The European Commission welcomes the political agreement on new rules for compulsory licensing, an essential intellectual property tool in the EUs crisis response arsenal.
The new regulation provides an EU-wide framework to swiftly issue a compulsory license in clearly defined cross-border crises or emergencies. The Commission can grant an EU-wide license for the use of protected inventions concerning crisis products if a crisis is declared under relevant EU crisis instruments.
Currently, compulsory licensing is regulated at the national level, resulting in 27 different regimes. This fragmentation causes uncertainty and delays in EU-wide crises that require rapid and coordinated action. By creating an EU mechanism for issuing compulsory licenses in crisis situations, the new regulation fills this gap. The proposal also allows for a Union license for export purposes, in addition to existing national capabilities.
The compulsory licensing mechanism is strictly a last resort, subject to strict conditions to ensure its use remains targeted, proportional, and temporary. It includes robust safeguards, such as clear limitations on the scope and duration of licenses, and the requirement to provide fair and adequate remuneration to rights holders, in compliance with the TRIPS agreement. While national regimes remain intact, this regulation offers a coordinated solution for cross-border actions and strengthens the integrity of the internal market by ensuring the free movement of crisis products.
Next Steps
The provisional agreement must be formally approved by the European Parliament and the Council. Once adopted, the regulation will be published in the Official Journal of the EU and will enter into force on the day of publication.
Background
Compulsory licensing is a legal mechanism allowing authorities to exceptionally permit the use of a patented invention without the patent holders consent under defined conditions. In crises, such as pandemics, it can be a last resort to provide access to patented products when voluntary agreements are unavailable or do not meet urgency requirements.
The Union compulsory licensing regulation is a key component of the EUs broader crisis preparedness and response framework and is included in the Preparedness Union Strategy action plan. It complements existing EU instruments, including Regulation (EU) 2022/2371, Regulation (EU) 2022/2372, and the Regulation (EU) 2024/2747. It also supports the Unitary Patent system, operational since 1 June 2023, to create a more integrated EU patent landscape.
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