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))

P8_TA(2018)0366 A8-0280/2018

(Special legislative procedure – consultation)

The European Parliament,

–  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 Rule 78c of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0280/2018),

1.  Approves the Commission proposal as amended;

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;

3.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

4.  Asks the Council to consult Parliament again if it intends to substantially amend the Commission proposal;

5.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Text proposed by the Commission   Amendment Amendment 1 Proposal for a directive Recital 1 (1)  In 1967, when the Council adopted the common system of value added tax (VAT) by means of Council Directives 67/227/EEC42 and 67/228/EEC43 , 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/EC44 , 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/EEC42 and 67/228/EEC43, 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/EC44, 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. _________________ _________________ 42 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). 42 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). 43 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). 43 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). 44 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). 44 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). Amendment 2 Proposal for a directive Recital 1 a (new) (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) (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 (2)  In its VAT Action Plan45 , 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 Plan45, 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. _________________ _________________ 45 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). 45 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). Amendment 5 Proposal for a directive Recital 3 (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. Amendment 6 Proposal for a directive Recital 3 a (new) (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 (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. Amendment 8 Proposal for a directive Recital 5 (5)  The Council, in its conclusions of 8 November 201646 , 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 201646 , 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. _________________ _________________ 46 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). 46 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). Amendment 9 Proposal for a directive Recital 6 (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. Amendment 10 Proposal for a directive Recital 7 (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. Amendment 11 Proposal for a directive Recital 8 (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. Amendment 12 Proposal for a directive Recital 9 (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. Amendment 13 Proposal for a directive Recital 9 a (new) (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) (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 (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. Amendment 16 Proposal for a directive Recital 13 a (new) (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) (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) (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) (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 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 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 (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; Amendment 23 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 2 – point a a (new) (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; (iii)  abuse of Union funds and programmes; (iv)  bankruptcy or insolvency fraud; (v)  insurance fraud or other financial fraud; (vi)  bribery and/or corruption; (vii)  cybercrime; (viii)  participation in a criminal organisation; (ix)  offences in the field of competition law; (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 (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; Amendment 25 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 2 – point c (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. Amendment 26 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 2 – subparagraph 1 a (new) 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) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 2 b (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 2 c (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 3 – subparagraph 1 – point d a (new) (da)   taxable persons which do not have or cease to have a valid VAT registration number; Amendment 31 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 3 – subparagraph 2 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. Amendment 32 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 4 – subparagraph 1 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. Amendment 33 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 4 – point a (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)* and in Council Directive (EU) .../... of ... on a Common Consolidated Corporate Tax Base (CCCTB)**, as well as in Council Directive (EU) .../... of ... laying down rules relating to the corporate taxation of a significant digital presence*** 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****; _________________ * 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. ** 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. *** 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. **** 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. Amendment 34 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 4 – subparagraph 2 – point c (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. deleted Amendment 35 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 4 a (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 5 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 6 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 6 a (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 6 b (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 1 Directive 2006/112/EC Article 13a – paragraph 7 a (new) 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 Proposal for a directive Article 1 – paragraph 1 – point 3 Directive 2006/112/EC Article 138 – paragraph 1 – point b (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; Amendment 42 Proposal for a directive Article 1 – paragraph 1 – point 4 Directive 2006/112/EC Article 138a – paragraph 3 – point b (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; Amendment 43 Proposal for a directive Article 1 – paragraph 1 – point 5 Directive 2006/112/EC Article 243 – paragraph 3 – subparagraph 2 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.’ Amendment 44 Proposal for a directive Article 1 – paragraph 1 – point 6 Directive 2006/112/EC Article 262 – paragraph 1 – introductory part 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 Proposal for a directive Article 1 – paragraph 1 – point 6 Directive 2006/112/EC Article 262 – paragraph 1 a (new) 1a.  The information referred to in paragraph 1 shall be accessible to all involved tax authorities via VIES. Amendment 46 Proposal for a directive Article 1 – paragraph 1 – point 6 a (new) Directive 2006/112/EC Title XIV – Chapter 2 a (new) (6a)  the following Chapter is inserted in Title XIV: ‘Chapter 2a VAT dispute resolution mechanism 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.  The mechanism shall not preclude the application of national legislation or provisions of international agreements where it is necessary to prevent tax evasion, tax fraud or abuse. 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 Proposal for a directive Article 1 – paragraph 1 – point 6 b (new) Directive 2006/112/EC Title XIV – Chapter 2 b (new) (6b)  the following Chapter is inserted in Title XIV: ‘Chapter 2b Automated notification mechanism 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 Proposal for a directive Article 1 – paragraph 1 – point 9 Directive 2006/112/EC Articles 403 and 404 (9)  Articles 403 and 404 are deleted. (9)  Article 403 is deleted. Amendment 49 Proposal for a directive Article 1 – paragraph 1 – point 9 a (new) Directive 2006/112/EC Article 404 (9a)  Article 404 is replaced by the following: "Article 404 ‘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." 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 Proposal for a directive Article 1 – paragraph 1 – point 9 b (new) Directive 2006/112/EC Article 404 a (new) (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 Proposal for a directive Article 2 – paragraph 1 – subparagraph 2 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. Amendment 52 Proposal for a directive Article 2 – paragraph 2 a (new) 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.

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))

P8_TA(2018)0367 A8-0283/2018

(Special legislative procedure – consultation)

The European Parliament,

–  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 Rule 78c of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0283/2018),

1.  Approves the Commission proposal;

2.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.  Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

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))

P8_TA(2018)0368 A8-0285/2018

(Special legislative procedure – consultation)

The European Parliament,

–  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 Rule 78c of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0285/2018),

1.  Approves the Commission proposal;

2.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.  Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

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)

P8_TA(2018)0369 A8-0289/2018

(Ordinary legislative procedure: first reading)

Text proposed by the Commission   Amendment Amendment 1 Proposal for a regulation Citation 1 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 (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. Amendment 3 Proposal for a regulation Recital 1 a (new) (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) (1b)  The Council conclusions of 16 June 2016 and the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines1a 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. ____________________ 1a OJ C 263, 25.7.2018, p. 4. Amendment 5 Proposal for a regulation Recital 1 c (new) (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 (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. Amendment 7 Proposal for a regulation Recital 2 a (new) (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) (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 (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. Amendment 10 Proposal for a regulation Recital 3 a (new) (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 (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. Amendment 12 Proposal for a regulation Recital 4 a (new) (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) (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 (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. Amendment 15 Proposal for a regulation Recital 6 (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 Council1a, 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. ____________________ 1a 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). Amendment 16 Proposal for a regulation Recital 6 a (new) (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 (7)  The Council in its Conclusions of December 20148 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 patients8, 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. __________________ __________________ 8 OJ C 438, 6.12.2014, p. 12. 8 OJ C 438, 6.12.2014, p. 12. Amendment 18 Proposal for a regulation Recital 8 (8)  The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines,9 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 20179 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. __________________ __________________ 9 European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI). 9 European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI). Amendment 19 Proposal for a regulation Recital 10 (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. Amendment 20 Proposal for a regulation Recital 11 (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. Amendment 21 Proposal for a regulation Recital 12 (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,11 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 Council12 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 Council11, 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 Council12, given the need for greater clinical evidence concerning all of those new health technologies. __________________ __________________ 11 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). 11 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 (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). 12 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). Amendment 22 Proposal for a regulation Recital 13 (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. Amendment 23 Proposal for a regulation Recital 14 (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. Amendment 24 Proposal for a regulation Recital 15 (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. Amendment 25 Proposal for a regulation Recital 15 a (new) (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 (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. Amendment 27 Proposal for a regulation Recital 16 a (new) (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 (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) (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 (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 Council1a 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 Council1b 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 Council1c. 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. _________________ 1a 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). 1b 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). 1c 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). Amendment 31 Proposal for a regulation Recital 19 (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. Amendment 32 Proposal for a regulation Recital 19 a (new) (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) (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) (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 (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. Amendment 36 Proposal for a regulation Recital 20 a (new) (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 (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. Amendment 38 Proposal for a regulation Recital 21 a (new) (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) (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 (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. Amendment 41 Proposal for a regulation Recital 23 (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. Amendment 42 Proposal for a regulation Recital 24 (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. Amendment 43 Proposal for a regulation Recital 24 a (new) (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) (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 (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 Council13. __________________ __________________ 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 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). Amendment 46 Proposal for a regulation Recital 25 a (new) (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) (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) (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 (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 2016.14 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. __________________ 14 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). Amendment 50 Proposal for a regulation Recital 27 (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. Amendment 51 Proposal for a regulation Recital 28 (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. Amendment 52 Proposal for a regulation Recital 28 a (new) (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) (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 (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. Amendment 55 Proposal for a regulation Recital 31 (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. Amendment 56 Proposal for a regulation Recital 32 (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. Amendment 57 Proposal for a regulation Recital 34 (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, Amendment 58 Proposal for a regulation Article 1 – paragraph 1 – introductory part 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 Proposal for a regulation Article 1 – paragraph 1 – point a (a)  a support framework and procedures for cooperation on health technology assessment at Union level; (a)  a support framework and procedures for cooperation on the clinical assessment of health technology at Union level; Amendment 60 Proposal for a regulation Article 1 – paragraph 1 – point b (b)  common rules for the clinical assessment of health technologies. (b)  common methodologies for the clinical assessment of health technologies. Amendment 61 Proposal for a regulation Article 1 – paragraph 2 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 Proposal for a regulation Article 2 – paragraph 1 – point b a (new) (ba)  ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746; Amendment 63 Proposal for a regulation Article 2 – paragraph 1 – point b b (new) (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; Amendment 64 Proposal for a regulation Article 2 – paragraph 1 – point e (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; (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; Amendment 65 Proposal for a regulation Article 2 – paragraph 1 – point g a (new) (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. Amendment 202 Proposal for a regulation Article 2 – paragraph 1 – point g b (new) (gb)  ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events. Amendment 66 Proposal for a regulation Article 3 – paragraph 2 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 Proposal for a regulation Article 3 – paragraph 3 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 Proposal for a regulation Article 3 – paragraph 4 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 Proposal for a regulation Article 3 – paragraph 5 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 Proposal for a regulation Article 3 – paragraph 6 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 Proposal for a regulation Article 3 – paragraph 7 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 Proposal for a regulation Article 3 – paragraph 8 – point c (c)  ensure cooperation 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; Amendment 73 Proposal for a regulation Article 3 – paragraph 8 – point d (d)  ensure appropriate involvement of stakeholders in its work; (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; Amendment 74 Proposal for a regulation Article 3 – paragraph 10 a (new) 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 Proposal for a regulation Article 4 – paragraph 2 – subparagraph 1 a (new) 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 Proposal for a regulation Article 4 – paragraph 3 – point c (c)  consult the Commission on the draft annual work programme and take into account 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. Amendment 77 Proposal for a regulation Article 4 – paragraph 5 a (new) 5a.  Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27. Amendment 78 Proposal for a regulation Article 5 – paragraph 1 – point a a (new) (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; Amendment 79 Proposal for a regulation Article 5 – paragraph 1 – point b (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; Amendment 80 Proposal for a regulation Article 5 – paragraph 1 – point c (c)  in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/74617 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation. (c)  in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746[1] 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. __________________ __________________ 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 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). Amendment 81 Proposal for a regulation Article 5 – paragraph 2 – point e a (new) (ea)  the need for greater clinical evidence; Amendment 82 Proposal for a regulation Article 5 – paragraph 2 – point e b (new) (eb)  at the request of the health technology developer; Amendment 83 Proposal for a regulation Article 6 – paragraph 1 – subparagraph 2 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/EEC1a. _________________ 1a 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). Amendment 84 Proposal for a regulation Article 6 – paragraph 2 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; (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; (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. 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 Proposal for a regulation Article 6 – paragraph 2 a (new) 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 Proposal for a regulation Article 6 – paragraph 3 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 Proposal for a regulation Article 6 – paragraph 5 – introductory part 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 Proposal for a regulation Article 6 – paragraph 5 – point a (a)  an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment; (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; Amendment 89 Proposal for a regulation Article 6 – paragraph 5 – point b (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. Amendment 90 Proposal for a regulation Article 6 – paragraph 5 – subparagraph 1 a (new) 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. Amendment 205 Proposal for a regulation Article 6 – paragraph 6 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 Proposal for a regulation Article 6 – paragraph 7 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 Proposal for a regulation Article 6 – paragraph 8 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 Proposal for a regulation Article 6 – paragraph 9 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 Proposal for a regulation Article 6 – paragraph 10 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 Proposal for a regulation Article 6 – paragraph 11 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 Proposal for a regulation Article 6 – paragraph 12 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 (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 Proposal for a regulation Article 6 – paragraph 13 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 Proposal for a regulation Article 6 – paragraph 14 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 Proposal for a regulation Article 6 – paragraph 14 a (new) 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 Proposal for a regulation Article 6 – paragraph 14 b (new) 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 Proposal for a regulation Article 6 – paragraph 14 c (new) 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 Proposal for a regulation Article 7 – paragraph 1 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 Proposal for a regulation Article 7 – paragraph 2 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 Proposal for a regulation Article 7 – paragraph 3 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 Proposal for a regulation Article 7 – paragraph 4 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 Amendment 107 Proposal for a regulation Article 7 – paragraph 5 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 Proposal for a regulation Article 7 – paragraph 6 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 Proposal for a regulation Article 8 – paragraph 1 – introductory part 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 Proposal for a regulation Article 8 – paragraph 1 – point a (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; (a)  use the joint clinical assessment reports in their health technology assessments at Member State level; Amendment 111 Proposal for a regulation Article 8 – paragraph 1 – point b (b)  apply joint clinical assessment reports, in their health technology assessments at Member State level. (b)  not duplicate the joint clinical assessment at Member State level. Amendment 112 Proposal for a regulation Article 8 – paragraph 1 a (new) 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 Proposal for a regulation Article 8 – paragraph 2 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 Proposal for a regulation Article 9 – paragraph 1 – point b (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; Amendment 115 Proposal for a regulation Article 9 – paragraph 1 – point b a (new) (ba)  at the request of a Member State or a health technology developer that considers that there is new clinical evidence; Amendment 116 Proposal for a regulation Article 9 – paragraph 1 – point b b (new) (bb)  five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges. Amendment 117 Proposal for a regulation Article 9 – paragraph 1 – subparagraph 1 a (new) 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. Amendment 118 Proposal for a regulation Article 9 – paragraph 2 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 Proposal for a regulation Article 11 – paragraph 1 – introductory part 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 Proposal for a regulation Article 11 – paragraph 1 – point a (a)  submissions of information, data and evidence by health technology developers; deleted Amendment 121 Proposal for a regulation Article 11 – paragraph 1 – point c (c)  determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments; (c)  determining the detailed procedural steps and their timing; Amendment 122 Proposal for a regulation Article 11 – paragraph 1 – point f (f)  cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices. (f)  cooperation with the bodies and expert panels. Amendment 123 Proposal for a regulation Article 12 – paragraph 1 – subparagraph 1 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. Amendment 124 Proposal for a regulation Article 12 – paragraph 2 – point f a (new) (fa)  Union clinical research priorities ; Amendment 125 Proposal for a regulation Article 12 – paragraph 3 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 Proposal for a regulation Article 13 – title Preparation of Joint Scientific Consultation Reports Joint scientific consultation procedure Amendment 127 Proposal for a regulation Article 13 – paragraph 1 – subparagraph 2 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. Amendment 128 Proposal for a regulation Article 13 – paragraph 2 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 Proposal for a regulation Article 13 – paragraph 3 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 Proposal for a regulation Article 13 – paragraph 7 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 Proposal for a regulation Article 13 – paragraph 8 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 Proposal for a regulation Article 13 – paragraph 9 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 Proposal for a regulation Article 13 – paragraph 10 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 Proposal for a regulation Article 13 – paragraph 12 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 Proposal for a regulation Article 14 – paragraph 2 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 Proposal for a regulation Article 14 – paragraph 3 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 Proposal for a regulation Article 16 – paragraph 1 – point a (a)  submissions of requests from health technology developers and their involvement in the preparation of joint scientific consultation reports; (a)  submissions of requests from health technology developers; Amendment 138 Proposal for a regulation Article 16 – paragraph 1 – point d (d)  the consultation of patients, 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; Amendment 139 Proposal for a regulation Article 17 – paragraph 1 – introductory part 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 : Amendment 140 Proposal for a regulation Article 17 – paragraph 1 – point a – introductory part (a)  the contents of: (a)  the procedure for: Amendment 141 Proposal for a regulation Article 17 – paragraph 1 – point a – point iii a (new) (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. Amendment 142 Proposal for a regulation Article 17 – paragraph 1 – point b (b)  the rules for determining the stakeholders to be consulted for the purpose of this Section. deleted Amendment 143 Proposal for a regulation Article 18 – paragraph 2 – point b (b)  patient organisations; (b)  patient and consumer organisations and health professionals at its annual meeting; Amendment 144 Proposal for a regulation Article 18 – paragraph 2 a (new) 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 Proposal for a regulation Article 19 – paragraph 1 – introductory part 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 Proposal for a regulation Article 19 – paragraph 1 – point d a (new) (da)  clinical assessments of medicinal products and medical devices carried out by Member States; Amendment 147 Proposal for a regulation Article 19 – paragraph 1 – point d b (new) (db)  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 Proposal for a regulation Article 19 – paragraph 1 – point d c (new) (dc)  the development of best medical practice guides based on scientific evidence; Amendment 149 Proposal for a regulation Article 19 – paragraph 1 – point d d (new) (dd)  disinvestment in obsolete technologies; Amendment 150 Proposal for a regulation Article 19 – paragraph 1 – point d e (new) (de)  the tightening of the rules on clinical evidence generation and its monitoring. Amendment 151 Proposal for a regulation Article 19 – paragraph 3 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 Proposal for a regulation Article 20 – paragraph 1 – point b (b)  clinical assessments of medicinal products and medical devices carried out by Member States. deleted Amendment 153 Proposal for a regulation Article 20 – paragraph 1 – subparagraph 1 a (new) 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 Proposal for a regulation Article 22 – paragraph 1 – introductory part 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 Proposal for a regulation Article 22 – paragraph 1 – point a – point i (i)  ensuring that health technology authorities and bodies carry out clinical assessments in an independent and transparent manner, free from conflicts of interest; (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); Amendment 156 Proposal for a regulation Article 22 – paragraph 1 – point a – point ii (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; Amendment 157 Proposal for a regulation Article 22 – paragraph 1 – point a – point iii (iii)  the consultation of patients, clinical experts, and other stakeholders in clinical assessments. (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; Amendment 158 Proposal for a regulation Article 22 – paragraph 1 – point a – point iii a (new) (iiia)  addressing potential conflicts of interest; Amendment 159 Proposal for a regulation Article 22 – paragraph 1 – point a – point iii b (new) (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. Amendment 160 Proposal for a regulation Article 22 – paragraph 1 – point b (b)  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. Amendment 208/rev Proposal for a regulation Article 22 – paragraph 1 a (new) 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; (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; (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; (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; (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; (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. 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. 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. 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. Amendment 162 Proposal for a regulation Article 23 – paragraph 1 – introductory part 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: Amendment 163 Proposal for a regulation Article 23 – paragraph 1 – point a – introductory part (a)  the contents of: (a)  the format and templates of: Amendment 164 Proposal for a regulation Article 23 – paragraph 1 – point b (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. Amendment 165 Proposal for a regulation Article 24 – title Union Funding Funding Amendment 166 Proposal for a regulation Article 24 – paragraph 2 a (new) 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 Proposal for a regulation Article 24 – paragraph 2 b (new) 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 Proposal for a regulation Article 25 – paragraph 1 – point a (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; Amendment 169 Proposal for a regulation Article 25 – paragraph 1 – point b (b)  provide the secretariat for the Coordination Group and provide administrative, scientific and IT support; (b)  provide the secretariat for the Coordination Group and provide administrative and IT support; Amendment 170 Proposal for a regulation Article 25 – paragraph 1 – point d (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; Amendment 171 Proposal for a regulation Article 25 – paragraph 1 – point f (f)  facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of confidential information. (f)  facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of information. Amendment 172 Proposal for a regulation Article 26 – paragraph 1 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 Proposal for a regulation Article 26 – paragraph 2 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 Proposal for a regulation Article 26 – paragraph 3 – introductory part 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 Proposal for a regulation Article 26 – paragraph 3 – point a (a)  update stakeholders on the work of the group; (a)  exchange of information on the work of the Coordination Group and the assessment process; Amendment 176 Proposal for a regulation Article 26 – paragraph 3 – point b (b)  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; Amendment 177 Proposal for a regulation Article 26 – paragraph 3 – point b a (new) (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. Amendment 178 Proposal for a regulation Article 26 – paragraph 3 – point b b (new) (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; Amendment 179 Proposal for a regulation Article 26 – paragraph 3 – point b c (new) (bc)  drawing up a list of priorities for medical research; Amendment 180 Proposal for a regulation Article 26 – paragraph 3 – point b d (new) (bd)  seeking input into the annual work programme and the annual study prepared by the Coordination Group; Amendment 181 Proposal for a regulation Article 26 – paragraph 3 – subparagraph 1 a (new) 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 Proposal for a regulation Article 26 – paragraph 4 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 Proposal for a regulation Article 27 – paragraph 1 – introductory part 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 Proposal for a regulation Article 27 – paragraph 1 – point d a (new) (da)  a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests; Amendment 185 Proposal for a regulation Article 27 – paragraph 1 – point d b (new) (db)  all information whose publication is required under this Regulation; Amendment 186 Proposal for a regulation Article 27 – paragraph 1 – point d c (new) (dc)  final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union; Amendment 187 Proposal for a regulation Article 27 – paragraph 1 – point d d (new) (dd)  a list of organisations included in the stakeholder network; Amendment 188 Proposal for a regulation Article 27 – paragraph 2 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 Proposal for a regulation Article 28 – title Implementation Report Evaluation report on the transitional period Amendment 190 Proposal for a regulation Article 28 – paragraph 1 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. Amendment 191 Proposal for a regulation Article 31 Article 31 deleted 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. Amendment 192 Proposal for a regulation Article 32 – title Preparation of Implementing and Delegated Acts Preparation of Implementing Acts Amendment 193 Proposal for a regulation Article 32 – paragraph 1 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 Proposal for a regulation Article 32 – paragraph 2 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 Proposal for a regulation Article 33 – paragraph 1 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 Proposal for a regulation Article 34 – paragraph 1 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 Proposal for a regulation Article 34 – paragraph 2 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 Proposal for a regulation Article 34 – paragraph 2 a (new) 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 Proposal for a regulation Article 34 – paragraph 3 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).

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)

P8_TA(2018)0370 A8-0287/2018

(Ordinary legislative procedure – recast)

Text proposed by the Commission   Amendment Amendment 1 Proposal for a regulation Recital 3 (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. Amendment 2 Proposal for a regulation Recital 4 a (new) (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) (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) (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 (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. Amendment 6 Proposal for a regulation Recital 9 (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. Amendment 7 Proposal for a regulation Recital 10 a (new) (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 (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. Amendment 9 Proposal for a regulation Recital 12 a (new) (12 a)  The Commission’s evaluation of Directive 1999/94/EC of the European Parliament and of the Council 1a 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) 2017/9481b 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. _______________ 1a 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). 1b 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). Amendment 10 Proposal for a regulation Recital 13 (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. Amendment 11 Proposal for a regulation Recital 14 (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. Amendment 12 Proposal for a regulation Recital 14 a (new) (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 (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. Amendment 14 Proposal for a regulation Recital 16 (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. Amendment 15 Proposal for a regulation Recital 17 (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. Amendment 16 Proposal for a regulation Recital 17 a (new) (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 (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. Amendment 18 Proposal for a regulation Recital 25 a (new) (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 (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. Amendment 21 Proposal for a regulation Recital 38 (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. Amendment 22 Proposal for a regulation Recital 41 (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)23 and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector24 , 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)23 and the recommendation of the European Parliament, following its inquiry into emission measurements in the automotive sector24 , 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. __________________ __________________ 23 High Level Group of Scientific Advisors, Scientific Opinion 1/2016 "Closing the gap between light-duty vehicle real-world CO2 emissions and laboratory testing" 23 High Level Group of Scientific Advisors, Scientific Opinion 1/2016 "Closing the gap between light-duty vehicle real-world CO2 emissions and laboratory testing". 24 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)) 24 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)). Amendment 23 Proposal for a regulation Recital 41 a (new) (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 (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. Amendment 24 Proposal for a regulation Recital 46 (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. Amendment 25 Proposal for a regulation Article 1 – paragraph 1 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 Proposal for a regulation Article 1 – paragraph 4 4.  From 1 January 2025 the following EU fleet-wide targets shall apply: 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; (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 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 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 Proposal for a regulation Article 1 – paragraph 4 – subparagraph 1 a (new) 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 Proposal for a regulation Article 1 — paragraph 5 5.  From 1 January 2030 the following targets shall apply: 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; (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 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 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 Proposal for a regulation Article 1 — paragraph 5 — subparagraph 1 a (new) 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 Proposal for a regulation Article 2 – paragraph 1 – point b (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’). (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. Amendment 31 Proposal for a regulation Article 2 – paragraph 4 a (new) 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 Proposal for a regulation Article 3 – paragraph 1 – point n a (new) (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. Amendment 33 Proposal for a regulation Article 4 – paragraph 3 a (new) 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 Proposal for a regulation Article 4 – paragraph 3 b (new) 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 (c)  the conditions are substantially included in the test procedures referred to under Article 1. Amendment 35 Proposal for a regulation Article 4 – paragraph 3 c (new) 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 Proposal for a regulation Article 7 – paragraph 1 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 Proposal for a regulation Article 7 – paragraph 4 – subparagraph 3 The register shall be publicly available. The register shall be publicly available, including in digital format. Amendment 38 Proposal for a regulation Article 7 – paragraph 5 – subparagraph 1 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. Amendment 39 Proposal for a regulation Article 7 – paragraph 8 – subparagraph 3 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). Amendment 40 Proposal for a regulation Article 7 – paragraph 8 a (new) 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 Proposal for a regulation Article 8 – paragraph 4 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 Proposal for a regulation Article 10 – paragraph 3 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 Proposal for a regulation Article 11 – paragraph 1 – subparagraph 2 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. Amendment 44 Proposal for a regulation Article 11 – paragraph 1 – subparagraph 3 a (new) 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 Proposal for a regulation Article 11 – paragraph 1 – subparagraph 4 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. Amendment 46 Proposal for a regulation Article 11 – paragraph 2 – point d (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. (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. Amendment 47 Proposal for a regulation Article 12 – paragraph 1 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 Proposal for a regulation Article 12 – paragraph 1 a (new) 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 Proposal for a regulation Article 12 – paragraph 1 b (new) 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 Proposal for a regulation Article 12 – paragraph 1 c (new) 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 Proposal for a regulation Article 12 – paragraph 2 a (new) 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 Proposal for a regulation Article 12 – paragraph 2 b (new) 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 Proposal for a regulation Article 12 – paragraph 3 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 Proposal for a regulation Article 14 — paragraph 1 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 Council29. 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 Council29, 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. ___________________ ___________________ 29.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) 29.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) Amendment 54 Proposal for a regulation Article 14 – paragraph 2 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 Proposal for a regulation Article 14 – paragraph 3 a (new) 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 Proposal for a regulation Article 14 – paragraph 3 b (new) 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 Proposal for a regulation Article 16 – paragraph 1 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 Proposal for a regulation Article 16 – paragraph 2 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 Proposal for a regulation Article 16 – paragraph 4 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 Proposal for a regulation Article 17 – paragraph 1 Regulation (EC) No 715/2007 Article 11a – paragraph 2 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 Proposal for a regulation Article 17 – paragraph 1 a (new) Regulation (EC) No 715/2007 Article 14 a (new) 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*. 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. ___________________ * OJ L 123, 12.5.2016, p. 1.”. Amendment 62 Proposal for a regulation Annex I – part A – point 6.3 – paragraph 1 a (new) 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. Amendment 63 Proposal for a regulation Annex I – part A – point 6.3 – paragraph 3 – subparagraph 2 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 Amendment 98 Proposal for a regulation Annex I — part A — point 6.3 — paragraph 4 — subparagraph 3 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. Amendment 65 Proposal for a regulation Annex I – part B – point 6.3.1 – paragraph 1 a (new) 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. Amendment 66 Proposal for a regulation Annex I – part B – point 6.3.1 – paragraph 3 – subparagraph 3 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. Amendment 67 Proposal for a regulation Annex I – part B – point 6.3.1 – paragraph 4 – subparagraph 3 x is 15% x is 20 % Amendment 68 Proposal for a regulation Annex I – part B – point 6.3.2 – paragraph 1 a (new) 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. Amendment 69 Proposal for a regulation Annex I – part B – point 6.3.2 – paragraph 3 – subparagraph 3 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 Amendment 99 Proposal for a regulation Annex I — part B — point 6.3.2 — paragraph 4 — subparagraph 3 x is 30% x is 35 %