Changes from adopted text to adopted text

Removed(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;

Removed(c) the duration of the licence shall be indicated;

Removed(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;

Removed(e) products made under the licence shall be clearly identified, through specific labelling or marking, as being produced pursuant to this Regulation. The products shall be distinguished from those made by the rights-holder through special packaging or special colouring or shaping, provided that such distinction is feasible and does not have a significant impact on the price. The packaging and any associated literature shall bear an indication that the product is subject to a compulsory licence under this Regulation, giving the name of the competent authority and any identifying reference number, and specifying clearly that the product is exclusively for export to and distribution in the importing country or countries concerned. Details of the product characteristics shall be made available to the customs authorities of the Member States;

Removed(f) before shipment to the importing country or countries cited in the application, the licensee shall post on a website the following information;

Removed(i) the quantities being supplied under the licence and the importing countries to which they are supplied,

Removed(ii) the distinguishing features of the product or products concerned. The website address shall be communicated to the competent authority;

Removed(g) if the product(s) covered by the compulsory licence are patented in the importing countries cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import, sale or distribution of the products;

Removed(h) 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 in the form of a declaration of exportation certified by the customs authority concerned, and proof of importation from one of the bodies referred to in Article 18a(2), point (e);

Removed(i) the licensee shall be responsible for the payment of adequate remuneration to the rights-holder as determined by the competent authority as follows:

Removed(i) in situations of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, the remuneration shall be a maximum of 4 % of the total price to be paid by the importing country or on its behalf,

Removed(ii) in all other cases, the remuneration shall be determined taking into account the economic value of the use authorised under the licence to the importing country or countries concerned, as well as humanitarian or non-commercial circumstances relating to the issue of the licence;

Removed(j) the licence conditions are without prejudice to the method of distribution in the importing country. Distribution may be carried out for example by any of the bodies listed in Article 18a (2), point (f), and on commercial or non-commercial terms including completely without charge. [Am. 93]

Removed4. In the event of an application referred to in paragraph 2 under this Article, the competent authority referred to in Articles 1 to 11, 16 and 17 shall be the Commission.

Removed5. The Commission is empowered to adopt implementing acts in order to:

Removed(a) grant a compulsory licence;

Removed(b) reject the application for a compulsory licence;

Removed(c) amend or terminate the compulsory licence.

RemovedThose 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 the impacts of the public health problems, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b (3).” [Am. 94]

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

Removed“Article 18b Committee Procedure

Removed1. The Commission shall be assisted by a committee (‘the Compulsory Licensing Committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Removed2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Removed3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply.”

RemovedArticle 24 Committee Procedure

Removed1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Removed2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Removed3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Removed4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 thereof, shall apply.

RemovedArticle 25 Evaluation

RemovedThe Commission shall, by the last day of the third year following the granting of the Union compulsory licence in accordance with Article 7, present an evaluation report to the Council, the European Parliament and the European Economic and Social Committee on the application of this Regulation.

RemovedBy ... [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. [Am. 95]

RemovedIn 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. [Am. 96]

RemovedArticle 26 Entry into force and application [Am. 97]

RemovedThis Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

RemovedThis Regulation shall be binding in its entirety and directly applicable in all Member States.

RemovedIt shall apply from [the first day of the month following the period of twelve months after the date of entry into force]. [Am. 98]

RemovedDone at …,

RemovedFor the European Parliament For the Council

RemovedThe President The President

RemovedAnnex - Crisis or emergency modes referred to in Article 4 and competent advisory bodies as referred to in Article 6(2) are listed below: