Procedure : 2018/0018(COD)
Document stages in plenary
Document selected : A8-0289/2018

Texts tabled :

A8-0289/2018

Debates :

PV 01/10/2018 - 16
CRE 01/10/2018 - 16
PV 13/02/2019 - 14
CRE 13/02/2019 - 14

Votes :

PV 03/10/2018 - 9.4
CRE 03/10/2018 - 9.4
Explanations of votes
PV 14/02/2019 - 10.6

Texts adopted :

P8_TA(2018)0369
P8_TA(2019)0120

REPORT     ***I
PDF 1661kWORD 258k
24.9.2018
PE 622.011v02-00 A8-0289/2018

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))

Committee on the Environment, Public Health and Food Safety

Rapporteur: Soledad Cabezón Ruiz

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 MINORITY OPINION
 OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS
 OPINION of the Committee on Industry, Research and Energy
 OPINION of the Committee on the Internal Market and Consumer Protection
 PROCEDURE – COMMITTEE RESPONSIBLE
 FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0051),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0024/2018),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 59 and 39 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A8-0289/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

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

Amendment    1

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114 and 168(4) thereof,

Amendment    2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1)  The development of health technologies is a key driver of economic growth and innovation in the Union. It forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

(1)  The development of health technologies is key to achieving the high level of health protection that health policies must ensure, for the benefit of all citizens. Health technologies are an innovative sector of the economy which form part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

Amendment    3

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

 

(1a)  Expenditure on medicines stood at 1.41% of GDP in 2014 and accounted for 17.1% of overall health expenditure, of which it is a major component. Health expenditure in the Union amounts to 10% of GDP, i.e., EUR 1 300 000 million per annum, EUR 220 000 million of which is pharmaceutical expenditure and EUR 110 000 million expenditure on medical devices.

Amendment    4

Proposal for a regulation

Recital 1 b (new)

Text proposed by the Commission

Amendment

 

(1b)  The Council conclusions of 16 June 2016 and the European Parliament resolution of 2 March 2017 on EU options for improving access to medicines (2016/2057(INI)) highlighted that there are many barriers to access to medicine and innovative technologies in the Union, with the main barriers being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value.

Amendment    5

Proposal for a regulation

Recital 1 c (new)

Text proposed by the Commission

Amendment

 

(1c)  Marketing authorisations for medicinal products are granted by the European Medicines Agency on the basis of the principles of safety and efficacy. Normally the national health technology assessment agencies assess comparative effectiveness, because marketing authorisations are not accompanied by a comparative effectiveness study.

Amendment    6

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2)  Health Technology Assessment (HTA) is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.

(2)  Health Technology Assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added therapeutic value of a health technology in comparison with other new or existing health technologies.

Amendment    7

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

 

(2a)  As the World Health Organisation (WHO) stated at the 67th World Health Assembly in May 2014, HTA has to be a tool in support of universal health coverage.

Amendment    8

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

 

(2b)  HTA should be instrumental in promoting innovation which offers the best outcomes for patients and society as a whole and is a necessary tool for ensuring the proper application and use of health technologies.

Amendment    9

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3)  HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.

(3)  HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains (which form the ‘HTA Core model’) four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.

Amendment    10

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

 

(3a)  Health professionals, patients and health institutions need to know whether or not a new health technology represents an improvement on existing health technologies, in terms of benefits and risks. Joint clinical assessments therefore aim to identify the added therapeutic value of new or existing health technologies in comparison with other new or existing health technologies, by undertaking a comparative assessment based on comparative trials against the current best proven intervention (‘standard treatment’) or against the current most common treatment where no such standard treatment exists.

Amendment    11

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4)  The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

(4)  HTA is an important tool for promoting high-quality innovation, steering research towards addressing the unmet diagnostic, therapeutic or procedural needs of healthcare systems as well as steering clinical and social priorities. HTA can also improve scientific evidence used to inform clinical decision-making, efficiency in use of resources, the sustainability of health systems, patient access to these health technologies, and the competitiveness of the sector through greater predictability and more efficient research. Member States use the outcome of HTA to augment the scientific evidence that informs decisions to introduce health technologies into their systems, i.e., to inform decisions on how to allocate resources. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

Amendment    12

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

 

(4a)  Cooperation in the field of HTA can also play a role throughout the health technology cycle: in the early developmental stage through ‘horizon scanning’ in order to pinpoint technologies that will have a major impact; in the early dialogue and scientific advisory stages; in better study design to ensure greater research efficiency; and in the core stages of the overall assessment, once the technology is already established. Finally, HTA can help in decision-making on divestment in cases where a technology becomes obsolete and unsuitable compared to better alternative options that are available. Greater collaboration between Member States in the field of HTA should also help improve and harmonise standards of care as well as diagnostic and new-born screening practices across the Union.

Amendment    13

Proposal for a regulation

Recital 4 b (new)

Text proposed by the Commission

Amendment

 

(4b)  Cooperation in the field of HTA can extend beyond pharmaceutical products and medical devices. It can also cover areas such as diagnostics used to supplement treatment, surgical procedures, prevention, screening and health promotion programmes, information and communications technology (ICT) tools, health-care organisation plans and integrated care processes. Different demands are involved in assessing different technologies, depending on their specific features, meaning that a cohesive approach which can cater for these different technologies is needed in the field of HTA. Moreover, in specific areas such as treatments for rare diseases, paediatric medicines, precision medicine and advanced therapies, the added value of cooperation at Union level is likely to be even greater.

Amendment    14

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5)  The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with multiple and divergent requests for data. It can also lead to both duplications and variations in outcomes that increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market.

(5)  The carrying out of parallel assessments by multiple Member States and divergences between national laws, regulations and administrative provisions on the processes and methodologies of assessment can result in health technology developers being confronted with a duplication of requests for data that could increase the financial and administrative burdens that act as a barrier to the free movement of the health technologies concerned and the smooth functioning of the internal market. In some justified cases where the specificities of the national and regional healthcare systems and priorities need to be taken into account, a complementary assessment on certain aspects might be necessary. However, assessments that are not relevant for decisions in certain Member States could delay the implementation of innovative technologies and thus access of patients to beneficial innovative treatments.

Amendment    15

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6)  While Member States have carried out some joint assessments within the framework of the EU co-funded joint actions, the production of output has been inefficient, relying on project-based cooperation in the absence of a sustainable model of cooperation. Use of the results of the joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed.

(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/EC of the European Parliament and of the Council*, 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.

* Directive 2011/24/EC of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L88, 4.4.2011, p. 45).  

Amendment    16

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission

Amendment

 

(6a)  However, within the joint actions, the production of output has been inefficient and, in the absence of a sustainable model of cooperation, relying on project-based cooperation. Use of the results of the joint actions, including their joint clinical assessments, at Member State-level has remained low, meaning that the duplication of assessments on the same health technology by HTA authorities and bodies in different Member States within identical or similar timeframes has not been sufficiently addressed.

Amendment    17

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(8)  The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines,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

Text proposed by the Commission

Amendment

(10)  In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA.

(10)  In order to ensure a better functioning of the internal market and contribute to a high level of human health protection it is appropriate to approximate the rules on carrying out clinical assessments at national level and clinical assessments of certain health technologies at Union level, and which also support the continuation of voluntary cooperation between Member States on certain aspects of HTA. That approximation should guarantee the highest quality standards and be aligned to best available practice. It should not stimulate a convergence towards the lowest common denominator nor force HTA bodies with more expertise and higher standards to accept lower requirements. It should rather lead to an improvement of the HTA capacity and quality at the national and regional level.

Amendment    20

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11)  In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology, and in particular, to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology. The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.

(11)  In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology. The joint clinical assessment provided for by this Regulation constitutes a scientific analysis of the relative effects of health technology on efficacy, safety and effectiveness, commonly referred to as clinical outcomes, that is evaluated in relation to the comparative indicators currently deemed appropriate and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. It will include consideration of the degree of certainty on the relative outcomes, based on the available evidence. The outcome of such joint clinical assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence. The assessment conducted by each Member State as part of its national appraisal therefore falls outside the scope of this Regulation.

Amendment    21

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12)  In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,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

Text proposed by the Commission

Amendment

(13)  In order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, it is appropriate to establish conditions for the updating of assessments, in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment.

(13)  In order to ensure that joint clinical assessments carried out on health technologies remain accurate, relevant, of high quality and based on the best scientific evidence available at any given time, it is appropriate to establish a flexible, regulated procedure for the updating of assessments, in particular when new evidence or additional data becomes available subsequent to the initial assessment and such new evidence or additional data may augment the scientific evidence and thus increase the quality of the assessment.

Amendment    23

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14)  A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.

(14)  A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility and proven expertise for overseeing the carrying out of joint clinical assessments and other joint work within the scope of this Regulation.

Amendment    24

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15)  In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the need to provide expertise on the HTA of medicinal products and medical devices.

(15)  In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national or regional HTA authorities and bodies which inform decision-making to conduct such assessments, as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the possibility of providing expertise on the HTA of medicinal products and medical devices. The organisational structure should respect the distinctive mandates of the sub-groups conducting the joint clinical assessments and the joint scientific consultations. Any conflict of interest should be avoided.

Amendment    25

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission

Amendment

 

(15a)  Transparency and public awareness of the process is essential. All clinical data being evaluated should have therefore the highest level of transparency and public awareness in order to gain confidence in the system. In case there is confidential data for commercial reasons, the confidentiality needs to be clearly defined and justified and the confidential data well delimitated and protected.

Amendment    26

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16)  In order that the harmonised procedures fulfil their internal market objective, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

(16)  In order that the harmonised procedures fulfil their internal market objective and reach their aim of improving innovation and the quality of clinical evidence, Member States should take account of the results of joint clinical assessments and not repeat them. According to national needs, Member States should have the right to complement the joint clinical assessments with additional clinical evidence and analyses to account for differences in comparators or the national specific treatment setting. Such complementary clinical assessments should be duly justified and proportionate and should be notified to the Commission and the Coordination Group. In addition, compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the clinical added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as the non-clinical data and criteria specific to the Member State concerned, at national and/or regional level. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

Amendment    27

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

 

(16a)  In order for the clinical assessment to be used for the purposes of the national reimbursement decision, it should ideally concern the population for which the drug would be reimbursed in a given Member State.

Amendment    28

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17)  The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation.

deleted

Amendment    29

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

 

(17a)  The joint scientific consultation, when addressing orphan medicinal products, has to ensure that any new approach should not result in unnecessary delays for the orphan medicinal products assessment compared to the current situation and taking into account the pragmatic approach undergone through the EUnetHTA.

Amendment    30

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18)  The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devices.

(18)  The establishment of a time-frame for the joint clinical assessments for health technologies should take into account the time-frames set out in Regulation (EC) No 726/2004 of the European Parliament and of the Council* for completing the centralised procedure for authorising medicines and the CE conformity marking for medical devices provided for in Regulation (EU) 2017/745 of the European Parliament and of the Council**and the CE conformity marking for in vitro diagnostic medical devices provided for in Regulation (EU) 2017/746 of the European Parliament and of the Council***. 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.

 

 

_________________

 

* Regulation (EU) 2017/745 of 31 March 2004 of the European Parliament and of the Council 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).

 

** 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).

 

***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

Text proposed by the Commission

Amendment

(19)  In all cases the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere with the CE marking of medical devices or market access of health technologies. This work should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation.

(19)  In any event the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, without delaying or interfering with the CE marking of medical devices.

Amendment    32

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

 

(19a)  HTA work covered under this Regulation should be separate and distinct from regulatory assessments of the safety and efficacy of health technologies carried out pursuant to other Union legislative acts and should have no bearing on other aspects falling outside the scope of this Regulation adopted in accordance with other Union legislative acts.

Amendment    33

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

 

(19b)  In the case of orphan medicinal products, the joint report should not re-assess the criteria of the orphan designation. However, assessors and co-assessors should have full access to the data used by the authorities responsible for granting the marketing authorisation of a medicinal product, as well as the possibility of using or generating additional relevant data for the purpose of assessing a medicinal product in the context of a joint clinical assessment.

Amendment    34

Proposal for a regulation

Recital 19 c (new)

Text proposed by the Commission

Amendment

 

(19c)  Regulation (EU) 2017/745 concerning medical devices and Regulation (EU) 2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy. However, the gradual increase in the supply of medical devices to address clinical conditions has heralded a paradigm shift towards a new model in which the market is highly fragmented, innovation is chiefly incremental and clinical evidence is lacking, which means that closer cooperation and more frequent exchanges of information between assessment bodies are needed. It is therefore necessary to move towards a centralised authorisation system that assesses devices on the basis of safety, efficacy and quality. It is also one of the areas in which Member States are calling for greater collaboration via a future European HTA. Currently 20 Member States, together with Norway, have HTA systems for medical devices in place and 12 Member States, together with Norway, have established guidelines and are engaging in initial dialogues. EUnetHTA has been conducting high-quality evaluations of the relative efficacy of medical devices based on a methodology that can be taken as a benchmark for this Regulation.

Amendment    35

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20)  In order to facilitate effective participation by health technology developers in joint clinical assessments, such developers should, in appropriate cases, be afforded an opportunity to engage in joint scientific consultations with the Coordination Group to obtain guidance on the evidence and data that is likely to be required for the purposes of clinical assessment. Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.

(20)  Health technology developers can conduct joint scientific consultations with the Coordination Group or working groups set up for this purpose and composed of professionals from national or regional assessment bodies to obtain guidance on the clinical needs of research and the optimal design of studies to obtain the best possible evidence and maximise research efficiency. Given the preliminary nature of the consultation, any guidance offered should not bind either the health technology developers or HTA authorities and bodies.

Amendment    36

Proposal for a regulation

Recital 20 a (new)

Text proposed by the Commission

Amendment

 

(20a)  Joint scientific consultations should concern the clinical study design, the determination of best comparators based on the best medical practice in the interest of patients. The consultation process should be transparent.

Amendment    37

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21)  Joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.

(21)  Joint scientific consultations could necessitate the sharing of commercially confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.

Amendment    38

Proposal for a regulation

Recital 21 a (new)

Text proposed by the Commission

Amendment

 

(21a)  Joint clinical assessments necessitate all available clinical data and publicly available scientific evidence from health technology developers. The clinical data employed, the studies, the methodology and the clinical results used should be made public. The highest possible level of public openness in scientific data and assessments will allow progress to be made in biomedical research and ensure the highest possible level of confidence in the system. Where commercially sensitive data is shared, the confidentiality of such data should be protected by presenting it in an anonymised format with the redaction of reports before publication, preserving the public interest.

Amendment    39

Proposal for a regulation

Recital 21 b (new)

Text proposed by the Commission

Amendment

 

(21b)  According to the European Ombudsman, where information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure of that information will generally defeat any claim of commercial sensitivity. Public health should always prevail over commercial interests.

Amendment    40

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22)  In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems. Such scanning should facilitate the prioritisation of technologies that are to be selected for joint clinical assessment.

(22)  In order to ensure the efficient use of available resources, it is appropriate to provide for "horizon scanning", to allow the early identification of emerging health technologies that are likely to have the most impact on patients, public health and healthcare systems, as well as to steer research strategically. Such scanning should facilitate the prioritisation of technologies that are to be selected by the Coordination Group for joint clinical assessment.

Amendment    41

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23)  The Union should continue to support voluntary cooperation on HTA between Member States in areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems. Such voluntary cooperation should also facilitate synergies with initiatives under the digital single market strategy in relevant digital and data-driven areas of health and care with a view to the provision of additional real world evidence relevant for HTA.

(23)  The Union should continue to support voluntary cooperation on HTA between Member States in other areas such as in the development and implementation of vaccination programmes, and capacity building of national HTA systems.

Amendment    42

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24)  In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However, in order to preserve the integrity of the joint work, rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest.

(24)  In order to preserve the objectivity, transparency and quality of the joint work, rules should be developed to ensure the independence, public openness and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest.

Amendment    43

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

 

(24a)  Dialogue between the Coordination Group and patient organisations, consumer organisations, health non-governmental organisations, health experts and professionals should be ensured, especially through a stakeholder network, with a guarantee of the independence, transparency and impartiality of the decisions taken.

Amendment    44

Proposal for a regulation

Recital 24 b (new)

Text proposed by the Commission

Amendment

 

(24b)  In order to ensure efficient decision-making and facilitate access to medicines, an appropriated cooperation between decision-makers at key stages of the medicines’ life-cycle is important.

Amendment    45

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25)  In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission to establish a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions. It should also take into account initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13

(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.

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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)

Text proposed by the Commission

Amendment

 

(25a)  The methodological framework, in accordance with the Declaration of Helsinki, should guarantee high quality and high clinical evidence by choosing the most appropriate benchmarks. It should be based on high standards of quality, the best available scientific evidence, stemming primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews; and should take into account clinical criteria that are useful, relevant, tangible, concrete and tailored to suit the given clinical situation, with preference given to end points. The documentation to be provided by the applicant should relate to the most up-to-date and public data.

Amendment    47

Proposal for a regulation

Recital 25 b (new)

Text proposed by the Commission

Amendment

 

(25b)  Any specificities in the methodology, such as for vaccines, should be justified and adapted to very specific circumstances, should have the same scientific rigour and the same scientific standards, and should never be to the detriment of the quality of health technologies or clinical evidence.

Amendment    48

Proposal for a regulation

Recital 25 c (new)

Text proposed by the Commission

Amendment

 

(25c)  The Commission should provide administrative support for the joint work of the Coordination Group, which, after consultation with the stakeholders, should submit the final report on this work.

Amendment    49

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26)  In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the contents of documents to be submitted, reports, and summary reports of clinical assessments, the contents of documents for requests, and reports of joint scientific consultations, and the rules for selecting stakeholders. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.14 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

Text proposed by the Commission

Amendment

(27)  In order to ensure that sufficient resources are available for the joint work provided for under this Regulation, the Union should provide funding for the joint work and voluntary cooperation, and for the support framework to support these activities. The funding should cover the costs of producing joint clinical assessment and joint scientific consultation reports. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group.

(27)  In order to ensure that sufficient resources are available for the joint work and stable administrative support provided for under this Regulation, the Union should ensure stable and permanent public funding under the Multiannual Financial Framework for the joint work and voluntary cooperation, as well as for the support framework to support these activities. Member States should also have the possibility to second national experts to the Commission in order to support the secretariat of the Coordination Group. The Commission should establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments for research on unmet medical needs. Under no event can those fees be used to fund the joint work provided for in this Regulation.

Amendment    51

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28)  In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data.

(28)  In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication, as well as all information on the procedure, methodology, training and interests of assessors of and participants in the stakeholder network, and the reports and results of the joint work, which should be made public. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data.

Amendment    52

Proposal for a regulation

Recital 28 a (new)

Text proposed by the Commission

Amendment

 

(28a)  Cooperation should be based on the principle of good governance, which encompasses transparency, objectivity, independent experience and fair procedures. Trust is a precondition for successful cooperation and can only be achieved if all stakeholders make genuine commitments and if there is access to high-quality experience, capacity-building and the highest quality of execution.

Amendment    53

Proposal for a regulation

Recital 28 b (new)

Text proposed by the Commission

Amendment

 

(28b)  Since there is currently no commonly agreed definition of what constitutes high-quality innovation or added therapeutic value, the Union should adopt definitions of these terms with the agreement or consensus of all parties.

Amendment    54

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30)  During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States. This should not affect the obligation of Member States to apply harmonised rules to clinical assessments carried out at a national level. During the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work.

(30)  During the transitional period, participation in joint clinical assessments and joint scientific consultations should not be mandatory for Member States. Moreover, during the transitional period, Member States not participating in the joint work may at any time decide to participate. In order to ensure a stable and smooth organisation of the joint work and the functioning of the internal market, Members States which are already participating should not be allowed to withdraw from the framework for joint work. Clinical assessments which have started in Member States before the application of this Regulation should be continued, unless Member States decide to stop them.

Amendment    55

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31)  In order to ensure that the support framework continues to be as efficient and cost-effective as possible, the Commission should report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework no later than two years after the end of the transitional period. The report may in particular consider whether there is a need to move this support framework to a Union agency and introduce a fee-paying mechanism through which health technology developers would also contribute to the financing of the joint work.

(31)  After the transitional period and before the harmonised system for HTA established under this Regulation becomes mandatory, the Commission should submit an impact assessment report on the whole of the procedure that has been introduced. That impact assessment report should evaluate, among other criteria, the progress made in relation to patients access to new health technologies and the functioning of the internal market, the impact on the quality of innovation and on the sustainability of health systems, as well as the appropriateness of the scope of the joint clinical assessments and the functioning of the support framework.

Amendment    56

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32)  The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme.

(32)  The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme. The results of that evaluation should also be communicated to the European Parliament and Council.

Amendment    57

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34)  Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments at national level and establish a framework of mandatory joint clinical assessments of certain health technologies at Union level, cannot be sufficiently achieved by the Member States but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

(34)  Since the objectives of this Regulation, namely to approximate the rules of the Member States on carrying out clinical assessments of the health technologies falling under the scope of this Regulation, cannot be sufficiently achieved by the Member States alone but can rather, by reason of their scale and effects, be better achieved at Union-level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

Amendment    58

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  This Regulation establishes:

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:

Amendment    59

Proposal for a regulation

Article 1 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  a support framework and procedures for cooperation on health technology assessment at Union level;

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

2.  This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.

2.  This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them. Furthermore, this Regulation shall not interfere with the exclusive national competence of Member States for national pricing or reimbursement decisions.

Amendment    62

Proposal for a regulation

Article 2 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  ‘in vitro diagnostic medical device’ means an in vitro diagnostic medical device as defined in Regulation (EU) 2017/746;

Amendment    63

Proposal for a regulation

Article 2 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

 

(bb)  ‘assessment of a medical device' means the assessment of a method composed of more than one medical device or a method composed of a medical device and a defined care chain of other treatments;

Amendment    64

Proposal for a regulation

Article 2 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e)  'clinical assessment' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

(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)

Text proposed by the Commission

Amendment

 

(ga)  ‘appraisal’ means drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria in the national care context.

Amendment    66

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups.

2.  Member States shall designate their national or regional authorities and bodies responsible for health technology assessment at national level as members of the Coordination Group and its sub-groups.

Amendment    67

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3.  The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State.

3.  The Coordination Group shall act by consensus or, where no consensus is reached, by a two-thirds majority of Member States present, the quorum for Coordination Group meetings being two thirds of the members of the Coordination Group. There shall be one vote per Member State.

 

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

Text proposed by the Commission

Amendment

4.  Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

4.  Meetings of the Coordination Group shall be co-chaired by the Commission, without the right to vote, and a co-chair elected annually from among the members of the group on a rotating basis. Co-chairs shall perform purely administrative functions.

Amendment    69

Proposal for a regulation

Article 3 – paragraph 5

Text proposed by the Commission

Amendment

5.  Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes.

5.  Members of the Coordination Group, being national or regional assessment authorities or bodies, shall appoint their representatives in the Coordination Group and the sub-groups in which they are members on an ad-hoc or permanent basis. Member States may terminate such appointments where it is warranted by the requirements of the appointment. However, in view of the workload, the composition of sub-groups, or the specific knowledge required, there may be more than one expert assessor for each Member State, without prejudice to the principle that, for the purposes of decision-taking, each Member State shall have one vote only. The appointments shall take into account the expertise necessary in order to achieve the objectives of the sub-group. The European Parliament, the Council and the Commission, shall be informed of all appointments and possible terminations of appointment.

Amendment    70

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6.  Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality.

6.  In order to ensure high quality of work, members of the Coordination Group shall be drawn from national or regional health technology assessment agencies or bodies responsible for that field.

 

Members serving in the Coordination Group, and experts and assessors in general, shall not have financial interests in any type of health technology developer industry or insurance company that may affect their impartiality. They shall undertake to act independently and in the public interest and shall make an annual declaration of interests. Those declarations of interests shall be recorded on the IT platform referred to in Article 27 and shall made accessible to the public.

 

At every meeting, members of the Coordination Group shall declare any specific interest that may be considered to adversely affect their independence in relation to agenda items. When a conflict of interest arises, the member of the Coordination Group concerned shall withdraw from the meeting whilst the relevant items of the agenda are being dealt with. The procedural rules for conflicts of interest shall be laid down in accordance with point (a)(iiia) of Article 22(1).

 

In order to ensure transparency and public awareness of the process and to promote confidence in the system, all clinical data being evaluated shall have the highest level of transparency and public communication. Where data is confidential for commercial reasons, its confidentiality shall be clearly defined and justified and the confidential data shall be well delimitated and protected.

Amendment    71

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

7.  The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27.

7.  The Commission shall publish an up-to-date list of the designated members of the Coordination Group and its sub-groups and other experts, together with their qualifications and areas of expertise and their annual declaration of interest, on the IT platform referred to in Article 27.

 

The information referred to in the first subparagraph shall be updated by the Commission annually and whenever considered necessary in the light of possible new circumstances. Those updates shall be publicly accessible.

Amendment    72

Proposal for a regulation

Article 3 – paragraph 8 – point c

Text proposed by the Commission

Amendment

(c)  ensure cooperation with relevant Union level bodies to facilitate additional evidence generation necessary for its work;

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

10a.  The rules of procedure of the Coordination Group and its sub-groups, the agendas for their meetings, the decisions adopted, and the details of votes and explanations of votes, including minority opinions, shall, in any event, be accessible to the public.

Amendment    75

Proposal for a regulation

Article 4 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

Points (a) (b) and (c) of the first subparagraph shall be determined according to the extent of their impact on patients, public health or health care systems.

Amendment    76

Proposal for a regulation

Article 4 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c)  consult the Commission on the draft annual work programme and take into account its opinion.

(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)

Text proposed by the Commission

Amendment

 

5a.  Both the annual report and the annual work programme shall be published on the IT platform referred to in Article 27.

Amendment    78

Proposal for a regulation

Article 5 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  other medicinal products not subject to the authorisation procedure provided for in Regulation (EC) No 726/2004 where the health technology developer has opted for the centralised authorisation procedure, provided that the medicinal products in question constitute a major technical, scientific or therapeutic innovation, or their authorisation is in the interest of public health;

Amendment    79

Proposal for a regulation

Article 5 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation;

(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

Text proposed by the Commission

Amendment

(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.

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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)

Text proposed by the Commission

Amendment

 

(ea)  the need for greater clinical evidence;

Amendment    82

Proposal for a regulation

Article 5 – paragraph 2 – point e b (new)

Text proposed by the Commission

Amendment

 

(eb)  at the request of the health technology developer;

Amendment    83

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23.

The joint clinical assessment report shall be accompanied by a summary report, which shall contain at least the clinical data compared, the end-points, the comparators, the methodology, the clinical evidence used, and conclusions as regards efficacy, safety, and relative efficacy, the limits of the assessment, diverging views, a summary of the consultations carried out, and the observations made. They shall be prepared in accordance with the requirements laid down by the Coordination Group and shall be made public, regardless of the report´s conclusions.

 

For medicinal products referred to in point (a) of Article 5(1), the joint clinical assessment report shall be adopted by the Coordination Group within 80-100 days in order to ensure compliance with timelines for pricing and reimbursement set out in Council Directive 89/105/EEC*.

 

_________________

 

* 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

Text proposed by the Commission

Amendment

2.  The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment.

2.  The designated sub-group shall request the health technology developer to submit all available up-to-date documentation containing the information, data and studies, including both negative and positive results, that is necessary for the joint clinical assessment. That documentation shall include the available data from all tests performed and from all the studies in which the technology was used, both of which are of paramount importance to ensure that assessments are of high quality.

 

For medicinal products referred to in point (a) of Article 5(1), the documentation shall at least include:

 

(a)  the submission file;

 

(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)

Text proposed by the Commission

Amendment

 

2a.  The Coordination Group may justifiably consider, in the case of orphan medicines, that there is no substantive reason or additional evidence to support further clinical analysis beyond the significant benefit assessment already carried by the European Medicines Agency.

Amendment    86

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3.  The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.

3.  The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The assessor and a co-assessor shall be different from those previously appointed under Article 13(3) except in exceptional and justified situations where the necessary specific expertise is not available, and subject to approval of the Coordination Group. The appointments shall take into account the scientific expertise necessary for the assessment.

Amendment    87

Proposal for a regulation

Article 6 – paragraph 5 – introductory part

Text proposed by the Commission

Amendment

5.  The conclusions of the joint clinical assessment report shall be limited to the following:

5.  The conclusions of the joint clinical assessment report shall include:

Amendment    88

Proposal for a regulation

Article 6 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a)  an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment;

(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

Text proposed by the Commission

Amendment

(b)  the degree of certainty on the relative effects based on the available evidence.

(b)  the degree of certainty on the relative effects based on the best available clinical evidence and compared to the best standard therapies. The assessment shall be based on the clinical end-points established in accordance with international standards of evidence-based medicine, in particular with regard to improving the state of health, shortening the duration of the disease, prolonging survival, reducing side effects or improving the quality of life. Reference shall also be made to subgroup-specific differences.

Amendment    90

Proposal for a regulation

Article 6 – paragraph 5 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

The conclusions shall not include an appraisal.

 

The assessor and the co-assessor shall make sure that the choice of relevant patient groups is representative of the participating Member States in order to enable them to take appropriate decisions on funding these technologies from national health budgets.

Amendment    91

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

6.  Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

6.  Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended. Where new clinical data become available during the process, the health technology developer concerned may also proactively communicate this new information to the assessor.

Amendment    92

Proposal for a regulation

Article 6 – paragraph 7

Text proposed by the Commission

Amendment

7.  The members of the designated sub-group shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. The Commission may also provide comments.

7.  The members of the designated sub-group or the Coordination Group, in a minimum period of 30 working days, shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report.

Amendment    93

Proposal for a regulation

Article 6 – paragraph 8

Text proposed by the Commission

Amendment

8.  The assessor shall provide the draft joint clinical assessment report and the summary report to the submitting health technology developer and set a time-frame in which the developer may submit comments.

8.  The assessor shall provide the draft joint clinical assessment report and the summary report to the health technology developer for comments.

Amendment    94

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9.  The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments.

9.  Patients, consumer organisations, health professionals, NGOs, other health technology developer associations and clinical experts may submit comments during the joint clinical assessment within a time-frame set by the designated sub-group.

 

The Commission shall make public the declarations of interest of all consulted stakeholders in the IT platform referred to in Article 27.

Amendment    95

Proposal for a regulation

Article 6 – paragraph 10

Text proposed by the Commission

Amendment

10.  Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the designated sub-group and to the Commission for comments.

10.  Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the Coordination Group for comments. The Commission shall publish all comments, which shall be duly answered, on the IT platform referred to in Article 27.

Amendment    96

Proposal for a regulation

Article 6 – paragraph 11

Text proposed by the Commission

Amendment

11.  The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and the Commission and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.

11.  The assessor, with the assistance of the co-assessor, shall take into account the comments of the Coordination Group and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for a final approval.

Amendment    97

Proposal for a regulation

Article 6 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States.

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a two-thirds majority of Member States present, the quorum for Coordination Group meetings being two-thirds of the members of the Group.

 

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

Text proposed by the Commission

Amendment

13.  The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report.

13.  The assessor shall ensure that the approved joint clinical assessment report and the summary report contain the clinical information which is the subject of the assessment and set out the methodology and studies used. The assessor shall consult the developer on the report before its publication. The developer shall have 10 working days to notify the assessor about any information it considers to be confidential and to justify its commercially sensitive nature. As a last resort, the assessor and the co-assessor shall decide as to whether the developer’s claim of confidentiality is justified.

Amendment    99

Proposal for a regulation

Article 6 – paragraph 14

Text proposed by the Commission

Amendment

14.  The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission.

14.  The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission, which shall include both reports on the IT platform.

Amendment    100

Proposal for a regulation

Article 6 – paragraph 14 a (new)

Text proposed by the Commission

Amendment

 

14a.  Upon receipt of the approved joint clinical assessment report and summary report, the submitting health technology developer may notify its objections in writing to the Coordination Group and the Commission within seven working days. In such a case, the developer shall provide detailed grounds for its objections. The Coordination Group shall evaluate the objections within seven working days and shall revise the report, as necessary.

 

The Coordination Group shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections of the submitting health technology developer and the Commission were addressed.

Amendment    101

Proposal for a regulation

Article 6 – paragraph 14 b (new)

Text proposed by the Commission

Amendment

 

14b.  The joint clinical assessment report and the summary report shall be ready in not less than 80 days and not more than 100 days, except in justified cases where, owing to clinical necessity, the process needs to be accelerated or delayed respectively.

Amendment    102

Proposal for a regulation

Article 6 – paragraph 14 c (new)

Text proposed by the Commission

Amendment

 

14c.  Where the submitting health technology developer withdraws the application for a marketing authorisation, giving reasons, or where the European Medicines Agency terminates an assessment, the Coordination Group shall be informed so that it terminates the joint clinical assessment procedure. The Commission shall publish the reasons for withdrawal of the application or termination of the assessment on the IT platform referred to in Article 27.

Amendment    103

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1.  Where the Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

1.  The Commission shall include the name of the health technology which has been the subject of the report and the approved summary report, regardless of whether or not it has been adopted, in a list of technologies having undergone joint clinical assessment (the "List of Assessed Health Technologies" or the "List") at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

Amendment    104

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission

Amendment

2.  Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report.

2.  Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the procedural legal requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request a review of the assessment, giving reasons.

Amendment    105

Proposal for a regulation

Article 7 – paragraph 3

Text proposed by the Commission

Amendment

3.  The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline. The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group. Article 6, paragraphs 12 to 14 shall apply.

3.  The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the Commission, from a procedural point of view, prior to a final opinion.

Amendment    106

Proposal for a regulation

Article 7 – paragraph 4

Text proposed by the Commission

Amendment

4.  Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.

deleted

Justification

The deletion of this paragraph is justified by the changes made to paragraph 1 on the need for the name of the health technology which is the subject of the report and the summary report, whether the results are positive or negative, to be published in every instance in the List of Assessed Technologies.

Amendment    107

Proposal for a regulation

Article 7 – paragraph 5

Text proposed by the Commission

Amendment

5.  If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

5.  If the Commission concludes that the modified approved joint assessment report and summary report do not comply with the procedural requirements laid down in this Regulation, the health technology which is the subject of the assessment shall be included in the List, together with the summary report of the assessment and the Commission’s comments, and all of which shall be published on the IT platform referred to in Article 27. The Commission shall inform the Coordination Group thereof, setting out the reasons for the negative report. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

Amendment    108

Proposal for a regulation

Article 7 – paragraph 6

Text proposed by the Commission

Amendment

6.  For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List.

6.  For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish, on the IT platform referred to in Article 27, the approved joint clinical assessment report and summary report as well as all the comments by stakeholders and interim reports, and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List.

Amendment    109

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  Member States shall:

1.  For the health technologies included on the List of Assessed Health Technologies or in respect of which a joint clinical assessment has been initiated, Member States shall:

Amendment    110

Proposal for a regulation

Article 8 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

1a.  The requirement set out in point (b) of paragraph 1 shall not prevent Member States or regions from carrying out assessments on the added clinical value of the technologies concerned as part of national or regional appraisal processes which may consider clinical as well as non-clinical data and evidence specific to the Member State concerned which were not included in the joint clinical assessment and which are necessary to complete the health technology assessment or the overall pricing and reimbursement process.

 

Such complementary assessments may compare the technology concerned against a comparator which represents the best available and evidence-based standard of care in the Member State concerned and which, despite that Member State´s request during the scoping phase, was not included in the joint clinical assessment. They may also assess the technology in a care context specific to the Member State concerned, based on its clinical practice, or the setting chosen for reimbursement.

 

Any such measure shall be justified, necessary and proportionate to achieving this aim, shall not duplicate work done at Union level and shall not unduly delay patient access to those technologies.

 

Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so.

Amendment    113

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

2.  Member States shall submit information, through the IT platform referred to in Article 27, on how account has been taken of the joint clinical assessment report in the health technology assessment at Member State level as well as other clinical data and additional evidence taken into account so that the Commission may facilitate the exchange of this information among Member States.

Amendment    114

Proposal for a regulation

Article 9 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available.

(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)

Text proposed by the Commission

Amendment

 

(ba)  at the request of a Member State or a health technology developer that considers that there is new clinical evidence;

Amendment    116

Proposal for a regulation

Article 9 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

 

(bb)  five years after the assessment, significant new clinical evidence exist, or earlier when new evidence or clinical data emerges.

Amendment    117

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

In the cases referred to under points (a), (b), (ba) and (bb) of the first subparagraph, the technology developer shall submit the additional information. In the event of a failure to do so, the earlier joint assessment would no longer fall within the scope of Article 8.

 

The ‘EVIDENT’ database shall be maintained to gather clinical evidence as it arises from the real-life use of health technology and to monitor the results in terms of health.

Amendment    118

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2.  The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

2.  The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

 

Updates of joint clinical assessments are requested when new information has been published or made available which was not available at the time of the initial joint report. When an update of the joint clinical assessment report is requested, the member who proposed it can update the joint clinical assessment report and propose it for adoption by other Member States by mutual recognition. When updating the joint clinical assessment report, the Member State shall apply the methods and standards as laid down by the Coordination Group.

 

Where Member States cannot agree on an update, the case is referred to the Coordination Group. The Coordination Group shall decide whether to carry out an update based on the new information.

 

When an update is approved by mutual recognition or after the Coordination Group’s decision, the joint clinical assessment report is considered updated.

Amendment    119

Proposal for a regulation

Article 11 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall develop, by means of implementing acts, procedural rules for:

1.  The Commission shall, in accordance with this Regulation, develop, by means of implementing acts, procedural rules for:

Amendment    120

Proposal for a regulation

Article 11 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  submissions of information, data and evidence by health technology developers;

deleted

Amendment    121

Proposal for a regulation

Article 11 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c)  determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments;

(c)  determining the detailed procedural steps and their timing;

Amendment    122

Proposal for a regulation

Article 11 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f)  cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices.

(f)  cooperation with the bodies and expert panels.

Amendment    123

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint clinical assessment.

Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning the clinical aspects for the optimal design of scientific studies and research to obtain the best scientific evidence, improve predictability, align research priorities and enhance the quality and efficiency of said research, in order to obtain the best evidence.

Amendment    124

Proposal for a regulation

Article 12 – paragraph 2 – point f a (new)

Text proposed by the Commission

Amendment

 

(fa)  Union clinical research priorities ;

Amendment    125

Proposal for a regulation

Article 12 – paragraph 3

Text proposed by the Commission

Amendment

3.  Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

3.  Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

 

Joint scientific consultations shall not prejudice the objectivity and independence of joint technological assessments nor its results or conclusions. The assessor and co-assessor appointed to carry them out pursuant to Article 13(3) shall not be the same as the assessor and co-assessor appointed pursuant to Article 6(3) for the joint technological assessment.

 

The subject and the summarised substance of the consultations shall be published on the IT platform referred to in Article 27.

Amendment    126

Proposal for a regulation

Article 13 – title

Text proposed by the Commission

Amendment

Preparation of Joint Scientific Consultation Reports

Joint scientific consultation procedure

Amendment    127

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedural rules and documentation established pursuant to Articles 16 and 17.

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedure and documentation established pursuant to Articles 16 and 17 .

Amendment    128

Proposal for a regulation

Article 13 – paragraph 2

Text proposed by the Commission

Amendment

2.  The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation.

2.  The designated sub-group shall request the health technology developer to submit the available and up-to-date documentation containing all stages of information processing, data and studies necessary for the joint scientific consultation, such as available data from all tests performed and from all the studies in which the technology was used. A tailored clinical assessment pathway may be developed for orphan medicinal products due to the limited number of patients enrolled in clinical trials and/or the lack of a comparator. All that information shall be made publicly available, upon completion of the joint clinical assessments.

 

The designated sub-group and the health technology developer concerned shall hold a joint meeting based on the documentation described in first subparagraph.

Amendment    129

Proposal for a regulation

Article 13 – paragraph 3

Text proposed by the Commission

Amendment

3.  The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment.

3.  The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation, who shall not be the same as the assessor and a co-assessor to be appointed pursuant to Article 6(3). The appointments shall take into account the scientific expertise.

Amendment    130

Proposal for a regulation

Article 13 – paragraph 7

Text proposed by the Commission

Amendment

7.  The assessor shall provide the draft joint scientific consultation report to the submitting health technology developer and set a time-frame in which the developer may submit comments.

7.  The assessor shall provide the draft joint scientific consultation report, and provide it to the health technology developer for comments, setting a time-frame for those comments.

Amendment    131

Proposal for a regulation

Article 13 – paragraph 8

Text proposed by the Commission

Amendment

8.  The designated sub-group shall ensure that stakeholders, including patients and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.

8.  The health technology developer, patients, health professionals and clinical experts may submit comments during the joint scientific consultation.

Amendment    132

Proposal for a regulation

Article 13 – paragraph 9

Text proposed by the Commission

Amendment

9.  Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.

9.  Following receipt and consideration of any information and comments provided in accordance with paragraphs 2, 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments. All comments, which shall be public and answered when required, shall be published on the IT platform referred to in Article 27, following finalisation of the joint clinical assessment. The published comments shall include stakeholders comments and any differences of opinion expressed by members of the sub-group in the course of the procedure.

Amendment    133

Proposal for a regulation

Article 13 – paragraph 10

Text proposed by the Commission

Amendment

10.  Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice.

10.  Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate the time-frame.

Amendment    134

Proposal for a regulation

Article 13 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

12.  The Coordination Group shall, no later than 100 days following the start of the preparation of the report referred to in paragraph 4, approve the final joint scientific consultation report, wherever possible by consensus or, where no consensus is reached, by a two-thirds majority of Member States present, the quorum for Coordination Group meetings being two-thirds of the members of the Coordination Group.

Amendment    135

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

2.  The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.

2.  The Coordination Group shall include summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27. That information shall include the subject of the consultations and the comments.

 

The scientific consultation reports shall be made public upon completion of the joint clinical assessments.

Amendment    136

Proposal for a regulation

Article 14 – paragraph 3

Text proposed by the Commission

Amendment

3.  Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated and where the contents of the request are the same as those covered by the joint scientific consultation.

3.  Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology referred to in Article 5 for which a joint scientific consultation has been initiated, unless additional clinical data and evidence were not taken into account and such data and evidence are considered necessary. Such national scientific consultations shall be submitted to the Commission for publication on the IT platform referred to in Article 27.

Amendment    137

Proposal for a regulation

Article 16 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  submissions of requests from health technology developers and their involvement in the preparation of joint scientific consultation reports;

(a)  submissions of requests from health technology developers;

Amendment    138

Proposal for a regulation

Article 16 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning:

The Commission shall be empowered to adopt implementing acts in accordance with Articles 30 and 32 concerning :

Amendment    140

Proposal for a regulation

Article 17 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a)  the contents of:

(a)  the procedure for:

Amendment    141

Proposal for a regulation

Article 17 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

 

(iiia)  stakeholder involvement for the purpose of this section, including rules on conflict of interest. Declarations of interest shall be made publicly available for all stakeholders and experts consulted. Stakeholders and experts with a conflict of interest shall not participate in the process.

Amendment    142

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section.

deleted

Amendment    143

Proposal for a regulation

Article 18 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

2a.  When preparing the study, the Coordination Group shall ensure that commercially confidential information provided by the health technology developer is adequately protected. To that end, the Coordination Group shall give the health technology developer an opportunity to submit comments with respect to the contents of the study and shall take due account of those comments.

Amendment    145

Proposal for a regulation

Article 19 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall support cooperation and the exchange of scientific information among Member States on:

1.  The Commission shall support any further cooperation and the exchange of scientific information among Member States on the following issues:

Amendment    146

Proposal for a regulation

Article 19 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da)  clinical assessments of medicinal products and medical devices carried out by Member States;

Amendment    147

Proposal for a regulation

Article 19 – paragraph 1 – point d b (new)

Text proposed by the Commission

Amendment

 

(db)  measures relating to compassionate use in clinical practice in order to improve the evidence basis and to create a register for this purpose;

Amendment    148

Proposal for a regulation

Article 19 – paragraph 1 – point d c (new)

Text proposed by the Commission

Amendment

 

(dc)  the development of best medical practice guides based on scientific evidence;

Amendment    149

Proposal for a regulation

Article 19 – paragraph 1 – point d d (new)

Text proposed by the Commission

Amendment

 

(dd)  disinvestment in obsolete technologies;

Amendment    150

Proposal for a regulation

Article 19 – paragraph 1 – point d e (new)

Text proposed by the Commission

Amendment

 

(de)  the tightening of the rules on clinical evidence generation and its monitoring.

Amendment    151

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3.  The cooperation referred to in paragraph 1 points (b) and (c) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23.

3.  The cooperation referred to in paragraph 1 points (b), (c), (db) and (de) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23.

Amendment    152

Proposal for a regulation

Article 20 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  clinical assessments of medicinal products and medical devices carried out by Member States.

deleted

Amendment    153

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

Where relevant and appropriate, Member States shall be encouraged to apply the common procedural rules and methodology referred to in this Regulation for the clinical assessment of medicinal products and medical devices not falling within the scope of this Regulation and carried out by Member States at national level.

Amendment    154

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall adopt implementing acts concerning:

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, and after consulting all relevant stakeholders, the Commission shall adopt implementing acts concerning:

Amendment    155

Proposal for a regulation

Article 22 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i)  ensuring that health technology authorities and bodies carry out clinical assessments in an independent and transparent manner, free from conflicts of interest;

(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

Text proposed by the Commission

Amendment

(ii)  the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments;

(ii)  the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments, subject to the provisions of the previous articles;

Amendment    157

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii)  the consultation of patients, clinical experts, and other stakeholders in clinical assessments.

(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)

Text proposed by the Commission

Amendment

 

(iiia)  addressing potential conflicts of interest;

Amendment    159

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

 

(iiib)  ensuring that the assessment of medical devices is able to take place at the appropriate point in time after market launch, allowing for the use of clinical effectiveness data, including real world data. The appropriate time point shall be identified in cooperation with relevant stakeholders.

Amendment    160

Proposal for a regulation

Article 22 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(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    161

Proposal for a regulation

Article 22 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Within [6 months] from the 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 assessment 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 methodology takes 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 that should 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 its clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That package 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, is required to be carried out in exceptional cases and 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)  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 case where 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 from the Coordination Group.

Amendment    162

Proposal for a regulation

Article 23 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning:

The Coordination Group, following the same procedure set up in Article 2(.1.a) shall establish :

Amendment    163

Proposal for a regulation

Article 23 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a)  the contents of:

(a)  the format and templates of:

Amendment    164

Proposal for a regulation

Article 23 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter.

(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

Text proposed by the Commission

Amendment

Union Funding

Funding

Amendment    166

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The Union shall ensure stable and permanent public funding for the joint work on HTA that shall be conducted without the direct or indirect funding by developers of health technologies.

Amendment    167

Proposal for a regulation

Article 24 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

 

2b.  The Commission may establish a system of charges for health technology developers requesting both joint scientific consultations and joint clinical assessments which it shall use to finance research regarding unmet medical needs or clinical priorities. Such a system of charges shall under no circumstances used to finance activities under this Regulation.

Amendment    168

Proposal for a regulation

Article 25 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  host on its premises and co-chair the meetings of the Coordination Group;

(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

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(d)  verify that the work of the Coordination Group is carried out in an independent and transparent manner;

(d)  verify that the work of the Coordination Group is carried out in an independent and transparent manner, in accordance with the established rules of procedure;

Amendment    171

Proposal for a regulation

Article 25 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f)  facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of confidential information.

(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

Text proposed by the Commission

Amendment

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications, such as legitimacy, representation, transparency and accountability.

 

The organisations to be addressed by the open call for applications shall be patient associations, consumer organisations, non-governmental organisations in the field of health, health technology developers and health professionals.

 

Best practices in preventing conflict of interest shall apply to the selection of members of the stakeholder network.

 

The European Parliament shall have two representatives in the stakeholder network.

Amendment    173

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

2.  The Commission shall publish the list of stakeholder organisations included in the stakeholder network.

2.  The Commission shall publish the list of stakeholder organisations included in the stakeholder network. Stakeholders shall not have conflict of interest and their declarations of interests shall be published in the IT platform.

Amendment    174

Proposal for a regulation

Article 26 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3.  The Commission shall organise ad-hoc meetings between the stakeholder network and the Coordination Group in order to:

3.  The Commission shall organise a meeting between the stakeholder network and the Coordination Group at least once a year in order to promote a constructive dialogue. The roles of the stakeholder network shall include:

Amendment    175

Proposal for a regulation

Article 26 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(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)

Text proposed by the Commission

Amendment

 

(ba)  supporting access to real-life experiences on diseases and their management and on the actual use of health technologies, in the interests of a better understanding of the value which stakeholders attach to the scientific evidence provided during the assessment process.

Amendment    178

Proposal for a regulation

Article 26 – paragraph 3 – point b b (new)

Text proposed by the Commission

Amendment

 

(bb)  contributing to more focused and efficient communication with and between stakeholders in order to support their role in the safe and rational use of health technologies;

Amendment    179

Proposal for a regulation

Article 26 – paragraph 3 – point b c (new)

Text proposed by the Commission

Amendment

 

(bc)  drawing up a list of priorities for medical research;

Amendment    180

Proposal for a regulation

Article 26 – paragraph 3 – point b d (new)

Text proposed by the Commission

Amendment

 

(bd)  seeking input into the annual work programme and the annual study prepared by the Coordination Group;

Amendment    181

Proposal for a regulation

Article 26 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

The interests and the founding documents of the stakeholders, as well as a summary of annual meetings and possible activities, shall be published on the IT platform referred to in Article 27.

Amendment    182

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4.  On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

4.  On the request of the Coordination Group, the Commission shall invite patients, health professionals and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group, as observers.

Amendment    183

Proposal for a regulation

Article 27 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall develop and maintain an IT platform containing information on:

1.  Building on the work already undertaken by the EUnetHTA Joint Actions, the Commission shall develop and maintain an IT platform containing information on:

Amendment    184

Proposal for a regulation

Article 27 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da)  a list of members of the Coordination Group, its sub-groups and other experts, together with their declaration of financial interests;

Amendment    185

Proposal for a regulation

Article 27 – paragraph 1 – point d b (new)

Text proposed by the Commission

Amendment

 

(db)  all information whose publication is required under this Regulation;

Amendment    186

Proposal for a regulation

Article 27 – paragraph 1 – point d c (new)

Text proposed by the Commission

Amendment

 

(dc)  final joint clinical assessment reports and summary reports in a lay-friendly format in all official languages of the European Union;

Amendment    187

Proposal for a regulation

Article 27 – paragraph 1 – point d d (new)

Text proposed by the Commission

Amendment

 

(dd)  a list of organisations included in the stakeholder network;

Amendment    188

Proposal for a regulation

Article 27 – paragraph 2

Text proposed by the Commission

Amendment

2.  The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.

2.  The Commission shall ensure public access to the information contained in the IT platform.

Amendment    189

Proposal for a regulation

Article 28 – title

Text proposed by the Commission

Amendment

Implementation Report

Evaluation report on the transitional period

Amendment    190

Proposal for a regulation

Article 28 – paragraph 1

Text proposed by the Commission

Amendment

No later than two years after the end of the transitional period referred to in Article 33(1), the Commission shall report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter.

At the end of the transitional period referred to in Article 33 and before the harmonised system for health technology assessment established under this Regulation becomes mandatory, the Commission shall submit an impact assessment report on the whole of the procedure that has been introduced, which shall evaluate, among other criteria, the progress made in relation to patient access to new health technologies and the functioning of the internal market, the impact on the quality of innovation, such as the development of innovative medicinal products in areas of unmet need, on the sustainability of health systems, the HTA quality and the capacity at the national and regional level, as well as the appropriateness of the scope of the joint clinical assessments and the functioning of the support framework.

Amendment    191

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

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.

 

Justification

This Regulation should make no provision for delegated acts.

Amendment    192

Proposal for a regulation

Article 32 – title

Text proposed by the Commission

Amendment

Preparation of Implementing and Delegated Acts

Preparation of Implementing Acts

Amendment    193

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1.  The Commission shall adopt the implementing and delegated acts referred to in Articles 11, 16, 17, 22, and 23, at the latest by the date of application of this Regulation.

1.  The Commission shall adopt the implementing acts referred to in Articles 11, 16, 17 and 22, at the latest by the date of application of this Regulation.

Justification

This Regulation should make no provision for delegated acts.

Amendment    194

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

2.  When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.

2.  When preparing those implementing acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors, and shall consider the work already undertaken in the EUnetHTA Joint Actions.

Amendment    195

Proposal for a regulation

Article 33 – paragraph 1

Text proposed by the Commission

Amendment

1.  Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 3 years after the date of application].

1.  Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 4 years after the date of application] for medicinal products referred to in points (a) and (aa) of Article 5(1), and until ... [insert date 7 years after the date of application] for medical devices referred in Article point (b) of Article 5(1) and for in vitro diagnostic medical devices referred in point (c) of Article 5(1).

Amendment    196

Proposal for a regulation

Article 34 – paragraph 1

Text proposed by the Commission

Amendment

1.  Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

1.  Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on the grounds set out in Article 8(1a), and on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

Amendment    197

Proposal for a regulation

Article 34 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so.

2.  Member States shall notify the Commission and the Coordination Group of their intention to carry out a clinical assessment using other means together with the justifications for doing so.

Amendment    198

Proposal for a regulation

Article 34 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The Coordination Group may assess whether the request fulfils the grounds referred to in paragraph 1, and may submit its conclusions to the Commission.

Amendment    199

Proposal for a regulation

Article 34 – paragraph 3

Text proposed by the Commission

Amendment

3.  The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.

3.  The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved. The Commission’s decision shall be published on the IT platform referred to in Article 27.


EXPLANATORY STATEMENT

The Commission’s proposal is timely and represents a high degree of added value for the EU. It constitutes a further step towards closer EU integration, in an area as important as health. The fundamental aim of the proposal is to introduce joint clinical assessment of health technologies at EU level.

EU citizens value their health highly, as Eurobarometer surveys have repeatedly shown. As the TFEU recognises, improvements to citizens’ health must be a political priority for the EU in all its actions, but particularly in areas which have a specific bearing on health.

The right to health is a fundamental right. It is important to the integrity of the individual and to personal development, but also as a key factor in social cohesion and productivity. The welfare system, which is one of the defining features of the EU, where healthcare systems play a crucial role in society, makes it possible to achieve high standards of health in the EU.

Over the past few decades, the regulation of European arrangements governing medicines has contributed significantly to progress in health. The harmonisation of the arrangements governing medicines at Community level dates back to the 1960s, when Directive 65/65/EC was adopted. In 1995, the European Medicines Agency was set up. It assesses centrally the safety and efficacy of a large number of medicines before they are authorised for sale. More recently, Directive 2001/83/EC has provided the main basis for the EU’s pharmaceutical legislation.

On the other hand, treating medicines as consumer goods subject to the laws of the market has fuelled the development of an industry which is one of the EU’s most competitive economic sectors, despite strong competition from the United States and emerging economies. However, the policies that regulate that industry must be compatible with the ultimate aim of guaranteeing public access to medicines.

Health spending in the EU represents 10% of GDP, totalling EUR 1 300 trillion/year, EUR 220 trillion of which is accounted for by expenditure on pharmaceutical products and EUR 110 trillion, a figure on the rise, by investment in new medical devices. Spending on pharmaceutical products represents 1.41% of GDP and 17.1% of healthcare spending in the EU.

As the June 2016 Council Conclusions recognise, there is major concern at EU level about the functioning of the medicines system. Patient access to medicines and the sustainability of health systems is being undermined by the high cost of new drugs which do always bring significant advances in treatment. At the same time, there are areas which are not economically attractive for researchers, such as vaccines, paediatric treatments and antimicrobial resistance, for which, as in the case of rare diseases, incentives or new research models are needed.

In the last decade, the price of anti-cancer drugs has increased by up to 10 times(1) more than their effectiveness as treatments. A number of recent studies on cancer drug authorisations have pointed out that on the basis of an average of five years’ monitoring only 14-15% of the drugs improve survival rates(2).

A very high percentage of new medicinal products brought on to the European market offer no advantage over existing products. What is more, of the clinical trials approved in the EU, only 30% involve more than 1000 patients and a monitoring period longer than a year(3). At the same time, more and more medicinal products are securing early authorisation, and those products are six times more likely to be withdrawn from the market and four times more likely to trigger significant alerts, and three times as many are withdrawn from the market(4).

In short, we need more and better clinical evidence as the basis for determining the relative efficacy and therapeutic benefits of medicines, i.e. their quality. In itself, the marketing authorisation, based as it is on an assessment of efficacy and safety, does not guarantee that a new treatment is a step forward, or even rule out it being a step backward, as the studies and comparative assessments required do not need to show how the efficacy of a treatment compares with that of others. It is not ethically satisfactory either, as only efficacy and safety need to be proved for medicines to obtain that authorisation. At the request of patients, healthcare professionals and consumer organisations, Regulation (EC) No 726/2004 recognises the significance of added therapeutic value for the first time. However, it did not make it obligatory for that added value to be assessed during the marketing authorisation process.

Until now, Member States have been carrying out the relative efficacy assessment, using their own methodology and criteria, as part of the process of establishing prices and reimbursement arrangements before a medicinal product is introduced into their national health systems.

There are serious concerns about the growing difficulties faced by European citizens in accessing suitable treatment in the EU, whether because of the price, the non-availability of a treatment or the quality of new products. Those concerns are shared by the European Parliament, which is drawing up an own-initiative report on measures to improve access to medicines. The report proposes a number of measures which suggest that, in fact, a directive is needed which makes global regulation possible, clears the way for the right balance to be struck between all parties and interests, with the focus on the patient, guarantees access to medicines and the sustainability of healthcare systems and fosters high-quality R&D.

The proposals include an assessment at EU level of the added therapeutic value of health technologies and the harmonisation of the criteria used in clinical trials of medicinal products in order to improve the level of clinical evidence, encourage high-quality innovation and make it possible to identify technologies which offer genuine added value. Similarly, better research and innovation and doing away with unnecessary duplication would make the European pharmaceutical industry more competitive.

The Commission proposal focuses on the need to bring an end to the distortion of the internal market resulting from the duplication of clinical assessments by Member States, which makes it difficult for the industry to plan ahead. Member States are not carrying out such assessments on a whim, however; rather they are doing so in response to the lack of clinical evidence on which to base assessments, the inadequate arrangements for the exchange of information, specific circumstances in each country and the very nature of the market for medicinal products, which does not ensure that every health technology is available in every Member State, and the barrier to access constituted by high prices.

What is more, although the functioning of the internal market needs to be improved, that objective must not be the sole or the main justification for the proposal, as that would constitute a missed opportunity to enhance the quality of innovation and of health technologies, guide the setting of clinical priorities in research and improve the sustainability of health systems and, ultimately, patients’ access to health technologies, by making the fundamental right to health central to the proposal.

Article 168(4) TFEU confers on the EU the legislative power to establish high safety and quality standards for medicinal products, whilst the Member States are responsible for determining what resources should be allocated to health services and medical care (Article 168(7)) and to public health in general. The EU plays an important supporting, coordinating and complementary role vis-à-vis the Member States and, in any event, must ensure that all its policies encourage a high level of health. Member States are responsible for establishing the prices of and reimbursement arrangements for medicinal products. However, they must not distort competition, through the use of discriminatory criteria or by taking discriminatory decisions, or the functioning of the internal market (Article 114 TFEU), as the Court of Justice of the EU has ruled.

In that context, with the support of the Commission, since 2010 the Member States have been working together on a voluntary basis through the EUnetHTA - cooperation which they are keen to continue, given the excellent results. That presupposes, however, the establishment of a permanent, stable system which ensures that the objectives set are achieved and, at the same time, that the principle of subsidiarity is complied with, through the use of a joint, regulated assessment methodology which can be tailored to specific national circumstances.

The Commission proposal calls for mandatory participation and uptake, which may make the Member States dig in their heels if the joint assessment does not involve a high-quality, objective, independent and transparent process, carried out in a coordinated manner at EU level by national authorities and bodies which already conduct the same assessments at national level, using a joint, public methodology. For the proposal to succeed, it must generate sufficient levels of trust among the parties, in keeping with the overriding interest of patient welfare, and, at all events, improve the Member States’ decision-making capacity, the clinical evidence available, the effective use of research resources, predictability and competitiveness for the industry and the quality of innovative research. The Commission would be the guarantor of the proper functioning of the process, providing administrative and financial support independently of technology developers and maintaining confidence in the process. These are the principles and areas for improvement which Parliament believes must be included in the proposal.

At the same time, interaction and exchange of information between patients, consumers, experts, professionals, NGOs in the health field and technology developers and assessors may generate more feedback from those with first-hand experience of the use of health technologies and in setting research priorities.

As regards assessments, the increasing importance of medical devices must be taken into account. The clinical evidence needed for assessment and decision-making must be improved. Legislation has recently been adopted on their safety and transparency, but not on their efficacy, never mind their relative efficacy. Their specific situation – their greater decentralisation on the European market and the lack of real evidence required to secure marketing authorisation cannot justify a move towards a centralised authorisation system which also covers the aspects of efficacy and effectiveness, on ethical grounds or to facilitate decision-making at the time of their introduction into health systems; indeed, the reverse is true. The need for more evidence on medical devices has led 20 Member States and Norway to introduce clinical assessment schemes, adopt guidelines and carry out public consultation procedures at an early stage. The outcome of those procedures shows that there would be public support for applying the European assessment arrangements to medical devices, a move which would also help to cut red tape, particularly for SMEs.

The proposal may also help to further cooperation in emerging fields, such as precision medicine, disinvestment in obsolete technology and the preparation of clinical practice guidelines. It may also increase knowledge about compassionate use of medicines or the progress made towards introducing a new mechanism for establishing prices and assessing innovative, orphan or anti-cancer drugs. If the future is more ‘personalised’ medicines, geared towards small groups of patients, new systems to assess and determine the price to pay for those medicines are essential.

(1)

Kelly R and Smith T. 2014. Delivering maximun clinical benefit at an affordable price: enganging stakeholders in cancer care. The lancet oncology 15/3):e112-e8 and European Parliament, October 2016, Links between pharmaceutical R&D Models and Access to Affordable Medicines.

(2)

Davis, Naci, Gurpinar et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BJM 2017;359:j4530 I doi:10.1136/bmj.j4530.

(3)

Prescrire Editorial Office ‘Essais avant AMM: trop peu de patients’ [Tests before marketing authorisation – too few patients], Prescrire medical journal, 2014: 34 (363) :57.

(4)

Prescrire Editorial Office ‘AMM prématurées = danger’ [Premature marketing authorisations = danger] Prescrire medical journal, 2008; 28 (297) : 535.


MINORITY OPINION

pursuant to Rule 56(3) of the Rules of Procedure

Joëlle Mélin

This minority opinion seeks to explain our vote against the proposal.

Indeed, this joint health technology assessment (HTA) report at Union level carries with it numerous risks.

Naturally, there is a clear breach of the subsidiarity principle.

But there is also a worrying tendency to abuse the system, which already occurred in France after an evaluation procedure concerning the actual clinical benefits of medicinal products some ten years ago: negative ratings led to a refusal to reimburse products, followed by the actual disappearance of numerous medicinal products that were very useful, such as those from many laboratories.

It will, of course, be the same for medicinal products in Europe, for many medical devices, despite their CE marking, and for many treatment techniques, first those of surgeons, followed by those of all nursing staff in Europe, as clearly stated in the text: administrative and judicial burdens will ultimately put an end to freedom of care.

Our group looks forward to hearing the reactions from the trilogue, particularly those of the Council.


OPINION OF THE COMMITTEE ON LEGAL AFFAIRS ON THE LEGAL BASIS

Ms Adina-Ioana Vălean

Chair

Committee on the Environment, Public Health and Food Safety

STRASBOURG

Subject:  Opinion on the legal basis of 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))

Dear Chair,

By letter dated 3 July 2018, you asked the Committee on Legal Affairs, pursuant to Rule 39(2) of Parliament’s Rules of Procedure, to provide the Committee on the Environment, Public Health and Food Safety with an opinion on the appropriateness of a modification of the legal basis of the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU.

More specifically, the Commission proposal is based on Article 114 of the Treaty on the Functioning of the European Union (TFEU) alone. The Rapporteur and another Member tabled similar amendments aiming at changing the legal basis to Articles 114, 168(4) and 168(7) TFEU.(1)

I - Background

“Health technology” is to be understood in a broad sense comprising medicinal products, medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare. Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. That process assesses a new or existing technology and compares it with other health technologies and / or the current standard of care. HTA covers different aspects ranging from clinical domains (e.g. safety, clinical effectiveness) to non-clinical domains (e.g. economic, ethical organisational). It is used to inform decision-making in Member States by providing a scientific evidence base for decisions on the pricing and reimbursement of health technologies.

Cooperation between Member States has been ongoing since the 1980s on a voluntary basis. The on-going EU cooperation on HTA mainly consists in EUnetHTA Joint Actions and HTA Network, which was established by the cross-Border Healthcare Directive (Directive 2011/24/EU) in order to provide strategic and political guidance to the scientific and technical cooperation.

The Commission committed in its communication “Upgrading the Single Market: more opportunities for people and business” to introduce an initiative on Health technology assessment with a view to improving the functioning of the Single Market of health technologies, in particular in order to avoid duplication of efforts for Member States and industry.

The Commission considers that the on-going EU cooperation on HTA, although having illustrated benefits of EU cooperation, has not contributed to the removal of the fragmentation of the internal market, or the duplication of assessments. It identifies three major problems: (1) impeded and distorted market access due to the fact that technology developers have to deal with diverging national HTA processes and methodologies which can potentially lead to different HTA conclusions; (2) Duplication of work for national HTA bodies means that they carry out in parallel or within a similar time-frame, clinical assessments on the same health technologies. (3) Unsustainability of HTA cooperation, as the current EU cooperation on HTA is project-based with no guarantee for the continuation of activities or their financing in the long-term. By carrying joint clinical assessments, economies of scale, greater business predictability, increased quality and consistency and improved transparency for patients would be achieved in the long run.

II - Relevant Treaty Articles

The following Article of the Treaty on the Functioning of the European Union is presented as the legal basis in the Commission proposal:

Under Chapter 3 on “Approximation of laws”:

Article 114

(ex Article 95 TEC)

1. Save where otherwise provided in the Treaties, the following provisions shall apply for the

achievement of the objectives set out in Article 26. The European Parliament and the Council shall, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

2. Paragraph 1 shall not apply to fiscal provisions, to those relating to the free movement of persons nor to those relating to the rights and interests of employed persons.

3. The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the European Parliament and the Council will also seek to achieve this objective.

4. If, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.

5. Moreover, without prejudice to paragraph 4, if, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.

6. The Commission shall, within six months of the notifications as referred to in paragraphs 4

and 5, approve or reject the national provisions involved after having verified whether or not they are a means of arbitrary discrimination or a disguised restriction on trade between Member States and whether or not they shall constitute an obstacle to the functioning of the internal market.

In the absence of a decision by the Commission within this period the national provisions referred to in paragraphs 4 and 5 shall be deemed to have been approved.

When justified by the complexity of the matter and in the absence of danger for human health, the Commission may notify the Member State concerned that the period referred to in this paragraph may be extended for a further period of up to six months.

7. When, pursuant to paragraph 6, a Member State is authorised to maintain or introduce national provisions derogating from a harmonisation measure, the Commission shall immediately examine whether to propose an adaptation to that measure.

8. When a Member State raises a specific problem on public health in a field which has been the subject of prior harmonisation measures, it shall bring it to the attention of the Commission which shall immediately examine whether to propose appropriate measures to the Council.

9. By way of derogation from the procedure laid down in Articles 258 and 259, the Commission and any Member State may bring the matter directly before the Court of Justice of the European

Union if it considers that another Member State is making improper use of the powers provided for in this Article.

10. The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 36, provisional measures subject to a Union control procedure.

The ENVI request concerns also Article 168 Under Title XIV “Public health” and notably paragraphs 4 and 7:

Article 168

(ex Article 152 TEC)

1. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.

Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health.

The Union shall complement the Member States' action in reducing drugs-related health damage, including information and prevention.

2. The Union shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. It shall in particular encourage cooperation between the Member States to improve the complementarity of their health services in cross-border areas.

Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas referred to in paragraph 1. The Commission may, in close contact with the Member States, take any useful initiative to promote such coordination, in particular initiatives aiming at the establishment of guidelines and indicators, the organisation of exchange of best practice, and the preparation of the necessary elements for periodic monitoring and evaluation.

The European Parliament shall be kept fully informed.

3. The Union and the Member States shall foster cooperation with third countries and the

competent international organisations in the sphere of public health.

4. By way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures;

(b) measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health;

(c) measures setting high standards of quality and safety for medicinal products and devices for medical use.

5. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, may also adopt incentive measures designed to protect and improve human health and in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health, and measures which have as their direct objective the protection of public health regarding tobacco and the abuse of alcohol, excluding any harmonisation of the laws and regulations of the Member States.

6. The Council, on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article.

7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them. The measures referred to in paragraph 4(a) shall not affect national provisions on the donation or medical use of organs and blood.

In addition, given the cross references made, the following Articles should be looked at:

Article 2(5)

5. In certain areas and under the conditions laid down in the Treaties, the Union shall have competence to carry out actions to support, coordinate or supplement the actions of the Member States, without thereby superseding their competence in these areas.

Article 4

1. The Union shall share competence with the Member States where the Treaties confer on it a

competence which does not relate to the areas referred to in Articles 3 and 6.

2. Shared competence between the Union and the Member States applies in the following

principal areas:

[...]

(k) common safety concerns in public health matters, for the aspects defined in this Treaty.

[...]

Article 6

The Union shall have competence to carry out actions to support, coordinate or supplement the actions of the Member States. The areas of such action shall, at European level, be:

(a) protection and improvement of human health;

[...]

III – CJEU case law on the choice of legal basis

The Court of Justice has traditionally viewed the question of the appropriate legal basis as an issue of constitutional significance, guaranteeing compliance with the principle of conferral of powers (Article 5 TEU) and determining the nature and scope of the Union’s competence.(2) The choice of a legal basis is therefore not discretionary. According to settled case law of the Court of Justice, the choice of legal basis for a Union measure must rest on objective factors amenable to judicial review, which include in particular the aim and content of the measure. If examination of a measure reveals that it pursues a twofold purpose or that it has a twofold component one of which is identifiable as the main or predominant purpose or component, whereas the other is merely incidental, that measure must be based on a single legal basis, namely that required by the main or predominant purpose or component.(3)

IV - Aim and content of the proposal

The Explanatory Memorandum enumerates the objectives of the proposal, and distinguishes between the general objectives, namely to ensure a better functioning of the internal market and to contribute to a high level of human health protection, the specific objectives, namely to improve the availability of innovative health technologies for EU patients, to ensure efficient use of resources and strengthen the quality of HTA across the EU, and to improve business predictability, and the operational objectives, namely promote convergence in HTA tools, procedures and methodologies, reduce duplication of efforts for HTA bodies and industry, ensure the use of joint outputs in Member States, ensure the long-term sustainability of EU HTA cooperation.

Recital 5 states that “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 request for data” and that “[i]t can also lead to both duplication 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 in the internal market”.

According to recital 6, “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.”

Recital 10 provides that “[I]n 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.”

Recital 16 states that “[i]n 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.”

Finally, according to recital 34, the objectives of the proposed regulation is “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”.

Article 1 of the proposal explains that the regulation establishes a support framework and procedures for cooperation on health technology assessment at Union level and common rules for the clinical assessment of health technologies. It should be noted that the scope of the proposed regulation is limited to those aspects of HTA that relate to the clinical assessment of a health technology.

To this end, Chapter II establishes the four pillars of the future cooperation between Member States (namely: joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation) and Chapter III (Articles 20 to 23) sets out harmonised rules - including common procedural rules and methodology - for joint clinical assessments and clinical assessments of medicinal products and medical devices carried out by Member States.

More specifically, the proposal establishes the Member State Coordination Group on Health Technology Assessment (Article 3) that shall carry out joint clinical assessments (Article 5) on certain medicinal products, medical devices and in vitro diagnostic medical devices.

According to Article 8(1), Member States shall not carry out a clinical assessment where such assessment has been done in accordance with the Regulation and shall apply joint clinical assessment reports adopted under the Regulation, in their health technology assessments at Member State level. At the same time, Article 34 contains a “safeguard clause” according to which Member States may, subject to the Commission approval, carry out a clinical assessment using means other than the rules provided for in Chapter III of the Regulation, if it is to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim. The proposal gives the Commission the power to adopt, by means of implementing acts, detailed procedural rules for joint clinical assessment.

The proposal also provides for the possibility for health technology developers to request the Coordination Group a joint scientific consultation in order to obtain scientific advice concerning data and evidence likely to be required as part of a joint clinical assessment (Article 12). When a joint consultation has been initiated on a health technology, Member States shall not carry out a scientific consultation or an equivalent consultation when the content of the requests are the same (Article 14(3)).

The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems (Article 18). The Commission shall support cooperation and the exchange of scientific information among Member States on a range of topics (Article 19).

Finally, the proposal provides for a support framework and in particular rules on Union funding, and deletes Article 15 of Directive 2011/24/EU, which deals with cooperation on health technology assessment.

V- Analysis of the legal basis

It has to be noted from the outset that this analysis is based on the Commission's proposal. Further analysis of the legal basis could be necessary if amendments adopted in the vote in committee substantially altered the aim and content of the proposal.

Article 114(1) TFEU establishes that the Parliament and the Council are to adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. According to case-law, while a mere finding of disparities between national rules is not sufficient to justify having recourse to Article 114 TFEU, it is otherwise where there are differences between the laws, regulations or administrative provisions of the Member States which are such as to obstruct the fundamental freedoms and thus have a direct effect on the functioning of the internal market. It is also settled case-law that although recourse to Article 114 TFEU as a legal basis is possible if the aim is to prevent the emergence of future obstacles to trade as a result of divergences in national laws, the emergence of such obstacles must be likely and the measure in question must be designed to prevent them. (4)

The Court has also held that, provided that the conditions for recourse to Article 114 TFEU as a legal basis are fulfilled, the EU legislature cannot be prevented from relying on that legal basis on the ground that public health protection is a decisive factor in the choices to be made.(5)

The first subparagraph of Article 168(1) TFEU provides that a high level of human health protection is to be ensured in the definition and implementation of all EU policies and activities, and that Article 114(3) TFEU explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed.”(6)

Art. 168(4) TFEU sets out that, by way of derogation from Article 2(5) and Article 6(a) and in accordance with Article 4(2)(k) that provides that the Union shares competence with the Member States regarding “common safety concerns in public health matters, for the aspects defined in [the] Treaty”, the European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in Article 168 through adopting, in order to meet common safety concerns, certain measures relating to public health. Those measures shall contribute to the achievement of the objective of ensuring a high level of human health protection set out in Art. 168(1) TFEU, “in order to meet common safety concerns”.

Among those measures, Article 168(4)(c), which provides for “measures setting high standards of quality and safety for medicinal products and devices for medical use”, is a priori the only one relevant for the legislative proposal at issue.

It should be added that, contrary to the measures adopted under Article 168(5), Article 168(4) does not exclude any harmonisation of the laws and regulations of the Member States.

Article 168(7) TFEU does not provide for the adoption of any legal act by the Union and consequently is not a legal basis. It will therefore not be assessed further.

According to the Court, the legal basis of an act must be determined having regards to its aim and content.

As mentioned above, the proposal aims at approximating 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. It will remove some of the divergences in the internal market arising from procedural and methodological differences in clinical assessments carried out in Member States and the duplication of those across the EU. By fully harmonising certain procedures on HTA, it is to remove certain existing obstacles and will genuinely enhance the functioning of the internal market. The regulation has a clear internal market objective and as stated above, the fact that public health protection is a component of the proposal does not prevent the regulation from being based on Article 114 TFEU. According to Article 168(1) TFEU, a high level of human health protection must be ensured in the definition and implementation of all Union policies and activities. This implies that high level of human health protection has to be ensured also when the Union acts under other provisions of the Treaty. Given that the conditions for recourse to Article 114 TFEU as a legal basis are fulfilled, the regulation shall rely on this legal basis even when public health protection is a decisive factor in the choices made; in this respect Article 114 TFEU explicitly requires that, in achieving harmonisation, a high level of protection of human health should be guaranteed taking account in particular of any new development based on scientific facts.

When it comes to Article 168(4), in order to be a valid second legal basis, the public health component should not be secondary in respect to the internal market component. It does not clearly appear from the aim and content of the proposal that the proposed instrument has two equal-ranking objectives. In addition, the proposed regulation should contribute to the achievement of the public health objectives set for in Article 168 TFEU and shall set “measures setting high standards of quality and safety for medicinal products and devices for medical use” (Article 168(4)(c)) in order to meet common safety concerns. Although the proposal addresses the relative quality and safety of products, it is not obvious whether there is any genuine “common safety concern” to which it would respond, or whether it really sets health standards in a way that would justify recourse to the specific legal basis in Article 168(4)(c) (either in combination with Art. 114 TFEU or alone).

Finally, according to case-law, a general Treaty article constitutes a sufficient legal basis even though the measure in question also seeks, in a subordinate manner, to attain an aim sought by a specific Treaty article(7). The choice of Article 114 TFEU appears therefore to be correct and sufficient.

Having said that, a possible recourse to the twofold legal basis of Articles 114 and 168(4)(c) TFEU would not put at risk the validity of the act. In fact, according to the case-law, a possible error in the citations of an act is no more than a purely formal defect, unless it gave rise to irregularity in the procedure applicable to the adoption of that act. If recourse to a twofold legal basis does not give rise to irregularity in the procedure for adopting the legislative act, such act would in principle not be annulled by the Court on that account.(8)

VI - Conclusion and recommendation

Based on the Commission proposal and in light of the above, it should be concluded that the Commission proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU has been rightly based on Article 114 TFEU. Further analysis of the legal basis could be necessary if amendments adopted in the vote in committee substantially altered the aim and content of the proposal.

The addition of Article 168 paragraph 4 (c) TFEU would not give rise to irregularity in the procedure that renders the regulation invalid.

Article 168 paragraph 7 TFEU is not a legal basis and therefore cannot be added as such in the citations.

At its meeting of 10 September 2018 the Committee on Legal Affairs accordingly decided unanimously(9) to recommend to the Committee on the Environment, Public health and Food safety to retain Article 114 TFEU as the appropriate legal basis of the proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU. Addition of Article 168(4)(c) would not seem to result in invalidity of the measure.

Yours sincerely,

Pavel Svoboda

(1)

Considering the amendments in annex to the ENVI letter, the reference to Article 192 TFEU (environment) in the letter itself should be read as a reference to Article 114 TFEU.

(2)

Opinion 2/00 [2001] ECR I-9713, paragraph 5

(3)

See judgment of 8 September 2009, Commission v Parliament and Council, C-411/06, EU:C:2009:518, paragraphs 45 to 47

(4)

See e.g. judgement of 4 May 2016, Philip Morris, C-547/14, EU:C:2016:325, para. 57-64.

(5)

See in British American Tobacco (Investments) and Imperial Tobacco, C‑491/01, EU:C:2002:741, paragraph 62; Arnold André, C‑434/02, EU:C:2004:800, paragraph 32; Swedish Match, C‑210/03, EU:C:2004:802, paragraph 31; and Germany v Parliament and Council, C‑380/03, EU:C:2006:772, paragraph 39.

(6)

See e.g. judgement of 4 May 2016, Philip Morris, C-547/14, EU:C:2016:325, para. 57-64.

(7)

See judgement of 9 October 2001, Netherlands v. European Parliament and Council, C-377/98, EU:C:2001:523, paras 27-28; judgement of 10 December 2002, British American Tobacco (Investments) and Imperial Tobacco, C491/01, EU:C:2002:741, paras 93-94

(8)

See judgment of 14 December 2004, Swedish Match, C-210/03, EU:C:2004:802, p. 43-44.

(9)

The following were present for the final vote: Pavel Svoboda (Chair), Mady Delvaux, Laura Ferrara (Vice-Chair), Axel Voss (rapporteur for opinion), Alex Mayer (for Mary Honeyball pursuant to Rule 200(2)), Joëlle Bergeron, Geoffroy Didier, Pascal Durand, Sylvia-Yvonne Kaufmann, Julia Reda, Evelyn Regner, Virginie Rozière, Francis Zammit Dimech, Tadeusz Zwiefka.


OPINION of the Committee on Industry, Research and Energy (12.9.2018)

for the Committee on the Environment, Public Health and Food Safety

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))

Rapporteur for opinion: Lieve Wierinck

SHORT JUSTIFICATION

State of Play

After more than 20 years of voluntary cooperation on Health Technology Assessments (HTA), the European Commission has proposed to reinforce the cooperation amongst Member States in this area. Since 2006, Member States have been working together on HTA under the EUnetHTA support framework on a voluntary basis. Currently, more than 50 HTA bodies are operating in the European Union (EU), conducting assessments using different methodologies in different HTA capacities. Within the EU, HTAs are fragmented with different systems, different procedures and different requirements regarding the type of clinical evidence. This contributes to distorted market access, which constitutes an impediment to the rapid uptake of innovations in the field of health. Current voluntary cooperation has had some successes (cfr. Joint Actions) but is has not eliminated the multitude of approaches. The Rapporteur acknowledges that the aim of this legislative proposal is limited to the clinical aspects of HTA, leaving the socio-economic aspects linked more closely to the national context, out of the scope of this proposal.

Benefits of a reinforced cooperation on EU level

With a reinforced cooperation system for certain HTA, all EU countries can benefit from efficiency gains and make better use of their resources, thus maximising the EU-added value. The timelines and speed of bringing innovation to the market and enabling patients’ access to innovation is important. The proposal aims to help the take-up of true innovation. For example, new innovative medicines can be instantly beneficial for patients with unmet medical needs. The Rapporteur underlines that the healthcare sector is a crucial part of our economy and accounts for approximately 10% of the EU’s GDP. A reinforced cooperation would boost the efficiency and cost-effectiveness of industries and manufacturers involved in the healthcare sector and thus their competitiveness on a global scale. The providence of broader resources, more extensive scientific evidence to national decision makers, the enabling of pooling expertise and the support of innovation throughout the EU will also boost the general competitiveness of the EU.

Methodology

The Rapporteur underlines that the methodologies within this legislative proposal are not clearly defined and should be further developed in the future. In addition, the Rapporteur stresses that the European Commission should act in a supportive capacity in the execution and choice of methodologies. The Coordination Group, as a college of independent HTA experts from all Member States, should have a decisive role in the selection and development process. Finally, the Rapporteur questions the appropriateness where the European Commission has allocated the role of establishing and carrying out the methodology (i.e. implementing acts).

The standardisation of methodologies on joint HTAs should harmonise the quality and reliability of HTAs throughout the EU. The rapporteur stresses the need for an approach wherein the scientific evidence used in the joint HTAs is of the highest quality, and thus acknowledged and overseen by the Coordination Group as such.

Coordination Group

The Rapporteur welcomes the core tasks of the Coordination Group, which are the following:

•  Joint clinical assessments focusing on the most innovative health technologies with the most potential impact for patients.

•  Joint Scientific consultations whereby developers can seek advice from HTA authorities.

•  Identification of emerging health technologies to identify promising technologies at an early stage.

•  Voluntary cooperation in other areas.

The Rapporteur also underlines the steering role and priority setting of the Coordination Group within the process of joint HTAs and stresses the need for a structured involvement of patient organisations, industry and other stakeholders.

The importance of data collection

Data collection and sharing is important between Member States, HTA bodies and regulators in order to reduce redundancy, promote generation of further evidence and facilitate European collaboration in the HTA domain. The Rapporteur highlights the need for transparency and the importance of sharing HTA research outcomes, both negative and positive ones.

In the current HTA voluntary cooperation, there is a multitude of registries of data and different approaches to data collection. The gathering of quality data is essential to ensure that information exchange is compatible and comparable between Member States. Given the sensitive nature of health information, the Rapporteur emphasises the importance of confidential handling of data.

The Rapporteur also supports the development of an IT platform containing all the information on the core tasks of the Coordination Group.

Mandatory Uptake

The Rapporteur supports the principle of mandatory uptake of joint clinical assessments, referring to the approach of the Coordination Group to assess the level of quality of each joint HTA.

The mandatory uptake ensures a non-duplication of assessments and cost-effectiveness of all Member States’ resources. The Rapporteur underlines that the proposal makes a clear distinction between assessment of evidence, which is carried out at the EU level, and appraisal, which is performed at the national level. Therefore, there is no common appraisal on a European level. The Regulation shall not affect Member States’ decision-making on technologies to be made available or reimbursed at national level.

Scope of the reinforced cooperation

The proposal would cover all medical devices and in-vitro medical devices undergoing the scrutiny procedure laid down in the marketing (CE) authorisation of the Regulation on Medical Devices (2017/745, 2017/746).

The application of the Medical Devices Regulation fundamentally differs from the application of medicines. The application of the Medical Devices Regulation includes much more complex factors, as surgical skills or the application by nurses. They fall under procurement procedures at Member States’ level.

The Regulation (EU) 2017/745 will not enter into force until 26 May 2020. It would be premature to refer to those medical devices subject to the scrutiny procedure when it is still unclear which devices would eventually be CE-marked under the scrutiny procedure. Other than for medicinal products, the spirit of Regulation (EC) 2017/745 and (EU) 2017/746 reflects a decentralised approach and already provides for some efficacy assessment.

Member States have other means to ensure the most cost-efficient use for medical devices. As the aim of the proposal is to reduce administrative burden, and not to add to it, it is not consistent with the aim of the proposal to include medical devices in the scope of the Joint HTA.

It is considered that the need for an HTA on Medical Devices needs to originate from the Member State’s authorities. Therefore, the Rapporteur recommends excluding medical devices from the scope of a mandatory Joint HTA.

AMENDMENTS

The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment    1

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2)  Health Technology Assessment (HTA) is an evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.

(2)  Health Technology Assessment (HTA) is an evidence-based, multidisciplinary process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and should be carried out in a systematic, independent and transparent manner. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies.

Amendment    2

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3)  HTA covers both clinical and non-clinical aspects of a health technology. The EU co-funded joint actions on HTA (EUnetHTA Joint Actions) have identified nine domains by reference to which health technologies are assessed. Of these nine domains, four are clinical and five are non-clinical. The four clinical domains of assessment concern the identification of a health problem and current technology, the examination of the technical characteristics of the technology under assessment, its relative safety, and its relative clinical effectiveness. The five non-clinical assessment domains concern cost and economic evaluation of a technology, its ethical, organisational, social, and legal aspects. The clinical domains are therefore more suited to joint assessment at EU-level on their scientific evidence base, while the assessment of non-clinical domains tends to be more closely related to national and regional contexts and approaches.

(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. The assessment of non-clinical domains should closely related to national and regional contexts, approaches and competences.

Amendment    3

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4)  The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

(4)  HTA can assist Member States in creating and maintaining sustainable and comprehensive healthcare systems while stimulating innovation and increasing sector competitiveness, which will ultimately deliver better outcomes for patients.

Amendment    4

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8)  The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines,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 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 health technologies compared with the best available alternative taking into account the level of innovation and value for the patients.

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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    5

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11)  In accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the Member States remain responsible for the organisation and delivery of their healthcare. As such, it is appropriate to limit the scope of Union rules to those aspects of HTA that relate to the clinical assessment of a health technology, and in particular, to ensure that the assessment conclusions are confined to findings relating to the comparative effectiveness of a health technology. The outcome of such assessments should not therefore affect the discretion of Member States in relation to subsequent decisions on pricing and reimbursement of health technologies, including the fixing of criteria for such pricing and reimbursement which may depend on both clinical and non-clinical considerations, and which remain solely a matter of national competence.

(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. In this connection, the joint clinical assessment provided for by this Regulation constitutes a scientific analysis of the relative effects of health technology on clinical outcomes, evaluated in relation to the chosen comparative indicators and chosen groups or subgroups of patients, taking into account the HTA Core Model criteria. This 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 should therefore fall outside the scope of this proposal.

Amendment    6

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12)  In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,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 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 given the need for greater clinical evidence concerning all of these new technologies.

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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    7

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14)  A coordination group composed of representatives from Member States' health technology assessment authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.

(14)  A coordination group composed of representatives from Member States' health technology assessment of national and regional authorities and bodies should be established with responsibility for overseeing the carrying out of joint clinical assessments and other joint work.

Amendment    8

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15)  In order to ensure a Member-State led approach to joint clinical assessments and scientific consultations, Member States should designate national HTA authorities and bodies which inform decision-making as members of the Coordination Group. The designated authorities and bodies should ensure an appropriately high level of representation in the Coordination Group and technical expertise in its sub-groups, taking into account the need to provide expertise on the HTA of medicinal products and medical devices.

(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 research 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.

Amendment    9

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16)  In order that the harmonised procedures fulfil their internal market objective, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

(16)  In order that the harmonised procedures fulfil their internal market objectives, increase the efficiency of clinical evaluations, contribute to the sustainability of healthcare systems and maximise innovation, Member States should be required to take full account of the joint clinical assessment results. Compliance with this obligation does not prevent Member States from carrying out additional clinical analyses to the extent that they are missing from the joint clinical assessment and are deemed necessary within the national health technology assessment context. Member States remain free to carry 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.

Amendment    10

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

 

(19a)  The Commission should be supported in its objective to achieve Better Regulation. Safety and performance of health technologies is to be carried out within the European Medicines Agency and under the Medical Devices Regulation, while the purpose of this Regulation is to jointly assess the efficacy of new health technologies.

Amendment    11

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24)  In order to ensure the inclusiveness and transparency of the joint work, the Coordination Group should engage and consult widely with interested parties and stakeholders. However, in order to preserve the integrity of the joint work, rules should be developed to ensure the independence and impartiality of the joint work and ensure that such consultation does not give rise to any conflicts of interest.

(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. Furthermore, these rules and all consultations should be made public.

Amendment    12

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25)  In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission to establish a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions. It should also take into account initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13

(25)  In order to ensure a uniform approach to the joint work provided for in this Regulation, the Coordination Group together with the Commission should 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 and the Coordination Group should take into account the results of the work already undertaken in the EUnetHTA Joint Actions and in particular the methodological guidelines and evidence submission template. 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. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish procedures for joint clinical assessments and procedures for joint scientific consultations. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13 The procedural and methodological framework are updated at the frequency deemed necessary by the Commission and the Coordination Group to ensure that they should be adapted to the evolution of science. In developing the methodological framework, the Commission and in collaboration with the Coordination Group should consider the specificity and corresponding challenges of certain types of health technologies, advanced therapies or life-prolonging therapies where innovative clinical study designs may be required. These may result in evidential uncertainty at the time of the marketing authorization. As such innovative clinical study designs are often accepted for the purposes of regulatory assessments, the methodology for joint clinical assessments should not prevent these health technologies from reaching patients. The Commission and the Coordination Group should therefore ensure that the methodology provides for a sufficient level of clinical evidence to enable an adequate assessment of such health technologies. Such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission, including, for instance, data from case control studies, real world evidence, as well as the acceptance of indirect treatment comparators.

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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    13

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26)  In order to ensure that this Regulation is fully operational and to adapt it to technical and scientific development, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the contents of documents to be submitted, reports, and summary reports of clinical assessments, the contents of documents for requests, and reports of joint scientific consultations, and the rules for selecting stakeholders. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.14 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)  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, but with the obligation to periodically inform the European Parliament and the Council of these documents and reports . 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.

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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).

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    14

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28)  In order to facilitate the joint work and the exchange of information between Member States on HTA, provision should be made for the establishment of an IT platform that contains appropriate databases and secure channels for communication. The Commission should also ensure a link between the IT platform and other data infrastructures relevant for the purposes of HTA such as registries of real world data.

(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. The IT platform should ensure the publication and transparency for both the joint scientific consultations and the joint technology assessment with regards to the final reports with a summary of all observations. Given the sensitive nature of health information, the confidential handling of data should be safeguarded when commercially or personally sensible.

Amendment    15

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32)  The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making of 13 April 2016, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and EU added value and should be supported by a monitoring programme.

(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 should also be communicated to the European Parliament and Council.

Amendment    16

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  This Regulation establishes:

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:

Justification

This proposed amendment implements recitals (3) and (25).

Amendment    17

Proposal for a regulation

Article 1 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  This Regulation aims to foster and strengthen national health systems by promoting measures for research into and the production and distribution of health technologies, with free, universal access.

Amendment    18

Proposal for a regulation

Article 2 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e)  'clinical assessment' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

(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, which, for medicinal products shall occur at the time of regulatory approval, whereas for medical devices may occur following market launch of medical devices;

Amendment    19

Proposal for a regulation

Article 2 – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga)  ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life, including pain, recovery rates, length of stay in hospitals and adverse events, including re-admissions, complications, blood loss, infections;

Justification

This article aims at clarifying an important concept included in the draft HTA Regulation article 6.5 (a), in line with international practice at HTA agencies’ level.

Amendment    20

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups.

2.  Member States shall designate their national authorities and bodies responsible for health technology assessment which inform decision-making as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States shall designate more than one authority or body responsible for health technology assessment which inform decision-making at national level as members of the Coordination Group and one or more of its sub-groups.

Amendment    21

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3.  The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State.

3.  The Coordination Group shall act by consensus, or, where no consensus is reached, vote by 2/3 majority. The documentation shall be transparent, and votes documented. Dissensions and minority opinion shall be motivated and included in the assessment. There shall be one vote per Member State.

Amendment    22

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

4.  Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

4.  Meetings of the Coordination Group shall be co-chaired by the Commission without the right to vote and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

Amendment    23

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6.  Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality.

6.  Members of the Coordination Group, and their appointed representatives shall respect the principles of transparency, independence, impartiality, and confidentiality of specific information.

Amendment    24

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

7.  The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27.

7.  The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27. The Commission shall regularly update the Coordination Group about any changes to this list or related information.

Amendment    25

Proposal for a regulation

Article 3 – paragraph 8 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  adopt rules on conflict of interest for the functioning of the Coordination Group and the conduction of joint clinical assessments and joint scientific consultations;

Amendment    26

Proposal for a regulation

Article 3 – paragraph 8 – point c

Text proposed by the Commission

Amendment

(c)  ensure cooperation with relevant Union level bodies to facilitate additional evidence generation necessary for its work;

(c)  ensure cooperation with all relevant Union level bodies to facilitate additional evidence generation necessary for its work;

Amendment    27

Proposal for a regulation

Article 3 – paragraph 8 – point d

Text proposed by the Commission

Amendment

(d)  ensure appropriate involvement of stakeholders in its work;

(d)  ensure appropriate and regular involvement of stakeholders in its work;

Justification

In line with due process and experience with EUnetHTA Joint Actions, it is important to ensure that stakeholders receive regular information on the activities of the Coordination Group

Amendment    28

Proposal for a regulation

Article 3 – paragraph 8 – point e – point iii

Text proposed by the Commission

Amendment

(iii)  identification of emerging health technologies;

(iii)  identification of emerging health technologies, taking into account that following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications;

Amendment    29

Proposal for a regulation

Article 3 – paragraph 10 a (new)

Text proposed by the Commission

Amendment

 

10a.  Each national authority and body responsible for health technology assessment as members of the Coordination Group and its sub-groups, and each member and staff of each national authority and body responsible for health technology assessment shall in accordance with Union or Member State law be subject to a duty of professional secrecy both during and after their term of office, with regard to any confidential information which has come to their knowledge in the course of the performance of their tasks or exercise of their powers.

Justification

This amendment reflects that Health Technology Assessment should be a completely trustful process that ensures the confidentiality of sensitive data at all levels.

Amendment    30

Proposal for a regulation

Article 4 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c)  consult the Commission on the draft annual work programme and take into account its opinion.

(c)  consult the Commission on the draft annual work programme.

Amendment    31

Proposal for a regulation

Article 4 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca)  take into account that following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

This amendment reflects that after the end of the transitional period, because the linkage with the centralised marketing authorisation procedure (see Art. 5(1) of the HTA Proposal and proposed amendment to Art. 6(1) above as well as recital (17) and (18) and access to joint scientific assessment for these products, see the proposed amendment to Art. 12(4)) will ensure that the Coordination Group is informed in good time about emerging health technologies.

Amendment    32

Proposal for a regulation

Article 5 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation;

(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 that are considered to be a major innovation and with potential significant impact on national health care systems;

Amendment    33

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c)  in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/74617 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) 2017/74617 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation that are considered to be a major innovation and with potential significant impact on national 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    34

Proposal for a regulation

Article 5 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2.  The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following criteria:

2.  The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following cumulative criteria:

Amendment    35

Proposal for a regulation

Article 5 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea)  the voluntary submission of health technology developer.

Amendment    36

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group.

The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. With respect to medicinal products, the Coordination Group shall initiate joint clinical assessments in accordance with the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

Connection with EMA timeline implements recitals (17) and (18), see also Article 11 (1) (e).

Amendment    37

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2.  The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment.

2.  The designated sub-group shall meet relevant health technology developers to agree on the scope of the assessment and submit documentation from relevant sources including clinical trials but also inter alia patient registries, databases or European Reference Networks, containing the information, data and evidence necessary for the joint clinical assessment.

Amendment    38

Proposal for a regulation

Article 6 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a)  an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment;

(a)  a description of the relative effects of the health technology being assessed on the patient-relevant health outcomes agreed for the assessment;

Justification

The joint clinical assessment shall provide a factual description of the relative effects of the health technology. Judgements should not be made about the magnitude of the effect, which should belong to the national appraisal phase of the process.

Amendment    39

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9.  The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments.

9.  The designated sub-group shall ensure that stakeholders, experts, including experts from patient organisations and consumer organisations, where relevant, and clinical assessors, who are identified by the stakeholder network or by the Coordination Group 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.

Amendment    40

Proposal for a regulation

Article 6 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States.

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a 2/3 majority of Member States. Diverging views shall be outlined in the report.

Amendment    41

Proposal for a regulation

Article 6 – paragraph 13

Text proposed by the Commission

Amendment

13.  The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report.

13.  The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report. The assessor shall consult the developer on the report before its publication. The developer shall have a period of 7 working days to point out which information, if any, it considers confidential and to justify the commercially sensitive nature of that information.

Amendment  42

Proposal for a regulation

Article 8 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;

(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. Member States shall have the right to add clinical evidence in the joint clinical assessment report in accordance with their national context. Additional clinical evidence can complement the conclusions reached in the joint clinical assessment report.

Amendment    43

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

2.  Member States shall 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 final report shall be made publicly available. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

Amendment    44

Proposal for a regulation

Article 9 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group should need to reconsider the conclusions of the initial assessment. Should additional important evidence become available significantly prior to the renewal of the marketing authorisation, the Coordination Group should also consider carrying out an update on joint clinical assessment.

Amendment    45

Proposal for a regulation

Article 11 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  submissions of information, data and evidence by health technology developers;

(a)  submissions of information, data and evidence by health technology developers, including the protection of developers' confidential information;

Amendment    46

Proposal for a regulation

Article 11 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  the application of the selection criteria referred to in Article 10(a)(ii);

Amendment    47

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2.  Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

deleted

Amendment    48

Proposal for a regulation

Article 13 – paragraph 8

Text proposed by the Commission

Amendment

8.  The designated sub-group shall ensure that stakeholders, including patients and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.

8.  The designated sub-group shall ensure that stakeholders, including patients, consumers 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.

Amendment    49

Proposal for a regulation

Article 13 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a two-thirds majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

Amendment    50

Proposal for a regulation

Article 13 – paragraph 12 a (new)

Text proposed by the Commission

Amendment

 

12a.  Delegates participating in the elaboration of joint scientific consultations for a health technology may not participate in the joint clinical assessment of this particular technology.

Amendment    51

Proposal for a regulation

Article 16 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d)  the consultation of patients, clinical experts and other relevant stakeholders;

(d)  the consultation of patients, health professionals, experts from consumer organisations where relevant, clinical experts and other relevant stakeholders;

Amendment    52

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section.

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section. Declarations on conflicts of interests of stakeholders shall be publicly available. Experts with conflict of interests shall not participate in the process.

Amendment    53

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

1.  The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems.

1.  The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorization applications.

Amendment    54

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2.  In the preparation of the study, the Coordination Group shall consult:

2.  In the preparation of the study, the Coordination Group shall be conscious of breakthrough innovation and seek the input of all relevant stakeholders with the aim of exploring new possibilities in innovation. The Coordination Group shall consult all relevant stakeholders, including but not limited to:

Amendment    55

Proposal for a regulation

Article 18 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca)  health professionals;

Amendment    56

Proposal for a regulation

Article 19 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d)  the provision of additional evidence necessary to support health technology assessments.

(d)  the provision of additional evidence necessary to support health technology assessments, including computer modelling and simulation data.

Justification

All possibilities in the search for additional evidence should be explored.

Amendment    57

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall adopt implementing acts concerning:

1.  The Commission shall adopt delegated acts in accordance with Article 31 concerning:

Amendment    58

Proposal for a regulation

Article 22 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii)  the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments;

(ii)  the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments including as regards to the protection of developer's confidential information;

Amendment    59

Proposal for a regulation

Article 22 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii)  the consultation of patients, clinical experts, and other stakeholders in clinical assessments.

(iii)  the consultation of patients, experts from consumer organisations when relevant, clinical experts, and other stakeholders in clinical assessments. The declarations of conflicts of interest of consulted stakeholders shall be publicly available.

Amendment    60

Proposal for a regulation

Article 22 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  methodologies used to formulate the contents and design of clinical assessments.

(b)  methodologies used to formulate the contents and design of clinical assessments, based on the common tools and methodologies for cooperation developed after many years of cooperation through EUnetHTA Joint Actions, BeNeLuxA and Valletta. They shall be developed after consultations with all stakeholders, in a transparent manner, regularly updated to reflect the evolution of science and publicly available.

 

For medicinal products referred to in Article 5(1)(a) and Article 32 (2) the Commission shall, when adopting delegated acts, take into account the distinctive characteristics of the medicinal product and medical device sectors. The methodology shall provide for a sufficient level of flexibility, on the condition that it will maintain the highest level possible in clinical evidence, allowing an adequate management of evidential uncertainty in specific cases, including but not limited to:

 

(a)  orphan medicinal products where limited patient populations may affect the feasibility of a randomized clinical trial or the statistical relevance of the data;

 

(b)  medicinal products which the European Medicines Agency has granted a conditional marketing authorization pursuant to Article 14(7) of Regulation (EC) No.726/2004 or which benefit from a PRIME designation granted by the Agency;

 

(c)  medicinal products authorized based on clinical evidence from clinical trials with specific designs to account for the nature of the health technology or other considerations.

 

The methodology shall also:

 

(a)  provide for a suitable mechanism to identify the patient-relevant health outcome, taking due account of the roles and preferences of relevant stakeholders, including patients, physicians, regulators, HTA bodies and health technology developers;

 

(b)  take into account potential changes relating to the relevant comparator at national level due to the rapidly evolving standards of care.

Amendment    61

Proposal for a regulation

Article 23 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

The data and evidence referred to in point i of point a of the first paragraph shall be limited to the best available evidence at the time of the submission for clinical assessment and may include data from other sources than randomised clinical trials.

Justification

In developing the delegated act, the Commission should limit the data and evidence that can be requested from the health technology developer to the evidence available at the time of the submission. A sufficient level of flexibility should be provided by ensuring that developers can submit the best evidence available, including data from observational studies (case-control studies, real world observational studies etc.)

Amendment    62

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  In any event, the Union shall ensure stable and permanent public funding under the Multiannual Financial Framework.

Amendment    63

Proposal for a regulation

Article 25 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e)  facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information;

(e)  facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information; the sharing of confidential information needs to be proportionate to and aligned with the requirements for the joint clinical assessments and be discussed with the health technology developer or other relevant stakeholders;

Amendment    64

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. The Commission services shall take the following criteria into account when assessing applications:

 

(i)  demonstrated current or planned engagement in HTA development (activity reports, work plans, position papers, active working groups, EU-funded actions);

 

(ii)  professional expertise relevant to the aims of the Pool at EU level;

 

(iii)  geographical coverage of several Member States, with preference for a balanced coverage;

Amendment    65

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4.  On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

4.  On the request of the Coordination Group, the Commission shall invite patient, clinical and other experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

Amendment    66

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

This amendment reflects that there will be no need for such a study following the end of the transitional period, because the linkage with the centralised marketing authorisation procedure (see Art. 5(1) of the HTA Proposal and proposed amendment to Art. 6(1) above as well as recital (17) and (18) and access to joint scientific assessment for these products, see the proposed amendment to Art. 12(4)) will ensure that the Coordination Group is informed in good time about emerging health technologies.

Amendment    67

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  All confidential data provided by a manufacturer shall be covered by a clear confidentiality agreement. The Commission shall ensure the protection of confidential data against unauthorised access or disclosure, and ensure the integrity of data stored against accidental or unauthorised destruction, accidental loss or alteration.

Amendment    68

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

2.  When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.

2.  When preparing those implementing and delegated 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.

Justification

This proposed amendment implements recitals (3) and (25.)

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

Proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU

References

COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)

Committee responsible

       Date announced in plenary

ENVI

8.2.2018

 

 

 

Opinion by

       Date announced in plenary

ITRE

8.2.2018

Rapporteur

       Date appointed

Lieve Wierinck

15.3.2018

Discussed in committee

16.5.2018

 

 

 

Date adopted

3.9.2018

 

 

 

Result of final vote

+:

–:

0:

33

9

4

Members present for the final vote

Xabier Benito Ziluaga, José Blanco López, Jonathan Bullock, Cristian-Silviu Buşoi, Jerzy Buzek, Angelo Ciocca, Jakop Dalunde, Christian Ehler, Ashley Fox, András Gyürk, Rebecca Harms, Barbara Kappel, Peter Kouroumbashev, Zdzisław Krasnodębski, Christelle Lechevalier, Janusz Lewandowski, Paloma López Bermejo, Edouard Martin, Tilly Metz, Angelika Mlinar, Dan Nica, Angelika Niebler, Miroslav Poche, Julia Reda, Paul Rübig, Massimiliano Salini, Neoklis Sylikiotis, Patrizia Toia, Evžen Tošenovský, Vladimir Urutchev, Kathleen Van Brempt, Martina Werner, Lieve Wierinck, Anna Záborská, Flavio Zanonato, Carlos Zorrinho

Substitutes present for the final vote

Tamás Deutsch, Françoise Grossetête, Benedek Jávor, Barbara Kudrycka, Vladimír Maňka, Luděk Niedermayer, Dominique Riquet, Maria Spyraki

Substitutes under Rule 200(2) present for the final vote

Laura Agea, John Howarth

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

33

+

ALDE

Angelika Mlinar, Dominique Riquet, Lieve Wierinck

ECR

Ashley Fox, Zdzisław Krasnodębski, Evžen Tošenovský

EFDD

Laura Agea

ENF

Angelo Ciocca, Barbara Kappel, Christelle Lechevalier

PPE

Cristian-Silviu Buşoi, Jerzy Buzek, Tamás Deutsch, Christian Ehler, Françoise Grossetête, András Gyürk, Barbara Kudrycka, Janusz Lewandowski, Angelika Niebler, Luděk Niedermayer, Paul Rübig, Massimiliano Salini, Maria Spyraki, Vladimir Urutchev, Anna Záborská

S&D

José Blanco López, John Howarth, Peter Kouroumbashev, Dan Nica, Miroslav Poche, Patrizia Toia, Martina Werner, Carlos Zorrinho

9

-

EFDD

Jonathan Bullock

GUE/NGL

Xabier Benito Ziluaga, Paloma López Bermejo, Neoklis Sylikiotis

VERTS/ALE

Jakop Dalunde, Rebecca Harms, Benedek Jávor, Tilly Metz, Julia Reda

4

0

S&D

Vladimír Maňka, Edouard Martin, Kathleen Van Brempt, Flavio Zanonato

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention


OPINION of the Committee on the Internal Market and Consumer Protection (20.7.2018)

for the Committee on the Environment, Public Health and Food Safety

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))

Rapporteur for opinion: Cristian-Silviu Buşoi

AMENDMENTS

The Committee on the Internal Market and Consumer Protection calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the following amendments:

Amendment    1

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1)  The development of health technologies is a key driver of economic growth and innovation in the Union. It forms part of an overall market for healthcare expenditure that accounts for 10% of EU gross domestic product. Health technologies encompass medicinal products, medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

(1)  The development of health technologies is a key to improving health policies through access to more progressive health technologies, and thus achieving a high level of health protection. At the same time, health technologies are an innovative sector of the economy, which 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.

Amendment    2

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4)  The outcome of HTA is used to inform decisions concerning the allocation of budgetary resources in the field of health, for example, in relation to establishing the pricing or reimbursement levels of health technologies. HTA can therefore assist Member States in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients.

(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, while patients have the right to health protection and protection against the financial, social and medical consequences of a disease, as well as unrestrained access to the latest therapeutic discoveries, which should be guaranteed by law in all Member States.

Amendment    3

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12)  In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,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 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 classified as high risk class IIb implantable devices and class III devices pursuant to Article 51 of Regulation (EU) 2017/745 of the European Parliament and of the Council12 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 which have already been marketed in at least one Member State.

_________________

_________________

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    4

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13)  In order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, it is appropriate to establish conditions for the updating of assessments, in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment.

(13)  To ensure timely patient access to health technologies across the Union, in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant, and in order to avoid duplications between the regulatory assessments carried out by the European Medicines Agency and the joint clinical assessments, it is appropriate to establish synergies, and 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.

Amendment    5

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission

Amendment

 

(15a)  The cooperation between HTA authorities should be based on the principles of good governance, objectivity, independence and transparency.

Amendment    6

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16)  In order that the harmonised procedures fulfil their internal market objective, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. Compliance with this obligation does not prevent Member States from carrying out non-clinical assessments on the same health technology, or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

(16)  In order that the harmonised procedures fulfil their internal market objective and at the same time support access to medical innovations, Member States should be required to take full account of the results of joint clinical assessments and not repeat those assessments. According to national needs, Member States should have the right to complement joint clinical assessments with additional clinical evidence. In addition, this 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 non-clinical data and criteria. It also does not prevent Member States from forming their own recommendations or decisions on pricing or reimbursement.

Amendment    7

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17)  The time-frame for joint clinical assessments for medicinal products should, in as far as possible, be fixed by reference to the time-frame applicable to the completion of the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004. Such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients. As a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation.

(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. In certain Member States, clinical assessments can start even before the marketing authorisation has been granted by the Commission. In order to support the objectives of this Regulation and to avoid that joint clinical assessments result in delays in those Member States compared to the status quo, as a rule, the process should be completed by the time of the publication of the Commission decision granting marketing authorisation.

Amendment    8

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18)  The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placed on the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devices.

(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 and, if possible, in the presence of producers.

Amendment    9

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21)  Joint clinical assessments and joint scientific consultations necessitate the sharing of confidential information between health technology developers and HTA authorities and bodies. In order to ensure the protection of such information, information provided to the Coordination Group in the framework of assessments and consultations should only be disclosed to a third party after a confidentiality agreement has been concluded. In addition, it is necessary for any information made public about the results of joint scientific consultations to be presented in an anonymised format with the redaction of any information of a commercially sensitive nature.

(21)  Given the sensitive nature of health information and the confidential handling of commercially sensitive data, these should be safeguarded at all times. 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 with the technology developer that has provided the information. 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. It should be clarified that the provisions concerning protection of confidential information do not prevent in any way public disclosure of joint scientific consultations being evaluated. 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 should facilitate progress in biomedical research and ensure the highest possible level of confidence in the system.

Amendment    10

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25)  In order to ensure a uniform approach to the joint work provided for in this Regulation, implementing powers should be conferred on the Commission to establish a common procedural and methodological framework for clinical assessments, procedures for joint clinical assessments and procedures for joint scientific consultations. Where appropriate, distinct rules should be developed for medicinal products and medical devices. In the development of such rules, the Commission should take into account the results of the work already undertaken in the EUnetHTA Joint Actions. It should also take into account initiatives on HTA funded through the Horizon 2020 research programme, as well as regional initiatives on HTA such as the Beneluxa and Valletta Declaration initiatives. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.13

(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, after consulting the Coordination Group, 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 and the Coordination Group should take into account the results of the work already undertaken in the EUnetHTA Joint Actions and in particular the methodological guidelines and evidence submission template. 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. The procedural and methodological frameworks should be updated at the frequency deemed necessary by the Commission and the Coordination Group to ensure that those frameworks are adapted to scientific evolution. In developing the methodological framework, the Commission, in collaboration with the Coordination Group, should consider the specificity and corresponding challenges of certain types of health technologies, advanced therapies or life-prolonging therapies where innovative clinical study designs may be required. These may result in evidential uncertainty at the time of the marketing authorisation. As such innovative clinical study designs are often accepted for the purposes of regulatory assessments, the methodology for joint clinical assessments should not prevent these health technologies from reaching patients. The Commission and the Coordination Group should therefore ensure that the methodology provides for a high standard of clinical evidence, while preserving the necessary flexibility, to enable an adequate assessment of such health technologies. Such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission, including, for instance, data from case control studies, real world observational data, as well as the acceptance of indirect treatment comparators. The methodological rules to be developed should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is nevertheless needed. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.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).

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    11

Proposal for a regulation

Recital 25 a (new)

Text proposed by the Commission

Amendment

 

(25a)   The Commission, together with the Member States, should adapt the framework of the joint clinical assessment of vaccines to take into account the preventive nature of vaccines that brings benefits to individuals and populations over a long time horizon, and should involve the appropriate national bodies in the joint clinical assessment of vaccines. The adaption of that framework should be completed by the end of the implementation period of this Regulation to ensure that it is ready to be used during the transition period. 

Amendment    12

Proposal for a regulation

Article 1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  This Regulation establishes:

1.  Taking into account the results of the work already undertaken in the EUnetHTA Joint Actions, this Regulation establishes:

Justification

This proposed amendment implements recitals (3) and (25).

Amendment    13

Proposal for a regulation

Article 2 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e)  'clinical assessment' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

(e)  'clinical assessment' means a compilation and analysis 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 at the time of regulatory approval;

Justification

It is important to clearly delineate the scope of joint clinical assessments to clarify that they focus on the factual review and analysis of available evidence. The assessment excludes any valuation (i.e. setting a value) of a product, as this step is called appraisal and remains the full prerogative of Member States. The addition of “at the time of regulatory approval” aims at clarifying that assessments shall take place in parallel to the regulatory process in order to aim for availability of report at launch, hence avoiding any delay to national patient access procedures.

Amendment    14

Proposal for a regulation

Article 2 – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

 

(ga)  ‘patient-relevant health outcomes’ means data that captures or predicts mortality, morbidity, health-related quality of life and adverse events;

Justification

This article aims at clarifying an important concept included in the draft HTA Regulation article 6.5 (a), in line with international practice at HTA agencies’ level.

Amendment    15

Proposal for a regulation

Article 2 – paragraph 1 – point g b (new)

Text proposed by the Commission

Amendment

 

(gb)  ´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.

Amendment    16

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups.

2.  Member States shall designate their national authorities and bodies responsible for health technology assessment that inform decision-making at national level 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. Each Member State may appoint to the Coordination Group at least one authority or body responsible with expertise in the field of medicinal products.

Amendment    17

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3.  The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State.

3.  The Coordination Group shall act by consensus, or, where necessary, vote by a two-thirds majority. There shall be one vote per Member State.

Amendment    18

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

4.  Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

4.  Meetings of the Coordination Group shall be co-chaired by the Commission without the right to vote and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

Amendment    19

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6.  Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality.

6.  Members of the Coordination Group, their staff and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality. They shall be subject to a duty of professional secrecy under Union or Member State legislation both during and after their term of office, with regard to any confidential information that has come to their knowledge in the course of the performance of their tasks or exercise of their powers.

Amendment    20

Proposal for a regulation

Article 3 – paragraph 8 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  adopt rules on conflicts of interest for the functioning of the Coordination Group and the conduct of joint clinical assessments and joint scientific consultations.

Amendment    21

Proposal for a regulation

Article 3 – paragraph 8 – point d

Text proposed by the Commission

Amendment

(d)  ensure appropriate involvement of stakeholders in its work;

(d)  ensure appropriate and regular involvement of stakeholders in its work;

Justification

In line with due process and experience with EUnetHTA Joint Actions, it is important to ensure that stakeholders receive regular information on the activities of the Coordination Group.

Amendment    22

Proposal for a regulation

Article 3 – paragraph 8 – point d a (new)

Text proposed by the Commission

Amendment

 

(da)  ensure the highest level of transparency of the clinical data being evaluated. In case of information of a commercially sensitive nature, the confidentiality shall be strictly defined and justified and the confidential information shall be well-defined;

Amendment    23

Proposal for a regulation

Article 3 – paragraph 8 – point e – point iii

Text proposed by the Commission

Amendment

(iii)  identification of emerging health technologies;

(iii)  identification of emerging health technologies; following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications;

Justification

This amendment reflects that there will be no need for a subgroup identifying emerging health technologies after the end of the transitional period referred to in article 33.1, because the linkage with the centralised marketing authorisation procedure above as well as recital (17) and (18) and access to joint scientific assessment for these products, will ensure that the Coordination Group is informed in good time about emerging health technologies

Amendment    24

Proposal for a regulation

Article 4 – paragraph 3 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca)  consult patient organisations, health professionals, clinical experts and other relevant stakeholders;

Amendment    25

Proposal for a regulation

Article 4 – paragraph 3 – point c b (new)

Text proposed by the Commission

Amendment

 

(cb)  take into account that following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Amendment    26

Proposal for a regulation

Article 5

Text proposed by the Commission

Amendment

Article 5

Article 5

Scope of Joint Clinical Assessments

Scope of Joint Clinical Assessments

1.  The Coordination Group shall carry out joint clinical assessments on:

1.  The Coordination Group shall carry out joint clinical assessments on:

(a)  medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC;

(a)  medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC, and medicinal products authorised under Article 8(3) of Directive 2001/83/EC not incorporating a new active substance;

(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 which are considered to be a major innovation and with potential significant impact on national health care systems;

(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) 2017/74617 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation and which are considered to be a major innovation and with potential significant impact on national health care systems.

2.  The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following criteria:

2.  The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following cumulative criteria:

(a)  unmet medical needs;

(a)  unmet medical needs;

(b)  potential impact on patients, public health, or healthcare systems;

(b)  potential impact on patients, public health, or healthcare systems;

(c)  significant cross-border dimension;

(c)  significant cross-border dimension;

(d)  major Union-wide added value;

(d)  major Union-wide added value;

(e)  the available resources.

(e)  the available resources.

 

(ea)  voluntary submission by a health technology developer;

 

(eb)  identification by the stakeholder network.

__________________

__________________

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    27

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group.

The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. With respect to medicinal products, the Coordination Group shall initiate joint clinical assessments in accordance with the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

Connection with EMA timeline implements recitals (17) and (18).

Amendment    28

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23.

The joint clinical assessment report shall be accompanied by a summary report and shall be prepared in accordance with the requirements in this Article, the requirements established pursuant to Articles 11, 22, and 23, taking into account the results of the work already undertaken in the EUnetHTA Joint Actions and the EUnetHTA procedures for joint clinical assessments of medicinal products.

Justification

This amendment reflect the practice established in EUnetHTA joint assessments.

Amendment    29

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2.  The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment.

2.  The designated sub-group shall meet with relevant health technology developers on the scope of the assessment and on the documentation containing the information, data and evidence necessary for the joint clinical assessment to be submitted. The relationship between evaluators and health technology developers shall be independent and impartial. Developers of health technologies may be consulted, but shall not participate actively in the evaluation process.

Amendment    30

Proposal for a regulation

Article 6 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The designated sub-group shall request, in addition to the data referred to in paragraph 2, data from relevant sources, such as patient registries, databases or European Reference Networks, where that data is deemed necessary to complete the information provided by the health technology developers and to perform a more accurate clinical assessment of the health technology.

Justification

Assessors could request/order/subcontract complementary analysis from other sources such as databases, patient registries, health medical records, drug utilisation studies, European Reference Networks and patients’ organisations.

Amendment    31

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3.  The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.

3.  The designated sub-group shall appoint, from among its members, an assessor and a co-assessor from different Member States to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment and prioritise those assessors with the relevant scientific expertise necessary for the assessment.

Amendment    32

Proposal for a regulation

Article 6 – paragraph 5 – point a

Text proposed by the Commission

Amendment

(a)  an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment;

(a)  a description of the relative effects of the health technology being assessed on the patient-relevant health outcomes agreed for the assessment;

Justification

The joint clinical assessment shall provide a factual description of the relative effects of the health technology. Judgements should not be made about the magnitude of the effect, which should belong to the national appraisal phase of the process.

Amendment    33

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

 

5a.  The joint clinical assessment report shall neither refer to non-clinical assessment domains nor shall it draw conclusions on the added value of the technologies concerned, since those shall remain part of national appraisal processes.

Amendment    34

Proposal for a regulation

Article 6 – paragraph 6

Text proposed by the Commission

Amendment

6.  Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

6.  Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend once the time period set for the preparation of the report and to request additional evidence from the health technology developer, provided that such evidence is available in advance of the marketing authorisation. Having agreed with the health technology developer on the necessary additional evidence and the time needed to prepare it, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

Justification

While it is legitimate for the co-assessors to have an opportunity to request additional evidence where the submission is incomplete, such evidence should be limited to data available at the stage of submission for marketing authorisation. These provisions should not be used to unduly delay the clinical assessments by requiring data that the health technology developer does not have or may need an unreasonable amount of time to generate.

Amendment    35

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

9.  The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments.

9.  The designated sub-group shall ensure that all relevant stakeholders, including patient organisations, health professionals 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.

Amendment    36

Proposal for a regulation

Article 6 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States.

12.  The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a two-thirds majority of Member States.

Amendment    37

Proposal for a regulation

Article 6 – paragraph 14 a (new)

Text proposed by the Commission

Amendment

 

14a.  Upon receipt of an approved joint clinical assessment report and summary report, the submitting health technology developer may object in writing to the Coordination Group and the Commission within seven working days, providing detailed grounds for the objections. The Coordination Group shall evaluate the objections within 30 working days and may revise the report if and as necessary. It shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections were addressed.

Amendment    38

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  All of the necessary steps leading to the inclusion of the name of the health technology that has been the subject of the approved report and summary report shall be completed by the time of the publication of the Commission decision granting the marketing authorisation.

Justification

This amendment implements recital 17. The timeline should be more clearly defined in the Regulation proposal to ensure that the joint clinical assessment reports are done completed by the time of the publication of the Commission decision granting marketing authorisation. This timeline is proposed to avoid potential delays in access to medicines.

Amendment    39

Proposal for a regulation

Article 8 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;

deleted

Amendment    40

Proposal for a regulation

Article 8 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Paragraph 1(b) shall not prevent Member States 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 did not form part of the joint clinical assessment and which are necessary to complete the general assessment of health technology.

Amendment    41

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2.  Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

2.  Member States shall 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 final report shall be made publicly available. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

Amendment    42

Proposal for a regulation

Article 9

Text proposed by the Commission

Amendment

Article 9

Article 9

Updates of Joint Clinical Assessments

Updates of Joint Clinical Assessments

1.  The Coordination Group shall carry out updates of joint clinical assessments where:

1.  The Coordination Group shall carry out updates of joint clinical assessments where:

(a)  the Commission Decision to grant the marketing authorisation of a medicinal product referred to in Article 5(1)(a) was conditional on the fulfilment of additional post-authorisation requirements;

(a)  the Commission Decision to grant the marketing authorisation of a medicinal product referred to in Article 5(1)(a) was conditional on the fulfilment of additional post-authorisation requirements;

(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;

 

(ba)  the health technology developer requests an update on the grounds that additional evidence is made available for which the Coordination Group would need to reconsider the conclusions of the initial assessment.

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 more than one of its members.

 

2a.  The Coordination Group may carry out updates of joint clinical assessments where additional important evidence becomes available significantly prior to the renewal of the marketing authorisation.

3.  Updates shall be carried out in accordance with the procedural rules established pursuant to Article 11(1)(d).

3.  Updates shall be carried out in accordance with the procedural rules established pursuant to Article 6 and Article 11(1)(d).

Amendment    43

Proposal for a regulation

Article 10 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii)  select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the selection criteria referred to in Article 5(2).

(ii)  select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the following selection criteria:

 

  unmet medical needs, where there is no treatment or only unsatisfactory treatment is available;

 

  potential impact on patients and public health, considering, inter alia, the burden of disease measured by mortality and morbidity, and the life-threatening or chronically debilitating nature of the disease targeted by the health technology;

 

  a significant cross-border dimension;

 

  the available resources of the Coordination Group.

Amendment    44

Proposal for a regulation

Article 11 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  submissions of information, data and evidence by health technology developers;

(a)  submissions of information, data and evidence by health technology developers, including the protection of developers' confidential information;

Amendment    45

Proposal for a regulation

Article 11 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  the application of the selection criteria referred to in Article 5(2);

Justification

The selection criteria for medical devices and centrally approved medicines during the transition phase referred in Article 33(1) and Article 10 are currently relatively vague. It is important that the criteria and their application by the Coordination Group are transparent to all stakeholders, including health technology developers.

Amendment    46

Proposal for a regulation

Article 11 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c)  determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments;

(c)  determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments, including for appeal mechanisms for health technology developers;

Justification

This amendment complements the inclusion of a review mechanism, so that the Commission will adopt appropriate procedural provisions (deadlines etc.).

Amendment    47

Proposal for a regulation

Article 11 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f)  cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices.

(f)  cooperation between the European Medicines Agency and the Coordination Group on the preparation and update of joint clinical assessments of medicinal products. This cooperation shall take into account that the Coordination Group, due to its competences in clinical aspects, is the competent body to detect and prioritise the emerging technologies based on impact on health.

Amendment    48

Proposal for a regulation

Article 12 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a.  Paragraphs (2) and (3) of this Article shall not apply to medicinal products.

Justification

This amendment ensures that all medicinal products, which will be subject to mandatory joint clinical assessments following the transition period, have access to the opportunity of a joint scientific consultation. Given development timelines of medicinal products, it is important to ensure that no limitation is set to scientific consultations for medicinal products.

Amendment    49

Proposal for a regulation

Article 13 – paragraph 2

Text proposed by the Commission

Amendment

2.  The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation.

2.  The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation. All relevant data and information shall be made publicly available.

Amendment    50

Proposal for a regulation

Article 13 – paragraph 3

Text proposed by the Commission

Amendment

3.  The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment.

3.  The designated sub-group shall appoint from among its members, an assessor and a co-assessor, from different Member States, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment.

Amendment    51

Proposal for a regulation

Article 13 – paragraph 8

Text proposed by the Commission

Amendment

8.  The designated sub-group shall ensure that stakeholders, including patients, and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.

8.  The designated sub-group shall ensure that all relevant stakeholders, including patient organisations, health professionals 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.

Amendment    52

Proposal for a regulation

Article 13 – paragraph 12

Text proposed by the Commission

Amendment

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

12.  The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a two-thirds majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

Amendment    53

Proposal for a regulation

Article 16 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d)  the consultation of patients, clinical experts and other relevant stakeholders;

(d)  the consultation of patient organisations, health professionals, clinical experts and other relevant stakeholders;

Amendment    54

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section.

(b)  the rules for determining the stakeholders to be consulted for the purpose of this Section, including on the prevention of conflicts of interest.

Amendment    55

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

1.  The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems.

1.  The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

This amendment ensures that all medicinal products, which will be subject to mandatory joint clinical assessments following the transition period, have access to the opportunity of a joint scientific consultation. Given development timelines of medicinal products, it is important to ensure that no limitation is set to scientific consultations for medicinal products.

Amendment    56

Proposal for a regulation

Article 18 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2.  In the preparation of the study, the Coordination Group shall consult:

2.  In the preparation of the study, the Coordination Group shall consult all relevant stakeholders, including:

Amendment    57

Proposal for a regulation

Article 18 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  health professionals;

Amendment    58

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

Article 22

Article 22

Common Procedural Rules and Methodology

Common Procedural Rules and Methodology

1.  The Commission shall adopt implementing acts concerning:

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning:

(a)  procedural rules for:

(a)  procedural rules for:

(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 health technology authorities and bodies carry out clinical assessments in an independent and transparent manner, free from conflicts of interest;

(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;

(iii)  the consultation of patients, clinical experts, and other stakeholders in clinical assessments.

(iii)  the consultation of patient organisations, health professionals, clinical experts, and other relevant stakeholders in clinical assessments, including rules on avoiding conflicts of interest;

(b)  methodologies used to formulate the contents and design of clinical assessments.

(b)  methodologies used to formulate the contents and design of clinical assessments, based on the common tools and methodologies for cooperation developed after many years of cooperation through EUnetHTA Joint Actions, BeNeLuxA and Valletta. Those methodologies shall be developed after consultation of the Coordination Group and all relevant stakeholders, including patient organisations, health professionals and clinical experts, in a transparent manner, they shall be regularly updated to reflect the evolution of science and shall be made publicly available.

 

For medicinal products referred to in Article 5(1)(a)and Article 32(2), the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors. The methodology shall provide for a sufficient level of flexibility, on condition that it will maintain the highest level possible in clinical evidence, allowing an adequate management of evidential uncertainty in specific cases, including but not limited to:

 

(i)  orphan medicinal products where limited patient populations may affect the feasibility of a randomised clinical trial or the statistical relevance of the data;

 

(ii)  medicinal products for which the European Medicines Agency has granted a conditional marketing authorisation pursuant to Article 14(7)of Regulation (EC) No 726/2004 or which benefit from a PRIME designation granted by the Agency;

 

(iii)  medicinal products authorized based on clinical evidence from clinical trials with specific designs to account for the nature of the health technology or other considerations.

 

The methodology shall also:

 

(i)  provide for a suitable mechanism to identify the patient-relevant health outcome, taking due account of the roles and preferences of relevant stakeholders, including patient organisations, health professionals, clinical experts, regulators, HTA bodies and health technology developers;

 

(ii)  take into account potential changes relating to the relevant comparator at national level due to the rapidly evolving standards of care.

2.  Implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 30(2).

 

Amendment    59

Proposal for a regulation

Article 23 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

The data and evidence referred to in point (i) of point (a) shall be limited to the best available evidence at the time of the submission for clinical assessment and may include data from sources other than randomised clinical trials.

Justification

In developing the delegated act, the Commission should limit the data and evidence that can be requested from the health technology developer to the evidence available at the time of the submission. A sufficient level of flexibility should be provided by ensuring that developers can submit the best evidence available, including data from observational studies (case-control studies, real world observational studies etc.)

Amendment    60

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

1.  The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council.18

1.  The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The Union shall guarantee a sufficient, stable and continuing public funding of the Coordination Group. This public funding shall be ensured without any direct or indirect involvement of HTA developers. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council.18

___________________

____________________

18 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

18 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).

Amendment    61

Proposal for a regulation

Article 24 – paragraph 2

Text proposed by the Commission

Amendment

2.  The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.

2.  The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance, approved by the Commission, compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.

Amendment    62

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

1.  The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications. The stakeholder network shall include at least patient organisations, health professionals and clinical experts. The selection criteria shall aim at preventing conflicts of interest.

Amendment    63

Proposal for a regulation

Article 26 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  A qualified representative of the European Parliament shall also be included in the stakeholder network. That representative shall report to the European Parliament on a regular basis about the recent developments within the stakeholder network.

Amendment    64

Proposal for a regulation

Article 26 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3.  The Commission shall organise ad-hoc meetings between the stakeholder network and the Coordination Group in order to:

3.  The Commission shall organise meetings on a regular basis between the stakeholder network and the Coordination Group in order to:

Amendment    65

Proposal for a regulation

Article 26 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a)  update stakeholders on the work of the group;

(a)  update stakeholders on the work of the group; all members of the stakeholder network shall have access to all relevant data and information;

Amendment    66

Proposal for a regulation

Article 26 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b)  provide for an exchange of information on the work of the Coordination Group.

(b)  provide for an exchange of information between the Coordination Group and the stakeholder network.

Amendment    67

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Following the end of the transitional period referred to in Article 33(1), with respect to medicinal products, the identification of emerging health technologies shall follow the EMA pre-notification of medicinal products prior to marketing authorisation applications.

Justification

This amendment reflects that there will be no need for such a study following the end of the transitional period, because the linkage with the centralised marketing authorisation procedure will ensure that the Coordination Group is informed in good time about emerging health technologies.

Amendment    68

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  All confidential data provided by a manufacturer shall be covered by a clear confidentiality agreement. The Commission shall also ensure the protection of confidential data against unauthorised access or disclosure, and ensure the integrity of data stored against accidental or unauthorised destruction, accidental loss or alteration.

Amendment    69

Proposal for a regulation

Article 27 a (new)

Text proposed by the Commission

Amendment

 

Article 27a

 

Common rules on data

 

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning data collection, interoperability of data and the comparability of data.

 

2.  Assessors and co-assessors shall 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 purposes of assessing a medicinal product in the context of a joint HTA.

 

3.  The confidential handling of commercially sensitive data shall be safeguarded at all times.

Amendment    70

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1.  No later than five years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions.

1.  No later than four years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions.

Amendment    71

Proposal for a regulation

Article 31 – paragraph 3

Text proposed by the Commission

Amendment

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.

3.  The delegation of power referred to in Articles 17, 22, 23 and 27a 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    72

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

2.  When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.

2.  When preparing those implementing and delegated 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.

Justification

This proposed amendment implements recitals (3) and (25.)

Amendment    73

Proposal for a regulation

Article 32 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  In preparing the implementing and delegating acts, the Commission shall seek input from the stakeholder network and the general public.

Amendment    74

Proposal for a regulation

Article 34 – paragraph 1

Text proposed by the Commission

Amendment

1.  Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

1.  Member States may carry out a clinical assessment as a provisional measure using means other than the rules provided for in Chapter III of this Regulation, namely 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.

Justification

This proposed amendment reflects Article 114(10) TFEU, which is applicable to the HTA proposal as it is based on Article 114 TFEU as its legal basis. Article 114(10 TFEU) provides that: "10. The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 36, provisional measures subject to a Union control procedure."

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

Proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU

References

COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)

Committee responsible

       Date announced in plenary

ENVI

8.2.2018

 

 

 

Opinion by

       Date announced in plenary

IMCO

8.2.2018

Rapporteur

       Date appointed

Cristian-Silviu Buşoi

21.3.2018

Discussed in committee

4.6.2018

19.6.2018

11.7.2018

 

Date adopted

12.7.2018

 

 

 

Result of final vote

+:

–:

0:

26

8

4

Members present for the final vote

John Stuart Agnew, Pascal Arimont, Dita Charanzová, Carlos Coelho, Sergio Gaetano Cofferati, Anna Maria Corazza Bildt, Daniel Dalton, Nicola Danti, Dennis de Jong, Pascal Durand, Maria Grapini, Liisa Jaakonsaari, Eva Maydell, Marlene Mizzi, Nosheena Mobarik, Jiří Pospíšil, Christel Schaldemose, Andreas Schwab, Olga Sehnalová, Jasenko Selimovic, Ivan Štefanec, Catherine Stihler, Richard Sulík, Róża Gräfin von Thun und Hohenstein, Mylène Troszczynski, Mihai Ţurcanu, Anneleen Van Bossuyt, Marco Zullo

Substitutes present for the final vote

Biljana Borzan, Birgit Collin-Langen, Julia Reda, Marc Tarabella, Matthijs van Miltenburg, Sabine Verheyen

Substitutes under Rule 200(2) present for the final vote

Asim Ademov, Isabella De Monte, Sylvie Goddyn, Kateřina Konečná

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

26

+

ALDE

Dita Charanzová, Matthijs van Miltenburg, Jasenko Selimovic

ECR

Anneleen Van Bossuyt

PPE

Asim Ademov, Pascal Arimont, Carlos Coelho, Birgit Collin-Langen, Anna Maria Corazza Bildt, Eva Maydell, Jiří Pospíšil, Andreas Schwab, Ivan Štefanec, Róża Gräfin von Thun und Hohenstein, Mihai Ţurcanu, Sabine Verheyen

S&D

Biljana Borzan, Sergio Gaetano Cofferati, Nicola Danti, Isabella De Monte, Maria Grapini, Liisa Jaakonsaari, Marlene Mizzi, Christel Schaldemose, Olga Sehnalová, Catherine Stihler

8

-

ECR

Daniel Dalton, Nosheena Mobarik, Richard Sulík

EFDD

John Stuart Agnew

ENF

Sylvie Goddyn, Mylène Troszczynski

GUE/NGL

Dennis de Jong, Kateřina Konečná

4

0

EFDD

Marco Zullo

S&D

Marc Tarabella

VERTS/ALE

Pascal Durand, Julia Reda

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention


PROCEDURE – COMMITTEE RESPONSIBLE

Title

Proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU

References

COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)

Date submitted to Parliament

31.1.2018

 

 

 

Committee responsible

       Date announced in plenary

ENVI

8.2.2018

 

 

 

Committees asked for opinions

       Date announced in plenary

ECON

8.2.2018

EMPL

8.2.2018

ITRE

8.2.2018

IMCO

8.2.2018

 

JURI

8.2.2018

FEMM

8.2.2018

 

 

Not delivering opinions

       Date of decision

ECON

31.5.2018

EMPL

15.3.2018

JURI

21.2.2018

FEMM

20.6.2018

Rapporteurs

       Date appointed

Soledad Cabezón Ruiz

26.2.2018

 

 

 

Legal basis disputed

       Date of JURI opinion

JURI

10.9.2018

 

 

 

Discussed in committee

7.6.2018

9.7.2018

 

 

Date adopted

13.9.2018

 

 

 

Result of final vote

+:

–:

0:

40

3

2

Members present for the final vote

Marco Affronte, Margrete Auken, Catherine Bearder, Simona Bonafè, Paul Brannen, Soledad Cabezón Ruiz, Nessa Childers, Miriam Dalli, Seb Dance, Angélique Delahaye, Mark Demesmaeker, José Inácio Faria, Elisabetta Gardini, Arne Gericke, Jens Gieseke, Sylvie Goddyn, Françoise Grossetête, Jytte Guteland, Jean-François Jalkh, Karin Kadenbach, Urszula Krupa, Giovanni La Via, Jo Leinen, Peter Liese, Joëlle Mélin, Rory Palmer, Massimo Paolucci, Gilles Pargneaux, Piernicola Pedicini, Bolesław G. Piecha, John Procter, Annie Schreijer-Pierik, Renate Sommer, Adina-Ioana Vălean, Damiano Zoffoli, Davor Škrlec

Substitutes present for the final vote

Inés Ayala Sender, Linnéa Engström, Eleonora Evi, Carolina Punset, Bart Staes, Tiemo Wölken

Substitutes under Rule 200(2) present for the final vote

Santiago Fisas Ayxelà, Tonino Picula, Inmaculada Rodríguez-Piñero Fernández, Lieve Wierinck

Date tabled

24.9.2018


FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

40

+

ALDE

Catherine Bearder, Carolina Punset, Lieve Wierinck

ECR

Arne Gericke, Bolesław G. Piecha

EFDD

Eleonora Evi, Piernicola Pedicini

PEE

Angélique Delahaye, José Inácio Faria, Santiago Fisas Ayxelà, Elisabetta Gardini, Jens Gieseke, Françoise Grossetête, Giovanni La Via, Peter Liese, Annie Schreijer-Pierik, Renate Sommer, Adina-Ioana Vălean

S&D

Inés Ayala Sender, Simona Bonafè, Paul Brannen, Soledad Cabezón Ruiz, Nessa Childers, Miriam Dalli, Seb Dance, Jytte Guteland, Karin Kadenbach, Jo Leinen, Rory Palmer, Massimo Paolucci, Gilles Pargneaux, Tonino Picula, Inmaculada Rodríguez-Piñero Fernández, Tiemo Wölken, Damiano Zoffoli

VERTS/ALE

Marco Affronte, Margrete Auken, Linnéa Engström, Davor Škrlec, Bart Staes

3

-

ENF

Sylvie Goddyn, Jean-François Jalkh, Joëlle Mélin

2

0

ECR

Urszula Krupa, John Procter

Key to symbols:

+  :  in favour

-  :  against

0  :  abstention

Last updated: 25 September 2018Legal notice