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

Removed:2a. The Commission shall reply to the observations made by the licensee or the rights-holder and in case of a rejection of the observations, it shall provide a justification within a reasonable period of time which shall not exceed 7 days. [Am. 76]

Removed:3. The Commission shall base its decisions only on objections on which the parties concerned have been able to comment.

Removed:4. The rights of defence of the parties concerned shall be fully respected in the proceedings. They shall be entitled to have access to the Commission's file under the terms of a negotiated disclosure, subject to the legitimate interest of the licensee or the rights-holder or other person concerned in the protection of their commercially sensitive information and trade secrets fully in line with existing legislation on the protection of data and trade secrets. The Commission shall have the power to adopt decisions setting out such terms of disclosure, in case of disagreement between the parties. The right of access to the file of the Commission shall not extend to confidential information and internal documents of the Commission, other competent authorities or other public authorities of the Member States. In particular, the right of access shall not extend to correspondence between the Commission and those authorities. Nothing in this paragraph shall prevent the Commission from disclosing and using information necessary to prove an infringement. [Am. 77]

Removed:5. If the Commission considers it necessary, it may also hear other natural or legal persons. Applications to be heard on the part of such persons shall, where they show a sufficient interest, be granted.

Removed:Article 20 Publication of decisions

Removed:1. The Commission shall publish the decisions it adopts pursuant to Article 15 and Articles 16. Such publication shall state the names of the parties and the main content of the decision, including any fines or penalties imposed.

Removed:2. The publication shall have regard to the rights and legitimate interests of the licensee, the rights-holder or any third parties in the protection of their confidential information.

Removed:Article 21 Review by the Court of Justice of the European Union

Removed:In accordance with Article 261 and 263 TFEU, the Court of Justice of the European Union has unlimited jurisdiction to review decisions by which the Commission has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed.: [Am. 78]

Removed:(1) has granted a compulsory licence. It may cancel or amend its terms and conditions; [Am. 79]

Removed:(2) has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed. [Am. 80]

Removed:Article 22 Reporting on national compulsory licences

Removed:When a national compulsory licence has been granted for the public interest or for the purpose of addressing a national crisis or emergency, the Member State shall notify the Commission of the granting of the licence and of the specific conditions attached to it. Theit.The information provided shall include the following: [Am. 81]

Removed:(a) the purpose of the national compulsory licence and its legal basis in national law;

Removed:(b) the name and address of the licensee;

Removed:(c) the products concerned and, to the extent possible, the concerned intellectual property rights and rights-holders;

Removed:(d) the remuneration to be paid to the rights-holder;

Removed:(e) the quantity of products to be supplied under the licence;

Removed:(f) the duration of the licence.

Removed:Article 23 Amendments to Regulation (EC) No 816/2006

Removed:Regulation (EC) No 816/2006 is amended as follows:

Removed:(-a) Article 6(2) is replaced by the following:

Removed:“(2) If the person applying for a compulsory licence is submitting multiple applications to authorities for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.” [Am. 82]

Removed:(-aa) Point (c) of Article 6(3) is replaced by the following:

Removed:“(c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;” [Am. 83]

Removed:(-ab) Point (e) of Article 6(3) is replaced by the following:

Removed:“(e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9;” [Am. 84]

Removed:(-ac) Point (f) of Article 6(3) is replaced by the following:

Removed:“(f) evidence of a specific request from:

Removed:(i) authorised representatives of the importing country or countries; or

Removed:(ii) a non-governmental organisation acting with the formal authorisation of one or more importing countries; or

Removed:(iii) UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries, indicating the expected quantity of product required.” [Am. 85]

Removed:(-ad) Article 7 is replaced by the following:

Removed:“Article 7

Removed:Rights of the rights-holder

Removed:The competent authority shall notify the rights-holder without delay of the application for a compulsory licence. Before the grant of the compulsory licence, the competent authority may give the rights-holder an opportunity to comment on the application and to provide the competent authority with any relevant information regarding the application.” [Am. 86]

Removed:(-ae) Article 9(1) is replaced by the following:

Removed:“1. The applicant shall provide evidence to the competent authority that he has made efforts to obtain authorisation from the rights-holder and that such efforts have not been successful within a period of thirty days before submitting the application.” [Am. 87]

Removed:(-af) Article 10(1) is replaced by the following:

Removed:“1. The licence granted shall be non-assignable, except with that part of the enterprise or organisation that makes use of the licence, and non-exclusive. It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee.” [Am. 88]

Removed:(-ag) Article 10(2) is replaced by the following:

Removed:“2. The expected amount of product(s) manufactured under the licence shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application, taking into account the amount of product(s) manufactured under other compulsory licences granted elsewhere.” [Am. 89]

Removed:(-ah) Article 10(8) is replaced by the following:

Removed:“8. The competent authority may, on its own initiative, if national law allows the competent authority to act on its own initiative, request from the licensee proof of exportation of the product, through a declaration of exportation, certified by the customs authority concerned, and proof of importation from one of the bodies referred to in Article 6(3)(f).” [Am. 90]

Removed:(a) The following Article 18a is inserted:

Removed:“Article 18a

Removed:Union compulsory licence

Removed:1. The Commission may also grant a compulsory licence where the activities ofof patents relating to the manufacture and saleof pharmaceutical products for export spread across different Member States and would therefore require compulsory licences for the same product in more than one Member Stateto countries with public health problems. [Am. 91]

Removed:2. Any person may submit an application for a compulsory licence under paragraph 1. The application shall fulfil the requirements laid down in Article 6 (3) and shall specify the Member States to be covered by the compulsory licence.contain the following information:

Removed:(a) the name and contact details of the applicant and of any agent or representative whom the applicant has appointed to act for him before the competent authority;

Removed:(b) the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;

Removed:(c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;

Removed:(d) the importing country or countries;

Removed:(e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9;

Removed:(f) evidence of a specific request from

Removed:(i) authorised representatives of the importing country or countries; or

Removed:(ii) a non-governmental organisation acting with the formal authorisation of one or more importing countries; or

Removed:(iii) UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries. [Am. 92]

Removed:3. The compulsory licence granted in accordance with paragraph 1 shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole territory of the Union. and shall be subject to the following conditions:

Removed:(a) the licence granted shall be non-assignable, except with that part of the enterprise or organisation that makes use of the licence, and non-exclusive. It shall contain the specific conditions as set out in this paragraph;