BETA


2023/0129(COD) Compulsory licensing of patents in crisis situations

Progress: Awaiting Council's 1st reading position

RoleCommitteeRapporteurShadows
Lead JURI VÁZQUEZ LÁZARA Adrián (icon: Renew Renew) DIDIER Geoffroy (icon: EPP EPP), WÖLKEN Tiemo (icon: S&D S&D), HAUTALA Heidi (icon: Verts/ALE Verts/ALE), MAUREL Emmanuel (icon: GUE/NGL GUE/NGL)
Committee Opinion DEVE
Committee Opinion INTA SCHOLZ Helmut (icon: GUE/NGL GUE/NGL) Heidi HAUTALA (icon: Verts/ALE Verts/ALE), Kathleen VAN BREMPT (icon: S&D S&D), Samira RAFAELA (icon: RE RE), Dominik TARCZYŃSKI (icon: ECR ECR)
Committee Opinion ENVI
Committee Opinion ITRE
Committee Opinion IMCO
Lead committee dossier:
Legal Basis:
RoP 57, TFEU 114, TFEU 207

Events

2024/03/13
   EP - Text adopted by Parliament, 1st reading/single reading
Documents
2024/03/13
   EP - Decision by Parliament, 1st reading
Documents
2024/03/12
   EP - Debate in Parliament
2024/02/19
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.

The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:

Subject matter

This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.

The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.

Union compulsory licence

The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.

The Union compulsory license that may be granted by the Commission should:

- have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;

- be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;

- only be granted against payment of an adequate remuneration to the rights-holder;

- be strictly limited to the precisely defined territory of the Union;

- clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.

Advisory body

The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.

The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.

Remuneration

The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.

Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.

Obligations to be fulfilled by the licensee

Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.

Additional measures complementing the Union compulsory licence

Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.

Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.

Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.

If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.

Documents
2024/02/13
   EP - Vote in committee, 1st reading
2023/12/04
   EP - Committee opinion
Documents
2023/11/14
   EP - Amendments tabled in committee
Documents
2023/10/16
   EP - Committee draft report
Documents
2023/10/05
   EP - Referral to associated committees announced in Parliament
2023/09/20
   ESC - Economic and Social Committee: opinion, report
Documents
2023/09/06
   CZ_CHAMBER - Contribution
Documents
2023/09/06
   IT_CHAMBER - Contribution
Documents
2023/07/20
   PT_PARLIAMENT - Contribution
Documents
2023/06/26
   EP - VÁZQUEZ LÁZARA Adrián (Renew) appointed as rapporteur in JURI
2023/06/12
   EP - Committee referral announced in Parliament, 1st reading
2023/05/24
   EP - SCHOLZ Helmut (GUE/NGL) appointed as rapporteur in INTA
2023/04/27
   EC - Document attached to the procedure
Documents
2023/04/27
   EC - Document attached to the procedure
2023/04/27
   EC - Document attached to the procedure
2023/04/27
   EC - Document attached to the procedure
2023/04/27
   EC - Legislative proposal published
Details

PURPOSE: to establish a new EU-wide compulsory licensing instrument.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: crises require the setting-up of exceptional, swift, and adequate measures able to provide means to address the consequences of the crisis. In this context, the use of patented products or processes could prove indispensable to address the consequences of a crisis.

The COVID-19 crisis highlighted that an appropriate balance between patent rights and other rights and interests is a staple of the patent system. During the COVID-19 crisis, the conflicting interests were access to health products and preserving innovation incentives that are key to developing new health products, such as vaccines and therapeutics. The pandemic added another element to the discussion: the role intellectual property rights could and should play in a crisis.

Voluntary licensing agreements usually suffice to licence the patent rights on these products and allow their supply in the Union territory. However, they may not always be available or only under inadequate conditions such as lengthy delivery times. In such cases, compulsory licensing can provide a solution to allow access to patented products, in particular products necessary to tackle the consequences of a crisis.

It is therefore important that, in the context of said crisis mechanisms, the Union can rely on an efficient and effective compulsory licensing scheme at Union level, which is uniformly applicable within the Union.

Currently, legislation on compulsory licensing of patents in the EU is fragmented: EU countries regulate their own national compulsory licensing schemes, subject to different conditions, scopes, and procedures. In addition, national compulsory licensing schemes are designed to meet the needs of the population of the issuing Member State and to satisfy the public interest of that Member State only. These purely national systems are unable to rely on cross-border value chains and therefore unfit to tackle EU crises.

This proposal is part of the EU patent package, which also provides for the introduction of a system for Unitary Supplementary Protection Certificates and an initiative on standard essential patents .

CONTENT: this proposal lays down the procedure and conditions for granting a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.

More specifically, it establishes Union compulsory licensing of the following intellectual property rights in force in one or more Member States:

- patents, including published patent applications;

- utility models; or

- supplementary protection certificates.

An effective EU compulsory licensing mechanism will:

- serve as an effective tool in crisis times as a last resort when voluntary agreements do not work;

- ensure an appropriate territorial reach of compulsory licensing to cover cross-border supply chains;

- build on EU crisis mechanisms.

Documents

  • Text adopted by Parliament, 1st reading/single reading: T9-0143/2024
  • Decision by Parliament, 1st reading: T9-0143/2024
  • Debate in Parliament: Debate in Parliament
  • Committee report tabled for plenary, 1st reading: A9-0042/2024
  • Committee opinion: PE753.730
  • Amendments tabled in committee: PE756.107
  • Committee draft report: PE753.706
  • Economic and Social Committee: opinion, report: CES2306/2023
  • Contribution: COM(2023)0224
  • Contribution: COM(2023)0224
  • Contribution: COM(2023)0224
  • Document attached to the procedure: SEC(2023)0173
  • Document attached to the procedure: EUR-Lex
  • Document attached to the procedure: SWD(2023)0120
  • Document attached to the procedure: EUR-Lex
  • Document attached to the procedure: SWD(2023)0121
  • Document attached to the procedure: EUR-Lex
  • Document attached to the procedure: SWD(2023)0122
  • Legislative proposal published: COM(2023)0224
  • Legislative proposal published: EUR-Lex
  • Document attached to the procedure: SEC(2023)0173
  • Document attached to the procedure: EUR-Lex SWD(2023)0120
  • Document attached to the procedure: EUR-Lex SWD(2023)0121
  • Document attached to the procedure: EUR-Lex SWD(2023)0122
  • Economic and Social Committee: opinion, report: CES2306/2023
  • Committee draft report: PE753.706
  • Amendments tabled in committee: PE756.107
  • Committee opinion: PE753.730
  • Text adopted by Parliament, 1st reading/single reading: T9-0143/2024
  • Contribution: COM(2023)0224
  • Contribution: COM(2023)0224
  • Contribution: COM(2023)0224

Votes

Octroi de licences obligatoires pour la gestion de crise et modification du règlement (CE) nº 816/2016 - Compulsory licensing for crisis management and amending Regulation (EC) 816/2006 - Zwangslizenzen für das Krisenmanagement sowie Änderung der Verordnung (EG) Nr. 816/2006 - A9-0042/2024 - Adrián Vázquez Lázara - Article 11 - Am 104 #

2024/03/13 Outcome: -: 340, +: 270, 0: 16
FR ES PT IE DE MT EL LU CY EE LV LT AT FI SK BE HR DK SI HU NL BG CZ SE RO IT PL
Total
74
57
20
13
86
4
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1
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A9-0042/2024 - Adrián Vázquez Lázara - Article 12, § 3 - Am 105 #

2024/03/13 Outcome: -: 352, +: 262, 0: 8
FR PT ES MT LU IE CY EE FI EL DE LV HR LT SK SI AT HU BE NL DK BG CZ SE IT RO PL
Total
74
20
56
4
5
13
1
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16
87
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A9-0042/2024 - Adrián Vázquez Lázara - Article 12, § 5 - Am 106 #

2024/03/13 Outcome: -: 347, +: 265, 0: 12
FR ES PT IE DE MT LU CY SK FI EL LV HR EE LT SI AT HU BE NL DK BG CZ SE RO IT PL
Total
73
56
20
13
86
4
5
1
12
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A9-0042/2024 - Adrián Vázquez Lázara - Article 12, § 6, partie introductive - Am 107 #

2024/03/13 Outcome: -: 345, +: 261, 0: 10
FR ES PT IE DE MT LU FI CY SK EL LV EE LT HR AT SI BE NL DK HU BG CZ SE RO IT PL
Total
72
57
19
13
86
4
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A9-0042/2024 - Adrián Vázquez Lázara - Article 12, § 6, point a - Am 108 #

2024/03/13 Outcome: -: 350, +: 264, 0: 7
FR ES PT IE LU MT CY DE EL LV HR EE LT FI SK SI AT HU BE NL DK BG CZ SE IT RO PL
Total
72
57
20
13
4
4
1
86
16
7
12
7
9
11
12
8
18
15
19
27
11
17
20
19
65
26
45
icon: S&D S&D
129

Luxembourg S&D

For (1)

1

Cyprus S&D

1

Greece S&D

1

Latvia S&D

2

Estonia S&D

2

Lithuania S&D

2

Slovakia S&D

For (1)

1

Slovenia S&D

2

Belgium S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
63

Spain Verts/ALE

3

Portugal Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Greece Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Austria Verts/ALE

2

Belgium Verts/ALE

3

Netherlands Verts/ALE

3

Denmark Verts/ALE

For (1)

1

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Italy Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: The Left The Left
32

Belgium The Left

For (1)

1

Netherlands The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Sweden The Left

For (1)

1
icon: NI NI
36

France NI

Against (1)

1

Germany NI

Against (1)

2

Latvia NI

1

Croatia NI

Against (1)

Abstain (1)

2

Belgium NI

For (1)

1

Netherlands NI

Against (1)

1

Czechia NI

Against (1)

1

Romania NI

Against (1)

1
icon: Renew Renew
89

Ireland Renew

2

Luxembourg Renew

For (1)

1

Greece Renew

Against (1)

1

Latvia Renew

Against (1)

1

Croatia Renew

For (1)

1

Estonia Renew

For (1)

Against (2)

3

Lithuania Renew

Against (1)

1

Finland Renew

2

Slovakia Renew

Against (1)

3

Slovenia Renew

2

Austria Renew

Against (1)

1

Hungary Renew

2

Belgium Renew

2

Bulgaria Renew

3

Sweden Renew

3

Poland Renew

1
icon: ID ID
51

Estonia ID

Against (1)

1

Austria ID

3

Denmark ID

Against (1)

1

Czechia ID

Against (1)

1
icon: ECR ECR
59

France ECR

Against (1)

1

Germany ECR

Against (1)

1

Greece ECR

Against (1)

1

Croatia ECR

Against (1)

1

Finland ECR

1

Slovakia ECR

Against (1)

1

Bulgaria ECR

2

Sweden ECR

3

Romania ECR

Abstain (1)

1
icon: PPE PPE
162

Luxembourg PPE

Against (1)

1

Malta PPE

Against (1)

1

Latvia PPE

3

Estonia PPE

Against (1)

1

Slovakia PPE

3

Slovenia PPE

4

Hungary PPE

Against (1)

1

Denmark PPE

Against (1)

1

A9-0042/2024 - Adrián Vázquez Lázara - Considérant 3 - Am 100 #

2024/03/13 Outcome: -: 347, +: 262, 0: 12
FR PT ES DE IE MT LU CY FI EL LV HR EE LT SK NL SI AT HU BE DK BG CZ SE RO IT PL
Total
72
20
55
87
13
4
5
1
10
16
7
12
7
9
12
27
8
18
15
19
11
17
20
19
27
64
46
icon: S&D S&D
129

Luxembourg S&D

For (1)

1

Cyprus S&D

1

Greece S&D

1

Latvia S&D

2

Estonia S&D

2

Lithuania S&D

2

Slovakia S&D

For (1)

1

Slovenia S&D

2

Belgium S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
63

Portugal Verts/ALE

1

Spain Verts/ALE

3

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Finland Verts/ALE

3

Greece Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Netherlands Verts/ALE

3

Austria Verts/ALE

2

Belgium Verts/ALE

3

Denmark Verts/ALE

For (1)

1

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Italy Verts/ALE

2

Poland Verts/ALE

For (1)

1
icon: The Left The Left
32

Netherlands The Left

For (1)

1

Belgium The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Sweden The Left

For (1)

1
icon: NI NI
36

France NI

Against (1)

1

Germany NI

Against (1)

2

Latvia NI

1

Croatia NI

Against (1)

Abstain (1)

2

Netherlands NI

Against (1)

1

Belgium NI

For (1)

1

Czechia NI

Against (1)

1

Romania NI

Against (1)

1
icon: Renew Renew
87

Ireland Renew

2

Luxembourg Renew

For (1)

Against (1)

2

Finland Renew

Against (1)

1

Greece Renew

Against (1)

1

Latvia Renew

Against (1)

1

Croatia Renew

For (1)

1

Estonia Renew

For (1)

Against (2)

3

Lithuania Renew

Against (1)

1

Slovakia Renew

Against (1)

3

Slovenia Renew

2

Austria Renew

Against (1)

1

Hungary Renew

2

Belgium Renew

2

Bulgaria Renew

3

Sweden Renew

3

Poland Renew

1
icon: ID ID
52

Estonia ID

Against (1)

1

Austria ID

3

Denmark ID

Against (1)

1

Czechia ID

Against (1)

1
icon: ECR ECR
60

France ECR

Against (1)

1

Germany ECR

Against (1)

1

Finland ECR

1

Greece ECR

Against (1)

1

Croatia ECR

Against (1)

1

Slovakia ECR

Against (1)

1

Bulgaria ECR

2

Sweden ECR

3

Romania ECR

Abstain (1)

1
icon: PPE PPE
162

Malta PPE

Against (1)

1

Luxembourg PPE

Against (1)

1

Latvia PPE

3

Estonia PPE

Against (1)

1

Slovakia PPE

3

Netherlands PPE

Abstain (1)

5

Slovenia PPE

4

Hungary PPE

Against (1)

1

Denmark PPE

Against (1)

1

A9-0042/2024 - Adrián Vázquez Lázara - Considérant 28 - Am 101 #

2024/03/13 Outcome: -: 347, +: 267, 0: 10
FR ES PT IE DE MT LU CY SK EL LV HR EE LT FI BE SI AT HU NL DK BG CZ SE RO IT PL
Total
74
57
20
13
86
4
5
1
12
16
7
12
7
9
11
19
8
18
15
27
11
17
20
19
26
65
45
icon: S&D S&D
130

Luxembourg S&D

For (1)

1

Cyprus S&D

1

Slovakia S&D

For (1)

1

Greece S&D

1

Latvia S&D

2

Estonia S&D

2

Lithuania S&D

2

Belgium S&D

2

Slovenia S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
64

Spain Verts/ALE

3

Portugal Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Greece Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Belgium Verts/ALE

3

Austria Verts/ALE

2

Netherlands Verts/ALE

3

Denmark Verts/ALE

For (1)

1

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Italy Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: The Left The Left
32

Belgium The Left

For (1)

1

Netherlands The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Sweden The Left

For (1)

1
icon: NI NI
36

France NI

Against (1)

1

Germany NI

Against (1)

2

Latvia NI

1

Croatia NI

Against (1)

Abstain (1)

2

Belgium NI

For (1)

1

Netherlands NI

Against (1)

1

Czechia NI

Against (1)

1

Romania NI

Against (1)

1
icon: Renew Renew
89

Ireland Renew

2

Luxembourg Renew

For (1)

Against (1)

2

Slovakia Renew

Against (1)

3

Greece Renew

Against (1)

1

Latvia Renew

Against (1)

1

Croatia Renew

For (1)

1

Estonia Renew

For (1)

Against (2)

3

Lithuania Renew

Against (1)

1

Finland Renew

2

Belgium Renew

2

Slovenia Renew

2

Austria Renew

Against (1)

1

Hungary Renew

2

Bulgaria Renew

3

Sweden Renew

3

Poland Renew

1
icon: ID ID
52

Estonia ID

Against (1)

1

Belgium ID

For (1)

3

Austria ID

3

Denmark ID

Against (1)

1

Czechia ID

Against (1)

1
icon: ECR ECR
59

France ECR

Against (1)

1

Germany ECR

Against (1)

1

Slovakia ECR

Against (1)

1

Greece ECR

Against (1)

1

Croatia ECR

Against (1)

1

Finland ECR

1

Bulgaria ECR

2

Sweden ECR

3

Romania ECR

Abstain (1)

1
icon: PPE PPE
162

Ireland PPE

Abstain (1)

5

Malta PPE

Against (1)

1

Luxembourg PPE

Against (1)

1

Slovakia PPE

3

Latvia PPE

3

Estonia PPE

Against (1)

1

Slovenia PPE

4

Hungary PPE

Against (1)

1

Denmark PPE

Against (1)

1

A9-0042/2024 - Adrián Vázquez Lázara - Considérant 29 - Am 102 #

2024/03/13 Outcome: -: 351, +: 262, 0: 8
FR ES PT IE MT LU CY DE EL LV HR EE LT FI SK SI AT HU BE NL DK BG CZ SE RO IT PL
Total
71
57
20
12
4
5
1
86
16
7
12
7
9
11
12
8
18
15
19
27
11
16
20
19
27
65
46
icon: S&D S&D
129

Luxembourg S&D

For (1)

1

Cyprus S&D

1

Greece S&D

1

Latvia S&D

2

Estonia S&D

2

Lithuania S&D

2

Slovakia S&D

For (1)

1

Slovenia S&D

2

Belgium S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
63

Spain Verts/ALE

3

Portugal Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Greece Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Austria Verts/ALE

2

Belgium Verts/ALE

3

Netherlands Verts/ALE

3

Denmark Verts/ALE

For (1)

1

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Italy Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: The Left The Left
32

Belgium The Left

For (1)

1

Netherlands The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Sweden The Left

For (1)

1
icon: NI NI
36

France NI

Against (1)

1

Germany NI

Against (1)

2

Latvia NI

1

Croatia NI

Against (1)

Abstain (1)

2

Belgium NI

For (1)

1

Netherlands NI

Against (1)

1

Czechia NI

Against (1)

1

Romania NI

Against (1)

1
icon: Renew Renew
88

Ireland Renew

For (1)

1

Luxembourg Renew

For (1)

Against (1)

2

Greece Renew

Against (1)

1

Latvia Renew

Against (1)

1

Croatia Renew

For (1)

1

Estonia Renew

For (1)

Against (2)

3

Lithuania Renew

Against (1)

1

Finland Renew

2

Slovakia Renew

Against (1)

3

Slovenia Renew

2

Austria Renew

Against (1)

1

Hungary Renew

2

Belgium Renew

2

Bulgaria Renew

3

Sweden Renew

3

Poland Renew

1
icon: ID ID
52

Estonia ID

Against (1)

1

Austria ID

3

Denmark ID

Against (1)

1

Czechia ID

Against (1)

1
icon: ECR ECR
60

France ECR

Against (1)

1

Germany ECR

Against (1)

1

Greece ECR

Against (1)

1

Croatia ECR

Against (1)

1

Finland ECR

1

Slovakia ECR

Against (1)

1

Bulgaria ECR

2

Sweden ECR

3

Romania ECR

Abstain (1)

1
icon: PPE PPE
161

Ireland PPE

Abstain (1)

5

Malta PPE

Against (1)

1

Luxembourg PPE

Against (1)

1

Latvia PPE

3

Estonia PPE

Against (1)

1

Slovakia PPE

3

Slovenia PPE

4

Hungary PPE

Against (1)

1

Denmark PPE

Against (1)

1

A9-0042/2024 - Adrián Vázquez Lázara - Considérant 30 - Am 103 #

2024/03/13 Outcome: -: 343, +: 264, 0: 11
FR ES PT IE DE MT LU CY SK EL LV EE LT FI HR NL BE SI AT HU DK BG CZ SE RO IT PL
Total
74
57
20
13
86
4
5
1
12
16
7
7
9
11
11
25
19
8
18
15
11
16
20
19
25
65
44
icon: S&D S&D
128

Luxembourg S&D

For (1)

1

Cyprus S&D

1

Slovakia S&D

For (1)

1

Greece S&D

1

Latvia S&D

2

Estonia S&D

2

Lithuania S&D

2

Belgium S&D

2

Slovenia S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
64

Spain Verts/ALE

3

Portugal Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Greece Verts/ALE

For (1)

1

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Netherlands Verts/ALE

3

Belgium Verts/ALE

3

Austria Verts/ALE

2

Denmark Verts/ALE

For (1)

1

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Italy Verts/ALE

3

Poland Verts/ALE

For (1)

1
icon: The Left The Left
32

Netherlands The Left

For (1)

1

Belgium The Left

For (1)

1

Denmark The Left

1

Czechia The Left

1

Sweden The Left

For (1)

1
icon: NI NI
36

France NI

Against (1)

1

Germany NI

Against (1)

2

Latvia NI

1

Croatia NI

Against (1)

Abstain (1)

2

Netherlands NI

Against (1)

1

Belgium NI

For (1)

1

Czechia NI

Against (1)

1

Romania NI

Against (1)

1
icon: Renew Renew
89

Ireland Renew

2

Luxembourg Renew

For (1)

Against (1)

2

Slovakia Renew

Against (1)

3

Greece Renew

Against (1)

1

Latvia Renew

Against (1)

1

Estonia Renew

For (1)

Against (2)

3

Lithuania Renew

Against (1)

1

Finland Renew

2

Croatia Renew

For (1)

1

Belgium Renew

2

Slovenia Renew

2

Austria Renew

Against (1)

1

Hungary Renew

2

Bulgaria Renew

3

Sweden Renew

3

Poland Renew

1
icon: ID ID
53

Estonia ID

Against (1)

1

Austria ID

3

Denmark ID

Against (1)

1

Czechia ID

Against (1)

1
icon: ECR ECR
58

France ECR

Against (1)

1

Germany ECR

Against (1)

1

Slovakia ECR

Against (1)

1

Greece ECR

Against (1)

1

Finland ECR

1

Croatia ECR

Against (1)

1

Netherlands ECR

3

Bulgaria ECR

2

Sweden ECR

3

Romania ECR

Abstain (1)

1
icon: PPE PPE
158

Ireland PPE

Abstain (1)

5

Malta PPE

Against (1)

1

Luxembourg PPE

Against (1)

1

Slovakia PPE

3

Latvia PPE

3

Estonia PPE

Against (1)

1

Belgium PPE

Abstain (1)

4

Slovenia PPE

4

Hungary PPE

Against (1)

1

Denmark PPE

Against (1)

1

A9-0042/2024 - Adrián Vázquez Lázara - Proposition de la Commission #

2024/03/13 Outcome: +: 484, -: 121, 0: 20
DE PL ES FR RO NL BG PT IT IE AT BE LT FI CZ EL SI HR LV SK LU EE MT HU CY DK SE
Total
87
46
56
74
27
27
17
20
64
13
18
19
9
11
20
16
8
12
7
12
5
7
4
15
1
11
19
icon: PPE PPE
162

Slovakia PPE

Abstain (1)

3

Luxembourg PPE

For (1)

1

Estonia PPE

For (1)

1

Malta PPE

For (1)

1

Hungary PPE

1

Denmark PPE

Against (1)

1
icon: S&D S&D
130

Belgium S&D

2

Lithuania S&D

2

Czechia S&D

For (1)

1

Greece S&D

1

Slovenia S&D

2

Latvia S&D

2

Slovakia S&D

For (1)

1

Luxembourg S&D

For (1)

1

Estonia S&D

2

Cyprus S&D

1
icon: Verts/ALE Verts/ALE
64

Poland Verts/ALE

For (1)

1

Spain Verts/ALE

3

Netherlands Verts/ALE

3

Portugal Verts/ALE

1

Italy Verts/ALE

3

Ireland Verts/ALE

2

Austria Verts/ALE

2

Belgium Verts/ALE

3

Lithuania Verts/ALE

2

Finland Verts/ALE

3

Czechia Verts/ALE

3

Greece Verts/ALE

For (1)

1

Luxembourg Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Sweden Verts/ALE

2
icon: Renew Renew
89

Poland Renew

1

Ireland Renew

2

Austria Renew

For (1)

1

Belgium Renew

2

Lithuania Renew

1

Finland Renew

2

Greece Renew

1

Slovenia Renew

2

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovakia Renew

3

Luxembourg Renew

2

Estonia Renew

3

Hungary Renew

2

Sweden Renew

Against (1)

3
icon: The Left The Left
32

Netherlands The Left

For (1)

1

Portugal The Left

4

Belgium The Left

Against (1)

1

Czechia The Left

Abstain (1)

1

Denmark The Left

1

Sweden The Left

For (1)

1
icon: ECR ECR
60

Germany ECR

1

France ECR

Against (1)

1

Romania ECR

Abstain (1)

1

Netherlands ECR

Against (2)

Abstain (1)

5

Bulgaria ECR

2

Finland ECR

1

Greece ECR

Abstain (1)

1

Croatia ECR

Abstain (1)

1

Slovakia ECR

Abstain (1)

1

Sweden ECR

3
icon: NI NI
36

Germany NI

2

France NI

Against (1)

1

Romania NI

For (1)

1

Netherlands NI

Against (1)

1

Belgium NI

For (1)

1

Czechia NI

For (1)

1

Croatia NI

Against (1)

Abstain (1)

2

Latvia NI

1
icon: ID ID
52

Austria ID

3

Czechia ID

Against (1)

1

Estonia ID

Against (1)

1

Denmark ID

Against (1)

1
AmendmentsDossier
337 2023/0129(COD)
2023/10/30 INTA 88 amendments...
source: 754.992
2023/11/14 JURI 249 amendments...
source: 756.107

History

(these mark the time of scraping, not the official date of the change)

docs/8
date
2024-03-13T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0143_EN.html title: T9-0143/2024
type
Text adopted by Parliament, 1st reading/single reading
body
EP
events/5
date
2024-03-12T00:00:00
type
Debate in Parliament
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/CRE-9-2024-03-12-TOC_EN.html title: Debate in Parliament
events/6
date
2024-03-13T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0143_EN.html title: T9-0143/2024
links
Research document
procedure/stage_reached
Old
Awaiting Parliament's position in 1st reading
New
Awaiting Council's 1st reading position
docs/8
date
2024-03-13T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0143_EN.html title: T9-0143/2024
type
Text adopted by Parliament, 1st reading/single reading
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EP
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date
2024-03-12T00:00:00
type
Debate in Parliament
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EP
docs
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events/6
date
2024-03-13T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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events/4/summary
  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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EP
events/4/summary
  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
forecasts/0
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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  • The Committee on Legal Affairs adopted the report by Adrián VÁZQUEZ LÁZARA (Renew, ES) 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.
  • The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
  • Subject matter
  • This Regulation has the objective to ensure that a temporary and non-exclusive Union compulsory license may be granted to protect the public interest in the context of cross-border crisis or emergency situations in the Union.
  • The Regulation aims to lay down rules on the procedure and conditions for the granting as a last resort of a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • Union compulsory licence
  • The Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode in case no voluntary agreement with a view to ensuring the supply of crisis-relevant products has been reached between right-holder and the potential licensee within four weeks.
  • The Union compulsory license that may be granted by the Commission should:
  • - have a strict limitation concerning scope, field of use, necessary quantities, and a duration that is fully in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union;
  • - be strictly limited to the relevant and properly justified activities of crisis-relevant products in the Union;
  • - only be granted against payment of an adequate remuneration to the rights-holder;
  • - be strictly limited to the precisely defined territory of the Union;
  • - clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, excluding the rights-holder from product liability claims.
  • Advisory body
  • The advisory body responsible for the EU crisis or emergency mechanism should assist and advise the Commission in identifying and consulting right-holders or their representatives and potential licensees and in consulting other stakeholders and economic operators, including industry, academia and civil society.
  • The Commission should invite representatives of the European Parliament as observers to the relevant meetings of the advisory bodies, where possible. It should take the utmost account of the opinion of the advisory body. Where the Commission does not follow the opinion of the advisory body, it shall explain the reasons for its decision to the advisory body.
  • Remuneration
  • The amended text stipulated that the rights-holder should receive the remuneration within a pre-established timeframe as agreed with the Commission. The remuneration should be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.
  • Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. In such cases, rights holders should receive an adequate remuneration.
  • Obligations to be fulfilled by the licensee
  • Information acquired in relation to the Union compulsory licence should be treated with utmost confidentiality, refraining, in particular, from making trade secrets available to a third party without the consent of the Commission, which should inform and consult the rights-holder in this regard.
  • Additional measures complementing the Union compulsory licence
  • Where necessary, the Commission should decide, upon a reasoned request from the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee.
  • Where strictly necessary, the Commission should request the disclosure of the rights-holder’s trade secrets to the licensee to the extent required to provide him with the necessary know-how to achieve the objective for which the Union compulsory licence is granted under this Regulation. The lawful uses of the trade secrets by the licensee should be strictly limited to the manufacturing of the crisis-relevant products in view of fulfilling the objective for which the Union compulsory licence has been granted.
  • Where the rights-holder is requested to disclose his trade secrets, the Commission should, prior to the disclosure of trade secrets, order the licensee to put in place all appropriate technical and organisational measures that the rights-holder reasonably identifies as necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties.
  • If the licensee fails to implement the necessary measures required by the Commission, the Commission may withhold or, as the case may be, suspend the disclosure of trade secrets until the situation is corrected by the licensee.
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  • PURPOSE: to establish a new EU-wide compulsory licensing instrument.
  • PROPOSED ACT: Regulation of the European Parliament and of the Council.
  • ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
  • BACKGROUND: crises require the setting-up of exceptional, swift, and adequate measures able to provide means to address the consequences of the crisis. In this context, the use of patented products or processes could prove indispensable to address the consequences of a crisis.
  • The COVID-19 crisis highlighted that an appropriate balance between patent rights and other rights and interests is a staple of the patent system. During the COVID-19 crisis, the conflicting interests were access to health products and preserving innovation incentives that are key to developing new health products, such as vaccines and therapeutics. The pandemic added another element to the discussion: the role intellectual property rights could and should play in a crisis.
  • Voluntary licensing agreements usually suffice to licence the patent rights on these products and allow their supply in the Union territory. However, they may not always be available or only under inadequate conditions such as lengthy delivery times. In such cases, compulsory licensing can provide a solution to allow access to patented products, in particular products necessary to tackle the consequences of a crisis.
  • It is therefore important that, in the context of said crisis mechanisms, the Union can rely on an efficient and effective compulsory licensing scheme at Union level, which is uniformly applicable within the Union.
  • Currently, legislation on compulsory licensing of patents in the EU is fragmented: EU countries regulate their own national compulsory licensing schemes, subject to different conditions, scopes, and procedures. In addition, national compulsory licensing schemes are designed to meet the needs of the population of the issuing Member State and to satisfy the public interest of that Member State only. These purely national systems are unable to rely on cross-border value chains and therefore unfit to tackle EU crises.
  • This proposal is part of the EU patent package, which also provides for the introduction of a system for Unitary Supplementary Protection Certificates and an initiative on standard essential patents .
  • CONTENT: this proposal lays down the procedure and conditions for granting a Union compulsory licence of intellectual property rights that are necessary for the supply of crisis-relevant products to the Member States in the context of a Union crisis or emergency mechanism.
  • More specifically, it establishes Union compulsory licensing of the following intellectual property rights in force in one or more Member States:
  • - patents, including published patent applications;
  • - utility models; or
  • - supplementary protection certificates.
  • An effective EU compulsory licensing mechanism will:
  • - serve as an effective tool in crisis times as a last resort when voluntary agreements do not work;
  • - ensure an appropriate territorial reach of compulsory licensing to cover cross-border supply chains;
  • - build on EU crisis mechanisms.
procedure/title
Old
Pharmaceutical products: compulsory licensing for crisis management
New
Compulsory licensing of patents in crisis situations