The EU reforms the pharmaceutical market and proposes a new corporate regime to stimulate innovation.

The European institutions have reached a provisional agreement on pharmaceutical legislation and have advanced plans for the creation of the Unified European Company.

Brussels, December 11, 2025 The European Union has marked a double step forward in its strategy to enhance competitiveness and innovation. Negotiators from the Parliament and the Council have concluded an agreement on the complete revision of pharmaceutical policy, while the Legal Affairs Committee has approved recommendations for a new legal framework dedicated to innovative companies, aimed at reducing bureaucracy and retaining talent in Europe.

In short

A data protection period of eight years for medicines is introduced, with possibilities for extension.

The fight against antimicrobial resistance will be supported through transferable exclusivity vouchers.

MEPs propose the "Unified European Company" with digital registration within 48 hours.

The agreement on pharmaceutical legislation establishes a new balance between stimulating innovation and access to generic medicines. Companies will benefit from eight years of regulatory data protection, followed by one year of market protection. This period can be extended for products that meet unmet medical needs or provide significant clinical benefits. Additionally, to combat supply crises, authorization holders will be required to maintain shortage prevention plans, and the procedures of the European Medicines Agency will be simplified.

A new element in the fight against antibiotic resistance is the introduction of a transferable data exclusivity voucher, which offers an additional 12 months of protection for developers of priority antimicrobials.

In parallel, to support the business environment, MEPs have proposed the creation of the so-called "28th corporate regime." This provides for the establishment of the Unified European Company (S.EU), a legal form with harmonized rules, which would allow start-ups to register digitally quickly, with a minimum capital of one euro, and to move their headquarters between member states without complex dissolution procedures. Rapporteurs emphasized that this regime is essential for completing the internal market, ensuring a conducive space for increasing investments and developing European ideas.

https://2eu.brussels/ro/stiri/ue-reformeaza-piata-farmaceutica-si-propune-un-nou-regim-corporativ-pentru-stimularea-inovarii