The EU is creating a mechanism to impose mandatory licenses in crisis situations
The European Union has adopted a new legal framework that allows the European Commission to grant compulsory licenses for inventions protected by patents in situations of cross-border crisis or emergency, marking a significant expansion of the EU's ability to intervene directly in the single market during critical moments.
In brief
The regulation was published in the Official Journal on December 30, 2025
The Commission can issue compulsory licenses valid at the EU level
The measure applies only in officially declared cross-border crises
Licensing is a "last resort" and involves compensation for patent holders
The regulation aligns with WTO rules on intellectual property
The regulation on compulsory licensing for crisis management, which amends the existing framework from 2006, introduces for the first time a centralized mechanism at the level of the European Union. Based on this, the Commission can authorize the use of a protected invention when a product or technology is deemed essential for managing a crisis affecting multiple member states.
Until now, compulsory licensing was mainly managed at the national level, through different and often slow procedures. The new regulation allows for a single decision applicable across the entire EU, reducing fragmentation and speeding up responses in emergency situations, such as health, industrial, or supply crises.
The Commission emphasizes that this tool is designed as a measure of last resort, to be activated only after the declaration or triggering of a crisis within the framework of relevant European instruments. Licenses will have limited duration and purpose, and intellectual property rights holders will receive fair and adequate remuneration, in accordance with the WTO's TRIPS Agreement.
Politically, the regulation reflects the lessons learned during the COVID-19 pandemic, when access to critical technologies, such as vaccines or medical equipment, was hindered by fragmented negotiations and the lack of a rapid European instrument. At the same time, the measure sends a clear signal to the industry that, in exceptional situations, public interest can prevail over commercial exclusivity, without departing from international rules.
Compulsory licensing is a tool provided for by international intellectual property rules, but rarely used in the EU. The new regulation is part of the broader architecture of the Union's Crisis Preparedness, aimed at ensuring the continuity of the internal market and rapid access to essential products in major emergency situations. The actual impact of the mechanism will depend on how it is applied and the type of crises in which it will be activated.
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