Article 7 — Procedure for granting a Union compulsory licence

1. Where the Commission, in the context of a declared crisis or emergency mode and on the basis of preliminary information gathered under the relevant Union crisis or emergency mechanism, considers that the use of a protected invention which concerns crisis-relevant products is required to ensure the adequate supply of those products in the Union, it may initiate the procedure for granting a Union compulsory licence by publishing a notice on its website. The preliminary information referred to in the first subparagraph shall include information on the following: (a) the lack of adequate supply of crisis-relevant products; (b) the available manufacturing capacities; (c) the intellectual property rights and the right holder concerned. The Commission shall publish the notice referred to in the first subparagraph in the Official Journal of the European Union without undue delay. 2. The notice referred to in paragraph 1 shall include: (a) information about the crisis-relevant products in respect of which the Commission considers that there is lack of adequate supply; (b) information about the intellectual property rights and right holder concerned gathered at the time of the publication of the notice; (c) an invitation to the right holder, to potential licensees and to other persons with an interest to submit comments to the Commission and the competent advisory body on the envisaged Union compulsory licence, in particular on the following: (i) whether voluntary licensing agreements can be concluded with potential licensees, within a reasonable timeframe, on intellectual property rights for the purpose of carrying out relevant activities concerning the crisis-relevant products; (ii) the need to grant a Union compulsory licence; (iii) the envisaged content of the Union compulsory licence, including on the amount of the remuneration; (d) information about the competent advisory body. 3. Upon the publication of the notice on its website, the Commission shall request the competent advisory body to disseminate the notice further through appropriate channels and to provide an opinion containing an assessment of the need for a Union compulsory licence and of the envisaged content of such licence. The Commission shall set a time limit for the submission of that opinion. That time limit shall be reasonable and appropriate to the circumstances of the case, taking particular account of the urgency of the situation. Where justified, the Commission may set a new time limit for the submission of the opinion referred to in the first subparagraph. 4. The competent advisory body shall provide the opinion referred to in paragraph 3 of this Article in accordance with its rules of procedure. The opinion shall contain an assessment of the need for a Union compulsory licence and of the envisaged content of such licence. The information on the outcome of the tasks performed in accordance with Article 6 shall be annexed to the opinion. 5. The opinion of the competent advisory body shall not be binding on the Commission. 6. After receiving the opinion of the competent advisory body, the Commission shall assess whether continuing the procedure for granting a Union compulsory licence is justified. If continuing the procedure is justified, the Commission shall inform the right holder and potential licensees concerned individually, as soon as reasonably practicable, of the fact that it is considering granting a Union compulsory licence. The Commission shall provide them with: (a) the envisaged content of the Union compulsory licence; (b) a summary of the opinion of the competent advisory body; (c) an invitation to submit their comments and a time limit for doing so, including comments on whether a voluntary licensing agreement has been concluded. 7. Where, after considering the opinion of the competent advisory body and any comments received in accordance with paragraph 6, point (c), of this Article, as well as taking into account the public interest and the rights and interests of the right holder and the potential licensees, the Commission concludes that the conditions referred to in Article 4 are met, it shall grant the Union compulsory licence by means of an implementing act. Where the Commission’s decision to grant the Union compulsory licence departs from the opinion of the competent advisory body, that implementing act shall indicate the Commission’s reasons for departing from that opinion. 8. The implementing act referred to in paragraph 7 of this Article shall be adopted in accordance with the examination procedure referred to in Article 23(2). On duly justified imperative grounds of urgency relating to the impact of the crisis or emergency, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 23(3). 9. Where, based on the opinion of the competent advisory body and taking into account the rights and interests of the right holder and the potential licensees, the Commission comes to the conclusion that the conditions referred to in Article 4 are not met, the Commission shall publish in the Official Journal of the European Union a notice informing the public that the procedure initiated under paragraph 1 of this Article has ended. 10. Throughout the procedure for granting a Union compulsory licence, the Commission and the competent advisory body shall ensure that confidential information is protected. While respecting the confidentiality of the information, the Commission and the competent advisory body shall ensure that any information relied on for the purposes of the Commission’s implementing act referred to in paragraph 7 is disclosed to an extent that allows an understanding of the facts and considerations that led to the adoption of that implementing act. 11. Without prejudice to paragraph 7, voluntary licensing agreements may be concluded at any time during or after the procedure for granting a Union compulsory licence set out in this Article.