Changes from plenary report to adopted text

Added5. 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.

AddedArticle 20 Publication of decisions

Added1. 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.

Added2. 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.

AddedArticle 21 Review by the Court of Justice of the European Union

AddedIn 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]

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

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

AddedArticle 22 Reporting on national compulsory licences

AddedWhen 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]

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

Added(b) the name and address of the licensee;

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

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

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

Added(f) the duration of the licence.

AddedArticle 23 Amendments to Regulation (EC) No 816/2006

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

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

Added“(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]

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

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

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

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

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

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

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

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

Added(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]

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

Added“Article 7

AddedRights of the rights-holder

AddedThe 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]

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

Added“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]

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

Added“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]

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

Added“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]

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

Added“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]

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

Added“Article 18a

AddedUnion compulsory licence

Added1. 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]

Added2. 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:

Added(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;

Added(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;

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

Added(d) the importing country or countries;

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

Added(f) evidence of a specific request from

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

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

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

Added3. 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:

Added(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;

Added(b) 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(c) the duration of the licence shall be indicated;

Added(d) the licence shall be strictly limited to all acts necessary for the purpose of manufacturing the product in question for export and distribution in the country or countries cited in the application. No product made or imported under the compulsory licence shall be offered for sale or put on the market in any country other than that cited in the application, except where an importing country avails itself of the possibilities under subparagraph 6(i) of the Decision to export to fellow members of a regional trade agreement that share the health problem in question;