What changed between the draft committee report and the plenary report

Added:Article 10 – paragraph 2 – point b: (b) impose fines and periodic penalties on the licensee in accordance with Articles 15 and 16.

Added:Article 10 – paragraph 3: 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.

Added:Article 13 – paragraph 2: 2. In compliance with the good faith obligation, the rights-holder and the licensee shall make their best efforts to fulfil the objective of the Union compulsory licence, taking into account each other's interests as well as the public interest.

Added:\\ipolbrusnvf01\JURI\docep\AM\1296548EN.docxAmendment 66

Added:Article 13 a (new)

Added:Amendment: Article 13a / Additional measures complementing the Union compulsory licence / 1. Where necessary, the Commission shall decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. / 2. Where strictly necessary, the Commission shall request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee shall be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted. / 3. Where the rights-holder is requested to disclose his trade secrets in accordance with paragraph 3, the Commission shall, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties, including, as appropriate, the use of model contractual terms, confidentiality agreements, strict access protocols, technical standards or the applicat…

Added:Article 14 – paragraph 2: deleted

Added:Article 14 – paragraph 4: 4. When the Commission considers modifying, or terminating the Union compulsory licence, it shall consult the advisory body referred to in Article 6 as well as the rights-holders and licensees.

Added:Article 14 – paragraph 4 a (new): 4a. When considering terminating the Union compulsory licence, the Commission shall ensure that a sufficient transitional period is put in place.

Added:Article 14 – paragraph 6: 6. The implementing acts referred to in paragraph 1 and 3 shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).

Added:Article 15 – paragraph 1 – point c: (c) the rights-holder or the licensee fail to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and Article 13a(1) and (2), as specified in the relevant implementing act.

Added:Article 15 – paragraph 1 – point c a (new): (ca) the licensee does not comply with the prohibition referred in Article 11;

Added:Article 16 – paragraph 1 – point c: (c) the rights-holder or the licensee to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and Article 13a(1) and (2), as specified in the relevant implementing act.

Added:Article 16 – paragraph 1 – point c a (new): (ca) the licensee to put an end to an infringement of the prohibition referred in Article 11;

Added:Article 19 – paragraph 1: 1. Before adopting a decision pursuant to Article 15 or 16, the Commission shall give the licensee or the rights-holder the opportunity of being heard and fully involved in the procedure on the alleged infringement which is to be made subject to a fine or periodic penalty payments.

Added:Article 19 – paragraph 2 a (new): 2a. The Commission shall reply to the observations made by the licensee or the right 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.

Added:Article 19 – paragraph 4: 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.

Added:Article 21 – paragraph 1: 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:

Added:Article 21 – paragraph 1 – point 1 (new): (1) has granted a compulsory licence. It may cancel or amend its terms and conditions;

Added:Article 21 – paragraph 1 – point 2 (new): (2) has imposed fines or periodic penalty payments. It may cancel, reduce or increase the fine or periodic penalty payment imposed.

Added:Article 22 – paragraph 1 – introductory part: 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.The information provided shall include the following:

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a (new), Article 6 – paragraph 2: (-a) Article 6(2) is replaced by the following: / 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.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a a (new), Article 6 – paragraph 3 – point c: (-aa) Point (c) of Article 6(3) is replaced by the following: / (c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a b (new), Article 6 – paragraph 3 – point e: (-ab) Point (e) of Article 6(3) is replaced by the following: / (e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9;

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a c (new), Article 6 – paragraph 3 – point f: (-ac) Point (f) of Article 6(3) is replaced by the following: / indicating the expected quantity of product required.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a d (new), Article 7: (-ad) Article 7 is replaced by the following: / 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.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a e (new), Article 9 – paragraph 1: (-ae) Article 9(1) is replaced by the following: / 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.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a f (new), Article 10 – paragraph 1: (-af) Article 10(1) is replaced by the following: / 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.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a g (new), Article 10 – paragraph 2: (-ag) Article 10(2) is replaced by the following: / 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.

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point -a h (new), Article 10 – paragraph 8: (-ah) Article 10(8) is replaced by the following: / 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).

Added:Regulation (EC) No 816/2006

Added:Regulation (EC) No 816/2006

Added:Article 23 – paragraph 1 – point a, Article 18a – paragraph 2: 2. Any person may submit an application for a compulsory licence under paragraph 1. The application shall contain the following information: / (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; / (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; / (c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence; / (d) the importing country or countries; / (e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9; / (f) evidence of a specific request from: / (i) authorised representatives of the importing country or countries; or / (ii) a non-governmental organisation acting with the formal authorisation of one or more importing countries; or / (iii) UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries.

Added:Regulation (EC) No 816/2006

Added:Regulation No 816/2006/EC

Added:Article 23 – paragraph 1 – point a, Article 18a – paragraph 5 – subparagraph 2: Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 18b (2). On duly justified imperative grounds of urgency relating to public health problems, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b (3).

Added:Article 25 – paragraph 1 a (new): By ... [two years after the date of entry into force of this Regulation] and every two years thereafter, the Commission shall assess whether the list in the Annex is up-to-date in light of the adoption of future legislative acts in relation to an emergency or crisis mode. If the list of the Annex is no longer up-to-date, the Commission shall assess its consequences. The Commission shall submit its assessment to the European Parliament and the Council, accompanied, where appropriate, by legislative proposals to amend the Annex.

Added:Article 25 – paragraph 1 b (new): In case of exceptional threats to public safety or to national security, the Commission shall carry out the assessment pursuant to paragraph 1a without undue delay.

Added:Article 26 – title: Entry into force and application

Added:Article 26 – paragraph 1 a (new): It shall apply from [the first day of the month following the period of twelve months after the date of entry into force].