Regulation (EU) 2025/2645, which entered into force on 19 January 2026, has created a system of “Union compulsory licences.” It amends Regulation (EC) 816/2006.
The regulation establishes that in a crisis situation, when the availability of an essential product is threatened, the European Commission may authorise a third party, other than the rights holder, to exploit a protected invention. This authorisation, known as a compulsory licence, allows the beneficiary to manufacture or market the product concerned.
A regulation that complements national regimes
This Union mechanism is added to existing systems: national compulsory licences remain fully applicable.
A cross-border crisis may weaken supply chains for an essential product protected by intellectual property rights, such as a vaccine. Drawing on lessons learned from the COVID‑19 pandemic, the regulation aims to enable rapid supply.
The products concerned may be those protected by patents, but also by utility models and corresponding published applications, as well as supplementary protection certificates. Defence-related products are excluded from the scope of this regulation.
A last‑resort, strictly regulated solution
The mechanism remains exceptional. It allows the use of a product without the rights holder’s consent only in strictly regulated cases, after giving priority to voluntary agreements. The compulsory licence is intended to be used only as a last resort, when contractual solutions cannot ensure access to the necessary products.
This logic is accompanied by safeguards:
- the scope and duration of the licence are limited,
- remuneration for the rights holder is provided,
- there is no obligation to disclose trade secrets,
- the licensee is exposed to fines if certain obligations are not respected (export outside the EU prohibited, maximum production quantity, product labelling…).
By François‑Adrien CHAGNOLLAUD, 17 February 2026
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