Activities of Samira RAFAELA 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 (19)
Amendment 22 #
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’)3 . The TRIPS Agreement states that each WTO Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licences can be granted. The TRIPS Agreement, in Article 31bis, specifically allows for the export of products made with a compulsory license. Over the past two decades, only one export compulsory license has been issued and successfully executed, when in 2007 the Canadian government issued a compulsory licence for HIV medicines for export to Rwanda. __________________ 3 OJ L 336, 23.12.1994, p. 214
Amendment 32 #
Proposal for a Regulation
Recital 28
Recital 28
(28) It is imperative thatNotwithstanding the flexibilities included in the TRIPS Agreement, such as products for export covered under Regulation (EC) No 816/2006, products manufactured under a Union compulsory licence reach onlyshould be authorised predominantly to 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 34 #
Proposal for a Regulation
Recital 29
Recital 29
(29) A Union compulsory licence in the context of a Union crisis or emergency mechanism should only be granted to supply the internal market with crisis- relevant products. Therefore, it should be prohibited to exportExports of products manufactured under a Union compulsory licence should be permitted under the conditions established in Regulation (EC) No 816/2006. .
Amendment 37 #
Proposal for a Regulation
Recital 30
Recital 30
(30) Customs authorities should ensure, through a risk analysis approach, that products manufactured under a Union compulsory license are not exportedthat are not allowed for export are not exported, except when allowed by TRIPS flexibilities such as products manufactures in accordance with Regulation (EC) No 816/2006 . To identify such products, the main source of information to feed such customs risk- analysis should be the Union compulsory license itself. Information on each implementing act granting or modifying a Union compulsory license should thus be entered in the Electronic Customs Risk Management System (CRMS) referred to in Article 36 of Commission Implementing Regulation (EU) 2015/244710 . When customs authorities identify a product that is suspected not to comply with the export prohibirestriction, they should suspend the export of that product and notify the Commission immediately. The Commission should reach a conclusion on the compliance with the export prohibition within 10 working days, but should have the possibility of requiring the customs authorities to maintain the suspension where necessary. To help its assessment the Commission may consult the relevant rights-holder and other relevant stakeholders. Where the Commission concludes that a product does not comply with the export prohibirestriction, customs authorities should refuse its export. __________________ 10 Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).
Amendment 40 #
Proposal for a Regulation
Recital 37
Recital 37
(37) The possibility of a compulsory licence at Union level should not only be available for the supply of the Union market but also under certain conditions for export purposes concerning countries with public health problems, already regulated by Regulation (EC) No 816/2006 of the European Parliament and of the Council11 . Under that Regulation, the granting of such compulsory licences is decided and performed nationally by the competent authorities of the Member States that have received a corresponding application from a person that intends to manufacture and sell pharmaceutical products covered by a patent or a supplementary protection for export to eligible third countries. Regulation (EC) No 816/2006 only allows compulsory licensing covering the manufacturing of products across several Member States through national procedures. In the context of a cross-border manufacturing process different national compulsory licences would be needed. This can lead to a burdensome and lengthy process as this would require the launch of different national procedures with possibly different scope and conditions. In order to achieve the synergies and efficient process as for the Union crisis mechanisms, a Union compulsory licence should also be available, in the context of Regulation (EC) No 816/2006. This will facilitatshould be further facilitated by reviewing the conditions for issuing compulsory licences for export. A Union compulsory licence will facilitate the use of this mechanism and the manufacturing of the relevant products across several Member States and provide Union-level solution in order to avoid a situation where several compulsory licences for the same product in more than one Member States would be required for licensees to manufacture and export the products as planned. Any person considering to apply for a compulsory licence under, for the purposes and within the scope of Regulation (EC) No 816/2006 should have the possibility to request, with a single application, a compulsory licence under that Regulation that is valid throughout the Union, if that person, when relying on national compulsory licencing schemes of the Member States, would otherwise need to apply for multiple compulsory licences for the same crisis- relevant product in more than one Member State in order to realise its intended activities of manufacture and sale for export under Regulation (EC) No 816/2006. Therefore, Regulation (EC) No 816/2006 should be amended accordingly. __________________ 11 Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (OJ L 157, 9.6.2006, p. 1).
Amendment 41 #
Proposal for a Regulation
Recital 40
Recital 40
(40) Union compulsory licensing for crisis management is a tool that is only used in exceptional circumstances. The evaluation should therefore be conducted only where a Union compulsory licence has been granted by the Commission. The evaluation report should be submitted by the last day of the third year following the granting of the Union compulsory licence, to allow an adequate and substantiated assessment of this Regulation. If no compulsory licence has been granted within a timespan of five years, an automatic evaluation should be triggered which reviews and adjusts where necessary, among others, the conditions for issuing compulsory licences.
Amendment 43 #
Proposal for a Regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
Amendment 52 #
Proposal for a Regulation
Article 11 – title
Article 11 – title
Amendment 56 #
Proposal for a Regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
The export of products manufactured under a Union compulsory licence is prohibitedshall be authorised predominantly for the supply of the internal market, except for products authorised for export.
Amendment 59 #
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, notwithstanding those 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 and other relevant stakeholders.
Amendment 64 #
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, notwithstanding 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 77 #
Proposal for a Regulation
Article 23 – paragraph 1 - point -a b (new)
Article 23 – paragraph 1 - point -a b (new)
Regulation (EC) No 816/2006
Article 6 – paragraph 3– point c
Article 6 – paragraph 3– point c
(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; " Or. en (Regulation 816/2006/EC)
Amendment 80 #
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/EC
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
(-a c) Point (e) of Article 6(3) is amended as follows: "(e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9; "
Amendment 83 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a d (new)
Article 23 – paragraph 1 – point –a d (new)
Regulation (EC) No 816/2006/EC
Article 6 – paragraph 3 – point f
Article 6 – paragraph 3 – point f
Article 23a (-a d) Point (f) of Article 6(3) is amended as follows: "(f) evidence of a specific request from : [...] indicating the expected quantity of product required. "
Amendment 84 #
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/EC
Article 7
Article 7
(-a e) Article 7 is amended as follows: "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 shallmay give the rights-holder an opportunity to comment on the application and to provide the competent authority with any relevant information regarding the application. "
Amendment 87 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a f (new)
Article 23 – paragraph 1 – point –a f (new)
Regulation (EC) No 816/2006/EC
Article 9– paragraph 1
Article 9– paragraph 1
(-a f) Paragraph (1) of Article 9 is amended as follows: "1. The applicant shall provide evidence to satisfy 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. "
Amendment 92 #
Proposal for a Regulation
Article 23 – paragraph 1 – point –a h (new)
Article 23 – paragraph 1 – point –a h (new)
Regulation (EC) 816/2006
Article 10 – paragraph 2
Article 10 – paragraph 2
(-a h) Paragraph (2) of Article 10 is amended as follows: "2. The amount of product(s) manufactured under the licence shall not exceed what is expected to be 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. "
Amendment 104 #
Proposal for a Regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
Regulation (EC) No 816/2006
Article 18a – paragraph 1
Article 18a – paragraph 1
1. The Commission may also grant a compulsory licence where the activities of manufacture and sale for export spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State.
Amendment 106 #
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.