Union compulsory licensing for crisis management
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Current position & sources
Sources checked:
Regulation (EU) 2025/2645 has applied since 19 January 2026. It creates a last-resort Union compulsory licensing mechanism for declared EU crises or emergencies, subject to conditions, remuneration and procedural safeguards.
- Regulation (EU) 2025/2645 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (OJ publication; ELI)EUR-Lex / Publications Office of the European Union
- New rules on compulsory licensing for crisis management (News article, 5 January 2026)European Commission (DG GROW)
- Legislative Observatory (OEIL) procedure file 2023/0129(COD) – Compulsory licensing of patents in crisis situationsEuropean Parliament
Summary
Regulation (EU) 2025/2645 establishes an EU-level (Union-wide) compulsory licensing framework that the European Commission can use, as a measure of last resort, to ensure supply of crisis-relevant products during an EU-declared crisis or emergency mode. It sets conditions, procedure, safeguards and remuneration rules for licensing certain IP rights needed to manufacture/market crisis-relevant products, and amends Regulation (EC) No 816/2006 to enable an EU-wide compulsory licence for export in specific cross-border manufacturing situations.
Who is affected?
Right holders (patents/utility models/SPCs), potential licensees (manufacturers and suppliers), the European Commission (granting/enforcement via decisions/implementing acts), relevant advisory bodies under the triggering crisis mechanism, and customs authorities (for export controls where applicable).
Scope
Applies to Union compulsory licences for patents and published patent applications, utility models and published applications, and supplementary protection certificates, where a crisis or emergency mode has been activated under a Union crisis/emergency mechanism listed in the Regulation’s Annex, and where an EU-wide licence is necessary to secure supply of crisis-relevant products across the internal market (and related amendments to Regulation (EC) No 816/2006).
Key Points
- Creates a Union-wide compulsory licence granted by the Commission to exploit protected inventions for manufacturing/marketing crisis-relevant products during an EU-declared crisis or emergency mode.
- Covers patents (and published applications), utility models (and published applications) and supplementary protection certificates; it is without prejudice to EU rules on copyright/related rights and does not impose an obligation to disclose trade secrets.
- Operates as a measure of last resort: the Commission may grant a licence only if other means (including voluntary licensing) cannot ensure access within a reasonable timeframe, and right holders are given an opportunity to submit comments.
- Licences must be non-exclusive, limited to the Union, strictly limited in scope/duration to the crisis needs, granted only against adequate remuneration, and automatically expire when the crisis/emergency mode ends.
- Provides Commission enforcement tools against licensees for non-compliance, including fines (capped) and periodic penalty payments (linked to daily turnover), alongside procedural safeguards (e.g., right to be heard).
- Amends Regulation (EC) No 816/2006 by introducing a Commission-granted ‘Union compulsory licence’ for export where manufacture/sale for export spans multiple Member States; that Union export licence procedure does not apply to the UK in respect of Northern Ireland.
Key Deadlines
- — Commission to assess whether the Annex list of crisis/emergency mechanisms is up to date (first assessment)
Related Regulations
Frequently Asked Questions
Is this still only a proposal, or is it now law?
It is now EU law: the initiative became Regulation (EU) 2025/2645, signed on 2025-12-16, published on 2025-12-30, and in force from 2026-01-19.
When can the Commission grant a Union compulsory licence?
Only during a declared EU crisis or emergency mode under a Union crisis/emergency mechanism listed in the Regulation’s Annex, and only as a last resort when voluntary licensing or other means cannot ensure access to crisis-relevant products within a reasonable timeframe.
Which intellectual property rights can be covered?
Patents (and published patent applications), utility models (and published applications), and supplementary protection certificates can be covered by a Union compulsory licence.
What limits and safeguards apply to a Union compulsory licence?
The licence must be non-exclusive, limited to the Union, strictly limited in scope and duration to the crisis purpose, granted only against adequate remuneration, and it automatically expires when the crisis or emergency mode ends.
Are there penalties for non-compliance?
Yes. The Commission may impose fines on the licensee for specified non-compliance (up to EUR 300,000, or up to EUR 50,000 for SMEs) and may also impose periodic penalty payments (capped as a percentage of the licensee’s average daily turnover).
Does the Regulation affect compulsory licensing for export under Regulation (EC) No 816/2006?
Yes. It amends Regulation (EC) No 816/2006 by adding a Commission-granted Union compulsory licence for export where cross-border manufacturing/sale for export would otherwise require multiple national licences; that Union export-licence procedure does not apply to the UK in respect of Northern Ireland.
Key Terms
- Union compulsory licence
- A compulsory licence granted by the European Commission to exploit a protected invention to carry out relevant activities in the Union concerning crisis-relevant products or related manufacturing processes.
- Crisis or emergency mode
- A formally declared crisis/emergency mode under a Union crisis or emergency mechanism listed in the Regulation’s Annex.
- Crisis-relevant product
- A product indispensable for responding to, or addressing the impact of, a crisis or emergency in the Union.
- Relevant activities
- Manufacturing (making) or marketing (using, offering for sale, selling or importing) of crisis-relevant products.
- Right holder
- The holder(s) of the intellectual property rights covered (patents/patent applications, utility models/utility model applications, or SPCs).
- Competent advisory body
- The advisory body designated under the triggering Union crisis/emergency mechanism (or an ad hoc body set up by the Commission where none exists for that mechanism).