Sittings · Compare
What changed
Amendment 1
Proposal for a Regulationregulation
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 .
(3) The possibility of using compulsory licences is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’)3. AccordingThe toDoha it,Declaration on the TRIPS Agreement states that each WTO Member has not only the right to grant compulsory licenceslicences, andbut also the freedom to determine the grounds upon which such licences can beare granted. The TRIPS Agreement, in Article 31bis, specifically allows for the export of products made with a compulsory license. Over the past two decades, onlya onecompulsory exportlicense compulsoryfor licenceexport has beenonly issuedbeen andused successfullyonce executed.worldwide.
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3 OJ L 336, 23.12.1994, p. 214
Or. en
Amendment 2
Proposal for a Regulationregulation
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.
(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 destined for the supply of the internal market. The Union compulsory licenselicence should therefore define clear criteriaconditions for the licensee as well as the right-holdersrights-holder as regards the activities authorised under the licence. In order to facilitate monitoringlicence, ofwhich thedo distributionnot ofexceed productsthose manufacturedagreed under aTRIPS. UnionDirective compulsory2004/48/EC licence,of includingthe controlsEuropean byParliament customsand authorities,of the licenseeCouncil9 should ensure thatnot suchimpede productsthe havelegitimate specialproduction characteristicsand thatsupply makeof thempharmaceutical easilyproducts identifiablemanufactured andunder distinguishablea fromcompulsory thelicense productsas marketedprovided by the rights-holder.law.
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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
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 3
Proposal for a Regulationregulation
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 export products manufactured under a Union compulsory licence.
(29) A Union compulsory licence shouldunder predominantlythis Regulation should be granted to predominantly supply the internal market with relevant products. Exports ofA productsUnion manufacturedcompulsory underlicence aexclusively Unionfor compulsoryexport licenceshould arebe permitted under the conditions stablishedestablished in Regulation (EC) No 816/2006.
Or. en
Amendment 4
Proposal for a Regulationregulation
Recital 30
(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,ensure that products manufactured under a Union compulsory license are not exported, except when allowed by TRIPS flexibilities suchrelevant asEU productslegislation manufacturedor inthe accordanceflexibilities withforeseen Regulationin (EC)the NoTRIPS 816/2006.Agreement. 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,restriction, 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 prohibitionrestriction within 10 working days, but should have the possibility of requiring the customs authorities to maintain the suspension where necessary. To help its assessmentassessment, the Commission mayshould be able to consult the relevant rights-holder and other relevant stakeholders. Where the Commission concludes that a product does not comply with the export restrictions,restriction, 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 Regulationregulation
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 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.export, in order to make it fully in line with the TRIPS Agreement and its full spectrum of flexibilities. A Union compulsory licence will facilitate the use of this mechanism and all 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 Regulationregulation
Recital 40
Text proposed by the Commission
Amendment
(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.
(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 7
Proposal for a regulation
Article 5 – paragraph 1 – point e
Text proposed by the Commission
Amendment
(e) be limited to the territory of the Union;
deleted
Amendment 8
Proposal for a regulation
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;
(b) the analysis of theall 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 9
Amendment 7
Proposal for a regulation
Proposal for a Regulation
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;
(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 10
Amendment 8
Proposal for a regulation
Proposal for a Regulation
Article 11
Article 11 – paragraph 1
Text proposed by the Commission
Amendment
Prohibition of export
Destined use of products
The export of products manufactured under a Union compulsory licence is prohibited.
1. The products manufactured under a Union compulsory licence shall be authoriseddestined predominantly for the supply of the internal market, except for products manufactured under a Union compulsoryexclusively licensedestined for export under Regulation (EC) No 816/2006.
Or. en
2. The Commission shall, by means of an implementing act, set out the conditions under which a non-predominant part of the products manufactured under a Union compulsory licence may be exported to third countries. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2) and enter into force at the same time as the implementing act granting the Union compulsory licence, referred to in Article 7(7).
Amendment 911
Proposal for a Regulationregulation
Article 12 – paragraph 3
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 prohibitionrestrictions 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 itthe Commission to establish whether the product was manufactured under a Union compulsory license. To assess whether theBefore suspendedtaking productsa corresponddecision to the Unionsuspend compulsorythe license,export, the Commission may consult the relevant rights-holder.rights-holder and other relevant stakeholders.
Or. en
Amendment 12
Amendment 10
Proposal for a regulation
Proposal for a Regulation
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, 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 prohibitionrestrictions 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.
Or. en
Amendment 13
Amendment 11
Proposal for a regulation
Proposal for a Regulation
Article 12 – paragraph 6 – introductory part
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.
6. Where the release for export of a product has not been authorised:
2. Any person6. mayWhere submitthe anCommission applicationconcludes forthat a compulsoryproduct licencemanufactured under paragrapha 1.Union Thecompulsory applicationlicense shalldoes fulfilnot comply with the requirementsrestrictions laid down in Article 6 (3).11:
Or. en
Amendment 14
Amendment 12
Proposal for a regulation
Proposal for a Regulation
Article 12 – paragraph 6 – point a
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).
(a) where appropriate in view of the crisis or emergency context, the Commission may require customs authorities to oblige the exporter to take specific actions at their own costs, including supplying them to designated Member States, if need be, after rendering them compliant with Union law.
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).
(a) where appropriate, the Commission may request the exporter to take specific actions at their own costs, including supplying them to designated Member States, if need be, after rendering them compliant with Union law
Or. en
Amendment 15
Amendment 13
Proposal for a regulation
Proposal for a Regulation
Article 12 – paragraph 6 – point b
Article 23 – point -a (new)
Text proposed by the Commission
Regulation 816/2006/EC
Amendment
Article 6 - paragraph 3- point c
(b) in all other cases, customs authorities may take any necessary measure to ensure that the product concerned is disposed of in accordance with national law consistent with Union law. Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.
(b) in all other cases, the Commission may take any necessary measure to ensure that the product concerned is disposed of in accordance with national law consistent with Union law.
Amendment 16
Proposal for a regulation
Article 23 – paragraph 1 – point -a (new)
Regulation (EC) 816/2006
Article 6 – paragraph 2
Present text
Amendment
-a. Point (c) of Article 6(3)6(2) is amended as follows:
2. If the person applying for a compulsory licence is submitting 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.
2. If the person applying for a compulsory licence is submitting multiple applications to authorities for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.
Amendment 17
Proposal for a regulation
Article 23 – paragraph 1 – point -a a (new)
Regulation (EC) 816/2006
Article 6 – paragraph 3 – point c
Present text
Amendment
-a a. Point (c) of Article 6(3) is amended as follows:
(c) the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
(c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
Or. en
Amendment 18
(This amendment seeks to amend a provision within the existing act – Article 6(3)(c)- that was not referred to in the Commission proposal.)
Proposal for a regulation
Justification
Article 23 – paragraph 1 – point -a b (new)
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”).
Regulation (EC) 816/2006
Amendment 14
Article 6 – paragraph 3 – point e
Proposal for a Regulation
Article 23 – point -aa (new)
Regulation 816/2006/EC
6 - paragraph 3- point e
Present text
Amendment
-aa.-a b. 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;9
(e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9;
Or. en
Amendment 19
(This amendment seeks to amend a provision within the existing act – Article 6(3)(e)- that was not referred to in the Commission proposal.)
Proposal for a regulation
Justification
Article 23 – paragraph 1 – point -a c (new)
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.
Regulation (EC) 816/2006
Amendment 15
Article 6 – paragraph 3 – point f
Proposal for a Regulation
Article 23 – point -ab (new)
Regulation 816/2006/EC
Article 6 - paragraph 3 point f
Present text
Amendment
-ab.-a c. Point (f) of Article 6(3) is amended as follows:
(f) evidence of a specific request from : [...] indicating the quantity of product required.
(f) evidence of a specific request from: [...] indicating the expected quantity of product required.
[...]
Amendment 20
[...]
Proposal for a regulation
indicating the quantity of product required.
Article 23 – paragraph 1 – point -a d (new)
indicating the expected quantity of product required.
Regulation (EC) 816/2006
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
Amendment
-ac.-a d. 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 comment on the application and to provide the competent authority with any relevant information regarding the application.
Or. en
Amendment 21
(This amendment seeks to amend a provision within the existing act – Article 7- that was not referred to in the Commission proposal.)
Proposal for a regulation
Justification
Article 23 – paragraph 1 – point -a e (new)
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.
Regulation (EC) 816/2006
Amendment 17
Article 9 – paragraph 1
Proposal for a Regulation
Article 23 – point -ad (new)
Regulation 816/2006/EC
Article 9- paragraph 1
Present text
Amendment
-ad. Paragraph (1)-a ofe. Article 99(1) 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 applicationapplication.
Or. en
Amendment 22
(This amendment seeks to amend a provision within the existing act – Article 9(1)- that was not referred to in the Commission proposal.)
Proposal for a regulation
Justification
Article 23 – paragraph 1 – point -a f (new)
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.
Regulation (EC) 816/2006
Amendment 18
Proposal for a Regulation
Article 23 – point -ae (new)
Regulation 816/2006/EC
Article 10 – paragraph 1
Amendment
-ae. Paragraph (1)-a off. Article 1010(1) 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
Amendment 23
(This amendment seeks to amend a provision within the existing act – Article 10(1) - that was not referred to in the Commission proposal.)
Proposal for a regulation
Amendment 19
Article 23 – paragraph 1 – point -a g (new)
Proposal for a Regulation
Regulation (EC) 816/2006
Article 23 – point -af (new)
Regulation 816/2006/EC
Article 10 – paragraph 2
Amendment
-af. Paragraph (2)-a ofg. Article 1010(2) 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 expected 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
Amendment 24
(This amendment seeks to amend a provision within the existing act – Article 10(2)- that was not referred to in the Commission proposal.)
Proposal for a regulation
Amendment 20
Article 23 – paragraph 1 – point -a h (new)
Proposal for a Regulation
Regulation (EC) 816/2006
Article 23 – point -ag (new)
Regulation 816/2006/EC
Article 10 – paragraph 8
Amendment
-ag. Paragraph (8)(-a ofh) Article 1010(8) is amended as follows:
8. The competent authority may at the request of the rights-holderrightsholder 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 maymay, 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
Amendment 25
(This amendment seeks to amend a provision within the existing act – Article 10(8)- that was not referred to in the Commission proposal.)
Proposal for a regulation
Amendment 21
Article 23 – paragraph 1 – point a
Regulation (EC) 816/2006
Article 18a – paragraph 1
Text proposed by the Commissiont
Amendment
1. The Commission may 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.
1. The Commission may also grant a compulsory licence of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems.
Amendment 26
Proposal for a regulation
Article 23 – paragraph 1 – point a
Regulation (EC) 816/2006
Article 18a – paragraph 2
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 following requirements:
(a) the name and contact details of the applicant and of any agent or representative whom the applicant has appointed to act for him before the competent authority;
(b) the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;
(c) the expected amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
(d) the importing country or countries;
(e) where applicable, evidence of efforts of prior negotiation with the rights-holder pursuant to Article 9;
(f) evidence of a specific request from:
(i)authorised representatives of the importing country or countries; or
(ii)a non-governmental organisation acting with the formal authorisation of one or more importing countries; or
(iii) UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries.
Amendment 27
Proposal for a regulation
Article 23 – paragraph 1 – point a
Regulation (EC) 816/2006
Article 18a – paragraph 3
Text proposed by the Commissiont
Amendment
3. The compulsory licence granted in accordance with paragraph 1 shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole territory of the Union.
3. The compulsory licence granted in accordance with paragraph 1 shall specify that it is applicable to the whole territory of the Union and shall be subject to the following conditions:
(a) The licence granted shall be non-assignable, except with that part of the enterprise or organisation that makes use of the licence, and non-exclusive. It shall contain the specific conditions as set out in this paragraph;
(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;
(c) The duration of the licence shall be indicated;
(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;
(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 and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on 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;
(f) Before shipment to the importing country or countries cited in the application, the licensee shall post on a website the following information:
(i) the quantities being supplied under the licence and the importing countries to which they are supplied; (ii) the distinguishing features of the product or products concerned. The website address shall be communicated to the competent authority.
(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 and/or distribution of the products;
(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, through 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)(e);
(i) The licensee shall be responsible for the payment of adequate remuneration to the rights-holder as determined by the competent authority as follows:
(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;
(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.
(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)(f) and on commercial or non-commercial terms including completely without charge.
Amendment 28
Proposal for a Regulation
Article 23 – pointparagraph -ah1 (new)– point a
Regulation 816/2006/EC
Article 1018a -– paragraph 95 – pointsecond bsubparagraph
Present text
Text proposed by the Commission
Amendment
-ah. Point b of Article 10(9)is amended as follows:
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).
(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, as well as humanitarian or non-commercial circumstances relating to the issue of the licence
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).
(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.
PROCEDURE – COMMITTEE ASKED FOR OPINION
Or. en
Title
(This amendment seeks to amend a provision within the existing act – Article 10(9)(b)- that was not referred to in the Commission proposal.)
Compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Justification
References
This amendment takes the language from the new proposal, specifically Article 9(3), to ensure coherence between the 2 acts.
COM(2023)0224 – C9-0151/2023 – 2023/0129(COD)
Committee responsible
Date announced in plenary
JURI
12.6.2023
Opinion by
Date announced in plenary
INTA
12.6.2023
Associated committees - date announced in plenary
5.10.2023
Rapporteur for the opinion
Date appointed
Helmut Scholz
24.5.2023
Discussed in committee
19.9.2023
Date adopted
28.11.2023
Result of final vote
+:
–:
0:
20
13
1
Members present for the final vote
Barry Andrews, Anna-Michelle Asimakopoulou, Tiziana Beghin, Geert Bourgeois, Saskia Bricmont, Daniel Caspary, Paolo De Castro, Markéta Gregorová, Heidi Hautala, Danuta Maria Hübner, Karin Karlsbro, Martine Kemp, Miapetra Kumpula-Natri, Bernd Lange, Margarida Marques, Gabriel Mato, Sara Matthieu, Emmanuel Maurel, Carles Puigdemont i Casamajó, Samira Rafaela, Catharina Rinzema, Inma Rodríguez-Piñero, Helmut Scholz, Joachim Schuster, Mihai Tudose, Kathleen Van Brempt, Marie-Pierre Vedrenne, Jörgen Warborn, Iuliu Winkler, Jan Zahradil, Juan Ignacio Zoido Álvarez
Substitutes present for the final vote
Michiel Hoogeveen, Javier Moreno Sánchez, Ralf Seekatz
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the opinion, until the adoption thereof in committee:
Entity and/or person
Health Action International
Medicins sans Frontieres
Drugs for Neglected Diseases Initiative
Medicines Law & Policy
University of Amsterdam
Pramiti Parwani (University of Amsterdam)
Representatives from Unit C.4 – Intangible Economy (DG GROW)
The list above is drawn up under the exclusive responsibility of the rapporteur.
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
Key to symbols: