Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)) 1 1
Date: 2018-10-03
Institutions: Committee on Economic and Monetary Affairs, Committee on Employment and Social Affairs, Committee on Industry, Research and Energy, Committee on Legal Affairs, Committee on Women’s Rights and Gender Equality, Committee on the Environment, Climate and Food Safety, Committee on the Internal Market and Consumer Protection, European Parliament
Subjects: cross-border cooperation, exchange of information, health care, innovation, medical device, medical science, patient's rights, public health, scientific cooperation, technology assessment




C_2020011EN.01009401.xml










13.1.2020   


EN


Official Journal of the European Union


C 11/94






P8_TA(2018)0369
Health technology assessment***I
Amendments adopted by the European Parliament on 3 October 2018 on the proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU (COM(2018)0051 – C8-0024/2018 – 2018/0018(COD)) (1)

(Ordinary legislative procedure: first reading)
(2020/C 011/23)

Amendment 1


Proposal for a regulation


Citation 1









Text proposed by the Commission



 



Amendment





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


 


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





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

 (2)

highlighted that there are many barriers to access to medicine and innovative technologies in the Union, with the main barriers being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value.










 


 






Amendment 5


Proposal for a regulation


Recital 1 c (new)









Text proposed by the Commission



 



Amendment





 


 










(1c)






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











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/EU of the European Parliament and of the Council

 (3), 
and through three
 joint actions, 
each with specific objectives and a specific budget: EUnetHTA 1, 2010 to 2012 (EUR 6 million); EUnetHTA 2, 2012 to 2015 (EUR 9,5 million); and EUnetHTA 3, launched in June 2016 with an end date of 2020 (EUR 20 million). Given the timescales for those actions and in the interests of continuity, this Regulation establishes a more sustainable way of ensuring the continuation of the
 joint assessments. 
The main outcomes of the cooperation to date include the ‘HTA Core Model’ assessment model, which provides a framework for HTA reports; a database for sharing projects that are planned, ongoing or recently published by individual agencies (POP database); a data- and knowledge base for the storage of information and the stage reached in the assessment of promising technologies, or
 on the 
request for supplementary studies arising from the HTA; and a set of methodological guides and support tools for HTA agencies, including guidelines for adapting reports from one country to another
.








 


 






Amendment 16


Proposal for a regulation


Recital 6 a (new)









Text proposed by the Commission



 



Amendment





 


 










(6a)






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











Amendment 17


Proposal for a regulation


Recital 7









Text proposed by the Commission



 



Amendment











(7)




The Council
 in its Conclusions of December 2014 (4) acknowledged the key role of health technology assessment 
and
 called on the Commission to continue to support cooperation in a sustainable manner.






 








(7)


In its Conclusions of December 2014 
on innovation for the benefit of patients

 (5), 
the Council
 acknowledged the key role of health technology assessment 
as a health policy tool to support evidence-based, sustainable and equitable choices in health care and health technologies for the benefit of patients. The Council further
 called on the Commission to continue to support cooperation in a sustainable manner, 
and asked for joint work between Member States on HTA to be enhanced and for opportunities for cooperation on exchange of information between competent bodies to be explored
. 
In addition, in its Conclusions of December 2015 on personalised medicine for patients, the Council invited Member States and the Commission to strengthen HTA methodologies applicable to personalised medicine, and the Council Conclusions of June 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States provided further evidence that Member States see clear added value in cooperation on HTA. The joint report of October 2016 of the Commission's DG for Economic and Financial Affairs and the Economic Policy Committee further called for enhanced European cooperation on HTA.











 






Amendment 18


Proposal for a regulation


Recital 8









Text proposed by the Commission



 



Amendment











(8)


The European Parliament, in its resolution of 2 March 2017 on EU options for improving access to medicines, (6) called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value 
of medicines
.






 








(8)


The European Parliament, in its resolution of 2 March 2017 (7) on EU options for improving access to medicines, called on the Commission to propose legislation on a European system for health technology assessment as soon as possible and to harmonise transparent health technology assessment criteria in order to assess the added therapeutic value 
and relative effectiveness of health technologies compared with the best available alternative that takes into account the level of innovation and benefit for patients
.









 






Amendment 19


Proposal for a regulation


Recital 10









Text proposed by the Commission



 



Amendment











(10)


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






 








(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, (8) which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (9)

which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint
 clinical 
assessment should be made based on specific criteria
.






 








(12)


In order to ensure a wide application of harmonised rules 
and to foster collaboration among Member States
 on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, 
thereby reducing waste and ineffectiveness in healthcare
, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council (10), which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council (11), 
given the need for greater
 clinical 
evidence concerning all of those new health technologies
.









 






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

 (12)

for completing the centralised procedure for authorising medicines and the CE conformity marking
 for medical devices 
provided for in Regulation (EU) 2017/745 of the European Parliament and of the Council

 (*1)

and the CE conformity marking for in vitro diagnostic medical devices provided for in Regulation (EU) 2017/746 of the European Parliament and of the Council

 (*2). 
In any event, those assessments must take into account
 the availability of appropriate 
scientific
 evidence 
and supporting data in the quantity
 required to carry out a joint clinical assessment, 
and
 should take place 
in a time-frame as close as possible to their marketing authorisation, in the case of medicines, and, in any case, without unjustified and unnecessary delay.










 


 






Amendment 31


Proposal for a regulation


Recital 19









Text proposed by the Commission



 



Amendment











(19)


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








 








(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 Council (14).









 






Amendment 46


Proposal for a regulation


Recital 25 a (new)









Text proposed by the Commission



 



Amendment





 


 









(25a)




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










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.

 (15)

In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council should receive all documents at the same time as Member States' experts, and their experts systematically should be granted access to meetings of Commission expert groups dealing with the preparation of delegated acts.








 








(26)


The Commission 
should adopt implementing acts on procedural rules for the joint
 clinical assessments, joint scientific consultations, and for selecting stakeholders.









 


 





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 202


Proposal for a regulation


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









Text proposed by the Commission



 



Amendment





 


 










(gb)






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











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 203


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 
qualified
 majority.


Procedures undertaken by the Coordination Group shall be transparent with meeting minutes and votes documented and made publicly available, including any dissensions.








Amendment 68


Proposal for a regulation


Article 3 – paragraph 4









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) 2017/746 (16) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation.






 








(c)



in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 (17) for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation 
and considered to be a significant innovation and with potential significant impact on public health or health care systems
.









 






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

 (1).




 


 






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 205


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 shall 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 206


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 
qualified
 majority of Member States.


Diverging positions and the grounds on which those positions are based shall be recorded in the final report.




The final report shall include a sensitivity analysis if there is one or more of the following elements:









(a)





different opinions on the studies to be excluded on the grounds of severe bias;













(b)





diverging positions if studies shall be excluded as they do not reflect the up-to-date technological development; or













(c)





controversies as to the definition of irrelevance thresholds regarding patient-relevant endpoints.








The choice of the one or more comparators and patient-relevant endpoints shall be medically justified and documented in the final report.




The final report shall also include the results of the joint scientific consultation carried out in accordance with Article 13. The scientific consultation reports shall be made public upon completion of the joint clinical assessments.








Amendment 98


Proposal for a regulation


Article 6 – paragraph 13









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







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 207


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 
qualified
 majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.






Amendment 135


Proposal for a regulation


Article 14 – paragraph 2









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 208/rev


Proposal for a regulation


Article 22 – paragraph 1 a (new)









Text proposed by the Commission



 



Amendment





 


 





1a.
   
Within [6 months] from the date of entry into force of this Regulation, the Coordination Group shall draw up a draft implementing regulation concerning the methodologies to be consistently used to carry out joint clinical assessments and consultations and shall define the content of those assessments and consultations. The methodologies shall be developed on the basis of the existing EUnetHTA methodological guidelines and evidence submission templates. In any case, the methodologies shall comply with the following criteria:









(a)





the methodologies are based on high standards of quality, the best available scientific evidence, stemming, where practically feasible and ethically justifiable, primarily from double-blind randomised clinical trials, meta-analysis and systematic reviews;













(b)





the assessments of relative effectiveness are based on end-points which are relevant to the patient with useful, relevant, tangible and specific criteria suited to the clinical situation concerned;













(c)





the methodologies take into account the specificities of new procedures and certain types of medicinal products with less clinical evidence available at the time of the marketing authorisation (such as orphan medicinal products or conditional marketing authorisations). However, any such lack of evidence does not prevent the generation of additional evidence required to be post monitored and which may require post-assessment and shall not affect patients security or scientific quality;













(d)





the comparators are the reference comparators for the clinical entity concerned and the best and/or most commonly used technological or process based comparator;













(e)





for medicinal products, the technology developers, for the purpose of clinical assessment, provide the coordination group with the dossier in eCTD format submitted to the European Medicines Agency for centralised authorisation. That dossier shall include the clinical study report;













(f)





the information to be provided by the health technology developer relates to the most up-to-date and public data. Failure to comply with that requirement may trigger a penalty mechanism;













(g)





clinical trials are the studies par excellence in the biomedical field, so the use of another type of study, for example, epidemiological studies, may be carried out in exceptional cases and shall be fully justified;











 


 









(h)





common methods as well as data requirements and outcome measures take into account the specificities of medical devices and in vitro diagnostic medical devices;













(i)





regarding vaccines, the methodology takes into account the lifelong effect of a vaccine through an appropriate time horizon of the analyses; indirect effects such as herd immunity; and elements independent from the vaccine as such, for example coverage rates linked to programmes;













(j)





where practically feasible and ethically justifiable, the health technology developer conducts at least one randomised controlled clinical trial, comparing its health technology in terms of clinically relevant outcomes with an active comparator considered among the best current proven intervention at the time the trial was designed (standard treatment), or the most common intervention when no standard treatment exists. The technology developer shall provide the data and results of conducted comparative trials in the documentation dossier submitted for the joint clinical assessment.








In the case of a medical device, the methodology shall be adapted to its characteristics and specificities, taking as a basis the methodology already developed by EUnetHTA.




The Coordination Group shall submit the draft implementing regulation to the Commission for endorsement.




Within [3 months] of receipt of the draft measure, the Commission shall decide whether to endorse it by means of an implementing act adopted in accordance with the examination procedure referred to in Article 30(2).




Where the Commission intends not to endorse a draft measure or to endorse it in part or where it proposes amendments, it shall send the draft back to the Coordination Group, setting out the reasons. Within a period of [six weeks], the Coordination Group may amend the draft measure on the basis of the Commission’s indications and proposed amendments, and resubmit it to the Commission.




If, on the expiry of the [six-week period], the Coordination Group has not submitted an amended draft measure, or has submitted a draft measure that is not amended in a way consistent with the Commission’s proposed amendments, the Commission may adopt the implementing regulation with the amendments it considers relevant or reject it.




In the event that the Coordination Group does not submit a draft measure to the Commission within the time limit in accordance with [paragraph 1], the Commission may adopt the implementing regulation without a draft having been submitted from the Coordination Group.







Amendment 162


Proposal for a regulation


Article 23 – paragraph 1 – introductory part









Text proposed by the Commission



 



Amendment





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


 


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





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
Exercise of the Delegation



1.
   
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.






2.
   
The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from … [insert date of entry into force of this Regulation].






3.
   
The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.






4.
   
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.






5.
   
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.






6.
   
A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.






 




deleted







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.






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.









(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0289/2018).

(2)  

OJ C 263, 25.7.2018, p. 4

.

(3)  
Directive 2011/24/EU of 9 March 2011 of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).



(4)  OJ C 438, 6.12.2014, p. 12.

(5)  OJ C 438, 6.12.2014, p. 12.

(6)  European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).

(7)  European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 2016/2057(INI).

(8)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(9)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(10)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(11)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).

(12)  
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).



(*1)  
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).



(*2)  
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).



(13)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(14)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(15)  
Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission of 13 April 2016 on Better Law-Making (OJ L 123, 12.5.2016, p. 1).



(16)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

(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).

(1)  
Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).