Activities of Emmanuel MAUREL related to 2023/0129(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Amendments (21)
Amendment 135 #
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘crisis-relevant products’ means products or processes that are indispensable for responding to a crisis or emergency, for safeguarding public interests, for protecting public health or for addressing the impacts of a crisis or emergency in the Union;
Amendment 138 #
Proposal for a regulation
Article 3 – paragraph 1 – point e
Article 3 – paragraph 1 – point e
(e) ‘Union compulsory licence’ means a compulsory licence granted by the Commission or the competent authorities of the Member States to exploit a protected invention of crisis-relevant products for any of the relevant activities in the Union;
Amendment 141 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
The Commission may grant a Union compulsory licence where a crisis mode or an emergency mode listed in the Annex to this Regulation has been activated or declared in accordance with one of the Union acts listin the public interest, in particular in the following situations: (i) a national emergency or other circumstances of extreme necessity; or (ii) public non-commercial use; or (iii) a health crisis involving insufficient quantity or quality of supply or availability, excessively or abnormally high prices of a medical product, strategic stockpiling or any other situation considered inby that Annexe licensee.
Amendment 148 #
Proposal for a regulation
Article 5 – paragraph 1 – point a a (new)
Article 5 – paragraph 1 – point a a (new)
(aa) be granted to EU companies;
Amendment 157 #
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
Amendment 168 #
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. The advisory body referred to in paragraph 1 shall be the advisory body competent for the Union crisis or emergency mechanism as listed in Annex I to this Regulation (the ‘competent advisory body’). For the purposes of the present Regulation, the competent advisory body shall assist and advise the Commission as regards the following tasks:
Amendment 174 #
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) the identification and consultation of the representatives of right holders or their representatives as well as potential licensees and consulting other economic operators, researchers, members of civil society and the industry;
Amendment 180 #
Proposal for a regulation
Article 6 – paragraph 4 – point b
Article 6 – paragraph 4 – point b
(b) mayshall invite representatives of the European Parliament, representatives of economic operators, right holders, potential licensees, stakeholder organisations, social partners, members of civil society and experts to attend meetings of the advisory body as observers.
Amendment 187 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. The Commission shall adopt an implementing act laying down the rules of procedure for the ad hoc advisory body referred to in paragraph 5. The rules of procedure shall specify that the ad hoc advisory body shall not be set up for a period exceeding the duration of the crisis or emergency. The rules of procedure shall specify that the ad hoc advisory body must not have any conflicts of interest and shall lay down appropriate transparency measures. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 24 (3).
Amendment 192 #
Proposal for a regulation
Article 7 – paragraph 1 – point c a (new)
Article 7 – paragraph 1 – point c a (new)
(ca) barriers to the accessibility and affordability of the products concerned, such as excessively high prices or anti- competitive practices;
Amendment 200 #
Proposal for a regulation
Article 7 – paragraph 3 – point a
Article 7 – paragraph 3 – point a
(a) the possibility to reach as soon as possible a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products;
Amendment 202 #
Proposal for a regulation
Article 7 – paragraph 3 – point b
Article 7 – paragraph 3 – point b
Amendment 203 #
Proposal for a regulation
Article 7 – paragraph 3 – point c
Article 7 – paragraph 3 – point c
(c) the conditions under which the Commission intends to grant the Union compulsory licence, including the amount of the remuneration. The Commission shall not be required to examine the comments received. The procedure laid down in paragraph 3(a) shall not be required if it risks delaying, beyond a reasonable period of time, the granting of a compulsory licence and access to the crisis-critical products.
Amendment 208 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. When the Commission considers the granting of a Union compulsory licence, it shall without undue delay publish a notice to inform the public about the initiation of the procedure under this article. This notice shall also include, where already available and relevant, information on the subject of the compulsory licence and an invitation to submit comments in accordance with paragraph 3. The notice shall be published, and translated if necessary, in the Official Journal of the European Union.
Amendment 216 #
Proposal for a regulation
Article 7 – paragraph 6 – point c a (new)
Article 7 – paragraph 6 – point c a (new)
(ca) the identified public interest.
Amendment 222 #
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(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;
Amendment 230 #
Proposal for a regulation
Article 8 – paragraph 1 – point h
Article 8 – paragraph 1 – point h
(h) measures complementing the compulsory licence, which are necessary to achieve the objective of the compulsory licence, such as the requirement for the right-holder to share with the licensee the know-how needed to manufacture the product.
Amendment 261 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Amendment 263 #
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Where customs authorities identify a product that may fall under the prohibition laid down in Article 11, with the exception of the crisis-critical products covered by Regulation (EC) No 816/2006, 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.
Amendment 265 #
Proposal for a regulation
Article 12 – paragraph 5
Article 12 – paragraph 5
5. Where the Commission concludes that a product manufactured under a Union compulsory licence does not comply with the prohibition laid down in Article 11, without prejudice to the exceptions listed in Regulation (EC) No 816/2006, customs authorities shall not authorise its release for export. The Commission shall inform the concerned rights-holder of such non- compliance.
Amendment 298 #
Proposal for a regulation
Annex I
Annex I