Activities of Kathleen VAN BREMPT related to 2023/0129(COD)
Shadow opinions (1)
OPINION 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 (18)
Amendment 24 #
Proposal for a Regulation
Recital 3
Recital 3
(3) The possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3Doha Declaration on the TRIPS Agreement and Public Health made clear that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted, including the possibility of using compulsory licences in situations of national emergency or other circumstances of extreme urgency . __________________ 3 OJ L 336, 23.12.1994, p. 214
Amendment 30 #
Proposal for a Regulation
Recital 28
Recital 28
(28) It is imperative that products manufactured under a Union compulsory licence reach only the internal market. The Union compulsory licence should therefore impose clear conditions upon the licensee as regards the activities authorised under the licence, including the territorial reach of those activities. The rights-holder should be able to challenge actions and uses of the rights concerned by the Union compulsory licence that do not comply with the conditions of the licence, as infringement of its intellectual property rights in accordance with Directive 2004/48/EC of the European Parliament and of the Council9 . In order to facilitate monitoring of the distribution of products manufactured under a Union compulsory licence, including controls by customs authorities, the licensee should ensure that such products have special characteristics that make them easily identifiable and distinguishable from the products marketed by the rights-holder. __________________ 9 Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ L 157 30.4.2004, p. 45).
Amendment 35 #
Proposal for a Regulation
Recital 29
Recital 29
(29) A Union compulsory licence in the context of a Union crisis or emergency mechanism should onpredominantly be granted to supply the internal market with crisis- relevant products. TWherefore, it should be prohibited to export products manufactured under a Union compulsory licencen a Union compulsory licence has been exported to countries with public health emergencies, the whole production should be exported.
Amendment 45 #
Proposal for a Regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) the analysis of the crisis-relevant information gathered by Member States or the Commission and aggregated data received by other crisis-relevant bodies at Union and international level;
Amendment 47 #
Proposal for a Regulation
Article 6 – paragraph 2 – point c
Article 6 – paragraph 2 – point c
(c) the facilitation of exchanges and sharing of information with other relevant bodies and other crisis-relevant bodies at Union and national level, as well as at international level, where appropriate;
Amendment 55 #
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
The export ofproducts manufactured under a Union compulsory licence shall be authorised predominantly for the supply of the internal market, except for products manufactured under a Union compulsory licencse is prohibitedfor export to countries facing public health problems.
Amendment 75 #
Proposal for a Regulation
Article 23 – paragraph 1 – point -a a (new)
Article 23 – paragraph 1 – point -a a (new)
Regulation (EC) 816/2006
Article 6 – paragraph 2
Article 6 – paragraph 2
(-a a) Paragraph (2) of Article 6 is amended as follows: "2. If the person applying for a compulsory licence is submitting multiple applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned. "
Amendment 79 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a b (new)
Article 23 – paragraph 1 – point –a b (new)
(c) the-a b) Point (c) of Article 6(3) is amended as follows: "(c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence; "
Amendment 82 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a c (new)
Article 23 – paragraph 1 – point –a c (new)
Regulation (EC) No 816/2006
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
(-a c) Point (e) of Article 6 (3)e is amended as follows: "(e) where applicable, evidence of efforts for prior negotiation with the rights-holder pursuant to Article 9; "
Amendment 85 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a e (new)
Article 23 – paragraph 1 – point –a e (new)
Regulation (EC) No 816/2006
Article 7
Article 7
Amendment 88 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a g (new)
Article 23 – paragraph 1 – point –a g (new)
Regulation (EC) No 815/2006
Article 10– paragraph 1
Article 10– paragraph 1
(-a g) Paragraph (1) of Article 10 is amended as follows: "(1) The licence granted shall be non- assignable, except with that part of the enterprise or goodwill which enjoysnon-profit that makes use of the licence, and non-exclusive. It shall contain the specific conditions set out in paragraphs 2 to 9the relevant Articles of the TRIPS Agreement to be fulfilled by the licensee "
Amendment 91 #
Proposal for a Regulation
Article 23 – paragraph 1 –a h (new)
Article 23 – paragraph 1 –a h (new)
Regulation (EC) No 816/2006
Article 10 – paragraph 2
Article 10 – paragraph 2
(-a h) Paragraph 2 of Article 10 is deleted.
Amendment 94 #
Proposal for a Regulation
Article 23 – paragraph 1 –a i (new)
Article 23 – paragraph 1 –a i (new)
Regulation (EC) 816/2006
Article 10–paragraph 3
Article 10–paragraph 3
(-a i) Paragraph 3 of Article 10 is deleted. "
Amendment 96 #
Proposal for a Regulation
Article 23– paragraph – a j (new)
Article 23– paragraph – a j (new)
Regulation (EC) No 816/2006
Article 10– paragraph 4
Article 10– paragraph 4
(-a j) Paragraph 4 of Article 10 is deleted "
Amendment 98 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a k (new)
Article 23 – paragraph 1 – point –a k (new)
Regulation (EC)816/2006
Article 10– paragraph 5
Article 10– paragraph 5
(-a k) Paragraph 5 of Article 10 is deleted. "
Amendment 100 #
Proposal for a Regulation
Article 23 – paragraph 1- point -a l (new)
Article 23 – paragraph 1- point -a l (new)
Regulation (EC) No 816/2006
Article 10– paragraph 6
Article 10– paragraph 6
(-a l) Paragraph 6 of Article 10 is deleted.
Amendment 102 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a n (new)
Article 23 – paragraph 1 – point –a n (new)
(-a n) Paragraph 8 of Article 10 is deleted. "
Amendment 108 #
Proposal for a Regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
Regulation (EC) No 816/2006
Article 18a - paragraph 2
Article 18a - paragraph 2
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. . Or. en (see wording of art 18 a -2 of (EC) NO 816/2006)