Sittings · Document

DRAFT OPINION (COM(2023)0224 – C90151/2023 – 2023/0129(COD)) 2023-10-02

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

Committee on International Trade · Rapporteur: Helmut Scholz

PA_Legam

AMENDMENTS

The Committee on International Trade calls on the Committee on Legal Affairs, as the committee responsible, to take the following into account:

Amendment 1

Proposal for a Regulation

Recital 3

Text proposed by the Commission

Amendment

(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 .

(3) The possibility of using compulsory licences is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3. According to it, each WTO Member has the right to grant compulsory licences 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 licence has been issued and successfully executed.

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3 OJ L 336, 23.12.1994, p. 214

Or. en

Amendment 2

Proposal for a Regulation

Recital 28

Text proposed by the Commission

Amendment

(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.

(28) Notwithstanding 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 should be authorised predominantly for the supply of the internal market. The Union compulsory license should therefore define clear criteria for the licensee as well as the right-holders as regards the activities authorised under the licence. 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.

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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).

Or. en

Amendment 3

Proposal for a Regulation

Recital 29

Text proposed by the Commission

Amendment

(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 export products manufactured under a Union compulsory licence.

(29) A Union compulsory licence should predominantly be granted to supply the internal market with relevant products. Exports of products manufactured under a Union compulsory licence are permitted under the conditions stablished in Regulation (EC) No 816/2006.

Or. en

Amendment 4

Proposal for a Regulation

Recital 30

Text proposed by the Commission

Amendment

(30) Customs authorities should ensure, through a risk analysis approach, that products manufactured under a Union compulsory license are not exported. 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 prohibition, 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. Where the Commission concludes that a product does not comply with the export prohibition, customs authorities should refuse its export.

(30) Customs authorities should ensure, that products manufactured under a Union compulsory license are not exported, except when allowed by TRIPS flexibilities such as products manufactured in accordance with Regulation (EC) No 816/2006. To identify such products, the custom authorities should take into account the Union compulsory license. 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 prohibition, 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 restrictions, customs authorities should refuse its export.

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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).

Or. en

Amendment 5

Proposal for a Regulation

Recital 37

Text proposed by the Commission

Amendment

(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 facilitate 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.

(37) The possibility of a compulsory licence at Union level should not only be available for the supply of the Union market but also 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. In order to ensure the efficient processing of applications for compulsory licences under Regulation (EC) No 816/2006, Member States should have the ability to prescribe purely formal or administrative requirements, such as rules on the language of the application, the form to be used, and rules on applications made in electronic form. 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. Furthermore, empirical evidence demonstrates that certain conditions are difficult to meet. 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 should 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, 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.

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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).

Or. en

Amendment 6

Proposal for a Regulation

Article 6 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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;

(b) the analysis of the relevant information gathered by Member States or the Commission and aggregated data received by other relevant bodies at Union and international level;

Or. en

Amendment 7

Proposal for a Regulation

Article 6 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(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;

(c) the facilitation of exchanges and sharing of information with other relevant bodies and other relevant bodies at Union and national level, as well as at international level, where appropriate;

Or. en

Amendment 8

Proposal for a Regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

The export of products manufactured under a Union compulsory licence is prohibited.

The products 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 license for export under Regulation (EC) No 816/2006.

Or. en

Amendment 9

Proposal for a Regulation

Article 12 – paragraph 3

Text proposed by the Commission

Amendment

3. Where customs authorities identify a product that may fall under the prohibition laid down in Article 11, 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.

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.

Or. en

Amendment 10

Proposal for a Regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

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, customs authorities shall not authorise its release for export. The Commission shall inform the concerned rights-holder of such non-compliance.

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.

Or. en

Amendment 11

Proposal for a Regulation

Article 23 – paragraph 1 – point a

Regulation 816/2006/EC

Article 18

Text proposed by the Commission

Amendment

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.

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).

Or. en

Amendment 12

Proposal for a Regulation

Article 23 – paragraph 1 – point a

Regulation 816/2006/EC

Article 18

Text proposed by the Commission

Amendment

Those 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).

Those 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 public health problems, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 18b (3).

Or. en

Amendment 13

Proposal for a Regulation

Article 23 – point -a (new)

Regulation 816/2006/EC

Article 6 - paragraph 3- point c

Present text

Amendment

-a. Point (c) of Article 6(3) is amended as follows:

Or. en

(This amendment seeks to amend a provision within the existing act – Article 6(3)(c)- that was not referred to in the Commission proposal.)

Justification

The wording of the Commission Proposal 2023/0129 is different compared to the basic Regulation, as in Article 10(1)(a) it refers to "the number of crisis-relevant products [...] does not exceed what is necessary to meet the needs of the Union". Using ’ specific amount of product’ instead, in order to set a lower threshold, would render Regulation 816/2008 coherent with the rest of the provisions of the COM proposal .. The addition of "expected amount" instead of "amount" makes the wording WTO compatible (Annex to the TRIPS Agreement, 2 (a)(i.) which reads “specifies the names and expected quantities of the product needed”).

Amendment 14

Proposal for a Regulation

Article 23 – point -aa (new)

Regulation 816/2006/EC

6 - paragraph 3- point e

Present text

Amendment

-aa. Point (e) of Article 6(3) is amended as follows:

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

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

Or. en

(This amendment seeks to amend a provision within the existing act – Article 6(3)(e)- that was not referred to in the Commission proposal.)

Justification

The COM Proposal 2023/0129 is less stringent than the current Regulation 816/2008. Article 7(3) only mentions "the possibility to reach a voluntary licensing agreement", which is less burdensome than proof of prior negotiation. Article 31bis of the TRIPS agreement, which is the basis for this provision, requires that the requesting party has made efforts for prior negotiations, and not that actual negotiations have taken place or have been concluded unsuccessfully. Regulation 816/2008 should therefore be aligned.

Amendment 15

Proposal for a Regulation

Article 23 – point -ab (new)

Regulation 816/2006/EC

Article 6 - paragraph 3 point f

Present text

Amendment

-ab. Point (f) of Article 6(3) is amended as follows:

(f) evidence of a specific request from :

(f) evidence of a specific request from:

[...]

indicating the quantity of product required.

indicating the expected quantity of product required.

Or. en

(This amendment seeks to amend a provision within the existing act – Article 6(3)(f)- that was not referred to in the Commission proposal.)

Justification

Same reasoning as in AM 15 applies. Regulation 816 needs to be aligned to the language used in the TRIPS Agreement (Art. 31(b)).

Amendment 16

Proposal for a Regulation

Article 23 – point -ac (new)

Regulation 816/2006/EC

Article 7

Present text

Amendment

-ac. 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 shall give the rights-holder an opportunity to comment on the application and to provide the competent authority with any relevant information regarding the application.

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 may give the rights-holder an opportunity to provide the competent authority with any relevant information regarding the application.

Or. en

(This amendment seeks to amend a provision within the existing act – Article 7- that was not referred to in the Commission proposal.)

Justification

The wording of Article 7 of Regulation 816/2006 is slightly different from that of Article 7(3) in this proposal . Moreover, the TRIPS Agreement ( Article 31bis) does not require the competent authority to allow the rights-holder to “comment” on an application for a compulsory license, but instead requires efforts for prior negotiations with the rights-holder (which can be waived in case of an emergency), prior to the application of a compulsory license.

Amendment 17

Proposal for a Regulation

Article 23 – point -ad (new)

Regulation 816/2006/EC

Article 9- paragraph 1

Present text

Amendment

-ad. 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.

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

Or. en

(This amendment seeks to amend a provision within the existing act – Article 9(1)- that was not referred to in the Commission proposal.)

Justification

Article 31 of the TRIPS Agreement only refers to the applicant proving that he has made efforts to negotiate. The requirement that authorities are satisfied goes beyond what is in the TRIPS Agreement. Regulation 816/2006 should therefore be aligned to this.

Amendment 18

Proposal for a Regulation

Article 23 – point -ae (new)

Regulation 816/2006/EC

Article 10 – paragraph 1

Present text

Amendment

-ae. 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 enjoys the licence, and non-exclusive. It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee.

1. The licence granted shall be non-assignable, except with that part of the enterprise or non-profit 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.

Or. en

(This amendment seeks to amend a provision within the existing act – Article 10(1) - that was not referred to in the Commission proposal.)

Amendment 19

Proposal for a Regulation

Article 23 – point -af (new)

Regulation 816/2006/EC

Article 10 – paragraph 2

Present text

Amendment

-af. Paragraph (2) of Article 10 is amended as follows:

2. The 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.

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.

Or. en

(This amendment seeks to amend a provision within the existing act – Article 10(2)- that was not referred to in the Commission proposal.)

Amendment 20

Proposal for a Regulation

Article 23 – point -ag (new)

Regulation 816/2006/EC

Article 10 – paragraph 8

Present text

Amendment

-ag. Paragraph (8) of Article 10 is amended as follows:

8. The competent authority may at the request of the rights-holder or on its own initiative, if national law allows the competent authority to act on its own initiative, request access to books and records kept by the licensee, for the sole purpose of checking whether the terms of the licence, and in particular those relating to the final destination of the products, have been met. The books and records shall include 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).

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).

Or. en

(This amendment seeks to amend a provision within the existing act – Article 10(8)- that was not referred to in the Commission proposal.)

Amendment 21

Proposal for a Regulation

Article 23 – point -ah (new)

Regulation 816/2006/EC

Article 10 - paragraph 9 – point b

Present text

Amendment

-ah. Point b of Article 10(9)is amended as follows:

(b) 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, whether the rights-holder has received public support to develop the invention, the degree to which development costs have been amortized by the rights-holder, as well as humanitarian or non-commercial circumstances relating to the issue of the licence.

Or. en

(This amendment seeks to amend a provision within the existing act – Article 10(9)(b)- that was not referred to in the Commission proposal.)

Justification

This amendment takes the language from the new proposal, specifically Article 9(3), to ensure coherence between the 2 acts.