What changed between the adopted text of 13 Mar 2024 and the adopted text of 16 Dec 2025

Removed:This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory licence may be granted to protect the public interest in the context of cross-border crisis or emergency situations inin crises the Union has access to crisis-relevant products. To this end, This Regulation lays down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism. To this end, if no prior voluntary agreement has been reached within four weeks between right holder and licensee, the Commission may grant a Union compulsory licence. [Am. 26]

Removed:Article 2 Scope

Removed:1. This Regulation establishes Union compulsory licensing of the following intellectual property rights in force in one or more Member States:

Removed:(a) patents, including published patent applications;

Removed:(b) utility models; or

Removed:(c) supplementary protection certificates;

Removed:2. This Regulation is without prejudice to the rules laid down by other Union legal acts regulating copyright and related rights, including Directive 2001/29, Directive 2009/24 and the sui generis rights granted by Directive 96/9/EC on the legal protection of databases.

Removed:Article 3 Definitions

Removed:For the purposes of this Regulation, the following definitions shall apply:

Removed:(-a) ‘crisis mode or emergency mode’ means a crisis mode or an emergency mode, as applicable, listed in the Annex to this Regulation, which has been activated or declared in the context of a Union crisis or emergency mechanism listed in that Annex in accordance with one of the Union acts listed therein; [Am. 27]

Removed:(a) ‘crisis-relevant products’ means products or processes that are indispensable for responding to a crisis or emergency or for addressing the impacts of a crisis or emergency in the Union and for which the granting of a compulsory licence is the only means of ensuring the sufficient and timely availability and supply of such products or processes, as determined by the Commission through the guidance of the advisory body in accordance with Article 6; [Am. 28]

Removed:(b) ‘relevant activities’ means the acts of making, using, offering for sale, selling or importing.

Removed:(c) ‘rights-holder’ means a holder of any of the intellectual property rights referred to in Article 2(1);

Removed:(d) ‘protected invention’ means any invention protected by any of the intellectual property rights referred to in Article 2(1);

Removed:(e) ‘Union compulsory licence’ means a compulsory licence granted by the Commission to exploit a protected invention of crisis-relevant products for any of the relevant activities in the Union;

Removed:(f) ‘customs authorities’ means customs authorities as defined in Article 5, point (1), of Regulation (EU) No 952/2013 of the European Parliament and of the Council;

Removed:Article 4 Union compulsory licence

Removed:The Commission may grant a Union compulsory licence wherein the event of a crisis mode or an emergency mode listed in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products the Annex to this Regulation has been activated or declared in accordance with one of the Union acts listed in that Annexreached between right-holder and the potential licensee within four weeks. [Am. 29]

Removed:Article 5 General conditions of a Union compulsory licence

Removed:1. The Union compulsory licence that may be granted by the Commission in accordance with Article 4 shall, notwithstanding the obligations pursuant to Article 10: [Am. 30]

Removed:(a) be non-exclusive and non-assignable, except with that part of the enterprise or goodwill which enjoys such compulsory licence;

Removed:(b) have a strict limitation concerning scope, field of use, necessary quantities, and a and duration that is limited to thefully in line with the specific purpose for which the compulsory licence is granted and limitedissued, as well as strictly linked to the scope and duration of the crisis or emergency mode in the framework ofunder which it is granted within the Union; [Am. 31]

Removed:(c) be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union; [Am. 32]

Removed:(d) only be granted against payment of an adequate remuneration to the rights-holder determined in accordance with Article 9; [Am. 33]

Removed:(e) be strictly limited to the precisely defined territory of the Union; [Am. 34]

Removed:(f) only be granted to a person deemed to be in a position to exploit the protected invention in a manner that permits the proper carry out of the relevant activities of the crisis-relevant products and in accordance with the obligations referred to in Article 10.

Removed:(fa) clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims. [Am. 35]

Removed:2. A Union compulsory licence for an invention protected by a published patent application shall cover a patent granted based on that application, provided that the granting of that patent takes place while the Union compulsory licence is valid.

Removed:3. A Union compulsory licence for an invention protected by a patent shall cover a supplementary protection certificate issued with reference to that patent, provided that the transition from patent protection to protection conferred by a supplementary protection certificate takes place while the Union compulsory licence is valid.

Removed:Article 6 Advisory body

Removed:1. When the Commission considers the granting of a Union compulsory licence, it shall without undue delay consult an advisory body.

Removed:2. The advisory body referred to in paragraph 1 shall be the advisory body competent for the Union crisis or emergency mechanism as listed in Annex I to this Regulation (the ‘competent advisory body’). For the purposes of the present Regulation, the competent advisory body, which is to act in the public interest, shall assist and advise the Commission as regards the following tasks: [Am. 36]

Removed:(a) the gathering of crisis-relevant information, market intelligence and the analysis of those data;

Removed:(aa) the assessment of whether the obligation to give the rights-holder an opportunity to engage in negotiations for a voluntary agreement to be reached within four weeks, laid down in Article 4, has been complied with; [Am. 37]

Removed:(b) the analysis of the crisis-relevant information gathered by Member States or the Commission and aggregated data received by other crisis-relevant bodies at Union and international level;

Removed:(ba) the determination of crisis-relevant products; [Am. 38]

Removed:(c) the facilitation of exchanges and sharing of information with other relevant bodies and other crisis-relevant bodies at Union and national level, as well as at international level, where appropriate;

Removed:(d) the identification of the rights protecting the crisis-relevant product;

Removed:(e) the establishment of whether there is a need to grant a Union compulsory licence;

Removed:(f) the identification and consultation of the representatives of right holders or their representatives as well as potential licensees and consulting other stakeholders and economic operators, and theincluding industry, academia and civil society; [Am. 39]

Removed:(g) the establishment, if relevant, of whether the criteria for termination or modification of the Union compulsory licence set out in Article 15 have been fulfilled.

Removed:3. The advisory body shall cooperate and coordinate closely, where appropriate, with other relevant crisis-related bodies and with intellectual property offices at Union and national level.

Removed:4. For the purpose of the present Regulation, the Commission:

Removed:(a) shall ensure participation and invite representatives of other crisis-relevant bodies at Union level as observers to the relevant meetings of the advisory body in order to ensure coherence with the measures implemented through other Union mechanisms; and

Removed:(aa) shall invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible under the applicable legal acts referred to in Annex; [Am. 40]

Removed:(b) may invite representatives of the European Parliamentnational authorities responsible for issuing compulsory licences under national laws, representatives of economic operators, right holders, potential licensees, stakeholder organisations, social partners and experts to attend meetings of the advisory body as observers. [Am. 41]

Removed:5. In the absence of any existing competent advisory body, the tasks referred to in paragraph 2 shall be performed by an ad hoc advisory body set up by the Commission (the ‘ad hoc advisory body’). The Commission shall chair the ad hoc advisory body and ensure its secretariat. Each Member State shall have the right to be represented in The ad hoc advisory body shall be composed of representatives of the institutions and bodies of each Member State that exercise the competence to grant national compulsory licences under national law. [Am. 42]

Removed:6. The Commission shall adopt an implementing act laying down the rules of procedure for the ad hoc advisory body referred to in paragraph 5. The rules of procedure shall specify that the ad hoc advisory body shall not be set up for a period exceeding the duration of the crisis or emergency. The rules of procedure shall specify that the ad hoc advisory body shall enforce stringent safeguards to avoid any potential conflicts of interest, and to ensure accountability and transparency. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24 (3). [Am. 43]

Removed:Article 7 Procedure for granting a Union compulsory licence

Removed:1. The competent or, where relevant ad hoc, advisory body referred to in Article 6 shall provide the Commission with an opinion without undue delay. That opinion shall be issued in accordance with the rules of procedure of the advisory body and shall contain an assessment of the need for a Union compulsory licence and the conditions for such licence. The opinion shall take account of the following:

Removed:(a) the nature of the crisis or emergency;

Removed:(b) the scope of the crisis or emergency and how it is expected to evolve;

Removed:(ba) the rights and interests of the rights-holder and the potential licensee; [Am. 44]

Removed:(bb) existing national compulsory licences reported to the Commission in accordance with Article 22 in order to avoid overlaps or a situation of overproduction; [Am. 45]

Removed:(c) the shortage of crisis-relevant products and the existence of other means than a Union compulsory licence that could adequately and swiftly remedy such shortage.

Removed:2. The opinion of the advisory body shall not be binding on the Commission. The Commission may set a time limit for the advisory body to submit its opinion. The time limit shall be reasonable and appropriate to the circumstances of the situation, taking particular account of the urgency of the matter.

Removed:2a. The Commission shall take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body, without prejudice to the Commission's powers under paragraphs 7 and 8 of this Article. [Am. 46]

Removed:3. Before issuing the opinion, the advisory bodythe granting of a Union compulsory licence, the Commission shall give the rights-holder and the licensee an opportunity to comment within a reasonable timeframe on the following: [Am. 47]

Removed:(a) the possibility to promptly reach a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products and the fulfilment of the conditions referred to in Article 4(1a) for conducting meaningful negotiations for that purpose; [Am. 48]

Removed:(b) the need to grant the Union compulsory licence;