Court granted an interim injunction prohibiting Formycon from selling its biosimilar of Eylea® (aflibercept) in 22 countries and this has since been followed by similar results against a number of other manufacturers. Appeals are expected to be heard in 2026.
Perhaps the most significant news from the UPC came when two panels of the UPC CoA, deciding two distinct cases in the life sciences sector, presented a unified view on the test for inventive step in two judgments handed down on the same day. The test has marked differences to the EPO's "problem solution" approach. With the case load of the court growing and the advent of a third panel of the CoA in January 2026, this illustration of cooperation is well-timed.
Competition
At an EU level, the pharma sector remained a sector of focus for the European Commission in 2025 and will remain so in 2026. Following on from the Vifor and Teva/Copaxone cases in 2024, disparagement and patent enforcement strategies remain on the Commission's competition law enforcement radar. Whilst cartel enforcement by the Commission has been relatively rare in the pharma sector, in 2025 it fined Alchem for price-fixing and quota-allocation arrangements in the SNBB (hyoscine) active pharmaceutical ingredient cartel, following earlier settlement decisions against other cartel members.
In merger control, in 2025 the European Commission has been encouraging Member States to adopt "call-in" powers to review below threshold transactions, after the European Court of Justice overturned the Commission's use of Article 22 to review such cases. This had led to increased uncertainty for deal-making, and in 2025 NVIDIA appealed the Commission's revised approach to using Article 22 EUMR in such circumstances (with judgment expected in 2026). Related to merger control, the Commission is investigating Zoetis (veterinary products) for the potentially abusive termination of a pipeline product of its newly acquired subsidiary Nexvet. While the transaction was not reportable under national or EU merger control rules, the Commission confirmed its willingness to assess this potential exclusionary conduct under the abuse of dominance rules (Article 102 TFEU).
The Commission has also been busy working on revisions to its merger guidelines, with a draft expected to be published for consultation in 2026. It has also been working on its revisions to its technology transfer block exemption regulation and guidelines, consulting on a draft in 2025, with a final version expected before the end of April 2026. Both of these will be highly relevant to the pharma sector.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
