What changed between the plenary report and the adopted text

Added:6. When assessing whether a Union compulsory licence is to be granted, the Commission shall consider the following:

Added:(a) the opinion referred to in paragraph 2;

Added:(b) the rights and interests of the rights-holder and the licensee;

Added:(c) existing national compulsory licences reported to the Commission in accordance with Article 22. [Am. 50]

Added:7. Where the Commission finds that the requirements for a Union compulsory licence are met, the Commission shall grant it by means of an implementing act. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2). On duly justified imperative grounds of urgency relating to the impacts of the crisis, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 24(4). In case of procedure under Article 24(4), the implementing act shall remain in force for a period not exceeding 12 months.

Added:8. When adopting the implementing act, the Commission shall ensure the protection of confidential information. While respecting the confidentiality of the information, the Commission shall ensure that any information relied on for the purpose of its decision is disclosed to an extent that allows to understand the facts and considerations that led up to the adoption of the implementing act.

Added:Article 8 Content of the Union compulsory licence

Added:1. The Union compulsory licence shall specify the following:

Added:(a) the patent, patent application, supplementary protection certificate or utility model for which the licence is granted or, where the identification of those rights would significantly delay the granting of the licence, the non-proprietary name of the products which are to be manufactured under the licence; [Am. 51]

Added:(b) the right-holder, provided they can be identified with reasonable efforts having regard to the circumstances, including the urgency of the situation; [Am. 52]

Added:(c) the licensee, in particular the following information:

Added:(1) name, trade name and registered trade mark;

Added:(2) contact details;

Added:(3) unique identification number in the country where the licensee is established;

Added:(4) where available, the Economic Operators Registration and Identification (EORI) number;

Added:(d) the duration for which the Union compulsory licence is granted;

Added:(e) the remuneration to be paid to the rights-holder determined in accordance with Article 9;

Added:(f) the non-proprietary name of the crisis-relevant product which is to be manufactured under the Union compulsory licence and its commodity code (CN code) under which the crisis-relevant product is classified, as defined in Council Regulation (EEC) No 2658/87;

Added:(g) the details referred to in Article 10(1)(c), (d) and (e) allowing the identification of the crisis-relevant product manufactured under the Union compulsory licence and, where applicable, any other specific requirement under Union legislation applicable to the crisis-relevant products and allowing its identification.

Added:(h) measures complementing the compulsory licence, which areas referred to in Article 13a, including, where strictly necessary to achieve the objective of the compulsory licence, the obligation for the rights-holder to disclose trade secrets to the licensee when the conditions provided for in Article 13a (2) and (3) are fulfilled. [Am. 53]

Added:2. By way of derogation from paragraph 1, point (e), the Commission may determine the remuneration after the granting of the licence, by way of an implementing act, where that determination requires, further investigation and consultation. This implementing act shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).

Added:Article 9 Remuneration

Added:1. The licensee shall pay an adequate remuneration to the rights-holder. The amount of the remuneration shall be determined by the Commission and specified in the Union compulsory licence.

Added:1a. The rights-holder shall receive the remuneration within a pre-established timeframe as agreed with the Commission. [Am. 54]

Added:2. The remuneration shall not exceed 4 % ofbe determined based on the total gross revenue generated by the licensee through the relevantfrom the pertinent activities undergoverned by the Union compulsory licence. [Am. 55]

Added:3. When determining the remuneration, the Commission shall consider the following:

Added:(a) the economic value of the relevant activities authorised under the Union compulsory licence.

Added:(b) whether the rights-holder has received public support to develop the invention.

Added:(c) the degree to which development costs have been amortized by the rights-holder.

Added:(d) where relevant, the humanitarian circumstances relating to the granting of the Union compulsory licence.

Added:(da) the possible disclosure of trade secrets pursuant to Article 13a(2) and (3) and the relevant limitations to the protection of trade secrets according to Directive (EU) 2016/943; that disclosure shall give rise to adequate compensation for the rights-holder. [Am. 56]

Added:4. If the published patent application for which a compulsory licence has been granted does not subsequently lead to the granting of a patent, the rights-holder shall refund the remuneration paid under this article to the licensee.

Added:Article 10 Obligations to be fulfilled by the licensee

Added:1. The licensee shall be authorised to exploit the protected invention covered by the Union compulsory license only under the following obligations:

Added:(a) the number of crisis-relevant products manufactured under the Union compulsory licence does not exceed the defined quantities and what is necessary to meet the needs of the Union; [Am. 57]

Added:(b) the relevant activities are carried out solely for the supply of the crisis-relevant products in the Union market;

Added:(c) the products manufactured under the Union compulsory licence are clearly identified, through specific labelling or marking, as being manufactured and marketed pursuant to this Regulation.

Added:(ca) a detailed account of the products produced under the Union compulsory license; [Am. 58]

Added:(cb) treat the information acquired in relation to the Union compulsory licence with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard; [Am. 59]

Added:(cc) implement all necessary measures to preserve the confidentiality of the rights-holder’s trade secrets, as ordered by the Commission pursuant to Article 13a(3); [Am. 60]

Added:(cd) do not use trade secrets disclosed pursuant to Article 13a(2) beyond the duration of the Union compulsory licence or for any other purpose than those considered as lawful uses under Article 13a(2); [Am. 61]

Added:(d) the products manufactured under the Union compulsory licence can be distinguished from products manufactured and marketed by the rights-holder or under a voluntary licence granted by the rights-holder by way of special packaging, colouring or shaping, provided that such distinction is feasible and does not have a significant impact on the price of the products;

Added:(e) the packaging of the products manufactured under the Union compulsory licence and any associated marking or leaflet indicate that the products are subject to a Union compulsory licence under this Regulation and specify clearly that the products are exclusively for distribution in the Union and are not to be exported.

Added:(f) before the marketing of the products manufactured under the Union compulsory licence, the licensee shall make available on a website the following information:

Added:(1) the quantities of the products manufactured under the Union compulsory licence per Member State of manufacturing;

Added:(2) the quantities of the products supplied under the Union compulsory licence per Member State of supply;

Added:(3) the distinguishing features of the products under the Union compulsory licence.

Added:The address of the website shall be communicated to the Commission. The Commission shall communicate the address of the website to the Member States.

Added:2. In the event of a failure by the licensee to fulfil the obligations laid down in paragraph 1 of this Article the Commission may:

Added:(a) immediately terminate the Union compulsory licence in accordance with Article 14(3); or [Am. 62]

Added:(b) impose fines orand periodic penalties on the licensee in accordance with Articles 15 and 16. [Am. 63]

Added:3. The European Anti-Fraud Office (OLAF) in cooperation with the relevant national authorities of the Member States may, at the request of the rights-holder or on its own initiative, and on the basis of sufficient elements of proof of misuse, request access to books and records kept by the licensee, for the purpose of checking whether the content and the conditions of the Union compulsory licence, and in general the provisions of this Regulation, have been complied with. [Am. 64]

Added:4. The Commission is empowered to adopt implementing acts establishing rules for the specific labelling or marking referred to in paragraph 1, point (c), and for the packaging, colouring and shaping referred to in point (d) as well as rules for their use and, where relevant, their positioning on the product. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24(2).

Added:Article 11 Prohibition of export

Added:The export of products manufactured under a Union compulsory licence is prohibited.

Added:Article 12 Customs control

Added:1. The application of this article is without prejudice to other Union legal acts governing the export of products, in particular Articles 46, 47 and 267 of Regulation (EU) No 952/2013.

Added:2. Customs authorities shall rely on the Union compulsory license and modifications thereof to identify products that may fall under the prohibition laid down in Article 11. For that purpose, risk information as regards each Union compulsory licence and any modification thereof shall be entered in the relevant customs risk management system. Customs authorities shall take such risk information into consideration when they carry out controls on products placed under the customs procedure ‘export’ in accordance with Articles 46 and 47 of Regulation (EU) No 952/2013.

Added:3. Where customs authorities identify a product that may fall under the prohibition laid down in Article 11, they shall suspend its export. Customs authorities shall immediately notify the Commission of the suspension and provide it with all relevant information to enable it to establish whether the product was manufactured under a Union compulsory license. To assess whether the suspended products correspond to the Union compulsory license, the Commission may consult the relevant rights-holder.

Added:4. Where the export of a product has been suspended in accordance with paragraph 3, the product shall be released for export provided that all the other requirements and formalities under Union or national law relating to such export have been fulfilled, and either of the following conditions is fulfilled: