# Official Journal C 11/2020

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 11 |
| | |
| English edition | Information and Notices | Volume 6313 January 2020 |

ISSN 1977-091X

Official Journal

of the European Union

C 11

English edition

Information and Notices

Volume 6313 January 2020

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| Contents | page |
| --- | --- |
| | |
| | EUROPEAN PARLIAMENT
  2018-2019 SESSIONSittings of 1 to 4 October 2018
  The Minutes of this session have been published in OJ C 260, 2.8.2019 .
  TEXTS ADOPTED | 1 |

Contents

page

EUROPEAN PARLIAMENT
  2018-2019 SESSIONSittings of 1 to 4 October 2018
  The Minutes of this session have been published in OJ C 260, 2.8.2019 .
  TEXTS ADOPTED

EUROPEAN PARLIAMENT

The Minutes of this session have been published in OJ C 260, 2.8.2019 .

1

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| | I   Resolutions, recommendations and opinions |
| --- | --- |
| | RESOLUTIONS |
| | European Parliament |
| 2020/C 011/02 | European Parliament resolution of 3 October 2018 on International Financial Reporting Standards: IFRS 17 Insurance Contracts (2018/2689(RSP)) | 2 |
| | RESOLUTIONS |
| 2020/C 011/03 | European Parliament resolution of 3 October 2018 on distributed ledger technologies and blockchains: building trust with disintermediation (2017/2772(RSP)) | 7 |
| 2020/C 011/04 | European Parliament resolution of 3 October 2018 on addressing the specific needs of rural, mountainous and remote areas (2018/2720(RSP)) | 15 |
| 2020/C 011/05 | European Parliament resolution of 4 October 2018 on the deterioration of media freedom in Belarus, notably the case of Charter 97 (2018/2861(RSP)) | 18 |
| 2020/C 011/06 | European Parliament resolution of 4 October 2018 on the UAE, notably the situation of human rights defender Ahmed Mansoor (2018/2862(RSP)) | 21 |
| 2020/C 011/07 | European Parliament resolution of 4 October 2018 on mass arbitrary detention of Uyghurs and Kazakhs in the Xinjiang Uyghur Autonomous Region (2018/2863(RSP)) | 25 |
| 2020/C 011/08 | European Parliament resolution of 4 October 2018 on the public procurement strategy package (2017/2278(INI)) | 28 |
| 2020/C 011/09 | European Parliament resolution of 4 October 2018 on the EU’s input to a UN Binding Instrument on transnational corporations and other business enterprises with transnational characteristics with respect to human rights (2018/2763(RSP)) | 36 |
| 2020/C 011/10 | P8_TA(2018)0383 Situation in Yemen European Parliament resolution of 4 October 2018 on the situation in Yemen (2018/2853(RSP)) | 44 |
| 2020/C 011/11 | European Parliament resolution of 4 October 2018 on fighting customs fraud and protecting EU own resources (2018/2747(RSP)) | 50 |

I   Resolutions, recommendations and opinions

RESOLUTIONS

European Parliament

2020/C 011/02

European Parliament resolution of 3 October 2018 on International Financial Reporting Standards: IFRS 17 Insurance Contracts (2018/2689(RSP))

2

RESOLUTIONS

2020/C 011/03

European Parliament resolution of 3 October 2018 on distributed ledger technologies and blockchains: building trust with disintermediation (2017/2772(RSP))

7

2020/C 011/04

European Parliament resolution of 3 October 2018 on addressing the specific needs of rural, mountainous and remote areas (2018/2720(RSP))

15

2020/C 011/05

European Parliament resolution of 4 October 2018 on the deterioration of media freedom in Belarus, notably the case of Charter 97 (2018/2861(RSP))

18

2020/C 011/06

European Parliament resolution of 4 October 2018 on the UAE, notably the situation of human rights defender Ahmed Mansoor (2018/2862(RSP))

21

2020/C 011/07

European Parliament resolution of 4 October 2018 on mass arbitrary detention of Uyghurs and Kazakhs in the Xinjiang Uyghur Autonomous Region (2018/2863(RSP))

25

2020/C 011/08

European Parliament resolution of 4 October 2018 on the public procurement strategy package (2017/2278(INI))

28

2020/C 011/09

European Parliament resolution of 4 October 2018 on the EU’s input to a UN Binding Instrument on transnational corporations and other business enterprises with transnational characteristics with respect to human rights (2018/2763(RSP))

36

2020/C 011/10

P8_TA(2018)0383 Situation in Yemen European Parliament resolution of 4 October 2018 on the situation in Yemen (2018/2853(RSP))

44

2020/C 011/11

European Parliament resolution of 4 October 2018 on fighting customs fraud and protecting EU own resources (2018/2747(RSP))

50

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| | II   Information |
| --- | --- |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2020/C 011/12 | European Parliament decision of 2 October 2018 on the request for waiver of the immunity of Georgios Kyrtsos (2018/2069(IMM)) | 53 |

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2020/C 011/12

European Parliament decision of 2 October 2018 on the request for waiver of the immunity of Georgios Kyrtsos (2018/2069(IMM))

53

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| | III   Preparatory acts |
| --- | --- |
| | EUROPEAN PARLIAMENT |
| 2020/C 011/13 | P8_TA(2018)0359 Third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement ***I European Parliament legislative resolution of 2 October 2018 on the proposal for a regulation of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) (COM(2018)0139 – C8-0116/2018 – 2018/0066(COD)) | 55 |
| P8_TC1-COD(2018)0066 Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) | 56 |
| 2020/C 011/14 | European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Agreement for scientific and technological cooperation between the European Union and the Kingdom of Morocco setting out the terms and conditions for the participation of the Kingdom of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) (06534/2018 – C8-0150/2018 – 2018/0036(NLE)) | 57 |
| 2020/C 011/15 | European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Air Transport Agreement between the European Community and its Member States, of the one part, and Canada, of the other part (06730/2018 – C8-0160/2018 – 2009/0018(NLE)) | 58 |
| 2020/C 011/16 | European Parliament legislative resolution of 2 October 2018 on the proposal for a Council directive amending Directives 2006/112/EC and 2008/118/EC as regards the inclusion of the Italian municipality of Campione d’Italia and the Italian waters of Lake Lugano in the customs territory of the Union and in the territorial application of Directive 2008/118/EC (COM(2018)0261 – C8-0226/2018 – 2018/0124(CNS)) | 59 |
| 2020/C 011/17 | European Parliament resolution of 2 October 2018 on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund (application from the Netherlands – EGF/2018/001 NL/Financial service activities) (COM(2018)0548 – C8-0392/2018 – 2018/2220(BUD)) | 60 |
| 2020/C 011/18 | European Parliament legislative resolution of 2 October 2018 on the proposal for a directive of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services in view of changing market realities (COM(2016)0287 – C8-0193/2016 – 2016/0151(COD)) | 64 |
| P8_TC1-COD(2016)0151Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Directive (EU) 2018/... of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) in view of changing market realities | 65 |
| 2020/C 011/19 | European Parliament resolution of 2 October 2018 on the Council position on Draft amending budget No 5/2018 of the European Union for the financial year 2018, Section III – Commission: Cancellation of the reserve related to the support to Turkey from the Instrument for Pre-Accession (IPA II), reinforcement of the European Neighbourhood Instrument (ENI) and of the Humanitarian Aid for other urgent actions and modification of the establishment plan of the Innovation and Networks Executive Agency (INEA) in the context of the WiFi4EU initiative (11843/2018 – C8-0415/2018 – 2018/2165(BUD)) | 66 |
| 2020/C 011/20 | European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards harmonising and simplifying certain rules in the value added tax system and introducing the definitive system for the taxation of trade between Member States (COM(2017)0569 – C8-0363/2017 – 2017/0251(CNS)) | 69 |
| 2020/C 011/21 | European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC on the common system of value added tax as regards the period of application of the optional reverse charge mechanism in relation to supplies of certain goods and services susceptible to fraud and of the Quick Reaction Mechanism against VAT fraud (COM(2018)0298 – C8-0265/2018 – 2018/0150(CNS)) | 92 |
| 2020/C 011/22 | European Parliament legislative resolution of 3 October 2018 on the proposal for a Council regulation amending Regulation (EU) No 389/2012 on administrative cooperation in the field of excise duties as regards the content of electronic register (COM(2018)0349 – C8-0371/2018 – 2018/0181(CNS)) | 93 |
| 2020/C 011/23 | Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)) 1 1 | 94 |
| 2020/C 011/24 | Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council setting emission performance standards for new passenger cars and for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles and amending Regulation (EC) No 715/2007 (recast) (COM(2017)0676 – C8-0395/2017 – 2017/0293(COD)) 1 1 | 177 |
| 2020/C 011/25 | European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards rates of value added tax (COM(2018)0020 – C8-0023/2018 – 2018/0005(CNS)) | 211 |
| 2020/C 011/26 | P8_TA(2018)0379 EU Agency for Criminal Justice Cooperation (Eurojust) ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust) (COM(2013)0535 – C7-0240/2013 – 2013/0256(COD)) | 222 |
| P8_TC1-COD(2013)0256 Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA | 223 |
| 2020/C 011/27 | P8_TA(2018)0380 Mutual recognition of freezing and confiscation orders ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the mutual recognition of freezing and confiscation orders (COM(2016)0819 – C8-0002/2017 – 2016/0412(COD)) | 224 |
| P8_TC1-COD(2016)0412 Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the mutual recognition of freezing orders and confiscation orders | 225 |
| 2020/C 011/28 | P8_TA(2018)0381 Free flow of non-personal data in the European Union ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union (COM(2017)0495 – C8-0312/2017 – 2017/0228(COD)) | 226 |
| P8_TC1-COD(2017)0228Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union | 227 |

III   Preparatory acts

EUROPEAN PARLIAMENT

2020/C 011/13

P8_TA(2018)0359 Third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement ***I European Parliament legislative resolution of 2 October 2018 on the proposal for a regulation of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) (COM(2018)0139 – C8-0116/2018 – 2018/0066(COD))

55

P8_TC1-COD(2018)0066 Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification)

56

2020/C 011/14

European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Agreement for scientific and technological cooperation between the European Union and the Kingdom of Morocco setting out the terms and conditions for the participation of the Kingdom of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) (06534/2018 – C8-0150/2018 – 2018/0036(NLE))

57

2020/C 011/15

European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Air Transport Agreement between the European Community and its Member States, of the one part, and Canada, of the other part (06730/2018 – C8-0160/2018 – 2009/0018(NLE))

58

2020/C 011/16

European Parliament legislative resolution of 2 October 2018 on the proposal for a Council directive amending Directives 2006/112/EC and 2008/118/EC as regards the inclusion of the Italian municipality of Campione d’Italia and the Italian waters of Lake Lugano in the customs territory of the Union and in the territorial application of Directive 2008/118/EC (COM(2018)0261 – C8-0226/2018 – 2018/0124(CNS))

59

2020/C 011/17

European Parliament resolution of 2 October 2018 on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund (application from the Netherlands – EGF/2018/001 NL/Financial service activities) (COM(2018)0548 – C8-0392/2018 – 2018/2220(BUD))

60

2020/C 011/18

European Parliament legislative resolution of 2 October 2018 on the proposal for a directive of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services in view of changing market realities (COM(2016)0287 – C8-0193/2016 – 2016/0151(COD))

64

P8_TC1-COD(2016)0151Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Directive (EU) 2018/... of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) in view of changing market realities

65

2020/C 011/19

European Parliament resolution of 2 October 2018 on the Council position on Draft amending budget No 5/2018 of the European Union for the financial year 2018, Section III – Commission: Cancellation of the reserve related to the support to Turkey from the Instrument for Pre-Accession (IPA II), reinforcement of the European Neighbourhood Instrument (ENI) and of the Humanitarian Aid for other urgent actions and modification of the establishment plan of the Innovation and Networks Executive Agency (INEA) in the context of the WiFi4EU initiative (11843/2018 – C8-0415/2018 – 2018/2165(BUD))

66

2020/C 011/20

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards harmonising and simplifying certain rules in the value added tax system and introducing the definitive system for the taxation of trade between Member States (COM(2017)0569 – C8-0363/2017 – 2017/0251(CNS))

69

2020/C 011/21

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC on the common system of value added tax as regards the period of application of the optional reverse charge mechanism in relation to supplies of certain goods and services susceptible to fraud and of the Quick Reaction Mechanism against VAT fraud (COM(2018)0298 – C8-0265/2018 – 2018/0150(CNS))

92

2020/C 011/22

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council regulation amending Regulation (EU) No 389/2012 on administrative cooperation in the field of excise duties as regards the content of electronic register (COM(2018)0349 – C8-0371/2018 – 2018/0181(CNS))

93

2020/C 011/23

Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)) 1 1

1 1

94

2020/C 011/24

Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council setting emission performance standards for new passenger cars and for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles and amending Regulation (EC) No 715/2007 (recast) (COM(2017)0676 – C8-0395/2017 – 2017/0293(COD)) 1 1

1 1

177

2020/C 011/25

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards rates of value added tax (COM(2018)0020 – C8-0023/2018 – 2018/0005(CNS))

211

2020/C 011/26

P8_TA(2018)0379 EU Agency for Criminal Justice Cooperation (Eurojust) ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust) (COM(2013)0535 – C7-0240/2013 – 2013/0256(COD))

222

P8_TC1-COD(2013)0256 Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA

223

2020/C 011/27

P8_TA(2018)0380 Mutual recognition of freezing and confiscation orders ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the mutual recognition of freezing and confiscation orders (COM(2016)0819 – C8-0002/2017 – 2016/0412(COD))

224

P8_TC1-COD(2016)0412 Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the mutual recognition of freezing orders and confiscation orders

225

2020/C 011/28

P8_TA(2018)0381 Free flow of non-personal data in the European Union ***I European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union (COM(2017)0495 – C8-0312/2017 – 2017/0228(COD))

226

P8_TC1-COD(2017)0228Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union

227

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EN

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13.1.2020

| 13.1.2020 | EN | Official Journal of the European Union | C 11/1 |
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EN

Official Journal of the European Union

C 11/1

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EUROPEAN PARLIAMENT

2018-2019 SESSION

Sittings of 1 to 4 October 2018

The Minutes of this session have been published in OJ C 260, 2.8.2019.

TEXTS ADOPTED

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I Resolutions, recommendations and opinions

RESOLUTIONS

European Parliament

| 13.1.2020 | EN | Official Journal of the European Union | C 11/2 |
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13.1.2020

EN

Official Journal of the European Union

C 11/2

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P8_TA(2018)0372

International Financial Reporting Standards: IFRS 17 Insurance Contracts

European Parliament resolution of 3 October 2018 on International Financial Reporting Standards: IFRS 17 Insurance Contracts (2018/2689(RSP))

(2020/C 011/02)

The European Parliament,

| — | having regard to Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (1), |
| --- | --- |

—

having regard to Regulation (EC) No 1606/2002 of the European Parliament and of the Council of 19 July 2002 on the application of international accounting standards (1),

| — | having regard to Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (2), |
| --- | --- |

—

having regard to Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (2),

| — | having regard to Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (3), |
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—

having regard to Council Directive 91/674/EEC of 19 December 1991 on the annual accounts and consolidated accounts of insurance undertakings (3),

| — | having regard to Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (4), |
| --- | --- |

—

having regard to Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (4),

| — | having regard to the Commission Delegated Regulation (EU) 2015/35 of 10 October 2014 supplementing Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (5), |
| --- | --- |

—

having regard to the Commission Delegated Regulation (EU) 2015/35 of 10 October 2014 supplementing Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (5),

| — | having regard to International Financial Reporting Standard (IFRS) 17 Insurance Contracts, issued by the International Accounting Standards Board (IASB) on 18 May 2017, |
| --- | --- |

—

having regard to International Financial Reporting Standard (IFRS) 17 Insurance Contracts, issued by the International Accounting Standards Board (IASB) on 18 May 2017,

| — | having regard to the report by Philippe Maystadt of October 2013 entitled ‘Should IFRS standards be more “European”?’, |
| --- | --- |

—

having regard to the report by Philippe Maystadt of October 2013 entitled ‘Should IFRS standards be more “European”?’,

| — | having regard to its resolution of 7 June 2016 on International Accounting Standards (IAS) evaluation and the activities of the International Financial Reporting Standards (IFRS) Foundation, the European Financial Reporting Advisory Group (EFRAG) and the Public Interest Oversight Board (PIOB) (6), |
| --- | --- |

—

having regard to its resolution of 7 June 2016 on International Accounting Standards (IAS) evaluation and the activities of the International Financial Reporting Standards (IFRS) Foundation, the European Financial Reporting Advisory Group (EFRAG) and the Public Interest Oversight Board (PIOB) (6),

| — | having regard to its resolution of 6 October 2016 on International Financial Reporting Standards: IFRS 9 (7), |
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—

having regard to its resolution of 6 October 2016 on International Financial Reporting Standards: IFRS 9 (7),

| — | having regard to the Commission consultation document of 21 March 2018 entitled ‘Fitness check on the EU framework for public reporting by companies’, |
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—

having regard to the Commission consultation document of 21 March 2018 entitled ‘Fitness check on the EU framework for public reporting by companies’,

| — | having regard to the Commission’s call for endorsement advice to the EFRAG of 27 October 2017 in relation to IFRS 17, |
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—

having regard to the Commission’s call for endorsement advice to the EFRAG of 27 October 2017 in relation to IFRS 17,

| — | having regard to the opinion of the European Banking Authority and the comment letter of the European Securities and Markets Authority (ESMA) to the IASB’s exposure draft on insurance contracts, |
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—

having regard to the opinion of the European Banking Authority and the comment letter of the European Securities and Markets Authority (ESMA) to the IASB’s exposure draft on insurance contracts,

| — | having regard to the Commission report of 23 November 2017 on the activities of the IFRS Foundation, EFRAG and PIOB in 2016 (COM(2017)0684), |
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—

having regard to the Commission report of 23 November 2017 on the activities of the IFRS Foundation, EFRAG and PIOB in 2016 (COM(2017)0684),

| — | having regard to the report of the European Systemic Risk Board (ESRB) of July 2017 entitled ‘Financial stability implications of IFRS 9’, |
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—

having regard to the report of the European Systemic Risk Board (ESRB) of July 2017 entitled ‘Financial stability implications of IFRS 9’,

| — | having regard to the Global Financial Stability Report of the International Monetary Fund (IMF) of October 2017 entitled ‘Is Growth at Risk?’, |
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—

having regard to the Global Financial Stability Report of the International Monetary Fund (IMF) of October 2017 entitled ‘Is Growth at Risk?’,

| — | having regard to the press release on IFRS 17 issued by the Financial Stability Board (FSB) on 17 July 2017, |
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—

having regard to the press release on IFRS 17 issued by the Financial Stability Board (FSB) on 17 July 2017,

| — | having regard to the Paris Agreement on climate change, adopted on 12 December 2015, |
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—

having regard to the Paris Agreement on climate change, adopted on 12 December 2015,

| — | having regard to the FSB’s report of June 2017 entitled ‘Recommendations of the Task Force on Climate-related Financial Disclosure’, |
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—

having regard to the FSB’s report of June 2017 entitled ‘Recommendations of the Task Force on Climate-related Financial Disclosure’,

| — | having regard to the Commission communication of 8 March 2018 entitled ‘Action Plan: Financing Sustainable Growth’(COM(2018)0097), |
| --- | --- |

—

having regard to the Commission communication of 8 March 2018 entitled ‘Action Plan: Financing Sustainable Growth’(COM(2018)0097),

| — | having regard to the final report of the EU High-Level Expert Group on Sustainable Finance of 31 January 2018 entitled ‘Financing a Sustainable European Economy’, |
| --- | --- |

—

having regard to the final report of the EU High-Level Expert Group on Sustainable Finance of 31 January 2018 entitled ‘Financing a Sustainable European Economy’,

| — | having regard to the EFRAG’s background briefing papers on IFRS 17 on the release of the contractual service margin, on the transition requirements, and on the level of aggregation requirements, |
| --- | --- |

—

having regard to the EFRAG’s background briefing papers on IFRS 17 on the release of the contractual service margin, on the transition requirements, and on the level of aggregation requirements,

| — | having regard to the exchange of views on IFRS 17 between the Chair of the IASB, Hans Hoogervorst, the Chairman of the IFRS Foundation Trustees, Michel Prada, and the President of the EFRAG Board, Jean-Paul Gauzès, |
| --- | --- |

—

having regard to the exchange of views on IFRS 17 between the Chair of the IASB, Hans Hoogervorst, the Chairman of the IFRS Foundation Trustees, Michel Prada, and the President of the EFRAG Board, Jean-Paul Gauzès,

| — | having regard to the study of January 2016 prepared for its Committee on Economic and Monetary Affairs entitled ‘Changes to Accounting and Solvency Rules: The (possible) Impact on Insurance and Pensions’ (8), |
| --- | --- |

—

having regard to the study of January 2016 prepared for its Committee on Economic and Monetary Affairs entitled ‘Changes to Accounting and Solvency Rules: The (possible) Impact on Insurance and Pensions’ (8),

| — | having regard to the motion for a resolution of the Committee on Economic and Monetary Affairs, |
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—

having regard to the motion for a resolution of the Committee on Economic and Monetary Affairs,

| — | having regard to Rule 123(2) of its Rules of Procedure, |
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—

having regard to Rule 123(2) of its Rules of Procedure,

| A. | whereas on 18 May 2017, the International Accounting Standards Board (IASB) issued a new standard on insurance contracts, International Financial Reporting Standard (IFRS) 17; whereas, if endorsed by the EU, IFRS 17 will become effective in the EU on 1 January 2021 and will replace the interim standard IFRS 4; whereas IFRS 17 is the third major accounting standard issued by the IASB after IFRS 16 Leases and IFRS 9 Financial Instruments; whereas amendments to IFRS 4 addressed the mismatch in application dates between IFRS 17 and IFRS 9; |
| --- | --- |

A.

whereas on 18 May 2017, the International Accounting Standards Board (IASB) issued a new standard on insurance contracts, International Financial Reporting Standard (IFRS) 17; whereas, if endorsed by the EU, IFRS 17 will become effective in the EU on 1 January 2021 and will replace the interim standard IFRS 4; whereas IFRS 17 is the third major accounting standard issued by the IASB after IFRS 16 Leases and IFRS 9 Financial Instruments; whereas amendments to IFRS 4 addressed the mismatch in application dates between IFRS 17 and IFRS 9;

| B. | whereas IFRS 4 was only meant as a temporary standard, but permits the use of a wide range of national accounting standards and practices; whereas there is considerable diversity in current insurance accounting, including in the measurement of liabilities and the recognition of revenue and profits; |
| --- | --- |

B.

whereas IFRS 4 was only meant as a temporary standard, but permits the use of a wide range of national accounting standards and practices; whereas there is considerable diversity in current insurance accounting, including in the measurement of liabilities and the recognition of revenue and profits;

| C. | whereas IFRS 17 harmonises accounting rules for insurance contracts across different constituencies, and is intended to provide a more realistic description and to enable better comparability of financial statements within the insurance sector; |
| --- | --- |

C.

whereas IFRS 17 harmonises accounting rules for insurance contracts across different constituencies, and is intended to provide a more realistic description and to enable better comparability of financial statements within the insurance sector;

| D. | whereas in the Global Financial Stability Report of October 2017, the International Monetary Fund (IMF) called for improvements to the regulatory frameworks for life insurance in order to increase reporting transparency and build the industry’s resilience; whereas the Financial Stability Board (FSB) has welcomed IFRS 17; |
| --- | --- |

D.

whereas in the Global Financial Stability Report of October 2017, the International Monetary Fund (IMF) called for improvements to the regulatory frameworks for life insurance in order to increase reporting transparency and build the industry’s resilience; whereas the Financial Stability Board (FSB) has welcomed IFRS 17;

| E. | whereas the European insurance companies, in providing a wide range of insurance and re-insurance products, differ in their business models, including their investment and liability structures; whereas as major institutional investors, insurance companies are also important long-term investors; |
| --- | --- |

E.

whereas the European insurance companies, in providing a wide range of insurance and re-insurance products, differ in their business models, including their investment and liability structures; whereas as major institutional investors, insurance companies are also important long-term investors;

| F. | whereas the Commission is conducting a fitness check on the EU framework for public reporting by companies, for which it has examined possible interactions between IFRS 17, the Insurance Accounting Directive and Solvency II; |
| --- | --- |

F.

whereas the Commission is conducting a fitness check on the EU framework for public reporting by companies, for which it has examined possible interactions between IFRS 17, the Insurance Accounting Directive and Solvency II;

| G. | whereas the EFRAG is currently drafting its endorsement advice on IFRS 17 and carrying out a detailed impact analysis to this end; whereas in its background briefings, the EFRAG identified as controversial areas the level of aggregation, the contractual service margin, reinsurance, transitional requirements and operational impact; |
| --- | --- |

G.

whereas the EFRAG is currently drafting its endorsement advice on IFRS 17 and carrying out a detailed impact analysis to this end; whereas in its background briefings, the EFRAG identified as controversial areas the level of aggregation, the contractual service margin, reinsurance, transitional requirements and operational impact;

| H. | whereas its Committee on Economic and Monetary Affairs will carefully scrutinise IFRS 17; |
| --- | --- |

H.

whereas its Committee on Economic and Monetary Affairs will carefully scrutinise IFRS 17;

| 1. | Notes that IFRS 17 will necessitate a fundamental change in accounting for insurance contracts, but will bring greater consistency and transparency and seek to deliver increased comparability; |
| --- | --- |

1.

| 2. | Notes that considerable and significant efforts and costs will be needed to implement IFRS 17, not least for SMEs working in insurance, which is indicative of the complexity of the new standard; notes that implementation efforts are already in progress and that the IASB is providing implementation support, in particular by setting up a Transition Resource Group (TRG) for IFRS 17; |
| --- | --- |

2.

| 3. | Notes concerns relating to the presentation of general insurance contracts, including the risk of reduced quality of disclosure, undue increases in the expected cost of implementation and significant increases in the operational complexity of reporting under IFRS 17; calls on the EFRAG to consider the anticipated cost of this measure and whether it will hinder understanding of the financial impact of general insurance contracts; |
| --- | --- |

3.

| 4. | Notes that one of the aims of IFRS17 is to generate relevant information for shareholders by evaluating insurance contract liabilities; notes that this is a fundamentally complex process and may accentuate financial disturbances; |
| --- | --- |

4.

| 5. | Notes the EFRAG’s ongoing work in drafting its endorsement advice, in particular on the issues that is has identified, namely the level of aggregation, the contractual service margin, reinsurance, transitional requirements and operational impact; notes that the final endorsement advice is expected in December 2018; recommends that this timeframe be reviewed once the full scale and complexity of the issues identified in the field testing process are understood; welcomes the issues addressed by the Commission in its call for advice to the EFRAG, in particular the need to examine the potential effects on financial stability, competitiveness, and insurance markets, for insurance SMEs in particular, and the need for a cost-benefit analysis; calls on the EFRAG to check that all the core features of the insurance covers are reflected in a way that does not distort the social guarantees offered; |
| --- | --- |

5.

| 6. | Stresses the need to fully understand the interaction between IFRS 17, which employs a principles-based approach, and other regulatory requirements for insurance entities in the EU, in particular Solvency II, especially in relation to the cost of implementing IFRS 17; regrets the fact, however, that no field test has yet been developed to examine the potential repercussions of IFRS 17 for financial stability, competitiveness and the financial markets; calls on the Commission, therefore, to consider broader tests, including field tests, to assess these effects and interactions; welcomes the Commission’s ongoing fitness check on the EU framework for public reporting by companies; calls on the Commission to report to Parliament on the results of this check and to give them due consideration in the endorsement procedure; notes the concerns of the European Banking Authority (EBA) that IFRS 17 allows for inconsistent accounting treatment for similar transactions, depending on the industry of the issuers; calls on the EFRAG, therefore, to liaise closely with the EBA in order to assess whether these concerns are still valid in the context of the final requirements of IFRS 17 and whether transactions of a similar economic substance are handled consistently under IFRS 17; |
| --- | --- |

6.

| 7. | Notes the concerns put forward by the European Securities and Markets Authority (ESMA) as part of its response to the 2013 consultation on the IASB’s exposure draft on insurance contracts, on presenting the effects of changes in the discount rate partly in ‘other comprehensive income (OCI)’and partly in profit or loss, which could make financial statements too difficult to understand and thus impair the comparability of contracts with similar features; calls on the EFRAG, therefore, to liaise closely with the ESMA and to consider these concerns, if still relevant, when drawing up its endorsement advice, as part of the final requirements of IFRS 17 and to conclude whether IFRS 17 meets the endorsement criterion of understandability; notes the concerns put forward by the ESMA in its 2013 comment letter on the then proposed requirements, namely that IFRS 17 may fall short of providing sufficient clarity in the presentation of revenue, and that the determination of the discount rate and risk adjustment may hamper effective enforcement; calls on the EFRAG, therefore, to liaise closely with the ESMA and to consider these concerns, if still relevant, when drawing up its endorsement advice, as part of the final requirements of IFRS 17; notes the EBA’s concerns on IFRS 17 permitting an insurance entity to determine a discount rate using either a top-down or a bottom-up approach; calls on the EFRAG, therefore, to liaise closely with the EBA, and to consider these concerns, if still relevant, when drawing up its endorsement advice, as part of the final requirements of IFRS 17, notably whether this option might significantly increase the scope for judgement and inconsistency in application potentially leading to reduced comparability of financial information and subjective earnings’ management; welcomes the IASB’s research project on discount rates and encourages the IASB to develop a consistent and holistic approach to the methodology for estimating and applying discount rates; |
| --- | --- |

7.

| 8. | Calls on the Commission and EFRAG to consider the recommendations outlined in its resolutions of 7 June 2016 on IAS evaluation and 6 October 2016 on IFRS 9 for the endorsement of IFRS 17, most notably regarding the impact of new standards on financial stability and long-term investment in the EU, but also the risks entailed by the propensity of accounting provisions to cause pro-cyclical effects and/or higher volatility, particularly as IFRS 17 will shift the focus from historical cost to current values; recalls, in this regard, the Maystadt recommendations on the expansion of the ‘public good’criterion, namely that accounting standards should neither jeopardise the EU’s financial stability nor hinder its economic development; calls on the Commission to specifically examine whether the practice of some Member States of basing distribution of profits on IFRS accounts without applying any filters to unrealised gains is compliant with the Capital Maintenance Directive; |
| --- | --- |

8.

| 9. | Notes that in the wake of IFRS 17 and IFRS 9, two major changes in financial reporting standards are affecting accounting for insurance undertakings; notes, in particular, that changes in valuation now occur on both the assets and the liabilities side of insurers’ balance sheets, as investment assets are marked-to-market and the valuations of insurance contracts include forward-looking net cash flow estimates; calls on the EFRAG to assess the potential interaction and any mismatches between IFRS 9 and IFRS 17; |
| --- | --- |

9.

| 10. | Notes that exemptions to IFRS 17 and IFRS 9 allow for the application of IFRS 15 to relevant contracts; calls on the EFRAG to assess whether this treatment is appropriate; |
| --- | --- |

10.

| 11. | Calls on the Commission and the EFRAG to consider concerns relating to the level of aggregation, including requirements on how the business is run in practice and on grouping contracts into annual cohorts, which may give an unclear reflection of business management; |
| --- | --- |

11.

| 12. | Calls on the Commission and EFRAG to consider, furthermore, concerns relating to the level of aggregation insofar as the disaggregation of a portfolio on profitability criteria and annual cohorts may not reflect how the business is run, while possibly increasing costs, complexity and administrative burden for companies; |
| --- | --- |

12.

| 13. | Calls for a clarification on certain potential negative implications of the transitional requirements, particularly in terms of the complexity of the retrospective approaches and the limited availability of data in this regard; calls on the Commission and the EFRAG to consider the potential consequences on comparability and data issues of the need to apply multiple transition approaches for one portfolio of insurance contracts; |
| --- | --- |

13.

| 14. | Calls on the Commission and the EFRAG to consider the potential benefits for all stakeholders; |
| --- | --- |

14.

| 15. | Notes certain concerns relating to reinsurance contracts, which constitute a specific form of insurance; calls on the EFRAG to consider the impact of IFRS 17 requirements on accounting for reinsurance, by taking into account both the interests of the beneficiaries and the business models of reinsurance providers; |
| --- | --- |

15.

| 16. | Calls on the EFRAG’s newly established European Corporate Reporting Lab to deliver on the design of best practices in corporate reporting, notably as regards climate-related financial disclosures, in line with the recommendations of the Task Force on this issue; |
| --- | --- |

16.

| 17. | Notes that the true scale and complexity of IFRS 17 will only become clear once the EFRAG has completed its impact assessment; calls on the Commission and the EFRAG to examine, subject to the results of this assessment, the achievability of the current implementation timeline of IFRS 17, and to consider potential interaction with implementation dates in other jurisdictions; |
| --- | --- |

17.

| 18. | Calls on the Commission, together with the European Supervisory Authorities (ESAs), the ECB, the ESRB and the EFRAG, to closely monitor, in the event that it is endorsed, the implementation of IFRS 17 in the EU, to prepare an ex-post impact assessment no later than June 2024, and to present this assessment to Parliament and act in line with Parliament’s views thereon; |
| --- | --- |

18.

| 19. | Stresses that insurers are responsible for informing investors about the potential effects of the implementation of IFRS 17; |
| --- | --- |

19.

| 20. | Calls on the ESRB to establish a taskforce on IFRS 17; |
| --- | --- |

20.

| 21. | Calls on the Commission to ensure that IFRS 17 will, if adopted, be conducive to the European public good, including its sustainability and long-term investment objectives in line with the Paris Agreement; |
| --- | --- |

21.

| 22. | Instructs its President to forward this resolution to the Commission. |
| --- | --- |

22.

---

(1)  OJ L 243, 11.9.2002, p. 1.

(2)  OJ L 182, 29.6.2013, p. 19.

(3)  OJ L 374, 31.12.1991, p. 7.

(4)  OJ L 335, 17.12.2009, p. 1.

(5)  OJ L 12, 17.1.2015, p. 1.

(6)  Texts adopted, P8_TA(2016)0248.

(7)  Texts adopted, P8_TA(2016)0381.

(8)  http://www.europarl.europa.eu/RegData/etudes/STUD/2016/569996/IPOL_STU(2016)569996_EN.pdf.

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RESOLUTIONS

| 13.1.2020 | EN | Official Journal of the European Union | C 11/7 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/7

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P8_TA(2018)0373

Distributed ledger technologies and blockchains: building trust with disintermediation

European Parliament resolution of 3 October 2018 on distributed ledger technologies and blockchains: building trust with disintermediation (2017/2772(RSP))

(2020/C 011/03)

The European Parliament,

| — | having regard to the question to the Commission on distributed ledger technologies and blockchains: building trust with disintermediation (O-000092/2018 – B8-0405/2018), |
| --- | --- |

—

having regard to the question to the Commission on distributed ledger technologies and blockchains: building trust with disintermediation (O-000092/2018 – B8-0405/2018),

| — | having regard to the motion for a resolution of the Committee on Industry, Research and Energy, |
| --- | --- |

—

having regard to the motion for a resolution of the Committee on Industry, Research and Energy,

| — | having regard to its resolution of 26 May 2016 on virtual currencies (1), |
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—

having regard to its resolution of 26 May 2016 on virtual currencies (1),

| — | having regard to its resolution of 28 April 2017 on ‘FinTech: the influence of technology on the future of the financial sector (2), |
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—

having regard to its resolution of 28 April 2017 on ‘FinTech: the influence of technology on the future of the financial sector (2),

| — | having regard to its resolution of 6 February 2018 on ‘Geo-blocking and other forms of discrimination based on customers’nationality, place of residence or place of establishment’ (3), |
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—

having regard to its resolution of 6 February 2018 on ‘Geo-blocking and other forms of discrimination based on customers’nationality, place of residence or place of establishment’ (3),

| — | having regard to the General Data Protection Regulation (Regulation (EU) 2016/679), |
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—

having regard to the General Data Protection Regulation (Regulation (EU) 2016/679),

| — | having regard to the proposal for a regulation on extension of the duration of the European Fund for Strategic Investments (COM(2016)0597 – C8-0375/2016 – 2016/0276(COD)), |
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—

having regard to the proposal for a regulation on extension of the duration of the European Fund for Strategic Investments (COM(2016)0597 – C8-0375/2016 – 2016/0276(COD)),

| — | having regard to its resolution of 11 October 2017 on the Council position on the draft general budget of the European Union for the financial year 2018 (11815/2017 – C8-0313/2017 – 2017/2044(BUD)) (4), |
| --- | --- |

—

having regard to its resolution of 11 October 2017 on the Council position on the draft general budget of the European Union for the financial year 2018 (11815/2017 – C8-0313/2017 – 2017/2044(BUD)) (4),

| — | having regard to the Commission initiatives for the exploration of DLTs, among them ‘Blockchain4EU: Blockchain for Industrial Transformations’, ‘EU Blockchain and Observatory Forum’, ‘Blockchains for Social Good’and ‘Study on the Opportunity and Feasibility of an EU Blockchain Infrastructure’, |
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—

having regard to the Commission initiatives for the exploration of DLTs, among them ‘Blockchain4EU: Blockchain for Industrial Transformations’, ‘EU Blockchain and Observatory Forum’, ‘Blockchains for Social Good’and ‘Study on the Opportunity and Feasibility of an EU Blockchain Infrastructure’,

| — | having regard to Rules 128(5) and 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

| A. | whereas Distributed Ledger Technology (DLT) and blockchain can constitute a tool that promotes the empowerment of citizens by giving them the opportunity to control their own data and decide what data to share in the ledger, as well as the capacity to choose who else can see them; |
| --- | --- |

A.

whereas Distributed Ledger Technology (DLT) and blockchain can constitute a tool that promotes the empowerment of citizens by giving them the opportunity to control their own data and decide what data to share in the ledger, as well as the capacity to choose who else can see them;

| B. | whereas DLT is a general-purpose technology which can improve transaction cost efficiency by removing intermediaries and intermediation costs, as well as increasing transaction transparency, also reshaping value chains and improving organisational efficiency through trustworthy decentralisation; |
| --- | --- |

B.

whereas DLT is a general-purpose technology which can improve transaction cost efficiency by removing intermediaries and intermediation costs, as well as increasing transaction transparency, also reshaping value chains and improving organisational efficiency through trustworthy decentralisation;

| C. | whereas DLT can introduce, through the necessary encryption and control mechanisms, an IT-based paradigm that can democratise data and improve trust and transparency, providing a secure and efficient route for the execution of transactions; |
| --- | --- |

C.

whereas DLT can introduce, through the necessary encryption and control mechanisms, an IT-based paradigm that can democratise data and improve trust and transparency, providing a secure and efficient route for the execution of transactions;

| D. | whereas DLT promotes the pseudonymisation of users but not their anonymisation; |
| --- | --- |

D.

whereas DLT promotes the pseudonymisation of users but not their anonymisation;

| E. | whereas DLT is a still evolving technology which necessitates an innovation-friendly, enabling and encouraging framework that provides legal certainty and respects the principle of technology neutrality, while at the same time promoting consumer, investor and environmental protection, increasing the social value of the technology, reducing the digital divide and improving the digital skills of citizens; |
| --- | --- |

E.

whereas DLT is a still evolving technology which necessitates an innovation-friendly, enabling and encouraging framework that provides legal certainty and respects the principle of technology neutrality, while at the same time promoting consumer, investor and environmental protection, increasing the social value of the technology, reducing the digital divide and improving the digital skills of citizens;

| F. | whereas DLT can provide a framework of transparency, reduce corruption, detect tax evasion, allow the tracking of unlawful payments, facilitate anti-money laundering policies, and detect misappropriation of assets; |
| --- | --- |

F.

whereas DLT can provide a framework of transparency, reduce corruption, detect tax evasion, allow the tracking of unlawful payments, facilitate anti-money laundering policies, and detect misappropriation of assets;

| G. | whereas DLT makes it possible to ensure the integrity of data, and the ability to provide a tamper-evident audit trail permits new models of public administration and helps bring about improved safety; |
| --- | --- |

G.

whereas DLT makes it possible to ensure the integrity of data, and the ability to provide a tamper-evident audit trail permits new models of public administration and helps bring about improved safety;

| H. | whereas the regulatory approach toward DLT should be innovation-friendly and based on the principle of technology neutrality, enabling also the creation of innovation- friendly ecosystems and innovation hubs; |
| --- | --- |

H.

whereas the regulatory approach toward DLT should be innovation-friendly and based on the principle of technology neutrality, enabling also the creation of innovation- friendly ecosystems and innovation hubs;

| I. | whereas blockchain is only one of several types of DLTs; whereas some DLT solutions store all individual transactions in blocks which are attached to each other in chronological order in order to create a chain which ensures the security and integrity of the data; |
| --- | --- |

I.

whereas blockchain is only one of several types of DLTs; whereas some DLT solutions store all individual transactions in blocks which are attached to each other in chronological order in order to create a chain which ensures the security and integrity of the data;

| J. | whereas cyberattacks are considered to have less impact on such chains, as they need to successfully target a large number of copies rather than a centralised version; |
| --- | --- |

J.

whereas cyberattacks are considered to have less impact on such chains, as they need to successfully target a large number of copies rather than a centralised version;

| K. | whereas DLT can significantly improve key sectors of the economy as well as the quality of public services, providing high-level transactional experience to consumers and citizens and reducing the costs incurred by them; |
| --- | --- |

K.

whereas DLT can significantly improve key sectors of the economy as well as the quality of public services, providing high-level transactional experience to consumers and citizens and reducing the costs incurred by them;

| L. | whereas questions and concerns related to the application of horizontal regulation and rules, on issues such as data protection or taxation, can inhibit the potential for development of DLT in the EU; |
| --- | --- |

L.

whereas questions and concerns related to the application of horizontal regulation and rules, on issues such as data protection or taxation, can inhibit the potential for development of DLT in the EU;

| M. | whereas DLT applications have the potential quickly to become systemic, similarly to how digital innovations have fundamentally changed services in other sectors, such as telecommunications; |
| --- | --- |

M.

whereas DLT applications have the potential quickly to become systemic, similarly to how digital innovations have fundamentally changed services in other sectors, such as telecommunications;

| N. | whereas the risks and problems of the technology are not yet completely known; |
| --- | --- |

N.

whereas the risks and problems of the technology are not yet completely known;

DLT, decentralisation and applications

| 1. | Stresses that DLT reduces intermediation costs in a trusted environment between the transacting parties and allows peer-to-peer exchange of value that can empower citizens, disrupt legacy models, improve services and reduce costs throughout value chains, in a wide range of key sectors; |
| --- | --- |

1.

| 2. | Underlines the profound impact that DLT-based applications could have on the structure of public governance and the role of institutions, and asks the Commission to carry out a study assessing the potential scenarios of a wider uptake of public DLT-based networks; |
| --- | --- |

2.

| 3. | Highlights the wide range of DLT-based applications that could potentially affect all sectors of the economy; |
| --- | --- |

3.

Energy- and environment-friendly applications

| 4. | Underscores that DLT can transform and democratise the energy markets by allowing households to produce environment-friendly energy and exchange it on a peer-to-peer basis; stresses that such technologies provide scalability and flexibility for plant operators, suppliers and consumers; |
| --- | --- |

4.

| 5. | Underlines that DLT can support the production and consumption of green energy and could improve the efficiency of energy exchanges; notes that DLT can transform the grid operation and allow communities and individuals to provide grid services as well as to integrate renewable resources more efficiently; also stresses that DLT can create alternatives to state-sponsored renewable investment schemes; |
| --- | --- |

5.

| 6. | Notes that DLT can facilitate the energy transmission and distribution infrastructure and create a new transaction ecosystem surrounding electric vehicles; stresses that DLT improves energy reporting and enables accurate tracking of renewable or carbon certificates; |
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6.

| 7. | Stresses that DLT can support the electrification of poor rural communities through alternative payment and donation mechanisms; |
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7.

| 8. | Underlines the need to promote technical solutions that are less energy-consuming and are generally as environment-friendly as possible; stresses that several consensus mechanisms, among them ‘proof-of-work’, ‘proof-of-stake’, ‘proof-of-authority’and ‘proof-of-elapsed-time’, have different energy consumption needs; calls on the Commission to add an energy efficiency dimension in its activities related to DLT and to explore through research initiatives the energy impact and energy efficiency of the various consensus mechanisms; |
| --- | --- |

8.

| 9. | Calls for an assessment of governance models within the diverse consensus mechanisms under development, taking into account the potential needs of intermediary systems, actors and organisations in order to validate and verify the authenticity of the exchanges and to prevent fraudulent behaviour in good time; |
| --- | --- |

9.

| 10. | Highlights that DLT can bring new opportunities to the circular economy by incentivising recycling and enabling real-time trust and reputation systems; |
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10.

Transport

| 11. | Underscores the potential of DLT for mobility and logistics, including registration and administration of vehicles, verification of driving distances, smart insurance and charging of electric vehicles; |
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11.

Healthcare sector

| 12. | Highlights the potential of DLT to improve data efficiency and the reporting of clinical trials in the health sector, allowing digital data exchange across public and private institutions under the control of the citizens/patients; |
| --- | --- |

12.

| 13. | Recognises the potential for improvement of the efficiency of the healthcare sector through electronic health data interoperability, identity verification and a better distribution of medication; |
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13.

| 14. | Notes that DLT allows citizens to control their health data and benefit from transparency thereon, and to choose which data to share, also with regard to their use by insurance companies and the wider healthcare ecosystem; stresses that DLT applications should protect the privacy of sensitive health data; |
| --- | --- |

14.

| 15. | Calls on the Commission to explore DLT-based use-cases in the management of healthcare systems, and to identify benchmark cases and requirements that enable high- quality data entry and interoperability between different DLTs, depending on systems and on types of institution and their work processes; |
| --- | --- |

15.

Supply chains

| 16. | Underlines the significance of DLT in improving supply chains; notes that DLT can facilitate the forwarding and monitoring of origin of goods and their ingredients or components, improving transparency, visibility and compliance checking, by providing assurances that sustainability and human rights protocols are respected in the place of origin of a product, thus reducing the risk of illegal goods entering the supply chain and ensuring consumer protection; notes that DLT can be used as a tool to improve the efficiency of customs officers for counterfeit checking |
| --- | --- |

16.

Education

| 17. | Stresses the potential of DLT for verification of academic qualifications, encrypted educational certification (e.g. ‘blockcerts’) and credit transfer mechanisms; |
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17.

| 18. | Stresses that lack of knowledge about the potential of DLT discourages European citizens from using innovative solutions for their businesses; |
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18.

| 19. | Highlights the need to establish non-profit-making entities, for example research centres, that would be innovation hubs which would specialise in DLT technology in order to perform educational functions regarding the technology in Member State; |
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19.

| 20. | Calls on the Commission to explore the possibility of creating an EU-wide, highly scalable and interoperable network that makes use of the technological resources of educational institutions in the Union, with a view to adopting this technology for sharing data and information, thus contributing to the more effective recognition of academic and professional qualifications; also encourages Member States to adapt specialised curricula at university level in order to include the study of emerging technologies such as DLT; |
| --- | --- |

20.

| 21. | Recognises that for DLT to be trusted, awareness and understanding of the technology need to be improved; calls on the Member States to address this through targeted training and education; |
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21.

Creative industries and copyright

| 22. | Underlines that for ‘digitalised’creative content, DLT can enable the tracking and management of intellectual property and facilitate copyright and patent protection; emphasises that DLT can enable greater ownership and creative development by artists through an open public ledger that can also clearly identify ownership and copyright; highlights that DLT could help link creators to their work, thus enhancing safety and functionality in the context of a collaborative and open innovation ecosystem, especially in areas such as additive manufacturing and 3D printing; |
| --- | --- |

22.

| 23. | Notes that DLT might benefit authors by bringing more transparency and traceability to the use of their creative content, as well as cutting down on intermediaries, with regard to them receiving payment for their creative content; |
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23.

Financial sector

| 24. | Highlights the significance of DLT in financial intermediation and its potential for improving transparency and reducing transaction costs and hidden costs by better managing data and streamlining processes; draws attention to the interoperability challenges that use of the technology can pose for the financial sector; |
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24.

| 25. | Welcomes the research and experimentation that major financial institutions have undertaken in the exploration of the capabilities of DLT; stresses that use of the technology can also affect financial industry infrastructures and disrupt financial intermediation; |
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25.

| 26. | Calls on the Commission and the financial authorities to monitor developing trends and use-cases in the financial sector; |
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26.

| 27. | Emphasises the volatility and uncertainty surrounding cryptocurrencies; notes that the feasibility of alternative methods of payment and transfer of value using cryptocurrencies can be examined further; calls on the Commission and the ECB to provide feedback on the sources of volatility of cryptocurrencies, identify dangers for the public, and explore the possibilities of incorporating cryptocurrencies in the European payment system; |
| --- | --- |

27.

DLT ecosystem

Self-sovereignty, identity and trust

| 28. | Underscores that DLT enables users to identify themselves while being able to control what personal data they want to share; notes that a wide range of applications can allow different levels of transparency, raising the need for applications to be compliant with EU law; stresses also that data in a public ledger are pseudonymous and not anonymous; |
| --- | --- |

28.

| 29. | Underscores that DLT supports the emergence of new models to change the current concept and architecture of digital identities; notes that as a result digital identity is extended to people, organisations and objects, and further simplifies identity processes such as ‘Know Your Customer’while enabling personal control over data; |
| --- | --- |

29.

| 30. | Stresses that personal data management implies that users have the capacity and the technical knowledge and skills to manage their own data; is concerned about the dangers of misusing one’s own data and vulnerability to fraudulent schemes due to lack of knowledge; |
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30.

| 31. | Emphasises that digital identities are imperative for the future of this technology; considers that Member States should exchange best practices on how to ensure the security of such data; |
| --- | --- |

31.

| 32. | Underlines that although DLT promotes self-sovereign identity, the ‘right to be forgotten’is not easily applicable in this technology; |
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32.

| 33. | Emphasises that it is of the utmost importance that DLT uses are compliant with the EU legislation on data protection, and notably the General Data Protection Regulation (GDPR); calls on the Commission and the European Data Protection Supervisor (EDPS) to provide further guidance on this point; |
| --- | --- |

33.

| 34. | Stresses that trust in DLT is enabled by cryptographic algorithms that replace the third- party intermediary through a mechanism that performs the validation, safeguarding and preservation of transactions; |
| --- | --- |

34.

| 35. | Stresses that trust in permissionless blockchains is enabled by cryptographic algorithms, the participants, the network design and the structure, and that third-party intermediaries can be replaced through a mechanism that performs the validation, safeguarding and preservation of transactions and accelerates the clearing and settlement of certain securities transactions; notes that the efficiency of the safeguards is dependent on the proper implementation of the technology, and that this calls for technological developments that ensure genuine safety, thus enhancing trust; |
| --- | --- |

35.

Smart contracts

| 36. | Emphasises that smart contracts are an important element enabled by the DLT and can act as a key enabler of decentralised applications; stresses that the Commission needs to undertake an in-depth assessment of the potential and legal implications, e.g. risks relating to jurisdiction; believes that use-case monitoring will be beneficial in exploring the potential of smart contracts; |
| --- | --- |

36.

| 37. | Emphasises that legal certainty surrounding the validity of a digital cryptographic signature is a critical step towards facilitating smart contracts; |
| --- | --- |

37.

| 38. | Calls on the Commission to promote the development of technical standards with relevant international organisations such as ISO, ITU and CEN-CELENEC, and to conduct an in-depth analysis of the existing legal framework in individual Member States in relation to the enforceability of smart contracts; calls on the Commission, should potential barriers arise to the use of smart contracts within the Digital Single Market, to take appropriate measures to assess whether such barriers are proportionate; notes, however, that legal certainty can be enhanced by means of legal coordination or mutual recognition between Member States regarding smart contracts; |
| --- | --- |

38.

Interoperability, standardisation and scalability

| 39. | Stresses that there is a constellation of DLT technologies with various technological characteristics as well as different mechanisms concerning governance (permissioned and permissionless distributed ledgers) and consensus; |
| --- | --- |

39.

| 40. | Notes that ensuring efficiency requires interoperability: (i) between DLTs; (ii) between applications built on the same DLT; and (iii) between DLTs and legacy systems; |
| --- | --- |

40.

| 41. | Welcomes the initiatives of organisations such as ISO to establish standards for DLTs; calls on the Commission to continue to collaborate with other international organisations in standards setting; |
| --- | --- |

41.

| 42. | Emphasises the importance of taking a global approach to standards setting so that innovative companies are not regulated out of the EU; |
| --- | --- |

42.

| 43. | Underlines that trust generation through DLTs requires extended numbers of robust and expanded distributed ledgers, in order to avoid the concentration of data in the hands of a few market players, since this might lead to collusion; encourages the creation of DLT hubs across the EU, |
| --- | --- |

43.

Infrastructure security

| 44. | Recalls the importance of DLT infrastructure protection, and suggests that if we are to effectively reap the benefits of this technology, abuses of dominant position must not be allowed; |
| --- | --- |

44.

| 45. | Calls on the Commission to closely monitor technological developments (such as quantum computing), assess technological risks, support resilience to a cyberattack or a system breakdown, and promote data protection projects that ensure the sustainability of DLT platforms as part of the agenda of the EU Blockchain Observatory; calls on the Commission to allocate resources accordingly; |
| --- | --- |

45.

| 46. | Encourages the competent authorities and the Commission to develop stress testing for DLT applications; |
| --- | --- |

46.

Strategic importance of DLT for public infrastructure

| 47. | Underlines the efficiency potential of DLT for public sector services and management as regards reducing bureaucracy, especially with a view to enforcement of the eGovernment Action Plan, with particular reference to the EU-wide adoption of the digital Once-Only Principle (TOOP) and thus further reducing administrative burdens for citizens, businesses and public administrations; |
| --- | --- |

47.

| 48. | Underscores the potential of DLT to decentralise governance and improve the capacity of citizens to hold governments accountable; calls on the Commission to explore the improvement of traditional public services, including inter alia the digitalisation and decentralisation of public registries, land registry, licensing, citizen certification (e.g. birth or marriage certificates) and migration management, in particular by the development of concrete use-cases and pilots; calls on the Commission also to explore DLT applications that improve processes related to the privacy and confidentiality of data exchanges, as well as access to e-government services using a decentralised digital identity; |
| --- | --- |

48.

| 49. | Is aware of the risks associated with DLT applications, in particular the use of unpermissioned blockchain applications for criminal activities, including tax evasion, tax avoidance and money laundering, and insists that these issues must be monitored and addressed urgently by the Commission and the Member States; calls on the Commission, to this end, also to explore the potential of DLT in the areas of law enforcement, tracking of money laundering and shadow economy transactions, and tax monitoring; |
| --- | --- |

49.

| 50. | Calls on the Commission to monitor the potential of DLT for improving the social good, and to assess the social impact of the technology; |
| --- | --- |

50.

| 51. | Calls on the Commission to create DLT-based platforms that will allow the monitoring and tracking of EU funding to NGOs, thus increasing the visibility of the EU assistance programmes and the accountability of the recipients; |
| --- | --- |

51.

| 52. | Stresses, bearing in mind the efficiency opportunities DLT brings, the potential of DLT European public sector blockchains, compliant with EU law, that will enable decentralised cross-border transactions between Member States, thus facilitating the development of more secure and streamlined services, regulatory reporting, and data transactions between citizens and the EU institutions; |
| --- | --- |

52.

| 53. | Underlines that EU public sector blockchains would enable greater transparency, as well as more streamlined processing of information and development of more secure services for European citizens; stresses how a permissioned blockchain network shared between Member States could be designed in order to store citizens’ data in a secure and flexible manner; |
| --- | --- |

53.

| 54. | Calls on the Commission to evaluate the safety and efficiency of electronic voting systems, including those that employ DLTs, for both private and public sectors; encourages the further exploration of use-cases; |
| --- | --- |

54.

SMEs, technology transfer and financing

| 55. | Welcomes the potential of DLT to improve existing value chains, transform business models and thus promote innovation-driven prosperity; highlights the impact of streamlining supply chains and increasing interoperability among firms; |
| --- | --- |

55.

| 56. | Highlights that open blockchain protocols can lower entry barriers for SMEs and improve competition in digital marketplaces; |
| --- | --- |

56.

| 57. | Stresses that SMEs can benefit from disintermediation by reducing transaction costs, intermediation costs and red tape; notes that the use of DLT requires investment in specialised infrastructure or high-capacity services; |
| --- | --- |

57.

| 58. | Notes that innovative SMEs and start-ups need access to funding in order to develop DLT-based projects; calls on the EIB and the EIF to create funding opportunities that support DLT-based entrepreneurial endeavours to accelerate technology transfer; |
| --- | --- |

58.

| 59. | Asks the Commission to partner with Member States in order to ensure legal certainty for investors, users and citizens, both active and passive, while encouraging harmonisation within the Union and studying the idea of introducing a European passport of DLT-based projects; |
| --- | --- |

59.

| 60. | Underscores the potential of Initial Coin Offerings (ICOs) as an alternative investment instrument in funding SMEs and innovative start-ups and to accelerate technology transfer; stresses that lack of clarity with regard to the legal framework applicable to ICOs can negatively affect their potential; recalls that legal certainty can be instrumental in increasing investor and consumer protection and reducing the risks stemming from asymmetric information, fraudulent behaviour, illegal activities such as money laundering and tax evasion, and other risks as highlighted by the European Securities and Markets Authority (ESMA) in its 2017 report on ICOs; calls on the Commission to provide guidelines, standards and disclosure requirements, especially in the case of utility tokens that qualify more as a distinct asset class and less as a security; |
| --- | --- |

60.

| 61. | Emphasises the dangers related to ICOs; calls on the Commission and the regulatory authorities concerned to identify criteria that enhance investor protection and articulate disclosure requirements and obligations for the initiators of ICOs; stresses that legal clarity is essential for unleashing the potential of ICOs and preventing fraud and negative market signals; |
| --- | --- |

61.

| 62. | Underscores that ICOs can be an essential element within the capital markets union; calls on the Commission to explore the legal requirements that will allow this asset class to be blended with other financial vehicles in strengthening SMEs’ funding and innovation projects; |
| --- | --- |

62.

| 63. | Calls on the Commission to create an Observatory for the Monitoring of ICOs, as well as a database of their characteristics and taxonomy, distinguishing security and utility tokens; suggests that a model framework of regulatory sandboxes and a code of conduct accompanied by standards could be the beneficial outcome of such an observatory in terms of helping Member States explore ICOs’ possibilities; |
| --- | --- |

63.

| 64. | Welcomes the decision by the Commission and Council to include DLTs as a legitimate sector for funding in EFSI 2.0; |
| --- | --- |

64.

Policies for boosting DLTs in Europe

| 65. | Stresses that any regulatory approach toward DLT should be innovation-friendly, should enable passporting, and should be guided by the principles of technology neutrality and business-model neutrality; |
| --- | --- |

65.

| 66. | Urges the Commission and the Member States to develop and pursue digital skills training and retraining strategies that can ensure European society’s active and inclusive participation in the paradigm shift; |
| --- | --- |

66.

| 67. | Encourages the Commission and the national competent authorities to swiftly build up technical expertise and regulatory capacity, allowing for rapid legislative or regulatory action if and when appropriate; |
| --- | --- |

67.

| 68. | Underlines that the Union should not regulate DLT per se, but should try to remove existing barriers to implementing blockchains; welcomes the Commission’s approach of following a use-case method in exploring the regulatory environment around the use of DLT and the actors using it by sector, and calls on the Commission and the Member States to foster the convergence and harmonisation of regulatory approaches; |
| --- | --- |

68.

| 69. | Calls on the Commission to assess and develop a European legal framework in order to solve any jurisdictional problems that may arise in the event of fraudulent or criminal cases of DLT exchange; |
| --- | --- |

69.

| 70. | Notes that the use of cases is essential to the development of best practices in the DLT ecosystem and to the assessment and management of the effects on employment structure of automatising procedures; |
| --- | --- |

70.

| 71. | Welcomes forward-looking research frameworks aimed at improving assessment of the potential opportunities and challenges of emerging technologies in support of better decision-making, and, concretely, welcomes the Commission’s project ‘Blockchain4EU: Blockchain for Industrial Transformations’; |
| --- | --- |

71.

| 72. | Asks the Commission and the Member States to develop common initiatives to raise awareness and train citizens, businesses and public administrations with a view to facilitating the comprehension and uptake of this technology; |
| --- | --- |

72.

| 73. | Highlights the importance of research into and investment in DLT; notes that the post-2020 MFF should ensure funding for research initiatives and projects based on DLT, as basic research on DLT is needed, including on the potential risks and societal impact; |
| --- | --- |

73.

| 74. | Calls on the Commission to raise awareness concerning DLTs, to undertake initiatives for the education of citizens regarding the technology, and to address the problem of the digital gap between Member States; |
| --- | --- |

74.

| 75. | Recommends that existing and future DLT-related initiatives and pilot projects carried out by the Commission should be closely coordinated, possibly under the guidance of the EU Blockchain Observatory, so as to realise synergy effects and ensure the creation of real added value while avoiding costly double structures; invites the Commission to undertake regular exchanges with Parliament on the progress achieved in DLT-related pilot projects; |
| --- | --- |

75.

| 76. | Asks the Commission to undertake policy initiatives that promote the competitive position of the EU in the field of DLT; |
| --- | --- |

76.

| 77. | Emphasises that the Union has an excellent opportunity to become the global leader in the field of DLT and to be a credible actor in shaping its development and markets globally, in collaboration with our international partners; |
| --- | --- |

77.

o

o o

| 78. | Instructs its President to forward this resolution to the Commission and the Council. |
| --- | --- |

78.

---

(1)  Texts adopted, P8_TA(2016)0228.

(2)  Texts adopted, P8_TA(2017)0211.

(3)  Texts adopted, P8_TA(2018)0023.

(4)  Texts adopted, P8_TA(2017)0408.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/15 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/15

---

P8_TA(2018)0374

EU Agenda for Rural, Mountainous and Remote Areas

European Parliament resolution of 3 October 2018 on addressing the specific needs of rural, mountainous and remote areas (2018/2720(RSP))

(2020/C 011/04)

The European Parliament,

| — | having regard to Article 174 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 174 of the Treaty on the Functioning of the European Union,

| — | having regard to its resolution of 10 May 2016 on cohesion policy in mountainous regions of the EU (1), |
| --- | --- |

—

having regard to its resolution of 10 May 2016 on cohesion policy in mountainous regions of the EU (1),

| — | having regard to its resolution of 13 June 2017 on building blocks for a post-2020 EU cohesion policy (2), |
| --- | --- |

—

having regard to its resolution of 13 June 2017 on building blocks for a post-2020 EU cohesion policy (2),

| — | having regard to its resolution of 17 April 2018 entitled ‘Strengthening economic, social and territorial cohesion in the European Union: the 7th report of the European Commission’ (3), |
| --- | --- |

—

having regard to its resolution of 17 April 2018 entitled ‘Strengthening economic, social and territorial cohesion in the European Union: the 7th report of the European Commission’ (3),

| — | having regard to Rule 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) of its Rules of Procedure,

| A. | whereas rural, mountainous and remote areas constitute 80 % of EU territory, are home to 57 % of its population and account for 46 % of gross value added; |
| --- | --- |

A.

whereas rural, mountainous and remote areas constitute 80 % of EU territory, are home to 57 % of its population and account for 46 % of gross value added;

| B. | whereas GDP per capita in non-urbanised areas is 70 % of the EU average, while urban residents enjoy a GDP per capita as high as 123 % of the EU average; |
| --- | --- |

B.

whereas GDP per capita in non-urbanised areas is 70 % of the EU average, while urban residents enjoy a GDP per capita as high as 123 % of the EU average;

| C. | whereas the unemployment rate in non-urbanised areas increased from 7 % to 10.4 % between 2008 and 2012; |
| --- | --- |

C.

whereas the unemployment rate in non-urbanised areas increased from 7 % to 10.4 % between 2008 and 2012;

| D. | whereas a quarter of the population of rural, mountainous and remote areas has no access to the internet; |
| --- | --- |

D.

whereas a quarter of the population of rural, mountainous and remote areas has no access to the internet;

| E. | whereas it is important to support rural, mountainous and remote areas in overcoming the challenges they face; whereas one such challenge is rural depopulation, with elderly people (over 65) representing 20 % of the total population of these areas and young people continuing to leave; whereas many citizens outside urban areas should therefore be given the assurance that they could enjoy similar opportunities to those living in urban areas; |
| --- | --- |

E.

whereas it is important to support rural, mountainous and remote areas in overcoming the challenges they face; whereas one such challenge is rural depopulation, with elderly people (over 65) representing 20 % of the total population of these areas and young people continuing to leave; whereas many citizens outside urban areas should therefore be given the assurance that they could enjoy similar opportunities to those living in urban areas;

| F. | whereas the service sector only covers 24 % of non-urban employment; |
| --- | --- |

F.

whereas the service sector only covers 24 % of non-urban employment;

| G. | whereas the European economy, cities, industry (including tourism) and citizens largely depend on these areas for food, land use, energy, water, clean air and raw materials; |
| --- | --- |

G.

whereas the European economy, cities, industry (including tourism) and citizens largely depend on these areas for food, land use, energy, water, clean air and raw materials;

| H. | whereas rural, mountainous and remote areas are often located in border regions of Member States and near the EU’s external borders, and whereas in order to tackle their specific needs, promote cohesion and foster good neighbouring relations, full use should be made of the possibilities arising from cross-border cooperation, macro-regional strategies and existing instruments such as the European Grouping of Territorial Cooperation (EGTC); |
| --- | --- |

H.

whereas rural, mountainous and remote areas are often located in border regions of Member States and near the EU’s external borders, and whereas in order to tackle their specific needs, promote cohesion and foster good neighbouring relations, full use should be made of the possibilities arising from cross-border cooperation, macro-regional strategies and existing instruments such as the European Grouping of Territorial Cooperation (EGTC);

| I. | whereas representatives from 40 European countries have signed the Venhorst Declaration issued by the European Rural Parliament in 2017, which aims to promote cooperation in fields such as connectivity, infrastructure, services, strengthening local economies, and tackling poverty and social exclusion; |
| --- | --- |

I.

whereas representatives from 40 European countries have signed the Venhorst Declaration issued by the European Rural Parliament in 2017, which aims to promote cooperation in fields such as connectivity, infrastructure, services, strengthening local economies, and tackling poverty and social exclusion;

| 1. | Stresses the importance of rural, mountainous and remote areas for balanced territorial development in Europe and the need to strengthen them by addressing their specific needs through EU policies; |
| --- | --- |

1.

| 2. | Believes that fostering local development is essential to stabilising and counterbalancing negative trends on local markets, demographic dynamics and natural assets; |
| --- | --- |

2.

| 3. | Calls, moreover, for coordination of EU policies to ensure the development of rural territories; |
| --- | --- |

3.

| 4. | Underlines that investments directed at integrating rural, mountainous and remote areas into all policies are necessary to achieve EU priorities, including, but not limited to, smart, sustainable and inclusive growth, food safety and security, social inclusion, gender equality, climate change, job creation, digitalisation and an efficient internal market; |
| --- | --- |

4.

| 5. | Calls for the EU Agenda for Rural, Mountainous and Remote Areas to promote socioeconomic development, economic growth and diversification, social wellbeing, protection of nature, and cooperation and interconnection with urban areas in order to foster cohesion and prevent the risk of territorial fragmentation; urges the establishment of a Smart Villages Pact, with a view to ensuring a more effective, integrated and coordinated approach to EU policies with an impact on rural areas, involving all levels of government, in accordance with the principle of subsidiarity and the Urban Agenda for Europe set out in the Pact of Amsterdam; |
| --- | --- |

5.

| 6. | Asks, furthermore, for this EU Agenda for Rural, Mountainous and Remote Areas to incorporate a strategic framework for the development of rural, mountainous and remote areas, coordinated with strategies aimed at lagging and peripheral regions, in order to meet the objectives of rural proofing, smart villages, access to public services, digitalisation, training and innovation; calls, moreover, for smart cooperation and partnerships between rural and urban poles to be reinforced in order to rebalance the rural-urban relationship; |
| --- | --- |

6.

| 7. | Encourages rural areas and communities to develop projects such as smart villages, building on their existing strengths and assets and developing new opportunities, such as decentralised services, energy solutions, and digital technologies and innovations; |
| --- | --- |

7.

| 8. | Emphasises the need to support the further development of rural tourism and mountain agritourism while preserving the specificities of these areas, for example traditions and traditional local products, since tourism has a major social, economic and cultural impact; |
| --- | --- |

8.

| 9. | Underlines the potential of mountainous volcanic regions and volcanoes, in particular in terms of the contribution of volcanology to the achievement of renewable energy targets and to the prevention and management of natural disasters, such as volcanic eruptions; |
| --- | --- |

9.

| 10. | Calls on the Commission to include in the future legislative proposals provisions addressing the specificities of these areas and to provide for adequate funding, especially from the European Structural and Investment Funds, for cohesion policy post 2020; |
| --- | --- |

10.

| 11. | Stresses that the European Agricultural Fund for Rural Development (EAFRD) contributes significantly to economic and social cohesion, in particular in rural areas, and has an important territorial dimension; recommends, therefore, that EAFRD spending continue to be linked with cohesion policy, also with a view to facilitating integrated and complementary funding and to simplifying procedures for beneficiaries, so that regions can draw from different EU sources in order to optimise funding opportunities and invest in rural areas; |
| --- | --- |

11.

| 12. | Instructs its President to forward this resolution to the Council, the Commission, the Committee of the Regions and the Member States. |
| --- | --- |

12.

---

(1)  OJ C 76, 28.2.2018, p. 11.

(2)  Texts adopted, P8_TA(2017)0254.

(3)  Texts adopted, P8_TA(2018)0105.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/18 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/18

---

P8_TA(2018)0375

Deterioration of media freedom in Belarus, notably the case of Charter 97

European Parliament resolution of 4 October 2018 on the deterioration of media freedom in Belarus, notably the case of Charter 97 (2018/2861(RSP))

(2020/C 011/05)

The European Parliament,

| — | having regard to its previous resolutions on Belarus, |
| --- | --- |

—

having regard to its previous resolutions on Belarus,

| — | having regard to the Universal Declaration of Human Rights and to all human rights conventions to which Belarus is a party, |
| --- | --- |

—

having regard to the Universal Declaration of Human Rights and to all human rights conventions to which Belarus is a party,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas in February 2016 the EU lifted most of its restrictive measures against Belarusian officials and legal entities as a gesture of goodwill aimed at starting a policy of engagement with a view to encouraging Belarus to respect the principles of human rights, democracy and rule of law; |
| --- | --- |

A.

whereas in February 2016 the EU lifted most of its restrictive measures against Belarusian officials and legal entities as a gesture of goodwill aimed at starting a policy of engagement with a view to encouraging Belarus to respect the principles of human rights, democracy and rule of law;

| B. | whereas the EU has repeatedly reiterated that EU-Belarus relations can only be further advanced once they are based on trust and the values of democracy, the rule of law and fundamental freedoms; |
| --- | --- |

B.

whereas the EU has repeatedly reiterated that EU-Belarus relations can only be further advanced once they are based on trust and the values of democracy, the rule of law and fundamental freedoms;

| C. | whereas current policies in Belarus undermine these values, thereby preventing the EU from offering Belarus broader participation in the Eastern Partnership and closer relations, or from signing the EU-Belarus Partnership Priorities; |
| --- | --- |

C.

whereas current policies in Belarus undermine these values, thereby preventing the EU from offering Belarus broader participation in the Eastern Partnership and closer relations, or from signing the EU-Belarus Partnership Priorities;

| D. | whereas the situation in terms of freedom of media and freedom of speech is continuing to deteriorate in Belarus, as evidenced by severe harassment of independent news portals and journalists, as in the ‘BelTA case’; |
| --- | --- |

D.

whereas the situation in terms of freedom of media and freedom of speech is continuing to deteriorate in Belarus, as evidenced by severe harassment of independent news portals and journalists, as in the ‘BelTA case’;

| E. | whereas Belarusian authorities have recently initiated a wave of police harassment and intimidation against journalists; |
| --- | --- |

E.

whereas Belarusian authorities have recently initiated a wave of police harassment and intimidation against journalists;

| F. | whereas Reporters without Borders concludes that more than 100 journalists were arrested in 2017, mostly while covering opposition protests; whereas harassment of freelance journalists working for independent media outlets based abroad has reached unprecedented levels, with these journalists unable to get accreditation; |
| --- | --- |

F.

whereas Reporters without Borders concludes that more than 100 journalists were arrested in 2017, mostly while covering opposition protests; whereas harassment of freelance journalists working for independent media outlets based abroad has reached unprecedented levels, with these journalists unable to get accreditation;

| G. | whereas the leading independent news website Charter 97.org, which focuses on human rights and opposition causes and takes its name from Charter 97, a declaration of 1997 calling for democracy in Belarus that was signed by journalists, opposition politicians and rights activists, was forced to move to Warsaw, Poland, where it has been operating from since 2011, after it was blocked multiple times by the Belarusian authorities, with its offices raided twice by the police and its equipment confiscated that same year; |
| --- | --- |

G.

whereas the leading independent news website Charter 97.org, which focuses on human rights and opposition causes and takes its name from Charter 97, a declaration of 1997 calling for democracy in Belarus that was signed by journalists, opposition politicians and rights activists, was forced to move to Warsaw, Poland, where it has been operating from since 2011, after it was blocked multiple times by the Belarusian authorities, with its offices raided twice by the police and its equipment confiscated that same year;

| H. | whereas since 24 January 2018 access to the Charter 97 website has been blocked within Belarus, for an indefinite duration, without trial and amid vague allegations of ‘threats to the national interest’; whereas according to the editor-in-chief of Charter 97, Natalya Radina, in the month following the blocking of the Charter 97 website the number of visitors to the site from within Belarus decreased by 70 %; |
| --- | --- |

H.

whereas since 24 January 2018 access to the Charter 97 website has been blocked within Belarus, for an indefinite duration, without trial and amid vague allegations of ‘threats to the national interest’; whereas according to the editor-in-chief of Charter 97, Natalya Radina, in the month following the blocking of the Charter 97 website the number of visitors to the site from within Belarus decreased by 70 %;

| I. | whereas Ms Radina has received death threats; |
| --- | --- |

I.

whereas Ms Radina has received death threats;

| J. | whereas on 16 April 2018 access to the Charter 97 website was also blocked by the Russian authorities within the territory of the Russian Federation; |
| --- | --- |

J.

whereas on 16 April 2018 access to the Charter 97 website was also blocked by the Russian authorities within the territory of the Russian Federation;

| K. | whereas the founder of Charter 97, Aleh Byabenin, was found hanged at his home near Minsk in September 2010; whereas Belarus-born Pavel Sheremet, a spokesperson for the organisation behind Charter 97, was killed in a car bombing in Kiev, the capital of Ukraine, in July 2016; |
| --- | --- |

K.

whereas the founder of Charter 97, Aleh Byabenin, was found hanged at his home near Minsk in September 2010; whereas Belarus-born Pavel Sheremet, a spokesperson for the organisation behind Charter 97, was killed in a car bombing in Kiev, the capital of Ukraine, in July 2016;

| L. | whereas in early August 2018 Belarusian authorities carried out raids in the editorial offices of several independent Belarusian outlets, starting with Tut.by and followed by searches in BelaPAN, realty.by, Belaruskaya Navuka and Kultura; whereas the raids resulted in arrests and detention of journalists, including the editor-in-chief of Tut.by, over allegations that they had illegally accessed and used online information provided by the state-owned news agency BelTA; |
| --- | --- |

L.

whereas in early August 2018 Belarusian authorities carried out raids in the editorial offices of several independent Belarusian outlets, starting with Tut.by and followed by searches in BelaPAN, realty.by, Belaruskaya Navuka and Kultura; whereas the raids resulted in arrests and detention of journalists, including the editor-in-chief of Tut.by, over allegations that they had illegally accessed and used online information provided by the state-owned news agency BelTA;

| M. | whereas on 7 August 2018 Belarus’ Investigative Committee opened a criminal case under Article 349(2) of the Criminal Code punishable by up to two years in prison (illegal access to computer information committed out of other personal interest which caused substantial harm) against journalists and editors of a number of online resources and arrested 18 journalists, seven of whom were detained as suspects for three days; whereas there have been cases of pressure being put on journalists and their relatives and of them being forced to cooperate with the intelligence service and police; |
| --- | --- |

M.

whereas on 7 August 2018 Belarus’ Investigative Committee opened a criminal case under Article 349(2) of the Criminal Code punishable by up to two years in prison (illegal access to computer information committed out of other personal interest which caused substantial harm) against journalists and editors of a number of online resources and arrested 18 journalists, seven of whom were detained as suspects for three days; whereas there have been cases of pressure being put on journalists and their relatives and of them being forced to cooperate with the intelligence service and police;

| N. | whereas the latest amendments to the Law on Mass Media, adopted in June 2018, extend government control to online media outlets; whereas the changes, which will enter into force on 1 December 2018, will impose further bureaucratic hurdles for websites wishing to register as official online media outlets; |
| --- | --- |

N.

whereas the latest amendments to the Law on Mass Media, adopted in June 2018, extend government control to online media outlets; whereas the changes, which will enter into force on 1 December 2018, will impose further bureaucratic hurdles for websites wishing to register as official online media outlets;

| O. | whereas websites which choose not to register, despite the new legislation, or do not meet the new criteria, are denied accreditation with government institutions, thereby further censoring the press; whereas both registered and unregistered online media outlets will also be obliged to register the names of people who submit comments; whereas the owners of registered online media outlets will also be legally responsible for the content of such comments; |
| --- | --- |

O.

whereas websites which choose not to register, despite the new legislation, or do not meet the new criteria, are denied accreditation with government institutions, thereby further censoring the press; whereas both registered and unregistered online media outlets will also be obliged to register the names of people who submit comments; whereas the owners of registered online media outlets will also be legally responsible for the content of such comments;

| P. | whereas new legislation will require that authors of all posts and comments on online forums be identified and that website owners moderate such comments; |
| --- | --- |

P.

whereas new legislation will require that authors of all posts and comments on online forums be identified and that website owners moderate such comments;

| Q. | whereas the UN Special Rapporteur on the situation of human rights in Belarus, Miklós Haraszti, and the OSCE Representative on Freedom of the Media, Harlem Désir, have expressed the view that these legislative changes constitute an unacceptable restriction of freedom of speech and access to information; |
| --- | --- |

Q.

whereas the UN Special Rapporteur on the situation of human rights in Belarus, Miklós Haraszti, and the OSCE Representative on Freedom of the Media, Harlem Désir, have expressed the view that these legislative changes constitute an unacceptable restriction of freedom of speech and access to information;

| R. | whereas Belarus ranks 155th in the Reporters Without Borders’ 2017 World Press Freedom Index, which evaluates the level of press freedom in 180 countries each year; |
| --- | --- |

R.

whereas Belarus ranks 155th in the Reporters Without Borders’ 2017 World Press Freedom Index, which evaluates the level of press freedom in 180 countries each year;

| S. | whereas since the beginning of 2018, Belarusian journalists, whose right to gather, store and disseminate information is guaranteed by the Constitution, have been fined over 70 times for cooperation with foreign mass media without accreditation, the fines totalling over BYN 60 000; whereas Article 22.9 of the Code of Administrative Violations has become an efficient tool to harass independent journalists and media outlets such as Belsat TV, which has been operating from Poland since 2011; |
| --- | --- |

S.

whereas since the beginning of 2018, Belarusian journalists, whose right to gather, store and disseminate information is guaranteed by the Constitution, have been fined over 70 times for cooperation with foreign mass media without accreditation, the fines totalling over BYN 60 000; whereas Article 22.9 of the Code of Administrative Violations has become an efficient tool to harass independent journalists and media outlets such as Belsat TV, which has been operating from Poland since 2011;

| T. | whereas Belarus remains the only country in Europe that still practises capital punishment; |
| --- | --- |

T.

whereas Belarus remains the only country in Europe that still practises capital punishment;

| U. | whereas specific categories of people in Belarus are being subjected to false imprisonment and arbitrary detention, denial of proper care and contact with family members while in detention, state-organised physical and psychological violence, prosecution and conviction on spurious and falsified charges, disproportionate financial penalties, administrative sanctions and other forms of repression by the Belarusian authorities; whereas these categories include political prisoners (notably Mikhail Zhamchuzhny and Dzmitry Paliyenka), known political opponents, human rights activists, civil society actors, activists in environmental, non-governmental and civil society organisations, independent bloggers, journalists and editors, peaceful protestors from all walks of life, and, in particular, activists of independent trade unions (notably Henadz Fiadynich and Ihar Komlik); |
| --- | --- |

U.

whereas specific categories of people in Belarus are being subjected to false imprisonment and arbitrary detention, denial of proper care and contact with family members while in detention, state-organised physical and psychological violence, prosecution and conviction on spurious and falsified charges, disproportionate financial penalties, administrative sanctions and other forms of repression by the Belarusian authorities; whereas these categories include political prisoners (notably Mikhail Zhamchuzhny and Dzmitry Paliyenka), known political opponents, human rights activists, civil society actors, activists in environmental, non-governmental and civil society organisations, independent bloggers, journalists and editors, peaceful protestors from all walks of life, and, in particular, activists of independent trade unions (notably Henadz Fiadynich and Ihar Komlik);

| 1. | Strongly condemns the repeated harassment and detention of journalists and independent media in Belarus; urges the authorities to end all judicial harassment, intimidation and threats against journalists and independent media and to allow all news portals to operate freely; |
| --- | --- |

1.

| 2. | Considers the blocking of the news website Charter 97 by the Belarusian authorities since January 2018 unacceptable; reiterates its call on the Belarusian authorities to immediately and unconditionally lift the block imposed on internet access to the news website within Belarus; |
| --- | --- |

2.

| 3. | Strongly condemns the amendments adopted to the media law, which are being used to tighten control over the internet; reiterates its strong concern about the worsening climate for independent and opposition websites and media outlets and journalists in Belarus; |
| --- | --- |

3.

| 4. | Is of the view that independent media do not constitute a threat to the authorities but rather are an important element to the checks and balances system and hence should be seen by the government as a potential critical partner and not as an enemy; |
| --- | --- |

4.

| 5. | Regrets the fact that Belarus is continuing to persist with a repressive and undemocratic policy against journalists, lawyers, political activists, human rights defenders, civil society actors, trade unionists and others who are seen as a threat to the political establishment; underlines that such repression hinders any closer relationship with the EU and broader participation in the Eastern Partnership; |
| --- | --- |

5.

| 6. | Reiterates its calls on the Belarusian authorities to strengthen respect for democratic principles, rule of law, human rights and fundamental freedoms, including respect for truthful and unbiased journalism, in accordance with the Universal Declaration of Human Rights and the international and regional human rights instruments ratified by Belarus; |
| --- | --- |

6.

| 7. | Calls for the EU institutions to include in the EU-Belarus Partnership Priorities strong references to the independence of the media, freedom of speech and freedom of assembly; calls on the European External Action Service (EEAS) and the Member States to ensure that EU assistance programmes and other forms of bilateral cooperation, including financial assistance, must be linked to clear and tangible steps towards democratisation and openness, including comprehensive election reform and full respect for media freedom; |
| --- | --- |

7.

| 8. | Calls on the EEAS and the Commission to continue their support for civil society organisations in Belarus and abroad; stresses, in this context, the need to support all independent sources of information for Belarusian society, including media broadcasting in the Belarusian language, and those abroad such as Charter 97 and Belsat TV; |
| --- | --- |

8.

| 9. | Calls on the Vice President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy to closely monitor the situation of media freedom in Belarus, in cooperation with the Standing United Nations Rapporteur for Belarus; |
| --- | --- |

9.

| 10. | Urges the Belarusian authorities to allow full and unhindered functioning of political and public organisations and to repeal Article 193/1 of the Criminal Code curtailing the freedoms of peaceful assembly and association; |
| --- | --- |

10.

| 11. | Calls strongly for the unconditional and immediate release of political prisoners Mikhail Zhamchuzhny and Dzmitry Paliyenka, and for all former political prisoners to be fully rehabilitated; calls on the authorities to allow all independent trade unions to play their legitimate and central role in civil society without hindrance; regrets the conviction on 24 August 2018 of Henadz Fiadynich and Ihar Komlik, activists of the independent trade union REP, to four years of restricted freedom; |
| --- | --- |

11.

| 12. | Commends the work carried out by the current UN Special Rapporteur on the situation of human rights in Belarus, Miklós Haraszti, and draws the attention of his successor, Anaïs Marin, to the manifold abuses of power, curtailment of individual and collective freedoms and repression of civil society, independent trade unions and media, as clearly identified in Mr Haraszti’s reports; |
| --- | --- |

12.

| 13. | Calls, in this regard, for the Belarusian authorities to recognise the mandate of the UN Special Rapporteur on the situation of human rights in Belarus without delay, and for the Commission, the European Investment Bank and the European Bank for Reconstruction and Development to make the provision of any further financial or technical assistance to Belarus conditional on the circumstances set out above, while preserving the EU’s ability to directly fund Belarusian civil society; |
| --- | --- |

13.

| 14. | Remains concerned about the construction of a nuclear power plant in Ostrovets; notes the report on stress tests and recommendations published on 3 July 2018 and demands that stress test recommendations be implemented as a condition for any further advancement in EU-Belarus cooperation, in particular for the signing of the EU-Belarus Partnership Priorities; |
| --- | --- |

14.

| 15. | Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the governments and parliaments of the Member States and the President and Government of Belarus. |
| --- | --- |

15.

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| 13.1.2020 | EN | Official Journal of the European Union | C 11/21 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/21

---

P8_TA(2018)0376

The UAE, notably the situation of human rights defender Ahmed Mansoor

European Parliament resolution of 4 October 2018 on the UAE, notably the situation of human rights defender Ahmed Mansoor (2018/2862(RSP))

(2020/C 011/06)

The European Parliament,

| — | having regard to its previous resolutions, including that of 26 October 2012 on the human rights situation in the United Arab Emirates (1), |
| --- | --- |

—

having regard to its previous resolutions, including that of 26 October 2012 on the human rights situation in the United Arab Emirates (1),

| — | having regard to the statement of 4 June 2018 by the chair of the Subcommittee on Human Rights condemning the 10-year prison sentence issued against Ahmed Mansoor, |
| --- | --- |

—

having regard to the statement of 4 June 2018 by the chair of the Subcommittee on Human Rights condemning the 10-year prison sentence issued against Ahmed Mansoor,

| — | having regard to Article 30 of the Constitution of the United Arab Emirates (UAE), |
| --- | --- |

—

having regard to Article 30 of the Constitution of the United Arab Emirates (UAE),

| — | having regard to the Arab Charter on Human Rights, to which the UAE is a party, |
| --- | --- |

—

having regard to the Arab Charter on Human Rights, to which the UAE is a party,

| — | having regard to the EU Strategic Framework and the Action Plan on Human Rights and Democracy 2015-2019, |
| --- | --- |

—

having regard to the EU Strategic Framework and the Action Plan on Human Rights and Democracy 2015-2019,

| — | having regard to the Council conclusions of 16 October 2017 on the Mid-Term Review of the Action Plan on Human Rights and Democracy, |
| --- | --- |

—

having regard to the Council conclusions of 16 October 2017 on the Mid-Term Review of the Action Plan on Human Rights and Democracy,

| — | having regard to the EU Guidelines on Human Rights Defenders of 2004, as updated in 2008, |
| --- | --- |

—

having regard to the EU Guidelines on Human Rights Defenders of 2004, as updated in 2008,

| — | having regard to the statement by the UN Human Rights Experts of 12 June 2018 calling for the immediate release of jailed human rights defender Ahmed Mansoor, |
| --- | --- |

—

having regard to the statement by the UN Human Rights Experts of 12 June 2018 calling for the immediate release of jailed human rights defender Ahmed Mansoor,

| — | having regard to the Co-Chairs’ statement of 18 July 2016 at the 25th Joint Council and Ministerial Meeting of the European Union and of the Cooperation Council for the Arab States of the Gulf in Brussels, |
| --- | --- |

—

having regard to the Co-Chairs’ statement of 18 July 2016 at the 25th Joint Council and Ministerial Meeting of the European Union and of the Cooperation Council for the Arab States of the Gulf in Brussels,

| — | having regard to the Universal Declaration of Human Rights of 1948, |
| --- | --- |

—

having regard to the Universal Declaration of Human Rights of 1948,

| — | having regard to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment and to the International Covenant on Civil and Political Rights (ICCPR), to which the UAE is party, |
| --- | --- |

—

having regard to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment and to the International Covenant on Civil and Political Rights (ICCPR), to which the UAE is party,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas Ahmed Mansoor was arrested by UAE security officers in March 2017; whereas he is a prominent human rights activist and the 2015 laureate of the Martin Ennals Award for Human Rights Defenders; whereas Mr Mansoor may have been the last remaining human rights defender in the UAE who had been able to criticise the authorities publicly; |
| --- | --- |

A.

whereas Ahmed Mansoor was arrested by UAE security officers in March 2017; whereas he is a prominent human rights activist and the 2015 laureate of the Martin Ennals Award for Human Rights Defenders; whereas Mr Mansoor may have been the last remaining human rights defender in the UAE who had been able to criticise the authorities publicly;

| B. | whereas the UAE’s Ministry of Foreign Affairs and International Cooperation explained in a statement on 29 March 2017 that ‘the Office of Public Prosecution for Electronic Crimes ordered the detention of Mr Ahmed Mansoor on a charge of spreading false and misleading information over the Internet, through agendas aimed at disseminating antipathy and sectarianism’; whereas this and other official statements of the UAE authorities indicated that the sole reason for his detention, trial, and conviction was the content of his expression online, and the charges against him are based on alleged violations of the UAE’s repressive 2012 Cybercrime Law, which has allowed UAE authorities to silence human rights defenders and provided for long prison sentences and severe financial penalties for individuals who criticise the country’s rulers; |
| --- | --- |

B.

whereas the UAE’s Ministry of Foreign Affairs and International Cooperation explained in a statement on 29 March 2017 that ‘the Office of Public Prosecution for Electronic Crimes ordered the detention of Mr Ahmed Mansoor on a charge of spreading false and misleading information over the Internet, through agendas aimed at disseminating antipathy and sectarianism’; whereas this and other official statements of the UAE authorities indicated that the sole reason for his detention, trial, and conviction was the content of his expression online, and the charges against him are based on alleged violations of the UAE’s repressive 2012 Cybercrime Law, which has allowed UAE authorities to silence human rights defenders and provided for long prison sentences and severe financial penalties for individuals who criticise the country’s rulers;

| C. | whereas the Office of the UN High Commissioner on Human Rights has assessed that the arrest and secret detention of Ahmed Mansoor may constitute an act of reprisal for his engagement with UN human rights mechanisms and for the views he has expressed on social media, including Twitter, as well as for being an active member of organisations such as the Gulf Centre for Human Rights; |
| --- | --- |

C.

whereas the Office of the UN High Commissioner on Human Rights has assessed that the arrest and secret detention of Ahmed Mansoor may constitute an act of reprisal for his engagement with UN human rights mechanisms and for the views he has expressed on social media, including Twitter, as well as for being an active member of organisations such as the Gulf Centre for Human Rights;

| D. | whereas a group of UN human rights experts has called on the UAE Government to release Mr Mansoor, describing his arrest as a direct attack on the legitimate work of human rights defenders in the UAE; |
| --- | --- |

D.

whereas a group of UN human rights experts has called on the UAE Government to release Mr Mansoor, describing his arrest as a direct attack on the legitimate work of human rights defenders in the UAE;

| E. | whereas on 29 May 2018, Ahmed Mansoor was sentenced to 10 years in prison for exercising his right to freedom of speech in Twitter posts following a grossly unfair trial in Abu Dhabi; whereas he was also fined one million UAE dirhams (EUR 232 475) and was to be placed under surveillance for three years on his release; whereas Mr Mansoor has appealed against the sentence, but the timing of the appeal process remains unclear; |
| --- | --- |

E.

whereas on 29 May 2018, Ahmed Mansoor was sentenced to 10 years in prison for exercising his right to freedom of speech in Twitter posts following a grossly unfair trial in Abu Dhabi; whereas he was also fined one million UAE dirhams (EUR 232 475) and was to be placed under surveillance for three years on his release; whereas Mr Mansoor has appealed against the sentence, but the timing of the appeal process remains unclear;

| F. | whereas subsequently to his arrest in March 2017, Mr Mansoor has reportedly been prohibited from making any form of contact with his family, and has only been granted four visits by his wife since that date; whereas he has reportedly remained in solitary confinement since his arrest and allegedly subjected to torture; whereas according to the UAE authorities he is being detained in Al Sadr prison in Abu Dhabi; |
| --- | --- |

F.

whereas subsequently to his arrest in March 2017, Mr Mansoor has reportedly been prohibited from making any form of contact with his family, and has only been granted four visits by his wife since that date; whereas he has reportedly remained in solitary confinement since his arrest and allegedly subjected to torture; whereas according to the UAE authorities he is being detained in Al Sadr prison in Abu Dhabi;

| G. | whereas it appears that Mr Mansoor has not been able to appoint an independent lawyer of his own choosing in spite of government assertions that he may do so; whereas the right to see a lawyer is a basic right of any detained person, as outlined in Article 16 of the Arab Charter on Human Rights, which the UAE has ratified; |
| --- | --- |

G.

whereas it appears that Mr Mansoor has not been able to appoint an independent lawyer of his own choosing in spite of government assertions that he may do so; whereas the right to see a lawyer is a basic right of any detained person, as outlined in Article 16 of the Arab Charter on Human Rights, which the UAE has ratified;

| H. | whereas Ahmed Mansoor has been harassed and persecuted by the UAE authorities for more than six years and has repeatedly faced physical assault, death threats, and physical and electronic surveillance; whereas after seven months of pre-trial detention, he was sentenced to three years in prison for ‘insulting officials’in 2011 in a trial deemed unfair; whereas he was released after eight months on a presidential pardon, but the authorities never returned his passport, subjecting him to a de facto travel ban; |
| --- | --- |

H.

whereas Ahmed Mansoor has been harassed and persecuted by the UAE authorities for more than six years and has repeatedly faced physical assault, death threats, and physical and electronic surveillance; whereas after seven months of pre-trial detention, he was sentenced to three years in prison for ‘insulting officials’in 2011 in a trial deemed unfair; whereas he was released after eight months on a presidential pardon, but the authorities never returned his passport, subjecting him to a de facto travel ban;

| I. | whereas before his arrest Mr Mansoor was one of 133 signatories to a petition for universal and direct elections in the UAE and for the Federal National Council, a government advisory board, to be granted legislative powers; whereas Mr Mansoor also administered an online forum called Al-Hiwar al-Emarati that criticised UAE government policy and leaders; whereas he is a member of the Middle East and North Africa Advisory Committee at Human Rights Watch and an engaged actor with the UN Human Rights mechanisms; |
| --- | --- |

I.

whereas before his arrest Mr Mansoor was one of 133 signatories to a petition for universal and direct elections in the UAE and for the Federal National Council, a government advisory board, to be granted legislative powers; whereas Mr Mansoor also administered an online forum called Al-Hiwar al-Emarati that criticised UAE government policy and leaders; whereas he is a member of the Middle East and North Africa Advisory Committee at Human Rights Watch and an engaged actor with the UN Human Rights mechanisms;

| J. | whereas UAE residents who have spoken up on human rights issues are at serious risk of arbitrary detention, imprisonment, and torture; whereas the crackdown on peaceful activism calling for constitutional reform and reform in relation to human rights issues is still ongoing; whereas attacks on members of civil society, including efforts to silence, imprison or harass human rights activists, journalists, lawyers, and others have become increasingly common in recent years; |
| --- | --- |

J.

whereas UAE residents who have spoken up on human rights issues are at serious risk of arbitrary detention, imprisonment, and torture; whereas the crackdown on peaceful activism calling for constitutional reform and reform in relation to human rights issues is still ongoing; whereas attacks on members of civil society, including efforts to silence, imprison or harass human rights activists, journalists, lawyers, and others have become increasingly common in recent years;

| K. | whereas the UN Special Rapporteur on the Independence of Judges and Lawyers stated after her visit to the UAE in 2014 that lawyers who take up cases related to state security ‘have been harassed, threatened and had pressure exerted on them’; whereas she denounced the fact that the ‘judicial system remains under the de facto control of the executive branch of the government’; |
| --- | --- |

K.

whereas the UN Special Rapporteur on the Independence of Judges and Lawyers stated after her visit to the UAE in 2014 that lawyers who take up cases related to state security ‘have been harassed, threatened and had pressure exerted on them’; whereas she denounced the fact that the ‘judicial system remains under the de facto control of the executive branch of the government’;

| L. | whereas evidence has emerged that EU Member States have approved exports of various cybersurveillance technologies to countries with appalling human rights records, including the UAE; |
| --- | --- |

L.

whereas evidence has emerged that EU Member States have approved exports of various cybersurveillance technologies to countries with appalling human rights records, including the UAE;

| M. | whereas the death penalty continues to be applied in the UAE; whereas at least 19 people are currently on death row and there was one execution in 2017; |
| --- | --- |

M.

whereas the death penalty continues to be applied in the UAE; whereas at least 19 people are currently on death row and there was one execution in 2017;

| 1. | Strongly condemns the harassment, persecution and detention of Ahmed Mansoor as well as of all other human rights defenders solely on the basis of their human rights work and their use of their right to freedom of expression both online and offline; urges the UAE authorities to conduct thorough and impartial investigations into the attacks against civil society actors in order to bring the perpetrators to justice; |
| --- | --- |

1.

| 2. | Calls on the authorities to release Mr Mansoor immediately and unconditionally, and to drop all charges against him, as he is a prisoner of conscience detained solely for peacefully exercising his right to freedom of expression, including through his human rights work; also calls for the immediate and unconditional release of all prisoners of conscience in the UAE and for all charges against them to be dropped; |
| --- | --- |

2.

| 3. | Expresses its grave concern at the reports that Ahmed Mansoor has been subjected to forms of torture or ill-treatment while in detention, and that he is being held in solitary confinement; urges the authorities to investigate these allegations and grant him immediate and regular access to a lawyer, to his family, and to any medical care he may require; reminds the UAE authorities that prolonged and indefinite solitary confinement can amount to a form of torture or other cruel, inhuman or degrading treatment under international human rights law, and that the lack of an arrest warrant or any judicial oversight in his arrest and detention represents a breach of the fundamental principles of due process under international human rights law; |
| --- | --- |

3.

| 4. | Calls on the UAE authorities to ensure that detainees deemed to have broken the law undergo due process and are given a free and fair trial according to international standards; |
| --- | --- |

4.

| 5. | Calls on the UAE to review the Federal Law on combating cybercrimes in order to make it conform to international standards relating to the right of everyone to seek, receive, disseminate and impart information and ideas to others, the right to freedom of opinion, expression, and information, access to the internet and the right to privacy; urges the UAE authorities to amend the Counter-Terrorism Law, the 2012 Cybercrimes Law and Federal Law No 2/2008, which are repeatedly used to prosecute human rights defenders; |
| --- | --- |

5.

| 6. | Calls on the UAE authorities to stop all forms of harassment against individuals and immediately to lift the travel ban against human rights defenders, and insists that they guarantee, in all circumstances, that human rights defenders in the UAE are able to carry out their legitimate human rights activities, both inside and outside the country, without fear of reprisals; |
| --- | --- |

6.

| 7. | Calls for an EU-wide ban on the export, sale, update and maintenance of any form of security equipment to the UAE which can be or is used for internal repression, including internet surveillance technology; expresses its concern at the ever-increasing use of certain cybersurveillance dual-use technologies against activists and journalists; welcomes, in this regard, the EU institutions’ ongoing efforts to update the dual-use export control regulation; |
| --- | --- |

7.

| 8. | Is concerned at the increasing number of individuals who are being punished for collaborating with the UN and its different bodies; urges the UAE authorities to cease the obstruction and harassment of individuals engaged with various UN human rights mechanisms; urges the authorities, furthermore, to allow UN experts, international NGOs or EU officials access to visit Mr Mansoor; |
| --- | --- |

8.

| 9. | Calls for greater freedoms in the UAE; underlines that it is important that the UAE respect its international obligations under human rights law, and urges the authorities to ensure the protection of freedom of speech, thought and expression both online and offline for all UAE citizens, and to comply with all provisions of the United Nations Declaration on Human Rights Defenders, in particular Articles 1, 6(a), and 12(2); stresses that these freedoms are guaranteed not only by universal human rights instruments, but also by the Arab Charter on Human Rights, to which the UAE is a party; |
| --- | --- |

9.

| 10. | Calls on the UAE to confirm its intention to ‘uphold the highest standards in the promotion and protection of human rights’by ratifying the ICCPR and its optional protocols and by issuing a standing invitation to visit to all UN special procedure mandate holders; |
| --- | --- |

10.

| 11. | Calls on the VP/HR, the EU and its Member States to take a strong public stand towards this flagrant violation of human rights, including by demanding Mr Mansoor’s release in all contacts they have with the UAE authorities; urges the EU Delegation in Abu Dhabi to provide all appropriate support to Ahmed Mansoor, including prison visits, trial monitoring and the provision of legal or any other form of assistance that he might require; calls on the European External Action Service (EEAS) to report to the European Parliament on the actions undertaken so far by the EU Delegation in support of Mr Mansoor; |
| --- | --- |

11.

| 12. | Calls on the EEAS to propose, and for the Member States to adopt, EU targeted measures related to serious human rights violations; |
| --- | --- |

12.

| 13. | Reiterates its opposition to the death penalty in all circumstances and calls for a moratorium with a view to its abolition ; |
| --- | --- |

13.

| 14. | Encourages continued dialogue between the EU, its Member States, and the UAE; considers that regular interparliamentary meetings between Parliament and its partners in the Gulf region are an important forum for developing a constructive and frank dialogue on issues of common concern; stresses that interparliamentary discussions should not focus only on security and trade issues, but should also include respect for human rights as a crucial topic in their discussions; |
| --- | --- |

14.

| 15. | Instructs its President to forward this resolution to the Government and Parliament of the United Arab Emirates, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the Commission, the EU Special Representative for Human Rights, the parliaments and governments of the Member States, the United Nations High Commissioner for Human Rights and the governments of the Member States of the Gulf Cooperation Council; calls for the translation of this resolution into Arabic. |
| --- | --- |

15.

---

(1)  OJ C 72 E, 11.3.2014, p. 40.

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| 13.1.2020 | EN | Official Journal of the European Union | C 11/25 |
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13.1.2020

EN

Official Journal of the European Union

C 11/25

---

P8_TA(2018)0377

Mass arbitrary detention of Uyghurs and Kazakhs in the Xinjiang Uyghur Autonomous Region

European Parliament resolution of 4 October 2018 on mass arbitrary detention of Uyghurs and Kazakhs in the Xinjiang Uyghur Autonomous Region (2018/2863(RSP))

(2020/C 011/07)

The European Parliament,

| — | having regard to its previous resolutions on the situation in China, in particular those of 26 November 2009 on China: minority rights and application of the death penalty (1), of 10 March 2011 on the situation and cultural heritage in Kashgar (Xinjiang Uyghur Autonomous Region) (2), of 6 July 2017 on the cases of Nobel Laureate Liu Xiaobo and Lee Ming-che (3), of 15 December 2016 on the cases of the Larung Gar Tibetan Buddhist Academy and Ilham Tohti (4), and of 12 September 2018 on the State of EU-China relations (5), |
| --- | --- |

—

having regard to its previous resolutions on the situation in China, in particular those of 26 November 2009 on China: minority rights and application of the death penalty (1), of 10 March 2011 on the situation and cultural heritage in Kashgar (Xinjiang Uyghur Autonomous Region) (2), of 6 July 2017 on the cases of Nobel Laureate Liu Xiaobo and Lee Ming-che (3), of 15 December 2016 on the cases of the Larung Gar Tibetan Buddhist Academy and Ilham Tohti (4), and of 12 September 2018 on the State of EU-China relations (5),

| — | having regard to Article 36 of the Constitution of the People’s Republic of China, which guarantees all citizens the right to freedom of religious belief, and to Article 4 thereof, which upholds the rights of ‘minority nationalities’, |
| --- | --- |

—

having regard to Article 36 of the Constitution of the People’s Republic of China, which guarantees all citizens the right to freedom of religious belief, and to Article 4 thereof, which upholds the rights of ‘minority nationalities’,

| — | having regard to the EU-China Strategic Partnership which was launched in 2003 and to the joint communication of 22 June 2016 from the Commission and the EEAS to Parliament and the Council entitled ‘Elements for a new EU strategy on China’(JOIN(2016)0030), |
| --- | --- |

—

having regard to the EU-China Strategic Partnership which was launched in 2003 and to the joint communication of 22 June 2016 from the Commission and the EEAS to Parliament and the Council entitled ‘Elements for a new EU strategy on China’(JOIN(2016)0030),

| — | having regard to the 36th round of EU-China dialogue on human rights held in Beijing on 9-10 July 2018, |
| --- | --- |

—

having regard to the 36th round of EU-China dialogue on human rights held in Beijing on 9-10 July 2018,

| — | having regard to remarks in the address made by Michelle Bachelet, the UN High Commissioner for Human Rights, to the 39th session of the UN Human Rights Council on 10 September 2018, in which she expressed deep concern over ‘re-education camps’and asked the Chinese Government to admit independent investigators, |
| --- | --- |

—

having regard to remarks in the address made by Michelle Bachelet, the UN High Commissioner for Human Rights, to the 39th session of the UN Human Rights Council on 10 September 2018, in which she expressed deep concern over ‘re-education camps’and asked the Chinese Government to admit independent investigators,

| — | having regard to the recent general allegation letter sent in May 2018 by the UN Working Group on Enforced or Involuntary Disappearances (WGEID) to the Chinese Government, expressing concern about the continued deterioration of the situation and increase in the number of Uyghurs being arbitrarily detained, |
| --- | --- |

—

having regard to the recent general allegation letter sent in May 2018 by the UN Working Group on Enforced or Involuntary Disappearances (WGEID) to the Chinese Government, expressing concern about the continued deterioration of the situation and increase in the number of Uyghurs being arbitrarily detained,

| — | having regard to the International Covenant on Civil and Political Rights of 16 December 1966, |
| --- | --- |

—

having regard to the International Covenant on Civil and Political Rights of 16 December 1966,

| — | having regard to the Universal Declaration of Human Rights of 1948, |
| --- | --- |

—

having regard to the Universal Declaration of Human Rights of 1948,

| — | having regard to Rules 135(5) and 123(4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 135(5) and 123(4) of its Rules of Procedure,

| A. | whereas the promotion of and respect for universal human rights, democracy and the rule of law should remain at the centre of the long-standing relationship between the EU and China, in accordance with the EU’s commitment to uphold these very same values in its external action and China’s expressed interest in adhering to them in its own development and international cooperation; |
| --- | --- |

A.

whereas the promotion of and respect for universal human rights, democracy and the rule of law should remain at the centre of the long-standing relationship between the EU and China, in accordance with the EU’s commitment to uphold these very same values in its external action and China’s expressed interest in adhering to them in its own development and international cooperation;

| B. | whereas since President Xi Jinping assumed power, the human rights situation in China has deteriorated further, with the government stepping up its hostility toward peaceful dissent, the freedoms of expression and religion, and the rule of law; |
| --- | --- |

B.

whereas since President Xi Jinping assumed power, the human rights situation in China has deteriorated further, with the government stepping up its hostility toward peaceful dissent, the freedoms of expression and religion, and the rule of law;

| C. | whereas the situation in Xinjiang, which is home to around 11 million Uyghurs and ethnic Kazakhs, has rapidly deteriorated in recent years, as absolute control of Xinjiang has been elevated to a top priority, while further challenges are posed by periodic terrorist attacks in or allegedly connected to Xinjiang, by Uyghurs; |
| --- | --- |

C.

whereas the situation in Xinjiang, which is home to around 11 million Uyghurs and ethnic Kazakhs, has rapidly deteriorated in recent years, as absolute control of Xinjiang has been elevated to a top priority, while further challenges are posed by periodic terrorist attacks in or allegedly connected to Xinjiang, by Uyghurs;

| D. | whereas the UN Committee on the Elimination of Racial Discrimination has cited estimates that ‘from tens of thousands to upwards of a million Uighurs’may be being detained in the Xinjiang Uyghur Autonomous Region (XUAR), without being charged or tried, under the pretext of countering terrorism and religious extremism; whereas this would represent the largest mass incarceration of an ethnic minority population in the world today; |
| --- | --- |

D.

whereas the UN Committee on the Elimination of Racial Discrimination has cited estimates that ‘from tens of thousands to upwards of a million Uighurs’may be being detained in the Xinjiang Uyghur Autonomous Region (XUAR), without being charged or tried, under the pretext of countering terrorism and religious extremism; whereas this would represent the largest mass incarceration of an ethnic minority population in the world today;

| E. | whereas the US Congressional-Executive Commission on China has also stated that there is solid information that Uyghurs, Kazakhs and other primarily Muslim ethnic minorities in the XUAR have been subjected to arbitrary detention, torture, egregious restrictions on religious practice and culture, and a digital surveillance system so pervasive that every aspect of daily life is monitored – through facial recognition cameras, mobile phone scans, DNA collection and an extensive and intrusive police presence; |
| --- | --- |

E.

whereas the US Congressional-Executive Commission on China has also stated that there is solid information that Uyghurs, Kazakhs and other primarily Muslim ethnic minorities in the XUAR have been subjected to arbitrary detention, torture, egregious restrictions on religious practice and culture, and a digital surveillance system so pervasive that every aspect of daily life is monitored – through facial recognition cameras, mobile phone scans, DNA collection and an extensive and intrusive police presence;

| F. | whereas detainees are reportedly being held in poor conditions, subjected to political indoctrination, including mandatory courses in patriotism, and forced to denounce their ethnic and religious identity; whereas there are recent reports of deaths in custody including suicides; |
| --- | --- |

F.

whereas detainees are reportedly being held in poor conditions, subjected to political indoctrination, including mandatory courses in patriotism, and forced to denounce their ethnic and religious identity; whereas there are recent reports of deaths in custody including suicides;

| G. | whereas thousands of children have reportedly been separated from their parents, who are arbitrarily detained in internment camps, and are being held in overcrowded orphanages, even if only one of their parents is detained in a camp; |
| --- | --- |

G.

whereas thousands of children have reportedly been separated from their parents, who are arbitrarily detained in internment camps, and are being held in overcrowded orphanages, even if only one of their parents is detained in a camp;

| H. | whereas at the UN hearing of 13 August 2018 in Geneva, the Chinese delegation denied the accusations made by UN experts of having detained ethnic Uyghur Muslims in ‘re-education’camps in the western region of Xinjiang; whereas comprehensive evidence exists of the construction and upgrading of these facilities; |
| --- | --- |

H.

whereas at the UN hearing of 13 August 2018 in Geneva, the Chinese delegation denied the accusations made by UN experts of having detained ethnic Uyghur Muslims in ‘re-education’camps in the western region of Xinjiang; whereas comprehensive evidence exists of the construction and upgrading of these facilities;

| I. | whereas some foreign journalists have been pressured into refraining from reporting on sensitive issues such as Uyghur human rights and the use of internment camps, including in some cases through the refusal to renew press credentials; |
| --- | --- |

I.

whereas some foreign journalists have been pressured into refraining from reporting on sensitive issues such as Uyghur human rights and the use of internment camps, including in some cases through the refusal to renew press credentials;

| J. | whereas nowhere in the world is the population monitored as strictly as in the XUAR; whereas the provincial government has recruited tens of thousands of additional security personnel; |
| --- | --- |

J.

whereas nowhere in the world is the population monitored as strictly as in the XUAR; whereas the provincial government has recruited tens of thousands of additional security personnel;

| K. | whereas data is collected by an ‘integrated joint operations platform’that also stores further data on the population, including consumer habits, banking activity, health status and the DNA profile of every single inhabitant of the XUAR; whereas Muslims in the region are required to have a spyware app on their mobile phones and failure to install the app is an offence; |
| --- | --- |

K.

whereas data is collected by an ‘integrated joint operations platform’that also stores further data on the population, including consumer habits, banking activity, health status and the DNA profile of every single inhabitant of the XUAR; whereas Muslims in the region are required to have a spyware app on their mobile phones and failure to install the app is an offence;

| L. | whereas first-hand testimony and credible academic research have indicated that there is intentional targeting of Uyghurs with ties to people abroad and of those with religious beliefs; |
| --- | --- |

L.

whereas first-hand testimony and credible academic research have indicated that there is intentional targeting of Uyghurs with ties to people abroad and of those with religious beliefs;

| M. | whereas Uyghurs overseas have been pressured to return to China, often with the support of host states; whereas Chinese embassies abroad have refused to renew many Uyghur passports, leading to insecurity in terms of work and study; |
| --- | --- |

M.

whereas Uyghurs overseas have been pressured to return to China, often with the support of host states; whereas Chinese embassies abroad have refused to renew many Uyghur passports, leading to insecurity in terms of work and study;

| N. | whereas requests from the WGEID and the UN High Commissioner for Human Rights, and other UN Special Procedures mandates to send independent investigators to Xinjiang have been routinely denied by the Chinese Government; |
| --- | --- |

N.

whereas requests from the WGEID and the UN High Commissioner for Human Rights, and other UN Special Procedures mandates to send independent investigators to Xinjiang have been routinely denied by the Chinese Government;

| O. | whereas the Uyghur economics professor Ilham Tohti was sentenced to life imprisonment on 23 September 2014 on the charge of alleged separatism, after being detained in January of the same year; whereas seven of his former students were also detained and sentenced to imprisonment of between three and eight years for alleged collaboration with Mr Tohti; whereas Ilham Tohti has always rejected separatism and violence and has sought reconciliation based on respect for Uyghur culture; |
| --- | --- |

O.

whereas the Uyghur economics professor Ilham Tohti was sentenced to life imprisonment on 23 September 2014 on the charge of alleged separatism, after being detained in January of the same year; whereas seven of his former students were also detained and sentenced to imprisonment of between three and eight years for alleged collaboration with Mr Tohti; whereas Ilham Tohti has always rejected separatism and violence and has sought reconciliation based on respect for Uyghur culture;

| 1. | Is deeply concerned about the increasingly suppressive regime imposed on different minorities, in particular Uyghurs and Kazakhs, with additional restrictions being placed on the constitutional guarantees of their rights to freedom of cultural expression and religious belief, speech and expression, and peaceful assembly and association; demands that the authorities respect these fundamental freedoms; |
| --- | --- |

1.

| 2. | Calls on the Chinese Government to immediately end the mass arbitrary detention of members of the Uyghur and Kazakh minorities, to close all camps and detention centres and to release detained persons immediately and unconditionally; is deeply concerned by the numerous allegations of poor conditions, torture and deaths inside the camps; reminds the Chinese authorities that re-education facilities have no legal basis; |
| --- | --- |

2.

| 3. | Is alarmed by the reported deaths of Muhammad Salih Hajim, Abdulnehed Mehsum, Ayhan Memet and others, all elderly Uyghurs, academics and community leaders, in internment camps; |
| --- | --- |

3.

| 4. | Expresses its deep concern at the state’s implementation of measures to ensure the ‘comprehensive supervision’of the region through the installation of China’s ‘Skynet’electronic surveillance system in major urban areas, the installation of GPS trackers in motor vehicles, the use of facial recognition scanners at checkpoints and at train and petrol stations, and the blood-collecting activities of Xinjiang’s police force to further expand China’s DNA database; |
| --- | --- |

4.

| 5. | Emphasises that government control and the compulsory mass collection of citizens’ data primarily targets and affects Uyghurs, Kazakhs and other ethnic minorities, in violation of the prohibition of discrimination under international law; |
| --- | --- |

5.

| 6. | Urges the Chinese Government to release to the families concerned the full details of those forcibly disappeared in Xinjiang, including their names, whereabouts and current status; |
| --- | --- |

6.

| 7. | Is deeply concerned about China’s Counterterrorism Law (2015) and the Regulation on De-Extremification, which have an overly broad definition of what constitutes a terrorist act; calls, therefore, on China to clearly differentiate between peaceful dissent and violent extremism; |
| --- | --- |

7.

| 8. | Reiterates its call on the Chinese Government to immediately and unconditionally release Uyghur scholar Ilham Tohti and all others detained solely for the peaceful exercise of their freedom of expression and, pending their release, calls on China to ensure that they have regular, unrestricted access to their families and lawyers of their choice; calls, furthermore, for the release of Eli Mamut, Hailaite Niyazi, Memetjan Abdulla, Abduhelil Zunun and Abdukerim Abduweli, as requested by the EU during the 36th round of the EU-China Human Rights dialogue held in Beijing on 9-10 July 2018; |
| --- | --- |

8.

| 9. | Urges the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy (VP/HR), the European External Action Service (EEAS) and the Member States to monitor intensely the changing human rights developments in Xinjiang, including the increased government repression of Uyghurs, Kazakhs and other ethnic minorities, and to send a strong message to the highest level of the Chinese Government to end the grotesque human rights violations; |
| --- | --- |

9.

| 10. | Calls on the Chinese authorities to allow free, unhindered access for journalists and international observers to Xinjiang province; |
| --- | --- |

10.

| 11. | Recalls the importance for the EU and the Member States of raising the issue of human rights violations in Xinjiang with the Chinese authorities, including at leadership level, in line with the EU’s commitment to project a strong, clear and unified voice in its approach to the country, including at the yearly Human Rights Dialogue and the upcoming Euro-Asia Summit; |
| --- | --- |

11.

| 12. | Expresses its deep concern regarding the reports of harassment of Uyghurs abroad by the Chinese authorities aiming to compel them to act as informants against other Uyghurs, return to Xinjiang or remain silent about the situation there, sometimes by detaining their family members; |
| --- | --- |

12.

| 13. | Welcomes the decision taken by Germany and Sweden to suspend the return of all ethnic Uyghurs, Kazakhs or other Turkic Muslims to China in consideration of the risk of arbitrary detention, torture or other ill-treatment they would face in the country, and calls on all other Member States to follow suit and to expedite asylum claims by Turkic Muslims at risk of being forcibly returned to China; further calls on EU Member States to invoke domestic law, as appropriate, to investigate the Chinese Government’s intimidation of Turkic Muslim diaspora communities in Europe; |
| --- | --- |

13.

| 14. | Reminds China of its human rights obligations following its signing of a wide range of international human rights treaties and therefore recalls that China is expected to live up to these commitments; |
| --- | --- |

14.

| 15. | Instructs its President to forward this resolution to the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the Council, the Commission, the governments and parliaments of the Member States, and the Government and the Parliament of the People’s Republic of China. |
| --- | --- |

15.

---

(1)  OJ C 285 E, 21.10.2010, p. 80.

(2)  OJ C 199 E, 7.7.2012, p. 185.

(3)  OJ C 334, 19.9.2018, p. 137.

(4)  OJ C 238, 6.7.2018, p. 108.

(5)  Texts adopted, P8_TA(2018)0343.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/28 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/28

---

P8_TA(2018)0378

Public procurement strategy package

European Parliament resolution of 4 October 2018 on the public procurement strategy package (2017/2278(INI))

(2020/C 011/08)

The European Parliament,

| — | having regard to the Commission communication of 3 October 2017 on Making Public Procurement work in and for Europe (COM(2017)0572), |
| --- | --- |

—

having regard to the Commission communication of 3 October 2017 on Making Public Procurement work in and for Europe (COM(2017)0572),

| — | having regard to the Commission communication of 3 October 2017 on Helping investment through a voluntary ex-ante assessment of the procurement aspects for large infrastructure projects (COM(2017)0573), |
| --- | --- |

—

having regard to the Commission communication of 3 October 2017 on Helping investment through a voluntary ex-ante assessment of the procurement aspects for large infrastructure projects (COM(2017)0573),

| — | having regard to Commission Recommendation (EU) 2017/1805 of 3 October 2017 on the professionalisation of public procurement – Building an architecture for the professionalisation of public procurement (C(2017)6654) (1), |
| --- | --- |

—

having regard to Commission Recommendation (EU) 2017/1805 of 3 October 2017 on the professionalisation of public procurement – Building an architecture for the professionalisation of public procurement (C(2017)6654) (1),

| — | having regard to Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (2), |
| --- | --- |

—

having regard to Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (2),

| — | having regard to Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (3), |
| --- | --- |

—

having regard to Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (3),

| — | having regard to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (4), |
| --- | --- |

—

having regard to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (4),

| — | having regard to the Commission report of 17 May 2017 on the review of the practical application of the European Single Procurement Document (ESPD) (COM(2017)0242), |
| --- | --- |

—

having regard to the Commission report of 17 May 2017 on the review of the practical application of the European Single Procurement Document (ESPD) (COM(2017)0242),

| — | having regard to Directive 2014/55/EU of the European Parliament and of the Council of 16 April 2014 on electronic invoicing in public procurement (5), |
| --- | --- |

—

having regard to Directive 2014/55/EU of the European Parliament and of the Council of 16 April 2014 on electronic invoicing in public procurement (5),

| — | having regard to the Commission report of 11 October 2017 on the Assessment of the European Standard on electronic invoicing, according to Directive 2014/55/EU (COM(2017)0590), |
| --- | --- |

—

having regard to the Commission report of 11 October 2017 on the Assessment of the European Standard on electronic invoicing, according to Directive 2014/55/EU (COM(2017)0590),

| — | having regard to the European Economic and Social Committee opinion of 14 February 2018, |
| --- | --- |

—

having regard to the European Economic and Social Committee opinion of 14 February 2018,

| — | having regard to Rule 52 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 52 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Internal Market and Consumer Protection, the opinion of the Committee on International Trade and the position in the form of amendments of the Committee on the Environment, Public Health and Food Safety (A8-0229/2018), |
| --- | --- |

—

having regard to the report of the Committee on the Internal Market and Consumer Protection, the opinion of the Committee on International Trade and the position in the form of amendments of the Committee on the Environment, Public Health and Food Safety (A8-0229/2018),

| A. | whereas the full potential of public procurement in helping to build a competitive social market economy is yet to be unlocked, and whereas over 250 000 public authorities in the Union spend around 14 % of GDP, or nearly EUR 2 000 billion, each year on the purchase of services, works and supplies; |
| --- | --- |

A.

whereas the full potential of public procurement in helping to build a competitive social market economy is yet to be unlocked, and whereas over 250 000 public authorities in the Union spend around 14 % of GDP, or nearly EUR 2 000 billion, each year on the purchase of services, works and supplies;

| B. | whereas public procurement involves the spending of a considerable amount of taxpayers’ money, meaning that it should be carried out in an ethical manner, with transparency and integrity and in the most efficient way, in terms of both costs and quality delivered, in order to provide quality goods and services to citizens; |
| --- | --- |

B.

whereas public procurement involves the spending of a considerable amount of taxpayers’ money, meaning that it should be carried out in an ethical manner, with transparency and integrity and in the most efficient way, in terms of both costs and quality delivered, in order to provide quality goods and services to citizens;

| C. | whereas correctly implemented public procurement rules are a crucial tool in the service of a stronger single market and for the growth of EU companies and jobs in the Union and whereas the intelligent use of public procurement can be a strategic tool to achieve the EU’s goals of smart, sustainable and inclusive growth, accelerating the transition to more sustainable supply chains and business models; |
| --- | --- |

C.

whereas correctly implemented public procurement rules are a crucial tool in the service of a stronger single market and for the growth of EU companies and jobs in the Union and whereas the intelligent use of public procurement can be a strategic tool to achieve the EU’s goals of smart, sustainable and inclusive growth, accelerating the transition to more sustainable supply chains and business models;

| D. | whereas, when it comes to the transposition of EU rules on public procurement and concessions, the full transposition and implementation of EU law is essential to make it easier and cheaper for small and medium-sized enterprises to bid for public contracts, with full respect for the EU’s principles of transparency and competition; |
| --- | --- |

D.

whereas, when it comes to the transposition of EU rules on public procurement and concessions, the full transposition and implementation of EU law is essential to make it easier and cheaper for small and medium-sized enterprises to bid for public contracts, with full respect for the EU’s principles of transparency and competition;

| E. | whereas the Commission launched a targeted consultation on the draft Guidance on Public Procurement of Innovation on 3 October 2017, and a targeted consultation on the scope and structure of a Commission guide on socially responsible public procurement on 7 December 2017; |
| --- | --- |

E.

whereas the Commission launched a targeted consultation on the draft Guidance on Public Procurement of Innovation on 3 October 2017, and a targeted consultation on the scope and structure of a Commission guide on socially responsible public procurement on 7 December 2017;

| F. | whereas according to a 2016 survey, as mentioned in Commission communication COM(2017)0572, only four Member States relied on digital technologies for all major steps in public procurement, such as e-notification, e-access to tender documents, e-submission, e-evaluation, e-award, e-ordering, e-invoicing and e-payment; |
| --- | --- |

F.

whereas according to a 2016 survey, as mentioned in Commission communication COM(2017)0572, only four Member States relied on digital technologies for all major steps in public procurement, such as e-notification, e-access to tender documents, e-submission, e-evaluation, e-award, e-ordering, e-invoicing and e-payment;

| G. | whereas according to the European Semester thematic fact sheet on public procurement of November 2017, the number of tender procedures with only one bid increased from 14 % to 29 % for the period 2006-2016, and whereas, according to Commission communication COM(2017)0572, ‘SMEs win only 45 % of the value of public contracts above EU thresholds, clearly below their weight in the economy’; |
| --- | --- |

G.

whereas according to the European Semester thematic fact sheet on public procurement of November 2017, the number of tender procedures with only one bid increased from 14 % to 29 % for the period 2006-2016, and whereas, according to Commission communication COM(2017)0572, ‘SMEs win only 45 % of the value of public contracts above EU thresholds, clearly below their weight in the economy’;

| H. | whereas the new rules introduced by the 2014 directives, by facilitating public procurement and imposing more controls, should contribute to the implementation of the Europe 2020 Strategy for a sustainable, more social, innovative and inclusive economy; |
| --- | --- |

H.

whereas the new rules introduced by the 2014 directives, by facilitating public procurement and imposing more controls, should contribute to the implementation of the Europe 2020 Strategy for a sustainable, more social, innovative and inclusive economy;

| I. | whereas according to Commission communication COM(2017)0572, 55 % of public procurement procedures still use the lowest price as the only award criterion, instead of, for instance, strategic social and environmental criteria; |
| --- | --- |

I.

whereas according to Commission communication COM(2017)0572, 55 % of public procurement procedures still use the lowest price as the only award criterion, instead of, for instance, strategic social and environmental criteria;

| J. | whereas the European Union is committed to the United Nations Sustainable Development Goals (SDGs); |
| --- | --- |

J.

whereas the European Union is committed to the United Nations Sustainable Development Goals (SDGs);

| K. | whereas it is of crucial importance that suppliers trust that the Union’s public procurement systems offer simple and accessible digital procedures, full transparency, integrity and security of data; |
| --- | --- |

K.

whereas it is of crucial importance that suppliers trust that the Union’s public procurement systems offer simple and accessible digital procedures, full transparency, integrity and security of data;

Legislative framework and implementation

| 1. | Welcomes, almost four years after the extensive revision of the Union public procurement legislative framework was concluded, the set of non-legislative measures proposed by the Commission and expects that this will create impetus for better implementation; |
| --- | --- |

1.

| 2. | Is deeply disappointed by the pace at which many Member States have transposed the 2014 directives in the area of public procurement, and by the many delays, and deplores the fact that the Commission had to initiate infringement procedures against some Member States; urges the swift completion of transposition in all Member States without any further delay; |
| --- | --- |

2.

| 3. | Is concerned about the next round of deadlines provided by the directives regarding electronic procurement and the transition of Member States to full e-procurement, including e-invoicing; stresses the need for the Member States’ digital agendas to include the promotion of full e-procurement; |
| --- | --- |

3.

| 4. | Calls on the Commission to finalise swiftly the Guidance on Public Procurement of Innovation and the Guide on socially responsible public procurement, in order to facilitate the implementation of the respective legal provisions in the Member States; |
| --- | --- |

4.

| 5. | Asks the Commission to better and more clearly organise the guides and other tools developed to help Member States with the implementation of the public procurement framework, in a more accessible and user-friendly way that offers a good overview to all practitioners, while also paying attention to the languages available; |
| --- | --- |

5.

| 6. | Welcomes the new public procurement guidance for practitioners of February 2018, designed to help national, regional and local public officials ensure efficient and transparent public procurement procedures for EU-funded projects; |
| --- | --- |

6.

Strategic and coordinated procurement

| 7. | Points out that the current Union legislation, more than ever, allows for public procurement to be used as a strategic instrument to promote EU policy goals, and encourages the Member States to get the most that they can out of it; recalls that public procurement is also an important tool at a regional and local level to complement local and regional strategies and encourages public hearings and consultations with the end users of products and services; |
| --- | --- |

7.

| 8. | Calls for the extensive use of innovative procurement to achieve smart, green and inclusive growth and to strengthen the circular economy; underlines the importance of the circular economy and, in this regard, the new possibilities offered by the new public procurement directives as regards goods and services reused, repaired, remanufactured, refurbished and other sustainable and resource-efficient products and solutions; |
| --- | --- |

8.

| 9. | Calls on the Member States to use public procurement strategically in order to promote smart, sustainable and inclusive growth, including for SMEs and social enterprises; underlines that this requires Member States to systematically signal such policies at the highest level and support, to this end, procurers and practitioners in the public administration; |
| --- | --- |

9.

| 10. | Points out the importance of tendering conditions which are not overly burdensome, so that access to public contracts remains possible for all companies, including SMEs; |
| --- | --- |

10.

| 11. | Welcomes the example of adopting National Public Procurement Strategies and encourages more Member States to follow this example as a means of modernising and streamlining their public procurement systems and hence enhancing their efficiency; stresses that public procurement is a cross-cutting area for the various sectors of public administration, and that it is thus essential to have, in addition to coordination, a governance structure that involves the main stakeholders so that the fundamental decisions can be taken in a more collaborative manner and accepted by all those involved; |
| --- | --- |

11.

| 12. | Welcomes the fact that many Member States have made provisions for the use of quality criteria (including the best price-quality ratio) and encourages their systematic application; encourages contracting authorities to apply criteria other than simply the lowest price or cost effectiveness, taking into account qualitative, environmental and/or social aspects; |
| --- | --- |

12.

| 13. | While acknowledging that in some cases the low price can reflect innovative solutions and efficient management, is concerned about the excessive use of the lowest price as the primary award criterion in a number of Member States with disregard for quality, sustainability and social inclusion, and therefore calls on the Commission and the Member States to analyse and report on the reasons behind this situation and to propose suitable solutions where necessary; |
| --- | --- |

13.

| 14. | Calls on the Member States to ensure that public procurement practices are in line with the Convention on the Rights of Persons with Disabilities; calls on the Member States to encourage consultation with persons with disabilities and their representative organisations in this respect; |
| --- | --- |

14.

| 15. | Calls for the adoption of a European code of ethics for public procurement for the various actors in the procurement process; |
| --- | --- |

15.

| 16. | Stresses that it is important for contracting authorities to consider the full life-cycle of products, including their impact on the environment, in their purchasing decisions, when appropriate, and calls on the Commission to assist in the development of methodologies to implement the concept of ‘life-cycle costing’; |
| --- | --- |

16.

| 17. | Notes that innovative, social and environmental considerations are legitimate and essential award criteria in public procurement, and that contracting authorities can also pursue green, innovative or social goals through well-thought-out specifications and by allowing variant offers in a non-discriminatory way, provided that these characteristics are linked to the subject matter of the contract and are proportionate to its value and objectives; |
| --- | --- |

17.

| 18. | Recalls that the Union’s legislative framework on public procurement obliges Member States to ensure that contractors and subcontractors fully comply with the environmental, social and labour law provisions which apply at the place where the works are executed, services are provided or goods are produced or supplied, as set out in the applicable international conventions, in Union and national law as well as in collective agreements concluded in accordance with national law and practices; calls on the Commission to guarantee that this obligation is fulfilled by Member States in the transposition and application of the 2014 directives and to facilitate the exchange of best practices in this area; |
| --- | --- |

18.

| 19. | Acknowledges that a qualitative assessment of bids requires skilled procurers, and calls on the Commission to assist Member States with the dissemination of evaluation methodologies and practices, particularly through the organisation of workshops and training courses; underlines that such assistance should be available at all administrative levels where procurement is carried out; |
| --- | --- |

19.

| 20. | Points out that that socially responsible public procurement must take into account supply chains and the risks associated with modern-day slavery, social dumping and human rights violations; notes that efforts must be made to ensure that goods and services acquired through public procurement are not produced in a manner that violates human rights; calls on the Commission to include substantive provisions on ethics in supply chains in its new guide on social considerations in public procurement; |
| --- | --- |

20.

| 21. | Welcomes the efforts of several Member States to set up authorities that are responsible for coordinating procurement, and acknowledges that this contributes to conducting strategic and efficient procurement; |
| --- | --- |

21.

| 22. | Calls for more Member States to use the advantages of central purchasing and aggregation of public purchasing, and notes that Central Purchasing Bodies could and should speed up dissemination of expertise, of best practices and of innovation; |
| --- | --- |

22.

| 23. | Stresses that, especially with the aim of fostering innovation, it is important that contracting authorities engage with the market and make sufficient use of the pre-procurement phase as preparation for the next steps; believes that pre-procurement is also an essential phase for supporting SME involvement; |
| --- | --- |

23.

| 24. | Considers that the new partnership procedure will help to foster innovation, and encourages contracting authorities to cooperate with the market in order to develop innovative methodologies, products, works or services which do not yet exist; welcomes in this regard the fact that 17 innovation partnership procedures have been initiated to date; |
| --- | --- |

24.

| 25. | Welcomes the voluntary ex-ante assessment of procurement aspects for large infrastructure projects, as proposed by the Commission, and calls on the Commission to swiftly implement the helpdesk, the notification mechanism and the information exchange mechanism, while fully respecting confidentiality; |
| --- | --- |

25.

Digitalisation and sound management of the procurement procedures

| 26. | Regrets the slow uptake of digital technologies in public procurement in the Union, and calls on the Member States to strive for a rapid digital transformation of the procedures and for the introduction of e-processes for all major stages, namely from notification, access to tenders and submission to evaluation, contract award, ordering, invoicing and payment; |
| --- | --- |

26.

| 27. | Calls on the Commission and the Member States to put in place the eForms by the end of 2018 at the latest; |
| --- | --- |

27.

| 28. | Recalls that e-procurement offers a range of important benefits such as significant savings for all parties, simplified and shortened processes, reductions in red tape and administrative burdens, increased transparency and greater innovation as well as improved access of SMEs to public procurement markets; |
| --- | --- |

28.

| 29. | Agrees with the Commission that contract registers can be a cost-efficient tool for managing contracts, for improving transparency, integrity and data, and for better governance of public procurement; |
| --- | --- |

29.

| 30. | Calls on the Commission to look into the possibility of interlinking national contract registers with Tenders Electronic Daily (TED) to remove the obligation on contracting authorities to publish the same information in two systems; |
| --- | --- |

30.

| 31. | Draws attention to the difficulties that may arise for bidders, and especially SMEs, regarding requirements for certificates and signatures and encourages a light requirements regime in this respect, together with full application of the once-only principle in order to minimise the burden for bidders; |
| --- | --- |

31.

| 32. | Emphasises that all Member States should be in a position to provide all necessary data on public procurement implementation, including data on tenders, procedures and contracts and statistical information, also in order to enable the Commission to assess the single market on procurement; |
| --- | --- |

32.

| 33. | Calls on the Member States to promote the innovative use of open-format data, as such data are essential for any government to manage its public administration, and at the same time, to enable the economic potential of such data to be harnessed by companies, while also encouraging transparency and responsibility within institutions and bodies dealing with public procurement; points out that such data must always be published with due regard for the principle of proportionality and in accordance with the EU acquis on data protection and business secrecy; |
| --- | --- |

33.

Single market and improved access to procurement

| 34. | Points out that competitive bidding is vital in public procurement, and notes with regret a decrease in the intensity of competition in public procurement in the Union in recent years; urges the Member States recording a high percentage of notices with only one bidder to address the problem; |
| --- | --- |

34.

| 35. | Urges the Member States to increase joint procurement procedures, including cross-border, as facilitated by the revised EU rules, and calls on the Commission to provide in-depth support in this field; considers that such procedures should not however result in contracts of such size that SMEs are effectively excluded from consideration at the earliest stage of the process; |
| --- | --- |

35.

| 36. | Regrets that SMEs and social economy enterprises are still facing difficulties in accessing public procurement, and calls on the Commission to assess the effectiveness of the measures provided by the 2014 directives and to come forward with new solutions if necessary; |
| --- | --- |

36.

| 37. | Asks the Commission to report to Parliament on the implementation on the ground of the ‘apply or explain’principle in Article 46 of Directive 2014/24/EU, which requires contracting authorities to provide an indication of the main reasons for their decision not to subdivide into lots, which must be systematically explained in the procurement documents or the individual report; |
| --- | --- |

37.

| 38. | Calls on the Member States to support SMEs’ participation in tenders, for example by mandatory division into lots when possible or by placing a limit on the turnover required to participate in a tender procedure; highlights that division of public procurement contracts into lots fosters competition in the market as well as avoiding the risk of single-supplier dependency; calls on the Commission and the Member States to develop advisory services and training for SMEs to improve their participation in tendering processes; |
| --- | --- |

38.

| 39. | Calls on the Commission to analyse in particular the impediments to cross-border public procurement resulting from language, administrative, legal or any other barriers, and to propose solutions or intervene in order to guarantee functional cross-border procurement; |
| --- | --- |

39.

| 40. | Underlines the importance of ensuring interoperability in purchased goods and services and of avoiding vendor lock-in, and calls on the Commission to propose measures in this field; |
| --- | --- |

40.

| 41. | Regrets the lack of clear and consolidated public procurement data in the EU and notes that reliable data on access to public procurement are necessary to verify the accountability of public authorities, and are a means of combating fraud and corruption; |
| --- | --- |

41.

| 42. | Accepts the evaluation outcome of the Remedies Directive and the Commission’s decision not to propose a legislative revision, but calls for continuation of the cooperation of national review bodies and for more guidance from the Commission on the directives; |
| --- | --- |

42.

| 43. | Regrets that the Defence Procurement Directive has not yet delivered the desired results, in particular with regard to trans-national infrastructure projects, and urges the Commission and the Member States to intensify their efforts to better implement the currently applicable rules; |
| --- | --- |

43.

| 44. | Highlights the importance of transparency and the non-discriminatory nature of public procurement procedures; recalls the importance of having proper appeal procedures in place and the importance of access to guidance on how to launch an appeal; |
| --- | --- |

44.

International public procurement

| 45. | Calls for Union action to improve the access of EU suppliers to third-country public procurement markets, as the Union’s public procurement market is one of the most open in the world; |
| --- | --- |

45.

| 46. | Expresses concern over unfair competition within public procurement procedures as a result of state interference with third-country competitors, in particular, but not limited, to the market for electric vehicles and batteries; considers that there is a need to link trade defence instruments and public procurement practices; |
| --- | --- |

46.

| 47. | Stresses that public procurement markets are of major economic importance, given that procurement expenditure is estimated to account for 20 % of global GDP, and stresses that improving access to public procurement markets in third countries, as well as levelling the playing field for European businesses, can therefore be a major driver of growth in trade of goods and services, and also leads to greater choice and better value for tax payers’ money, both in the EU and in third countries; |
| --- | --- |

47.

| 48. | Points out that public procurement markets in third countries are often de jure and/or de facto closed to EU bidders; encourages the Commission to collect and provide better data on international public procurement procedures; recalls that the Commission estimates that more than half of the global procurement market is currently closed to free international competition owing to protectionist measures, which are on the rise globally, while approximately EUR 352 billion in value of EU public procurement is open to bidders from member countries of the WTO Agreement on Government Procurement; stresses the need for the EU to address this imbalance without resorting to protectionist measures; asks the Commission to ensure that European companies get similar market access to that enjoyed by our foreign competitors in the EU market and notes that the proposed so-called international procurement instrument (IPI) could under certain conditions be a means to create leverage for increasing market access; |
| --- | --- |

48.

| 49. | Welcomes the fact that one of the six priority areas for the Commission’s action in the field of public procurement is the improvement of access to procurement markets; stresses that improving access to public procurement markets in third countries, including at sub-national level, constitutes a strong offensive interest for the EU in trade negotiations, given that many EU companies are highly competitive in various sectors; stresses that government procurement should be included in each future trade agreement with a view to maximising the participation of European companies in foreign tenders; calls on the Commission to ensure compliance with and proper implementation of the provisions concerning public procurement markets contained in the EU’s free trade agreements; recalls that trade agreements should be used to improve access to third countries’ public procurement markets and that improved market access to third-country procurement markets, and enhanced rules for modern, efficient and transparent procurement procedures, which are crucial to obtaining better value for public money, should be key elements of any trade agreement to be concluded by the EU, while fully respecting the legitimate public policy objectives enshrined in the Union’s public procurement directives; stresses that third-country economic operators must comply with European social and environmental criteria in order to qualify for public procurement contracts, as laid out in Directives 2014/23/EU, 2014/24/EU and 2014/25/EU, and encourages, in line with this, the use of MEAT (most economically advantageous tenders) criteria for the award of such contracts; notes that bilateral and sub-regional free trade agreements do not always guarantee full access to procurement markets; asks the Commission to negotiate the greatest possible access to public procurement markets in third countries; |
| --- | --- |

49.

| 50. | Emphasises that any strategy to open up public procurement markets in third countries must concretely address the obstacles to and specific needs of SMEs to facilitate their access to markets, as they are particularly disadvantaged when it comes to penetrating third-country public procurement markets, while the effects on SMEs of exposure to new competitors from third countries must also be given due consideration; calls on the Commission to encourage the inclusion of SME-friendly procurement procedures (including cross-border initiatives and the division of tenders into lots) in trade agreements; stresses the benefits to be gained, by SMEs in particular, through digitalisation and the use of e-procurement in all public procurement processes with third countries; |
| --- | --- |

50.

| 51. | Points out that major emerging economies, such as Brazil, China, India and Russia, are not yet part of the GPA, while China and Russia are officially in the process of acceding, and asks the Commission to encourage and promote third countries in their efforts to join the GPA, as multilateral and plurilateral agreements are the best way to establish a level playing field in the long term; stresses that bilateral trade agreements with ambitious procurement provisions that respect the underlying principles of the GPA can be a stepping stone for enhanced multilateral cooperation; |
| --- | --- |

51.

| 52. | Highlights the importance of the GPA not only for providing de jure access to procurement markets in third countries, but also for enhancing the transparency and predictability of procurement procedures; encourages the Commission to promote the development of global and convergent standards for transparent procurement as an important tool for combating corruption; more specifically, asks the Commission to strive for the inclusion in trade agreements of provisions on joint rules for public procurement which enable reporting of corruption, simplify procedures and strengthen integrity and transparency for bidders; |
| --- | --- |

52.

Professionalisation

| 53. | Welcomes the Commission’s recommendations on professionalisation and calls on the Member States to develop national plans as a priority; suggests that each plan should differentiate between types of procurement, in particular as SME access to procurement in services and digital infrastructure may be facilitated in a different way to procurement access in the case of large infrastructure contracts; |
| --- | --- |

53.

| 54. | Calls on the Commission to propose the means for financial support from Union funds to support relevant actions on professionalisation in the Member States; |
| --- | --- |

54.

| 55. | Regrets the low level of professionalisation among those responsible for public purchasing and calls on the Member States to improve the skills of everyone involved in all stages of the public procurement process; |
| --- | --- |

55.

| 56. | Underlines that both procurers and suppliers need to be adequately trained in order to work efficiently at all procurement stages, and that attention must be given to all levels of public administration and to quality criteria, including social and environmental criteria, regarding professionalisation; believes that better results can be achieved by improving how public authorities consider what they will procure as well as how they procure it; without prejudice to the negotiated procedure, regrets that public procurement can often be captured by more experienced firms, which assist in the design phase of a procurement contract and as a consequence are better placed to win the contract; |
| --- | --- |

56.

| 57. | Asks Member States to encourage universities to further develop university courses in European public procurement law and to improve the training and career management of procurement practitioners, including those working in SMEs, including concerning the development and uptake of accessible IT tools; supports the creation of a common European framework of relevant technical and computer skills; |
| --- | --- |

57.

o

o o

| 58. | Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States. |
| --- | --- |

58.

---

(1)  OJ L 259, 7.10.2017, p. 28.

(2)  OJ L 94, 28.3.2014, p. 65.

(3)  OJ L 94, 28.3.2014, p. 243.

(4)  OJ L 94, 28.3.2014, p. 1.

(5)  OJ L 133, 6.5.2014, p. 1.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/36 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/36

---

P8_TA(2018)0382

The EU's input on a UN binding instrument on transnational corporations with respect to human rights

European Parliament resolution of 4 October 2018 on the EU’s input to a UN Binding Instrument on transnational corporations and other business enterprises with transnational characteristics with respect to human rights (2018/2763(RSP))

(2020/C 011/09)

The European Parliament,

| — | having regard to Articles 2, 3, 21 and 23 of the Treaty on European Union (TEU), |
| --- | --- |

—

having regard to Articles 2, 3, 21 and 23 of the Treaty on European Union (TEU),

| — | having regard to its resolution of 5 July 2016 on implementation of the 2010 recommendations of Parliament on social and environmental standards, human rights and corporate responsibility (1), |
| --- | --- |

—

having regard to its resolution of 5 July 2016 on implementation of the 2010 recommendations of Parliament on social and environmental standards, human rights and corporate responsibility (1),

| — | having regard to its resolution of 30 May 2018 on the Annual Report on the implementation of the Common Commercial Policy (2), |
| --- | --- |

—

having regard to its resolution of 30 May 2018 on the Annual Report on the implementation of the Common Commercial Policy (2),

| — | having regard to Articles 207 and 208 of the Treaty on the Functioning of the European Union (TFEU), |
| --- | --- |

—

having regard to Articles 207 and 208 of the Treaty on the Functioning of the European Union (TFEU),

| — | having regard to the EU Strategic Framework on Human Rights and Democracy as adopted by the Foreign Affairs Council on 25 June 2012, and to the Action Plan on Human Rights and Democracy 2015-2019 adopted by the Council on 20 July 2015, |
| --- | --- |

—

having regard to the EU Strategic Framework on Human Rights and Democracy as adopted by the Foreign Affairs Council on 25 June 2012, and to the Action Plan on Human Rights and Democracy 2015-2019 adopted by the Council on 20 July 2015,

| — | having regard to the UN Guiding Principles on Business and Human Rights (UNGPs), endorsed by the UN Human Rights Council in its resolution 17/4 of 16 June 2011, |
| --- | --- |

—

having regard to the UN Guiding Principles on Business and Human Rights (UNGPs), endorsed by the UN Human Rights Council in its resolution 17/4 of 16 June 2011,

| — | having regard to the Commission’s Trade for All Strategy, |
| --- | --- |

—

having regard to the Commission’s Trade for All Strategy,

| — | having regard to the Commission’s Sector Guides on Implementing the UNGPs (3), |
| --- | --- |

—

having regard to the Commission’s Sector Guides on Implementing the UNGPs (3),

| — | having regard to the Commission staff working document of 14 July 2015 on ‘Implementing the UN Guiding Principles on Business and Human Rights – State of Play’(SWD(2015)0144), |
| --- | --- |

—

having regard to the Commission staff working document of 14 July 2015 on ‘Implementing the UN Guiding Principles on Business and Human Rights – State of Play’(SWD(2015)0144),

| — | having regard to the opinion of the European Union Agency for Fundamental Rights (FRA) entitled ‘Improving access to remedy in the area of business and human rights at the EU level’ (4), |
| --- | --- |

—

having regard to the opinion of the European Union Agency for Fundamental Rights (FRA) entitled ‘Improving access to remedy in the area of business and human rights at the EU level’ (4),

| — | having regard to the UN Human Rights Council resolution 26/9 of 26 June 2014, whereby it decided ‘to establish an open-ended intergovernmental working group on transnational corporations and other business enterprises with respect to human rights, whose mandate shall be to elaborate an international legally binding instrument to regulate, in international human rights law, the activities of transnational corporations and other business enterprises’, |
| --- | --- |

—

having regard to the UN Human Rights Council resolution 26/9 of 26 June 2014, whereby it decided ‘to establish an open-ended intergovernmental working group on transnational corporations and other business enterprises with respect to human rights, whose mandate shall be to elaborate an international legally binding instrument to regulate, in international human rights law, the activities of transnational corporations and other business enterprises’,

| — | having regard to General comment No 24 (2017) of the UN Committee on Economic, Social and Cultural Rights (CESCR) on State obligations under the International Covenant on Economic, Social and Cultural Rights in the context of business activities (E/C.12/GC/24), |
| --- | --- |

—

having regard to General comment No 24 (2017) of the UN Committee on Economic, Social and Cultural Rights (CESCR) on State obligations under the International Covenant on Economic, Social and Cultural Rights in the context of business activities (E/C.12/GC/24),

| — | having regard to the Maastricht Principles on Extraterritorial Obligations of States in the area of Economic, Social and Cultural Rights (5), |
| --- | --- |

—

having regard to the Maastricht Principles on Extraterritorial Obligations of States in the area of Economic, Social and Cultural Rights (5),

| — | having regard to the United Nations Global Compact (6), |
| --- | --- |

—

having regard to the United Nations Global Compact (6),

| — | having regard to the OECD Guidelines for Multinational Enterprises, |
| --- | --- |

—

having regard to the OECD Guidelines for Multinational Enterprises,

| — | having regard to the International Labour Organisation’s Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, revised in 2017, |
| --- | --- |

—

having regard to the International Labour Organisation’s Tripartite Declaration of Principles concerning Multinational Enterprises and Social Policy, revised in 2017,

| — | having regard to the OECD Due Diligence Guidance for the garment and footwear sector, |
| --- | --- |

—

having regard to the OECD Due Diligence Guidance for the garment and footwear sector,

| — | having regard to the Children’s Rights and Business Principles developed by UNICEF, |
| --- | --- |

—

having regard to the Children’s Rights and Business Principles developed by UNICEF,

| — | having regard to the Council conclusions on Business and Human Rights adopted on 20 June 2016, |
| --- | --- |

—

having regard to the Council conclusions on Business and Human Rights adopted on 20 June 2016,

| — | having regard to the ISO 26000 Guidance Standard on Social Responsibility, |
| --- | --- |

—

having regard to the ISO 26000 Guidance Standard on Social Responsibility,

| — | having regard to the OECD Due Diligence Guidance for Responsible Business Conduct, |
| --- | --- |

—

having regard to the OECD Due Diligence Guidance for Responsible Business Conduct,

| — | having regard to Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (7), |
| --- | --- |

—

having regard to Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (7),

| — | having regard to Directive 2014/95/EU of the European Parliament and of the Council of 22 October 2014 amending Directive 2013/34/EU as regards disclosure of non-financial and diversity information by certain large undertakings and groups (8), |
| --- | --- |

—

having regard to Directive 2014/95/EU of the European Parliament and of the Council of 22 October 2014 amending Directive 2013/34/EU as regards disclosure of non-financial and diversity information by certain large undertakings and groups (8),

| — | having regard to Regulation (EU) 2017/821 of the European Parliament and of the Council of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas (9), |
| --- | --- |

—

having regard to Regulation (EU) 2017/821 of the European Parliament and of the Council of 17 May 2017 laying down supply chain due diligence obligations for Union importers of tin, tantalum and tungsten, their ores, and gold originating from conflict-affected and high-risk areas (9),

| — | having regard to the Council of Europe recommendation to Member States on human rights and business, adopted on 2 March 2016, |
| --- | --- |

—

having regard to the Council of Europe recommendation to Member States on human rights and business, adopted on 2 March 2016,

| — | having regard to its resolution of 13 March 2018 on gender equality in EU trade agreements (10), |
| --- | --- |

—

having regard to its resolution of 13 March 2018 on gender equality in EU trade agreements (10),

| — | having regard to its resolution of 13 December 2017 on the Annual Report on Human Rights and Democracy in the World 2016 and the European Union’s policy on the matter (11), |
| --- | --- |

—

having regard to its resolution of 13 December 2017 on the Annual Report on Human Rights and Democracy in the World 2016 and the European Union’s policy on the matter (11),

| — | having regard to its resolution of 16 November 2017 on the EU-Africa Strategy: a boost for development (12), |
| --- | --- |

—

having regard to its resolution of 16 November 2017 on the EU-Africa Strategy: a boost for development (12),

| — | having regard to its resolution of 27 April 2017 on the EU flagship initiative on the garment sector (13), |
| --- | --- |

—

having regard to its resolution of 27 April 2017 on the EU flagship initiative on the garment sector (13),

| — | having regard to its resolution of 14 February 2017 on the revision of the European Consensus on Development (14), |
| --- | --- |

—

having regard to its resolution of 14 February 2017 on the revision of the European Consensus on Development (14),

| — | having regard to its resolution of 12 September 2017 on the impact of international trade and the EU’s trade policies on global value chains (15), |
| --- | --- |

—

having regard to its resolution of 12 September 2017 on the impact of international trade and the EU’s trade policies on global value chains (15),

| — | having regard to Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (16), |
| --- | --- |

—

having regard to Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market (16),

| — | having regard to its resolution of 25 November 2010 on corporate social responsibility in international trade agreements (17), |
| --- | --- |

—

having regard to its resolution of 25 November 2010 on corporate social responsibility in international trade agreements (17),

| — | having regard to its resolution of 14 December 2016 on the Annual Report on human rights and democracy in the world and the European Union’s policy on the matter 2015 (18), |
| --- | --- |

—

having regard to its resolution of 14 December 2016 on the Annual Report on human rights and democracy in the world and the European Union’s policy on the matter 2015 (18),

| — | having regard to its resolution of 22 November 2016 on increasing the effectiveness of development cooperation (19), |
| --- | --- |

—

having regard to its resolution of 22 November 2016 on increasing the effectiveness of development cooperation (19),

| — | having regard to its resolution of 25 October 2016 on corporate liability for serious human rights abuses in third countries (20), |
| --- | --- |

—

having regard to its resolution of 25 October 2016 on corporate liability for serious human rights abuses in third countries (20),

| — | having regard to its resolution of 5 July 2016 on the fight against trafficking in human beings in the EU’s external relations (21), |
| --- | --- |

—

having regard to its resolution of 5 July 2016 on the fight against trafficking in human beings in the EU’s external relations (21),

| — | having regard to its resolution of 14 April 2016 on the private sector and development (22), |
| --- | --- |

—

having regard to its resolution of 14 April 2016 on the private sector and development (22),

| — | having regard to its resolution of 17 December 2015 on the Annual Report on Human Rights and Democracy in the World 2014 and the European Union’s policy on the matter (23), |
| --- | --- |

—

having regard to its resolution of 17 December 2015 on the Annual Report on Human Rights and Democracy in the World 2014 and the European Union’s policy on the matter (23),

| — | having regard to the study commissioned by its Subcommittee on Human Rights on ‘Implementation of the UN Guiding Principles on Business and Human Rights’ (24), |
| --- | --- |

—

having regard to the study commissioned by its Subcommittee on Human Rights on ‘Implementation of the UN Guiding Principles on Business and Human Rights’ (24),

| — | having regard to the questions to the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, to the Commission and to the Council on the EU’s input to a UN Binding Instrument on transnational corporations and other business enterprises with transnational characteristics with respect to human rights (O-000074/2018 – B8-0402/2018, O-000075/2018 – B8-0403/2018 and O-000078/2018 – B8-0404/2018), |
| --- | --- |

—

having regard to the questions to the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, to the Commission and to the Council on the EU’s input to a UN Binding Instrument on transnational corporations and other business enterprises with transnational characteristics with respect to human rights (O-000074/2018 – B8-0402/2018, O-000075/2018 – B8-0403/2018 and O-000078/2018 – B8-0404/2018),

| — | having regard to the motion for a resolution of the Committee on Development, |
| --- | --- |

—

having regard to the motion for a resolution of the Committee on Development,

| — | having regard to Rules 128(5) and 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 128(5) and 123(2) of its Rules of Procedure,

| A. | whereas the EU is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights; whereas its actions on the international scene (including its development and trade policies) must be guided by these principles and must be consistent with the principle of Policy Coherence for Development (PCD), as enshrined in Article 208 of the Treaty of Lisbon; whereas according to Article 208 of the TFEU the principle of PCD must be respected in all EU external actions; |
| --- | --- |

A.

whereas the EU is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights; whereas its actions on the international scene (including its development and trade policies) must be guided by these principles and must be consistent with the principle of Policy Coherence for Development (PCD), as enshrined in Article 208 of the Treaty of Lisbon; whereas according to Article 208 of the TFEU the principle of PCD must be respected in all EU external actions;

| B. | whereas the European Union is both a normative power and an economic power; whereas, as such, it needs to position itself as a leader in the dissemination of best practice and the development of global standards; |
| --- | --- |

B.

whereas the European Union is both a normative power and an economic power; whereas, as such, it needs to position itself as a leader in the dissemination of best practice and the development of global standards;

| C. | whereas the implementation of Agenda 2030 implies that economic development should go hand in hand with social justice, good governance, respect for human rights, including social rights and the right to human dignity and freedom for all, as well as high labour and environmental standards; whereas sustainable development, trade and human rights can have an impact on each other and may reinforce one another; |
| --- | --- |

C.

whereas the implementation of Agenda 2030 implies that economic development should go hand in hand with social justice, good governance, respect for human rights, including social rights and the right to human dignity and freedom for all, as well as high labour and environmental standards; whereas sustainable development, trade and human rights can have an impact on each other and may reinforce one another;

| D. | whereas human rights obligations rest primarily with States; whereas although States are not per se responsible for human rights violations by private actors, they may breach their international human rights law obligations where such violations can be attributed to them, or where they fail to take appropriate due diligence to prevent, investigate, punish and redress private actors’ abuse; whereas States generally have discretion in deciding what measures to take, making use of policies, legislation, regulations and adjudication; |
| --- | --- |

D.

whereas human rights obligations rest primarily with States; whereas although States are not per se responsible for human rights violations by private actors, they may breach their international human rights law obligations where such violations can be attributed to them, or where they fail to take appropriate due diligence to prevent, investigate, punish and redress private actors’ abuse; whereas States generally have discretion in deciding what measures to take, making use of policies, legislation, regulations and adjudication;

| E. | whereas due diligence is a concept referred to in the OECD Guidelines for Multinational Enterprises (25); |
| --- | --- |

E.

whereas due diligence is a concept referred to in the OECD Guidelines for Multinational Enterprises (25);

| F. | whereas States should fulfil their human rights obligations within their territory and/or jurisdiction; whereas States should set out clearly the expectation that obligation to protect implies regulating to ensure that all business enterprises domiciled in their territory and/or jurisdiction respect human rights throughout their operations, including through their subsidiaries, controlled companies and entities in their supply chain worldwide; |
| --- | --- |

F.

whereas States should fulfil their human rights obligations within their territory and/or jurisdiction; whereas States should set out clearly the expectation that obligation to protect implies regulating to ensure that all business enterprises domiciled in their territory and/or jurisdiction respect human rights throughout their operations, including through their subsidiaries, controlled companies and entities in their supply chain worldwide;

| G. | whereas the UN Guiding Principles on Business and Human Rights (UNGPs), endorsed by consensus in the Human Rights Council, remain the authoritative framework for preventing and addressing the risk of adverse impacts on human rights linked to business activity, and whereas the 2017 study commissioned by Parliament’s Subcommittee on Human Rights and entitled ‘Implementation of the UN Guiding Principles on Business and Human Rights’shows clearly that EU Member States are the most advanced in the global context in the implementation of the UNGPs, having the highest number of National Action Plans adopted or in progress; |
| --- | --- |

G.

whereas the UN Guiding Principles on Business and Human Rights (UNGPs), endorsed by consensus in the Human Rights Council, remain the authoritative framework for preventing and addressing the risk of adverse impacts on human rights linked to business activity, and whereas the 2017 study commissioned by Parliament’s Subcommittee on Human Rights and entitled ‘Implementation of the UN Guiding Principles on Business and Human Rights’shows clearly that EU Member States are the most advanced in the global context in the implementation of the UNGPs, having the highest number of National Action Plans adopted or in progress;

| H. | whereas the UNGPs apply to all States and to all business enterprises, both transnational and others, regardless of their size, sector, location, ownership and structure, and are grounded in the three pillars of the UN ‘protect-respect-remedy’framework, namely: 1) the State’s duty to protect against human rights abuses by third parties, including business; 2) the corporate responsibility to respect human rights; and 3) greater access for victims to effective remedy, both judicial and non-judicial; stresses that although the UNGPs are not legally binding, they are widely recognised and supported, and serve as the basis for policy approaches towards business and human rights internationally, as well as recognition of States’ existing obligations to respect, protect and fulfil human rights and fundamental freedoms, of the role of business enterprises as specialised organs of society performing specialised functions which are required to comply with all applicable laws and to respect human rights, and of the need for rights and obligations to be matched to appropriate and effective remedies when breached; whereas available evidence suggests that where the UNGPs are implemented, the incidence of corporate-related human rights harm is reduced; |
| --- | --- |

H.

whereas the UNGPs apply to all States and to all business enterprises, both transnational and others, regardless of their size, sector, location, ownership and structure, and are grounded in the three pillars of the UN ‘protect-respect-remedy’framework, namely: 1) the State’s duty to protect against human rights abuses by third parties, including business; 2) the corporate responsibility to respect human rights; and 3) greater access for victims to effective remedy, both judicial and non-judicial; stresses that although the UNGPs are not legally binding, they are widely recognised and supported, and serve as the basis for policy approaches towards business and human rights internationally, as well as recognition of States’ existing obligations to respect, protect and fulfil human rights and fundamental freedoms, of the role of business enterprises as specialised organs of society performing specialised functions which are required to comply with all applicable laws and to respect human rights, and of the need for rights and obligations to be matched to appropriate and effective remedies when breached; whereas available evidence suggests that where the UNGPs are implemented, the incidence of corporate-related human rights harm is reduced;

| I. | whereas the UN Global Compact calls on corporations to embrace, support and enact, within their sphere of influence, a set of core values in the areas of human rights, labour standards, the environment and the fight against corruption, making a commitment to those values and integrating them into their business operations on a voluntary basis; |
| --- | --- |

I.

whereas the UN Global Compact calls on corporations to embrace, support and enact, within their sphere of influence, a set of core values in the areas of human rights, labour standards, the environment and the fight against corruption, making a commitment to those values and integrating them into their business operations on a voluntary basis;

| J. | whereas corporations are one of the major players in economic globalisation, financial services and international trade, and are required to comply with all applicable laws and international treaties in force and to respect human rights; whereas these business enterprises as well as national corporations may at times cause or contribute to human rights violations or abuses and affect the rights of vulnerable groups such as minorities, indigenous people, women and children, or contribute to environmental problems; whereas they may also have an important role to play in offering positive incentives in terms of promoting human rights, democracy, environmental standards and corporate social responsibility; |
| --- | --- |

J.

whereas corporations are one of the major players in economic globalisation, financial services and international trade, and are required to comply with all applicable laws and international treaties in force and to respect human rights; whereas these business enterprises as well as national corporations may at times cause or contribute to human rights violations or abuses and affect the rights of vulnerable groups such as minorities, indigenous people, women and children, or contribute to environmental problems; whereas they may also have an important role to play in offering positive incentives in terms of promoting human rights, democracy, environmental standards and corporate social responsibility;

| K. | whereas there is an asymmetry between the rights and obligations of transnational corporations (TNCs), particularly in investment protection treaties, where investors are being granted broad rights, such as ‘fair and equitable treatment’, that are not necessarily matched by binding and enforceable obligations in terms of compliance with human rights and labour and environmental law throughout the whole supply chain; |
| --- | --- |

K.

whereas there is an asymmetry between the rights and obligations of transnational corporations (TNCs), particularly in investment protection treaties, where investors are being granted broad rights, such as ‘fair and equitable treatment’, that are not necessarily matched by binding and enforceable obligations in terms of compliance with human rights and labour and environmental law throughout the whole supply chain;

| L. | whereas the long-term positive impact on human rights of European businesses operating globally and leading by example through a non-discriminatory corporate culture is acknowledged; |
| --- | --- |

L.

whereas the long-term positive impact on human rights of European businesses operating globally and leading by example through a non-discriminatory corporate culture is acknowledged;

| M. | whereas the EU, with regard to the internal/external coherence of its policies, has played a leading role in negotiating and implementing a number of initiatives for global responsibility which go hand in hand with the promotion and respect of international standards in relation to business and human rights; whereas the EU and its Member States have also committed to a number of instruments, in particular the 2011 UNGPs and the 2016 Council of Europe recommendation on human rights and business; |
| --- | --- |

M.

whereas the EU, with regard to the internal/external coherence of its policies, has played a leading role in negotiating and implementing a number of initiatives for global responsibility which go hand in hand with the promotion and respect of international standards in relation to business and human rights; whereas the EU and its Member States have also committed to a number of instruments, in particular the 2011 UNGPs and the 2016 Council of Europe recommendation on human rights and business;

| N. | whereas in recent years, the EU and its Member States have started to adopt legislation to enhance corporate accountability and embed elements of Human Rights Due Diligence (HRDD) into legislation; whereas these measures are now helping to set global standards but can still be developed further, examples being the EU Conflict Minerals Regulation and the EU Non-Financial Reporting Directive (NFR), as well as the Timber Regulation (EUTR); whereas the Commission, however, has been reluctant to put forward further legislation for other sectors, such as garments, despite repeated calls from Parliament; whereas the multitude of national legislative initiatives might lead to an inefficient and unfair playing field within the EU; whereas a binding UN treaty could be a meaningful step forward in this regard; |
| --- | --- |

N.

whereas in recent years, the EU and its Member States have started to adopt legislation to enhance corporate accountability and embed elements of Human Rights Due Diligence (HRDD) into legislation; whereas these measures are now helping to set global standards but can still be developed further, examples being the EU Conflict Minerals Regulation and the EU Non-Financial Reporting Directive (NFR), as well as the Timber Regulation (EUTR); whereas the Commission, however, has been reluctant to put forward further legislation for other sectors, such as garments, despite repeated calls from Parliament; whereas the multitude of national legislative initiatives might lead to an inefficient and unfair playing field within the EU; whereas a binding UN treaty could be a meaningful step forward in this regard;

| O. | whereas victims of human rights violations in which EU businesses are involved may claim compensation before domestic courts in the EU under Regulation (EU) No 1215/2012; whereas the provisions laid down in this regulation require a stronger international framework in order to improve their efficiency with regard to the affected parties, while ensuring a level playing field between corporations domiciled in the EU and those which are not; |
| --- | --- |

O.

whereas victims of human rights violations in which EU businesses are involved may claim compensation before domestic courts in the EU under Regulation (EU) No 1215/2012; whereas the provisions laid down in this regulation require a stronger international framework in order to improve their efficiency with regard to the affected parties, while ensuring a level playing field between corporations domiciled in the EU and those which are not;

| P. | whereas a global holistic approach to corporate liability for human rights abuses is still lacking; whereas victims of human rights abuses involving transnational companies face multiple obstacles to accessing remedies, including judicial remedies and guarantees of non-repetition; whereas such obstacles to access to remedies constitute a further serious violation of human rights; whereas a holistic approach would provide legal certainty to both businesses and individuals, in the context of the proliferation of national due diligence initiatives; |
| --- | --- |

P.

whereas a global holistic approach to corporate liability for human rights abuses is still lacking; whereas victims of human rights abuses involving transnational companies face multiple obstacles to accessing remedies, including judicial remedies and guarantees of non-repetition; whereas such obstacles to access to remedies constitute a further serious violation of human rights; whereas a holistic approach would provide legal certainty to both businesses and individuals, in the context of the proliferation of national due diligence initiatives;

| Q. | whereas gender inequality implies that women are often particularly vulnerable to human rights violations, and face special burdens when seeking access to remedy; |
| --- | --- |

Q.

whereas gender inequality implies that women are often particularly vulnerable to human rights violations, and face special burdens when seeking access to remedy;

| R. | whereas the 2017 opinion of the Fundamental Rights Agency (FRA) found that more could be done to ensure effective judicial and non-judicial access to remedy for business-related human rights abuses within or outside the EU, including by providing victims with more assistance in accessing courts and the possibility to file class actions, facilitating the burden of proof, and incentivising due diligence obligations for companies, including for parent companies linked to human rights performance in subsidiaries or supply chains; |
| --- | --- |

R.

whereas the 2017 opinion of the Fundamental Rights Agency (FRA) found that more could be done to ensure effective judicial and non-judicial access to remedy for business-related human rights abuses within or outside the EU, including by providing victims with more assistance in accessing courts and the possibility to file class actions, facilitating the burden of proof, and incentivising due diligence obligations for companies, including for parent companies linked to human rights performance in subsidiaries or supply chains;

| S. | whereas the EU Charter of Fundamental Rights imposes both domestic and extraterritorial obligations on States regarding their duties to provide access to judicial remedies for victims of human rights violations; |
| --- | --- |

S.

whereas the EU Charter of Fundamental Rights imposes both domestic and extraterritorial obligations on States regarding their duties to provide access to judicial remedies for victims of human rights violations;

| T. | whereas a system of corporate liability for human rights abuses is currently being negotiated in the UN, within the UNHRC’s open-ended intergovernmental working group on transnational corporations and other business enterprises with respect to human rights (OEIGWG), established by the UN General Assembly in 2014; whereas both the EU and its Member States play a role at the OEIGWG, but the Commission has no mandate from the Council to conduct negotiations on behalf of the EU concerning its participation in the OEIGWG; |
| --- | --- |

T.

whereas a system of corporate liability for human rights abuses is currently being negotiated in the UN, within the UNHRC’s open-ended intergovernmental working group on transnational corporations and other business enterprises with respect to human rights (OEIGWG), established by the UN General Assembly in 2014; whereas both the EU and its Member States play a role at the OEIGWG, but the Commission has no mandate from the Council to conduct negotiations on behalf of the EU concerning its participation in the OEIGWG;

| 1. | Notes that the globalisation and increasing internationalisation of business activities and supply chains make the role that corporations play in ensuring respect for human rights more important, having already created a situation in which international norms, rules and cooperation are crucial to avoid human rights abuses in third countries; |
| --- | --- |

1.

| 2. | Is of the opinion that transnational corporations should refrain from financing or engaging in activities, commercial or non-commercial, that might fuel radicalism or extremism, in particular when it entails the manipulation of a religious creed, as well as from any direct or indirect support to any group promoting, advocating or justifying violence; |
| --- | --- |

2.

| 3. | Firmly believes that the private sector is an important partner in achieving the Sustainable Development Goals (SDGs) and in mobilising additional resources for development; stresses that, given their increasing role in development cooperation, private sector actors must align with development effectiveness principles and abide by the principles of corporate accountability throughout the whole life cycle of projects; |
| --- | --- |

3.

| 4. | Recalls that due diligence is a key component of the UN Guiding Principles’ second pillar regarding corporate responsibility and respect for human rights; stresses that effective due diligence practices can also help strengthen access to remedy; encourages the EU and its Member States to pursue the adoption of a coherent framework establishing mandatory human rights due diligence requirements for companies; |
| --- | --- |

4.

| 5. | Recalls that the NAP (National Action Plan) development process, if well-designed and adjusted to the local context, can contribute not only to ensuring an efficient implementation of the UNGPs but also to the strengthening of national human rights protection mechanisms; |
| --- | --- |

5.

| 6. | Reiterates its call for the UNGPs and other international corporate responsibility standards to be consistently raised by EU representatives in human rights dialogues with third countries; |
| --- | --- |

6.

| 7. | Strongly supports the full implementation, within and outside the EU, of the UNGPs, as unanimously endorsed by the Council in June 2011, and calls for the EU and the Member States to elaborate and adopt ambitious and operative action plans at both EU and national level that set out clear expectations for governments and all types of business enterprises for the swift, effective and comprehensive implementation of the said principles; takes the view that the NAPs should include indicators to measure achievement; stresses also that the EU should ensure independent and regular peer review of Member States’ NAPs and the progress made, particularly to facilitate access to remedy; recalls that the UNGPs can be complemented with parallel binding initiatives to cover their shortcomings; |
| --- | --- |

7.

| 8. | Considers it regrettable that a global approach is still lacking to the way in which transnational corporations abide by human rights law and ensure other remedy mechanisms, which may contribute to TNCs’ impunity for cases of human rights abuses and thus be detrimental to people’s rights and dignity; regrets that the UNGPs are not embodied in enforceable instruments; recalls that the poor implementation of UNGPs, as in the case of other internationally recognised standards, has been largely attributed to their non-binding character; |
| --- | --- |

8.

| 9. | Notes with concern that many obstacles persist regarding access to judicial remedy, particularly in case of transnational corporations, due to, for example, difficulties encountered by victims in identifying the competent court, lack of codification of certain human rights abuses in penal codes, or corruption, which can undermine legal proceedings in developing countries; recalls that appropriate non-judicial remedies are also of crucial importance, but are often lacking; calls on national governments to reinforce their efforts to ensure, through judicial, administrative, legislative or other appropriate means, that when human rights abuses occur within their territory and/or jurisdiction, those affected have access to effective remedy; |
| --- | --- |

9.

| 10. | Reaffirms the urgent need to act in an effective and coherent manner at all levels, including national, European and international, in order to effectively address human rights abuses by transnational corporations, to provide for access to remedies, to address legal problems resulting from the transnational character of the activities of business enterprises and TNCs and the growing complexity of global value chains and the extraterritorial dimension of transnational companies, as well as the related uncertainty as to where liability for human rights violations lies; reaffirms the need to fully implement the extraterritorial obligations of States, as set out in the Maastricht Principles and building on the various instruments of the Council of Europe, in particular the European Convention on Human Rights (ECHR); more broadly, urges the EU to take initiatives to improve access to remedy in extraterritorial cases, in line with the recommendations set in the 2017 FRA opinion; |
| --- | --- |

10.

| 11. | Reaffirms the primacy of human rights in international law, in accordance with Article 103 of the Charter of the United Nations, and the need to consolidate it through a clear system whereby human rights obligations effectively take precedence over other types of conflicting obligations, and provision is made for suitable mechanisms to enforce human rights law, for monitoring and for remedies, combined with appropriate penalties and compensation in the event of violations; insists that this is essential for overcoming globalisation imbalances and putting people’s rights and the planet first; stresses that coordination and the exchange of information and good practices will contribute positively to initiatives taken by businesses which have decided to respect human rights and social and environmental standards; |
| --- | --- |

11.

| 12. | Stresses that corporate social responsibility on a voluntary basis risks creating unfair competition for those who choose to comply with international standards; stresses that it is not sufficient for ensuring, in connection with the implementation of the duty of care, full conformity with international standards and obligations; |
| --- | --- |

12.

| 13. | Warmly welcomes in this context the work initiated in the United Nations through the OEIGWG to create a binding UN instrument on transnational corporations and other business enterprises with respect to human rights, and considers this to be a necessary step forward in the promotion and protection of human rights; |
| --- | --- |

13.

| 14. | Stresses that the binding treaty should build on the UNGP’s framework and encompass: the definition of mandatory due diligence obligations for TNCs and other business enterprises, including with respect to their subsidiaries, the recognition of the extraterritorial human rights obligations of States, the recognition of corporate criminal liability, mechanisms for coordination and cooperation among states on investigation, prosecution and enforcement of cross-border cases, and the setting-up of international judicial and non-judicial mechanisms for supervision and enforcement; is of the opinion that the new instrument should impose on States the obligation to adopt regulatory measures requiring companies to apply human rights due diligence policies and procedures, and proposes that this obligation should be enforced by means of companies being accountable in either the forum where the harm was caused, or the forum where the parent company is incorporated or where it has a substantial presence; |
| --- | --- |

14.

| 15. | Calls on the UN member states to protect the negotiations from commercial and other vested interests, following the example of the World Health Organization (WHO) and Article 5.3 of the WHO Framework Convention on Tobacco Control (WHO FCTC), including strong ethical rules to prevent conflicts of interest and unethical lobbying, and requiring full transparency regarding industry interactions with parties to the negotiations; |
| --- | --- |

15.

| 16. | Recalls the need to adopt a gender-sensitive approach throughout the process and to pay special attention to vulnerable groups such as indigenous people and children; |
| --- | --- |

16.

| 17. | Recalls that Parliament has voiced its unequivocal support for this multilateral OEIGWG process in eight different resolutions; |
| --- | --- |

17.

| 18. | Stresses the importance of the EU and its Member States being actively involved in this intergovernmental process through the creation of a working group including all the relevant departments of the Commission, the EEAS, the Council Working Group on Human Rights (COHOM) and the relevant committees of Parliament, on the basis of the principle of PCD; |
| --- | --- |

18.

| 19. | Reiterates once more its call for the EU and its Member States to engage genuinely and constructively in these negotiations and in the intergovernmental process aimed at the completion of the OEIGWG’s mandate; highlights the paramount importance of the EU constructively contributing to the achievement of a Binding Treaty which will effectively address the issue of corporate liability for human rights violations and related challenges; |
| --- | --- |

19.

| 20. | Calls on the UN member states to ensure that the negotiations leading to the treaty are conducted in a transparent fashion, with consultation of a broad range of rights-holders potentially impacted by the treaty, including civil society organisations and victim platforms; calls on the EU and its Member States to mainstream a meaningful gender approach in their negotiating position; |
| --- | --- |

20.

| 21. | Calls for the EU to ensure that any revision or future strategy document linked to the EU Strategic Framework and Action Plan on Human Rights and Democracy includes clear objectives and measurable benchmarks for the EU’s participation in the UN treaty negotiations; |
| --- | --- |

21.

| 22. | Decides to continue to closely follow the OEIGWG negotiation process; |
| --- | --- |

22.

| 23. | Instructs its President to forward this resolution to the Council, the Commission and the European External Action Service. |
| --- | --- |

23.

---

(1)  OJ C 101, 16.3.2018, p. 19.

(2)  Texts adopted, P8_TA(2018)0230.

(3)  https://ec.europa.eu/anti-trafficking/publications/european-commission-sector-guides-implementing-un-guiding-principles-business-and-hum-0_en

(4)  http://fra.europa.eu/sites/default/files/fra_uploads/fra-2017-opinion-01-2017-business-human-rights_en.pdf

(5)  http://www.etoconsortium.org/nc/en/main-navigation/library/maastricht-principles/?tx_drblob_pi1%5BdownloadUid%5D=23

(6)  https://www.unglobalcompact.org/

(7)  OJ L 351, 20.12.2012, p. 1.

(8)  OJ L 330, 15.11.2014, p. 1.

(9)  OJ L 130, 19.5.2017, p. 1.

(10)  Texts adopted, P8_TA(2018)0066.

(11)  Texts adopted, P8_TA(2017)0494.

(12)  Texts adopted, P8_TA(2017)0448.

(13)  OJ C 298, 23.8.2018, p. 100.

(14)  OJ C 252, 18.7.2018, p. 62.

(15)  OJ C 337, 20.9.2018, p. 33.

(16)  OJ L 295, 12.11.2010, p. 23.

(17)  OJ C 99 E, 3.4.2012, p. 101.

(18)  OJ C 238, 6.7.2018, p. 57.

(19)  OJ C 224, 27.6.2018, p. 36.

(20)  OJ C 215, 19.6.2018, p. 125.

(21)  OJ C 101, 16.3.2018, p. 47.

(22)  OJ C 58, 15.2.2018, p. 209.

(23)  OJ C 399, 24.11.2017, p. 151.

(24)  http://www.europarl.europa.eu/RegData/etudes/STUD/2017/578031/EXPO_STU(2017)578031_EN.pdf

(25)  http://www.oecd.org/corporate/mne/48004323.pdf

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/44 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/44

---

P8_TA(2018)0383

Situation in Yemen

European Parliament resolution of 4 October 2018 on the situation in Yemen (2018/2853(RSP))

(2020/C 011/10)

The European Parliament,

| — | having regard to its previous resolutions on Yemen, in particular those of 25 February 2016 (1) and 15 June 2017 (2) on the humanitarian situation in Yemen, and of 9 July 2015 (3) and 30 November 2017 (4) on the situation in Yemen, |
| --- | --- |

—

having regard to its previous resolutions on Yemen, in particular those of 25 February 2016 (1) and 15 June 2017 (2) on the humanitarian situation in Yemen, and of 9 July 2015 (3) and 30 November 2017 (4) on the situation in Yemen,

| — | having regard to the report published by the UN Human Rights Council Group of Regional and International Eminent Experts on Yemen on 28 August 2018 on the situation of human rights in Yemen, including violations and abuses since September 2014, |
| --- | --- |

—

having regard to the report published by the UN Human Rights Council Group of Regional and International Eminent Experts on Yemen on 28 August 2018 on the situation of human rights in Yemen, including violations and abuses since September 2014,

| — | having regard to the joint statements by Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) Federica Mogherini and Commissioner Christos Stylianides of 13 June 2018 on the latest developments around Hodeidah, Yemen, and of 4 August 2018 on the airstrikes in Hodeidah, |
| --- | --- |

—

having regard to the joint statements by Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy (VP/HR) Federica Mogherini and Commissioner Christos Stylianides of 13 June 2018 on the latest developments around Hodeidah, Yemen, and of 4 August 2018 on the airstrikes in Hodeidah,

| — | having regard to the annual report of the UN High Commissioner for Human Rights of 24 September 2018 on the situation in Yemen, |
| --- | --- |

—

having regard to the annual report of the UN High Commissioner for Human Rights of 24 September 2018 on the situation in Yemen,

| — | having regard to the Council conclusions of 25 June 2018 on Yemen, |
| --- | --- |

—

having regard to the Council conclusions of 25 June 2018 on Yemen,

| — | having regard to the statement by the President of the UN Security Council of 15 March 2018, |
| --- | --- |

—

having regard to the statement by the President of the UN Security Council of 15 March 2018,

| — | having regard to the statement of 6 September 2018 by the Special Envoy of the UN Secretary-General for Yemen, |
| --- | --- |

—

having regard to the statement of 6 September 2018 by the Special Envoy of the UN Secretary-General for Yemen,

| — | having regard to the statement by the World Food Programme Executive Director of 19 September 2018, |
| --- | --- |

—

having regard to the statement by the World Food Programme Executive Director of 19 September 2018,

| — | having regard to the Rome Statute of the International Criminal Court, |
| --- | --- |

—

having regard to the Rome Statute of the International Criminal Court,

| — | having regard to the UN Security Council resolutions on Yemen, in particular resolutions 2216 (2015), 2201 (2015) and 2140 (2014), |
| --- | --- |

—

having regard to the UN Security Council resolutions on Yemen, in particular resolutions 2216 (2015), 2201 (2015) and 2140 (2014),

| — | having regard to Rule 123(2) and (4) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) and (4) of its Rules of Procedure,

| A. | whereas the ongoing conflict in Yemen has entered its fourth year and more than 22 million people need humanitarian support; whereas over 17 million people are food insecure, among whom more than 8 million people are severely food insecure and at risk of starvation; whereas the current fragmentation of the conflict is a clear sign of the erosion of state unity; whereas the situation in Yemen also carries grave risks for the stability of the region; |
| --- | --- |

A.

whereas the ongoing conflict in Yemen has entered its fourth year and more than 22 million people need humanitarian support; whereas over 17 million people are food insecure, among whom more than 8 million people are severely food insecure and at risk of starvation; whereas the current fragmentation of the conflict is a clear sign of the erosion of state unity; whereas the situation in Yemen also carries grave risks for the stability of the region;

| B. | whereas the conflict started in 2015 when Iranian-backed Houthi rebels ousted the country’s internationally recognised president, who subsequently brought in a multinational coalition led by Saudi Arabia to fight the rebels and those troops allied to them; |
| --- | --- |

B.

whereas the conflict started in 2015 when Iranian-backed Houthi rebels ousted the country’s internationally recognised president, who subsequently brought in a multinational coalition led by Saudi Arabia to fight the rebels and those troops allied to them;

| C. | whereas since November 2017, the Saudi-led coalition has established a blockade on all imports to the Houthi-controlled territory, with the exception of urgent humanitarian and relief materials; whereas according to the OCHA, Yemen has received only 21 % of its fuel requirements and 68 % of its food import needs since the blockade began; whereas, in certain cases, Houthi rebels have blocked the delivery of essential medical supplies, food and humanitarian aid to government-controlled cities; |
| --- | --- |

C.

whereas since November 2017, the Saudi-led coalition has established a blockade on all imports to the Houthi-controlled territory, with the exception of urgent humanitarian and relief materials; whereas according to the OCHA, Yemen has received only 21 % of its fuel requirements and 68 % of its food import needs since the blockade began; whereas, in certain cases, Houthi rebels have blocked the delivery of essential medical supplies, food and humanitarian aid to government-controlled cities;

| D. | whereas in June 2018 the coalition led by Saudi Arabia and the United Arab Emirates (UAE) started an offensive to take the city of Hodeidah; whereas Save the Children has reported hundreds of civilian casualties in this operation; whereas Hodeidah is Yemen’s most important port and is the transit point for as much as 70 % of the country’s critical food and humanitarian aid; whereas, according to the UN, nearly 470 000 people have fled Hodeidah Governorate since early June 2018; whereas a further attack on Hodeidah would have devastating consequences for civilians; whereas parties to the conflict are obliged to allow and facilitate the rapid and unimpeded passage of humanitarian relief, including medicine, food and other items necessary for survival; |
| --- | --- |

D.

whereas in June 2018 the coalition led by Saudi Arabia and the United Arab Emirates (UAE) started an offensive to take the city of Hodeidah; whereas Save the Children has reported hundreds of civilian casualties in this operation; whereas Hodeidah is Yemen’s most important port and is the transit point for as much as 70 % of the country’s critical food and humanitarian aid; whereas, according to the UN, nearly 470 000 people have fled Hodeidah Governorate since early June 2018; whereas a further attack on Hodeidah would have devastating consequences for civilians; whereas parties to the conflict are obliged to allow and facilitate the rapid and unimpeded passage of humanitarian relief, including medicine, food and other items necessary for survival;

| E. | whereas the ceasefire negotiations led by the UN Special Envoy for Yemen, Martin Griffiths, resulted in a temporary cessation of the offensive; whereas the collapse of the latest attempt to hold peace talks in Geneva led to a resumption of hostilities on 7 September 2018; whereas since the offensive started, civilian deaths have increased by 164 %; whereas, in spite of the international pressure to achieve a stable and inclusive political solution to the crisis, the parties to the conflict and their regional and international backers, including Saudi Arabia and Iran, have failed to reach a ceasefire or any type of settlement, and the fighting and indiscriminate bombings continue unabated; |
| --- | --- |

E.

whereas the ceasefire negotiations led by the UN Special Envoy for Yemen, Martin Griffiths, resulted in a temporary cessation of the offensive; whereas the collapse of the latest attempt to hold peace talks in Geneva led to a resumption of hostilities on 7 September 2018; whereas since the offensive started, civilian deaths have increased by 164 %; whereas, in spite of the international pressure to achieve a stable and inclusive political solution to the crisis, the parties to the conflict and their regional and international backers, including Saudi Arabia and Iran, have failed to reach a ceasefire or any type of settlement, and the fighting and indiscriminate bombings continue unabated;

| F. | whereas on 9 August 2018, an air strike perpetrated by the Saudi-led coalition hit a school bus in a market in the northern province of Saada, killing scores of people, including at least 40 children, most of whom were under the age of 10; whereas this attack was followed two weeks later, on 24 August, by a new Saudi-led coalition strike killing 27 civilians, mostly children, who were fleeing the violence in the besieged southern city of Hodeidah; |
| --- | --- |

F.

whereas on 9 August 2018, an air strike perpetrated by the Saudi-led coalition hit a school bus in a market in the northern province of Saada, killing scores of people, including at least 40 children, most of whom were under the age of 10; whereas this attack was followed two weeks later, on 24 August, by a new Saudi-led coalition strike killing 27 civilians, mostly children, who were fleeing the violence in the besieged southern city of Hodeidah;

| G. | whereas the Saudi-led campaign and the intense aerial bombardments, including indiscriminate attacks in densely populated areas, exacerbate the humanitarian impact of the war; whereas the laws of war prohibit deliberate and indiscriminate attacks on civilians and civilian targets such as schools and hospitals; whereas, having regard to the findings of the Group of Independent Eminent International and Regional Experts (GEE), such attacks may amount to war crimes and the individuals who commit them may be prosecuted for these crimes; whereas the Saudi-led coalition’s investigations into alleged war crimes in Yemen have lacked credibility and failed to provide redress to civilian victims; |
| --- | --- |

G.

whereas the Saudi-led campaign and the intense aerial bombardments, including indiscriminate attacks in densely populated areas, exacerbate the humanitarian impact of the war; whereas the laws of war prohibit deliberate and indiscriminate attacks on civilians and civilian targets such as schools and hospitals; whereas, having regard to the findings of the Group of Independent Eminent International and Regional Experts (GEE), such attacks may amount to war crimes and the individuals who commit them may be prosecuted for these crimes; whereas the Saudi-led coalition’s investigations into alleged war crimes in Yemen have lacked credibility and failed to provide redress to civilian victims;

| H. | whereas since March 2015, more than 2 500 children have been killed, more than 3 500 children have been maimed or injured and a growing number of children have been recruited by armed forces on the ground; whereas women and children are particularly affected by the ongoing hostilities; whereas according to UNICEF, nearly two million children are out of school, which compromises the future of an entire generation of children in Yemen as a result of limited or no access to education, making them vulnerable to military recruitment and sexual and gender-based violence; |
| --- | --- |

H.

whereas since March 2015, more than 2 500 children have been killed, more than 3 500 children have been maimed or injured and a growing number of children have been recruited by armed forces on the ground; whereas women and children are particularly affected by the ongoing hostilities; whereas according to UNICEF, nearly two million children are out of school, which compromises the future of an entire generation of children in Yemen as a result of limited or no access to education, making them vulnerable to military recruitment and sexual and gender-based violence;

| I. | whereas in August 2018 a report compiled by the UN High Commissioner for Human Rights concluded that there are ‘reasonable grounds to believe’all parties to the conflict in Yemen may have committed war crimes; whereas forces on both sides of the conflict have been accused of firing heavy weapons into built-up areas and highly populated areas, including strikes on hospitals and other non-military structures; |
| --- | --- |

I.

whereas in August 2018 a report compiled by the UN High Commissioner for Human Rights concluded that there are ‘reasonable grounds to believe’all parties to the conflict in Yemen may have committed war crimes; whereas forces on both sides of the conflict have been accused of firing heavy weapons into built-up areas and highly populated areas, including strikes on hospitals and other non-military structures;

| J. | whereas the war has led to the destruction of infrastructure and the collapse of Yemen’s economy, and caused widespread disruption to basic commodities and the supply of utilities, sanitation and clean drinking water; whereas the regular payment of salaries of up to 1,4 million non-military Yemeni public workers effectively ceased at the end of 2016; |
| --- | --- |

J.

whereas the war has led to the destruction of infrastructure and the collapse of Yemen’s economy, and caused widespread disruption to basic commodities and the supply of utilities, sanitation and clean drinking water; whereas the regular payment of salaries of up to 1,4 million non-military Yemeni public workers effectively ceased at the end of 2016;

| K. | whereas preventing the use of UN flights for international media and human rights organisations impedes independent coverage of the situation in Yemen and contributes to the global neglect of the conflict; |
| --- | --- |

K.

whereas preventing the use of UN flights for international media and human rights organisations impedes independent coverage of the situation in Yemen and contributes to the global neglect of the conflict;

| L. | whereas gender-based sexual violence has increased exponentially since the start of the conflict; whereas the already limited capacity to address sexual and gender-based violence in the criminal justice system has collapsed, and no investigations have been conducted in relation to practices such as abducting and raping women, or threatening to, as a way of extorting money from their families and communities; |
| --- | --- |

L.

whereas gender-based sexual violence has increased exponentially since the start of the conflict; whereas the already limited capacity to address sexual and gender-based violence in the criminal justice system has collapsed, and no investigations have been conducted in relation to practices such as abducting and raping women, or threatening to, as a way of extorting money from their families and communities;

| M. | whereas human rights defenders have faced relentless harassment, threats and smear campaigns from all parties to the conflict; whereas women human rights defenders, journalists and activists have faced specific repression on the basis of their gender; |
| --- | --- |

M.

whereas human rights defenders have faced relentless harassment, threats and smear campaigns from all parties to the conflict; whereas women human rights defenders, journalists and activists have faced specific repression on the basis of their gender;

| N. | whereas Houthi de-facto authorities have conducted a systemic campaign of harassment, arbitrary and abusive detentions, and forced disappearances and torture against human rights defenders, journalists and religious minorities; whereas 24 Yemenis from the Baha’i minority, including one child, are facing charges that could result in the death penalty, for nothing other than their beliefs and peaceful actions; |
| --- | --- |

N.

whereas Houthi de-facto authorities have conducted a systemic campaign of harassment, arbitrary and abusive detentions, and forced disappearances and torture against human rights defenders, journalists and religious minorities; whereas 24 Yemenis from the Baha’i minority, including one child, are facing charges that could result in the death penalty, for nothing other than their beliefs and peaceful actions;

| O. | whereas Houthi rebels have been accused of causing mass civilian casualties during their siege of Taiz, Yemen’s third largest city; whereas they have waged a war of attrition against civilian populations in government-controlled areas; whereas they have also deployed banned anti-personnel landmines and recruited children; |
| --- | --- |

O.

whereas Houthi rebels have been accused of causing mass civilian casualties during their siege of Taiz, Yemen’s third largest city; whereas they have waged a war of attrition against civilian populations in government-controlled areas; whereas they have also deployed banned anti-personnel landmines and recruited children;

| P. | whereas Kamel Jendoubi, Chairman of the GEE that issued a Report to the Human Rights Council on the Situation of human rights in Yemen on 28 August 2018, is the victim of a smear campaign aimed at intimidating the GEE and casting doubts on its findings; |
| --- | --- |

P.

whereas Kamel Jendoubi, Chairman of the GEE that issued a Report to the Human Rights Council on the Situation of human rights in Yemen on 28 August 2018, is the victim of a smear campaign aimed at intimidating the GEE and casting doubts on its findings;

| Q. | whereas Yemen has signed the Rome Statute of the International Criminal Court but has yet to ratify it; whereas several provisions of the Rome Statute, including those related to war crimes, reflect customary international law; |
| --- | --- |

Q.

whereas Yemen has signed the Rome Statute of the International Criminal Court but has yet to ratify it; whereas several provisions of the Rome Statute, including those related to war crimes, reflect customary international law;

| R. | whereas in February 2018 Russia vetoed a UN Security Council resolution highlighting Iranian involvement in the conflict; |
| --- | --- |

R.

whereas in February 2018 Russia vetoed a UN Security Council resolution highlighting Iranian involvement in the conflict;

| S. | whereas there is an international arms embargo in place against the Iranian-backed Houthi rebels and, according to the 18th EU Annual Report on Arms Exports, EU Member States have continued to authorise transfers of arms to Saudi Arabia since the escalation of the conflict, in violation of Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment (5); whereas in the past year, some EU Member States have partly or totally suspended arms transfers to Saudi Arabia and the UAE; whereas Parliament has repeatedly called on the VP/HR to launch an initiative to impose an EU arms embargo on Saudi Arabia, in line with Common Position 2008/944/CFSP; |
| --- | --- |

S.

whereas there is an international arms embargo in place against the Iranian-backed Houthi rebels and, according to the 18th EU Annual Report on Arms Exports, EU Member States have continued to authorise transfers of arms to Saudi Arabia since the escalation of the conflict, in violation of Council Common Position 2008/944/CFSP of 8 December 2008 defining common rules governing control of exports of military technology and equipment (5); whereas in the past year, some EU Member States have partly or totally suspended arms transfers to Saudi Arabia and the UAE; whereas Parliament has repeatedly called on the VP/HR to launch an initiative to impose an EU arms embargo on Saudi Arabia, in line with Common Position 2008/944/CFSP;

| T. | whereas the majority of strikes carried out by US forces in Yemen are lethal drone strikes; whereas the decision to add certain persons to the target lists of drone operations is often made without court warrants or orders; whereas the targeting and subsequent killing of certain individuals can under certain circumstances be seen as extrajudicial killing; |
| --- | --- |

T.

whereas the majority of strikes carried out by US forces in Yemen are lethal drone strikes; whereas the decision to add certain persons to the target lists of drone operations is often made without court warrants or orders; whereas the targeting and subsequent killing of certain individuals can under certain circumstances be seen as extrajudicial killing;

| U. | whereas the war in Yemen has opened up space for extremist groups, including al-Qaeda in the Arabian Peninsula (AQAP), to extend their reach, thereby threatening the wider region; whereas a stable, secure Yemen with a properly functioning government is critical to international efforts to combat extremism and violence in the wider region and beyond, as well as to peace and stability within Yemen itself; |
| --- | --- |

U.

whereas the war in Yemen has opened up space for extremist groups, including al-Qaeda in the Arabian Peninsula (AQAP), to extend their reach, thereby threatening the wider region; whereas a stable, secure Yemen with a properly functioning government is critical to international efforts to combat extremism and violence in the wider region and beyond, as well as to peace and stability within Yemen itself;

| V. | whereas stability in the wider region is of critical importance for the EU; whereas the EU is committed to a comprehensive and strategic approach encompassing all relevant regional actors; whereas finding a political solution to the conflict under the auspices of the UN peace initiative in Yemen should be a priority for the EU and the international community as a whole; |
| --- | --- |

V.

whereas stability in the wider region is of critical importance for the EU; whereas the EU is committed to a comprehensive and strategic approach encompassing all relevant regional actors; whereas finding a political solution to the conflict under the auspices of the UN peace initiative in Yemen should be a priority for the EU and the international community as a whole;

| W. | whereas the EU remains committed to continuing to deliver life-saving aid to all people in need in Yemen; whereas at the same time, the EU shares the concerns of the UN and other donors about the continuing shrinking of humanitarian space; whereas from 2015 until now, the EU has contributed more than EUR 233 million in humanitarian funding to Yemen; |
| --- | --- |

W.

whereas the EU remains committed to continuing to deliver life-saving aid to all people in need in Yemen; whereas at the same time, the EU shares the concerns of the UN and other donors about the continuing shrinking of humanitarian space; whereas from 2015 until now, the EU has contributed more than EUR 233 million in humanitarian funding to Yemen;

| 1. | Condemns in the strongest terms the ongoing violence in Yemen and all attacks against civilians and civilian infrastructure; emphasises its concern over the conflict that is continuing to degenerate into one of the gravest current humanitarian, political, and economic crises; reminds all parties involved, including their regional and international backers, that the deliberate targeting of civilians and civilian infrastructure, including hospitals and medical personnel, water systems, ports, airports and markets, amounts to a grave violation of international law; |
| --- | --- |

1.

| 2. | Deeply regrets the loss of life caused by the conflict and the suffering of those caught up in the fighting, and expresses its condolences to the families of the victims; reaffirms its commitment to continuing to support Yemen and the Yemeni people; |
| --- | --- |

2.

| 3. | Calls on all parties to the conflict to cease hostilities immediately; urges Saudi Arabia and other actors involved to further lift the ongoing blockade of Yemen: calls on all directly or indirectly involved states and relevant actors, including Iran, to apply maximum pressure on all parties to work towards de-escalation and to immediately cease providing political, military and financial support to military actors on the ground, either directly or by proxy; |
| --- | --- |

3.

| 4. | Stresses that only a political, inclusive and negotiated solution to the conflict can restore peace and preserve the unity, sovereignty, independence and territorial integrity of Yemen; calls on all international and regional actors to engage constructively with the parties in Yemen to enable a de-escalation of the conflict and a negotiated settlement; |
| --- | --- |

4.

| 5. | Supports the efforts of the Special Envoy of the UN Secretary-General for Yemen, Martin Griffiths, to restart the political process; takes note of his statement to the UN Security Council of 11 September 2018‘that despite the absence of one of the sides to the Consultations in Geneva last week, and even if it certainly did not go as planned, we still managed to relaunch the political process with solid support clearly from the Yemeni people and the international community’; welcomes Mr Griffiths’ visit to Sana’a on 16 September 2018; calls for the Special Envoy to be given full and unhindered access to all parts of the territory of Yemen; calls on the VP/HR and all EU Member States to provide Mr Griffiths with political backing with a view to reaching a negotiated and inclusive settlement; |
| --- | --- |

5.

| 6. | Condemns all terror attacks in the strongest terms; is deeply concerned about the increased presence in Yemen of criminal and terrorist groups, including AQAP and ISIS/Daesh; calls on all parties to the conflict to take resolute action against such groups; condemns the presence of foreign fighters and calls for the removal of all such fighters from Yemen; |
| --- | --- |

6.

| 7. | Calls on all the parties to the conflict to allow for immediate and full humanitarian access to the conflict-affected areas in order to assist the population in need; calls on the Council and the UN Security Council, in implementing UN Security Council Resolution 2216 (2015), to identify the individuals obstructing the delivery of humanitarian assistance in Yemen and to impose targeted sanctions on them; |
| --- | --- |

7.

| 8. | Stresses that the UN Security Council has underlined its support for the UN Verification and Inspection Mechanism (UNVIM), and that the EU fully supports the continuation of UNVIM and the full and unhindered implementation of its mandate; |
| --- | --- |

8.

| 9. | Calls on all parties to immediately cease all attacks against freedom of expression, and to release all journalists and human rights defenders detained solely for having exercised their human rights; calls on all parties to cease obstructing the work of international media and humanitarian personnel in relation to the conflict; |
| --- | --- |

9.

| 10. | Calls on all parties to the conflict to take the necessary measures to ensure effective, impartial and independent investigations into all alleged violations and abuses of human rights and alleged violations of international humanitarian law, in accordance with international standards; is deeply concerned about reports of denial of freedom of religion or belief, which include discrimination, unlawful detention, the use of violence, and abuses of human rights, including sexual and other violence against women, men, girls and boys, in violation of international standards; |
| --- | --- |

10.

| 11. | Calls on all parties to the conflict to end the recruitment or use of children as soldiers and to put a stop to other grave violations committed against them in violation of applicable international law and standards; calls on all parties to release any children who have already been recruited and to cooperate with the UN with a view to their rehabilitation and reintegration into their communities; supports the vital work of UNICEF in Yemen; |
| --- | --- |

11.

| 12. | Calls on the Specialised Criminal Court in Houthi-controlled territory in Sana’a to acquit and release Asmaa al-Omeissy, Saeed al-Ruwaished and Ahmed Bawazeer, who were forcibly disappeared, tortured and sentenced to death after a grossly unfair trial for allegedly aiding an enemy country; |
| --- | --- |

12.

| 13. | Calls on the Specialised Criminal Court in Sana’a to immediately release the 25 followers of the Baha’i faith who are currently detained for peacefully practising their religion and face charges punishable by death; |
| --- | --- |

13.

| 14. | Reminds all parties to the conflict that they are accountable under international law for any crimes committed; urges the Member States to take all necessary measures to hold alleged perpetrators to account, notably through national or international prosecution of individuals, groups and organisations suspected of such violations or the application of the principle of universal jurisdiction, and by investigating and prosecuting the alleged perpetrators of atrocity crimes in Yemen; |
| --- | --- |

14.

| 15. | Praises the work undertaken by the UN GEE on Yemen and expresses its full solidarity with its Chairman, Kamel Jendoubi; welcomes the annual report of the UN High Commissioner for Human Rights of 24 September 2018 on the situation in Yemen, in which the UN Human Rights Council decided to extend the mandate of the GEE for a further period of one year, renewable as authorised by the Human Rights Council, to include gathering evidence of war crimes and crimes against humanity committed in Yemen, in order to prosecute and punish those guilty of such violations; calls for a referral of the situation in Yemen to the International Criminal Court (ICC); urges Yemen to join the ICC, which would allow for the prosecution of all those responsible for the crimes committed during the conflict, in the absence of a UN Security Council referral; |
| --- | --- |

15.

| 16. | Calls for the European Union and all Member States to provide cohesive, prompt and effective support to the GEE across all relevant UN bodies, and in the Human Rights Council in particular; |
| --- | --- |

16.

| 17. | Urges the Council, the VP/HR and the Member States to oppose extrajudicial killings, including the use of drones, to reaffirm the EU’s position under international law and to ensure that Member States do not perpetrate, facilitate or otherwise take part in unlawful lethal operations; urges the Council to adopt a Common Position on the use of armed drones; |
| --- | --- |

17.

| 18. | Calls on the EU to take the initiative at the next Human Rights Council meeting to raise the issue of membership by states with deeply questionable human rights records; |
| --- | --- |

18.

| 19. | Urges the VP/HR, the EEAS and the Member States to continue to conduct a dialogue with the countries of the region on human rights and fundamental freedoms; expresses its readiness to hold a constructive and open dialogue with authorities of the countries of the region on the fulfilment of their international human rights commitments; calls for an exchange of expertise on judicial and legal matters in order to strengthen the protection of individual rights in the countries of the region; |
| --- | --- |

19.

| 20. | Calls on the Council to effectively promote compliance with international humanitarian law, as provided for in the relevant EU guidelines; reiterates, in particular, the need for the strict application by all EU Member States of the rules laid down in Common Position 2008/944/CFSP; recalls, in this regard, Parliament’s resolutions on the situation in Yemen of 25 February 2016 and 30 November 2017; urges all EU Member States in this context to refrain from selling arms and any military equipment to Saudi Arabia, the UAE and any member of the international coalition, as well as to the Yemeni Government and other parties to the conflict; |
| --- | --- |

20.

| 21. | Denounces the destruction of Yemeni cultural heritage by the airstrikes of the Saudi-led coalition, including the Old City of Sana’a and the historic city of Zabid; regrets and recalls the responsibility of the coalition for this destruction and stresses that it will be held accountable also for such acts; calls on the UN Secretary-General to refer the issue of the protection of all cultural sites under threat from the conflict in Yemen to the Security Council, with a view to the adoption of a resolution on the matter; |
| --- | --- |

21.

| 22. | Welcomes the UN 2018 Yemen Humanitarian Response Plan and the 2018 High-Level Pledging Event for the Humanitarian Crisis in Yemen, in which international donors pledged more than USD two billion; deplores, however, the fact that a funding gap still exists for Yemen; welcomes the fact that the EU is committed to assisting those affected by the conflict in Yemen and has pledged EUR 107,5 million; calls on all donors to swiftly disburse their pledges; welcomes the fact that the EU will continue to provide development assistance to Yemen, giving priority to interventions directed at stabilising the country, and will work in stable areas with local authorities to promote resilience, to help to maintain the provision of basic services and to foster sustainable livelihoods for communities; |
| --- | --- |

22.

| 23. | Reserves the right to reconsider the matter until a negotiated solution is reached; recommends that its Subcommittee on Human Rights monitor human rights developments in Yemen and produce a report on the violations of human and civil rights perpetrated in the country; |
| --- | --- |

23.

| 24. | Instructs its President to forward this resolution to the Council, the Commission, the Vice-President of the Commission / High Representative of the Union for Foreign Affairs and Security Policy, the governments and parliaments of the Member States, the Secretary-General of the United Nations, the Secretary-General of the Gulf Cooperation Council, the Secretary-General of the League of Arab States and the Government of Yemen. |
| --- | --- |

24.

---

(1)  OJ C 35, 31.1.2018, p. 142.

(2)  OJ C 331, 18.9.2018, p. 146.

(3)  OJ C 265, 11.8.2017, p. 93.

(4)  Texts adopted, P8_TA(2017)0473.

(5)  OJ L 335, 13.12.2008, p. 99.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/50 |
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P8_TA(2018)0384

Fighting customs fraud and protecting EU own resources

European Parliament resolution of 4 October 2018 on fighting customs fraud and protecting EU own resources (2018/2747(RSP))

(2020/C 011/11)

The European Parliament,

| — | having regard to the seventeenth report of the European Anti-Fraud Office on the year 2016, |
| --- | --- |

—

having regard to the seventeenth report of the European Anti-Fraud Office on the year 2016,

| — | having regard to Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (1), |
| --- | --- |

—

having regard to Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (1),

| — | having regard to Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (2) and to Commission Decisions (EU) 2018/1094 of 1 August 2018 confirming the participation of the Netherlands in the enhanced cooperation on the establishment of the European Public Prosecutor's Office (3) and (EU) 2018/1103 of 7 August 2018 confirming the participation of Malta in the enhanced cooperation on the establishment of the European Public Prosecutor's Office (4), |
| --- | --- |

—

having regard to Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (2) and to Commission Decisions (EU) 2018/1094 of 1 August 2018 confirming the participation of the Netherlands in the enhanced cooperation on the establishment of the European Public Prosecutor's Office (3) and (EU) 2018/1103 of 7 August 2018 confirming the participation of Malta in the enhanced cooperation on the establishment of the European Public Prosecutor's Office (4),

| — | having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (5) and to the related delegated and implementing acts, |
| --- | --- |

—

having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (5) and to the related delegated and implementing acts,

| — | having regard to the Commission communication of 7 April 2016 on an action plan on VAT (COM(2016)0148), |
| --- | --- |

—

having regard to the Commission communication of 7 April 2016 on an action plan on VAT (COM(2016)0148),

| — | having regard to the European Court of Auditors’ special report No 24/2015 of 3 March 2016 entitled ‘Tackling intra-Community VAT fraud: More action needed’, |
| --- | --- |

—

having regard to the European Court of Auditors’ special report No 24/2015 of 3 March 2016 entitled ‘Tackling intra-Community VAT fraud: More action needed’,

| — | having regard to customs procedure 42, which provides for VAT exemption on goods imported into one Member State when they will subsequently be shipped to another Member State, |
| --- | --- |

—

having regard to customs procedure 42, which provides for VAT exemption on goods imported into one Member State when they will subsequently be shipped to another Member State,

| — | having regard to Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (6), |
| --- | --- |

—

having regard to Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (6),

| — | having regard to the European Court of Auditors’ special report No 19/2017 of 5 December 2017 entitled ‘Import procedures: shortcomings in the legal framework and an ineffective implementation impact the financial interests of the EU’, |
| --- | --- |

—

having regard to the European Court of Auditors’ special report No 19/2017 of 5 December 2017 entitled ‘Import procedures: shortcomings in the legal framework and an ineffective implementation impact the financial interests of the EU’,

| — | having regard to the motion for a resolution of the Committee on Budgetary Control, |
| --- | --- |

—

having regard to the motion for a resolution of the Committee on Budgetary Control,

| — | having regard to Rule 123(2) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 123(2) of its Rules of Procedure,

| A. | whereas traditional own resources, comprised mainly of duties on imports from outside the EU and sugar levies, account for around 12,8 % of EU own resources; |
| --- | --- |

A.

whereas traditional own resources, comprised mainly of duties on imports from outside the EU and sugar levies, account for around 12,8 % of EU own resources;

| B. | whereas in early 2017 the European Anti-Fraud Office (OLAF) concluded an investigation into a case of customs fraud in the UK, the main conclusions of which appear in the 2017 OLAF activity report; |
| --- | --- |

B.

whereas in early 2017 the European Anti-Fraud Office (OLAF) concluded an investigation into a case of customs fraud in the UK, the main conclusions of which appear in the 2017 OLAF activity report;

| C. | whereas OLAF calculated a loss for EU budget own resources of EUR 1.987 billion in terms of lost customs duties due on textiles and shoes imported from China through the UK in the period 2013-2016; |
| --- | --- |

C.

whereas OLAF calculated a loss for EU budget own resources of EUR 1.987 billion in terms of lost customs duties due on textiles and shoes imported from China through the UK in the period 2013-2016;

| D. | whereas, as a means of comparison, in 2016 OLAF recommended the financial recovery of a total amount of EUR 631,1 million as a result of 272 investigations it carried out; |
| --- | --- |

D.

whereas, as a means of comparison, in 2016 OLAF recommended the financial recovery of a total amount of EUR 631,1 million as a result of 272 investigations it carried out;

| E. | whereas the fraud in question involves undervaluation, whereby importers can derive profit from evading customs duties and related taxes, paying much less than what is legally due; |
| --- | --- |

E.

whereas the fraud in question involves undervaluation, whereby importers can derive profit from evading customs duties and related taxes, paying much less than what is legally due;

| F. | whereas the investigation also revealed substantial VAT evasion in connection with imports through the UK through abuse of the suspension of the payment of VAT, the so-called customs procedure 42; whereas these losses are cumulatively estimated to be in the range of EUR 3,2 billion for the period 2013-2016, which also represents a loss for the EU budget; |
| --- | --- |

F.

whereas the investigation also revealed substantial VAT evasion in connection with imports through the UK through abuse of the suspension of the payment of VAT, the so-called customs procedure 42; whereas these losses are cumulatively estimated to be in the range of EUR 3,2 billion for the period 2013-2016, which also represents a loss for the EU budget;

| G. | whereas OLAF has issued a financial recommendation to the Commission’s Directorate-General for Budget, an administrative recommendation to the Commission’s Directorate-General for Taxation and Customs Union and a judicial recommendation to the UK Crown Prosecution Service to initiate judicial proceedings against those involved in fraudulently evading customs duties and against those knowingly involved in laundering the proceeds of this offence; |
| --- | --- |

G.

whereas OLAF has issued a financial recommendation to the Commission’s Directorate-General for Budget, an administrative recommendation to the Commission’s Directorate-General for Taxation and Customs Union and a judicial recommendation to the UK Crown Prosecution Service to initiate judicial proceedings against those involved in fraudulently evading customs duties and against those knowingly involved in laundering the proceeds of this offence;

| H. | whereas OLAF is currently investigating a new customs undervaluation case involving the port of Piraeus in Greece, which represents a serious loss for EU resources and is estimated to have cost Italy tens of millions of euros in unpaid VAT, though the total could be far higher as the investigation is still ongoing; |
| --- | --- |

H.

whereas OLAF is currently investigating a new customs undervaluation case involving the port of Piraeus in Greece, which represents a serious loss for EU resources and is estimated to have cost Italy tens of millions of euros in unpaid VAT, though the total could be far higher as the investigation is still ongoing;

| I. | whereas the UK and Greek cases are far from being isolated and should act as a trigger to take action; |
| --- | --- |

I.

whereas the UK and Greek cases are far from being isolated and should act as a trigger to take action;

| J. | whereas the European Court of Auditors has pointed out that there is no harmonised and standardised application of customs controls by Member States and that this may incentivise fraudsters to choose the weakest link in the chain to perform their fraudulent imports; |
| --- | --- |

J.

whereas the European Court of Auditors has pointed out that there is no harmonised and standardised application of customs controls by Member States and that this may incentivise fraudsters to choose the weakest link in the chain to perform their fraudulent imports;

| 1. | Welcomes the infringement procedure initiated by the Commission on 8 March 2018 as a follow-up to the UK customs fraud case; |
| --- | --- |

1.

| 2. | Calls on the Commission to take all necessary measures to recover uncollected EU own resources to provide revenue for the EU budget; |
| --- | --- |

2.

| 3. | Calls on the Directorate-General for Taxation and Customs Union to take action in order to prevent future abuse of customs procedure 42; |
| --- | --- |

3.

| 4. | Requests that the Commission follow up on the OLAF recommendations and report back accordingly, and regrets the fact that it can take up to 10 years to recover funds; |
| --- | --- |

4.

| 5. | Urges the Commission to ensure that Member States fully comply with the provisions of the Union Customs Code, which entered into force on 1 May 2016, and to clarify any provisions that may lead to confusion; calls on the Commission and the Member States to make sure that the application of the common rules by customs authorities is organised in such a manner that fraud, including carousel fraud, is effectively prevented and controls are reinforced at ports, airports and land borders and on the internet; |
| --- | --- |

5.

| 6. | Calls on the Commission to contribute to the completion and financial sustainability of the EU customs information systems; |
| --- | --- |

6.

| 7. | Calls on the Commission to develop a suitable methodology and produce periodic estimates of the customs gap as from 2019, and to report back to Parliament every six months in this regard; |
| --- | --- |

7.

| 8. | Calls on the Council to reach a swift agreement with Parliament on a Union legal framework for customs infringements and sanctions, in order to allow harmonised administrative sanctions and the application of the same criteria in consideration of violations; recalls that Parliament adopted its position back in October 2016; calls on the Commission to facilitate this agreement; |
| --- | --- |

8.

| 9. | Regrets the fact that not all EU Member States have agreed to be part of the European Public Prosecutor’s Office; |
| --- | --- |

9.

| 10. | Urges the Commission and the Member States to conclude as soon as possible their discussions on efforts towards implementing a definitive VAT system, which aims to harmonise the way VAT is collected and paid across the EU in order, among other things, to avoid fraud; |
| --- | --- |

10.

| 11. | Calls on the Commission to develop an action plan to ensure the full and timely implementation of the VAT regulations in all Member States with a view to securing this source of EU own resources; |
| --- | --- |

11.

| 12. | Calls on the Commission to consider transferring the responsibilities of customs authorities from national to EU level as regards ensuring harmonised treatment at all EU points of entry, monitoring the performance and activities of customs administrations, and collecting and processing customs data; |
| --- | --- |

12.

| 13. | Endorses the objectives of the Customs 2020 Regulation (EU) No 1294/2013 (7) to support customs authorities in protecting the financial and economic interests of the Union and of the Member States, including the fight against fraud; emphasises that the Commission must take appropriate measures ensuring that the financial interests of the Union are protected by the application of preventive measures against fraud; |
| --- | --- |

13.

| 14. | Instructs its President to forward this resolution to the Commission. |
| --- | --- |

14.

---

(1)  OJ L 198, 28.7.2017, p. 29.

(2)  OJ L 283, 31.10.2017, p. 1.

(3)  OJ L 196, 2.8.2018, p. 1.

(4)  OJ L 201, 8.8.2018, p. 2.

(5)  OJ L 269, 10.10.2013, p. 1.

(6)  OJ L 168, 7.6.2014, p. 105.

(7)  OJ L 347, 20.12.2013, p. 209.

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 13.1.2020 | EN | Official Journal of the European Union | C 11/53 |
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P8_TA(2018)0358

Request for the waiver of the immunity of Georgios Kyrtsos

European Parliament decision of 2 October 2018 on the request for waiver of the immunity of Georgios Kyrtsos (2018/2069(IMM))

(2020/C 011/12)

The European Parliament,

| — | having regard to the request for waiver of the immunity of Georgios Kyrtsos, forwarded on 28 March 2018 by the Deputy Prosecutor General at the Supreme Court of Greece, in order to allow criminal proceedings against him for the offence of failing to pay amounts owing to the State (Criminal Case Files ABM: IG 2017/11402 and EG 10-17/337, submitted with Document 1 160 350 of 28 March 2018), and announced in plenary on 2 May 2018, |
| --- | --- |

—

having regard to the request for waiver of the immunity of Georgios Kyrtsos, forwarded on 28 March 2018 by the Deputy Prosecutor General at the Supreme Court of Greece, in order to allow criminal proceedings against him for the offence of failing to pay amounts owing to the State (Criminal Case Files ABM: IG 2017/11402 and EG 10-17/337, submitted with Document 1 160 350 of 28 March 2018), and announced in plenary on 2 May 2018,

| — | having heard Georgios Kyrtsos in accordance with Rule 9(6) of its Rules of Procedure, |
| --- | --- |

—

having heard Georgios Kyrtsos in accordance with Rule 9(6) of its Rules of Procedure,

| — | having regard to Articles 8 and 9 of Protocol No 7 on the Privileges and Immunities of the European Union, and to Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage, |
| --- | --- |

—

having regard to Articles 8 and 9 of Protocol No 7 on the Privileges and Immunities of the European Union, and to Article 6(2) of the Act of 20 September 1976 concerning the election of the members of the European Parliament by direct universal suffrage,

| — | having regard to the judgments of the Court of Justice of the European Union of 12 May 1964, 10 July 1986, 15 and 21 October 2008, 19 March 2010, 6 September 2011 and 17 January 2013 (1), |
| --- | --- |

—

having regard to the judgments of the Court of Justice of the European Union of 12 May 1964, 10 July 1986, 15 and 21 October 2008, 19 March 2010, 6 September 2011 and 17 January 2013 (1),

| — | having regard to Article 62 of the Constitution of the Hellenic Republic, |
| --- | --- |

—

having regard to Article 62 of the Constitution of the Hellenic Republic,

| — | having regard to Rule 5(2), Rule 6(1) and Rule 9 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 5(2), Rule 6(1) and Rule 9 of its Rules of Procedure,

| — | having regard to the report of the Committee on Legal Affairs (A8-0291/2018), |
| --- | --- |

—

having regard to the report of the Committee on Legal Affairs (A8-0291/2018),

| A. | whereas the Prosecutor’s Office at the Supreme Court of Greece has requested the waiver of the immunity of Georgios Kyrtsos, Member of the European Parliament, in connection with criminal proceedings referring to the non-payment of amounts owing to the State (exceeding EUR 200 000), under the provisions of Article 25(1) and (6) of Law 1882/1990, as replaced by the provisions of Article 23(1) of Law 2523/1997 and Article 25(1) of Law 1882/90 as replaced by Article 34(1) of Law 3220/2004, Article 3(1) of Law 3943/2011, Article 20 of Law 4321/2015 and, finally, Article 8 of Law 4337/2015; |
| --- | --- |

A.

whereas the Prosecutor’s Office at the Supreme Court of Greece has requested the waiver of the immunity of Georgios Kyrtsos, Member of the European Parliament, in connection with criminal proceedings referring to the non-payment of amounts owing to the State (exceeding EUR 200 000), under the provisions of Article 25(1) and (6) of Law 1882/1990, as replaced by the provisions of Article 23(1) of Law 2523/1997 and Article 25(1) of Law 1882/90 as replaced by Article 34(1) of Law 3220/2004, Article 3(1) of Law 3943/2011, Article 20 of Law 4321/2015 and, finally, Article 8 of Law 4337/2015;

| B. | whereas Article 9 of Protocol No 7 on the Privileges and Immunities of the European Union states that Members of the European Parliament enjoy, in the territory of their own State, the immunities accorded to members of the parliament of that State; |
| --- | --- |

B.

whereas Article 9 of Protocol No 7 on the Privileges and Immunities of the European Union states that Members of the European Parliament enjoy, in the territory of their own State, the immunities accorded to members of the parliament of that State;

| C. | whereas Article 62 of the Constitution of the Hellenic Republic provides that, during their parliamentary term, members of parliament may not be prosecuted, arrested, imprisoned or otherwise confined without prior leave granted by parliament; |
| --- | --- |

C.

whereas Article 62 of the Constitution of the Hellenic Republic provides that, during their parliamentary term, members of parliament may not be prosecuted, arrested, imprisoned or otherwise confined without prior leave granted by parliament;

| D. | whereas Georgios Kyrtsos has been acting as legal representative (CEO) of the company ‘Free Sunday Publishing House Ltd.’since 29 June 2009; |
| --- | --- |

D.

whereas Georgios Kyrtsos has been acting as legal representative (CEO) of the company ‘Free Sunday Publishing House Ltd.’since 29 June 2009;

| E. | whereas Georgios Kyrtsos, in his capacity as legal representative of Free Sunday Publishing House Ltd., is accused of failing to pay six hundred and twenty-seven thousand seven hundred and fifty-two euros and sixty five cents (EUR 627 752,65) owed to the State; |
| --- | --- |

E.

whereas Georgios Kyrtsos, in his capacity as legal representative of Free Sunday Publishing House Ltd., is accused of failing to pay six hundred and twenty-seven thousand seven hundred and fifty-two euros and sixty five cents (EUR 627 752,65) owed to the State;

| F. | whereas the alleged offence clearly has no direct link with the office of Georgios Kyrtsos as a Member of the European Parliament, but instead relates to his former position as manager of his newspaper company; |
| --- | --- |

F.

whereas the alleged offence clearly has no direct link with the office of Georgios Kyrtsos as a Member of the European Parliament, but instead relates to his former position as manager of his newspaper company;

| G. | whereas, for the purposes of Article 8 of Protocol No 7 on the Privileges and Immunities of the European Union, the prosecution does not concern opinions expressed or votes cast in the performance of the duties of the Member of the European Parliament in question; |
| --- | --- |

G.

whereas, for the purposes of Article 8 of Protocol No 7 on the Privileges and Immunities of the European Union, the prosecution does not concern opinions expressed or votes cast in the performance of the duties of the Member of the European Parliament in question;

| H. | whereas there is no reason to suspect that the intention underlying criminal proceedings is to damage a Member’s political activity (fumus persecutionis); |
| --- | --- |

H.

whereas there is no reason to suspect that the intention underlying criminal proceedings is to damage a Member’s political activity (fumus persecutionis);

| 1. | Decides to waive the immunity of Georgios Kyrtsos; |
| --- | --- |

1.

| 2. | Instructs its President to forward this decision and the report of its committee responsible immediately to the Greek authorities and to Georgios Kyrtsos. |
| --- | --- |

2.

---

(1)  Judgment of the Court of Justice of 12 May 1964, Wagner v Fohrmann and Krier, 101/63, ECLI:EU:C:1964:28; judgment of the Court of Justice of 10 July 1986, Wybot v Faure and others, 149/85, ECLI:EU:C:1986:310; judgment of the General Court of 15 October 2008, Mote v Parliament, T-345/05, ECLI:EU:T:2008:440; judgment of the Court of Justice of 21 October 2008, Marra v De Gregorio and Clemente, C-200/07 and C-201/07, ECLI:EU:C:2008:579; judgment of the General Court of 19 March 2010, Gollnisch v Parliament, T-42/06, ECLI:EU:T:2010:102; judgment of the Court of Justice of 6 September 2011, Patriciello, C-163/10, ECLI:EU:C:2011:543; judgment of the General Court of 17 January 2013, Gollnisch v Parliament, T-346/11 and T-347/11, ECLI:EU:T:2013:23.

---

III Preparatory acts

EUROPEAN PARLIAMENT

| 13.1.2020 | EN | Official Journal of the European Union | C 11/55 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/55

---

P8_TA(2018)0359

Third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement ***I

European Parliament legislative resolution of 2 October 2018 on the proposal for a regulation of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification) (COM(2018)0139 – C8-0116/2018 – 2018/0066(COD))

(Ordinary legislative procedure – codification)

(2020/C 011/13)

The European Parliament,

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2018)0139), |
| --- | --- |

—

having regard to the Commission proposal to the European Parliament and the Council (COM(2018)0139),

| — | having regard to Article 294(2) and Article 77(2)(a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0116/2018), |
| --- | --- |

—

having regard to Article 294(2) and Article 77(2)(a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0116/2018),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the Interinstitutional Agreement of 20 December 1994 - Accelerated working method for official codification of legislative texts (1), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 20 December 1994 - Accelerated working method for official codification of legislative texts (1),

| — | having regard to Rules 103 and 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 103 and 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Legal Affairs (A8-0290/2018), |
| --- | --- |

—

having regard to the report of the Committee on Legal Affairs (A8-0290/2018),

| A. | whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance; |
| --- | --- |

A.

whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance;

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

| 2. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

2.

---

(1)  OJ C 102, 4.4.1996, p. 2.

---

P8_TC1-COD(2018)0066

Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council listing the third countries whose nationals must be in possession of visas when crossing the external borders and those whose nationals are exempt from that requirement (codification)

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/1806.)

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/57 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/57

---

P8_TA(2018)0360

EU-Morocco Agreement for scientific and technological cooperation: terms and conditions for the participation of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) ***

European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Agreement for scientific and technological cooperation between the European Union and the Kingdom of Morocco setting out the terms and conditions for the participation of the Kingdom of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) (06534/2018 – C8-0150/2018 – 2018/0036(NLE))

(Consent)

(2020/C 011/14)

The European Parliament,

| — | having regard to the draft Council decision (06534/2018), |
| --- | --- |

—

having regard to the draft Council decision (06534/2018),

| — | having regard the draft Agreement for scientific and technological cooperation between the European Union and the Kingdom of Morocco setting out the terms and conditions for the participation of the Kingdom of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) (06533/2018), |
| --- | --- |

—

having regard the draft Agreement for scientific and technological cooperation between the European Union and the Kingdom of Morocco setting out the terms and conditions for the participation of the Kingdom of Morocco in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) (06533/2018),

| — | having regard to the request for consent submitted by the Council in accordance with Article 186 and Article 218(6) second subparagraph, point (a)(v) of the Treaty on the Functioning of the European Union (C8-0150/2018), |
| --- | --- |

—

having regard to the request for consent submitted by the Council in accordance with Article 186 and Article 218(6) second subparagraph, point (a)(v) of the Treaty on the Functioning of the European Union (C8-0150/2018),

| — | having regard to Decision (EU) 2017/1324 of the European Parliament and of the Council of 4 July 2017 on the participation of the Union in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) jointly undertaken by several Member States, |
| --- | --- |

—

having regard to Decision (EU) 2017/1324 of the European Parliament and of the Council of 4 July 2017 on the participation of the Union in the Partnership for Research and Innovation in the Mediterranean Area (PRIMA) jointly undertaken by several Member States,

| — | having regard to Rule 99(1) and (4), and Rule 108(7) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 99(1) and (4), and Rule 108(7) of its Rules of Procedure,

| — | having regard to the recommendation of the Committee on Industry, Research and Energy (A8-0281/2018), |
| --- | --- |

—

having regard to the recommendation of the Committee on Industry, Research and Energy (A8-0281/2018),

| 1. | Gives its consent to conclusion of the agreement; |
| --- | --- |

1.

| 2. | Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of the Kingdom of Morocco. |
| --- | --- |

2.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/58 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/58

---

P8_TA(2018)0361

EU-Canada air transport agreement ***

European Parliament legislative resolution of 2 October 2018 on the draft Council decision on the conclusion, on behalf of the Union, of the Air Transport Agreement between the European Community and its Member States, of the one part, and Canada, of the other part (06730/2018 – C8-0160/2018 – 2009/0018(NLE))

(Consent)

(2020/C 011/15)

The European Parliament,

| — | having regard to the draft Council decision (06730/2018), |
| --- | --- |

—

having regard to the draft Council decision (06730/2018),

| — | having regard to the Agreement on Air Transport between Canada and the European Community and its Member States (1), |
| --- | --- |

—

having regard to the Agreement on Air Transport between Canada and the European Community and its Member States (1),

| — | having regard to the request for consent submitted by the Council in accordance with Articles 100(2) and Article 218(6), second subparagraph, point (a), of the Treaty on the Functioning of the European Union (C8-0160/2018), |
| --- | --- |

—

having regard to the request for consent submitted by the Council in accordance with Articles 100(2) and Article 218(6), second subparagraph, point (a), of the Treaty on the Functioning of the European Union (C8-0160/2018),

| — | having regard to Rule 99(1) and (4), and Rule 108(7) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 99(1) and (4), and Rule 108(7) of its Rules of Procedure,

| — | having regard to the recommendation of the Committee on Transport and Tourism (A8-0254/2018), |
| --- | --- |

—

having regard to the recommendation of the Committee on Transport and Tourism (A8-0254/2018),

| 1. | Gives its consent to conclusion of the agreement; |
| --- | --- |

1.

| 2. | Instructs its President to forward its position to the Council, the Commission and the governments and parliaments of the Member States and of Canada. |
| --- | --- |

2.

---

(1)  OJ L 207, 6.8.2010, p. 32

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/59 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/59

---

P8_TA(2018)0362

Inclusion of the Italian municipality of Campione d’Italia and the Italian waters of Lake Lugano in the customs territory of the Union *

European Parliament legislative resolution of 2 October 2018 on the proposal for a Council directive amending Directives 2006/112/EC and 2008/118/EC as regards the inclusion of the Italian municipality of Campione d’Italia and the Italian waters of Lake Lugano in the customs territory of the Union and in the territorial application of Directive 2008/118/EC (COM(2018)0261 – C8-0226/2018 – 2018/0124(CNS))

(Special legislative procedure – consultation)

(2020/C 011/16)

The European Parliament,

| — | having regard to the Commission proposal to the Council (COM(2018)0261), |
| --- | --- |

—

having regard to the Commission proposal to the Council (COM(2018)0261),

| — | having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0226/2018), |
| --- | --- |

—

having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0226/2018),

| — | having regard to Rule 78c of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 78c of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0284/2018), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0284/2018),

| 1. | Approves the Commission proposal; |
| --- | --- |

1.

| 2. | Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
| --- | --- |

2.

| 3. | Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament; |
| --- | --- |

3.

| 4. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

4.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/60 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/60

---

P8_TA(2018)0363

Mobilisation of the European Globalisation Adjustment Fund: application EGF/2018/001 NL/Financial service activities

European Parliament resolution of 2 October 2018 on the proposal for a decision of the European Parliament and of the Council on the mobilisation of the European Globalisation Adjustment Fund (application from the Netherlands – EGF/2018/001 NL/Financial service activities) (COM(2018)0548 – C8-0392/2018 – 2018/2220(BUD))

(2020/C 011/17)

The European Parliament,

| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2018)0548 – C8-0392/2018), |
| --- | --- |

—

having regard to the Commission proposal to the European Parliament and the Council (COM(2018)0548 – C8-0392/2018),

| — | having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1) (EGF Regulation), |
| --- | --- |

—

having regard to Regulation (EU) No 1309/2013 of the European Parliament and of the Council of 17 December 2013 on the European Globalisation Adjustment Fund (2014-2020) and repealing Regulation (EC) No 1927/2006 (1) (EGF Regulation),

| — | having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (2), and in particular Article 12 thereof, |
| --- | --- |

—

having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (2), and in particular Article 12 thereof,

| — | having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (3) (IIA of 2 December 2013), and in particular point 13 thereof, |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (3) (IIA of 2 December 2013), and in particular point 13 thereof,

| — | having regard to the trilogue procedure provided for in point 13 of the IIA of 2 December 2013, |
| --- | --- |

—

having regard to the trilogue procedure provided for in point 13 of the IIA of 2 December 2013,

| — | having regard to the letter of the Committee on Employment and Social Affairs, |
| --- | --- |

—

having regard to the letter of the Committee on Employment and Social Affairs,

| — | having regard to the letter of the Committee on Regional Development, |
| --- | --- |

—

having regard to the letter of the Committee on Regional Development,

| — | having regard to the report of the Committee on Budgets (A8-0294/2018), |
| --- | --- |

—

having regard to the report of the Committee on Budgets (A8-0294/2018),

| A. | whereas the Union has set up legislative and budgetary instruments to provide additional support to workers who are suffering from the consequences of major structural changes in world trade patterns or of the global financial and economic crisis, and to assist their reintegration into the labour market; |
| --- | --- |

A.

whereas the Union has set up legislative and budgetary instruments to provide additional support to workers who are suffering from the consequences of major structural changes in world trade patterns or of the global financial and economic crisis, and to assist their reintegration into the labour market;

| B. | whereas the Union’s financial assistance to workers made redundant should be dynamic and made available as quickly and efficiently as possible; |
| --- | --- |

B.

whereas the Union’s financial assistance to workers made redundant should be dynamic and made available as quickly and efficiently as possible;

| C. | whereas the Netherlands submitted application EGF/2018/001 NL/Financial service activities for a financial contribution from the EGF, following 1 324 redundancies in the economic sector classified under the NACE Revision 2 Division 64 (Financial service activities, except insurance and pension funding) in the NUTS level 2 regions of NL 12 - Friesland, NL 13 - Drenthe and NL 21 - Overijssel in the Netherlands, the first application in this economic sector since the establishment of the EGF; |
| --- | --- |

C.

whereas the Netherlands submitted application EGF/2018/001 NL/Financial service activities for a financial contribution from the EGF, following 1 324 redundancies in the economic sector classified under the NACE Revision 2 Division 64 (Financial service activities, except insurance and pension funding) in the NUTS level 2 regions of NL 12 - Friesland, NL 13 - Drenthe and NL 21 - Overijssel in the Netherlands, the first application in this economic sector since the establishment of the EGF;

| D. | whereas the application is based on the intervention criteria of point (b) of Article 4(1) of the EGF Regulation, which requires at least 500 workers being made redundant over a reference period of nine months in enterprises operating in the same economic sector defined at NACE Revision 2 Division and located in one region or two contiguous regions defined at NUTS 2 level in a Member State; |
| --- | --- |

D.

whereas the application is based on the intervention criteria of point (b) of Article 4(1) of the EGF Regulation, which requires at least 500 workers being made redundant over a reference period of nine months in enterprises operating in the same economic sector defined at NACE Revision 2 Division and located in one region or two contiguous regions defined at NUTS 2 level in a Member State;

| 1. | Agrees with the Commission that the conditions set out in Article 4(1) of the EGF Regulation are met and that the Netherlands is entitled to a financial contribution of EUR 1 192 500 under that Regulation, which represents 60 % of the total cost of EUR 1 987 500; |
| --- | --- |

1.

| 2. | Notes that the Dutch authorities submitted the application on 23 February 2018, and that, following the provision of additional information by the Netherlands, the Commission finalised its assessment on 20 July 2018 and notified it to Parliament on 20 August 2018; |
| --- | --- |

2.

| 3. | Notes that the Netherlands argues that the redundancies are linked to the global financial and economic crisis and its impact on the services and functioning of the Dutch banks; acknowledges that the low interest rate environment introduced as a response to the financial crisis, the stricter regulatory conditions, the substantial decline in the mortgage market and in the credit provision for small and medium-sized enterprises (SMEs) caused falling profitability and created an urgent need for reduction of costs; regrets that as a result the banks reduced their staff, mainly by closing regional branch offices and transforming towards online banking; |
| --- | --- |

3.

| 4. | Acknowledges that, although there has been some recovery in recent years, lending in the mortgage market remains lower than before the financial crisis; |
| --- | --- |

4.

| 5. | Regrets that the financial sectors in other Member States face similar pressures; acknowledges that, in some cases, the redundancies may be spread over too long a period to meet the EGF criteria; invites, nevertheless, the governments of Member States to consider whether the EGF might play a useful role in enabling employees to adjust to these changes; |
| --- | --- |

5.

| 6. | Recalls that the redundancies that occurred in 20 enterprises operating in the Dutch banking sector are expected to have a significant adverse effect on the local economy, that unemployment in the three provinces covered by the application (Friesland, Drenthe and Overijssel) is higher than the national average, and that the impact of the layoffs is linked to the difficulties of redeployment due to the scarcity of jobs, to the low educational background of the dismissed workers, and to the high number of job seekers; |
| --- | --- |

6.

| 7. | Notes that the application relates to 1 324 workers made redundant; questions, however, why only 450 of them will be targeted by the proposed measures; points to the fact that the majority of the redundant workers are women (59 %) who are part of the administrative personnel or receptionists; further notes that 27 % of the redundant workers are over 55 years old; acknowledges, in view of this, the importance of active labour market measures co-funded by the EGF for improving the chances of reintegration in the labour market of these vulnerable groups; |
| --- | --- |

7.

| 8. | Welcomes the decision of the Netherlands to target assistance on vulnerable groups and to help people changing profession, sector or region, including training for the retail sector and for new occupational profiles, such as transport, IT services and technical professions, which offer greater job opportunities; |
| --- | --- |

8.

| 9. | Notes that the Netherlands is planning seven types of actions for the redundant workers covered by this application: (i) intake, (ii) job search assistance, (iii) mobility pool, (iv) entrepreneurship promotion training and coaching, (v) training and re-training, (vi) outplacement assistance, (vii) entrepreneurship promotion grant; |
| --- | --- |

9.

| 10. | Notes that the mobility pool accounts for almost 30% of the total package of personalised services; understands that this involves coaching for people who would otherwise have difficulty in finding employment; |
| --- | --- |

10.

| 11. | Acknowledges that the coordinated package of personalised services has been drawn up in consultation with stakeholders and social partners such as the Dutch Banking Association (NVB), the Dutch Federation for Trade Unions (FNV) and the National Christian Trade Union Federation (CNV); |
| --- | --- |

11.

| 12. | Stresses that the Dutch authorities have confirmed that the eligible actions do not receive assistance from other Union funds or financial instruments; |
| --- | --- |

12.

| 13. | Reiterates that assistance from the EGF must not replace actions which are the responsibility of companies, by virtue of national law or collective agreements, or measures for restructuring companies or sectors; |
| --- | --- |

13.

| 14. | Calls on the Commission to urge national authorities to provide more details, in future proposals, on the sectors which have growth prospects and are therefore likely to hire people, as well as to gather substantiated data on the impact of the EGF funding, including on the quality of jobs and the reintegration rate achieved through the EGF; |
| --- | --- |

14.

| 15. | Recalls that in line with Article 7 of the EGF Regulation, the design of the coordinated package of personalised services should anticipate future labour market perspectives and required skills and should be compatible with the shift towards a resource-efficient and sustainable economy; |
| --- | --- |

15.

| 16. | Recalls its appeal to the Commission to ensure public access to all the documents related to EGF cases; |
| --- | --- |

16.

| 17. | Approves the decision annexed to this resolution; |
| --- | --- |

17.

| 18. | Instructs its President to sign the decision with the President of the Council and arrange for its publication in the Official Journal of the European Union; |
| --- | --- |

18.

| 19. | Instructs its President to forward this resolution, including its Annex, to the Council and the Commission. |
| --- | --- |

19.

---

(1)  OJ L 347, 20.12.2013, p. 855.

(2)  OJ L 347, 20.12.2013, p. 884.

(3)  OJ C 373, 20.12.2013, p. 1.

---

ANNEX

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the mobilisation of the European Globalisation Adjustment Fund following an application from the Netherlands – EGF/2018/001 NL/Financial service activities

(The text of this annex is not reproduced here since it corresponds to the final act, Decision (EU) 2018/1675.)

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/64 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/64

---

P8_TA(2018)0364

Provision of audiovisual media services***I

European Parliament legislative resolution of 2 October 2018 on the proposal for a directive of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services in view of changing market realities (COM(2016)0287 – C8-0193/2016 – 2016/0151(COD))

(Ordinary legislative procedure: first reading)

(2020/C 011/18)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2016)0287), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2016)0287),

| — | having regard to Article 294(2) and Articles 53(1) and 62 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0193/2016), |
| --- | --- |

—

having regard to Article 294(2) and Articles 53(1) and 62 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0193/2016),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the opinion of the European Economic and Social Committee of 19 October 2016 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 19 October 2016 (1),

| — | having regard to the opinion of the Committee of Regions of 7 December 2016 (2), |
| --- | --- |

—

having regard to the opinion of the Committee of Regions of 7 December 2016 (2),

| — | having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 13 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 13 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Culture and Education and the opinions of the Committee on Environment, Public Health and Food Safety, the Committee on Internal Market and Consumer Protection, the Committee on Legal Affairs, and the Committee on Civil Liberties, Justice and Home Affairs (A8-0192/2017), |
| --- | --- |

—

having regard to the report of the Committee on Culture and Education and the opinions of the Committee on Environment, Public Health and Food Safety, the Committee on Internal Market and Consumer Protection, the Committee on Legal Affairs, and the Committee on Civil Liberties, Justice and Home Affairs (A8-0192/2017),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
| --- | --- |

2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

---

(1)  OJ C 34, 2.2.2017, p. 157.

(2)  OJ C 185, 9.6.2017, p. 41.

---

P8_TC1-COD(2016)0151

Position of the European Parliament adopted at first reading on 2 October 2018 with a view to the adoption of Directive (EU) 2018/... of the European Parliament and of the Council amending Directive 2010/13/EU on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) in view of changing market realities

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Directive (EU) 2018/1808.)

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/66 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/66

---

P8_TA(2018)0365

Draft Amending Budget No 5/2018: cancellation of the reserve related to the support to Turkey from the Instrument for Pre-Accession (IPA II), reinforcement of the European Neighbourhood Instrument (ENI) and of the Humanitarian Aid for other urgent actions and modification of the establishment plan of the Innovation & Networks Executive Agency (INEA) in the context of the WiFi4EU initiative

European Parliament resolution of 2 October 2018 on the Council position on Draft amending budget No 5/2018 of the European Union for the financial year 2018, Section III – Commission: Cancellation of the reserve related to the support to Turkey from the Instrument for Pre-Accession (IPA II), reinforcement of the European Neighbourhood Instrument (ENI) and of the Humanitarian Aid for other urgent actions and modification of the establishment plan of the Innovation and Networks Executive Agency (INEA) in the context of the WiFi4EU initiative (11843/2018 – C8-0415/2018 – 2018/2165(BUD))

(2020/C 011/19)

The European Parliament,

| — | having regard to Article 314 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 314 of the Treaty on the Functioning of the European Union,

| — | having regard to Article 106a of the Treaty establishing the European Atomic Energy Community, |
| --- | --- |

—

having regard to Article 106a of the Treaty establishing the European Atomic Energy Community,

| — | having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (1), and in particular Article 41 thereof, |
| --- | --- |

—

having regard to Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (1), and in particular Article 41 thereof,

| — | having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU, and repealing Regulation (EU, Euratom) No 966/2012 (2), and in particular Article 44 thereof, |
| --- | --- |

—

having regard to Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU, and repealing Regulation (EU, Euratom) No 966/2012 (2), and in particular Article 44 thereof,

| — | having regard to the general budget of the European Union for the financial year 2018, as definitively adopted on 30 November 2017 (3), |
| --- | --- |

—

having regard to the general budget of the European Union for the financial year 2018, as definitively adopted on 30 November 2017 (3),

| — | having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (4), |
| --- | --- |

—

having regard to Council Regulation (EU, Euratom) No 1311/2013 of 2 December 2013 laying down the multiannual financial framework for the years 2014-2020 (4),

| — | having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (5), |
| --- | --- |

—

having regard to the Interinstitutional Agreement of 2 December 2013 between the European Parliament, the Council and the Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management (5),

| — | having regard to Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (6), |
| --- | --- |

—

having regard to Council Decision 2014/335/EU, Euratom of 26 May 2014 on the system of own resources of the European Union (6),

| — | having regard to Draft amending budget No 5/2018, which the Commission adopted on 10 July 2018 (COM(2018)0537), |
| --- | --- |

—

having regard to Draft amending budget No 5/2018, which the Commission adopted on 10 July 2018 (COM(2018)0537),

| — | having regard to the position on Draft amending budget No 5/2018 which the Council adopted on 18 September 2018 and forwarded to Parliament on 20 September 2018 (11843/2018 – C8-0415/2018), |
| --- | --- |

—

having regard to the position on Draft amending budget No 5/2018 which the Council adopted on 18 September 2018 and forwarded to Parliament on 20 September 2018 (11843/2018 – C8-0415/2018),

| — | having regard to the letter of the Committee on Foreign Affairs, |
| --- | --- |

—

having regard to the letter of the Committee on Foreign Affairs,

| — | having regard to Rules 88 and 91 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rules 88 and 91 of its Rules of Procedure,

| — | having regard to the report of the Committee on Budgets (A8-0292/2018), |
| --- | --- |

—

having regard to the report of the Committee on Budgets (A8-0292/2018),

| A. | whereas, at the insistence of Parliament, the budgetary authority decided, within the context of the 2018 budgetary procedure, to place in reserve EUR 70 million of commitment appropriations and EUR 35 million of payment appropriations of the Union’s support to Turkey from the Instrument for Pre-Accession (IPA II) on the budget item 22 02 03 01 Support for political reforms and related progressive alignment with the Union acquis; |
| --- | --- |

A.

whereas, at the insistence of Parliament, the budgetary authority decided, within the context of the 2018 budgetary procedure, to place in reserve EUR 70 million of commitment appropriations and EUR 35 million of payment appropriations of the Union’s support to Turkey from the Instrument for Pre-Accession (IPA II) on the budget item 22 02 03 01 Support for political reforms and related progressive alignment with the Union acquis;

| B. | whereas Parliament and the Council decided that for the amounts put in reserve to be released, Turkey would need to make “measurable sufficient improvements in the fields of rule of law, democracy, human rights and press freedom, according to the annual report of the Commission”; whereas the Commission’s annual report on Turkey from 17 April 2018 (7) confirmed unequivocally a backsliding of the rule of law, democracy and human rights in Turkey; whereas the condition set by the budgetary authority has therefore not been met; |
| --- | --- |

B.

whereas Parliament and the Council decided that for the amounts put in reserve to be released, Turkey would need to make “measurable sufficient improvements in the fields of rule of law, democracy, human rights and press freedom, according to the annual report of the Commission”; whereas the Commission’s annual report on Turkey from 17 April 2018 (7) confirmed unequivocally a backsliding of the rule of law, democracy and human rights in Turkey; whereas the condition set by the budgetary authority has therefore not been met;

| C. | whereas the Commission has proposed to fully cancel the amounts which have been placed in reserve, both in commitment and payment appropriations, as well as the related budgetary remarks; |
| --- | --- |

C.

whereas the Commission has proposed to fully cancel the amounts which have been placed in reserve, both in commitment and payment appropriations, as well as the related budgetary remarks;

| D. | whereas the Commission has proposed to reinforce the European Neighbourhood Instrument (ENI) with EUR 70 million in commitment appropriations in order to fund actions linked to the Central Mediterranean migratory route through the North Africa window of the EU Trust Fund for Africa (EUR 28 million) and to fulfil part of the Union pledge made at the 24-25 April 2018 Brussels II conference “Supporting the future of Syria and the region”(EUR 42 million, which are to be transferred to the EU Regional Trust Fund in Response to the Syrian Crisis (the ‘Madad’Fund)); |
| --- | --- |

D.

whereas the Commission has proposed to reinforce the European Neighbourhood Instrument (ENI) with EUR 70 million in commitment appropriations in order to fund actions linked to the Central Mediterranean migratory route through the North Africa window of the EU Trust Fund for Africa (EUR 28 million) and to fulfil part of the Union pledge made at the 24-25 April 2018 Brussels II conference “Supporting the future of Syria and the region”(EUR 42 million, which are to be transferred to the EU Regional Trust Fund in Response to the Syrian Crisis (the ‘Madad’Fund));

| E. | whereas the Commission has proposed to reinforce Humanitarian Aid with EUR 35 million in payment appropriations to meet needs triggered by the EUR 124,8 million reinforcements at the end of 2017 which did not include payment appropriations; |
| --- | --- |

E.

whereas the Commission has proposed to reinforce Humanitarian Aid with EUR 35 million in payment appropriations to meet needs triggered by the EUR 124,8 million reinforcements at the end of 2017 which did not include payment appropriations;

| F. | whereas the Commission has also proposed to reinforce the establishment plan of the innovation and Networks Executive Agency (INEA) in the context of the WiFi4EU initiative, by adding one post of temporary agent at grade AD7; whereas this amendment can be financed within the Agency’s budget for this year; |
| --- | --- |

F.

whereas the Commission has also proposed to reinforce the establishment plan of the innovation and Networks Executive Agency (INEA) in the context of the WiFi4EU initiative, by adding one post of temporary agent at grade AD7; whereas this amendment can be financed within the Agency’s budget for this year;

| 1. | Takes note of Draft amending budget No 5/2018 as submitted by the Commission, which is devoted to cancelling, both in commitment and payment appropriations, the reserve related to Turkey from the IPA II, to reinforcing of the ENI in commitment appropriations and of Humanitarian Aid in payments appropriations, and to reinforcing the establishment plan of the INEA in the context of the WiFi4EU initiative; |
| --- | --- |

1.

| 2. | Expresses its concern at the continuing deterioration in fundamental rights and freedoms and the rule of law in Turkey and Turkey’s further drifting away from European values; |
| --- | --- |

2.

| 3. | Reiterates that any decision related to IPA II funding in Turkey should not be made to the detriment of Union support to Turkish civil society, which should be further increased; |
| --- | --- |

3.

| 4. | Insists on the need to apply workable solutions along the Central Mediterranean migratory route, in cooperation with relevant international, national or regional authorities, and fully respecting international human rights standards with regard to the treatment of migrants; |
| --- | --- |

4.

| 5. | Approves the Council position on Draft amending budget No 5/2018; |
| --- | --- |

5.

| 6. | Instructs its President to declare that Amending budget No 5/2018 has been definitively adopted and arrange for its publication in the Official Journal of the European Union; |
| --- | --- |

6.

| 7. | Instructs its President to forward this resolution to the Council, the Commission, the other institutions and bodies concerned and the national parliaments. |
| --- | --- |

7.

---

(1)  OJ L 298, 26.10.2012, p. 1.

(2)  OJ L 193, 30.7.2018, p. 1.

(3)  OJ L 57, 28.2.2018.

(4)  OJ L 347, 20.12.2013, p. 884.

(5)  OJ C 373, 20.12.2013, p. 1.

(6)  OJ L 168, 7.6.2014, p. 105.

(7)  COM(2018)0450, SWD(2018)0153.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/69 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/69

---

P8_TA(2018)0366

Harmonising and simplifying certain rules in the VAT system *

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards harmonising and simplifying certain rules in the value added tax system and introducing the definitive system for the taxation of trade between Member States (COM(2017)0569 – C8-0363/2017 – 2017/0251(CNS))

(Special legislative procedure – consultation)

(2020/C 011/20)

The European Parliament,

| — | having regard to the Commission proposal to the Council (COM(2017)0569), |
| --- | --- |

—

having regard to the Commission proposal to the Council (COM(2017)0569),

| — | having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0363/2017), |
| --- | --- |

—

having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0363/2017),

| — | having regard to Rule 78c of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 78c of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0280/2018), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0280/2018),

| 1. | Approves the Commission proposal as amended; |
| --- | --- |

1.

| 2. | Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union; |
| --- | --- |

2.

| 3. | Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
| --- | --- |

3.

| 4. | Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal; |
| --- | --- |

4.

| 5. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

5.

Amendment 1

Proposal for a directive

Recital 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (1) | In 1967, when the Council adopted the common system of value added tax (VAT) by means of Council Directives 67/227/EEC (1) and 67/228/EEC (2), the commitment was made to establish a definitive VAT system operating within the European Community in the same way as it would within a single Member State. Since the political and technical conditions were not ripe for such a system, when the fiscal frontiers between Member States were abolished by the end of 1992 transitional VAT arrangements were adopted. Council Directive 2006/112/EC (3), which is currently in force, provides that these transitional rules have to be replaced by definitive arrangements. |

Text proposed by the Commission

Amendment

(1)

In 1967, when the Council adopted the common system of value added tax (VAT) by means of Council Directives 67/227/EEC (1) and 67/228/EEC (2), the commitment was made to establish a definitive VAT system operating within the European Community in the same way as it would within a single Member State. Since the political and technical conditions were not ripe for such a system, when the fiscal frontiers between Member States were abolished by the end of 1992 transitional VAT arrangements were adopted. Council Directive 2006/112/EC (3), which is currently in force, provides that these transitional rules have to be replaced by definitive arrangements.

| (1) | In 1967, when the Council adopted the common system of value added tax (VAT) by means of Council Directives 67/227/EEC (4) and 67/228/EEC (5), the commitment was made to establish a definitive VAT system operating within the European Community in the same way as it would within a single Member State. Since the political and technical conditions were not ripe for such a system, when the fiscal frontiers between Member States were abolished by the end of 1992 transitional VAT arrangements were adopted. Council Directive 2006/112/EC (6), which is currently in force, provides that these transitional rules have to be replaced by definitive arrangements.
  However, those rules have now been in place for several decades, resulting in a complex transitional VAT system susceptible to intra-Union cross-border VAT fraud. Those transitional rules suffer from numerous shortcomings, which result in the VAT system being neither fully efficient nor compatible with the requirements of a true single market. |
| --- | --- |

(1)

In 1967, when the Council adopted the common system of value added tax (VAT) by means of Council Directives 67/227/EEC (4) and 67/228/EEC (5), the commitment was made to establish a definitive VAT system operating within the European Community in the same way as it would within a single Member State. Since the political and technical conditions were not ripe for such a system, when the fiscal frontiers between Member States were abolished by the end of 1992 transitional VAT arrangements were adopted. Council Directive 2006/112/EC (6), which is currently in force, provides that these transitional rules have to be replaced by definitive arrangements.
  However, those rules have now been in place for several decades, resulting in a complex transitional VAT system susceptible to intra-Union cross-border VAT fraud. Those transitional rules suffer from numerous shortcomings, which result in the VAT system being neither fully efficient nor compatible with the requirements of a true single market.

Amendment 2

Proposal for a directive

Recital 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (1a) | In its Communication of 28 October 2015 entitled Upgrading the Single Market: more opportunities for people and business, the Commission identified the complexity of the current VAT regulations as one of the major obstacles to the completion of the single market. At the same time, the VAT gap, defined as the difference between the amount of VAT revenue actually collected and the theoretical amount that is expected to be collected, has been increasing, reaching EUR 151,5 billion in 2015 in the EU-28. This illustrates the need for an urgent and comprehensive reform of the VAT system towards a definitive VAT regime, to facilitate and simplify cross-border intra-Union trade and make the system more fraud-proof. |

Text proposed by the Commission

Amendment

(1a)

In its Communication of 28 October 2015 entitled Upgrading the Single Market: more opportunities for people and business, the Commission identified the complexity of the current VAT regulations as one of the major obstacles to the completion of the single market. At the same time, the VAT gap, defined as the difference between the amount of VAT revenue actually collected and the theoretical amount that is expected to be collected, has been increasing, reaching EUR 151,5 billion in 2015 in the EU-28. This illustrates the need for an urgent and comprehensive reform of the VAT system towards a definitive VAT regime, to facilitate and simplify cross-border intra-Union trade and make the system more fraud-proof.

Amendment 3

Proposal for a directive

Recital 1 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (1b) | The creation of a single EU VAT area is crucial for decreasing compliance costs for businesses, reducing the risks of cross-border VAT fraud and for simplifying VAT-related procedures. The VAT definitive system will strengthen the Single Market and create better business conditions for cross-border trade. It should include the necessary changes due to technological developments and digitalisation, changes in business models and the globalisation of the economy. |

Text proposed by the Commission

Amendment

(1b)

The creation of a single EU VAT area is crucial for decreasing compliance costs for businesses, reducing the risks of cross-border VAT fraud and for simplifying VAT-related procedures. The VAT definitive system will strengthen the Single Market and create better business conditions for cross-border trade. It should include the necessary changes due to technological developments and digitalisation, changes in business models and the globalisation of the economy.

Amendment 4

Proposal for a directive

Recital 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (2) | In its VAT Action Plan (7), the Commission announced its intention to put forward a proposal setting out the principles for a definitive VAT system for cross-border business-to-business (B2B) trade between Member States that would be based on the taxation of cross-border supplies of goods in the Member State of destination. |

Text proposed by the Commission

Amendment

(2)

In its VAT Action Plan (7), the Commission announced its intention to put forward a proposal setting out the principles for a definitive VAT system for cross-border business-to-business (B2B) trade between Member States that would be based on the taxation of cross-border supplies of goods in the Member State of destination.

| (2) | The current EU VAT system which was introduced in 1993 is similar to the European customs system. However, equivalent checks are lacking, which makes it a target for cross-border fraud. The current VAT system should be fundamentally changed in the way that the supply of goods from one Member State to another is taxed as if they were supplied and acquired within one Member State.
  In its VAT Action Plan (8), the Commission announced its intention to put forward a proposal setting out the principles for a definitive VAT system for cross-border business-to-business (B2B) trade between Member States that would be based on the taxation of cross-border supplies of goods in the Member State of destination.
  That change should contribute to the reduction of VAT-related cross-border frauds by EUR 40 billion annually. |
| --- | --- |

(2)

The current EU VAT system which was introduced in 1993 is similar to the European customs system. However, equivalent checks are lacking, which makes it a target for cross-border fraud. The current VAT system should be fundamentally changed in the way that the supply of goods from one Member State to another is taxed as if they were supplied and acquired within one Member State.
  In its VAT Action Plan (8), the Commission announced its intention to put forward a proposal setting out the principles for a definitive VAT system for cross-border business-to-business (B2B) trade between Member States that would be based on the taxation of cross-border supplies of goods in the Member State of destination.
  That change should contribute to the reduction of VAT-related cross-border frauds by EUR 40 billion annually.

Amendment 5

Proposal for a directive

Recital 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (3) | This would require replacing the current system consisting of an exempt supply in the Member State of departure of the goods and a taxed intra-Community acquisition of goods in the Member State of destination by a system of a single supply taxed in and in accordance with the VAT rates of the Member State of destination. As a rule, the VAT will be charged by the supplier who will be able to verify the applicable VAT rate of any Member State online by means of a web portal.
  However, where the person acquiring the goods is a certified taxable person (a reliable taxpayer recognised as such by Member States), the reverse charge mechanism would apply and the certified taxable person should be liable to VAT on the intra-Union supply.
  The VAT definitive system will also be based on the concept of a single registration scheme (One-Stop Shop (OSS)) for businesses allowing for the payment and deduction of the VAT due. |

Text proposed by the Commission

Amendment

(3)

This would require replacing the current system consisting of an exempt supply in the Member State of departure of the goods and a taxed intra-Community acquisition of goods in the Member State of destination by a system of a single supply taxed in and in accordance with the VAT rates of the Member State of destination. As a rule, the VAT will be charged by the supplier who will be able to verify the applicable VAT rate of any Member State online by means of a web portal.
  However, where the person acquiring the goods is a certified taxable person (a reliable taxpayer recognised as such by Member States), the reverse charge mechanism would apply and the certified taxable person should be liable to VAT on the intra-Union supply.
  The VAT definitive system will also be based on the concept of a single registration scheme (One-Stop Shop (OSS)) for businesses allowing for the payment and deduction of the VAT due.

| (3) | This would require replacing the current system consisting of an exempt supply in the Member State of departure of the goods and a taxed intra-Community acquisition of goods in the Member State of destination by a system of a single supply taxed in and in accordance with the VAT rates of the Member State of destination. As a rule, the VAT will be charged by the supplier who will be able to verify the applicable VAT rate of any Member State online by means of a web portal. The VAT definitive system will also be based on the concept of a single registration scheme (One-Stop Shop (OSS)) for businesses allowing for the payment and deduction of the VAT due.
  OSS is the core of the new destination-based system without which complexity of the VAT system and the administrative burden would increase significantly. Therefore, extension of the Mini One-Stop Shop (MOSS) to cover all B2B services and sales of goods should take place within proposed improvements of the current system. |
| --- | --- |

(3)

This would require replacing the current system consisting of an exempt supply in the Member State of departure of the goods and a taxed intra-Community acquisition of goods in the Member State of destination by a system of a single supply taxed in and in accordance with the VAT rates of the Member State of destination. As a rule, the VAT will be charged by the supplier who will be able to verify the applicable VAT rate of any Member State online by means of a web portal. The VAT definitive system will also be based on the concept of a single registration scheme (One-Stop Shop (OSS)) for businesses allowing for the payment and deduction of the VAT due.
  OSS is the core of the new destination-based system without which complexity of the VAT system and the administrative burden would increase significantly. Therefore, extension of the Mini One-Stop Shop (MOSS) to cover all B2B services and sales of goods should take place within proposed improvements of the current system.

Amendment 6

Proposal for a directive

Recital 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (3a) | To ensure interoperability, ease of use and future fraud-proofing, OSS for businesses should operate with a harmonised cross-border IT system, based on common standards and allowing for automatic retrieval and input of data, for example, through the use of unified standard forms. |

Text proposed by the Commission

Amendment

(3a)

To ensure interoperability, ease of use and future fraud-proofing, OSS for businesses should operate with a harmonised cross-border IT system, based on common standards and allowing for automatic retrieval and input of data, for example, through the use of unified standard forms.

Amendment 7

Proposal for a directive

Recital 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (4) | These principles should be established in the Directive and should replace the current concept according to which the definitive arrangements shall be based on the taxation in the Member State of origin. |

Text proposed by the Commission

Amendment

(4)

These principles should be established in the Directive and should replace the current concept according to which the definitive arrangements shall be based on the taxation in the Member State of origin.

| (4) | These principles should be established in the Directive and should replace the current concept according to which the definitive arrangements shall be based on the taxation in the Member State of origin
  with a definitive VAT system
  .
  Those new principles would enable the Member States to better fight VAT fraud, especially Missing Trader Intra-Community (MTIC), estimated to amount to at least EUR 50 billion a year. |
| --- | --- |

(4)

These principles should be established in the Directive and should replace the current concept according to which the definitive arrangements shall be based on the taxation in the Member State of origin
  with a definitive VAT system
  .
  Those new principles would enable the Member States to better fight VAT fraud, especially Missing Trader Intra-Community (MTIC), estimated to amount to at least EUR 50 billion a year.

Amendment 8

Proposal for a directive

Recital 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (5) | The Council, in its conclusions of 8 November 2016 (9), invited the Commission to make certain improvements to the Union VAT rules for cross-border transactions, regarding the role of the VAT identification number in the context of the exemption for intra-Community supplies, call-off stock arrangements, chain transactions and the proof of transport for the purposes of the exemption for intra-Community transactions. |

Text proposed by the Commission

Amendment

(5)

The Council, in its conclusions of 8 November 2016 (9), invited the Commission to make certain improvements to the Union VAT rules for cross-border transactions, regarding the role of the VAT identification number in the context of the exemption for intra-Community supplies, call-off stock arrangements, chain transactions and the proof of transport for the purposes of the exemption for intra-Community transactions.

| (5) | The Council, in its conclusions of 8 November 2016 (10), invited the Commission to make certain improvements to the Union VAT rules for cross-border transactions, regarding
  four areas:
  the role of the VAT identification number in the context of the exemption for intra-Community supplies, call-off stock arrangements, chain transactions and the proof of transport for the purposes of the exemption for intra-Community transactions. |
| --- | --- |

(5)

The Council, in its conclusions of 8 November 2016 (10), invited the Commission to make certain improvements to the Union VAT rules for cross-border transactions, regarding
  four areas:
  the role of the VAT identification number in the context of the exemption for intra-Community supplies, call-off stock arrangements, chain transactions and the proof of transport for the purposes of the exemption for intra-Community transactions.

Amendment 9

Proposal for a directive

Recital 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (6) | Given this demand and the fact that
  it will take several years for
  the definitive VAT system for intra-Union trade to be implemented, these specific measures, intended to harmonise and simplify certain arrangements for businesses, are appropriate. |

Text proposed by the Commission

Amendment

(6)

Given this demand and the fact that
  it will take several years for
  the definitive VAT system for intra-Union trade to be implemented, these specific measures, intended to harmonise and simplify certain arrangements for businesses, are appropriate.

| (6) | Given this demand and the fact that the definitive VAT system for intra-Union trade
  is yet
  to be
  duly
  implemented, these specific measures, intended to harmonise and simplify certain arrangements for businesses, are appropriate
  only in a transitional manner
  . |
| --- | --- |

(6)

Given this demand and the fact that the definitive VAT system for intra-Union trade
  is yet
  to be
  duly
  implemented, these specific measures, intended to harmonise and simplify certain arrangements for businesses, are appropriate
  only in a transitional manner
  .

Amendment 10

Proposal for a directive

Recital 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (7) | The creation of the certified taxable person status is needed for the efficient application of the improvements to the Union VAT rules for cross-border transactions as well as for the gradual transition towards the definitive system for intra-Union trade. |

Text proposed by the Commission

Amendment

(7)

The creation of the certified taxable person status is needed for the efficient application of the improvements to the Union VAT rules for cross-border transactions as well as for the gradual transition towards the definitive system for intra-Union trade.

| (7) | The creation of the certified taxable person status is needed for the efficient application of the improvements to the Union VAT rules for cross-border transactions as well as for the gradual transition towards the definitive system for intra-Union trade.
  However, strict criteria, applied in a harmonised way by all Member States, need to be put in place to determine which enterprises can benefit from the status of the certified taxable person, and common rules and provisions resulting in fines and penalties for those who do not comply with them should be established. |
| --- | --- |

(7)

The creation of the certified taxable person status is needed for the efficient application of the improvements to the Union VAT rules for cross-border transactions as well as for the gradual transition towards the definitive system for intra-Union trade.
  However, strict criteria, applied in a harmonised way by all Member States, need to be put in place to determine which enterprises can benefit from the status of the certified taxable person, and common rules and provisions resulting in fines and penalties for those who do not comply with them should be established.

Amendment 11

Proposal for a directive

Recital 8

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (8) | In the current system no distinction is made between reliable and less reliable taxable persons as regards the VAT rules to be applied. The granting of the certified taxable person status on the basis of certain objective criteria should enable the identification of those reliable taxable persons. This status would allow them to benefit from the application of certain
  fraud-sensitive
  rules not applicable to other taxable persons. |

Text proposed by the Commission

Amendment

(8)

In the current system no distinction is made between reliable and less reliable taxable persons as regards the VAT rules to be applied. The granting of the certified taxable person status on the basis of certain objective criteria should enable the identification of those reliable taxable persons. This status would allow them to benefit from the application of certain
  fraud-sensitive
  rules not applicable to other taxable persons.

| (8) | In the current system no distinction is made between reliable and less reliable taxable persons as regards the VAT rules to be applied. The granting of the certified taxable person status on the basis of certain objective criteria,
  to be applied in a harmonised way by Member States
  , should enable the identification of those reliable taxable persons
  and those who do not fully comply with the criteria
  . This status would allow them to benefit from the application of certain
  simplified and user-friendly
  rules not applicable to other taxable persons. |
| --- | --- |

(8)

In the current system no distinction is made between reliable and less reliable taxable persons as regards the VAT rules to be applied. The granting of the certified taxable person status on the basis of certain objective criteria,
  to be applied in a harmonised way by Member States
  , should enable the identification of those reliable taxable persons
  and those who do not fully comply with the criteria
  . This status would allow them to benefit from the application of certain
  simplified and user-friendly
  rules not applicable to other taxable persons.

Amendment 12

Proposal for a directive

Recital 9

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (9) | Access to the certified taxable person status should be based on criteria harmonised at Union level and therefore certification provided by one Member State should be valid in the whole Union. |

Text proposed by the Commission

Amendment

(9)

Access to the certified taxable person status should be based on criteria harmonised at Union level and therefore certification provided by one Member State should be valid in the whole Union.

| (9) | Access to the certified taxable person status should be based on
  clearly defined
  criteria
  and should be available to businesses including SMEs. Those criteria should be
  harmonised at Union level and therefore certification provided by one Member State should be valid in the whole Union.
  The Commission should therefore present implementing acts and comprehensive and easy to use guidelines, facilitating harmonisation and administrative cooperation between the authorities and ensuring interoperability among Member States whilst verifying the proper application by Member States of such harmonised criteria across the Union. Those guidelines should be closely aligned to the criteria of the Authorised Economic Operator under the Union Customs Code, in order to reduce the administrative burden and to ensure uniform implementation and compliance across Member States. |
| --- | --- |

(9)

Access to the certified taxable person status should be based on
  clearly defined
  criteria
  and should be available to businesses including SMEs. Those criteria should be
  harmonised at Union level and therefore certification provided by one Member State should be valid in the whole Union.
  The Commission should therefore present implementing acts and comprehensive and easy to use guidelines, facilitating harmonisation and administrative cooperation between the authorities and ensuring interoperability among Member States whilst verifying the proper application by Member States of such harmonised criteria across the Union. Those guidelines should be closely aligned to the criteria of the Authorised Economic Operator under the Union Customs Code, in order to reduce the administrative burden and to ensure uniform implementation and compliance across Member States.

Amendment 13

Proposal for a directive

Recital 9 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (9a) | With particular focus on the higher compliance costs for SMEs, the Commission should present simplified administrative procedures for SMEs to obtain the status of certified taxable persons. |

Text proposed by the Commission

Amendment

(9a)

With particular focus on the higher compliance costs for SMEs, the Commission should present simplified administrative procedures for SMEs to obtain the status of certified taxable persons.

Amendment 14

Proposal for a directive

Recital 9 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (9b) | Information on whether an economic operator is a certified taxable person should be accessible via the VIES system. |

Text proposed by the Commission

Amendment

(9b)

Information on whether an economic operator is a certified taxable person should be accessible via the VIES system.

Amendment 15

Proposal for a directive

Recital 10

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (10) | Certain taxable persons covered by particular arrangements excluding them from the general VAT rules,
  or who only occasionally carry out economic activities
  , should not be granted the certified taxable person status as far as those particular arrangements or occasional activities are concerned. Otherwise the smooth application of the proposed changes could be disrupted. |

Text proposed by the Commission

Amendment

(10)

Certain taxable persons covered by particular arrangements excluding them from the general VAT rules,
  or who only occasionally carry out economic activities
  , should not be granted the certified taxable person status as far as those particular arrangements or occasional activities are concerned. Otherwise the smooth application of the proposed changes could be disrupted.

| (10) | Certain taxable persons covered by particular arrangements excluding them from the general VAT rules should not be granted the certified taxable person status as far as those particular arrangements or occasional activities are concerned. Otherwise the smooth application of the proposed changes could be disrupted.
  In addition, special attention should be paid to ensuring that SMEs are not put at a competitive disadvantage compared to large enterprises in respect of the obtainment of the status of certified taxable persons. |
| --- | --- |

(10)

Certain taxable persons covered by particular arrangements excluding them from the general VAT rules should not be granted the certified taxable person status as far as those particular arrangements or occasional activities are concerned. Otherwise the smooth application of the proposed changes could be disrupted.
  In addition, special attention should be paid to ensuring that SMEs are not put at a competitive disadvantage compared to large enterprises in respect of the obtainment of the status of certified taxable persons.

Amendment 16

Proposal for a directive

Recital 13 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (13a) | The EU VAT cross-border ruling pilot project should be the basis for a fully developed Union tool which would prevent conflict of VAT rules on tax disputes and would resolve cases of intra-Union cross-border disputes in VAT cases. National mechanisms will continue to apply for internal VAT tax disputes between the taxpayer concerned and the national tax authority. |

Text proposed by the Commission

Amendment

(13a)

The EU VAT cross-border ruling pilot project should be the basis for a fully developed Union tool which would prevent conflict of VAT rules on tax disputes and would resolve cases of intra-Union cross-border disputes in VAT cases. National mechanisms will continue to apply for internal VAT tax disputes between the taxpayer concerned and the national tax authority.

Amendment 17

Proposal for a directive

Recital 13 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (13b) | This Directive provides for provisional arrangements prior to the adoption by Member States of a definitive system for the taxation of trade between Member States, and should be accompanied by corresponding implementing acts and guidelines. This Directive, implementing acts and guidelines should enter into force at the same time. |

Text proposed by the Commission

Amendment

(13b)

This Directive provides for provisional arrangements prior to the adoption by Member States of a definitive system for the taxation of trade between Member States, and should be accompanied by corresponding implementing acts and guidelines. This Directive, implementing acts and guidelines should enter into force at the same time.

Amendment 18

Proposal for a directive

Recital 13 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (13c) | A mechanism should be established to ensure a transparent and direct information system which automatically notifies tax payers of updates and changes in the VAT rates of Member States. Such a mechanism should be based on harmonised standards and reporting forms, ensuring uniform reporting and data retrieval across Member States. Member States should be obliged to ensure that all information regarding their national VAT rates are correct and up to date. Member States should furthermore ensure that any changes to national VAT rates are notified via such a system within a reasonable time of their adoption and in any case before the changes become applicable. |

Text proposed by the Commission

Amendment

(13c)

A mechanism should be established to ensure a transparent and direct information system which automatically notifies tax payers of updates and changes in the VAT rates of Member States. Such a mechanism should be based on harmonised standards and reporting forms, ensuring uniform reporting and data retrieval across Member States. Member States should be obliged to ensure that all information regarding their national VAT rates are correct and up to date. Member States should furthermore ensure that any changes to national VAT rates are notified via such a system within a reasonable time of their adoption and in any case before the changes become applicable.

Amendment 19

Proposal for a directive

Recital 15 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (15a) | In keeping with the public interest and the financial interests of the Union, whistleblowers should enjoy effective legal protection, in order to facilitate the detection and prevention of all forms of fraud. |

Text proposed by the Commission

Amendment

(15a)

In keeping with the public interest and the financial interests of the Union, whistleblowers should enjoy effective legal protection, in order to facilitate the detection and prevention of all forms of fraud.

Amendment 20

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13 a – paragraph 1 – subparagraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Any taxable person who has a place of business or a fixed establishment
  in the Community or in absence of place of business and fixed establishment has his permanent address or usual residence
  in the Community and who, in the course of his economic activity, carries out, or intends to carry out, any of the transactions referred to in Articles 17a, 20 and 21, or transactions in accordance with the conditions specified in
  Article
  138 may apply to the tax authorities for the status of certified taxable person. | | Any taxable person who has a place of business or a fixed establishment in the Community and who, in the course of his economic activity, carries out, or intends to carry out, any of the transactions referred to in Articles 17a, 20 and 21, or transactions in accordance with the conditions specified in
  Articles
  138
  and 138a
  may apply to the tax authorities for the status of certified taxable person. |

Text proposed by the Commission

Amendment

Any taxable person who has a place of business or a fixed establishment
  in the Community or in absence of place of business and fixed establishment has his permanent address or usual residence
  in the Community and who, in the course of his economic activity, carries out, or intends to carry out, any of the transactions referred to in Articles 17a, 20 and 21, or transactions in accordance with the conditions specified in
  Article
  138 may apply to the tax authorities for the status of certified taxable person.

Any taxable person who has a place of business or a fixed establishment in the Community and who, in the course of his economic activity, carries out, or intends to carry out, any of the transactions referred to in Articles 17a, 20 and 21, or transactions in accordance with the conditions specified in
  Articles
  138
  and 138a
  may apply to the tax authorities for the status of certified taxable person.

Amendment 21

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 1 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Where the applicant is a taxable person who has been granted the status of an authorised economic operator for customs purposes, the criteria in paragraph 2 shall be deemed to have been met. | | Where the applicant is a taxable person who has been granted the status of an authorised economic operator for customs purposes
  only
  , the criteria in paragraph 2 shall be deemed to have been met. |

Text proposed by the Commission

Amendment

Where the applicant is a taxable person who has been granted the status of an authorised economic operator for customs purposes, the criteria in paragraph 2 shall be deemed to have been met.

Where the applicant is a taxable person who has been granted the status of an authorised economic operator for customs purposes
  only
  , the criteria in paragraph 2 shall be deemed to have been met.

Amendment 22

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | the absence of any serious infringement or repeated infringements of taxation rules and customs legislation,
  as well as of any
  record of serious criminal offences relating to
  the
  economic activity
  of the applicant
  ; |

Text proposed by the Commission

Amendment

(a)

the absence of any serious infringement or repeated infringements of taxation rules and customs legislation,
  as well as of any
  record of serious criminal offences relating to
  the
  economic activity
  of the applicant
  ;

| (a) | the absence of any serious infringement or repeated infringements of taxation rules and customs legislation
  in the last three years of economic activity, the absence of any serious tax adjustment by tax administrations, or no
  record of serious criminal offences relating to
  his or her
  economic activity,
  regardless of whether the activity has taken place within the Union or elsewhere
  ; |
| --- | --- |

(a)

the absence of any serious infringement or repeated infringements of taxation rules and customs legislation
  in the last three years of economic activity, the absence of any serious tax adjustment by tax administrations, or no
  record of serious criminal offences relating to
  his or her
  economic activity,
  regardless of whether the activity has taken place within the Union or elsewhere
  ;

Amendment 23

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 – point a a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (aa) | the absence of any record of serious criminal offences relating to the economic activity of the applicant, such as, but not limited to:










  (i) | money laundering; |

Text proposed by the Commission

Amendment

(aa)

the absence of any record of serious criminal offences relating to the economic activity of the applicant, such as, but not limited to:

(i)

money laundering;

| (ii) | tax evasion and tax fraud; |
| --- | --- |

(ii)

tax evasion and tax fraud;

| (iii) | abuse of Union funds and programmes; |
| --- | --- |

(iii)

abuse of Union funds and programmes;

| (iv) | bankruptcy or insolvency fraud; |
| --- | --- |

(iv)

bankruptcy or insolvency fraud;

| (v) | insurance fraud or other financial fraud; |
| --- | --- |

(v)

insurance fraud or other financial fraud;

| (vi) | bribery and/or corruption; |
| --- | --- |

(vi)

bribery and/or corruption;

| (vii) | cybercrime; |
| --- | --- |

(vii)

cybercrime;

| (viii) | participation in a criminal organisation; |
| --- | --- |

(viii)

participation in a criminal organisation;

| (ix) | offences in the field of competition law; |
| --- | --- |

(ix)

offences in the field of competition law;

| (x) | direct or indirect involvement in terrorist activities; |
| --- | --- |

(x)

direct or indirect involvement in terrorist activities;

Amendment 24

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the demonstration by the applicant of a high level of control of his operations and of the flow of goods, either by means of a system managing commercial and, where appropriate, transport records, which allows appropriate tax controls, or by means of a reliable or certified internal audit trail; |

Text proposed by the Commission

Amendment

(b)

the demonstration by the applicant of a high level of control of his operations and of the flow of goods, either by means of a system managing commercial and, where appropriate, transport records, which allows appropriate tax controls, or by means of a reliable or certified internal audit trail;

| (b) | the demonstration by the applicant of a high level of control of his operations and of the flow of goods, either by means of a system managing commercial and, where appropriate, transport records, which allows appropriate tax controls, or by means of a reliable or certified internal audit trail,
  in accordance with the implementing acts and guidelines to be adopted by the Commission
  ; |
| --- | --- |

(b)

the demonstration by the applicant of a high level of control of his operations and of the flow of goods, either by means of a system managing commercial and, where appropriate, transport records, which allows appropriate tax controls, or by means of a reliable or certified internal audit trail,
  in accordance with the implementing acts and guidelines to be adopted by the Commission
  ;

Amendment 25

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | evidence of financial solvency of the applicant, which shall be deemed to be proven either where the applicant has good financial standing, which enables him to fulfil his commitments, with due regard to the characteristics of the type of business activity concerned, or through the production of guarantees provided by insurance or other financial institutions or by other economically reliable third parties. |

Text proposed by the Commission

Amendment

(c)

evidence of financial solvency of the applicant, which shall be deemed to be proven either where the applicant has good financial standing, which enables him to fulfil his commitments, with due regard to the characteristics of the type of business activity concerned, or through the production of guarantees provided by insurance or other financial institutions or by other economically reliable third parties.

| (c) | evidence of financial solvency of the applicant
  during the last three years
  , which shall be deemed to be proven either where the applicant has good financial standing, which enables him to fulfil his commitments, with due regard to the characteristics of the type of business activity concerned, or through the production of guarantees provided by insurance or other financial institutions or by other economically reliable third parties.
  The applicant shall possess a bank account in a financial institution established in the Union. |
| --- | --- |

(c)

evidence of financial solvency of the applicant
  during the last three years
  , which shall be deemed to be proven either where the applicant has good financial standing, which enables him to fulfil his commitments, with due regard to the characteristics of the type of business activity concerned, or through the production of guarantees provided by insurance or other financial institutions or by other economically reliable third parties.
  The applicant shall possess a bank account in a financial institution established in the Union.

Amendment 26

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | Where the applicant has been denied the status of an authorised economic operator in accordance with the Union Customs Code during the last three years, the applicant shall not be granted the status of a certified taxable person. |

Text proposed by the Commission

Amendment

Where the applicant has been denied the status of an authorised economic operator in accordance with the Union Customs Code during the last three years, the applicant shall not be granted the status of a certified taxable person.

Amendment 27

Proposal for a directive

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  In order to ensure a harmonised interpretation in the granting of the certified taxable person status, the Commission shall adopt by means of an implementing act further guidance for Member States regarding the evaluation of those criteria, which shall be valid across the Union. The first implementing act shall be adopted no later than one month after the entry into force of this Directive. |

Text proposed by the Commission

Amendment

2a.
     
  In order to ensure a harmonised interpretation in the granting of the certified taxable person status, the Commission shall adopt by means of an implementing act further guidance for Member States regarding the evaluation of those criteria, which shall be valid across the Union. The first implementing act shall be adopted no later than one month after the entry into force of this Directive.

Amendment 28

Amendment 28

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2b.
     
  The Commission shall adopt implementing acts and guidelines in close connection to the implementing acts and guidelines for the authorised economic operator for customs purposes. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2b.
     
  The Commission shall adopt implementing acts and guidelines in close connection to the implementing acts and guidelines for the authorised economic operator for customs purposes.

Amendment 29

Amendment 29

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 2 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2c.
     
  The criteria set out in paragraph 2 shall be commonly applied by all Member States based on clearly and precisely defined rules and procedures in an implementing act. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2c.
     
  The criteria set out in paragraph 2 shall be commonly applied by all Member States based on clearly and precisely defined rules and procedures in an implementing act.

Amendment 30

Amendment 30

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 3 – subparagraph 1 – point d a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (da) | taxable persons which do not have or cease to have a valid VAT registration number; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(da)

(da)

taxable persons which do not have or cease to have a valid VAT registration number;

taxable persons which do not have or cease to have a valid VAT registration number;

Amendment 31

Amendment 31

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 3 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| However, the taxable persons mentioned under points (a) to (d) may be granted the status of a certified taxable person for the other economic activities that they carry out. | | However, the taxable persons mentioned under points (a) to (d) may be granted the status of a certified taxable person for the other economic activities that they carry out,
  under the precondition that the results of those activities do not interfere with the activities which excluded those taxable persons from being granted the status of a certified taxable person in the first place
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

However, the taxable persons mentioned under points (a) to (d) may be granted the status of a certified taxable person for the other economic activities that they carry out.

However, the taxable persons mentioned under points (a) to (d) may be granted the status of a certified taxable person for the other economic activities that they carry out,
  under the precondition that the results of those activities do not interfere with the activities which excluded those taxable persons from being granted the status of a certified taxable person in the first place
  .

under the precondition that the results of those activities do not interfere with the activities which excluded those taxable persons from being granted the status of a certified taxable person in the first place

Amendment 32

Amendment 32

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 4 – subparagraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| A taxable person who applies for the status of a certified taxable person shall supply all the information required by the tax authorities in order to enable them to take a decision. | | A taxable person who applies for the status of a certified taxable person shall supply all the information required by the tax authorities in order to enable them to take a decision.
  The Commission shall set up simplified administrative procedures for SMEs to obtain the status of a certified taxable person. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

A taxable person who applies for the status of a certified taxable person shall supply all the information required by the tax authorities in order to enable them to take a decision.

A taxable person who applies for the status of a certified taxable person shall supply all the information required by the tax authorities in order to enable them to take a decision.
  The Commission shall set up simplified administrative procedures for SMEs to obtain the status of a certified taxable person.

The Commission shall set up simplified administrative procedures for SMEs to obtain the status of a certified taxable person.

Amendment 33

Amendment 33

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 4 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | those of the Member State where the applicant has established his business; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

those of the Member State where the applicant has established his business;

| (a) | those of the Member State where the applicant has established his business
  as defined in Council Directive (EU) .../... of ... on a Common Corporate Tax Base (CCTB)

   (*1)

  and in Council Directive (EU) .../... of ... on a Common Consolidated Corporate Tax Base (CCCTB)

   (*2),
  as well as in Council Directive (EU) .../... of ... laying down rules relating to the corporate taxation of a significant digital presence

   (*3)

  and in Council Directive (EU) .../... of ... on the common system of a digital services tax on revenues resulting from the provision of certain digital services

   (*4); |
| --- | --- |

(a)

those of the Member State where the applicant has established his business
  as defined in Council Directive (EU) .../... of ... on a Common Corporate Tax Base (CCTB)

   (*1)

  and in Council Directive (EU) .../... of ... on a Common Consolidated Corporate Tax Base (CCCTB)

   (*2),
  as well as in Council Directive (EU) .../... of ... laying down rules relating to the corporate taxation of a significant digital presence

   (*3)

  and in Council Directive (EU) .../... of ... on the common system of a digital services tax on revenues resulting from the provision of certain digital services

   (*4);

as defined in Council Directive (EU) .../... of ... on a Common Corporate Tax Base (CCTB)

*1

and in Council Directive (EU) .../... of ... on a Common Consolidated Corporate Tax Base (CCCTB)

*2

as well as in Council Directive (EU) .../... of ... laying down rules relating to the corporate taxation of a significant digital presence

*3

and in Council Directive (EU) .../... of ... on the common system of a digital services tax on revenues resulting from the provision of certain digital services

*4

Amendment 34

Amendment 34

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 4 – subparagraph 2 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | those of the Member State where the applicant has his permanent address or where he usually resides, where he has neither a place of business nor a fixed establishment. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

those of the Member State where the applicant has his permanent address or where he usually resides, where he has neither a place of business nor a fixed establishment.

those of the Member State where the applicant has his permanent address or where he usually resides, where he has neither a place of business nor a fixed establishment.

deleted

deleted

Amendment 35

Amendment 35

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 4 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 4a.
     
  Where the status of a certified taxable person is granted, that information shall be made available via the VIES system. Changes to that status shall be updated in the system without delay. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4a.
     
  Where the status of a certified taxable person is granted, that information shall be made available via the VIES system. Changes to that status shall be updated in the system without delay.

Amendment 36

Amendment 36

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 5.   Where the application is refused, the grounds for refusal shall be notified by the tax authorities to the applicant together with the decision. Member States shall ensure that the applicant is granted a right of appeal against any decision to refuse an application. | | 5.   Where the application is refused, the grounds for refusal shall be notified by the tax authorities to the applicant together with the decision. Member States shall ensure that the applicant is granted a right of appeal against any decision to refuse an application.
  An appeal procedure harmonised at the Union level shall be established by 1 June 2020 by means of an implementing act, and shall include the obligation for Member States to inform other Member States of that refusal and the reasons accompanying that decision through their tax authorities. The appeal procedure shall be initiated within a reasonable time of the announcement of the decision to the applicant, to be determined by the implementing act, and should take into account any implemented remedy procedure. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5.   Where the application is refused, the grounds for refusal shall be notified by the tax authorities to the applicant together with the decision. Member States shall ensure that the applicant is granted a right of appeal against any decision to refuse an application.

5.   Where the application is refused, the grounds for refusal shall be notified by the tax authorities to the applicant together with the decision. Member States shall ensure that the applicant is granted a right of appeal against any decision to refuse an application.
  An appeal procedure harmonised at the Union level shall be established by 1 June 2020 by means of an implementing act, and shall include the obligation for Member States to inform other Member States of that refusal and the reasons accompanying that decision through their tax authorities. The appeal procedure shall be initiated within a reasonable time of the announcement of the decision to the applicant, to be determined by the implementing act, and should take into account any implemented remedy procedure.

Amendment 37

Amendment 37

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 6.   The taxable person who has been granted the status of certified taxable person shall inform the tax authorities
  without delay
  of any factor arising after the decision was taken, which may affect or influence the continuation of that status. The tax status shall be withdrawn by the tax authorities where the criteria set out in paragraph 2 are no longer met. | | 6.   The taxable person who has been granted the status of certified taxable person shall inform the tax authorities
  within 1 month
  of any factor arising after the decision was taken, which may affect or influence the continuation of that status. The tax status shall be withdrawn by the tax authorities where the criteria set out in paragraph 2 are no longer met.
  Tax authorities of the Member States having granted the status of a certified taxable person shall review that decision, at least every two years, to ensure that the conditions are still met. If the taxable person has not informed the tax authorities of any factor possibly affecting the certified taxable person status as laid down in the implementing act or has purposefully concealed it, it shall be subject to proportionate, efficient and dissuasive sanctions, including the loss of the certified taxable person status. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6.   The taxable person who has been granted the status of certified taxable person shall inform the tax authorities
  without delay
  of any factor arising after the decision was taken, which may affect or influence the continuation of that status. The tax status shall be withdrawn by the tax authorities where the criteria set out in paragraph 2 are no longer met.

6.   The taxable person who has been granted the status of certified taxable person shall inform the tax authorities
  within 1 month
  of any factor arising after the decision was taken, which may affect or influence the continuation of that status. The tax status shall be withdrawn by the tax authorities where the criteria set out in paragraph 2 are no longer met.
  Tax authorities of the Member States having granted the status of a certified taxable person shall review that decision, at least every two years, to ensure that the conditions are still met. If the taxable person has not informed the tax authorities of any factor possibly affecting the certified taxable person status as laid down in the implementing act or has purposefully concealed it, it shall be subject to proportionate, efficient and dissuasive sanctions, including the loss of the certified taxable person status.

Amendment 38

Amendment 38

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 6 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 6a.
     
  A taxable person who has been refused the status of a certified taxable person, or who on his or her own initiative has informed the tax authority that he or she no longer meets the criteria set out in paragraph 2, may no earlier than six months from the date of the refusal of that status or its withdrawal re-apply for a certified taxable person status provided that all relevant criteria are met. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6a.
     
  A taxable person who has been refused the status of a certified taxable person, or who on his or her own initiative has informed the tax authority that he or she no longer meets the criteria set out in paragraph 2, may no earlier than six months from the date of the refusal of that status or its withdrawal re-apply for a certified taxable person status provided that all relevant criteria are met.

Amendment 39

Amendment 39

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 6 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 6b.
     
  A certified taxable person who ceases to have a VAT identification number shall have his or her status as a certified taxable person withdrawn automatically. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6b.
     
  A certified taxable person who ceases to have a VAT identification number shall have his or her status as a certified taxable person withdrawn automatically.

Amendment 40

Amendment 40

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 1

Article 1 – paragraph 1 – point 1

Directive 2006/112/EC

Article 13a – paragraph 7 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 7a.
     
  Procedures relating to refused applications, changes to the situation of the taxable person, appeal procedures and procedures to re-apply for the certified taxable person status shall be defined in an implementing act and shall be commonly applied in all Member States. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7a.
     
  Procedures relating to refused applications, changes to the situation of the taxable person, appeal procedures and procedures to re-apply for the certified taxable person status shall be defined in an implementing act and shall be commonly applied in all Member States.

Amendment 41

Amendment 41

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 3

Article 1 – paragraph 1 – point 3

Directive 2006/112/EC

Article 138 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the taxable person or non-taxable legal person for whom the supply is made is identified for VAT purposes in a Member State other than that in which dispatch or transport of the goods begins; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

the taxable person or non-taxable legal person for whom the supply is made is identified for VAT purposes in a Member State other than that in which dispatch or transport of the goods begins;

| (b) | the taxable person or non-taxable legal person for whom the supply is made is identified for VAT purposes in a Member State other than that in which dispatch or transport of the goods begins
  and possesses a VAT identification number accessible via VIES
  ; |
| --- | --- |

(b)

the taxable person or non-taxable legal person for whom the supply is made is identified for VAT purposes in a Member State other than that in which dispatch or transport of the goods begins
  and possesses a VAT identification number accessible via VIES
  ;

and possesses a VAT identification number accessible via VIES

Amendment 42

Amendment 42

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 4

Article 1 – paragraph 1 – point 4

Directive 2006/112/EC

Article 138a – paragraph 3 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | ‘intermediary operator’ shall mean a supplier in the chain other than the first supplier, who dispatches or transports the goods, himself or by a third party on his behalf; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

‘intermediary operator’ shall mean a supplier in the chain other than the first supplier, who dispatches or transports the goods, himself or by a third party on his behalf;

| (b) | ‘intermediary operator’ shall mean a supplier in the chain other than the first supplier
  or the last receiver/customer
  , who dispatches or transports the goods, himself or by a third party on his behalf; |
| --- | --- |

(b)

‘intermediary operator’ shall mean a supplier in the chain other than the first supplier
  or the last receiver/customer
  , who dispatches or transports the goods, himself or by a third party on his behalf;

or the last receiver/customer

Amendment 43

Amendment 43

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 5

Article 1 – paragraph 1 – point 5

Directive 2006/112/EC

Article 243 – paragraph 3 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Every certified taxable person to whom goods are supplied under the call-off stock arrangements referred to in Article 17a shall keep a register of those goods. | | Every certified taxable person to whom goods are supplied under the call-off stock arrangements referred to in Article 17a shall keep a
  digitalised
  register of those goods
  accessible to tax authorities
  .
  ’ |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Every certified taxable person to whom goods are supplied under the call-off stock arrangements referred to in Article 17a shall keep a register of those goods.

Every certified taxable person to whom goods are supplied under the call-off stock arrangements referred to in Article 17a shall keep a
  digitalised
  register of those goods
  accessible to tax authorities
  .
  ’

digitalised

accessible to tax authorities

’

Amendment 44

Amendment 44

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 6

Article 1 – paragraph 1 – point 6

Directive 2006/112/EC

Article 262 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   Every taxable person identified for VAT purposes shall submit a recapitulative statement of the following: | | 1.   Every taxable person identified for VAT purposes shall submit a recapitulative statement
  to the competent tax authority
  of the following: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Every taxable person identified for VAT purposes shall submit a recapitulative statement of the following:

1.   Every taxable person identified for VAT purposes shall submit a recapitulative statement
  to the competent tax authority
  of the following:

Amendment 45

Amendment 45

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 6

Article 1 – paragraph 1 – point 6

Directive 2006/112/EC

Article 262 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1a.
     
  The information referred to in paragraph 1 shall be accessible to all involved tax authorities via VIES. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1a.
     
  The information referred to in paragraph 1 shall be accessible to all involved tax authorities via VIES.

Amendment 46

Amendment 46

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 6 a (new)

Article 1 – paragraph 1 – point 6 a (new)

Directive 2006/112/EC

Title XIV – Chapter 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (6a) | the following Chapter is inserted in Title XIV: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(6a)

(6a)

the following Chapter is inserted in Title XIV:

Article 398a

1.
     
  A VAT dispute resolution mechanism shall be set up by 1 June 2020 to resolve disputes between Member States of claimed or filed or suspected erroneous cross-border VAT payments, and applied where the Mutual Agreement Procedure does not lead to a result within two years.

2.
     
  The mechanism referred to in paragraph 1 shall be composed of Member States’ competent authorities.

3.
     
  A VAT dispute resolution mechanism shall be set up by 1 June 2020 to resolve disputes between Member States of claimed or filed or suspected erroneous cross-border VAT payments, and applied where the Mutual Agreement Procedure does not lead to a result within two years.

4.
     
  The mechanism shall also encompass an online VAT dispute resolution platform with the aim of allowing Member States to resolve disputes without the direct intervention of the mechanism nor competent authorities, by setting out clear approaches on how to relieve disputes when they occur, and procedures to resolve disputes.’;

Amendment 47

Amendment 47

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 6 b (new)

Article 1 – paragraph 1 – point 6 b (new)

Directive 2006/112/EC

Title XIV – Chapter 2 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (6b) | the following Chapter is inserted in Title XIV: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(6b)

(6b)

the following Chapter is inserted in Title XIV:

Article 398b

An automated notification mechanism shall be set up by 1 June 2020. That mechanism shall ensure automatic notifications to tax payers on changes and updates to the VAT rates of Member States. Such automatic notifications shall be activated before the change becomes applicable and at the latest five days after the decision has been taken.’;

Amendment 48

Amendment 48

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 9

Article 1 – paragraph 1 – point 9

Directive 2006/112/EC

Articles 403 and 404

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (9) | Articles 403 and 404 are
  deleted. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(9)

Articles 403 and 404 are
  deleted.

Articles 403 and 404 are

| (9) | Article 403 is
  deleted. |
| --- | --- |

(9)

Article 403 is
  deleted.

Article 403 is

Amendment 49

Amendment 49

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 9 a (new)

Article 1 – paragraph 1 – point 9 a (new)

Directive 2006/112/EC

Article 404

| Present text | | Amendment |
| --- | --- | --- |
| "
  Article 404




  Every four years starting from the adoption of this Directive, the Commission shall, on the basis of information obtained from the Member States, present a report to the European Parliament and to the Council on the operation of the common system of VAT in the Member States and, in particular, on the operation of the transitional arrangements for taxing trade between Member States. That report shall be accompanied, where appropriate, by proposals concerning the definitive arrangements.
  " | | (9a) | Article 404 is replaced by the following: |

Present text

Present text

Amendment

Amendment

"
  Article 404

Every four years starting from the adoption of this Directive, the Commission shall, on the basis of information obtained from the Member States, present a report to the European Parliament and to the Council on the operation of the common system of VAT in the Member States and, in particular, on the operation of the transitional arrangements for taxing trade between Member States. That report shall be accompanied, where appropriate, by proposals concerning the definitive arrangements.
  "

(9a)

(9a)

Article 404 is replaced by the following:

‘
  Article 404

By ... [one year after the date of entry into force of this Directive], and every three years thereafter, the Commission shall forward to the European Parliament and the Council a report on the exemption scheme for imports from third countries and its compatibility with the European framework and on cooperation with the competent authorities of third States, in particular as regards the combating of fraud. By ... [two years after the date of entry into force of this Directive], and every three years thereafter, the Commission shall forward to the European Parliament and the Council a report on national practices as regards the imposition of administrative and criminal penalties on legal and natural persons found guilty of VAT fraud. The Commission shall work with the competent national and European authorities to follow up, if appropriate, the recommendations designed to bring about a minimum degree of harmonisation.’;

Amendment 50

Amendment 50

Article 1 – paragraph 1 – point 9 b (new)

Article 1 – paragraph 1 – point 9 b (new)

Proposal for a directive

Proposal for a directive

Directive 2006/112/EC

Article 404 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (9b) | the following Article 404a is inserted: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(9b)

(9b)

the following Article 404a is inserted:

‘
  Article 404a

Every three years, each Member State shall submit a report assessing the effectiveness of the VAT fraud monitoring system to the Commission, which shall forward it to OLAF.’;

Amendment 51

Amendment 51

Article 2 – paragraph 1 – subparagraph 2

Article 2 – paragraph 1 – subparagraph 2

Proposal for a directive

Proposal for a directive

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| They shall apply those provisions from 1 January 2019. | | They shall apply those provisions
  together with the implementing acts and guidelines
  from 1 January 2019. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

They shall apply those provisions from 1 January 2019.

They shall apply those provisions
  together with the implementing acts and guidelines
  from 1 January 2019.

together with the implementing acts and guidelines

Amendment 52

Amendment 52

Proposal for a directive

Proposal for a directive

Article 2 – paragraph 2 a (new)

Article 2 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  By ... [date of adoption of this Directive] and every three years thereafter, the Commission shall, on the basis of information obtained from the Member States, present a report to the European Parliament and to the Council on the implementation of the criteria to define a certified taxable person in the Member States and, in particular, on the impact it can have in fighting VAT fraud. That report shall be accompanied, where appropriate, by a proposal for a legislative act. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  By ... [date of adoption of this Directive] and every three years thereafter, the Commission shall, on the basis of information obtained from the Member States, present a report to the European Parliament and to the Council on the implementation of the criteria to define a certified taxable person in the Member States and, in particular, on the impact it can have in fighting VAT fraud. That report shall be accompanied, where appropriate, by a proposal for a legislative act.

---

(1)  First Council Directive 67/227/EEC of 11 April 1967 on the harmonisation of legislation of Member States concerning turnover taxes (OJ 71, 14.4.1967, p. 1301).

1

(2)  Second Council Directive 67/228/EEC of 11 April 1967 on the harmonisation of legislation of Member States concerning turnover taxes — Structure and procedures for application of the common system of value added tax (OJ 71, 14.4.1967, p. 1303).

2

(3)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

3

(4)  First Council Directive 67/227/EEC of 11 April 1967 on the harmonisation of legislation of Member States concerning turnover taxes (OJ 71, 14.4.1967, p. 1301).

4

(5)  Second Council Directive 67/228/EEC of 11 April 1967 on the harmonisation of legislation of Member States concerning turnover taxes — Structure and procedures for application of the common system of value added tax (OJ 71, 14.4.1967, p. 1303).

5

(6)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

6

(7)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on an action plan on VAT - Towards a single EU VAT area - Time to decide (COM(2016)0148 of 7.4.2016).

7

(8)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on an action plan on VAT - Towards a single EU VAT area - Time to decide (COM(2016)0148 of 7.4.2016).

8

(9)  Council conclusions of 8 November 2016 on Improvements to the current EU VAT rules for cross-border transactions (No. 14257/16 FISC 190 ECOFIN 1023 of 9 November 2016).

9

(10)  Council conclusions of 8 November 2016 on Improvements to the current EU VAT rules for cross-border transactions (No. 14257/16 FISC 190 ECOFIN 1023 of 9 November 2016).

10

(*1)  
  OJ: Please insert in the text the number of the Directive contained in document 2016/0337(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

*1

OJ: Please insert in the text the number of the Directive contained in document 2016/0337(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

(*2)  
  OJ: Please insert in the text the number of the Directive contained in document 2016/0336(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

*2

OJ: Please insert in the text the number of the Directive contained in document 2016/0336(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

(*3)  
  OJ: Please insert in the text the number of the Directive contained in document 2018/0072(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

*3

OJ: Please insert in the text the number of the Directive contained in document 2018/0072(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

(*4)  
  OJ: Please insert in the text the number of the Directive contained in document 2018/0073(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

*4

OJ: Please insert in the text the number of the Directive contained in document 2018/0073(CNS) and insert the number, date, title and OJ reference of that Directive in the footnote.

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| 13.1.2020 | EN | Official Journal of the European Union | C 11/92 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/92

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P8_TA(2018)0367

VAT: period of application of the reverse charge mechanism and of the Quick Reaction Mechanism *

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC on the common system of value added tax as regards the period of application of the optional reverse charge mechanism in relation to supplies of certain goods and services susceptible to fraud and of the Quick Reaction Mechanism against VAT fraud (COM(2018)0298 – C8-0265/2018 – 2018/0150(CNS))

(Special legislative procedure – consultation)

(2020/C 011/21)

The European Parliament,

| — | having regard to the Commission proposal to the Council (COM(2018)0298), |
| --- | --- |

—

having regard to the Commission proposal to the Council (COM(2018)0298),

| — | having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0265/2018), |
| --- | --- |

—

having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0265/2018),

| — | having regard to Rule 78c of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 78c of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0283/2018), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0283/2018),

| 1. | Approves the Commission proposal; |
| --- | --- |

1.

| 2. | Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
| --- | --- |

2.

| 3. | Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament; |
| --- | --- |

3.

| 4. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

4.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/93 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/93

---

P8_TA(2018)0368

Administrative cooperation in the field of excise duties as regards the content of electronic register *

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council regulation amending Regulation (EU) No 389/2012 on administrative cooperation in the field of excise duties as regards the content of electronic register (COM(2018)0349 – C8-0371/2018 – 2018/0181(CNS))

(Special legislative procedure – consultation)

(2020/C 011/22)

The European Parliament,

| — | having regard to the Commission proposal to the Council (COM(2018)0349), |
| --- | --- |

—

having regard to the Commission proposal to the Council (COM(2018)0349),

| — | having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0371/2018), |
| --- | --- |

—

having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0371/2018),

| — | having regard to Rule 78c of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 78c of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0285/2018), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0285/2018),

| 1. | Approves the Commission proposal; |
| --- | --- |

1.

| 2. | Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
| --- | --- |

2.

| 3. | Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament; |
| --- | --- |

3.

| 4. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

4.

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/94 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/94

---

P8_TA(2018)0369

Health technology assessment***I

Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)) (1)

(Ordinary legislative procedure: first reading)

(2020/C 011/23)

Amendment 1

Proposal for a regulation

Citation 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Having regard to the Treaty on the Functioning of the European Union, and in particular
  Article 114
  thereof, | | Having regard to the Treaty on the Functioning of the European Union, and in particular
  Articles 114 and 168(4)
  thereof, |

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular
  Article 114
  thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular
  Articles 114 and 168(4)
  thereof,

Amendment 2

Proposal for a regulation

Recital 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (1) | The development of health technologies is
  a key driver of economic growth and innovation in the Union. It forms
  part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment. |

Text proposed by the Commission

Amendment

(1)

The development of health technologies is
  a key driver of economic growth and innovation in the Union. It forms
  part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

| (1) | The development of health technologies is
  key to achieving the high level of health protection that health policies must ensure, for the benefit of all citizens. Health technologies are an innovative sector of the economy which form
  part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment. |
| --- | --- |

(1)

The development of health technologies is
  key to achieving the high level of health protection that health policies must ensure, for the benefit of all citizens. Health technologies are an innovative sector of the economy which form
  part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

Amendment 3

Proposal for a regulation

Recital 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (1a) | Expenditure on medicines stood at 1,41% of GDP in 2014 and accounted for 17,1% of overall health expenditure, of which it is a major component. Health expenditure in the Union amounts to 10% of GDP, i.e., EUR 1 300 000 million per annum, EUR 220 000 million of which is pharmaceutical expenditure and EUR 110 000 million expenditure on medical devices. |

Text proposed by the Commission

Amendment

(1a)

Expenditure on medicines stood at 1,41% of GDP in 2014 and accounted for 17,1% of overall health expenditure, of which it is a major component. Health expenditure in the Union amounts to 10% of GDP, i.e., EUR 1 300 000 million per annum, EUR 220 000 million of which is pharmaceutical expenditure and EUR 110 000 million expenditure on medical devices.

Amendment 4

Proposal for a regulation

Recital 1 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (1b) | The Council conclusions of 16 June 2016 and the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines

   (2)

  highlighted that there are many barriers to access to medicine and innovative technologies in the Union, with the main barriers being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value. |

Text proposed by the Commission

Amendment

(1b)

The Council conclusions of 16 June 2016 and the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines

   (2)

  highlighted that there are many barriers to access to medicine and innovative technologies in the Union, with the main barriers being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value.

Amendment 5

Proposal for a regulation

Recital 1 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (1c) | Marketing authorisations for medicinal products are granted by the European Medicines Agency on the basis of the principles of safety and efficacy. Normally the national health technology assessment agencies assess comparative effectiveness, because marketing authorisations are not accompanied by a comparative effectiveness study. |

Text proposed by the Commission

Amendment

(1c)

Marketing authorisations for medicinal products are granted by the European Medicines Agency on the basis of the principles of safety and efficacy. Normally the national health technology assessment agencies assess comparative effectiveness, because marketing authorisations are not accompanied by a comparative effectiveness study.

Amendment 6

Proposal for a regulation

Recital 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (2) | Health Technology Assessment (HTA) is
  an
  evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies. |

Text proposed by the Commission

Amendment

(2)

Health Technology Assessment (HTA) is
  an
  evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.

| (2) | Health Technology Assessment (HTA) is
  a scientific
  evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added
  therapeutic
  value of a health technology in comparison with other new or existing health technologies. |
| --- | --- |

(2)

Health Technology Assessment (HTA) is
  a scientific
  evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added
  therapeutic
  value of a health technology in comparison with other new or existing health technologies.

Amendment 7

Proposal for a regulation

Recital 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (2a) | As the World Health Organisation (WHO) stated at the 67th World Health Assembly in May 2014, HTA has to be a tool in support of universal health coverage. |

Text proposed by the Commission

Amendment

(2a)

As the World Health Organisation (WHO) stated at the 67th World Health Assembly in May 2014, HTA has to be a tool in support of universal health coverage.

Amendment 8

Proposal for a regulation

Recital 2 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (2b) | HTA should be instrumental in promoting innovation which offers the best outcomes for patients and society as a whole and is a necessary tool for ensuring the proper application and use of health technologies. |

Text proposed by the Commission

Amendment

(2b)

HTA should be instrumental in promoting innovation which offers the best outcomes for patients and society as a whole and is a necessary tool for ensuring the proper application and use of health technologies.

Amendment 9

Proposal for a regulation

Recital 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (3) | HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches. |

Text proposed by the Commission

Amendment

(3)

HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.

| (3) | HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains
  (which form the ‘HTA Core model’)
  four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches. |
| --- | --- |

(3)

HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains
  (which form the ‘HTA Core model’)
  four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.

Amendment 10

Proposal for a regulation

Recital 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (3a) | Health professionals, patients and health institutions need to know whether or not a new health technology represents an improvement on existing health technologies, in terms of benefits and risks. Joint clinical assessments therefore aim to identify the added therapeutic value of new or existing health technologies in comparison with other new or existing health technologies, by undertaking a comparative assessment based on comparative trials against the current best proven intervention (‘standard treatment’) or against the current most common treatment where no such standard treatment exists. |

Text proposed by the Commission

Amendment

(3a)

Health professionals, patients and health institutions need to know whether or not a new health technology represents an improvement on existing health technologies, in terms of benefits and risks. Joint clinical assessments therefore aim to identify the added therapeutic value of new or existing health technologies in comparison with other new or existing health technologies, by undertaking a comparative assessment based on comparative trials against the current best proven intervention (‘standard treatment’) or against the current most common treatment where no such standard treatment exists.

Amendment 11

Proposal for a regulation

Recital 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (4) | The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients. |

Text proposed by the Commission

Amendment

(4)

The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

| (4) | HTA is an important tool for promoting high-quality innovation, steering research towards addressing the unmet diagnostic, therapeutic or procedural needs of healthcare systems as well as steering clinical and social priorities. HTA can also improve scientific evidence used to inform clinical decision-making, efficiency in use of resources, the sustainability of health systems, patient access to these health technologies, and the competitiveness of the sector through greater predictability and more efficient research. Member States use
  the outcome of HTA
  to augment the scientific evidence that informs decisions to introduce health technologies into their systems, i.e.
  , to inform decisions
  on how to allocate
  resources. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients. |
| --- | --- |

(4)

HTA is an important tool for promoting high-quality innovation, steering research towards addressing the unmet diagnostic, therapeutic or procedural needs of healthcare systems as well as steering clinical and social priorities. HTA can also improve scientific evidence used to inform clinical decision-making, efficiency in use of resources, the sustainability of health systems, patient access to these health technologies, and the competitiveness of the sector through greater predictability and more efficient research. Member States use
  the outcome of HTA
  to augment the scientific evidence that informs decisions to introduce health technologies into their systems, i.e.
  , to inform decisions
  on how to allocate
  resources. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

Amendment 12

Proposal for a regulation

Recital 4 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4a) | Cooperation in the field of HTA can also play a role throughout the health technology cycle: in the early developmental stage through ‘horizon scanning’ in order to pinpoint technologies that will have a major impact; in the early dialogue and scientific advisory stages; in better study design to ensure greater research efficiency; and in the core stages of the overall assessment, once the technology is already established. Finally, HTA can help in decision-making on divestment in cases where a technology becomes obsolete and unsuitable compared to better alternative options that are available. Greater collaboration between Member States in the field of HTA should also help improve and harmonise standards of care as well as diagnostic and new-born screening practices across the Union. |

Text proposed by the Commission

Amendment

(4a)

Cooperation in the field of HTA can also play a role throughout the health technology cycle: in the early developmental stage through ‘horizon scanning’ in order to pinpoint technologies that will have a major impact; in the early dialogue and scientific advisory stages; in better study design to ensure greater research efficiency; and in the core stages of the overall assessment, once the technology is already established. Finally, HTA can help in decision-making on divestment in cases where a technology becomes obsolete and unsuitable compared to better alternative options that are available. Greater collaboration between Member States in the field of HTA should also help improve and harmonise standards of care as well as diagnostic and new-born screening practices across the Union.

Amendment 13

Proposal for a regulation

Recital 4 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4b) | Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. It can also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology (ICT) tools, health-care organisation plans and integrated care processes. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines, precision medicine and advanced therapies, the added value of cooperation at Union level is likely to be even greater. |

Text proposed by the Commission

Amendment

(4b)

Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. It can also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology (ICT) tools, health-care organisation plans and integrated care processes. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines, precision medicine and advanced therapies, the added value of cooperation at Union level is likely to be even greater.

Amendment 14

Proposal for a regulation

Recital 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (5) | The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment
  can
  result in health technology developers being confronted with
  multiple and divergent
  requests for data.
  It can also lead to both duplications and variations in outcomes
  that increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market. |

Text proposed by the Commission

Amendment

(5)

The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment
  can
  result in health technology developers being confronted with
  multiple and divergent
  requests for data.
  It can also lead to both duplications and variations in outcomes
  that increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market.

| (5) | The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment
  can
  result in health technology developers being confronted with
  a duplication of
  requests for data that
  could
  increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market.
  In some justified cases where the specificities of the national and regional healthcare systems and priorities need to be taken into account, a complementary assessment on certain aspects might be necessary. However, assessments that are not relevant for decisions in certain Member States could delay the implementation of innovative technologies and thus access of patients to beneficial innovative treatments. |
| --- | --- |

(5)

The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment
  can
  result in health technology developers being confronted with
  a duplication of
  requests for data that
  could
  increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market.
  In some justified cases where the specificities of the national and regional healthcare systems and priorities need to be taken into account, a complementary assessment on certain aspects might be necessary. However, assessments that are not relevant for decisions in certain Member States could delay the implementation of innovative technologies and thus access of patients to beneficial innovative treatments.

Amendment 15

Proposal for a regulation

Recital 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (6) | While
  Member States have carried out some joint assessments within the framework of the EU co-funded joint actions,
  the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the
  joint actions,
  including their
  joint
  clinical assessments, at Member State-level has remained low, meaning that the duplication of
  assessments on the
  same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed
  . |

Text proposed by the Commission

Amendment

(6)

While
  Member States have carried out some joint assessments within the framework of the EU co-funded joint actions,
  the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the
  joint actions,
  including their
  joint
  clinical assessments, at Member State-level has remained low, meaning that the duplication of
  assessments on the
  same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed
  .

| (6) | Member States have carried out some joint assessments within the framework of the EU co-funded joint actions.
  Those assessments were carried out in three stages, under Article 15 of Directive 2011/24/EU of the European Parliament and of the Council

   (3),
  and through three
  joint actions,
  each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9,5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Given the timescales for those actions and in the interests of continuity, this Regulation establishes a more sustainable way of ensuring the continuation of the
  joint assessments.
  The main outcomes of the cooperation to date include the ‘HTA Core Model’ assessment model, which provides a framework for HTA reports; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data- and knowledge base for the storage of information and the stage reached in the assessment of promising technologies, or
  on the
  request for supplementary studies arising from the HTA; and a set of methodological guides and support tools for HTA agencies, including guidelines for adapting reports from one country to another
  . |
| --- | --- |

(6)

Member States have carried out some joint assessments within the framework of the EU co-funded joint actions.
  Those assessments were carried out in three stages, under Article 15 of Directive 2011/24/EU of the European Parliament and of the Council

   (3),
  and through three
  joint actions,
  each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9,5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Given the timescales for those actions and in the interests of continuity, this Regulation establishes a more sustainable way of ensuring the continuation of the
  joint assessments.
  The main outcomes of the cooperation to date include the ‘HTA Core Model’ assessment model, which provides a framework for HTA reports; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data- and knowledge base for the storage of information and the stage reached in the assessment of promising technologies, or
  on the
  request for supplementary studies arising from the HTA; and a set of methodological guides and support tools for HTA agencies, including guidelines for adapting reports from one country to another
  .

Amendment 16

Proposal for a regulation

Recital 6 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (6a) | However, within the joint actions, the production of output has been inefficient and, in the absence of a sustainable model of cooperation, relying on project-based cooperation. Use of the results of the joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed. |

Text proposed by the Commission

Amendment

(6a)

However, within the joint actions, the production of output has been inefficient and, in the absence of a sustainable model of cooperation, relying on project-based cooperation. Use of the results of the joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed.

Amendment 17

Proposal for a regulation

Recital 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (7) | The Council
  in its Conclusions of December 2014 (4) acknowledged the key role of health technology assessment
  and
  called on the Commission to continue to support cooperation in a sustainable manner. |

Text proposed by the Commission

Amendment

(7)

The Council
  in its Conclusions of December 2014 (4) acknowledged the key role of health technology assessment
  and
  called on the Commission to continue to support cooperation in a sustainable manner.

| (7) | In its Conclusions of December 2014
  on innovation for the benefit of patients

   (5),
  the Council
  acknowledged the key role of health technology assessment
  as a health policy tool to support evidence-based, sustainable and equitable choices in health care and health technologies for the benefit of patients. The Council further
  called on the Commission to continue to support cooperation in a sustainable manner,
  and asked for joint work between Member States on HTA to be enhanced and for opportunities for cooperation on exchange of information between competent bodies to be explored
  .
  In addition, in its Conclusions of December 2015 on personalised medicine for patients, the Council invited Member States and the Commission to strengthen HTA methodologies applicable to personalised medicine, and the Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States provided further evidence that Member States see clear added value in cooperation on HTA. The joint report of October 2016 of the Commission's DG for Economic and Financial Affairs and the Economic Policy Committee further called for enhanced European cooperation on HTA. |
| --- | --- |

(7)

In its Conclusions of December 2014
  on innovation for the benefit of patients

   (5),
  the Council
  acknowledged the key role of health technology assessment
  as a health policy tool to support evidence-based, sustainable and equitable choices in health care and health technologies for the benefit of patients. The Council further
  called on the Commission to continue to support cooperation in a sustainable manner,
  and asked for joint work between Member States on HTA to be enhanced and for opportunities for cooperation on exchange of information between competent bodies to be explored
  .
  In addition, in its Conclusions of December 2015 on personalised medicine for patients, the Council invited Member States and the Commission to strengthen HTA methodologies applicable to personalised medicine, and the Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States provided further evidence that Member States see clear added value in cooperation on HTA. The joint report of October 2016 of the Commission's DG for Economic and Financial Affairs and the Economic Policy Committee further called for enhanced European cooperation on HTA.

Amendment 18

Proposal for a regulation

Recital 8

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (8) | The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines, (6) called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value
  of medicines
  . |

Text proposed by the Commission

Amendment

(8)

The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines, (6) called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value
  of medicines
  .

| (8) | The European Parliament, in its resolution of 2 March 2017 (7) on EU options for improving access to medicines, called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value
  and relative effectiveness of health technologies compared with the best available alternative that takes into account the level of innovation and benefit for patients
  . |
| --- | --- |

(8)

The European Parliament, in its resolution of 2 March 2017 (7) on EU options for improving access to medicines, called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value
  and relative effectiveness of health technologies compared with the best available alternative that takes into account the level of innovation and benefit for patients
  .

Amendment 19

Proposal for a regulation

Recital 10

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (10) | In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA. |

Text proposed by the Commission

Amendment

(10)

In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA.

| (10) | In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA.
  That approximation should guarantee the highest quality standards and be aligned to best available practice. It should not stimulate a convergence towards the lowest common denominator nor force HTA bodies with more expertise and higher standards to accept lower requirements. It should rather lead to an improvement of the HTA capacity and quality at the national and regional level. |
| --- | --- |

(10)

In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA.
  That approximation should guarantee the highest quality standards and be aligned to best available practice. It should not stimulate a convergence towards the lowest common denominator nor force HTA bodies with more expertise and higher standards to accept lower requirements. It should rather lead to an improvement of the HTA capacity and quality at the national and regional level.

Amendment 20

Proposal for a regulation

Recital 11

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (11) | In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology,
  and in particular, to ensure that the
  assessment
  conclusions are confined to findings relating
  to the comparative
  effectiveness of a health technology
  . The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence. |

Text proposed by the Commission

Amendment

(11)

In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology,
  and in particular, to ensure that the
  assessment
  conclusions are confined to findings relating
  to the comparative
  effectiveness of a health technology
  . The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.

| (11) | In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology.
  The joint clinical
  assessment
  provided for by this Regulation constitutes a scientific analysis of the relative effects of health technology on efficacy, safety and effectiveness, commonly referred to as clinical outcomes, that is evaluated in relation
  to the comparative
  indicators currently deemed appropriate and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. It will include consideration of the degree of certainty on the relative outcomes, based on the available evidence
  . The outcome of such
  joint clinical
  assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.
  The assessment conducted by each Member State as part of its national appraisal therefore falls outside the scope of this Regulation. |
| --- | --- |

(11)

In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology.
  The joint clinical
  assessment
  provided for by this Regulation constitutes a scientific analysis of the relative effects of health technology on efficacy, safety and effectiveness, commonly referred to as clinical outcomes, that is evaluated in relation
  to the comparative
  indicators currently deemed appropriate and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. It will include consideration of the degree of certainty on the relative outcomes, based on the available evidence
  . The outcome of such
  joint clinical
  assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.
  The assessment conducted by each Member State as part of its national appraisal therefore falls outside the scope of this Regulation.

Amendment 21

Proposal for a regulation

Recital 12

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (12) | In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council, (8) which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (9)

  which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint
  clinical
  assessment should be made based on specific criteria
  . |

Text proposed by the Commission

Amendment

(12)

In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council, (8) which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (9)

  which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint
  clinical
  assessment should be made based on specific criteria
  .

| (12) | In order to ensure a wide application of harmonised rules
  and to foster collaboration among Member States
  on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies,
  thereby reducing waste and ineffectiveness in healthcare
  , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council (10), which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (11),
  given the need for greater
  clinical
  evidence concerning all of those new health technologies
  . |
| --- | --- |

(12)

In order to ensure a wide application of harmonised rules
  and to foster collaboration among Member States
  on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies,
  thereby reducing waste and ineffectiveness in healthcare
  , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council (10), which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (11),
  given the need for greater
  clinical
  evidence concerning all of those new health technologies
  .

Amendment 22

Proposal for a regulation

Recital 13

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (13) | In order to ensure that joint clinical assessments carried out on health technologies remain accurate
  and
  relevant, it is appropriate to establish
  conditions
  for the updating of assessments, in particular
  where
  additional data available subsequent to the initial assessment
  has the potential to
  increase the
  accuracy
  of the assessment. |

Text proposed by the Commission

Amendment

(13)

In order to ensure that joint clinical assessments carried out on health technologies remain accurate
  and
  relevant, it is appropriate to establish
  conditions
  for the updating of assessments, in particular
  where
  additional data available subsequent to the initial assessment
  has the potential to
  increase the
  accuracy
  of the assessment.

| (13) | In order to ensure that joint clinical assessments carried out on health technologies remain accurate, relevant,
  of high quality and based on the best scientific evidence available at any given time
  , it is appropriate to establish
  a flexible, regulated procedure
  for the updating of assessments, in particular
  when new evidence or
  additional data
  becomes
  available subsequent to the initial assessment
  and such new evidence or additional data may augment the scientific evidence and thus
  increase the
  quality
  of the assessment. |
| --- | --- |

(13)

In order to ensure that joint clinical assessments carried out on health technologies remain accurate, relevant,
  of high quality and based on the best scientific evidence available at any given time
  , it is appropriate to establish
  a flexible, regulated procedure
  for the updating of assessments, in particular
  when new evidence or
  additional data
  becomes
  available subsequent to the initial assessment
  and such new evidence or additional data may augment the scientific evidence and thus
  increase the
  quality
  of the assessment.

Amendment 23

Proposal for a regulation

Recital 14

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (14) | A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work. |

Text proposed by the Commission

Amendment

(14)

A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.

| (14) | A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility
  and proven expertise
  for overseeing the carrying out of joint clinical assessments and other joint work
  within the scope of this Regulation. |
| --- | --- |

(14)

A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility
  and proven expertise
  for overseeing the carrying out of joint clinical assessments and other joint work
  within the scope of this Regulation.

Amendment 24

Proposal for a regulation

Recital 15

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (15) | In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the
  need to provide
  expertise on the HTA of medicinal products and medical devices. |

Text proposed by the Commission

Amendment

(15)

In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the
  need to provide
  expertise on the HTA of medicinal products and medical devices.

| (15) | In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national
  or regional
  HTA authorities and bodies which inform decision-making
  to conduct such assessments
  , as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the
  possibility of providing
  expertise on the HTA of medicinal products and medical devices.
  The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations. Any conflict of interest should be avoided. |
| --- | --- |

(15)

In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national
  or regional
  HTA authorities and bodies which inform decision-making
  to conduct such assessments
  , as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the
  possibility of providing
  expertise on the HTA of medicinal products and medical devices.
  The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations. Any conflict of interest should be avoided.

Amendment 25

Proposal for a regulation

Recital 15 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (15a) | Transparency and public awareness of the process is essential. All clinical data being evaluated should have therefore the
  highest
  level of transparency and public awareness in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated and protected. |

Text proposed by the Commission

Amendment

(15a)

Transparency and public awareness of the process is essential. All clinical data being evaluated should have therefore the
  highest
  level of transparency and public awareness in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated and protected.

Amendment 26

Proposal for a regulation

Recital 16

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (16) | In order that the harmonised procedures fulfil their internal market objective, Member States should
  be required to
  take
  full
  account of the results of joint clinical assessments and not repeat
  those assessments
  . Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement. |

Text proposed by the Commission

Amendment

(16)

In order that the harmonised procedures fulfil their internal market objective, Member States should
  be required to
  take
  full
  account of the results of joint clinical assessments and not repeat
  those assessments
  . Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

| (16) | In order that the harmonised procedures fulfil their internal market objective
  and reach their aim of improving innovation and the quality of clinical evidence
  , Member States should take account of the results of joint clinical assessments and not repeat
  them
  .
  According to national needs, Member States should have the right to complement the joint clinical assessments with additional clinical evidence and analyses to account for differences in comparators or the national specific treatment setting. Such complementary clinical assessments should be duly justified and proportionate and should be notified to the Commission and the Coordination Group. In addition
  , compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the
  clinical
  added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as
  the
  non-clinical data and criteria
  specific to the Member State concerned, at national and/or regional level
  . It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement. |
| --- | --- |

(16)

In order that the harmonised procedures fulfil their internal market objective
  and reach their aim of improving innovation and the quality of clinical evidence
  , Member States should take account of the results of joint clinical assessments and not repeat
  them
  .
  According to national needs, Member States should have the right to complement the joint clinical assessments with additional clinical evidence and analyses to account for differences in comparators or the national specific treatment setting. Such complementary clinical assessments should be duly justified and proportionate and should be notified to the Commission and the Coordination Group. In addition
  , compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the
  clinical
  added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as
  the
  non-clinical data and criteria
  specific to the Member State concerned, at national and/or regional level
  . It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

Amendment 27

Proposal for a regulation

Recital 16 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (16a) | In order for the clinical assessment to be used for the purposes of the national reimbursement decision, it should ideally concern the population for which the drug would be reimbursed in a given Member State. |

Text proposed by the Commission

Amendment

(16a)

In order for the clinical assessment to be used for the purposes of the national reimbursement decision, it should ideally concern the population for which the drug would be reimbursed in a given Member State.

Amendment 28

Proposal for a regulation

Recital 17

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (17) | The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation. |

Text proposed by the Commission

Amendment

(17)

The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation.

deleted

Amendment 29

Proposal for a regulation

Recital 17 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (17a) | The joint scientific consultation, when addressing orphan medicinal products, has to ensure that any new approach should not result in unnecessary delays for the orphan medicinal products assessment compared to the current situation and taking into account the pragmatic approach undergone through the EUnetHTA. |

Text proposed by the Commission

Amendment

(17a)

The joint scientific consultation, when addressing orphan medicinal products, has to ensure that any new approach should not result in unnecessary delays for the orphan medicinal products assessment compared to the current situation and taking into account the pragmatic approach undergone through the EUnetHTA.

Amendment 30

Proposal for a regulation

Recital 18

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (18) | The establishment of a time-frame for the joint clinical assessments for
  medical devices
  should take into account the
  highly decentralised market access pathway
  for medical devices
  and
  the availability of appropriate evidence
  data
  required to carry out a joint clinical assessment.
  As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it
  should
  be possible for assessments of such devices to
  take place
  following market launch of medical devices
  . |

Text proposed by the Commission

Amendment

(18)

The establishment of a time-frame for the joint clinical assessments for
  medical devices
  should take into account the
  highly decentralised market access pathway
  for medical devices
  and
  the availability of appropriate evidence
  data
  required to carry out a joint clinical assessment.
  As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it
  should
  be possible for assessments of such devices to
  take place
  following market launch of medical devices
  .

| (18) | The establishment of a time-frame for the joint clinical assessments for
  health technologies
  should take into account the
  time-frames set out in Regulation (EC) No 726/2004 of the European Parliament and of the Council

   (12)

  for completing the centralised procedure for authorising medicines and the CE conformity marking
  for medical devices
  provided for in Regulation (EU) 2017/745 of the European Parliament and of the Council

   (*1)

  and the CE conformity marking for in vitro diagnostic medical devices provided for in Regulation (EU) 2017/746 of the European Parliament and of the Council

   (*2).
  In any event, those assessments must take into account
  the availability of appropriate
  scientific
  evidence
  and supporting data in the quantity
  required to carry out a joint clinical assessment,
  and
  should take place
  in a time-frame as close as possible to their marketing authorisation, in the case of medicines, and, in any case, without unjustified and unnecessary delay. |
| --- | --- |

(18)

The establishment of a time-frame for the joint clinical assessments for
  health technologies
  should take into account the
  time-frames set out in Regulation (EC) No 726/2004 of the European Parliament and of the Council

   (12)

  for completing the centralised procedure for authorising medicines and the CE conformity marking
  for medical devices
  provided for in Regulation (EU) 2017/745 of the European Parliament and of the Council

   (*1)

  and the CE conformity marking for in vitro diagnostic medical devices provided for in Regulation (EU) 2017/746 of the European Parliament and of the Council

   (*2).
  In any event, those assessments must take into account
  the availability of appropriate
  scientific
  evidence
  and supporting data in the quantity
  required to carry out a joint clinical assessment,
  and
  should take place
  in a time-frame as close as possible to their marketing authorisation, in the case of medicines, and, in any case, without unjustified and unnecessary delay.

Amendment 31

Proposal for a regulation

Recital 19

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (19) | In
  all cases
  the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results,
  and not delay or interfere
  with the CE marking of medical devices
  or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out
  pursuant
  to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation. |

Text proposed by the Commission

Amendment

(19)

In
  all cases
  the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results,
  and not delay or interfere
  with the CE marking of medical devices
  or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out
  pursuant
  to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation.

| (19) | In
  any event
  the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results,
  without delaying or interfering
  with the CE marking of medical devices. |
| --- | --- |

(19)

In
  any event
  the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results,
  without delaying or interfering
  with the CE marking of medical devices.

Amendment 32

Proposal for a regulation

Recital 19 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (19a) | HTA work covered under this Regulation should be separate and distinct from regulatory assessments of the safety and efficacy of health technologies carried out pursuant to other Union legislative acts and should have no bearing on other aspects falling outside the scope of this Regulation adopted in accordance with other Union legislative acts. |

Text proposed by the Commission

Amendment

(19a)

HTA work covered under this Regulation should be separate and distinct from regulatory assessments of the safety and efficacy of health technologies carried out pursuant to other Union legislative acts and should have no bearing on other aspects falling outside the scope of this Regulation adopted in accordance with other Union legislative acts.

Amendment 33

Proposal for a regulation

Recital 19 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (19b) | In the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint clinical assessment. |

Text proposed by the Commission

Amendment

(19b)

In the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint clinical assessment.

Amendment 34

Proposal for a regulation

Recital 19 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (19c) | Regulation (EU) 2017/745 concerning medical devices and Regulation (EU) 2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy. However, the gradual increase in the supply of medical devices to address clinical conditions has heralded a paradigm shift towards a new model in which the market is highly fragmented, innovation is chiefly incremental and clinical evidence is lacking, which means that closer cooperation and more frequent exchanges of information between assessment bodies are needed. It is therefore necessary to move towards a centralised authorisation system that assesses devices on the basis of safety, efficacy and quality. It is also one of the areas in which Member States are calling for greater collaboration via a future European HTA. Currently 20 Member States, together with Norway, have HTA systems for medical devices in place and 12 Member States, together with Norway, have established guidelines and are engaging in initial dialogues. EUnetHTA has been conducting high-quality evaluations of the relative efficacy of medical devices based on a methodology that can be taken as a benchmark for this Regulation. |

Text proposed by the Commission

Amendment

(19c)

Regulation (EU) 2017/745 concerning medical devices and Regulation (EU) 2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy. However, the gradual increase in the supply of medical devices to address clinical conditions has heralded a paradigm shift towards a new model in which the market is highly fragmented, innovation is chiefly incremental and clinical evidence is lacking, which means that closer cooperation and more frequent exchanges of information between assessment bodies are needed. It is therefore necessary to move towards a centralised authorisation system that assesses devices on the basis of safety, efficacy and quality. It is also one of the areas in which Member States are calling for greater collaboration via a future European HTA. Currently 20 Member States, together with Norway, have HTA systems for medical devices in place and 12 Member States, together with Norway, have established guidelines and are engaging in initial dialogues. EUnetHTA has been conducting high-quality evaluations of the relative efficacy of medical devices based on a methodology that can be taken as a benchmark for this Regulation.

Amendment 35

Proposal for a regulation

Recital 20

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (20) | In order to facilitate effective participation by
  health technology developers
  in joint clinical assessments, such developers should, in appropriate cases, be afforded an opportunity to engage in
  joint scientific consultations with the Coordination Group to obtain guidance on the evidence and
  data that is likely to be required for the purposes of clinical assessment
  . Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies. |

Text proposed by the Commission

Amendment

(20)

In order to facilitate effective participation by
  health technology developers
  in joint clinical assessments, such developers should, in appropriate cases, be afforded an opportunity to engage in
  joint scientific consultations with the Coordination Group to obtain guidance on the evidence and
  data that is likely to be required for the purposes of clinical assessment
  . Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.

| (20) | Health technology developers
  can conduct
  joint scientific consultations with the
  Coordination
  Group
  or working groups set up for this purpose and composed of professionals from national or regional assessment bodies
  to obtain guidance on the
  clinical needs of research and the optimal design of studies to obtain the best possible
  evidence and
  maximise research efficiency
  . Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies. |
| --- | --- |

(20)

Health technology developers
  can conduct
  joint scientific consultations with the
  Coordination
  Group
  or working groups set up for this purpose and composed of professionals from national or regional assessment bodies
  to obtain guidance on the
  clinical needs of research and the optimal design of studies to obtain the best possible
  evidence and
  maximise research efficiency
  . Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.

Amendment 36

Proposal for a regulation

Recital 20 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (20a) | Joint scientific consultations should concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients. The consultation process should be transparent. |

Text proposed by the Commission

Amendment

(20a)

Joint scientific consultations should concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients. The consultation process should be transparent.

Amendment 37

Proposal for a regulation

Recital 21

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (21) | Joint clinical assessments and
  joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of
  assessments and
  consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature. |

Text proposed by the Commission

Amendment

(21)

Joint clinical assessments and
  joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of
  assessments and
  consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.

| (21) | Joint scientific consultations
  could
  necessitate the sharing of
  commercially
  confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature. |
| --- | --- |

(21)

Joint scientific consultations
  could
  necessitate the sharing of
  commercially
  confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.

Amendment 38

Proposal for a regulation

Recital 21 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (21a) | Joint clinical assessments necessitate all available clinical data and publicly available scientific evidence from health technology developers. The clinical data employed, the studies, the methodology and the clinical results used should be made public. The highest possible level of public openness in scientific data and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system. Where commercially sensitive data is shared, the confidentiality of such data should be protected by presenting it in an anonymised format with the redaction of reports before publication, preserving the public interest. |

Text proposed by the Commission

Amendment

(21a)

Joint clinical assessments necessitate all available clinical data and publicly available scientific evidence from health technology developers. The clinical data employed, the studies, the methodology and the clinical results used should be made public. The highest possible level of public openness in scientific data and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system. Where commercially sensitive data is shared, the confidentiality of such data should be protected by presenting it in an anonymised format with the redaction of reports before publication, preserving the public interest.

Amendment 39

Proposal for a regulation

Recital 21 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (21b) | According to the European Ombudsman, where information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure of that information will generally defeat any claim of commercial sensitivity. Public health should always prevail over commercial interests. |

Text proposed by the Commission

Amendment

(21b)

According to the European Ombudsman, where information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure of that information will generally defeat any claim of commercial sensitivity. Public health should always prevail over commercial interests.

Amendment 40

Proposal for a regulation

Recital 22

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (22) | In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems. Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment. |

Text proposed by the Commission

Amendment

(22)

In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems. Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment.

| (22) | In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems,
  as well as to steer research strategically
  . Such scanning should facilitate the prioritisation of technologies that are to be selected
  by the Coordination Group
  for joint clinical assessment. |
| --- | --- |

(22)

In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems,
  as well as to steer research strategically
  . Such scanning should facilitate the prioritisation of technologies that are to be selected
  by the Coordination Group
  for joint clinical assessment.

Amendment 41

Proposal for a regulation

Recital 23

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (23) | The Union should continue to support voluntary cooperation on HTA between Member States in areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems.
  Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven areas of health and care with a view to the provision of additional real world evidence relevant for HTA. |

Text proposed by the Commission

Amendment

(23)

The Union should continue to support voluntary cooperation on HTA between Member States in areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems.
  Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven areas of health and care with a view to the provision of additional real world evidence relevant for HTA.

| (23) | The Union should continue to support voluntary cooperation on HTA between Member States in
  other
  areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems. |
| --- | --- |

(23)

The Union should continue to support voluntary cooperation on HTA between Member States in
  other
  areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems.

Amendment 42

Proposal for a regulation

Recital 24

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (24) | In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However
  , in order to preserve the
  integrity
  of the joint work, rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest. |

Text proposed by the Commission

Amendment

(24)

In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However
  , in order to preserve the
  integrity
  of the joint work, rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest.

| (24) | In order to preserve the
  objectivity, transparency and quality
  of the joint work, rules should be developed to ensure the independence, public
  openness
  and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest. |
| --- | --- |

(24)

In order to preserve the
  objectivity, transparency and quality
  of the joint work, rules should be developed to ensure the independence, public
  openness
  and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest.

Amendment 43

Proposal for a regulation

Recital 24 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (24a) | Dialogue between the Coordination Group and patient organisations, consumer organisations, health non-governmental organisations, health experts and professionals should be ensured, especially through a stakeholder network, with a guarantee of the independence, transparency and impartiality of the decisions taken. |

Text proposed by the Commission

Amendment

(24a)

Dialogue between the Coordination Group and patient organisations, consumer organisations, health non-governmental organisations, health experts and professionals should be ensured, especially through a stakeholder network, with a guarantee of the independence, transparency and impartiality of the decisions taken.

Amendment 44

Proposal for a regulation

Recital 24 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (24b) | In order to ensure efficient decision-making and facilitate access to medicines, an appropriated cooperation between decision-makers at key stages of the medicines’ life-cycle is important. |

Text proposed by the Commission

Amendment

(24b)

In order to ensure efficient decision-making and facilitate access to medicines, an appropriated cooperation between decision-makers at key stages of the medicines’ life-cycle is important.

Amendment 45

Proposal for a regulation

Recital 25

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (25) | In order to ensure a uniform approach to the joint work provided for in this Regulation,
  implementing powers should be conferred on
  the Commission
  to establish
  a common procedural
  and methodological
  framework
  for clinical assessments, procedures
  for joint clinical assessments and
  procedures for
  joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the
  Commission should take into account the
  results of the work already undertaken in the EUnetHTA Joint Actions.
  It should also take into account
  initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council. (13) |

Text proposed by the Commission

Amendment

(25)

In order to ensure a uniform approach to the joint work provided for in this Regulation,
  implementing powers should be conferred on
  the Commission
  to establish
  a common procedural
  and methodological
  framework
  for clinical assessments, procedures
  for joint clinical assessments and
  procedures for
  joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the
  Commission should take into account the
  results of the work already undertaken in the EUnetHTA Joint Actions.
  It should also take into account
  initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council. (13)

| (25) | In order to ensure a uniform approach to the joint work provided for in this Regulation,
  the Coordination Group, composed of national and/or regional authorities and bodies responsible for health technology assessment, with proven capacity, independence and impartiality
  , should
  draw up the methodology for ensuring high quality of work as a whole.
  The Commission
  should endorse, by means of implementing acts, that methodology and
  a common procedural framework for joint clinical assessments and joint scientific consultations. Where appropriate,
  and in justified cases
  , distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the results of the work already undertaken in the EUnetHTA Joint Actions,
  and in particular the methodological guidelines and evidence submission templates
  , initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives
  should be taken into account
  . Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14). |
| --- | --- |

(25)

In order to ensure a uniform approach to the joint work provided for in this Regulation,
  the Coordination Group, composed of national and/or regional authorities and bodies responsible for health technology assessment, with proven capacity, independence and impartiality
  , should
  draw up the methodology for ensuring high quality of work as a whole.
  The Commission
  should endorse, by means of implementing acts, that methodology and
  a common procedural framework for joint clinical assessments and joint scientific consultations. Where appropriate,
  and in justified cases
  , distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the results of the work already undertaken in the EUnetHTA Joint Actions,
  and in particular the methodological guidelines and evidence submission templates
  , initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives
  should be taken into account
  . Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (14).

Amendment 46

Proposal for a regulation

Recital 25 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (25a) | The methodological framework, in accordance with the Declaration of Helsinki, should guarantee high quality and high clinical evidence by choosing the most appropriate benchmarks. It should be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; and should take into account clinical criteria that are useful, relevant, tangible, concrete and tailored to suit the given clinical situation, with preference given to end points. The documentation to be provided by the applicant should relate to the most up-to-date and public data. |

Text proposed by the Commission

Amendment

(25a)

The methodological framework, in accordance with the Declaration of Helsinki, should guarantee high quality and high clinical evidence by choosing the most appropriate benchmarks. It should be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; and should take into account clinical criteria that are useful, relevant, tangible, concrete and tailored to suit the given clinical situation, with preference given to end points. The documentation to be provided by the applicant should relate to the most up-to-date and public data.

Amendment 47

Proposal for a regulation

Recital 25 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (25b) | Any specificities in the methodology, such as for vaccines, should be justified and adapted to very specific circumstances, should have the same scientific rigour and the same scientific standards, and should never be to the detriment of the quality of health technologies or clinical evidence. |

Text proposed by the Commission

Amendment

(25b)

Any specificities in the methodology, such as for vaccines, should be justified and adapted to very specific circumstances, should have the same scientific rigour and the same scientific standards, and should never be to the detriment of the quality of health technologies or clinical evidence.

Amendment 48

Proposal for a regulation

Recital 25 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (25c) | The Commission should provide administrative support for the joint work of the Coordination Group, which, after consultation with the stakeholders, should submit the final report on this work. |

Text proposed by the Commission

Amendment

(25c)

The Commission should provide administrative support for the joint work of the Coordination Group, which, after consultation with the stakeholders, should submit the final report on this work.

Amendment 49

Proposal for a regulation

Recital 26

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (26) | In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to
  the Commission
  in respect of the contents of documents to be submitted, reports, and summary reports of
  clinical assessments,
  the contents of documents for requests, and reports of
  joint scientific consultations, and
  the rules
  for selecting stakeholders.
  It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

   (15)

  In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically should be granted access to meetings of Commission expert groups dealing with the preparation of delegated acts. |

Text proposed by the Commission

Amendment

(26)

In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to
  the Commission
  in respect of the contents of documents to be submitted, reports, and summary reports of
  clinical assessments,
  the contents of documents for requests, and reports of
  joint scientific consultations, and
  the rules
  for selecting stakeholders.
  It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

   (15)

  In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically should be granted access to meetings of Commission expert groups dealing with the preparation of delegated acts.

| (26) | The Commission
  should adopt implementing acts on procedural rules for the joint
  clinical assessments, joint scientific consultations, and for selecting stakeholders. |
| --- | --- |

(26)

The Commission
  should adopt implementing acts on procedural rules for the joint
  clinical assessments, joint scientific consultations, and for selecting stakeholders.

Amendment 50

Proposal for a regulation

Recital 27

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (27) | In order to ensure that sufficient resources are available for the joint work provided for under this Regulation, the Union should
  provide
  funding for the joint work and voluntary cooperation,
  and
  for the support framework to support these activities.
  The funding should cover the costs of producing joint clinical assessment and joint scientific consultation reports
  . Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group. |

Text proposed by the Commission

Amendment

(27)

In order to ensure that sufficient resources are available for the joint work provided for under this Regulation, the Union should
  provide
  funding for the joint work and voluntary cooperation,
  and
  for the support framework to support these activities.
  The funding should cover the costs of producing joint clinical assessment and joint scientific consultation reports
  . Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.

| (27) | In order to ensure that sufficient resources are available for the joint work
  and stable administrative support
  provided for under this Regulation, the Union should
  ensure stable and permanent public
  funding
  under the Multiannual Financial Framework
  for the joint work and voluntary cooperation,
  as well as
  for the support framework to support these activities. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.
  The Commission should establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments for research on unmet medical needs. Under no event can those fees be used to fund the joint work provided for in this Regulation. |
| --- | --- |

(27)

In order to ensure that sufficient resources are available for the joint work
  and stable administrative support
  provided for under this Regulation, the Union should
  ensure stable and permanent public
  funding
  under the Multiannual Financial Framework
  for the joint work and voluntary cooperation,
  as well as
  for the support framework to support these activities. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.
  The Commission should establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments for research on unmet medical needs. Under no event can those fees be used to fund the joint work provided for in this Regulation.

Amendment 51

Proposal for a regulation

Recital 28

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (28) | In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data. |

Text proposed by the Commission

Amendment

(28)

In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data.

| (28) | In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication,
  as well as all information on the procedure, methodology, training and interests of assessors of and participants in the stakeholder network, and the reports and results of the joint work, which should be made public
  . The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data. |
| --- | --- |

(28)

In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication,
  as well as all information on the procedure, methodology, training and interests of assessors of and participants in the stakeholder network, and the reports and results of the joint work, which should be made public
  . The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data.

Amendment 52

Proposal for a regulation

Recital 28 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (28a) | Cooperation should be based on the principle of good governance, which encompasses transparency, objectivity, independent experience and fair procedures. Trust is a precondition for successful cooperation and can only be achieved if all stakeholders make genuine commitments and if there is access to high-quality experience, capacity-building and the highest quality of execution. |

Text proposed by the Commission

Amendment

(28a)

Cooperation should be based on the principle of good governance, which encompasses transparency, objectivity, independent experience and fair procedures. Trust is a precondition for successful cooperation and can only be achieved if all stakeholders make genuine commitments and if there is access to high-quality experience, capacity-building and the highest quality of execution.

Amendment 53

Proposal for a regulation

Recital 28 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (28b) | Since there is currently no commonly agreed definition of what constitutes high-quality innovation or added therapeutic value, the Union should adopt definitions of these terms with the agreement or consensus of all parties. |

Text proposed by the Commission

Amendment

(28b)

Since there is currently no commonly agreed definition of what constitutes high-quality innovation or added therapeutic value, the Union should adopt definitions of these terms with the agreement or consensus of all parties.

Amendment 54

Proposal for a regulation

Recital 30

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (30) | During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States.
  This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level.
  During the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work. |

Text proposed by the Commission

Amendment

(30)

During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States.
  This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level.
  During the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work.

| (30) | During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States.
  Moreover
  , during the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work.
  Clinical assessments which have started in Member States before the application of this Regulation should be continued, unless Member States decide to stop them. |
| --- | --- |

(30)

During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States.
  Moreover
  , during the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work.
  Clinical assessments which have started in Member States before the application of this Regulation should be continued, unless Member States decide to stop them.

Amendment 55

Proposal for a regulation

Recital 31

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (31) | In order to ensure that the support framework continues to be as efficient and cost-effective as possible
  , the Commission should report on the
  implementation
  of the
  provisions on
  the scope of the joint clinical assessments and
  on
  the functioning of the support framework
  no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work. |

Text proposed by the Commission

Amendment

(31)

In order to ensure that the support framework continues to be as efficient and cost-effective as possible
  , the Commission should report on the
  implementation
  of the
  provisions on
  the scope of the joint clinical assessments and
  on
  the functioning of the support framework
  no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work.

| (31) | After the transitional period and before the harmonised system for HTA established under this Regulation becomes mandatory
  , the Commission should
  submit an impact assessment
  report on the
  whole
  of the
  procedure that has been introduced. That impact assessment report should evaluate, among other criteria, the progress made in relation to patients access to new health technologies and the functioning of the internal market, the impact on the quality of innovation and on the sustainability of health systems, as well as the appropriateness of
  the scope of the joint clinical assessments and the functioning of the support framework. |
| --- | --- |

(31)

After the transitional period and before the harmonised system for HTA established under this Regulation becomes mandatory
  , the Commission should
  submit an impact assessment
  report on the
  whole
  of the
  procedure that has been introduced. That impact assessment report should evaluate, among other criteria, the progress made in relation to patients access to new health technologies and the functioning of the internal market, the impact on the quality of innovation and on the sustainability of health systems, as well as the appropriateness of
  the scope of the joint clinical assessments and the functioning of the support framework.

Amendment 56

Proposal for a regulation

Recital 32

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (32) | The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme. |

Text proposed by the Commission

Amendment

(32)

The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme.

| (32) | The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme.
  The results of that evaluation should also be communicated to the European Parliament and Council. |
| --- | --- |

(32)

The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme.
  The results of that evaluation should also be communicated to the European Parliament and Council.

Amendment 57

Proposal for a regulation

Recital 34

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (34) | Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments
  at national level and establish a framework of mandatory joint clinical assessments of certain
  health technologies
  at Union level
  , cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, |

Text proposed by the Commission

Amendment

(34)

Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments
  at national level and establish a framework of mandatory joint clinical assessments of certain
  health technologies
  at Union level
  , cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

| (34) | Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments
  of the
  health technologies
  falling under the scope of this Regulation
  , cannot be sufficiently achieved by the Member States
  alone
  but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective, |
| --- | --- |

(34)

Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments
  of the
  health technologies
  falling under the scope of this Regulation
  , cannot be sufficiently achieved by the Member States
  alone
  but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

Amendment 58

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   This Regulation establishes: | | 1.   
  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions
  , this Regulation establishes: |

Text proposed by the Commission

Amendment

1.   This Regulation establishes:

1.   
  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions
  , this Regulation establishes:

Amendment 59

Amendment 59

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 1 – point a

Article 1 – paragraph 1 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | a support framework and procedures for cooperation on health technology
  assessment
  at Union level; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

a support framework and procedures for cooperation on health technology
  assessment
  at Union level;

assessment

| (a) | a support framework and procedures for cooperation on
  the clinical assessment of
  health technology at Union level; |
| --- | --- |

(a)

a support framework and procedures for cooperation on
  the clinical assessment of
  health technology at Union level;

the clinical assessment of

Amendment 60

Amendment 60

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 1 – point b

Article 1 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | common
  rules
  for the clinical assessment of health technologies. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

common
  rules
  for the clinical assessment of health technologies.

rules

| (b) | common
  methodologies
  for the clinical assessment of health technologies. |
| --- | --- |

(b)

common
  methodologies
  for the clinical assessment of health technologies.

methodologies

Amendment 61

Amendment 61

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 2

Article 1 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. | | 2.   This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.
  Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing or reimbursement decisions. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.

2.   This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.
  Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing or reimbursement decisions.

Amendment 62

Amendment 62

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point b a (new)

Article 2 – paragraph 1 – point b a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (ba) | ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ba)

(ba)

‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746;

‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746;

Amendment 63

Amendment 63

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point b b (new)

Article 2 – paragraph 1 – point b b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (bb) | ‘assessment of a medical device’ means the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(bb)

(bb)

‘assessment of a medical device’ means the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments;

‘assessment of a medical device’ means the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments;

Amendment 64

Amendment 64

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point e

Article 2 – paragraph 1 – point e

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (e) | ‘clinical assessment’ means
  a compilation and evaluation of the available
  scientific
  evidence on
  a health technology in
  comparison
  with one or more other health technologies based on the following clinical domains
  of health technology assessment
  : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(e)

‘clinical assessment’ means
  a compilation and evaluation of the available
  scientific
  evidence on
  a health technology in
  comparison
  with one or more other health technologies based on the following clinical domains
  of health technology assessment
  : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

a compilation and evaluation of the available

evidence on

comparison

of health technology assessment

| (e) | ‘
  joint
  clinical assessment’ means
  the systematic collection of
  scientific
  information and its comparative evaluation and a synthesis of these procedures, the comparison of the
  health technology in
  question
  with one or more other health technologies
  or existing procedures, constituting a benchmark for a particular clinical indication and
  , based on
  the best available clinical scientific evidence and on patient relevant clinical criteria, taking into account
  the following clinical domains: the description of the health problem addressed by the health technology and the current use of other health technologies
  or procedures
  addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology; |
| --- | --- |

(e)

‘
  joint
  clinical assessment’ means
  the systematic collection of
  scientific
  information and its comparative evaluation and a synthesis of these procedures, the comparison of the
  health technology in
  question
  with one or more other health technologies
  or existing procedures, constituting a benchmark for a particular clinical indication and
  , based on
  the best available clinical scientific evidence and on patient relevant clinical criteria, taking into account
  the following clinical domains: the description of the health problem addressed by the health technology and the current use of other health technologies
  or procedures
  addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

joint

the systematic collection of

information and its comparative evaluation and a synthesis of these procedures, the comparison of the

question

or existing procedures, constituting a benchmark for a particular clinical indication and

the best available clinical scientific evidence and on patient relevant clinical criteria, taking into account

or procedures

Amendment 65

Amendment 65

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point g a (new)

Article 2 – paragraph 1 – point g a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (ga) | ‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria in the national care context. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ga)

(ga)

‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria in the national care context.

‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria in the national care context.

Amendment 202

Amendment 202

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point g b (new)

Article 2 – paragraph 1 – point g b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (gb) | ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(gb)

(gb)

‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events.

‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events.

Amendment 66

Amendment 66

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 2

Article 3 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   Member States shall designate their national authorities and bodies responsible for health technology assessment
  as members
  of the Coordination Group and its sub-groups
  and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups. | | 2.   Member States shall designate their national
  or regional
  authorities and bodies responsible for health technology assessment
  at national level as members
  of the Coordination Group and its sub-groups. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   Member States shall designate their national authorities and bodies responsible for health technology assessment
  as members
  of the Coordination Group and its sub-groups
  and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups.

2.   Member States shall designate their national
  or regional
  authorities and bodies responsible for health technology assessment
  at national level as members
  of the Coordination Group and its sub-groups.

Amendment 203

Amendment 203

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 3

Article 3 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The Coordination Group shall act by consensus, or, where necessary, vote by
  simple
  majority.
  There shall be one vote per Member State. | | 3.   The Coordination Group shall act by consensus, or, where necessary, vote by
  qualified
  majority.


  Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available, including any dissensions. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The Coordination Group shall act by consensus, or, where necessary, vote by
  simple
  majority.
  There shall be one vote per Member State.

3.   The Coordination Group shall act by consensus, or, where necessary, vote by
  qualified
  majority.

Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available, including any dissensions.

Amendment 68

Amendment 68

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 4

Article 3 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected
  from
  the members of the group
  for a set term to be determined in its rules of procedure
  . | | 4.   Meetings of the Coordination Group shall be co-chaired by the Commission,
  without the right to vote
  , and a co-chair elected
  annually from among
  the members of the group
  on a rotating basis. Co-chairs shall perform purely administrative functions
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected
  from
  the members of the group
  for a set term to be determined in its rules of procedure
  .

4.   Meetings of the Coordination Group shall be co-chaired by the Commission,
  without the right to vote
  , and a co-chair elected
  annually from among
  the members of the group
  on a rotating basis. Co-chairs shall perform purely administrative functions
  .

Amendment 69

Amendment 69

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 5

Article 3 – paragraph 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 5.   Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis,
  and inform
  the Commission
  of their
  appointment
  and any subsequent changes
  . | | 5.   Members of the Coordination Group,
  being national or regional assessment authorities or bodies
  , shall appoint their representatives in the Coordination Group and the sub-groups in which they are members on an ad-hoc or permanent basis.
  Member States may terminate such appointments where it is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub-groups, or the specific knowledge required, there may be more than one expert assessor for each Member State, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The appointments shall take into account the expertise necessary in order to achieve the objectives of the sub-group.
  The
  European Parliament, the Council and the
  Commission,
  shall be informed of all appointments and possible terminations of
  appointment. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5.   Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis,
  and inform
  the Commission
  of their
  appointment
  and any subsequent changes
  .

5.   Members of the Coordination Group,
  being national or regional assessment authorities or bodies
  , shall appoint their representatives in the Coordination Group and the sub-groups in which they are members on an ad-hoc or permanent basis.
  Member States may terminate such appointments where it is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub-groups, or the specific knowledge required, there may be more than one expert assessor for each Member State, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The appointments shall take into account the expertise necessary in order to achieve the objectives of the sub-group.
  The
  European Parliament, the Council and the
  Commission,
  shall be informed of all appointments and possible terminations of
  appointment.

Amendment 70

Amendment 70

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 6

Article 3 – paragraph 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 6.   Members of the Coordination Group,
  and their appointed representatives
  shall
  respect the principles of independence
  , impartiality,
  and
  confidentiality. | | 6.   
  In order to ensure high quality of work
  , members of the Coordination Group shall
  be drawn from national or regional health technology assessment agencies or bodies responsible for that field.




  Members serving in the Coordination Group, and experts and assessors in general, shall not have financial interests in any type of health technology developer industry or insurance company that may affect their
  impartiality.
  They shall undertake to act independently and in the public interest and shall make an annual declaration of interests. Those declarations of interests shall be recorded on the IT platform referred to in Article 27 and shall made accessible to the public.




  At every meeting, members of the Coordination Group shall declare any specific interest that may be considered to adversely affect their independence in relation to agenda items. When a conflict of interest arises, the member of the Coordination Group concerned shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with. The procedural rules for conflicts of interest shall be laid down in accordance with point (a)(iiia) of Article 22(1).




  In order to ensure transparency and public awareness of the process and to promote confidence in the system, all clinical data being evaluated shall have the highest level of transparency and public communication. Where data is confidential for commercial reasons, its
  confidentiality
  shall be clearly defined and justified and the confidential data shall be well delimitated and protected
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6.   Members of the Coordination Group,
  and their appointed representatives
  shall
  respect the principles of independence
  , impartiality,
  and
  confidentiality.

6.   
  In order to ensure high quality of work
  , members of the Coordination Group shall
  be drawn from national or regional health technology assessment agencies or bodies responsible for that field.

Members serving in the Coordination Group, and experts and assessors in general, shall not have financial interests in any type of health technology developer industry or insurance company that may affect their
  impartiality.
  They shall undertake to act independently and in the public interest and shall make an annual declaration of interests. Those declarations of interests shall be recorded on the IT platform referred to in Article 27 and shall made accessible to the public.

At every meeting, members of the Coordination Group shall declare any specific interest that may be considered to adversely affect their independence in relation to agenda items. When a conflict of interest arises, the member of the Coordination Group concerned shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with. The procedural rules for conflicts of interest shall be laid down in accordance with point (a)(iiia) of Article 22(1).

In order to ensure transparency and public awareness of the process and to promote confidence in the system, all clinical data being evaluated shall have the highest level of transparency and public communication. Where data is confidential for commercial reasons, its
  confidentiality
  shall be clearly defined and justified and the confidential data shall be well delimitated and protected
  .

Amendment 71

Amendment 71

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 7

Article 3 – paragraph 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 7.   The Commission shall publish
  a
  list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27. | | 7.   The Commission shall publish
  an up-to-date
  list of the designated members of the Coordination Group and its sub-groups
  and other experts, together with their qualifications and areas of expertise and their annual declaration of interest
  , on the IT platform referred to in Article 27.


  The information referred to in the first subparagraph shall be updated by the Commission annually and whenever considered necessary in the light of possible new circumstances. Those updates shall be publicly accessible. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7.   The Commission shall publish
  a
  list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27.

7.   The Commission shall publish
  an up-to-date
  list of the designated members of the Coordination Group and its sub-groups
  and other experts, together with their qualifications and areas of expertise and their annual declaration of interest
  , on the IT platform referred to in Article 27.

The information referred to in the first subparagraph shall be updated by the Commission annually and whenever considered necessary in the light of possible new circumstances. Those updates shall be publicly accessible.

Amendment 72

Amendment 72

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 8 – point c

Article 3 – paragraph 8 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | ensure cooperation
  with relevant
  Union level
  bodies to facilitate additional evidence generation necessary for its work; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

ensure cooperation
  with relevant
  Union level
  bodies to facilitate additional evidence generation necessary for its work;

ensure cooperation

Union level

| (c) | cooperate
  with relevant
  Union-level
  bodies to facilitate additional evidence generation necessary for its work; |
| --- | --- |

(c)

cooperate
  with relevant
  Union-level
  bodies to facilitate additional evidence generation necessary for its work;

cooperate

Union-level

Amendment 73

Amendment 73

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 8 – point d

Article 3 – paragraph 8 – point d

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (d) | ensure appropriate
  involvement of
  stakeholders
  in
  its work; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(d)

ensure appropriate
  involvement of
  stakeholders
  in
  its work;

involvement of

in

| (d) | ensure appropriate
  consultation of relevant
  stakeholders
  and experts when pursuing
  its work.
  Such consultations shall be documented, including publicly available declarations of interest from the stakeholders consulted and shall be incorporated in the final joint assessment report
  ; |
| --- | --- |

(d)

ensure appropriate
  consultation of relevant
  stakeholders
  and experts when pursuing
  its work.
  Such consultations shall be documented, including publicly available declarations of interest from the stakeholders consulted and shall be incorporated in the final joint assessment report
  ;

consultation of relevant

and experts when pursuing

Such consultations shall be documented, including publicly available declarations of interest from the stakeholders consulted and shall be incorporated in the final joint assessment report

Amendment 74

Amendment 74

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 10 a (new)

Article 3 – paragraph 10 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 10a.
     
  The rules of procedure of the Coordination Group and its sub-groups, the agendas for their meetings, the decisions adopted, and the details of votes and explanations of votes, including minority opinions, shall, in any event, be accessible to the public. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

10a.
     
  The rules of procedure of the Coordination Group and its sub-groups, the agendas for their meetings, the decisions adopted, and the details of votes and explanations of votes, including minority opinions, shall, in any event, be accessible to the public.

Amendment 75

Amendment 75

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 2 – subparagraph 1 a (new)

Article 4 – paragraph 2 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | Points (a), (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Points (a), (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems.

Points (a), (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems.

Amendment 76

Amendment 76

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 3 – point c

Article 4 – paragraph 3 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | consult the Commission on the draft annual work programme and take into account
  its opinion
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

consult the Commission on the draft annual work programme and take into account
  its opinion
  .

its opinion

| (c) | consult the Commission
  and the stakeholder network, at annual meetings under Article 26
  , on the draft annual work programme and take into account
  their comments
  . |
| --- | --- |

(c)

consult the Commission
  and the stakeholder network, at annual meetings under Article 26
  , on the draft annual work programme and take into account
  their comments
  .

and the stakeholder network, at annual meetings under Article 26

their comments

Amendment 77

Amendment 77

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 5 a (new)

Article 4 – paragraph 5 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 5a.
     
  Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5a.
     
  Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27.

Amendment 78

Amendment 78

Proposal for a regulation

Proposal for a regulation

Article 5 – paragraph 1 – point a a (new)

Article 5 – paragraph 1 – point a a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (aa) | other medicinal products not subject to the authorisation procedure provided for in Regulation (EC) No 726/2004 where the health technology developer has opted for the centralised authorisation procedure, provided that the medicinal products in question constitute a major technical, scientific or therapeutic innovation, or their authorisation is in the interest of public health; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(aa)

(aa)

other medicinal products not subject to the authorisation procedure provided for in Regulation (EC) No 726/2004 where the health technology developer has opted for the centralised authorisation procedure, provided that the medicinal products in question constitute a major technical, scientific or therapeutic innovation, or their authorisation is in the interest of public health;

other medicinal products not subject to the authorisation procedure provided for in Regulation (EC) No 726/2004 where the health technology developer has opted for the centralised authorisation procedure, provided that the medicinal products in question constitute a major technical, scientific or therapeutic innovation, or their authorisation is in the interest of public health;

Amendment 79

Amendment 79

Proposal for a regulation

Proposal for a regulation

Article 5 – paragraph 1 – point b

Article 5 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation;

| (b) | medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation
  and considered to be a significant innovation and with potential significant impact on public health or health care systems
  ; |
| --- | --- |

(b)

medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation
  and considered to be a significant innovation and with potential significant impact on public health or health care systems
  ;

and considered to be a significant innovation and with potential significant impact on public health or health care systems

Amendment 80

Amendment 80

Proposal for a regulation

Proposal for a regulation

Article 5 – paragraph 1 – point c

Article 5 – paragraph 1 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 (16) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 (16) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation.

in vitro

16

| (c) | in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 (17) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation
  and considered to be a significant innovation and with potential significant impact on public health or health care systems
  . |
| --- | --- |

(c)

in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 (17) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation
  and considered to be a significant innovation and with potential significant impact on public health or health care systems
  .

in vitro

17

and considered to be a significant innovation and with potential significant impact on public health or health care systems

Amendment 81

Amendment 81

Proposal for a regulation

Proposal for a regulation

Article 5 – paragraph 2 – point e a (new)

Article 5 – paragraph 2 – point e a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (ea) | the need for greater clinical evidence; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ea)

(ea)

the need for greater clinical evidence;

the need for greater clinical evidence;

Amendment 82

Amendment 82

Proposal for a regulation

Proposal for a regulation

Article 5 – paragraph 2 – point e b (new)

Article 5 – paragraph 2 – point e b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (eb) | at the request of the health technology developer; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(eb)

(eb)

at the request of the health technology developer;

at the request of the health technology developer;

Amendment 83

Amendment 83

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Article 6 – paragraph 1 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The joint clinical assessment report shall be accompanied by a summary report
  and
  they shall be prepared in accordance with the requirements in
  this
  Article
  and the requirements established pursuant to Articles 11, 22, and 23. | | The joint clinical assessment report shall be accompanied by a summary report,
  which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made.
  They shall be prepared in accordance with the requirements
  laid down by the Coordination Group and shall be made public, regardless of the report's conclusions.




  For medicinal products referred to
  in
  point (a) of
  Article
  5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC

   (1). |
| | |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The joint clinical assessment report shall be accompanied by a summary report
  and
  they shall be prepared in accordance with the requirements in
  this
  Article
  and the requirements established pursuant to Articles 11, 22, and 23.

and

this

and the requirements established pursuant to Articles 11, 22, and 23.

The joint clinical assessment report shall be accompanied by a summary report,
  which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made.
  They shall be prepared in accordance with the requirements
  laid down by the Coordination Group and shall be made public, regardless of the report's conclusions.

which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made.

laid down by the Coordination Group and shall be made public, regardless of the report's conclusions.

For medicinal products referred to
  in
  point (a) of
  Article
  5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC

   (1).

For medicinal products referred to

point (a) of

5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC

1

Amendment 84

Amendment 84

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 2

Article 6 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The designated sub-group shall request
  relevant
  health technology
  developers
  to submit documentation containing the information, data and
  evidence
  necessary for the joint clinical assessment. | | 2.
     The designated sub-group shall request
  the
  health technology
  developer
  to submit
  all available up-to-date
  documentation containing the information, data and
  studies, including both negative and positive results, that is
  necessary for the joint clinical assessment.
  That documentation shall include the available data from all tests performed and from all the studies in which the technology was used, both of which are of paramount importance to ensure that assessments are of high quality.




  For medicinal products referred to in point (a) of Article 5(1), the documentation shall at least include:








  (a) | the submission file; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The designated sub-group shall request
  relevant
  health technology
  developers
  to submit documentation containing the information, data and
  evidence
  necessary for the joint clinical assessment.

2.
     The designated sub-group shall request
  the
  health technology
  developer
  to submit
  all available up-to-date
  documentation containing the information, data and
  studies, including both negative and positive results, that is
  necessary for the joint clinical assessment.
  That documentation shall include the available data from all tests performed and from all the studies in which the technology was used, both of which are of paramount importance to ensure that assessments are of high quality.

For medicinal products referred to in point (a) of Article 5(1), the documentation shall at least include:

(a)

the submission file;

| (b) | an indication of the marketing authorisation status; |
| --- | --- |

(b)

an indication of the marketing authorisation status;

| (c) | if available, the European public assessment report (EPAR), including the Summary of Product Characteristics (SPC); the European Medicines Agency shall provide the relevant adopted scientific assessment reports to the Coordination Group. |
| --- | --- |

(c)

if available, the European public assessment report (EPAR), including the Summary of Product Characteristics (SPC); the European Medicines Agency shall provide the relevant adopted scientific assessment reports to the Coordination Group.

| (d) | where applicable, the results of additional studies requested by the Coordination Group and available to the health technology developer; |
| --- | --- |

(d)

where applicable, the results of additional studies requested by the Coordination Group and available to the health technology developer;

| (e) | where applicable and if available to the health technology developer, already available HTA reports on the health technology concerned; |
| --- | --- |

(e)

where applicable and if available to the health technology developer, already available HTA reports on the health technology concerned;

| (f) | information on studies and study registries available to the health technology developer. |
| --- | --- |

(f)

information on studies and study registries available to the health technology developer.

Health technology developers shall be obliged to submit all of the requested data.

Assessors may also access public databases and sources of clinical information, such as patient registries, databases or European Reference Networks, where such access is deemed necessary to complement the information provided by the developer and to perform a more accurate clinical assessment of the health technology. The reproducibility of the assessment implies that such information shall be made public.

The relationship between evaluators and health technology developers shall be independent and impartial. Developers of health technologies may be consulted but shall not actively participate in the evaluation process.

Amendment 85

Amendment 85

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 2 a (new)

Article 6 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  The Coordination Group may justifiably consider, in the case of orphan medicines, that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  The Coordination Group may justifiably consider, in the case of orphan medicines, that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency.

Amendment 86

Amendment 86

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 3

Article 6 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment. | | 3.   The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment.
  The assessor and a co-assessor shall be different from those previously appointed under Article 13(3) except in exceptional and justified situations where the necessary specific expertise is not available, and subject to approval of the Coordination Group.
  The appointments shall take into account the scientific expertise necessary for the assessment. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.

3.   The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment.
  The assessor and a co-assessor shall be different from those previously appointed under Article 13(3) except in exceptional and justified situations where the necessary specific expertise is not available, and subject to approval of the Coordination Group.
  The appointments shall take into account the scientific expertise necessary for the assessment.

Amendment 87

Amendment 87

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 5 – introductory part

Article 6 – paragraph 5 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 5.   The conclusions of the joint clinical assessment report shall
  be limited to the following
  : | | 5.   The conclusions of the joint clinical assessment report shall
  include
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5.   The conclusions of the joint clinical assessment report shall
  be limited to the following
  :

5.   The conclusions of the joint clinical assessment report shall
  include
  :

Amendment 88

Amendment 88

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 5 – point a

Article 6 – paragraph 5 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | an analysis of the relative
  effects
  of the health technology being assessed
  on the patient-relevant health outcomes
  chosen for the assessment; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

an analysis of the relative
  effects
  of the health technology being assessed
  on the patient-relevant health outcomes
  chosen for the assessment;

effects

on the patient-relevant health outcomes

| (a) | an analysis of the relative
  effectiveness and safety
  of the health technology being assessed
  in terms of the clinical end-points relevant to the clinical entity and patient group
  chosen for the assessment,
  including mortality, morbidity and quality of life, and compared to one or more comparator treatments to be determined by the Coordination Group
  ; |
| --- | --- |

(a)

an analysis of the relative
  effectiveness and safety
  of the health technology being assessed
  in terms of the clinical end-points relevant to the clinical entity and patient group
  chosen for the assessment,
  including mortality, morbidity and quality of life, and compared to one or more comparator treatments to be determined by the Coordination Group
  ;

effectiveness and safety

in terms of the clinical end-points relevant to the clinical entity and patient group

including mortality, morbidity and quality of life, and compared to one or more comparator treatments to be determined by the Coordination Group

Amendment 89

Amendment 89

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 5 – point b

Article 6 – paragraph 5 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the degree of certainty on the relative effects based on the available evidence. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

the degree of certainty on the relative effects based on the available evidence.

| (b) | the degree of certainty on the relative effects based on the
  best
  available
  clinical
  evidence
  and compared to the best standard therapies
  .
  The assessment shall be based on the clinical end-points established in accordance with international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference shall also be made to subgroup-specific differences. |
| --- | --- |

(b)

the degree of certainty on the relative effects based on the
  best
  available
  clinical
  evidence
  and compared to the best standard therapies
  .
  The assessment shall be based on the clinical end-points established in accordance with international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference shall also be made to subgroup-specific differences.

best

clinical

and compared to the best standard therapies

The assessment shall be based on the clinical end-points established in accordance with international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference shall also be made to subgroup-specific differences.

Amendment 90

Amendment 90

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 1 a (new)

Article 6 – paragraph 5 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | The conclusions shall not include an appraisal.




  The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The conclusions shall not include an appraisal.

The conclusions shall not include an appraisal.

The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets.

The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets.

Amendment 205

Amendment 205

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 6

Article 6 – paragraph 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 6.   Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. | | 6.   Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.
  Where new clinical data become available during the process, the health technology developer concerned shall also proactively communicate this new information to the assessor. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6.   Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

6.   Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.
  Where new clinical data become available during the process, the health technology developer concerned shall also proactively communicate this new information to the assessor.

Amendment 92

Amendment 92

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 7

Article 6 – paragraph 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 7.   The members of the designated sub-group shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report.
  The Commission may also provide comments. | | 7.   The members of the designated sub-group
  or the Coordination Group, in a minimum period of 30 working days
  , shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7.   The members of the designated sub-group shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report.
  The Commission may also provide comments.

7.   The members of the designated sub-group
  or the Coordination Group, in a minimum period of 30 working days
  , shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report.

Amendment 93

Amendment 93

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 8

Article 6 – paragraph 8

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 8.
     The assessor shall provide the draft joint clinical assessment report and the summary report to the
  submitting
  health technology developer
  and set a time-frame in which the developer may submit
  comments. | | 8.   The assessor shall provide the draft joint clinical assessment report and the summary report to the health technology developer
  for
  comments. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

8.
     The assessor shall provide the draft joint clinical assessment report and the summary report to the
  submitting
  health technology developer
  and set a time-frame in which the developer may submit
  comments.

8.   The assessor shall provide the draft joint clinical assessment report and the summary report to the health technology developer
  for
  comments.

Amendment 94

Amendment 94

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 9

Article 6 – paragraph 9

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 9.   
  The designated sub-group shall ensure that stakeholders, including
  patients and clinical experts,
  are given an opportunity to provide
  comments during the
  preparation of the draft
  joint clinical assessment
  report and the summary report and set
  a time-frame
  in which they may submit comments. | | 9.   Patients,
  consumer organisations, health professionals, NGOs, other health technology developer associations
  and clinical experts
  may submit
  comments during the joint clinical assessment
  within
  a time-frame
  set by the designated sub-group.




  The Commission shall make public the declarations of interest of all consulted stakeholders in the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

9.   
  The designated sub-group shall ensure that stakeholders, including
  patients and clinical experts,
  are given an opportunity to provide
  comments during the
  preparation of the draft
  joint clinical assessment
  report and the summary report and set
  a time-frame
  in which they may submit comments.

9.   Patients,
  consumer organisations, health professionals, NGOs, other health technology developer associations
  and clinical experts
  may submit
  comments during the joint clinical assessment
  within
  a time-frame
  set by the designated sub-group.

The Commission shall make public the declarations of interest of all consulted stakeholders in the IT platform referred to in Article 27.

Amendment 95

Amendment 95

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 10

Article 6 – paragraph 10

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 10.   Following receipt and consideration of any comments provided in
  accordance
  with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the
  designated sub-group and to the Commission
  for comments. | | 10.   Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the
  Coordination Group
  for comments.
  The Commission shall publish all comments, which shall be duly answered, on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

10.   Following receipt and consideration of any comments provided in
  accordance
  with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the
  designated sub-group and to the Commission
  for comments.

10.   Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the
  Coordination Group
  for comments.
  The Commission shall publish all comments, which shall be duly answered, on the IT platform referred to in Article 27.

Amendment 96

Amendment 96

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 11

Article 6 – paragraph 11

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 11.   The assessor, with the assistance of the co-assessor, shall take into account the comments of the
  designated sub-group and the Commission
  and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval. | | 11.   The assessor, with the assistance of the co-assessor, shall take into account the comments of the
  Coordination Group
  and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for
  a final
  approval. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

11.   The assessor, with the assistance of the co-assessor, shall take into account the comments of the
  designated sub-group and the Commission
  and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.

11.   The assessor, with the assistance of the co-assessor, shall take into account the comments of the
  Coordination Group
  and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for
  a final
  approval.

Amendment 206

Amendment 206

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 12

Article 6 – paragraph 12

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 12.   The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by
  a simple
  majority of Member States. | | 12.   The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by
  qualified
  majority of Member States.


  Diverging positions and the grounds on which those positions are based shall be recorded in the final report.




  The final report shall include a sensitivity analysis if there is one or more of the following elements:









  (a) | different opinions on the studies to be excluded on the grounds of severe bias; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

12.   The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by
  a simple
  majority of Member States.

12.   The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by
  qualified
  majority of Member States.

Diverging positions and the grounds on which those positions are based shall be recorded in the final report.

The final report shall include a sensitivity analysis if there is one or more of the following elements:

(a)

different opinions on the studies to be excluded on the grounds of severe bias;

| (b) | diverging positions if studies shall be excluded as they do not reflect the up-to-date technological development; or |
| --- | --- |

(b)

diverging positions if studies shall be excluded as they do not reflect the up-to-date technological development; or

| (c) | controversies as to the definition of irrelevance thresholds regarding patient-relevant endpoints. |
| --- | --- |

(c)

controversies as to the definition of irrelevance thresholds regarding patient-relevant endpoints.

The choice of the one or more comparators and patient-relevant endpoints shall be medically justified and documented in the final report.

The final report shall also include the results of the joint scientific consultation carried out in accordance with Article 13. The scientific consultation reports shall be made public upon completion of the joint clinical assessments.

Amendment 98

Amendment 98

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 13

Article 6 – paragraph 13

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 13.   The assessor shall ensure
  the removal of any information of a commercially sensitive nature from
  the approved joint clinical assessment report and the summary report. | | 13.   The assessor shall ensure
  that
  the approved joint clinical assessment report and the summary report
  contain the clinical information which is the subject of the assessment and set out the methodology and studies used
  .
  The assessor shall consult the developer on the report before its publication. The developer shall have 10 working days to notify the assessor about any information it considers to be confidential and to justify its commercially sensitive nature. As a last resort, the assessor and the co-assessor shall decide as to whether the developer’s claim of confidentiality is justified. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

13.   The assessor shall ensure
  the removal of any information of a commercially sensitive nature from
  the approved joint clinical assessment report and the summary report.

13.   The assessor shall ensure
  that
  the approved joint clinical assessment report and the summary report
  contain the clinical information which is the subject of the assessment and set out the methodology and studies used
  .
  The assessor shall consult the developer on the report before its publication. The developer shall have 10 working days to notify the assessor about any information it considers to be confidential and to justify its commercially sensitive nature. As a last resort, the assessor and the co-assessor shall decide as to whether the developer’s claim of confidentiality is justified.

Amendment 99

Amendment 99

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 14

Article 6 – paragraph 14

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 14.   The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission. | | 14.   The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission,
  which shall include both reports on the IT platform
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14.   The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission.

14.   The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission,
  which shall include both reports on the IT platform
  .

Amendment 100

Amendment 100

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 14 a (new)

Article 6 – paragraph 14 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 14a.
     
  Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may notify its objections in writing to the Coordination Group and the Commission within seven working days. In such a case, the developer shall provide detailed grounds for its objections. The Coordination Group shall evaluate the objections within seven working days and shall revise the report, as necessary.




  The Coordination Group shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections of the submitting health technology developer and the Commission were addressed. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14a.
     
  Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may notify its objections in writing to the Coordination Group and the Commission within seven working days. In such a case, the developer shall provide detailed grounds for its objections. The Coordination Group shall evaluate the objections within seven working days and shall revise the report, as necessary.

The Coordination Group shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections of the submitting health technology developer and the Commission were addressed.

Amendment 101

Amendment 101

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 14 b (new)

Article 6 – paragraph 14 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 14b.
     
  The joint clinical assessment report and the summary report shall be ready in not less than 80 days and not more than 100 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed respectively. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14b.
     
  The joint clinical assessment report and the summary report shall be ready in not less than 80 days and not more than 100 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed respectively.

Amendment 102

Amendment 102

Proposal for a regulation

Proposal for a regulation

Article 6 – paragraph 14 c (new)

Article 6 – paragraph 14 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 14c.
     
  Where the submitting health technology developer withdraws the application for a marketing authorisation, giving reasons, or where the European Medicines Agency terminates an assessment, the Coordination Group shall be informed so that it terminates the joint clinical assessment procedure. The Commission shall publish the reasons for withdrawal of the application or termination of the assessment on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14c.
     
  Where the submitting health technology developer withdraws the application for a marketing authorisation, giving reasons, or where the European Medicines Agency terminates an assessment, the Coordination Group shall be informed so that it terminates the joint clinical assessment procedure. The Commission shall publish the reasons for withdrawal of the application or termination of the assessment on the IT platform referred to in Article 27.

Amendment 103

Amendment 103

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 1

Article 7 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   
  Where
  the Commission
  considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it
  shall include the name of the health technology which has been the subject of the
  approved
  report and summary report, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group. | | 1.   The Commission shall include the name of the health technology which has been the subject of the report and
  the approved
  summary report,
  regardless of whether or not it has been adopted
  , in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   
  Where
  the Commission
  considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it
  shall include the name of the health technology which has been the subject of the
  approved
  report and summary report, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

1.   The Commission shall include the name of the health technology which has been the subject of the report and
  the approved
  summary report,
  regardless of whether or not it has been adopted
  , in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

Amendment 104

Amendment 104

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 2

Article 7 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the
  substantive and procedural
  requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request
  it to
  review
  the report and summary report
  . | | 2.   Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the
  procedural legal
  requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request
  a
  review
  of the assessment, giving reasons
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the
  substantive and procedural
  requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request
  it to
  review
  the report and summary report
  .

2.   Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the
  procedural legal
  requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request
  a
  review
  of the assessment, giving reasons
  .

Amendment 105

Amendment 105

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 3

Article 7 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   
  The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline.
  The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the
  health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group
  .
  Article 6, paragraphs 12 to 14 shall apply. | | 3.   The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the
  Commission, from a procedural point of view, prior to a final opinion
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   
  The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline.
  The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the
  health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group
  .
  Article 6, paragraphs 12 to 14 shall apply.

3.   The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the
  Commission, from a procedural point of view, prior to a final opinion
  .

Amendment 106

Amendment 106

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 4

Article 7 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   
  Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies. | | deleted |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   
  Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.

deleted

deleted

Amendment 107

Amendment 107

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 5

Article 7 – paragraph 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 5.   If the Commission concludes that the modified approved joint
  clinical
  assessment report and summary report do not comply with the
  substantive and
  procedural requirements laid down in this Regulation,
  it shall decline to include the name of
  the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the
  non-inclusion
  . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report. | | 5.   If the Commission concludes that the modified approved joint assessment report and summary report do not comply with the procedural requirements laid down in this Regulation, the health technology
  which is the subject of the assessment shall be included
  in the List,
  together with the summary report of the assessment and the Commission’s comments, and all of which shall be published on the IT platform referred to in Article 27
  . The Commission shall inform the Coordination Group thereof, setting out the reasons for the
  negative report
  . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5.   If the Commission concludes that the modified approved joint
  clinical
  assessment report and summary report do not comply with the
  substantive and
  procedural requirements laid down in this Regulation,
  it shall decline to include the name of
  the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the
  non-inclusion
  . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

5.   If the Commission concludes that the modified approved joint assessment report and summary report do not comply with the procedural requirements laid down in this Regulation, the health technology
  which is the subject of the assessment shall be included
  in the List,
  together with the summary report of the assessment and the Commission’s comments, and all of which shall be published on the IT platform referred to in Article 27
  . The Commission shall inform the Coordination Group thereof, setting out the reasons for the
  negative report
  . The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

Amendment 108

Amendment 108

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 6

Article 7 – paragraph 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 6.   For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report
  on the IT platform referred to in Article 27
  and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. | | 6.   For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish,
  on the IT platform referred to in Article 27
  , the approved joint clinical assessment report and summary report
  as well as all the comments by stakeholders and interim reports
  , and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6.   For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report
  on the IT platform referred to in Article 27
  and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List.

6.   For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish,
  on the IT platform referred to in Article 27
  , the approved joint clinical assessment report and summary report
  as well as all the comments by stakeholders and interim reports
  , and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List.

Amendment 109

Amendment 109

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Article 8 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   Member States shall: | | 1.   
  For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated
  , Member States shall: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Member States shall:

1.   
  For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated
  , Member States shall:

Amendment 110

Amendment 110

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 1 – point a

Article 8 – paragraph 1 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a
  joint clinical assessment
  has been initiated
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a
  joint clinical assessment
  has been initiated
  ;

not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a

has been initiated

| (a) | use the
  joint clinical assessment
  reports in their health technology assessments at Member State level
  ; |
| --- | --- |

(a)

use the
  joint clinical assessment
  reports in their health technology assessments at Member State level
  ;

use the

reports in their health technology assessments at Member State level

Amendment 111

Amendment 111

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 1 – point b

Article 8 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | apply
  joint clinical assessment
  reports, in their health technology assessments
  at Member State level. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

apply
  joint clinical assessment
  reports, in their health technology assessments
  at Member State level.

apply

reports, in their health technology assessments

| (b) | not duplicate the
  joint clinical assessment at Member State level. |
| --- | --- |

(b)

not duplicate the
  joint clinical assessment at Member State level.

not duplicate the

Amendment 112

Amendment 112

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 1 a (new)

Article 8 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1a.   
  The requirement set out in point (b) of paragraph 1 shall not prevent Member States or regions from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which were not included in the joint clinical assessment and which are necessary to complete the health technology assessment or the overall pricing and reimbursement process.




  Such complementary assessments may compare the technology concerned against a comparator which represents the best available and evidence-based standard of care in the Member State concerned and which, despite that Member State's request during the scoping phase, was not included in the joint clinical assessment. They may also assess the technology in a care context specific to the Member State concerned, based on its clinical practice, or the setting chosen for reimbursement.




  Any such measure shall be justified, necessary and proportionate to achieving this aim, shall not duplicate work done at Union level and shall not unduly delay patient access to those technologies.




  Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1a.   
  The requirement set out in point (b) of paragraph 1 shall not prevent Member States or regions from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which were not included in the joint clinical assessment and which are necessary to complete the health technology assessment or the overall pricing and reimbursement process.

Such complementary assessments may compare the technology concerned against a comparator which represents the best available and evidence-based standard of care in the Member State concerned and which, despite that Member State's request during the scoping phase, was not included in the joint clinical assessment. They may also assess the technology in a care context specific to the Member State concerned, based on its clinical practice, or the setting chosen for reimbursement.

Any such measure shall be justified, necessary and proportionate to achieving this aim, shall not duplicate work done at Union level and shall not unduly delay patient access to those technologies.

Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so.

Amendment 113

Amendment 113

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 2

Article 8 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   Member States shall
  notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by
  information
  on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States
  through the IT platform referred to in Article 27. | | 2.   Member States shall
  submit
  information, through the IT platform referred to in Article 27,
  on how account has been taken of the joint clinical assessment report in the health technology assessment at Member State level as well as other clinical data and additional evidence taken into account so that the Commission may facilitate the exchange of this information among Member States
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   Member States shall
  notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by
  information
  on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States
  through the IT platform referred to in Article 27.

2.   Member States shall
  submit
  information, through the IT platform referred to in Article 27,
  on how account has been taken of the joint clinical assessment report in the health technology assessment at Member State level as well as other clinical data and additional evidence taken into account so that the Commission may facilitate the exchange of this information among Member States
  .

Amendment 114

Amendment 114

Proposal for a regulation

Proposal for a regulation

Article 9 – paragraph 1 – point b

Article 9 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available.

| (b) | the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available
  within the deadline set in that report
  ; |
| --- | --- |

(b)

the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available
  within the deadline set in that report
  ;

within the deadline set in that report

Amendment 115

Amendment 115

Proposal for a regulation

Proposal for a regulation

Article 9 – paragraph 1 – point b a (new)

Article 9 – paragraph 1 – point b a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (ba) | at the request of a Member State or a health technology developer that considers that there is new clinical evidence; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ba)

(ba)

at the request of a Member State or a health technology developer that considers that there is new clinical evidence;

at the request of a Member State or a health technology developer that considers that there is new clinical evidence;

Amendment 116

Amendment 116

Proposal for a regulation

Proposal for a regulation

Article 9 – paragraph 1 – point b b (new)

Article 9 – paragraph 1 – point b b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (bb) | five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(bb)

(bb)

five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges.

five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges.

Amendment 117

Amendment 117

Proposal for a regulation

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 1 a (new)

Article 9 – paragraph 1 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8.




  The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8.

In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8.

The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health.

The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health.

Amendment 118

Amendment 118

Proposal for a regulation

Proposal for a regulation

Article 9 – paragraph 2

Article 9 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members. | | 2.   The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.


  Updates of joint clinical assessments are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint clinical assessment report is requested, the member who proposed it can update the joint clinical assessment report and propose it for adoption by other Member States by mutual recognition. When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group.




  Where Member States cannot agree on an update, the case is referred to the Coordination Group. The Coordination Group shall decide whether to carry out an update based on the new information.




  When an update is approved by mutual recognition or after the Coordination Group’s decision, the joint clinical assessment report is considered updated. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

2.   The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

Updates of joint clinical assessments are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint clinical assessment report is requested, the member who proposed it can update the joint clinical assessment report and propose it for adoption by other Member States by mutual recognition. When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group.

Where Member States cannot agree on an update, the case is referred to the Coordination Group. The Coordination Group shall decide whether to carry out an update based on the new information.

When an update is approved by mutual recognition or after the Coordination Group’s decision, the joint clinical assessment report is considered updated.

Amendment 119

Amendment 119

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – introductory part

Article 11 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.
     The Commission shall develop, by means of implementing acts, procedural rules for: | | 1.   The Commission shall,
  in accordance with this Regulation
  , develop, by means of implementing acts, procedural rules for: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.
     The Commission shall develop, by means of implementing acts, procedural rules for:

1.   The Commission shall,
  in accordance with this Regulation
  , develop, by means of implementing acts, procedural rules for:

Amendment 120

Amendment 120

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – point a

Article 11 – paragraph 1 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | submissions of information, data and evidence by health technology developers; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

submissions of information, data and evidence by health technology developers;

submissions of information, data and evidence by health technology developers;

deleted

deleted

Amendment 121

Amendment 121

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – point c

Article 11 – paragraph 1 – point c

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (c) | determining the detailed procedural steps and their timing,
  and the overall duration of joint clinical assessments
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

determining the detailed procedural steps and their timing,
  and the overall duration of joint clinical assessments
  ;

and the overall duration of joint clinical assessments

| (c) | determining the detailed procedural steps and their timing; |
| --- | --- |

(c)

determining the detailed procedural steps and their timing;

Amendment 122

Amendment 122

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – point f

Article 11 – paragraph 1 – point f

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (f) | cooperation with the
  notified
  bodies and expert panels
  on the preparation and update of joint clinical assessments of medical devices. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(f)

cooperation with the
  notified
  bodies and expert panels
  on the preparation and update of joint clinical assessments of medical devices.

notified

on the preparation and update of joint clinical assessments of medical devices.

| (f) | cooperation with the
  bodies and expert panels. |
| --- | --- |

(f)

cooperation with the
  bodies and expert panels.

bodies and expert panels.

Amendment 123

Amendment 123

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 1

Article 12 – paragraph 1 – subparagraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning
  data and evidence likely to be required as part of a joint
  clinical
  assessment
  . | | Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning
  the
  clinical
  aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning
  data and evidence likely to be required as part of a joint
  clinical
  assessment
  .

data and evidence likely to be required as part of a joint

assessment

Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning
  the
  clinical
  aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence
  .

the

aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence

Amendment 124

Amendment 124

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 2 – point f a (new)

Article 12 – paragraph 2 – point f a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (fa) | Union clinical research priorities ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(fa)

(fa)

Union clinical research priorities ;

Union clinical research priorities ;

Amendment 125

Amendment 125

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 3

Article 12 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2. | | 3.   Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.


  Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions. The assessor and co-assessor appointed to carry them out pursuant to Article 13(3) shall not be the same as the assessor and co-assessor appointed pursuant to Article 6(3) for the joint technological assessment.




  The subject and the summarised substance of the consultations shall be published on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

3.   Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions. The assessor and co-assessor appointed to carry them out pursuant to Article 13(3) shall not be the same as the assessor and co-assessor appointed pursuant to Article 6(3) for the joint technological assessment.

The subject and the summarised substance of the consultations shall be published on the IT platform referred to in Article 27.

Amendment 126

Amendment 126

Proposal for a regulation

Proposal for a regulation

Article 13 – title

Article 13 – title

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Preparation of
  Joint Scientific Consultation
  Reports | | Joint scientific consultation
  procedure |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Preparation of
  Joint Scientific Consultation
  Reports

Preparation of

Reports

Joint scientific consultation
  procedure

procedure

Amendment 127

Amendment 127

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 2

Article 13 – paragraph 1 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the
  procedural rules
  and documentation established pursuant to Articles 16 and 17. | | The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the
  procedure
  and documentation established pursuant to Articles 16 and 17. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the
  procedural rules
  and documentation established pursuant to Articles 16 and 17.

procedural rules

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the
  procedure
  and documentation established pursuant to Articles 16 and 17.

procedure

Amendment 128

Amendment 128

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 2

Article 13 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The designated sub-group shall request the health technology developer to submit the documentation containing
  the
  information, data and
  evidence
  necessary for the joint scientific consultation. | | 2.   The designated sub-group shall request the health technology developer to submit the
  available and up-to-date
  documentation containing
  all stages of
  information
  processing
  , data and
  studies
  necessary for the joint scientific consultation,
  such as available data from all tests performed and from all the studies in which the technology was used
  .
  A tailored clinical assessment pathway may be developed for orphan medicinal products due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator. All that information shall be made publicly available, upon completion of the joint clinical assessments.




  The designated sub-group and the health technology developer concerned shall hold a joint meeting based on the documentation described in first subparagraph. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The designated sub-group shall request the health technology developer to submit the documentation containing
  the
  information, data and
  evidence
  necessary for the joint scientific consultation.

2.   The designated sub-group shall request the health technology developer to submit the
  available and up-to-date
  documentation containing
  all stages of
  information
  processing
  , data and
  studies
  necessary for the joint scientific consultation,
  such as available data from all tests performed and from all the studies in which the technology was used
  .
  A tailored clinical assessment pathway may be developed for orphan medicinal products due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator. All that information shall be made publicly available, upon completion of the joint clinical assessments.

The designated sub-group and the health technology developer concerned shall hold a joint meeting based on the documentation described in first subparagraph.

Amendment 129

Amendment 129

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 3

Article 13 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise
  necessary for the assessment. | | 3.   The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation,
  who shall not be the same as the assessor and a co-assessor to be appointed pursuant to Article 6(3)
  . The appointments shall take into account the scientific expertise. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise
  necessary for the assessment.

3.   The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation,
  who shall not be the same as the assessor and a co-assessor to be appointed pursuant to Article 6(3)
  . The appointments shall take into account the scientific expertise.

Amendment 130

Amendment 130

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 7

Article 13 – paragraph 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 7.   The assessor shall provide the draft joint scientific consultation report to the
  submitting
  health technology developer
  and set
  a time-frame
  in which the developer may submit comments
  . | | 7.   The assessor shall provide the draft joint scientific consultation report,
  and provide it
  to the health technology developer
  for comments, setting
  a time-frame
  for those comments
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7.   The assessor shall provide the draft joint scientific consultation report to the
  submitting
  health technology developer
  and set
  a time-frame
  in which the developer may submit comments
  .

7.   The assessor shall provide the draft joint scientific consultation report,
  and provide it
  to the health technology developer
  for comments, setting
  a time-frame
  for those comments
  .

Amendment 131

Amendment 131

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 8

Article 13 – paragraph 8

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 8.   The
  designated sub-group shall ensure that stakeholders
  ,
  including
  patients and clinical experts
  are given an opportunity to provide
  comments during the
  preparation of the draft
  joint scientific consultation
  report and set a time-frame in which they may submit comments. | | 8.   The
  health technology developer
  , patients,
  health professionals
  and clinical experts
  may submit
  comments during the joint scientific consultation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

8.   The
  designated sub-group shall ensure that stakeholders
  ,
  including
  patients and clinical experts
  are given an opportunity to provide
  comments during the
  preparation of the draft
  joint scientific consultation
  report and set a time-frame in which they may submit comments.

8.   The
  health technology developer
  , patients,
  health professionals
  and clinical experts
  may submit
  comments during the joint scientific consultation.

Amendment 132

Amendment 132

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 9

Article 13 – paragraph 9

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 9.   Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments. | | 9.   Following receipt and consideration of any
  information and
  comments provided in accordance with paragraphs
  2
  , 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.
  All comments, which shall be public and answered when required, shall be published on the IT platform referred to in Article 27, following finalisation of the joint clinical assessment. The published comments shall include stakeholders comments and any differences of opinion expressed by members of the sub-group in the course of the procedure. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

9.   Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.

9.   Following receipt and consideration of any
  information and
  comments provided in accordance with paragraphs
  2
  , 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.
  All comments, which shall be public and answered when required, shall be published on the IT platform referred to in Article 27, following finalisation of the joint clinical assessment. The published comments shall include stakeholders comments and any differences of opinion expressed by members of the sub-group in the course of the procedure.

Amendment 133

Amendment 133

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 10

Article 13 – paragraph 10

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 10.
     Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate
  with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice
  . | | 10.   Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate
  the time-frame
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

10.
     Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate
  with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice
  .

10.   Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate
  the time-frame
  .

Amendment 207

Amendment 207

Proposal for a regulation

Proposal for a regulation

Article 13 – paragraph 12

Article 13 – paragraph 12

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 12.   The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by
  a simple
  majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. | | 12.   The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by
  qualified
  majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

12.   The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by
  a simple
  majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

12.   The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by
  qualified
  majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

Amendment 135

Amendment 135

Proposal for a regulation

Proposal for a regulation

Article 14 – paragraph 2

Article 14 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Coordination Group shall include
  anonymised
  summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. | | 2.   The Coordination Group shall include summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.
  That information shall include the subject of the consultations and the comments.




  The scientific consultation reports shall be made public upon completion of the joint clinical assessments. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Coordination Group shall include
  anonymised
  summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.

2.   The Coordination Group shall include summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.
  That information shall include the subject of the consultations and the comments.

The scientific consultation reports shall be made public upon completion of the joint clinical assessments.

Amendment 136

Amendment 136

Proposal for a regulation

Proposal for a regulation

Article 14 – paragraph 3

Article 14 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated
  and where the contents of the request are the same as those covered by the joint
  scientific
  consultation
  . | | 3.   Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology
  referred to in Article 5
  for which a joint scientific consultation has been initiated,
  unless additional clinical data and evidence were not taken into account and such data and evidence are considered necessary. Such national
  scientific
  consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated
  and where the contents of the request are the same as those covered by the joint
  scientific
  consultation
  .

3.   Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology
  referred to in Article 5
  for which a joint scientific consultation has been initiated,
  unless additional clinical data and evidence were not taken into account and such data and evidence are considered necessary. Such national
  scientific
  consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27
  .

Amendment 137

Amendment 137

Proposal for a regulation

Proposal for a regulation

Article 16 – paragraph 1 – point a

Article 16 – paragraph 1 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | submissions of requests from health technology developers
  and their involvement in the preparation of joint scientific consultation reports
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

submissions of requests from health technology developers
  and their involvement in the preparation of joint scientific consultation reports
  ;

and their involvement in the preparation of joint scientific consultation reports

| (a) | submissions of requests from health technology developers; |
| --- | --- |

(a)

submissions of requests from health technology developers;

Amendment 138

Amendment 138

Proposal for a regulation

Proposal for a regulation

Article 16 – paragraph 1 – point d

Article 16 – paragraph 1 – point d

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (d) | the
  consultation of
  patients, clinical experts and other relevant stakeholders; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(d)

the
  consultation of
  patients, clinical experts and other relevant stakeholders;

consultation of

| (d) | the
  submission of comments by
  patients,
  health professionals, patient associations, social partners, non-governmental organisations
  , clinical experts and other relevant stakeholders; |
| --- | --- |

(d)

the
  submission of comments by
  patients,
  health professionals, patient associations, social partners, non-governmental organisations
  , clinical experts and other relevant stakeholders;

submission of comments by

health professionals, patient associations, social partners, non-governmental organisations

Amendment 139

Amendment 139

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1 – introductory part

Article 17 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The Commission shall be empowered to adopt
  delegated
  acts in accordance with
  Article 31
  concerning: | | The Commission shall be empowered to adopt
  implementing
  acts in accordance with
  Articles 30 and 32
  concerning: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission shall be empowered to adopt
  delegated
  acts in accordance with
  Article 31
  concerning:

delegated

Article 31

The Commission shall be empowered to adopt
  implementing
  acts in accordance with
  Articles 30 and 32
  concerning:

implementing

Articles 30 and 32

Amendment 140

Amendment 140

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1 – point a – introductory part

Article 17 – paragraph 1 – point a – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | the
  contents of
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

the
  contents of
  :

contents of

| (a) | the
  procedure for
  : |
| --- | --- |

(a)

the
  procedure for
  :

procedure for

Amendment 141

Amendment 141

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1 – point a – point iii a (new)

Article 17 – paragraph 1 – point a – point iii a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (iiia) | stakeholder involvement for the purpose of this section, including rules on conflict of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with a conflict of interest shall not participate in the process. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iiia)

(iiia)

stakeholder involvement for the purpose of this section, including rules on conflict of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with a conflict of interest shall not participate in the process.

stakeholder involvement for the purpose of this section, including rules on conflict of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with a conflict of interest shall not participate in the process.

Amendment 142

Amendment 142

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1 – point b

Article 17 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the rules for determining the stakeholders to be consulted for the purpose of this Section. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

(b)

the rules for determining the stakeholders to be consulted for the purpose of this Section.

the rules for determining the stakeholders to be consulted for the purpose of this Section.

deleted

deleted

Amendment 143

Amendment 143

Proposal for a regulation

Proposal for a regulation

Article 18 – paragraph 2 – point b

Article 18 – paragraph 2 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | patient organisations; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

patient organisations;

| (b) | patient
  and consumer
  organisations
  and health professionals at its annual meeting
  ; |
| --- | --- |

(b)

patient
  and consumer
  organisations
  and health professionals at its annual meeting
  ;

and consumer

and health professionals at its annual meeting

Amendment 144

Amendment 144

Proposal for a regulation

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Article 18 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To that end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To that end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments.

Amendment 145

Amendment 145

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – introductory part

Article 19 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall support cooperation and the exchange of scientific information among Member States on: | | 1.   The Commission shall support
  any further
  cooperation and the exchange of scientific information among Member States on
  the following issues
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall support cooperation and the exchange of scientific information among Member States on:

1.   The Commission shall support
  any further
  cooperation and the exchange of scientific information among Member States on
  the following issues
  :

Amendment 146

Amendment 146

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – point d a (new)

Article 19 – paragraph 1 – point d a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (da) | clinical assessments of medicinal products and medical devices carried out by Member States; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(da)

(da)

clinical assessments of medicinal products and medical devices carried out by Member States;

clinical assessments of medicinal products and medical devices carried out by Member States;

Amendment 147

Amendment 147

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – point d b (new)

Article 19 – paragraph 1 – point d b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (db) | measures relating to compassionate use in clinical practice in order to improve the evidence basis and to create a register for this purpose; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(db)

(db)

measures relating to compassionate use in clinical practice in order to improve the evidence basis and to create a register for this purpose;

measures relating to compassionate use in clinical practice in order to improve the evidence basis and to create a register for this purpose;

Amendment 148

Amendment 148

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – point d c (new)

Article 19 – paragraph 1 – point d c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (dc) | the development of best medical practice guides based on scientific evidence; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(dc)

(dc)

the development of best medical practice guides based on scientific evidence;

the development of best medical practice guides based on scientific evidence;

Amendment 149

Amendment 149

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – point d d (new)

Article 19 – paragraph 1 – point d d (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (dd) | disinvestment in obsolete technologies; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(dd)

(dd)

disinvestment in obsolete technologies;

disinvestment in obsolete technologies;

Amendment 150

Amendment 150

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 1 – point d e (new)

Article 19 – paragraph 1 – point d e (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (de) | the tightening of the rules on clinical evidence generation and its monitoring. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(de)

(de)

the tightening of the rules on clinical evidence generation and its monitoring.

the tightening of the rules on clinical evidence generation and its monitoring.

Amendment 151

Amendment 151

Proposal for a regulation

Proposal for a regulation

Article 19 – paragraph 3

Article 19 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The cooperation referred to in paragraph 1 points (b)
  and (c)
  may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23. | | 3.   The cooperation referred to in paragraph 1 points (b),
  (c), (db) and (de)
  may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The cooperation referred to in paragraph 1 points (b)
  and (c)
  may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23.

3.   The cooperation referred to in paragraph 1 points (b),
  (c), (db) and (de)
  may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23.

Amendment 152

Amendment 152

Proposal for a regulation

Proposal for a regulation

Article 20 – paragraph 1 – point b

Article 20 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | clinical assessments of medicinal products and medical devices carried out by Member States. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

(b)

clinical assessments of medicinal products and medical devices carried out by Member States.

clinical assessments of medicinal products and medical devices carried out by Member States.

deleted

deleted

Amendment 153

Amendment 153

Proposal for a regulation

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 a (new)

Article 20 – paragraph 1 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level.

Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level.

Amendment 154

Amendment 154

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Article 22 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall adopt implementing acts concerning: | | 1.   
  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, and after consulting all relevant stakeholders
  , the Commission shall adopt implementing acts concerning: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall adopt implementing acts concerning:

1.   
  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, and after consulting all relevant stakeholders
  , the Commission shall adopt implementing acts concerning:

Amendment 155

Amendment 155

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point a – point i

Article 22 – paragraph 1 – point a – point i

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (i) | ensuring that
  health technology authorities and bodies
  carry out clinical assessments in an independent and transparent manner, free from conflicts of interest; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

ensuring that
  health technology authorities and bodies
  carry out clinical assessments in an independent and transparent manner, free from conflicts of interest;

health technology authorities and bodies

| (i) | ensuring that
  the members of the Coordination Group
  carry out clinical assessments in an independent and transparent manner, free from conflicts of interest,
  in accordance with Article 3(6) and (7)
  ; |
| --- | --- |

(i)

ensuring that
  the members of the Coordination Group
  carry out clinical assessments in an independent and transparent manner, free from conflicts of interest,
  in accordance with Article 3(6) and (7)
  ;

the members of the Coordination Group

in accordance with Article 3(6) and (7)

Amendment 156

Amendment 156

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point a – point ii

Article 22 – paragraph 1 – point a – point ii

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (ii) | the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii)

the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments;

| (ii) | the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments,
  subject to the provisions of the previous articles
  ; |
| --- | --- |

(ii)

the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments,
  subject to the provisions of the previous articles
  ;

subject to the provisions of the previous articles

Amendment 157

Amendment 157

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii

Article 22 – paragraph 1 – point a – point iii

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (iii) | the consultation
  of patients, clinical experts, and other stakeholders in clinical assessments. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

the consultation
  of patients, clinical experts, and other stakeholders in clinical assessments.

the consultation

| (iii) | comments
  of patients,
  health professionals, consumer organisations
  , clinical experts, and other stakeholders in clinical assessments
  and the duly justified replies, subject to the provisions of the previous articles
  ; |
| --- | --- |

(iii)

comments
  of patients,
  health professionals, consumer organisations
  , clinical experts, and other stakeholders in clinical assessments
  and the duly justified replies, subject to the provisions of the previous articles
  ;

comments

health professionals, consumer organisations

and the duly justified replies, subject to the provisions of the previous articles

Amendment 158

Amendment 158

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii a (new)

Article 22 – paragraph 1 – point a – point iii a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (iiia) | addressing potential conflicts of interest; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iiia)

(iiia)

addressing potential conflicts of interest;

addressing potential conflicts of interest;

Amendment 159

Amendment 159

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii b (new)

Article 22 – paragraph 1 – point a – point iii b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (iiib) | ensuring that the assessment of medical devices is able to take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iiib)

(iiib)

ensuring that the assessment of medical devices is able to take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders.

ensuring that the assessment of medical devices is able to take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders.

Amendment 160

Amendment 160

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 – point b

Article 22 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | methodologies used to formulate the contents and design of clinical assessments
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

methodologies used to formulate the contents and design of clinical assessments
  .

methodologies used to formulate the contents and design of clinical assessments

| (b) | in order to guarantee the quality of the process, a penalty mechanism in the event of non-compliance by the technology developer with the requirements concerning the available information to be provided
  . |
| --- | --- |

(b)

in order to guarantee the quality of the process, a penalty mechanism in the event of non-compliance by the technology developer with the requirements concerning the available information to be provided
  .

in order to guarantee the quality of the process, a penalty mechanism in the event of non-compliance by the technology developer with the requirements concerning the available information to be provided

Amendment 208/rev

Amendment 208/rev

Proposal for a regulation

Proposal for a regulation

Article 22 – paragraph 1 a (new)

Article 22 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1a.
     
  Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:









  (a) | the methodologies are based on high standards of quality, the best available scientific evidence, stemming, where practically feasible and ethically justifiable, primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1a.
     
  Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:

(a)

the methodologies are based on high standards of quality, the best available scientific evidence, stemming, where practically feasible and ethically justifiable, primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews;

| (b) | the assessments of relative effectiveness are based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned; |
| --- | --- |

(b)

the assessments of relative effectiveness are based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned;

| (c) | the methodologies take into account the specificities of new procedures and certain types of medicinal products with less clinical evidence available at the time of the marketing authorisation (such as orphan medicinal products or conditional marketing authorisations). However, any such lack of evidence does not prevent the generation of additional evidence required to be post monitored and which may require post-assessment and shall not affect patients security or scientific quality; |
| --- | --- |

(c)

the methodologies take into account the specificities of new procedures and certain types of medicinal products with less clinical evidence available at the time of the marketing authorisation (such as orphan medicinal products or conditional marketing authorisations). However, any such lack of evidence does not prevent the generation of additional evidence required to be post monitored and which may require post-assessment and shall not affect patients security or scientific quality;

| (d) | the comparators are the reference comparators for the clinical entity concerned and the best and/or most commonly used technological or process based comparator; |
| --- | --- |

(d)

the comparators are the reference comparators for the clinical entity concerned and the best and/or most commonly used technological or process based comparator;

| (e) | for medicinal products, the technology developers, for the purpose of clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That dossier shall include the clinical study report; |
| --- | --- |

(e)

for medicinal products, the technology developers, for the purpose of clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That dossier shall include the clinical study report;

| (f) | the information to be provided by the health technology developer relates to the most up-to-date and public data. Failure to comply with that requirement may trigger a penalty mechanism; |
| --- | --- |

(f)

the information to be provided by the health technology developer relates to the most up-to-date and public data. Failure to comply with that requirement may trigger a penalty mechanism;

| (g) | clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, may be carried out in exceptional cases and shall be fully justified; |
| --- | --- |

(g)

clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, may be carried out in exceptional cases and shall be fully justified;

| (h) | common methods as well as data requirements and outcome measures take into account the specificities of medical devices and in vitro diagnostic medical devices; |
| --- | --- |

(h)

(h)

common methods as well as data requirements and outcome measures take into account the specificities of medical devices and in vitro diagnostic medical devices;

common methods as well as data requirements and outcome measures take into account the specificities of medical devices and in vitro diagnostic medical devices;

| (i) | regarding vaccines, the methodology takes into account the lifelong effect of a vaccine through an appropriate time horizon of the analyses; indirect effects such as herd immunity; and elements independent from the vaccine as such, for example coverage rates linked to programmes; |
| --- | --- |

(i)

(i)

regarding vaccines, the methodology takes into account the lifelong effect of a vaccine through an appropriate time horizon of the analyses; indirect effects such as herd immunity; and elements independent from the vaccine as such, for example coverage rates linked to programmes;

regarding vaccines, the methodology takes into account the lifelong effect of a vaccine through an appropriate time horizon of the analyses; indirect effects such as herd immunity; and elements independent from the vaccine as such, for example coverage rates linked to programmes;

| (j) | where practically feasible and ethically justifiable, the health technology developer conducts at least one randomised controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment. |
| --- | --- |

(j)

(j)

where practically feasible and ethically justifiable, the health technology developer conducts at least one randomised controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.

where practically feasible and ethically justifiable, the health technology developer conducts at least one randomised controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.

In the case of a medical device, the methodology shall be adapted to its characteristics and specificities, taking as a basis the methodology already developed by EUnetHTA.

In the case of a medical device, the methodology shall be adapted to its characteristics and specificities, taking as a basis the methodology already developed by EUnetHTA.

The Coordination Group shall submit the draft implementing regulation to the Commission for endorsement.

The Coordination Group shall submit the draft implementing regulation to the Commission for endorsement.

Within [3 months] of receipt of the draft measure, the Commission shall decide whether to endorse it by means of an implementing act adopted in accordance with the examination procedure referred to in Article 30(2).

Within [3 months] of receipt of the draft measure, the Commission shall decide whether to endorse it by means of an implementing act adopted in accordance with the examination procedure referred to in Article 30(2).

Where the Commission intends not to endorse a draft measure or to endorse it in part or where it proposes amendments, it shall send the draft back to the Coordination Group, setting out the reasons. Within a period of [six weeks], the Coordination Group may amend the draft measure on the basis of the Commission’s indications and proposed amendments, and resubmit it to the Commission.

Where the Commission intends not to endorse a draft measure or to endorse it in part or where it proposes amendments, it shall send the draft back to the Coordination Group, setting out the reasons. Within a period of [six weeks], the Coordination Group may amend the draft measure on the basis of the Commission’s indications and proposed amendments, and resubmit it to the Commission.

If, on the expiry of the [six-week period], the Coordination Group has not submitted an amended draft measure, or has submitted a draft measure that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing regulation with the amendments it considers relevant or reject it.

If, on the expiry of the [six-week period], the Coordination Group has not submitted an amended draft measure, or has submitted a draft measure that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing regulation with the amendments it considers relevant or reject it.

In the event that the Coordination Group does not submit a draft measure to the Commission within the time limit in accordance with [paragraph 1], the Commission may adopt the implementing regulation without a draft having been submitted from the Coordination Group.

In the event that the Coordination Group does not submit a draft measure to the Commission within the time limit in accordance with [paragraph 1], the Commission may adopt the implementing regulation without a draft having been submitted from the Coordination Group.

Amendment 162

Amendment 162

Proposal for a regulation

Proposal for a regulation

Article 23 – paragraph 1 – introductory part

Article 23 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The
  Commission shall be empowered to adopt delegated acts in accordance with
  Article
  31 concerning
  : | | The
  Coordination Group, following the same procedure set up in point (a) of
  Article
  2(1) shall establish
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The
  Commission shall be empowered to adopt delegated acts in accordance with
  Article
  31 concerning
  :

Commission shall be empowered to adopt delegated acts in accordance with

31 concerning

The
  Coordination Group, following the same procedure set up in point (a) of
  Article
  2(1) shall establish
  :

Coordination Group, following the same procedure set up in point (a) of

2(1) shall establish

Amendment 163

Amendment 163

Proposal for a regulation

Proposal for a regulation

Article 23 – paragraph 1 – point a – introductory part

Article 23 – paragraph 1 – point a – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | the
  contents
  of: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

the
  contents
  of:

contents

| (a) | the
  format and templates
  of: |
| --- | --- |

(a)

the
  format and templates
  of:

format and templates

Amendment 164

Amendment 164

Proposal for a regulation

Proposal for a regulation

Article 23 – paragraph 1 – point b

Article 23 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter.

| (b) | the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter,
  notwithstanding Article 26
  . |
| --- | --- |

(b)

the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter,
  notwithstanding Article 26
  .

notwithstanding Article 26

Amendment 165

Amendment 165

Proposal for a regulation

Proposal for a regulation

Article 24 – title

Article 24 – title

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Union
  Funding | | Funding |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Union
  Funding

Union

Funding

Amendment 166

Amendment 166

Proposal for a regulation

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Article 24 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  The Union shall ensure stable and permanent public funding for the joint work on HTA that shall be conducted without the direct or indirect funding by developers of health technologies. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  The Union shall ensure stable and permanent public funding for the joint work on HTA that shall be conducted without the direct or indirect funding by developers of health technologies.

Amendment 167

Amendment 167

Proposal for a regulation

Proposal for a regulation

Article 24 – paragraph 2 b (new)

Article 24 – paragraph 2 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2b.
     
  The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities. Such a system of charges shall under no circumstances used to finance activities under this Regulation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2b.
     
  The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities. Such a system of charges shall under no circumstances used to finance activities under this Regulation.

Amendment 168

Amendment 168

Proposal for a regulation

Proposal for a regulation

Article 25 – paragraph 1 – point a

Article 25 – paragraph 1 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | host on its premises and co-chair the meetings of the Coordination Group; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

host on its premises and co-chair the meetings of the Coordination Group;

| (a) | host on its premises and co-chair –
  with the right to speak, but not to vote
  – the meetings of the Coordination Group; |
| --- | --- |

(a)

host on its premises and co-chair –
  with the right to speak, but not to vote
  – the meetings of the Coordination Group;

with the right to speak, but not to vote

Amendment 169

Amendment 169

Proposal for a regulation

Proposal for a regulation

Article 25 – paragraph 1 – point b

Article 25 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | provide the secretariat for the Coordination Group and provide administrative,
  scientific
  and IT support; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

provide the secretariat for the Coordination Group and provide administrative,
  scientific
  and IT support;

scientific

| (b) | provide the secretariat for the Coordination Group and provide administrative and IT support; |
| --- | --- |

(b)

provide the secretariat for the Coordination Group and provide administrative and IT support;

Amendment 170

Amendment 170

Proposal for a regulation

Proposal for a regulation

Article 25 – paragraph 1 – point d

Article 25 – paragraph 1 – point d

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (d) | verify that the work of the Coordination Group is carried out in an independent and transparent manner; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(d)

verify that the work of the Coordination Group is carried out in an independent and transparent manner;

| (d) | verify that the work of the Coordination Group is carried out in an independent and transparent manner,
  in accordance with the established rules of procedure
  ; |
| --- | --- |

(d)

verify that the work of the Coordination Group is carried out in an independent and transparent manner,
  in accordance with the established rules of procedure
  ;

in accordance with the established rules of procedure

Amendment 171

Amendment 171

Proposal for a regulation

Proposal for a regulation

Article 25 – paragraph 1 – point f

Article 25 – paragraph 1 – point f

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (f) | facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of
  confidential
  information. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(f)

facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of
  confidential
  information.

confidential

| (f) | facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of information. |
| --- | --- |

(f)

facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of information.

Amendment 172

Amendment 172

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 1

Article 26 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. | | 1.   The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications,
  such as legitimacy, representation, transparency and accountability
  .


  The organisations to be addressed by the open call for applications shall be patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals.




  Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network.




  The European Parliament shall have two representatives in the stakeholder network. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

1.   The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications,
  such as legitimacy, representation, transparency and accountability
  .

The organisations to be addressed by the open call for applications shall be patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals.

Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network.

The European Parliament shall have two representatives in the stakeholder network.

Amendment 173

Amendment 173

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 2

Article 26 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Commission shall publish the list of stakeholder organisations included in the stakeholder network. | | 2.   The Commission shall publish the list of stakeholder organisations included in the stakeholder network.
  Stakeholders shall not have conflict of interest and their declarations of interests shall be published in the IT platform. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Commission shall publish the list of stakeholder organisations included in the stakeholder network.

2.   The Commission shall publish the list of stakeholder organisations included in the stakeholder network.
  Stakeholders shall not have conflict of interest and their declarations of interests shall be published in the IT platform.

Amendment 174

Amendment 174

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – introductory part

Article 26 – paragraph 3 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The Commission shall organise
  ad-hoc meetings
  between the stakeholder network and the Coordination Group in order to: | | 3.   The Commission shall organise
  a meeting
  between the stakeholder network and the Coordination Group
  at least once a year
  in order to
  promote a constructive dialogue. The roles of the stakeholder network shall include
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The Commission shall organise
  ad-hoc meetings
  between the stakeholder network and the Coordination Group in order to:

3.   The Commission shall organise
  a meeting
  between the stakeholder network and the Coordination Group
  at least once a year
  in order to
  promote a constructive dialogue. The roles of the stakeholder network shall include
  :

Amendment 175

Amendment 175

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point a

Article 26 – paragraph 3 – point a

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (a) | update stakeholders
  on the work of the group; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

update stakeholders
  on the work of the group;

update stakeholders

| (a) | exchange of information
  on the work of the
  Coordination
  Group
  and the assessment process
  ; |
| --- | --- |

(a)

exchange of information
  on the work of the
  Coordination
  Group
  and the assessment process
  ;

exchange of information

Coordination

and the assessment process

Amendment 176

Amendment 176

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point b

Article 26 – paragraph 3 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | provide for an exchange of information on the work of the Coordination Group. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

provide for an exchange of information on the work of the Coordination Group.

provide for an exchange of information on the work of the Coordination Group.

| (b) | participation in seminars or workshops or specific actions on particular aspects
  ; |
| --- | --- |

(b)

participation in seminars or workshops or specific actions on particular aspects
  ;

participation in seminars or workshops or specific actions on particular aspects

Amendment 177

Amendment 177

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point b a (new)

Article 26 – paragraph 3 – point b a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (ba) | supporting access to real-life experiences on diseases and their management and on the actual use of health technologies, in the interests of a better understanding of the value which stakeholders attach to the scientific evidence provided during the assessment process. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ba)

(ba)

supporting access to real-life experiences on diseases and their management and on the actual use of health technologies, in the interests of a better understanding of the value which stakeholders attach to the scientific evidence provided during the assessment process.

supporting access to real-life experiences on diseases and their management and on the actual use of health technologies, in the interests of a better understanding of the value which stakeholders attach to the scientific evidence provided during the assessment process.

Amendment 178

Amendment 178

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point b b (new)

Article 26 – paragraph 3 – point b b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (bb) | contributing to more focused and efficient communication with and between stakeholders in order to support their role in the safe and rational use of health technologies; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(bb)

(bb)

contributing to more focused and efficient communication with and between stakeholders in order to support their role in the safe and rational use of health technologies;

contributing to more focused and efficient communication with and between stakeholders in order to support their role in the safe and rational use of health technologies;

Amendment 179

Amendment 179

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point b c (new)

Article 26 – paragraph 3 – point b c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (bc) | drawing up a list of priorities for medical research; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(bc)

(bc)

drawing up a list of priorities for medical research;

drawing up a list of priorities for medical research;

Amendment 180

Amendment 180

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – point b d (new)

Article 26 – paragraph 3 – point b d (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (bd) | seeking input into the annual work programme and the annual study prepared by the Coordination Group; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(bd)

(bd)

seeking input into the annual work programme and the annual study prepared by the Coordination Group;

seeking input into the annual work programme and the annual study prepared by the Coordination Group;

Amendment 181

Amendment 181

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 3 – subparagraph 1 a (new)

Article 26 – paragraph 3 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27.

The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27.

Amendment 182

Amendment 182

Proposal for a regulation

Proposal for a regulation

Article 26 – paragraph 4

Article 26 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers. | | 4.   On the request of the Coordination Group, the Commission shall invite patients,
  health professionals
  and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group, as observers. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

4.   On the request of the Coordination Group, the Commission shall invite patients,
  health professionals
  and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group, as observers.

Amendment 183

Amendment 183

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 1 – introductory part

Article 27 – paragraph 1 – introductory part

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall develop and maintain an IT platform containing information on: | | 1.   
  Building on the work already undertaken by the EUnetHTA Joint Actions
  , the Commission shall develop and maintain an IT platform containing information on: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall develop and maintain an IT platform containing information on:

1.   
  Building on the work already undertaken by the EUnetHTA Joint Actions
  , the Commission shall develop and maintain an IT platform containing information on:

Amendment 184

Amendment 184

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 1 – point d a (new)

Article 27 – paragraph 1 – point d a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (da) | a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(da)

(da)

a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests;

a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests;

Amendment 185

Amendment 185

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 1 – point d b (new)

Article 27 – paragraph 1 – point d b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (db) | all information whose publication is required under this Regulation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(db)

(db)

all information whose publication is required under this Regulation;

all information whose publication is required under this Regulation;

Amendment 186

Amendment 186

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 1 – point d c (new)

Article 27 – paragraph 1 – point d c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (dc) | final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(dc)

(dc)

final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union;

final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union;

Amendment 187

Amendment 187

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 1 – point d d (new)

Article 27 – paragraph 1 – point d d (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (dd) | a list of organisations included in the stakeholder network; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(dd)

(dd)

a list of organisations included in the stakeholder network;

a list of organisations included in the stakeholder network;

Amendment 188

Amendment 188

Proposal for a regulation

Proposal for a regulation

Article 27 – paragraph 2

Article 27 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Commission shall ensure
  appropriate levels of
  access to the information contained in the IT platform
  for Member State bodies, members of the stakeholder network, and the general public
  . | | 2.   The Commission shall ensure
  public
  access to the information contained in the IT platform. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Commission shall ensure
  appropriate levels of
  access to the information contained in the IT platform
  for Member State bodies, members of the stakeholder network, and the general public
  .

2.   The Commission shall ensure
  public
  access to the information contained in the IT platform.

Amendment 189

Amendment 189

Proposal for a regulation

Proposal for a regulation

Article 28 – title

Article 28 – title

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Implementation Report | | Evaluation report on the transitional period |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Implementation Report

Implementation Report

Evaluation report on the transitional period

Evaluation report on the transitional period

Amendment 190

Amendment 190

Proposal for a regulation

Proposal for a regulation

Article 28 – paragraph 1

Article 28 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| No later than two years after
  the end of the transitional period referred to in Article
  33(1)
  , the Commission shall report on the
  implementation
  of the
  provisions on
  the scope of the joint clinical assessments and
  on
  the functioning of the support framework
  referred to in this Chapter
  . | | At
  the end of the transitional period referred to in Article
  33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory
  , the Commission shall
  submit an impact assessment
  report on the
  whole
  of the
  procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of
  the scope of the joint clinical assessments and the functioning of the support framework. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

No later than two years after
  the end of the transitional period referred to in Article
  33(1)
  , the Commission shall report on the
  implementation
  of the
  provisions on
  the scope of the joint clinical assessments and
  on
  the functioning of the support framework
  referred to in this Chapter
  .

No later than two years after

33(1)

implementation

provisions on

on

referred to in this Chapter

At
  the end of the transitional period referred to in Article
  33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory
  , the Commission shall
  submit an impact assessment
  report on the
  whole
  of the
  procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of
  the scope of the joint clinical assessments and the functioning of the support framework.

At

33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory

submit an impact assessment

whole

procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of

Amendment 191

Amendment 191

Proposal for a regulation

Proposal for a regulation

Article 31

Article 31

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Article 31
  Exercise of the Delegation



  1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.






  2.
     
  The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from ... [insert date of entry into force of this Regulation].






  3.
     
  The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.






  4.
     
  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.






  5.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.






  6.
     
  A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. | | deleted |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Article 31

Exercise of the Delegation

1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.
     
  The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from ... [insert date of entry into force of this Regulation].

3.
     
  The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.
     
  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

5.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.
     
  A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

deleted

deleted

Amendment 192

Amendment 192

Proposal for a regulation

Proposal for a regulation

Article 32 – title

Article 32 – title

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Preparation of Implementing
  and Delegated
  Acts | | Preparation of Implementing Acts |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Preparation of Implementing
  and Delegated
  Acts

and Delegated

Preparation of Implementing Acts

Amendment 193

Amendment 193

Proposal for a regulation

Proposal for a regulation

Article 32 – paragraph 1

Article 32 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.
     The Commission shall adopt the implementing
  and delegated
  acts referred to in Articles 11, 16, 17, 22,
  and 23
  , at the latest by the date of application of this Regulation. | | 1.   The Commission shall adopt the implementing acts referred to in Articles 11, 16, 17
  and
  22, at the latest by the date of application of this Regulation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.
     The Commission shall adopt the implementing
  and delegated
  acts referred to in Articles 11, 16, 17, 22,
  and 23
  , at the latest by the date of application of this Regulation.

1.   The Commission shall adopt the implementing acts referred to in Articles 11, 16, 17
  and
  22, at the latest by the date of application of this Regulation.

Amendment 194

Amendment 194

Proposal for a regulation

Proposal for a regulation

Article 32 – paragraph 2

Article 32 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   When preparing those implementing
  and delegated
  acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors. | | 2.   When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors,
  and shall consider the work already undertaken in the EUnetHTA Joint Actions
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   When preparing those implementing
  and delegated
  acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.

2.   When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors,
  and shall consider the work already undertaken in the EUnetHTA Joint Actions
  .

Amendment 195

Amendment 195

Proposal for a regulation

Proposal for a regulation

Article 33 – paragraph 1

Article 33 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date
  3
  years after the date of application]. | | 1.   Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date
  4
  years after the date of application]
  for medicinal products referred to in points (a) and (aa) of Article 5(1), and until ... [insert date 7 years after the date of application] for medical devices referred in Article point (b) of Article 5(1) and for in vitro diagnostic medical devices referred in point (c) of Article 5(1). |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date
  3
  years after the date of application].

1.   Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date
  4
  years after the date of application]
  for medicinal products referred to in points (a) and (aa) of Article 5(1), and until ... [insert date 7 years after the date of application] for medical devices referred in Article point (b) of Article 5(1) and for in vitro diagnostic medical devices referred in point (c) of Article 5(1).

Amendment 196

Amendment 196

Proposal for a regulation

Proposal for a regulation

Article 34 – paragraph 1

Article 34 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. | | 1.   Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation,
  on the grounds set out in Article 8(1a), and
  on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

1.   Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation,
  on the grounds set out in Article 8(1a), and
  on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

Amendment 197

Amendment 197

Proposal for a regulation

Proposal for a regulation

Article 34 – paragraph 2

Article 34 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so. | | 2.   Member States shall notify the Commission
  and the Coordination Group
  of their intention to carry out a clinical assessment using other means together with the justifications for doing so. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so.

2.   Member States shall notify the Commission
  and the Coordination Group
  of their intention to carry out a clinical assessment using other means together with the justifications for doing so.

Amendment 198

Amendment 198

Proposal for a regulation

Proposal for a regulation

Article 34 – paragraph 2 a (new)

Article 34 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  The Coordination Group may assess whether the request fulfils the grounds referred to in paragraph 1, and may submit its conclusions to the Commission. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  The Coordination Group may assess whether the request fulfils the grounds referred to in paragraph 1, and may submit its conclusions to the Commission.

Amendment 199

Amendment 199

Proposal for a regulation

Proposal for a regulation

Article 34 – paragraph 3

Article 34 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. | | 3.   The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.
  The Commission’s decision shall be published on the IT platform referred to in Article 27. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.

3.   The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.
  The Commission’s decision shall be published on the IT platform referred to in Article 27.

---

(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0289/2018).

1

(2)  

  OJ C 263, 25.7.2018, p. 4

  .

2

OJ C 263, 25.7.2018, p. 4

(3)  
  Directive 2011/24/EU of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

3

Directive 2011/24/EU of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

(4)  OJ C 438, 6.12.2014, p. 12.

4

(5)  OJ C 438, 6.12.2014, p. 12.

5

(6)  European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).

6

(7)  European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).

7

(8)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

8

(9)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

9

(10)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

10

(11)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

11

(12)  
  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

12

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(*1)  
  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

*1

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(*2)  
  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

*2

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

(13)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

13

(14)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

14

(15)  
  Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).

15

Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).

(16)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

16

(17)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

17

(1)  
  Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).

1

Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/177 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/177

---

P8_TA(2018)0370

Emission performance standards for new passenger cars and for new light commercial vehicles ***I

Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council setting emission performance standards for new passenger cars and for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles and amending Regulation (EC) No 715/2007 (recast) (COM(2017)0676 – C8-0395/2017 – 2017/0293(COD)) (1)

(Ordinary legislative procedure – recast)

(2020/C 011/24)

Amendment 1

Proposal for a regulation

Recital 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (3) | The European Strategy for Low-Emission Mobility16 sets a clear ambition: by mid-century
  , greenhouse gas emissions from
  transport will need to be at least 60% lower than in 1990 and
  be firmly on the path towards
  zero
  . Emissions of air pollutants from transport that harm our health need to be drastically reduced without delay. Emissions from conventional combustion engines will need to further
  reduce
  after 2020. Zero- and low emission vehicles will need to be deployed and gain significant market share by 2030. |

Text proposed by the Commission

Amendment

(3)

The European Strategy for Low-Emission Mobility16 sets a clear ambition: by mid-century
  , greenhouse gas emissions from
  transport will need to be at least 60% lower than in 1990 and
  be firmly on the path towards
  zero
  . Emissions of air pollutants from transport that harm our health need to be drastically reduced without delay. Emissions from conventional combustion engines will need to further
  reduce
  after 2020. Zero- and low emission vehicles will need to be deployed and gain significant market share by 2030.

| (3) | Transport is the only major sector in the Union where greenhouse gas emissions are still rising
  .
  In order to meet the Union's commitments made at the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (UNFCCC)
  ,
  held in Paris in 2015, the decarbonisation of the entire transport sector needs to be accelerated and
  greenhouse gas emissions from
  that sector should
  be firmly on the path towards
  zero-emission by mid-century
  . Emissions of air pollutants from transport that
  significantly
  harm our health,
  and the environment
  , need
  also
  to be drastically reduced without delay. Emissions from conventional combustion engines will need to
  be
  further
  reduced
  after 2020. Zero- and low emission vehicles will need to be deployed and gain significant market share by 2030. |
| --- | --- |

(3)

Transport is the only major sector in the Union where greenhouse gas emissions are still rising
  .
  In order to meet the Union's commitments made at the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (UNFCCC)
  ,
  held in Paris in 2015, the decarbonisation of the entire transport sector needs to be accelerated and
  greenhouse gas emissions from
  that sector should
  be firmly on the path towards
  zero-emission by mid-century
  . Emissions of air pollutants from transport that
  significantly
  harm our health,
  and the environment
  , need
  also
  to be drastically reduced without delay. Emissions from conventional combustion engines will need to
  be
  further
  reduced
  after 2020. Zero- and low emission vehicles will need to be deployed and gain significant market share by 2030.

Amendment 2

Proposal for a regulation

Recital 4 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4a) | The development of research, supply, processing and production strategies into light-weight component construction developments is crucial for advancement in a low-carbon transition in the automotive sector. There is a growing body of research into natural-fibre raw materials and their composites as part of a wider emerging role for the bio-economy and the renewable, recyclable and sustainable products it can produce. Those developments need to be framed around an understanding of the limitations concerning natural resources, land availability and hence the need to offering sustainable end-of-life solutions. |

Text proposed by the Commission

Amendment

(4a)

The development of research, supply, processing and production strategies into light-weight component construction developments is crucial for advancement in a low-carbon transition in the automotive sector. There is a growing body of research into natural-fibre raw materials and their composites as part of a wider emerging role for the bio-economy and the renewable, recyclable and sustainable products it can produce. Those developments need to be framed around an understanding of the limitations concerning natural resources, land availability and hence the need to offering sustainable end-of-life solutions.

Amendment 3

Proposal for a regulation

Recital 4 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4b) | A socially acceptable and just transition towards zero-emission mobility by mid-century requires changes in the whole automotive value chain, taking into consideration the potential adverse effect on citizens and regions in all Member States. It is important to consider the social effects of the transition and to be proactive in addressing the implications on jobs. It is of paramount importance, therefore, that current measures are also accompanied by targeted programmes at Union, national and regional levels for re-skilling, up-skilling and redeployment of workers, as well as education and job-seeking initiatives in adversely affected communities and regions conducted in close dialogue with the social partners and competent authorities. |

Text proposed by the Commission

Amendment

(4b)

A socially acceptable and just transition towards zero-emission mobility by mid-century requires changes in the whole automotive value chain, taking into consideration the potential adverse effect on citizens and regions in all Member States. It is important to consider the social effects of the transition and to be proactive in addressing the implications on jobs. It is of paramount importance, therefore, that current measures are also accompanied by targeted programmes at Union, national and regional levels for re-skilling, up-skilling and redeployment of workers, as well as education and job-seeking initiatives in adversely affected communities and regions conducted in close dialogue with the social partners and competent authorities.

Amendment 4

Proposal for a regulation

Recital 4 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4c) | A successful transition to zero- emission mobility requires a common policy framework for vehicles, infrastructures, electricity grids, sustainable battery production, supply and recycling, where economic and employment incentives are working together across Union, national, regional and local levels and are supported by stronger Union funding instruments. |

Text proposed by the Commission

Amendment

(4c)

A successful transition to zero- emission mobility requires a common policy framework for vehicles, infrastructures, electricity grids, sustainable battery production, supply and recycling, where economic and employment incentives are working together across Union, national, regional and local levels and are supported by stronger Union funding instruments.

Amendment 5

Proposal for a regulation

Recital 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (6) | The European Council Conclusions of October 2014 endorsed a greenhouse gas emissions reduction of 30% by 2030 compared to 2005 for the sectors that are not part of the European Union emissions trading system.
  Road transport
  provides a major contribution to the emissions of those sectors, and its
  emissions remain significantly above 1990 levels.
  If the road transport emissions increase further, it will offset
  reductions made by other sectors to combat climate change. |

Text proposed by the Commission

Amendment

(6)

The European Council Conclusions of October 2014 endorsed a greenhouse gas emissions reduction of 30% by 2030 compared to 2005 for the sectors that are not part of the European Union emissions trading system.
  Road transport
  provides a major contribution to the emissions of those sectors, and its
  emissions remain significantly above 1990 levels.
  If the road transport emissions increase further, it will offset
  reductions made by other sectors to combat climate change.

| (6) | Road transport emissions remain significantly above 1990 levels,
  offsetting
  reductions made by other sectors to combat climate change. |
| --- | --- |

(6)

Road transport emissions remain significantly above 1990 levels,
  offsetting
  reductions made by other sectors to combat climate change.

Amendment 6

Proposal for a regulation

Recital 9

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (9) | An evaluation of Regulations (EC) No 443/2009 and (EU) No 510/2011 in 2015 concluded that those Regulations have been relevant, broadly coherent, and have generated significant emissions savings, whilst being more cost-effective than originally anticipated. They have also generated significant added value for the Union that could not have been achieved to the same extent through national measures. |

Text proposed by the Commission

Amendment

(9)

An evaluation of Regulations (EC) No 443/2009 and (EU) No 510/2011 in 2015 concluded that those Regulations have been relevant, broadly coherent, and have generated significant emissions savings, whilst being more cost-effective than originally anticipated. They have also generated significant added value for the Union that could not have been achieved to the same extent through national measures.

| (9) | An evaluation of Regulations (EC) No 443/2009 and (EU) No 510/2011 in 2015 concluded that those Regulations have been relevant, broadly coherent, and have generated significant emissions savings, whilst being more cost-effective than originally anticipated. They have also generated significant added value for the Union that could not have been achieved to the same extent through national measures.
  However, that evaluation also concluded that actual CO2 savings achieved are considerably less than those suggested by the type-approval test performance and that the ‘emissions gap’between type-approval test and real-world performance has considerably undermined the effectiveness of the CO2 performance standards as well as consumers' trust in the potential fuel savings of new vehicles. |
| --- | --- |

(9)

An evaluation of Regulations (EC) No 443/2009 and (EU) No 510/2011 in 2015 concluded that those Regulations have been relevant, broadly coherent, and have generated significant emissions savings, whilst being more cost-effective than originally anticipated. They have also generated significant added value for the Union that could not have been achieved to the same extent through national measures.
  However, that evaluation also concluded that actual CO2 savings achieved are considerably less than those suggested by the type-approval test performance and that the ‘emissions gap’between type-approval test and real-world performance has considerably undermined the effectiveness of the CO2 performance standards as well as consumers' trust in the potential fuel savings of new vehicles.

Amendment 7

Proposal for a regulation

Recital 10 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (10a) | In order to ensure the effectiveness of this Regulation, CO2 emission reductions should be delivered under conditions encountered in normal vehicle operation and use. It is therefore appropriate to include a strict prohibition of defeat devices in this Regulation and to provide authorities with the means to ensure compliance with this prohibition. |

Text proposed by the Commission

Amendment

(10a)

In order to ensure the effectiveness of this Regulation, CO2 emission reductions should be delivered under conditions encountered in normal vehicle operation and use. It is therefore appropriate to include a strict prohibition of defeat devices in this Regulation and to provide authorities with the means to ensure compliance with this prohibition.

Amendment 8

Proposal for a regulation

Recital 12

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (12) | It is important that
  the setting of CO2 emissions reduction requirements continues to provide Union -wide predictability and planning security for vehicle manufacturers across their new car and light commercial vehicle fleets in the Union. |

Text proposed by the Commission

Amendment

(12)

It is important that
  the setting of CO2 emissions reduction requirements continues to provide Union -wide predictability and planning security for vehicle manufacturers across their new car and light commercial vehicle fleets in the Union.

| (12) | The setting of CO2 emissions reduction requirements continues to provide Union -wide predictability and planning security for vehicle manufacturers across their new car and light commercial vehicle fleets in the Union. |
| --- | --- |

(12)

The setting of CO2 emissions reduction requirements continues to provide Union -wide predictability and planning security for vehicle manufacturers across their new car and light commercial vehicle fleets in the Union.

Amendment 9

Proposal for a regulation

Recital 12 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (12 a) | The Commission’s evaluation of Directive 1999/94/EC of the European Parliament and of the Council

   (*1)

  in 2016 identified a need for further clarification and simplification of the legislation, which could increase its relevance, effectiveness, efficiency and coherence. Commission Recommendation (EU) 2017/948

   (*2)

  aims to encourage a harmonised application of Directive 1999/94/EC. Nevertheless, better designed and further harmonised Union requirements on car labelling that provide consumers with comparable, reliable and user friendly information about the benefits of low emission cars, including information concerning air pollutants and running costs in addition to CO2 emissions and fuel consumption, could support the uptake of the most fuel efficient and environmentally friendly cars across the Union. The Commission should therefore review Directive 1999/94/EC no later than 31 December 2019 and put forward a relevant legislative proposal. Furthermore, similar to passenger cars, the sector of light commercial vehicles could also benefit from the introduction of such a fuel economy and CO2 emissions label. Therefore, the Commission should also analyse those options for that sector, and where appropriate, put forward relevant legislative proposals. |

Text proposed by the Commission

Amendment

(12 a)

The Commission’s evaluation of Directive 1999/94/EC of the European Parliament and of the Council

   (*1)

  in 2016 identified a need for further clarification and simplification of the legislation, which could increase its relevance, effectiveness, efficiency and coherence. Commission Recommendation (EU) 2017/948

   (*2)

  aims to encourage a harmonised application of Directive 1999/94/EC. Nevertheless, better designed and further harmonised Union requirements on car labelling that provide consumers with comparable, reliable and user friendly information about the benefits of low emission cars, including information concerning air pollutants and running costs in addition to CO2 emissions and fuel consumption, could support the uptake of the most fuel efficient and environmentally friendly cars across the Union. The Commission should therefore review Directive 1999/94/EC no later than 31 December 2019 and put forward a relevant legislative proposal. Furthermore, similar to passenger cars, the sector of light commercial vehicles could also benefit from the introduction of such a fuel economy and CO2 emissions label. Therefore, the Commission should also analyse those options for that sector, and where appropriate, put forward relevant legislative proposals.

Amendment 10

Proposal for a regulation

Recital 13

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (13) | Reduction levels for the Union-wide fleets of new passenger cars and light commercial vehicles should
  therefore
  be set for 2025 and for 2030, taking into account the vehicle fleet renewal time and the need for the road transport sector to contribute to the
  2030
  climate and energy targets. This stepwise approach also provides a clear and early signal for the automotive industry not to delay the market introduction of energy efficient technologies and zero- and low-emission vehicles. |

Text proposed by the Commission

Amendment

(13)

Reduction levels for the Union-wide fleets of new passenger cars and light commercial vehicles should
  therefore
  be set for 2025 and for 2030, taking into account the vehicle fleet renewal time and the need for the road transport sector to contribute to the
  2030
  climate and energy targets. This stepwise approach also provides a clear and early signal for the automotive industry not to delay the market introduction of energy efficient technologies and zero- and low-emission vehicles.

| (13) | Reduction levels for the Union-wide fleets of new passenger cars and light commercial vehicles should be set for 2025 and for 2030, taking into account the vehicle fleet renewal time and the need for the road transport sector to contribute to the
  Union
  climate and energy targets
  for 2030 and beyond
  . This stepwise approach also provides a clear and early signal for the automotive industry not to delay the market introduction of energy efficient technologies and zero- and low-emission vehicles.
  In addition, in order to sustain the momentum of emissions reduction beyond 2030, at least the same emissions-reduction trajectory should apply as of 1 January 2031 allowing for the continued decarbonisation of the sector in line with the commitments under the Paris Agreement. |
| --- | --- |

(13)

Reduction levels for the Union-wide fleets of new passenger cars and light commercial vehicles should be set for 2025 and for 2030, taking into account the vehicle fleet renewal time and the need for the road transport sector to contribute to the
  Union
  climate and energy targets
  for 2030 and beyond
  . This stepwise approach also provides a clear and early signal for the automotive industry not to delay the market introduction of energy efficient technologies and zero- and low-emission vehicles.
  In addition, in order to sustain the momentum of emissions reduction beyond 2030, at least the same emissions-reduction trajectory should apply as of 1 January 2031 allowing for the continued decarbonisation of the sector in line with the commitments under the Paris Agreement.

Amendment 11

Proposal for a regulation

Recital 14

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (14) | While the Union is among the world's major producers of motor vehicles and demonstrates technological leadership in this sector, competition is increasing and the global automotive sector is changing rapidly through new innovations in electrified powertrains, and cooperative, connected and automated mobility. In order to retain its global competitiveness and access to markets, the Union needs a regulatory framework, including a particular
  incentive
  in the area of zero- and low-emission vehicles, which creates a large home market and supports technological development and innovation. |

Text proposed by the Commission

Amendment

(14)

While the Union is among the world's major producers of motor vehicles and demonstrates technological leadership in this sector, competition is increasing and the global automotive sector is changing rapidly through new innovations in electrified powertrains, and cooperative, connected and automated mobility. In order to retain its global competitiveness and access to markets, the Union needs a regulatory framework, including a particular
  incentive
  in the area of zero- and low-emission vehicles, which creates a large home market and supports technological development and innovation.

| (14) | While the Union is among the world's major producers of motor vehicles and demonstrates technological leadership in this sector, competition is increasing and the global automotive sector is changing rapidly through new innovations in electrified powertrains, and cooperative, connected and automated mobility.
  If the Union industry engages late in the necessary energy transition in the transport sector, it risks losing its leading role.
  In order to retain its global competitiveness and access to markets, the Union needs a regulatory framework, including a particular
  policy mechanism
  in the area of zero- and low-emission vehicles, which creates a large home market and supports technological development and innovation. |
| --- | --- |

(14)

While the Union is among the world's major producers of motor vehicles and demonstrates technological leadership in this sector, competition is increasing and the global automotive sector is changing rapidly through new innovations in electrified powertrains, and cooperative, connected and automated mobility.
  If the Union industry engages late in the necessary energy transition in the transport sector, it risks losing its leading role.
  In order to retain its global competitiveness and access to markets, the Union needs a regulatory framework, including a particular
  policy mechanism
  in the area of zero- and low-emission vehicles, which creates a large home market and supports technological development and innovation.

Amendment 12

Proposal for a regulation

Recital 14 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (14a) | It will not be possible to achieve the long-term goal of entirely decarbonising the Union mobility without technological innovation and technical progress. With that in mind, and in the face of increased international competition, it is essential that the Union and Member States continue their efforts to explore and develop initiatives that promote the synergies possible in the sector, taking as a model the recent European Battery Alliance, and support public and private investment in research and innovation in the Union car industry in order to maintain the Union’s technological leadership in that sector and to ensure the long-term sustainability of its industrial base, keeping it efficient and competitive on the world market. |

Text proposed by the Commission

Amendment

(14a)

It will not be possible to achieve the long-term goal of entirely decarbonising the Union mobility without technological innovation and technical progress. With that in mind, and in the face of increased international competition, it is essential that the Union and Member States continue their efforts to explore and develop initiatives that promote the synergies possible in the sector, taking as a model the recent European Battery Alliance, and support public and private investment in research and innovation in the Union car industry in order to maintain the Union’s technological leadership in that sector and to ensure the long-term sustainability of its industrial base, keeping it efficient and competitive on the world market.

Amendment 13

Proposal for a regulation

Recital 15

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (15) | A dedicated
  incentive
  mechanism should be introduced to facilitate a smooth transition towards zero-emission mobility. This crediting mechanism should be designed so as to promote the deployment on the Union market of zero- and low-emission vehicles. |

Text proposed by the Commission

Amendment

(15)

A dedicated
  incentive
  mechanism should be introduced to facilitate a smooth transition towards zero-emission mobility. This crediting mechanism should be designed so as to promote the deployment on the Union market of zero- and low-emission vehicles.

| (15) | A dedicated
  policy
  mechanism should be introduced to facilitate
  and accelerate
  a smooth transition towards zero-emission mobility. This crediting
  and debiting
  mechanism should be designed so as to promote the deployment on the Union market of zero- and low-emission vehicles
  and to ensure investment certainty for the timely and adequate roll-out of the necessary charging infrastructure. |
| --- | --- |

(15)

A dedicated
  policy
  mechanism should be introduced to facilitate
  and accelerate
  a smooth transition towards zero-emission mobility. This crediting
  and debiting
  mechanism should be designed so as to promote the deployment on the Union market of zero- and low-emission vehicles
  and to ensure investment certainty for the timely and adequate roll-out of the necessary charging infrastructure.

Amendment 14

Proposal for a regulation

Recital 16

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (16) | Setting a benchmark for the share of zero- and low-emission vehicles in the EU fleet together with a well-designed mechanism for adjusting a manufacturer's specific CO2 target based on the share of zero- and low-emission vehicles in the manufacturer's own fleet should provide a strong and credible signal for the development
  and
  deployment of such vehicles while still allowing for the further improvement of the efficiency of the conventional internal combustion engines. |

Text proposed by the Commission

Amendment

(16)

Setting a benchmark for the share of zero- and low-emission vehicles in the EU fleet together with a well-designed mechanism for adjusting a manufacturer's specific CO2 target based on the share of zero- and low-emission vehicles in the manufacturer's own fleet should provide a strong and credible signal for the development
  and
  deployment of such vehicles while still allowing for the further improvement of the efficiency of the conventional internal combustion engines.

| (16) | Setting
  a strong
  benchmark for the share of zero- and low-emission vehicles in the EU fleet together with a well-designed mechanism for adjusting a manufacturer's specific CO2 target based on the share of zero- and low-emission vehicles in the manufacturer's own fleet should provide a strong and credible signal for the development, deployment
  and marketing
  of such vehicles while still allowing for the further improvement of the efficiency of the conventional internal combustion engines. |
| --- | --- |

(16)

Setting
  a strong
  benchmark for the share of zero- and low-emission vehicles in the EU fleet together with a well-designed mechanism for adjusting a manufacturer's specific CO2 target based on the share of zero- and low-emission vehicles in the manufacturer's own fleet should provide a strong and credible signal for the development, deployment
  and marketing
  of such vehicles while still allowing for the further improvement of the efficiency of the conventional internal combustion engines.

Amendment 15

Proposal for a regulation

Recital 17

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (17) | In determining the
  credits
  for the zero- and low-emission vehicles, it is appropriate to account for the difference in CO2 emissions between the vehicles. The adjustment mechanism should ensure that a manufacturer exceeding the benchmark level would benefit from a higher specific CO2 target. In order to ensure a balanced approach, limits should be set to the level of adjustment possible within that mechanism. This will provide for incentives, promoting a timely roll-out of recharging and refuelling infrastructure and yielding high benefits for consumers, competitiveness, and the environment. |

Text proposed by the Commission

Amendment

(17)

In determining the
  credits
  for the zero- and low-emission vehicles, it is appropriate to account for the difference in CO2 emissions between the vehicles. The adjustment mechanism should ensure that a manufacturer exceeding the benchmark level would benefit from a higher specific CO2 target. In order to ensure a balanced approach, limits should be set to the level of adjustment possible within that mechanism. This will provide for incentives, promoting a timely roll-out of recharging and refuelling infrastructure and yielding high benefits for consumers, competitiveness, and the environment.

| (17) | In determining the
  benchmarks
  for the
  share of
  zero- and low-emission vehicles, it is appropriate to account for the difference in CO2 emissions between the vehicles, The adjustment mechanism should ensure that a manufacturer exceeding the benchmark level would benefit from a higher specific CO2 target,
  whereas a manufacturer not achieving the benchmark would have to comply with a stricter CO2 target
  . In order to ensure a balanced approach, limits should be set to the level of adjustment possible within that mechanism. This will provide for incentives, promoting a timely roll-out of recharging and refuelling infrastructure and yielding high benefits for consumers, competitiveness, and the environment. |
| --- | --- |

(17)

In determining the
  benchmarks
  for the
  share of
  zero- and low-emission vehicles, it is appropriate to account for the difference in CO2 emissions between the vehicles, The adjustment mechanism should ensure that a manufacturer exceeding the benchmark level would benefit from a higher specific CO2 target,
  whereas a manufacturer not achieving the benchmark would have to comply with a stricter CO2 target
  . In order to ensure a balanced approach, limits should be set to the level of adjustment possible within that mechanism. This will provide for incentives, promoting a timely roll-out of recharging and refuelling infrastructure and yielding high benefits for consumers, competitiveness, and the environment.

Amendment 16

Proposal for a regulation

Recital 17 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (17 a) | Timely and sufficient investments should be made in both the production and roll-out of zero- and low- emission vehicles and the overall supporting infrastructure that is required, including sustainable battery production, supply and recycling. Different support instruments at both Union and national level need to work together effectively, mobilising and incentivising significant public and private investment. Recharging and refuelling infrastructure needs to be put in place quickly in order to provide confidence to consumers and business certainty for vehicle manufacturers. Union battery and battery cell manufacturing, if possible, located close to vehicle manufacturing sites, should therefore be supported. |

Text proposed by the Commission

Amendment

(17 a)

Timely and sufficient investments should be made in both the production and roll-out of zero- and low- emission vehicles and the overall supporting infrastructure that is required, including sustainable battery production, supply and recycling. Different support instruments at both Union and national level need to work together effectively, mobilising and incentivising significant public and private investment. Recharging and refuelling infrastructure needs to be put in place quickly in order to provide confidence to consumers and business certainty for vehicle manufacturers. Union battery and battery cell manufacturing, if possible, located close to vehicle manufacturing sites, should therefore be supported.

Amendment 17

Proposal for a regulation

Recital 23

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (23) | A balance should however be ensured between incentives given to eco-innovations and those technologies for which the emission reduction effect is demonstrated on the official test procedure. As a consequence, it is appropriate to maintain a cap on the eco-innovation savings that a manufacturer may take into account for target compliance purposes. The Commission should have the possibility to review the level of the cap, in particular, to take into account the effects of the change in the official test procedure. It is also appropriate to clarify how the savings should be calculated for target compliance purposes. |

Text proposed by the Commission

Amendment

(23)

A balance should however be ensured between incentives given to eco-innovations and those technologies for which the emission reduction effect is demonstrated on the official test procedure. As a consequence, it is appropriate to maintain a cap on the eco-innovation savings that a manufacturer may take into account for target compliance purposes. The Commission should have the possibility to review the level of the cap, in particular, to take into account the effects of the change in the official test procedure. It is also appropriate to clarify how the savings should be calculated for target compliance purposes.

| (23) | A balance should however be ensured between incentives given to eco-innovations and those technologies for which the emission reduction effect is demonstrated on the official test procedure. As a consequence, it is appropriate to maintain a cap on the eco-innovation savings that a manufacturer may take into account for target compliance purposes. The Commission should have the possibility to review the level of the cap
  and adjust it downwards
  , in particular, to take into account the effects of the change in the official test procedure. It is also appropriate to clarify how the savings should be calculated for target compliance purposes. |
| --- | --- |

(23)

A balance should however be ensured between incentives given to eco-innovations and those technologies for which the emission reduction effect is demonstrated on the official test procedure. As a consequence, it is appropriate to maintain a cap on the eco-innovation savings that a manufacturer may take into account for target compliance purposes. The Commission should have the possibility to review the level of the cap
  and adjust it downwards
  , in particular, to take into account the effects of the change in the official test procedure. It is also appropriate to clarify how the savings should be calculated for target compliance purposes.

Amendment 18

Proposal for a regulation

Recital 25 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (25a) | In cases where for heavy light commercial vehicles of N1 category, Class III the inclusion of an electric battery might increase the weight of the vehicle to the extent that it is re-classified into N2 category, such a technical problem should be addressed. |

Text proposed by the Commission

Amendment

(25a)

In cases where for heavy light commercial vehicles of N1 category, Class III the inclusion of an electric battery might increase the weight of the vehicle to the extent that it is re-classified into N2 category, such a technical problem should be addressed.

Amendment 20

Proposal for a regulation

Recital 37

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (37) | The specific emissions of CO2 from new passenger cars and light commercial vehicles are measured on a harmonised basis in the Union according to the methodology laid down in Regulation (EC) No 715/2007. To minimise the administrative burden of this Regulation, compliance should be measured by reference to data on registrations of new cars and light commercial vehicles in the Union collected by Member States and reported to the Commission. To ensure the consistency of the data used to assess compliance, the rules for the collection and reporting of this data should be harmonised
  as far as possible
  . The competent authorities' responsibility to provide correct and complete data should therefore be clearly stated as well as the need for an effective cooperation between those authorities and the Commission in addressing data quality issues. |

Text proposed by the Commission

Amendment

(37)

The specific emissions of CO2 from new passenger cars and light commercial vehicles are measured on a harmonised basis in the Union according to the methodology laid down in Regulation (EC) No 715/2007. To minimise the administrative burden of this Regulation, compliance should be measured by reference to data on registrations of new cars and light commercial vehicles in the Union collected by Member States and reported to the Commission. To ensure the consistency of the data used to assess compliance, the rules for the collection and reporting of this data should be harmonised
  as far as possible
  . The competent authorities' responsibility to provide correct and complete data should therefore be clearly stated as well as the need for an effective cooperation between those authorities and the Commission in addressing data quality issues.

| (37) | The specific emissions of CO2 from new passenger cars and light commercial vehicles are measured on a harmonised basis in the Union according to the methodology laid down in Regulation (EC) No 715/2007. To minimise the administrative burden of this Regulation, compliance should be measured by reference to data on registrations of new cars and light commercial vehicles in the Union collected by Member States and reported to the Commission. To ensure the consistency of the data used to assess compliance, the rules for the collection and reporting of this data should be harmonised. The competent authorities' responsibility to provide correct and complete data should therefore be clearly stated as well as the need for an effective cooperation between those authorities and the Commission in addressing data quality issues. |
| --- | --- |

(37)

The specific emissions of CO2 from new passenger cars and light commercial vehicles are measured on a harmonised basis in the Union according to the methodology laid down in Regulation (EC) No 715/2007. To minimise the administrative burden of this Regulation, compliance should be measured by reference to data on registrations of new cars and light commercial vehicles in the Union collected by Member States and reported to the Commission. To ensure the consistency of the data used to assess compliance, the rules for the collection and reporting of this data should be harmonised. The competent authorities' responsibility to provide correct and complete data should therefore be clearly stated as well as the need for an effective cooperation between those authorities and the Commission in addressing data quality issues.

Amendment 21

Proposal for a regulation

Recital 38

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (38) | Manufacturers’ compliance with the targets under this Regulation should be assessed at Union level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year. The amounts of the excess emissions premium should be considered as revenue for the general budget of the Union. |

Text proposed by the Commission

Amendment

(38)

Manufacturers’ compliance with the targets under this Regulation should be assessed at Union level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year. The amounts of the excess emissions premium should be considered as revenue for the general budget of the Union.

| (38) | Manufacturers’ compliance with the targets under this Regulation should be assessed at Union level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year. The amounts of the excess emissions premium should be considered as revenue for the general budget of the Union
  and be used to contribute to a just transition towards zero-emission mobility. Those amounts should also be used to complement targeted programmes for re-skilling, up-skilling and education of workers affected by structural changes in the automotive sector, and for reallocation of labour and job-seeking initiatives in close dialogue with social partners, communities and competent authorities in the regions affected by the transition of jobs. |
| --- | --- |

(38)

Manufacturers’ compliance with the targets under this Regulation should be assessed at Union level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year. The amounts of the excess emissions premium should be considered as revenue for the general budget of the Union
  and be used to contribute to a just transition towards zero-emission mobility. Those amounts should also be used to complement targeted programmes for re-skilling, up-skilling and education of workers affected by structural changes in the automotive sector, and for reallocation of labour and job-seeking initiatives in close dialogue with social partners, communities and competent authorities in the regions affected by the transition of jobs.

Amendment 22

Proposal for a regulation

Recital 41

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (41) | The effectiveness of the targets set out in this Regulation in reducing CO2 emissions in reality is strongly dependent on the representativeness of the official test procedure. In accordance with the Opinion of the Scientific Advice Mechanism (SAM) (2) and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector (3), a mechanism should be put in place to assess the real world representativeness of vehicle CO2 emissions and energy consumption values determined in accordance with Regulation (EU) 2017/1151. The Commission should have the powers to ensure the public availability of
  such
  data, and,
  where necessary
  , develop the procedures needed for
  identifying and collecting the
  data required for performing such assessments. |

Text proposed by the Commission

Amendment

(41)

The effectiveness of the targets set out in this Regulation in reducing CO2 emissions in reality is strongly dependent on the representativeness of the official test procedure. In accordance with the Opinion of the Scientific Advice Mechanism (SAM) (2) and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector (3), a mechanism should be put in place to assess the real world representativeness of vehicle CO2 emissions and energy consumption values determined in accordance with Regulation (EU) 2017/1151. The Commission should have the powers to ensure the public availability of
  such
  data, and,
  where necessary
  , develop the procedures needed for
  identifying and collecting the
  data required for performing such assessments.

| (41) | The effectiveness of the targets set out in this Regulation in reducing CO2 emissions in reality is strongly dependent on the representativeness of the official test procedure. In accordance with the Opinion of the Scientific Advice Mechanism (SAM) (4) and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector (5), a mechanism should be put in place to assess the real world representativeness of vehicle CO2 emissions and energy consumption values determined in accordance with Regulation (EU) 2017/1151.
  The most reliable way to ensure the real world representativeness of type-approval values is by introducing a real-world CO2 emissions test. Therefore, the Commission should, by means of delegated acts, and with consideration of the appropriateness of using PEMS, develop the real-world CO2 emissions test and introduce it at the latest two years after the date of application of this Regulation. However, until that test becomes applicable, compliance with this Regulation should be ensured by using data from the fuel consumption meters reported by manufacturers and coupled with a limit, set for each manufacturer in 2021 as a percentage difference that is not to be exceeded.
  The Commission should have the powers to ensure the public availability of
  fuel consumption
  data, and
  to
  develop the procedures needed for
  reporting such
  data required for performing such assessments.
  The Commission should take appropriate measures in case of manufacturers’ non-compliance with the real-world CO2 emissions requirements under this Regulation. |
| --- | --- |

(41)

The effectiveness of the targets set out in this Regulation in reducing CO2 emissions in reality is strongly dependent on the representativeness of the official test procedure. In accordance with the Opinion of the Scientific Advice Mechanism (SAM) (4) and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector (5), a mechanism should be put in place to assess the real world representativeness of vehicle CO2 emissions and energy consumption values determined in accordance with Regulation (EU) 2017/1151.
  The most reliable way to ensure the real world representativeness of type-approval values is by introducing a real-world CO2 emissions test. Therefore, the Commission should, by means of delegated acts, and with consideration of the appropriateness of using PEMS, develop the real-world CO2 emissions test and introduce it at the latest two years after the date of application of this Regulation. However, until that test becomes applicable, compliance with this Regulation should be ensured by using data from the fuel consumption meters reported by manufacturers and coupled with a limit, set for each manufacturer in 2021 as a percentage difference that is not to be exceeded.
  The Commission should have the powers to ensure the public availability of
  fuel consumption
  data, and
  to
  develop the procedures needed for
  reporting such
  data required for performing such assessments.
  The Commission should take appropriate measures in case of manufacturers’ non-compliance with the real-world CO2 emissions requirements under this Regulation.

Amendment 23

Proposal for a regulation

Recital 41 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (41a) | Currently, there is no harmonised way to assess life-cycle emissions from light commercial vehicles. It is appropriate that the Commission provide such analysis by the end of 2026 to present a broad picture of carbon emissions from the light commercial vehicles sector. For that purpose, the Commission should develop, by means of delegated acts, a common Union methodology for the consistent data reporting, as from 2025, by manufacturers of the lifecycle CO2 emissions of all fuel types and vehicle powertrains they put on the market. Such methodology should also be in line with the relevant ISO standards and account for the global warming potential (GWP) of vehicle’s well-to-tank, tank-to-wheel, production and end-of-life emissions. The analysis by the Commission should be based on the data reported by manufacturers as well as any other available relevant data. |

Text proposed by the Commission

Amendment

(41a)

Currently, there is no harmonised way to assess life-cycle emissions from light commercial vehicles. It is appropriate that the Commission provide such analysis by the end of 2026 to present a broad picture of carbon emissions from the light commercial vehicles sector. For that purpose, the Commission should develop, by means of delegated acts, a common Union methodology for the consistent data reporting, as from 2025, by manufacturers of the lifecycle CO2 emissions of all fuel types and vehicle powertrains they put on the market. Such methodology should also be in line with the relevant ISO standards and account for the global warming potential (GWP) of vehicle’s well-to-tank, tank-to-wheel, production and end-of-life emissions. The analysis by the Commission should be based on the data reported by manufacturers as well as any other available relevant data.

Amendment 80

Proposal for a regulation

Recital 42

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (42) | In 2024 it is foreseen to review the progress achieved under the [Effort Sharing Regulation and Emissions Trading System Directive].
  It is
  therefore
  appropriate to assess the effectiveness of this Regulation
  in that same year
  to allow a coordinated and coherent assessment of
  the measures implemented under all these instruments. |

Text proposed by the Commission

Amendment

(42)

In 2024 it is foreseen to review the progress achieved under the [Effort Sharing Regulation and Emissions Trading System Directive].
  It is
  therefore
  appropriate to assess the effectiveness of this Regulation
  in that same year
  to allow a coordinated and coherent assessment of
  the measures implemented under all these instruments.

| (42) | It is appropriate to assess the effectiveness of this Regulation
  in 2023 in order
  to allow a
  timely, transparent
  , coordinated and coherent assessment of
  its implementation and the progress made towards achieving the set targets within the set timeline, also in relation to progress achieved under the Effort Sharing Regulation and Emissions Trading System Directive. |
| --- | --- |

(42)

It is appropriate to assess the effectiveness of this Regulation
  in 2023 in order
  to allow a
  timely, transparent
  , coordinated and coherent assessment of
  its implementation and the progress made towards achieving the set targets within the set timeline, also in relation to progress achieved under the Effort Sharing Regulation and Emissions Trading System Directive.

Amendment 24

Proposal for a regulation

Recital 46

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (46) | In order to amend or supplement non-essential elements of the provisions of this Regulation the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II and III as regards data requirements and data parameters, supplementing the rules on the interpretation of the eligibility criteria for derogations from the specific emissions targets, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2, adjusting the figure of M0 and TM0, referred to in Article 13, the 7 g CO2/km cap referred to in Article 11, and the adjustment of the formulae in Annex I referred to in Article 14(3). It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. |

Text proposed by the Commission

Amendment

(46)

In order to amend or supplement non-essential elements of the provisions of this Regulation the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II and III as regards data requirements and data parameters, supplementing the rules on the interpretation of the eligibility criteria for derogations from the specific emissions targets, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2, adjusting the figure of M0 and TM0, referred to in Article 13, the 7 g CO2/km cap referred to in Article 11, and the adjustment of the formulae in Annex I referred to in Article 14(3). It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

| (46) | In order to amend or supplement non-essential elements of the provisions of this Regulation the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II and III as regards data requirements and data parameters,
  establishing the requirements to ensure compliance with the prohibition of defeat devices and the required content of the extended documentation package referred to in Article 4(3c), establishing the rules and procedures for reporting life-cycle emissions referred to in Article 7(8a)
  , supplementing the rules on the interpretation of the eligibility criteria for derogations from the specific emissions targets, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2, adjusting the figure of M0 and TM0, referred to in Article 13, the 7 g CO2/km cap referred to in Article 11,
  developing a real-world CO2 emissions test referred to in Article 12(1a)
  and the adjustment of the formulae in Annex I referred to in Article 14(3). It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. |
| --- | --- |

(46)

In order to amend or supplement non-essential elements of the provisions of this Regulation the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending Annexes II and III as regards data requirements and data parameters,
  establishing the requirements to ensure compliance with the prohibition of defeat devices and the required content of the extended documentation package referred to in Article 4(3c), establishing the rules and procedures for reporting life-cycle emissions referred to in Article 7(8a)
  , supplementing the rules on the interpretation of the eligibility criteria for derogations from the specific emissions targets, on the content of applications for a derogation and on the content and assessment of programmes for the reduction of specific emissions of CO2, adjusting the figure of M0 and TM0, referred to in Article 13, the 7 g CO2/km cap referred to in Article 11,
  developing a real-world CO2 emissions test referred to in Article 12(1a)
  and the adjustment of the formulae in Annex I referred to in Article 14(3). It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts should systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Amendment 25

Proposal for a regulation

Article 1 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   This Regulation establishes CO2 emissions performance requirements for new passenger cars and for new light commercial vehicles in order to
  ensure
  the proper functioning of the internal market. | | 1.   This Regulation establishes CO2 emissions performance requirements for new passenger cars and for new light commercial vehicles in order to
  achieve the Union’s climate targets and to comply with its climate commitments at international level, in a manner which is consistent with
  the proper functioning of the internal market. |

Text proposed by the Commission

Amendment

1.   This Regulation establishes CO2 emissions performance requirements for new passenger cars and for new light commercial vehicles in order to
  ensure
  the proper functioning of the internal market.

1.   This Regulation establishes CO2 emissions performance requirements for new passenger cars and for new light commercial vehicles in order to
  achieve the Union’s climate targets and to comply with its climate commitments at international level, in a manner which is consistent with
  the proper functioning of the internal market.

Amendment 26

Amendment 26

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 4

Article 1 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   From 1 January 2025 the following EU fleet-wide targets shall apply:






  (a) | for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  15%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part A of Annex I; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   From 1 January 2025 the following EU fleet-wide targets shall apply:

(a)

for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  15%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part A of Annex I;

| (b) | for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a
  15%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part B of Annex I; |
| --- | --- |

(b)

for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a
  15%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part B of Annex I;

4.   From 1 January 2025 the following EU fleet-wide targets shall apply:

| (a) | for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  20 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part A of Annex I; |
| --- | --- |

(a)

for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  20 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part A of Annex I;

| (b) | for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a
  20 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part B of Annex I; |
| --- | --- |

(b)

for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a
  20 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.1 of Part B of Annex I;

Amendment 27

Amendment 27

Proposal for a regulation

Proposal for a regulation

Article 1 – paragraph 4 – subparagraph 1 a (new)

Article 1 – paragraph 4 – subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | From 1 January 2025, a benchmark equal to a 20 % market share of the sales of new passenger cars and new light commercial vehicles in 2025, shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

From 1 January 2025, a benchmark equal to a 20 % market share of the sales of new passenger cars and new light commercial vehicles in 2025, shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively.

From 1 January 2025, a benchmark equal to a 20 % market share of the sales of new passenger cars and new light commercial vehicles in 2025, shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively.

Amendments 81 and 95

Amendments 81 and 95

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 5

Article 1 — paragraph 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 5.   From 1 January 2030 the following targets shall apply:






  (a) | for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  30%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part A of Annex I; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

5.   From 1 January 2030 the following targets shall apply:

(a)

for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  30%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part A of Annex I;

| (b) | for the average emissions of the new light commercial vehicles fleet, an EU fleet- wide target equal to a
  30%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part B of Annex I. |
| --- | --- |

(b)

for the average emissions of the new light commercial vehicles fleet, an EU fleet- wide target equal to a
  30%
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part B of Annex I.

5.   From 1 January 2030 the following targets shall apply:

| (a) | for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  40 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part A of Annex I; |
| --- | --- |

(a)

for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a
  40 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part A of Annex I;

| (b) | for the average emissions of the new light commercial vehicles fleet, an EU fleet- wide target equal to a
  40 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part B of Annex I. |
| --- | --- |

(b)

for the average emissions of the new light commercial vehicles fleet, an EU fleet- wide target equal to a
  40 %
  reduction of the average of the specific emissions targets in 2021 determined in accordance with point 6.1.2 of Part B of Annex I.

Amendment 96

Amendment 96

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 5 — subparagraph 1 a (new)

Article 1 — paragraph 5 — subparagraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | From 1 January 2030, a benchmark equal to a 35 % market share of the sales of new passenger cars and new light commercial vehicles in 2030 shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

From 1 January 2030, a benchmark equal to a 35 % market share of the sales of new passenger cars and new light commercial vehicles in 2030 shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively.

From 1 January 2030, a benchmark equal to a 35 % market share of the sales of new passenger cars and new light commercial vehicles in 2030 shall apply to the share of zero- and low-emission vehicles, which shall be determined in accordance with point 6.3 of Part A of Annex I and point 6.3 of Part B of Annex I respectively.

Amendment 30

Amendment 30

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 1 – point b

Article 2 – paragraph 1 – point b

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (b) | category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2610  kg and to vehicles of category N1 to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 (‘light commercial vehicles’) which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new light commercial vehicles’). |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2610  kg and to vehicles of category N1 to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 (‘light commercial vehicles’) which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new light commercial vehicles’).

1

1

| (b) | category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2610  kg and to vehicles of category N1 to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 (‘light commercial vehicles’) which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new light commercial vehicles’).
  The Commission, in accordance with the objectives of this Regulation, is empowered to update, if necessary, the limit of the reference mass (2 610  kg) for light commercial vehicles using alternative fuels that require additional weight due to powertrains and energy storage systems (e.g. batteries) which are heavier than those used in conventional vehicles. |
| --- | --- |

(b)

category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2610  kg and to vehicles of category N1 to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 (‘light commercial vehicles’) which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new light commercial vehicles’).
  The Commission, in accordance with the objectives of this Regulation, is empowered to update, if necessary, the limit of the reference mass (2 610  kg) for light commercial vehicles using alternative fuels that require additional weight due to powertrains and energy storage systems (e.g. batteries) which are heavier than those used in conventional vehicles.

1

1

The Commission, in accordance with the objectives of this Regulation, is empowered to update, if necessary, the limit of the reference mass (2 610  kg) for light commercial vehicles using alternative fuels that require additional weight due to powertrains and energy storage systems (e.g. batteries) which are heavier than those used in conventional vehicles.

Amendment 31

Amendment 31

Proposal for a regulation

Proposal for a regulation

Article 2 – paragraph 4 a (new)

Article 2 – paragraph 4 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 4a.
     
  This Regulation shall apply to alternatively fuelled vehicles with a maximum authorised mass above 3 500  kg but not exceeding 4 250  kg, provided that the mass in excess of 3 500  kg is exclusively due to the excess of mass of the propulsion system in comparison with the propulsion system of a vehicle of the same dimensions equipped with a conventional internal combustion engine with positive ignition or compression ignition. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4a.
     
  This Regulation shall apply to alternatively fuelled vehicles with a maximum authorised mass above 3 500  kg but not exceeding 4 250  kg, provided that the mass in excess of 3 500  kg is exclusively due to the excess of mass of the propulsion system in comparison with the propulsion system of a vehicle of the same dimensions equipped with a conventional internal combustion engine with positive ignition or compression ignition.

Amendment 32

Amendment 32

Proposal for a regulation

Proposal for a regulation

Article 3 – paragraph 1 – point n a (new)

Article 3 – paragraph 1 – point n a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (na) | ‘defeat device’means an element of design which senses temperature, vehicle speed, engine speed (RPM), transmission gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any system or part of a system that increases CO2 emissions under conditions which may reasonably be expected to be encountered in normal vehicle operation and use. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(na)

(na)

‘defeat device’means an element of design which senses temperature, vehicle speed, engine speed (RPM), transmission gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any system or part of a system that increases CO2 emissions under conditions which may reasonably be expected to be encountered in normal vehicle operation and use.

‘defeat device’means an element of design which senses temperature, vehicle speed, engine speed (RPM), transmission gear, manifold vacuum or any other parameter for the purpose of activating, modulating, delaying or deactivating the operation of any system or part of a system that increases CO2

Amendment 33

Amendment 33

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Article 4 – paragraph 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 3a.
     
  The manufacturer shall equip vehicles so that the systems and components likely to affect emissions are designed, constructed and assembled so as to enable the passenger cars or the light commercial vehicles of the manufacturer, in normal use, to comply with the specific emission targets and other requirements pursuant to this Regulation and its implementing measures. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3a.
     
  The manufacturer shall equip vehicles so that the systems and components likely to affect emissions are designed, constructed and assembled so as to enable the passenger cars or the light commercial vehicles of the manufacturer, in normal use, to comply with the specific emission targets and other requirements pursuant to this Regulation and its implementing measures.

Amendment 34

Amendment 34

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 3 b (new)

Article 4 – paragraph 3 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 3b.   
  The use of defeat devices shall be prohibited. The prohibition shall not apply where:








  (a) | the need for the device is justified in terms of protecting the engine against damage or accident and for the safe operation of the vehicle; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3b.   
  The use of defeat devices shall be prohibited. The prohibition shall not apply where:

(a)

the need for the device is justified in terms of protecting the engine against damage or accident and for the safe operation of the vehicle;

| (b) | the device does not function beyond the requirements of engine starting; or |
| --- | --- |

(b)

the device does not function beyond the requirements of engine starting; or

| (c) | the conditions are substantially included in the test procedures referred to under Article 1. |
| --- | --- |

(c)

the conditions are substantially included in the test procedures referred to under Article 1.

Amendment 35

Amendment 35

Proposal for a regulation

Proposal for a regulation

Article 4 – paragraph 3 c (new)

Article 4 – paragraph 3 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 3c.
     
  In order for the approval authorities to be able to assess compliance with paragraphs 3a and 3b of this Article, the manufacturer shall provide an extended documentation package. The Commission is empowered to adopt a delegated act in accordance with Article 16 to supplement this Regulation with requirements to ensure compliance with the prohibition of defeat devices and the required content of the extended documentation package. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3c.
     
  In order for the approval authorities to be able to assess compliance with paragraphs 3a and 3b of this Article, the manufacturer shall provide an extended documentation package. The Commission is empowered to adopt a delegated act in accordance with Article 16 to supplement this Regulation with requirements to ensure compliance with the prohibition of defeat devices and the required content of the extended documentation package.

Amendment 36

Amendment 36

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 1

Article 7 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   For each calendar year, each Member State shall record information for each new passenger car and each new light commercial vehicle registered in its territory in accordance with Parts A of Annexes II and III. This information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall
  make every effort to
  ensure that reporting bodies operate in a transparent manner. Each Member State shall ensure that the specific emissions of CO2 of passenger cars which are not type-approved in accordance with Regulation (EC) No 715/2007 are measured and recorded in the certificate of conformity. | | 1.   For each calendar year, each Member State shall record information for each new passenger car and each new light commercial vehicle registered in its territory in accordance with Parts A of Annexes II and III. This information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall ensure that reporting bodies operate in a transparent manner. Each Member State shall ensure that the specific emissions of CO2 of passenger cars which are not type-approved in accordance with Regulation (EC) No 715/2007 are measured and recorded in the certificate of conformity. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   For each calendar year, each Member State shall record information for each new passenger car and each new light commercial vehicle registered in its territory in accordance with Parts A of Annexes II and III. This information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall
  make every effort to
  ensure that reporting bodies operate in a transparent manner. Each Member State shall ensure that the specific emissions of CO2 of passenger cars which are not type-approved in accordance with Regulation (EC) No 715/2007 are measured and recorded in the certificate of conformity.

1.   For each calendar year, each Member State shall record information for each new passenger car and each new light commercial vehicle registered in its territory in accordance with Parts A of Annexes II and III. This information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall ensure that reporting bodies operate in a transparent manner. Each Member State shall ensure that the specific emissions of CO2 of passenger cars which are not type-approved in accordance with Regulation (EC) No 715/2007 are measured and recorded in the certificate of conformity.

Amendment 37

Amendment 37

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 4 – subparagraph 3

Article 7 – paragraph 4 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The register shall be publicly available. | | The register shall be publicly available,
  including in digital format
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The register shall be publicly available.

The register shall be publicly available,
  including in digital format
  .

including in digital format

Amendment 38

Amendment 38

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 5 – subparagraph 1

Article 7 – paragraph 5 – subparagraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Manufacturers
  may
  , within three months of being notified of the provisional calculation under paragraph 4, notify the Commission of any errors in the data, specifying the Member State in which it considers that the error occurred. | | Manufacturers
  shall
  , within three months of being notified of the provisional calculation under paragraph 4, notify the Commission of any errors in the data, specifying the Member State in which it considers that the error occurred. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Manufacturers
  may
  , within three months of being notified of the provisional calculation under paragraph 4, notify the Commission of any errors in the data, specifying the Member State in which it considers that the error occurred.

may

Manufacturers
  shall
  , within three months of being notified of the provisional calculation under paragraph 4, notify the Commission of any errors in the data, specifying the Member State in which it considers that the error occurred.

shall

Amendment 39

Amendment 39

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 8 – subparagraph 3

Article 7 – paragraph 8 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The Commission
  may
  adopt detailed rules on the procedures for reporting such deviations and for taking them into account in the calculation of the average specific emissions. Those procedures shall be adopted by way of implementing acts in accordance with the examination procedure referred to in Article 15(2). | | The Commission
  shall
  adopt detailed rules on the procedures for reporting such deviations and for taking them into account in the calculation of the average specific emissions. Those procedures shall be adopted by way of implementing acts in accordance with the examination procedure referred to in Article 15(2). |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission
  may
  adopt detailed rules on the procedures for reporting such deviations and for taking them into account in the calculation of the average specific emissions. Those procedures shall be adopted by way of implementing acts in accordance with the examination procedure referred to in Article 15(2).

may

The Commission
  shall
  adopt detailed rules on the procedures for reporting such deviations and for taking them into account in the calculation of the average specific emissions. Those procedures shall be adopted by way of implementing acts in accordance with the examination procedure referred to in Article 15(2).

shall

Amendment 40

Amendment 40

Proposal for a regulation

Proposal for a regulation

Article 7 – paragraph 8 a (new)

Article 7 – paragraph 8 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 8a.   
  From 1 January 2025 onwards manufacturers shall report to the Commission, based on a harmonised Union methodology, the lifecycle CO2 emissions of all new passenger cars and light commercial vehicles they put on the market as from that date. For that purpose, the Commission shall adopt, no later than 31 December 2022, delegated acts in accordance with Article 16 in order to supplement this Regulation by specifying detailed rules on the procedures for reporting the full lifecycle CO2 emissions of all fuel types and vehicle powertrains registered on the Union market.




  No later than 31 December 2026, the Commission shall submit a report to the European Parliament and the Council with an analysis of the overall life-cycle emissions from new light duty vehicles in the Union, including an analysis of options for possible regulatory measures, in order to better direct future policy efforts in emissions cuts in the sector. That analysis shall be made publicly available. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

8a.   
  From 1 January 2025 onwards manufacturers shall report to the Commission, based on a harmonised Union methodology, the lifecycle CO2 emissions of all new passenger cars and light commercial vehicles they put on the market as from that date. For that purpose, the Commission shall adopt, no later than 31 December 2022, delegated acts in accordance with Article 16 in order to supplement this Regulation by specifying detailed rules on the procedures for reporting the full lifecycle CO2 emissions of all fuel types and vehicle powertrains registered on the Union market.

No later than 31 December 2026, the Commission shall submit a report to the European Parliament and the Council with an analysis of the overall life-cycle emissions from new light duty vehicles in the Union, including an analysis of options for possible regulatory measures, in order to better direct future policy efforts in emissions cuts in the sector. That analysis shall be made publicly available.

Amendment 41

Amendment 41

Proposal for a regulation

Proposal for a regulation

Article 8 – paragraph 4

Article 8 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   The amounts of the excess emissions premium shall be considered as revenue for the general budget of the Union. | | 4.   The amounts of the excess emissions premium shall be considered as revenue for the general budget of the Union.
  Those amounts shall be used to complement Union and national measures, in close cooperation with social partners, to promote skill formation and reallocation of workers in the automotive sector in all affected Member States, in particular in the regions and the communities most affected by the transition, in order to contribute to a just transition towards zero-emission mobility. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   The amounts of the excess emissions premium shall be considered as revenue for the general budget of the Union.

4.   The amounts of the excess emissions premium shall be considered as revenue for the general budget of the Union.
  Those amounts shall be used to complement Union and national measures, in close cooperation with social partners, to promote skill formation and reallocation of workers in the automotive sector in all affected Member States, in particular in the regions and the communities most affected by the transition, in order to contribute to a just transition towards zero-emission mobility.

Amendment 42

Amendment 42

Proposal for a regulation

Proposal for a regulation

Article 10 – paragraph 3

Article 10 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer. The application shall be submitted at the latest by 31 October of the first year in which the derogation shall apply. | | 3.   Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of
  passenger car or
  light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer. The application shall be submitted at the latest by 31 October of the first year in which the derogation shall apply. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer. The application shall be submitted at the latest by 31 October of the first year in which the derogation shall apply.

3.   Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of
  passenger car or
  light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer. The application shall be submitted at the latest by 31 October of the first year in which the derogation shall apply.

Amendment 43

Amendment 43

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – subparagraph 2

Article 11 – paragraph 1 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results. | | Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results,
  and only until the WLTP- measured value is not complemented or replaced by other data that are more representative of real-world emissions
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results.

Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results,
  and only until the WLTP- measured value is not complemented or replaced by other data that are more representative of real-world emissions
  .

and only until the WLTP- measured value is not complemented or replaced by other data that are more representative of real-world emissions

Amendment 44

Amendment 44

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – subparagraph 3 a (new)

Article 11 – paragraph 1 – subparagraph 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | Within 12 months of the approval of an innovative technology or innovative technology package, the supplier or the manufacturer of such approved innovative technology or package shall provide evidence based on results from real-driving emission tests on production vehicles to validate the contribution of such technology or package. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Within 12 months of the approval of an innovative technology or innovative technology package, the supplier or the manufacturer of such approved innovative technology or package shall provide evidence based on results from real-driving emission tests on production vehicles to validate the contribution of such technology or package.

Within 12 months of the approval of an innovative technology or innovative technology package, the supplier or the manufacturer of such approved innovative technology or package shall provide evidence based on results from real-driving emission tests on production vehicles to validate the contribution of such technology or package.

Amendment 45

Amendment 45

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 1 – subparagraph 4

Article 11 – paragraph 1 – subparagraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| The Commission may adjust the cap with effect from 2025 onwards. Those adjustments shall be performed by means of delegated acts in accordance with Article 16. | | The Commission may adjust the cap
  downwards
  with effect from 2025 onwards. Those adjustments shall be performed by means of delegated acts in accordance with Article 16. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission may adjust the cap with effect from 2025 onwards. Those adjustments shall be performed by means of delegated acts in accordance with Article 16.

The Commission may adjust the cap
  downwards
  with effect from 2025 onwards. Those adjustments shall be performed by means of delegated acts in accordance with Article 16.

downwards

Amendment 46

Amendment 46

Proposal for a regulation

Proposal for a regulation

Article 11 – paragraph 2 – point d

Article 11 – paragraph 2 – point d

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (d) | the innovative technologies must not be covered by mandatory provisions due to complementary additional measures complying with the 10 g CO2/km reduction referred to in Article 1 or be mandatory under other provisions of Union law. With effect from 1 January 2025, this criterion shall not apply with regard to efficiency improvements for air conditioning systems. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(d)

the innovative technologies must not be covered by mandatory provisions due to complementary additional measures complying with the 10 g CO2/km reduction referred to in Article 1 or be mandatory under other provisions of Union law. With effect from 1 January 2025, this criterion shall not apply with regard to efficiency improvements for air conditioning systems.

2

| (d) | the innovative technologies must not be covered by mandatory provisions due to complementary additional measures complying with the 10 g CO2/km reduction referred to in Article 1 or be mandatory under other provisions of Union law. With effect from 1 January 2025, this criterion shall not apply with regard to efficiency improvements for air conditioning
  and heating
  systems. |
| --- | --- |

(d)

the innovative technologies must not be covered by mandatory provisions due to complementary additional measures complying with the 10 g CO2/km reduction referred to in Article 1 or be mandatory under other provisions of Union law. With effect from 1 January 2025, this criterion shall not apply with regard to efficiency improvements for air conditioning
  and heating
  systems.

2

and heating

Amendment 47

Amendment 47

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 1

Article 12 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall monitor and assess the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151.
  It shall ensure that the public is informed of how that representativeness evolves over time | | 1.   The Commission shall monitor and assess the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall monitor and assess the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151.
  It shall ensure that the public is informed of how that representativeness evolves over time

1.   The Commission shall monitor and assess the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151.

Amendment 48

Amendment 48

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 1 a (new)

Article 12 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1a.
     
  In order to ensure the representativeness referred to in paragraph 1, compliance with this Regulation shall be measured, from 1 January 2023, by means of a real-world CO2 emissions test. The Commission shall adopt delegated acts in accordance with Article 16, at the latest two years after the date of application of this Regulation, in order to supplement this Regulation by developing the real-world CO2 emissions test using PEMS. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1a.
     
  In order to ensure the representativeness referred to in paragraph 1, compliance with this Regulation shall be measured, from 1 January 2023, by means of a real-world CO2 emissions test. The Commission shall adopt delegated acts in accordance with Article 16, at the latest two years after the date of application of this Regulation, in order to supplement this Regulation by developing the real-world CO2 emissions test using PEMS.

Amendment 49

Amendment 49

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 1 b (new)

Article 12 – paragraph 1 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1b.
     
  Until the real-world CO2 emissions test becomes applicable, compliance with this Regulation shall be measured on the basis of data from fuel consumption meters and subject to a limit set for each manufacturer in 2021 as a percentage difference, that is not to be exceeded, between that data and the manufacturer’s specific CO2 emissions that is measured for the purpose of type approval certification procedures initiated from 2021 onwards in accordance with Regulation (EC) No 715/2007. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1b.
     
  Until the real-world CO2 emissions test becomes applicable, compliance with this Regulation shall be measured on the basis of data from fuel consumption meters and subject to a limit set for each manufacturer in 2021 as a percentage difference, that is not to be exceeded, between that data and the manufacturer’s specific CO2 emissions that is measured for the purpose of type approval certification procedures initiated from 2021 onwards in accordance with Regulation (EC) No 715/2007.

Amendment 50

Amendment 50

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 1 c (new)

Article 12 – paragraph 1 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 1c.
     
  Where a manufacturer’s specific CO2 emissions exceed the limit set in paragraph 1b, the specific CO2 emission target for that manufacturer, which is used for the purpose of compliance with this Regulation, shall be adjusted by the exceedance identified. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1c.
     
  Where a manufacturer’s specific CO2 emissions exceed the limit set in paragraph 1b, the specific CO2 emission target for that manufacturer, which is used for the purpose of compliance with this Regulation, shall be adjusted by the exceedance identified.

Amendment 51

Amendment 51

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 2 a (new)

Article 12 – paragraph 2 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2a.
     
  The Commission shall ensure that the public is informed of how the real world representativeness referred to in paragraph 1 evolves over time. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2a.
     
  The Commission shall ensure that the public is informed of how the real world representativeness referred to in paragraph 1 evolves over time.

Amendment 52

Amendment 52

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 2 b (new)

Article 12 – paragraph 2 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 2b.
     
  Where appropriate accuracy standards for on-board fuel consumption measurement equipment are not available, the Commission shall mandate work to agree the technical standards and introduce them into Union law no later than 1 January 2020. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2b.
     
  Where appropriate accuracy standards for on-board fuel consumption measurement equipment are not available, the Commission shall mandate work to agree the technical standards and introduce them into Union law no later than 1 January 2020.

Amendment 53

Amendment 53

Proposal for a regulation

Proposal for a regulation

Article 12 – paragraph 3

Article 12 – paragraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 3.   The Commission
  may
  adopt
  the measures referred to in this Article by means of
  implementing acts in accordance with the examination procedure referred to in Article 15(2). | | 3.   The Commission
  shall, by means of implementing acts
  , adopt
  detailed rules on the procedures for reporting data from fuel consumption meters. Those
  implementing acts
  shall be adopted
  in accordance with the examination procedure referred to in Article 15(2). |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The Commission
  may
  adopt
  the measures referred to in this Article by means of
  implementing acts in accordance with the examination procedure referred to in Article 15(2).

3.   The Commission
  shall, by means of implementing acts
  , adopt
  detailed rules on the procedures for reporting data from fuel consumption meters. Those
  implementing acts
  shall be adopted
  in accordance with the examination procedure referred to in Article 15(2).

Amendment 82

Amendment 82

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 1

Article 14 — paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The Commission shall in
  2024
  submit a report to the European Parliament and the Council on the effectiveness of this Regulation, where appropriate, accompanied by a proposal for amending
  the
  Regulation.
  This
  report
  will
  consider, inter alia, the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151, the deployment on the Union market of zero- and low-emission vehicles
  and
  the roll-out of recharging and refuelling infrastructure reported under Directive 2014/94/EU of the European Parliament and of the Council (6). | | 1.   The Commission shall in
  2023
  submit a report to the European Parliament and the Council on the effectiveness of this Regulation, where appropriate, accompanied by a proposal for amending
  this
  Regulation.
  That
  report
  shall
  consider, inter alia, the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151, the deployment on the Union market of zero- and low-emission vehicles,
  in particular with respect to light commercial vehicles
  , the roll-out of recharging and refuelling infrastructure reported under Directive 2014/94/EU of the European Parliament and of the Council (7),
  the impact of this Regulation on consumers, particularly those on low and medium incomes. This report shall also consider options to incentivise the uptake of advanced low-carbon fuels, including biogas and synthetic fuels produced with renewable energy. |
| |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The Commission shall in
  2024
  submit a report to the European Parliament and the Council on the effectiveness of this Regulation, where appropriate, accompanied by a proposal for amending
  the
  Regulation.
  This
  report
  will
  consider, inter alia, the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151, the deployment on the Union market of zero- and low-emission vehicles
  and
  the roll-out of recharging and refuelling infrastructure reported under Directive 2014/94/EU of the European Parliament and of the Council (6).

1.   The Commission shall in
  2023
  submit a report to the European Parliament and the Council on the effectiveness of this Regulation, where appropriate, accompanied by a proposal for amending
  this
  Regulation.
  That
  report
  shall
  consider, inter alia, the real world representativeness of the CO2 emission and energy consumption values determined in accordance with Regulation (EU) 2017/1151, the deployment on the Union market of zero- and low-emission vehicles,
  in particular with respect to light commercial vehicles
  , the roll-out of recharging and refuelling infrastructure reported under Directive 2014/94/EU of the European Parliament and of the Council (7),
  the impact of this Regulation on consumers, particularly those on low and medium incomes. This report shall also consider options to incentivise the uptake of advanced low-carbon fuels, including biogas and synthetic fuels produced with renewable energy.

Amendment 54

Amendment 54

Proposal for a regulation

Proposal for a regulation

Article 14 – paragraph 2

Article 14 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Commission shall take into account the assessments performed pursuant to Article 12 and may, where appropriate, review the procedures for measuring CO2 emissions as set out under Regulation (EC) No 715/2007. The Commission shall, in particular, make appropriate proposals to adapt those procedures to reflect adequately the real world CO2 emissions of cars and light commercial vehicles. | | 2.   The Commission shall take into account the assessments performed pursuant to Article 12 and may, where appropriate, review the procedures for measuring CO2 emissions as set out under Regulation (EC) No 715/2007. The Commission shall, in particular, make appropriate proposals to adapt those procedures to reflect adequately the real world CO2 emissions of cars and light commercial vehicles,
  including using PEMS and remote-sensing
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Commission shall take into account the assessments performed pursuant to Article 12 and may, where appropriate, review the procedures for measuring CO2 emissions as set out under Regulation (EC) No 715/2007. The Commission shall, in particular, make appropriate proposals to adapt those procedures to reflect adequately the real world CO2 emissions of cars and light commercial vehicles.

2.   The Commission shall take into account the assessments performed pursuant to Article 12 and may, where appropriate, review the procedures for measuring CO2 emissions as set out under Regulation (EC) No 715/2007. The Commission shall, in particular, make appropriate proposals to adapt those procedures to reflect adequately the real world CO2 emissions of cars and light commercial vehicles,
  including using PEMS and remote-sensing
  .

Amendment 55

Amendment 55

Proposal for a regulation

Proposal for a regulation

Article 14 – paragraph 3 a (new)

Article 14 – paragraph 3 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 3a.
     
  By 31 December 2019, the Commission shall review Directive 1999/94/EC and, where appropriate, submit a relevant legislative proposal in order to provide consumers with accurate, robust and comparable information on the fuel consumption, CO2 emissions and air pollutant emissions of new passenger cars placed on the market.




  Within the context of the review referred to in the first subparagraph, the Commission shall also evaluate the options for introducing a fuel economy and CO2 emissions label for new light commercial vehicles, and, where appropriate, submit a relevant legislative proposal to that end. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3a.
     
  By 31 December 2019, the Commission shall review Directive 1999/94/EC and, where appropriate, submit a relevant legislative proposal in order to provide consumers with accurate, robust and comparable information on the fuel consumption, CO2 emissions and air pollutant emissions of new passenger cars placed on the market.

Within the context of the review referred to in the first subparagraph, the Commission shall also evaluate the options for introducing a fuel economy and CO2 emissions label for new light commercial vehicles, and, where appropriate, submit a relevant legislative proposal to that end.

Amendment 56

Amendment 56

Proposal for a regulation

Proposal for a regulation

Article 14 – paragraph 3 b (new)

Article 14 – paragraph 3 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | 3b.
     
  The Commission shall, where appropriate, submit a legislative proposal to the European Parliament and the Council in order to set additional emissions reduction targets for new passenger cars and new light commercial vehicles from 1 January 2031 with a view to maintaining at least the emissions-reduction trajectory achieved in the period up to 2030. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3b.
     
  The Commission shall, where appropriate, submit a legislative proposal to the European Parliament and the Council in order to set additional emissions reduction targets for new passenger cars and new light commercial vehicles from 1 January 2031 with a view to maintaining at least the emissions-reduction trajectory achieved in the period up to 2030.

Amendment 57

Amendment 57

Proposal for a regulation

Proposal for a regulation

Article 16 – paragraph 1

Article 16 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 1.   The power to adopt delegated acts referred to in the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) shall be conferred on the Commission for an indeterminate period of time from [the date of entry into force of this Regulation]. | | 1.   The power to adopt delegated acts referred to in
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7 (8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) shall be conferred on the Commission for an indeterminate period of time from [the date of entry into force of this Regulation]. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   The power to adopt delegated acts referred to in the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) shall be conferred on the Commission for an indeterminate period of time from [the date of entry into force of this Regulation].

1.   The power to adopt delegated acts referred to in
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7 (8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) shall be conferred on the Commission for an indeterminate period of time from [the date of entry into force of this Regulation].

Amendment 58

Amendment 58

Proposal for a regulation

Proposal for a regulation

Article 16 – paragraph 2

Article 16 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The delegation of power referred to in the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | | 2.   The delegation of power referred to in
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7(8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The delegation of power referred to in the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

2.   The delegation of power referred to in
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7(8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Amendment 59

Amendment 59

Proposal for a regulation

Proposal for a regulation

Article 16 – paragraph 4

Article 16 – paragraph 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 4.   A delegated act adopted pursuant to the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. | | 4.   A delegated act adopted pursuant to
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7(8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   A delegated act adopted pursuant to the second subparagraph of Article 7(7), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(2) and the second subparagraph of Article 14(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

4.   A delegated act adopted pursuant to
  Article 4(3c)
  , the second subparagraph of Article 7(7),
  Article 7(8a)
  , Article 10(8), the fourth subparagraph of Article 11(1),
  Article 12(1a)
  , Article 13(2) and the second subparagraph of Article 14(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Amendment 60

Amendment 60

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1

Article 17 – paragraph 1

Regulation (EC) No 715/2007

Article 11a – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   The Commission shall adopt
  implementing
  acts in accordance with Article
  15
  in order to determine the procedures for verifying the in-service conformity of light duty vehicles in respect of the certified CO2 and fuel consumption values. | | 2.   The Commission shall adopt
  delegated
  acts in accordance with Article
  14a
  in order to determine the procedures for verifying the in-service conformity of light duty vehicles in respect of the certified CO2 and fuel consumption values. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Commission shall adopt
  implementing
  acts in accordance with Article
  15
  in order to determine the procedures for verifying the in-service conformity of light duty vehicles in respect of the certified CO2 and fuel consumption values.

2.   The Commission shall adopt
  delegated
  acts in accordance with Article
  14a
  in order to determine the procedures for verifying the in-service conformity of light duty vehicles in respect of the certified CO2 and fuel consumption values.

Amendment 61

Amendment 61

Proposal for a regulation

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Article 17 – paragraph 1 a (new)

Regulation (EC) No 715/2007

Article 14 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | The following Article is inserted:




  “Article 14a


  Exercise of the delegation




  1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.






  2.
     
  The power to adopt delegated acts referred to in Article 11a(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.






  3.
     
  The delegation of power referred to in Article 11a(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.






  4.
     
  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making

   (*3).




  5.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.






  6.
     
  A delegated act adopted pursuant to Article 11a(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
| | |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The following Article is inserted:

The following Article is inserted:

“Article 14a

Exercise of the delegation

1.
     
  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.
     
  The power to adopt delegated acts referred to in Article 11a(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.
     
  The delegation of power referred to in Article 11a(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.
     
  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law Making

   (*3).

5.
     
  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.
     
  A delegated act adopted pursuant to Article 11a(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Amendment 62

Amendment 62

Proposal for a regulation

Proposal for a regulation

Annex I – part A – point 6.3 – paragraph 1 a (new)

Annex I – part A – point 6.3 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.




  For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula in order to calculate the relevant specific emission target of 2021 for each manufacturer. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula in order to calculate the relevant specific emission target of 2021 for each manufacturer.

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula in order to calculate the relevant specific emission target of 2021 for each manufacturer.

Amendment 63

Amendment 63

Proposal for a regulation

Proposal for a regulation

Annex I – part A – point 6.3 – paragraph 3 – subparagraph 2

Annex I – part A – point 6.3 – paragraph 3 – subparagraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| ZLEV factor is (1+y-x), unless this sum is larger than 1.05
  or lower than 1.0
  in which case the ZLEV factor shall be set to 1.05
  or
  1.0 as the case may be | | For the period 2025 to 2029
  , ZLEV factor is (1+y-x), unless this sum is larger than 1.05, in which case the ZLEV factor shall be set to 1.05;
  if this sum is between
  1.0
  and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95
  ;


  From 2030 onwards, ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than 0.95 in which case the ZLEV factor shall be set to 1.05 or 0.95
  as the case may be |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

ZLEV factor is (1+y-x), unless this sum is larger than 1.05
  or lower than 1.0
  in which case the ZLEV factor shall be set to 1.05
  or
  1.0 as the case may be

or lower than 1.0

or

For the period 2025 to 2029
  , ZLEV factor is (1+y-x), unless this sum is larger than 1.05, in which case the ZLEV factor shall be set to 1.05;
  if this sum is between
  1.0
  and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95
  ;

For the period 2025 to 2029

if this sum is between

and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95

From 2030 onwards, ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than 0.95 in which case the ZLEV factor shall be set to 1.05 or 0.95
  as the case may be

From 2030 onwards, ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than 0.95 in which case the ZLEV factor shall be set to 1.05 or 0.95

Amendment 98

Amendment 98

Proposal for a regulation

Proposal for a regulation

Annex I — part A — point 6.3 — paragraph 4 — subparagraph 3

Annex I — part A — point 6.3 — paragraph 4 — subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| x is
  15%
  in the years 2025 to 2029 and
  30%
  in 2030 onwards. | | x is
  20 %
  in the years 2025 to 2029 and
  35 %
  in 2030 onwards. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

x is
  15%
  in the years 2025 to 2029 and
  30%
  in 2030 onwards.

15%

30%

x is
  20 %
  in the years 2025 to 2029 and
  35 %
  in 2030 onwards.

20 %

35 %

Amendment 65

Amendment 65

Proposal for a regulation

Proposal for a regulation

Annex I – part B – point 6.3.1 – paragraph 1 a (new)

Annex I – part B – point 6.3.1 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.




  For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2

2

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer.

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer.

Amendment 66

Amendment 66

Proposal for a regulation

Proposal for a regulation

Annex I – part B – point 6.3.1 – paragraph 3 – subparagraph 3

Annex I – part B – point 6.3.1 – paragraph 3 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| ZLEV factor is (1+y-x), unless this sum is larger than 1.05
  or lower than 1.0
  in which case the ZLEV factor shall be set to 1.05
  or
  1.0
  as the case may be | | ZLEV factor is (1+y-x), unless this sum is larger than 1.05, in which case the ZLEV factor shall be set to 1.05;
  if this sum is between
  1.0
  and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

ZLEV factor is (1+y-x), unless this sum is larger than 1.05
  or lower than 1.0
  in which case the ZLEV factor shall be set to 1.05
  or
  1.0
  as the case may be

or lower than 1.0

or

as the case may be

ZLEV factor is (1+y-x), unless this sum is larger than 1.05, in which case the ZLEV factor shall be set to 1.05;
  if this sum is between
  1.0
  and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95.

if this sum is between

and 0.98, the ZLEV factor shall be set to 1.0; if this sum is lower than 0.95, the ZLEV factor shall be set to 0.95.

Amendment 67

Amendment 67

Proposal for a regulation

Proposal for a regulation

Annex I – part B – point 6.3.1 – paragraph 4 – subparagraph 3

Annex I – part B – point 6.3.1 – paragraph 4 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| x is
  15% | | x is
  20 % |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

x is
  15%

15%

x is
  20 %

20 %

Amendment 68

Amendment 68

Proposal for a regulation

Proposal for a regulation

Annex I – part B – point 6.3.2 – paragraph 1 a (new)

Annex I – part B – point 6.3.2 – paragraph 1 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.




  For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2 emissions and the declared WLTP CO2 emissions.

For the purpose of the calculation of this formula, the specific emissions target of 2021 as defined in point 4 shall be corrected to take into account the difference between the measured WLTP CO2

2

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer.

For new entrants, the Commission is empowered to adopt delegated acts in accordance with Article 16 in order to amend this Regulation by developing a formula to calculate the relevant specific emission target of 2021 for each manufacturer.

Amendment 69

Amendment 69

Proposal for a regulation

Proposal for a regulation

Annex I – part B – point 6.3.2 – paragraph 3 – subparagraph 3

Annex I – part B – point 6.3.2 – paragraph 3 – subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than
  1.0
  in which case the ZLEV factor shall be set to 1.05 or
  1.0
  as the case may be | | ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than
  0.95
  in which case the ZLEV factor shall be set to 1.05 or
  0.95
  as the case may be |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than
  1.0
  in which case the ZLEV factor shall be set to 1.05 or
  1.0
  as the case may be

1.0

1.0

ZLEV factor is (1+y-x), unless this sum is larger than 1.05 or lower than
  0.95
  in which case the ZLEV factor shall be set to 1.05 or
  0.95
  as the case may be

0.95

0.95

Amendment 99

Amendment 99

Proposal for a regulation

Proposal for a regulation

Annex I — part B — point 6.3.2 — paragraph 4 — subparagraph 3

Annex I — part B — point 6.3.2 — paragraph 4 — subparagraph 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| x is
  30% | | x is
  35 % |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

x is
  30%

30%

x is
  35 %

35 %

---

(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0287/2018).

1

(*1)  
  Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars (OJ L 12, 18.1.2000, p. 16).

*1

Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2

(*2)  
  Commission Recommendation (EU) 2017/948 of 31 May 2017 on the use of fuel consumption and CO2 emission values type-approved and measured in accordance with the World Harmonised Light Vehicles Test Procedure when making information available for consumers pursuant to Directive 1999/94/EC of the European Parliament and of the Council (OJ L 142, 2.6.2017, p. 100).

*2

Commission Recommendation (EU) 2017/948 of 31 May 2017 on the use of fuel consumption and CO2

(2)  High Level Group of Scientific Advisors, Scientific Opinion 1/2016 "Closing the gap between light-duty vehicle real-world CO2 emissions and laboratory testing"

2

2

(3)  European Parliament recommendation of 4 April 2017 to the Council and the Commission following the inquiry into emission measurements in the automotive sector (2016/2908(RSP))

3

(4)  High Level Group of Scientific Advisors, Scientific Opinion 1/2016 "Closing the gap between light-duty vehicle real-world CO2 emissions and laboratory testing"

4

2

(5)  European Parliament recommendation of 4 April 2017 to the Council and the Commission following the inquiry into emission measurements in the automotive sector (2016/2908(RSP))

5

(6)  Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1)

6

(7)  Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1)

7

(*3)  OJ L 123, 12.5.2016, p. 1.”

*3

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/211 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/211

---

P8_TA(2018)0371

Rates of value added tax*

European Parliament legislative resolution of 3 October 2018 on the proposal for a Council directive amending Directive 2006/112/EC as regards rates of value added tax (COM(2018)0020 – C8-0023/2018 – 2018/0005(CNS))

(Special legislative procedure – consultation)

(2020/C 011/25)

The European Parliament,

| — | having regard to the Commission proposal to the Council (COM(2018)0020), |
| --- | --- |

—

having regard to the Commission proposal to the Council (COM(2018)0020),

| — | having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0023/2018), |
| --- | --- |

—

having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0023/2018),

| — | having regard to Rule 78c of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 78c of its Rules of Procedure,

| — | having regard to the report of the Committee on Economic and Monetary Affairs (A8-0279/2018), |
| --- | --- |

—

having regard to the report of the Committee on Economic and Monetary Affairs (A8-0279/2018),

| 1. | Approves the Commission proposal as amended; |
| --- | --- |

1.

| 2. | Calls on the Commission to alter its proposal accordingly, in accordance with Article 293(2) of the Treaty on the Functioning of the European Union; |
| --- | --- |

2.

| 3. | Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament; |
| --- | --- |

3.

| 4. | Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal; |
| --- | --- |

4.

| 5. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

5.

Amendment 1

Proposal for a directive

Recital 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (1) | Rules on rates of value added tax (VAT) as currently set out in Council Directive 2006/112/EC (1) aim to preserve the functioning of the internal market and avoid distortions of competition. The rules were designed over two decades ago based on the origin principle. In its VAT Action Plan (2) and in the follow-up to this (3), the Commission announced its intention to adjust those rules for a definitive VAT system for cross-border business-to-business (B2B) trade in goods between Member States that would be based on the taxation in the Member State of destination. |

Text proposed by the Commission

Amendment

(1)

Rules on rates of value added tax (VAT) as currently set out in Council Directive 2006/112/EC (1) aim to preserve the functioning of the internal market and avoid distortions of competition. The rules were designed over two decades ago based on the origin principle. In its VAT Action Plan (2) and in the follow-up to this (3), the Commission announced its intention to adjust those rules for a definitive VAT system for cross-border business-to-business (B2B) trade in goods between Member States that would be based on the taxation in the Member State of destination.

| (1) | Rules on rates of value added tax (VAT) as currently set out in Council Directive 2006/112/EC (4) aim to preserve the functioning of the internal market and avoid distortions of competition. The rules were designed over two decades ago based on the origin principle and are no longer fit for purpose. In its VAT Action Plan (5) et le suivi de celui-ci and in the follow-up to this (6), the Commission announced its intention to adjust those rules for a definitive VAT system for cross-border business-to-business (B2B) trade in goods between Member States that would be based on the taxation in the Member State of destination. |
| --- | --- |

(1)

Rules on rates of value added tax (VAT) as currently set out in Council Directive 2006/112/EC (4) aim to preserve the functioning of the internal market and avoid distortions of competition. The rules were designed over two decades ago based on the origin principle and are no longer fit for purpose. In its VAT Action Plan (5) et le suivi de celui-ci and in the follow-up to this (6), the Commission announced its intention to adjust those rules for a definitive VAT system for cross-border business-to-business (B2B) trade in goods between Member States that would be based on the taxation in the Member State of destination.

Amendment 2

Proposal for a directive

Recital 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (2) | Under a definitive system where the supply of goods and services would be taxed in the Member State of destination, suppliers derive
  no significant
  benefit from being established in a lower-rate Member State. Greater diversity in VAT rates
  would not
  , under such a system,
  disrupt
  the functioning of the single market
  nor create distortions of
  competition. In those circumstances,
  it would be appropriate to grant more
  flexibility
  to Member States
  in the setting of rates. |

Text proposed by the Commission

Amendment

(2)

Under a definitive system where the supply of goods and services would be taxed in the Member State of destination, suppliers derive
  no significant
  benefit from being established in a lower-rate Member State. Greater diversity in VAT rates
  would not
  , under such a system,
  disrupt
  the functioning of the single market
  nor create distortions of
  competition. In those circumstances,
  it would be appropriate to grant more
  flexibility
  to Member States
  in the setting of rates.

| (2) | Under a definitive system where the supply of goods and services would be taxed in the Member State of destination, suppliers derive
  less
  benefit from being established in a lower-rate Member State. Greater diversity in VAT rates
  should
  , under such a system,
  be less of a disruption to
  the functioning of the single market
  and would not distort
  competition. In those circumstances,
  it should be possible to grant Member States a certain
  flexibility in the setting of rates.
  However, Member States should not ignore the objective of ensuring greater convergence in VAT rates. |
| --- | --- |

(2)

Under a definitive system where the supply of goods and services would be taxed in the Member State of destination, suppliers derive
  less
  benefit from being established in a lower-rate Member State. Greater diversity in VAT rates
  should
  , under such a system,
  be less of a disruption to
  the functioning of the single market
  and would not distort
  competition. In those circumstances,
  it should be possible to grant Member States a certain
  flexibility in the setting of rates.
  However, Member States should not ignore the objective of ensuring greater convergence in VAT rates.

Amendment 3

Proposal for a directive

Recital 3

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (3) | The removal of restrictions in
  parallell
  with the entry into force of the definitive arrangements for the taxation of trade between Member States should allow Member States to continue to apply reduced VAT rates
  that are currently granted as
  derogations under Chapter 4 of Title VIII of Directive 2006/112/EC and Annex X to Directive 2006/112/EC
  and
  which would otherwise expire with the entry into force of those arrangements. |

Text proposed by the Commission

Amendment

(3)

The removal of restrictions in
  parallell
  with the entry into force of the definitive arrangements for the taxation of trade between Member States should allow Member States to continue to apply reduced VAT rates
  that are currently granted as
  derogations under Chapter 4 of Title VIII of Directive 2006/112/EC and Annex X to Directive 2006/112/EC
  and
  which would otherwise expire with the entry into force of those arrangements.

| (3) | The removal of restrictions in
  parallel
  with the entry into force of the definitive arrangements for the taxation of trade between Member States should allow Member States to continue to apply reduced VAT rates
  in place of the
  derogations
  granted
   under Chapter 4 of Title VIII of Directive 2006/112/EC and Annex X to Directive 2006/112/EC, which would otherwise expire with the entry into force of those arrangements. |
| --- | --- |

(3)

The removal of restrictions in
  parallel
  with the entry into force of the definitive arrangements for the taxation of trade between Member States should allow Member States to continue to apply reduced VAT rates
  in place of the
  derogations
  granted
   under Chapter 4 of Title VIII of Directive 2006/112/EC and Annex X to Directive 2006/112/EC, which would otherwise expire with the entry into force of those arrangements.

Amendment 4

Proposal for a directive

Recital 4

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (4) | In a definitive VAT system all Member States should be treated equally and should therefore have the same restrictions in applying reduced VAT rates, which should remain an exception to the standard rate. Such equal treatment
  without restricting
  Member States current flexibility in setting VAT can be achieved by enabling all of them to apply a reduced rate for which the minimum requirement does not apply, as well as an exemption with the right to deduct input VAT, in addition to a maximum of two reduced rates of a minimum of 5%. |

Text proposed by the Commission

Amendment

(4)

In a definitive VAT system all Member States should be treated equally and should therefore have the same restrictions in applying reduced VAT rates, which should remain an exception to the standard rate. Such equal treatment
  without restricting
  Member States current flexibility in setting VAT can be achieved by enabling all of them to apply a reduced rate for which the minimum requirement does not apply, as well as an exemption with the right to deduct input VAT, in addition to a maximum of two reduced rates of a minimum of 5%.

| (4) | In a definitive VAT system all Member States should be treated equally and should therefore have the same restrictions in applying reduced VAT rates, which should remain an exception to the standard rate,
  in order to avoid disproportionate fragmentation of the VAT system within the internal market
  .
  Taking into account the general interest such as positive cultural, social or environmental effects of different services and goods and without restricting
  Member States
  ’
  current flexibility in setting VAT rates, such equal treatment can be achieved by enabling all of them to apply a reduced rate for which the minimum requirement does not apply, as well as an exemption with the right to deduct input VAT, in addition to a maximum of two reduced rates of a minimum of 5%.
  Within the limits provided for by this Directive, it should be possible for Member States to maintain existing or introduce new reduced VAT rates. This Directive will increase subsidiarity in the VAT system, making it possible for Member States to accommodate local conditions, preferences and traditions or choose a simple and uniform tax rate. However, Member States should avoid using reduced VAT rates for harmful or luxury products. |
| --- | --- |

(4)

In a definitive VAT system all Member States should be treated equally and should therefore have the same restrictions in applying reduced VAT rates, which should remain an exception to the standard rate,
  in order to avoid disproportionate fragmentation of the VAT system within the internal market
  .
  Taking into account the general interest such as positive cultural, social or environmental effects of different services and goods and without restricting
  Member States
  ’
  current flexibility in setting VAT rates, such equal treatment can be achieved by enabling all of them to apply a reduced rate for which the minimum requirement does not apply, as well as an exemption with the right to deduct input VAT, in addition to a maximum of two reduced rates of a minimum of 5%.
  Within the limits provided for by this Directive, it should be possible for Member States to maintain existing or introduce new reduced VAT rates. This Directive will increase subsidiarity in the VAT system, making it possible for Member States to accommodate local conditions, preferences and traditions or choose a simple and uniform tax rate. However, Member States should avoid using reduced VAT rates for harmful or luxury products.

Amendment 5

Proposal for a directive

Recital 4 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4a) | In line with the Commission's Digital Single Market Strategy

   (7)

  and in order to keep abreast of technological progress in a digital economy, to stimulate innovation, creation, investment and the production of new content, and to facilitate digital learning, knowledge transfer and the access to, and promotion of, culture in the digital environment, it should be possible for Member States to align the VAT rates for electronically supplied publications with lower VAT rates for publications on a physical support
  . |

Text proposed by the Commission

Amendment

(4a)

In line with the Commission's Digital Single Market Strategy

   (7)

  and in order to keep abreast of technological progress in a digital economy, to stimulate innovation, creation, investment and the production of new content, and to facilitate digital learning, knowledge transfer and the access to, and promotion of, culture in the digital environment, it should be possible for Member States to align the VAT rates for electronically supplied publications with lower VAT rates for publications on a physical support
  .

Amendment 6

Proposal for a directive

Recital 4 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4b) | Allowing Member States to apply reduced rates, including reduced rates without a minimum threshold, to printed publications and electronic publications should ensure the transfer of economic benefits to consumers, thereby promoting reading, and to publishers, thereby encouraging investment in new content and, in the case of newspapers and magazines, should reduce reliance on advertising. |

Text proposed by the Commission

Amendment

(4b)

Allowing Member States to apply reduced rates, including reduced rates without a minimum threshold, to printed publications and electronic publications should ensure the transfer of economic benefits to consumers, thereby promoting reading, and to publishers, thereby encouraging investment in new content and, in the case of newspapers and magazines, should reduce reliance on advertising.

Amendment 7

Proposal for a directive

Recital 4 c (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (4c) | Taking into account the importance of facilitating access to books, newspapers and periodicals for persons who are blind, visually impaired or otherwise print-disabled, adapted and audio electronic books, newspapers and periodicals are to be understood as not wholly or predominantly consisting of music or video content. Therefore, it should be possible to apply reduced VAT rates to publications in those formats. |

Text proposed by the Commission

Amendment

(4c)

Taking into account the importance of facilitating access to books, newspapers and periodicals for persons who are blind, visually impaired or otherwise print-disabled, adapted and audio electronic books, newspapers and periodicals are to be understood as not wholly or predominantly consisting of music or video content. Therefore, it should be possible to apply reduced VAT rates to publications in those formats.

Amendment 8

Proposal for a directive

Recital 5

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (5) | Distortions of competition could arise where the mechanism used for taxation would not be based on the destination principle. That is notably so with travel facilities supplied as a single service under the margin scheme for travel agents and goods supplied under the special arrangements for second-hand goods, works of art, collectors’ items and antiques but also in certain cases involving goods or services, such as financial services, that are exempted without right of deduction but for which a right of taxation may be granted. In order to mitigate any such distortions, a list of supplies of goods and services subject to the standard VAT rate (‘negative list’) should be established based on the statistical classification of products by activity. The list should be reviewed
  every five years. |

Text proposed by the Commission

Amendment

(5)

Distortions of competition could arise where the mechanism used for taxation would not be based on the destination principle. That is notably so with travel facilities supplied as a single service under the margin scheme for travel agents and goods supplied under the special arrangements for second-hand goods, works of art, collectors’ items and antiques but also in certain cases involving goods or services, such as financial services, that are exempted without right of deduction but for which a right of taxation may be granted. In order to mitigate any such distortions, a list of supplies of goods and services subject to the standard VAT rate (‘negative list’) should be established based on the statistical classification of products by activity. The list should be reviewed
  every five years.

| (5) | Distortions of competition could arise where the mechanism used for taxation would not be based on the destination principle. That is notably so with travel facilities supplied as a single service under the margin scheme for travel agents and goods supplied under the special arrangements for second-hand goods, works of art, collectors’ items and antiques but also in certain cases involving goods or services, such as financial services, that are exempted without right of deduction but for which a right of taxation may be granted. In order to mitigate any such distortions, a list of supplies of goods and services subject to the standard VAT rate (‘negative list’) should be established based on the statistical classification of products by activity.
  Every two years
  , the list should be reviewed
  by means of an implementing act, based on evidence provided by the Commission
  . |
| --- | --- |

(5)

Distortions of competition could arise where the mechanism used for taxation would not be based on the destination principle. That is notably so with travel facilities supplied as a single service under the margin scheme for travel agents and goods supplied under the special arrangements for second-hand goods, works of art, collectors’ items and antiques but also in certain cases involving goods or services, such as financial services, that are exempted without right of deduction but for which a right of taxation may be granted. In order to mitigate any such distortions, a list of supplies of goods and services subject to the standard VAT rate (‘negative list’) should be established based on the statistical classification of products by activity.
  Every two years
  , the list should be reviewed
  by means of an implementing act, based on evidence provided by the Commission
  .

Amendment 9

Proposal for a directive

Recital 6

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (6) | To avoid unnecessary complexity and subsequent rise in business costs, in particular for intra-Community trade, goods and services that can be used only as intermediate input to an economic activity should not be eligible for reduced rates in a definitive VAT system. Such rates should be applied
  only
  for the benefit of final consumers and the setting of such rates should ensure equal treatment of similar goods or services supplied by different taxable persons. They should therefore be applied to pursue, in a consistent manner, an objective of general interest. |

Text proposed by the Commission

Amendment

(6)

To avoid unnecessary complexity and subsequent rise in business costs, in particular for intra-Community trade, goods and services that can be used only as intermediate input to an economic activity should not be eligible for reduced rates in a definitive VAT system. Such rates should be applied
  only
  for the benefit of final consumers and the setting of such rates should ensure equal treatment of similar goods or services supplied by different taxable persons. They should therefore be applied to pursue, in a consistent manner, an objective of general interest.

| (6) | The current fragmentation of the VAT system within the internal market places obstacles in the way of the development of small and medium-sized enterprises (SMEs).
  To avoid
  further
  unnecessary complexity and subsequent rise in business costs, in particular for intra-Community trade, goods and services that can be used only as intermediate input to an economic activity should not be eligible for reduced rates in a definitive VAT system. Such rates should be applied for the benefit of final consumers and the setting of such rates should ensure equal treatment of similar goods or services supplied by different taxable persons. They should therefore be applied to pursue, in a consistent manner, an objective of general interest. |
| --- | --- |

(6)

The current fragmentation of the VAT system within the internal market places obstacles in the way of the development of small and medium-sized enterprises (SMEs).
  To avoid
  further
  unnecessary complexity and subsequent rise in business costs, in particular for intra-Community trade, goods and services that can be used only as intermediate input to an economic activity should not be eligible for reduced rates in a definitive VAT system. Such rates should be applied for the benefit of final consumers and the setting of such rates should ensure equal treatment of similar goods or services supplied by different taxable persons. They should therefore be applied to pursue, in a consistent manner, an objective of general interest.

Amendment 10

Proposal for a directive

Recital 6 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (6a) | With particular focus on the needs of SMEs engaging in intra-Community cross-border businesses and in order to facilitate trade and increase legal certainty in the single market, the Commission, in cooperation with Member States, should establish a comprehensive and publicly accessible Union VAT Web information portal for businesses. That multilingual portal should provide quick, up-to-date and accurate access to relevant information about the implementation of the VAT system in the different Member States and in particular about the correct VAT rates for different goods and services in the different Member States, as well as the conditions for zero-rate. Such a portal might also help to address the current VAT gap. |

Text proposed by the Commission

Amendment

(6a)

With particular focus on the needs of SMEs engaging in intra-Community cross-border businesses and in order to facilitate trade and increase legal certainty in the single market, the Commission, in cooperation with Member States, should establish a comprehensive and publicly accessible Union VAT Web information portal for businesses. That multilingual portal should provide quick, up-to-date and accurate access to relevant information about the implementation of the VAT system in the different Member States and in particular about the correct VAT rates for different goods and services in the different Member States, as well as the conditions for zero-rate. Such a portal might also help to address the current VAT gap.

Amendment 11

Proposal for a directive

Recital 6 b (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (6b) | A number of economic activities within the Union have focused on sustainable development based on a greener economy on the one hand and inclusive growth on the other. Such domains are of key importance in the sustainable development of rural and outlying areas, contributing to the economic and social revitalisation of rural areas. Given their close attachment to social, health, environmental, nutritional, cultural and gender equality issues, their specific activities are fully in line with ‘Strategy 2020’ambitions and Commission objectives. In this regard, Member States should therefore seize the opportunities offered by Article 98(1) and (2) of this Directive, provided that they respect its principles, taking particular account of the implications for their public finances and for the Union budget. |

Text proposed by the Commission

Amendment

(6b)

A number of economic activities within the Union have focused on sustainable development based on a greener economy on the one hand and inclusive growth on the other. Such domains are of key importance in the sustainable development of rural and outlying areas, contributing to the economic and social revitalisation of rural areas. Given their close attachment to social, health, environmental, nutritional, cultural and gender equality issues, their specific activities are fully in line with ‘Strategy 2020’ambitions and Commission objectives. In this regard, Member States should therefore seize the opportunities offered by Article 98(1) and (2) of this Directive, provided that they respect its principles, taking particular account of the implications for their public finances and for the Union budget.

Amendment 12

Proposal for a directive

Recital 7

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (7) | For the public finances of Member States to remain sound and in order to prevent excessive macroeconomic imbalances, an appropriate level of revenue should be ensured. Given that VAT is an important source of revenue, it is therefore vital, as a safeguard for national budgets, to set a minimum for the weighted average rate to be respected at any time by the Member States. |

Text proposed by the Commission

Amendment

(7)

For the public finances of Member States to remain sound and in order to prevent excessive macroeconomic imbalances, an appropriate level of revenue should be ensured. Given that VAT is an important source of revenue, it is therefore vital, as a safeguard for national budgets, to set a minimum for the weighted average rate to be respected at any time by the Member States.

| (7) | For the public finances of Member States to remain sound and in order to prevent excessive macroeconomic imbalances, an appropriate level of revenue should be ensured. Given that VAT is an important source of revenue, it is therefore vital, as a safeguard for national budgets
  and the Union budget
  , to set a minimum for the weighted average rate to be respected at any time by the Member States. |
| --- | --- |

(7)

For the public finances of Member States to remain sound and in order to prevent excessive macroeconomic imbalances, an appropriate level of revenue should be ensured. Given that VAT is an important source of revenue, it is therefore vital, as a safeguard for national budgets
  and the Union budget
  , to set a minimum for the weighted average rate to be respected at any time by the Member States.

Amendment 13

Proposal for a directive

Recital 8

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| (8) | While the application of different rates in certain remote areas continue to be possible, it
  it
  necessary to ensure that the standard rate respects the minimum of 15%. |

Text proposed by the Commission

Amendment

(8)

While the application of different rates in certain remote areas continue to be possible, it
  it
  necessary to ensure that the standard rate respects the minimum of 15%.

| (8) | While the application of different rates in certain remote areas continues to be possible, it
  is
  necessary to ensure that the standard rate respects the minimum of 15%
  and the maximum of 25 %
  . |
| --- | --- |

(8)

While the application of different rates in certain remote areas continues to be possible, it
  is
  necessary to ensure that the standard rate respects the minimum of 15%
  and the maximum of 25 %
  .

Amendment 14

Proposal for a directive

Article 1 – paragraph 1 – point 1a (new)

Directive 2006/112/EC

Article 97

| Present text | | Amendment |
| --- | --- | --- |
| The standard rate shall
  not be lower than 15 %. | | (1a) | Article 97 is replaced by the following: |

Present text

Amendment

The standard rate shall
  not be lower than 15 %.

(1a)

‘
  The
  standard rate
  shall permanently remain at least
  15 %
  and shall not exceed 25 %.
  ’

Amendment 15

Amendment 15

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 2

Article 1 – paragraph 1 – point 2

Directive 2006/112/EC

Article 98 – paragraph 2

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 2.   By way of derogation from paragraph 1, Member States may in addition to the two reduced rates apply a
  reduced
  rate lower than the minimum of 5% and an exemption with deductibility of the VAT paid at the preceding stage. | | 2.   By way of derogation from paragraph 1, Member States may in addition to the two reduced rates apply a
  reduced
  rate lower than the minimum of 5% and an exemption with deductibility of the VAT paid at the preceding stage. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   By way of derogation from paragraph 1, Member States may in addition to the two reduced rates apply a
  reduced
  rate lower than the minimum of 5% and an exemption with deductibility of the VAT paid at the preceding stage.

2.   By way of derogation from paragraph 1, Member States may in addition to the two reduced rates apply a
  reduced
  rate lower than the minimum of 5% and an exemption with deductibility of the VAT paid at the preceding stage.

Amendment 16

Amendment 16

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 2

Article 1 – paragraph 1 – point 2

Directive 2006/112/EC

Article 98 – paragraph 3 – subparagraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| Reduced rates and exemptions applied pursuant to paragraphs 1 and 2 shall
  only
  benefit the final consumer and shall be applied to pursue, in a consistent manner, an objective of general interest. | | Reduced rates and exemptions applied pursuant to paragraphs 1 and 2 shall benefit the final consumer and shall be applied to pursue, in a consistent manner, an objective of general interest.
  Priority shall be given to goods or services having a positive impact on the general interest, such as cultural, social or environmental benefits
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Reduced rates and exemptions applied pursuant to paragraphs 1 and 2 shall
  only
  benefit the final consumer and shall be applied to pursue, in a consistent manner, an objective of general interest.

only

Reduced rates and exemptions applied pursuant to paragraphs 1 and 2 shall benefit the final consumer and shall be applied to pursue, in a consistent manner, an objective of general interest.
  Priority shall be given to goods or services having a positive impact on the general interest, such as cultural, social or environmental benefits
  .

Priority shall be given to goods or services having a positive impact on the general interest, such as cultural, social or environmental benefits

Amendment 17

Amendment 17

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 5

Article 1 – paragraph 1 – point 5

Directive 2006/112/EC

Article 100 – paragraph -1 (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | The Commission is empowered to amend the scope of Annex IIIa by means of an implementing act, when necessary and provided there is evidence related to distortion of competition justifying the update of the list of supplies of goods and services. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission is empowered to amend the scope of Annex IIIa by means of an implementing act, when necessary and provided there is evidence related to distortion of competition justifying the update of the list of supplies of goods and services.

The Commission is empowered to amend the scope of Annex IIIa by means of an implementing act, when necessary and provided there is evidence related to distortion of competition justifying the update of the list of supplies of goods and services.

Amendment 18

Amendment 18

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 5

Article 1 – paragraph 1 – point 5

Directive 2006/112/EC

Article 100 – paragraph 1

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| By 31 December
  2026
  and every
  five
  years thereafter, the Commission shall submit to the Council a report on the scope of Annex IIIa, accompanied by any proposals to amend that Annex, where necessary. | | By 31 December
  2021
  and every
  two
  years thereafter, the Commission shall submit to the
  European Parliament and the
  Council a report on the scope of Annex IIIa, accompanied by any proposals to amend that Annex, where necessary. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

By 31 December
  2026
  and every
  five
  years thereafter, the Commission shall submit to the Council a report on the scope of Annex IIIa, accompanied by any proposals to amend that Annex, where necessary.

2026

five

By 31 December
  2021
  and every
  two
  years thereafter, the Commission shall submit to the
  European Parliament and the
  Council a report on the scope of Annex IIIa, accompanied by any proposals to amend that Annex, where necessary.

2021

two

European Parliament and the

Amendment 19

Amendment 19

Proposal for a directive

Proposal for a directive

Article 1 – paragraph 1 – point 5 a (new)

Article 1 – paragraph 1 – point 5 a (new)

Directive 2006/112/EC

Article 100 a (new)

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| | | (5a) | The following Article is inserted: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(5a)

The following Article is inserted:

‘Article 100a

The Commission, in cooperation with the Member States, shall establish a comprehensive, multilingual and publicly accessible Union VAT Web Information Portal on which businesses and consumers can quickly and effectively obtain accurate information on VAT rates – including which goods or services benefit from reduced rates or exemptions – and all relevant information on the implementation of the definitive VAT system in the different Member States.
  ’

Amendment 20

Amendment 20

Proposal for a directive

Proposal for a directive

Annex

Annex

Directive 2006/112/EC

Annex IIIa – row 5 – column B

| Text proposed by the Commission | | Amendment |
| --- | --- | --- |
| 11.01 | | 11.01 |
| 11.02 | | 11.02 |
| 11.03 | | 11.03 |
| | | 11.04 |
| 11.05 | | 11.05 |
| 47.00.25 | | 47.00.25 |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

11.01

11.01

11.02

11.02

11.03

11.03

11.04

11.04

11.05

11.05

47.00.25

47.00.25

Amendment 21

Amendment 21

Proposal for a directive

Proposal for a directive

Annex

Annex

Directive 2006/112/EC

Annex IIIa – row 7 – columns C and D

| Text proposed by the Commission |
| --- |
| Supply, hire, maintenance and repair of bicycles, baby carriages and invalid carriages | 30.92 |
| 33.17.19 |
| 47.00.65 |
| | 47.00.75 |
| | 77.21.10 |
| | 77.29.19 |
| | 95.29.12 |
| Supply of motor cars and other motor vehicles principally designed for the transport of <10 persons, incl. station wagons and racing cars, other than those vehicles with spark-ignition engine only or with compression-ignition internal combustion piston engine (diesel or semi-diesel) only | 29.10.24 |
| 45.11.2 |
| 45.11.3 |

Text proposed by the Commission

Text proposed by the Commission

Supply, hire, maintenance and repair of bicycles, baby carriages and invalid carriages

30.92

33.17.19

47.00.65

47.00.75

77.21.10

77.29.19

95.29.12

Supply of motor cars and other motor vehicles principally designed for the transport of <10 persons, incl. station wagons and racing cars, other than those vehicles with spark-ignition engine only or with compression-ignition internal combustion piston engine (diesel or semi-diesel) only

Supply of motor cars and other motor vehicles principally designed for the transport of <10 persons, incl. station wagons and racing cars, other than those vehicles with spark-ignition engine only or with compression-ignition internal combustion piston engine (diesel or semi-diesel) only

29.10.24

29.10.24

45.11.2

45.11.2

45.11.3

45.11.3

| Amendment |
| --- |
| Supply, hire, maintenance and repair of bicycles, baby carriages and invalid carriages | 30.92 |
| 33.17.19 |
| 47.00.65 |
| | 47.00.75 |
| | 77.21.10 |
| | 77.29.19 |
| | 95.29.12 |

Amendment

Amendment

Supply, hire, maintenance and repair of bicycles, baby carriages and invalid carriages

30.92

33.17.19

47.00.65

47.00.75

77.21.10

77.29.19

95.29.12

Amendment 22

Amendment 22

Proposal for a directive

Proposal for a directive

Annex

Annex

Directive 2006/112/EC

Annex IIIa – row 10 – columns C and D

| Text proposed by the Commission |
| --- |
| None | None |

Text proposed by the Commission

Text proposed by the Commission

None

None

None

None

| Amendment |
| --- |
| Pacemakers; hearing aids | 26.60.14 |

Amendment

Amendment

Pacemakers; hearing aids

Pacemakers; hearing aids

26.60.14

26.60.14

---

(1)  OJ L 347, 11.12.2006, p. 1.

1

(2)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on an action plan on VAT – Towards a single EU VAT area – Time to decide (COM(2016)0148 of 7 April 2016)

2

(3)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the follow-up to the Action Plan on VAT – Towards a single EU VAT area – Time to act (COM(2017)0566 of 4 October 2017).

3

(4)  OJ L 347, 11.12.2006, p. 1.

4

(5)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on an action plan on VAT – Towards a single EU VAT area – Time to decide (COM(2016)0148 of 7 April 2016)

5

(6)  Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the follow-up to the Action Plan on VAT – Towards a single EU VAT area – Time to act (COM(2017)0566 of 4 October 2017).

6

(7)  
  COM(2015)0192

7

COM(2015)0192

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/222 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/222

---

P8_TA(2018)0379

EU Agency for Criminal Justice Cooperation (Eurojust) ***I

European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust) (COM(2013)0535 – C7-0240/2013 – 2013/0256(COD))

(Ordinary legislative procedure: first reading)

(2020/C 011/26)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2013)0535), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2013)0535),

| — | having regard to Article 294(2) and Article 85 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0240/2013), |
| --- | --- |

—

having regard to Article 294(2) and Article 85 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0240/2013),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
| --- | --- |

—

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the provisional agreement approved by the responsible committee under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the provisional agreement approved by the responsible committee under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Budgetary Control and the Committee on Legal Affairs (A8-0320/2017), |
| --- | --- |

—

having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Budgetary Control and the Committee on Legal Affairs (A8-0320/2017),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
| --- | --- |

2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

---

P8_TC1-COD(2013)0256

Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the European Union Agency for Criminal Justice Cooperation (Eurojust), and replacing and repealing Council Decision 2002/187/JHA

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/1727.)

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/224 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/224

---

P8_TA(2018)0380

Mutual recognition of freezing and confiscation orders ***I

European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on the mutual recognition of freezing and confiscation orders (COM(2016)0819 – C8-0002/2017 – 2016/0412(COD))

(Ordinary legislative procedure: first reading)

(2020/C 011/27)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2016)0819), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2016)0819),

| — | having regard to Article 294(2) and Article 82(1), second subparagraph, point (a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0002/2017), |
| --- | --- |

—

having regard to Article 294(2) and Article 82(1), second subparagraph, point (a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0002/2017),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
| --- | --- |

—

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Czech Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 20 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Economic and Monetary Affairs and the Committee on Legal Affairs (A8-0001/2018), |
| --- | --- |

—

having regard to the report of the Committee on Civil Liberties, Justice and Home Affairs and the opinions of the Committee on Economic and Monetary Affairs and the Committee on Legal Affairs (A8-0001/2018),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
| --- | --- |

2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

---

P8_TC1-COD(2016)0412

Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on the mutual recognition of freezing orders and confiscation orders

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/1805.)

---

| 13.1.2020 | EN | Official Journal of the European Union | C 11/226 |
| --- | --- | --- | --- |

13.1.2020

EN

Official Journal of the European Union

C 11/226

---

P8_TA(2018)0381

Free flow of non-personal data in the European Union ***I

European Parliament legislative resolution of 4 October 2018 on the proposal for a regulation of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union (COM(2017)0495 – C8-0312/2017 – 2017/0228(COD))

(Ordinary legislative procedure: first reading)

(2020/C 011/28)

The European Parliament,

| — | having regard to the Commission proposal to Parliament and the Council (COM(2017)0495), |
| --- | --- |

—

having regard to the Commission proposal to Parliament and the Council (COM(2017)0495),

| — | having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0312/2017), |
| --- | --- |

—

having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0312/2017),

| — | having regard to Article 294(3) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

| — | having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the French Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity, |
| --- | --- |

—

having regard to the reasoned opinion submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the French Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity,

| — | having regard to the opinion of the European Economic and Social Committee of 15 February 2018 (1), |
| --- | --- |

—

having regard to the opinion of the European Economic and Social Committee of 15 February 2018 (1),

| — | after consulting the Committee of the Regions, |
| --- | --- |

—

after consulting the Committee of the Regions,

| — | having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 29 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 29 June 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

| — | having regard to Rule 59 of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 59 of its Rules of Procedure,

| — | having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on Industry, Research and Energy (A8-0201/2018), |
| --- | --- |

—

having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinion of the Committee on Industry, Research and Energy (A8-0201/2018),

| 1. | Adopts its position at first reading hereinafter set out; |
| --- | --- |

1.

| 2. | Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal; |
| --- | --- |

2.

| 3. | Instructs its President to forward its position to the Council, the Commission and the national parliaments. |
| --- | --- |

3.

---

(1)  OJ C 227, 28.6.2018, p. 78.

---

P8_TC1-COD(2017)0228

Position of the European Parliament adopted at first reading on 4 October 2018 with a view to the adoption of Regulation (EU) 2018/... of the European Parliament and of the Council on a framework for the free flow of non-personal data in the European Union

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2018/1807.)

---