EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 31.1.2018  
COM(2018) 51 final  
2018/0018 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on health technology assessment and amending Directive 2011/24/EU  
(Text with EEA relevance)  
{SWD(2018)  41 final} - {SWD(2018)  42 final}    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
Health technology assessment (HTA) is a multidisciplinary process that summarises 
information about the medical, social, economic and ethical issues related to the use 
of a health technology in a systematic, transparent, unbiased and robust manner. Its 
aim is to inform the formulation of safe and effective health policies that are patient 
focused and see k to achieve best value. The term "health technology” is to be 
understood in a broad sense comprising medicinal products, a medical device or 
medical and surgical procedures as well as measures for disease prevention, 
diagnosis or treatment used in healthc are. 
HTA is thus an evidence -based process that independently and objectively assesses a 
new or existing technology and compares it with other health technologies and / or 
the current standard of care. HTA is primarily used to inform decision -making in 
Mem ber States by providing a scientific evidence base for decisions on the pricing 
and reimbursement of health technologies. HTA can cover different aspects 
(domains) ranging from clinical domains (e.g. safety, clinical effectiveness) to non -
clinical domains (e.g. economic, ethical, organisational). This proposal focuses on 
clinical assessments which are typically based on global evidence (e.g. worldwide 
clinical trials in the case of medicinal products and multi -national clinical trials for 
medical devices) c ompared with non -clinical assessments which include domains 
that are often more sensitive to national / regional contexts.  
At EU level, cooperation on HTA has been ongoing since the 1980s. To support 
cooperation between HTA bodies, the European Union has m ade substantial 
investments. Two Joint Actions (EUnetHTA JA) have been carried out together with 
a number of projects. A third Joint Action (EUnetHTA Joint Action 3) was launched 
in June 2016 and runs until 2020 with a total budget of EUR 20 million. Parti cipation 
in the Joint Actions has been very high, including participation from all EU Member 
States. The third Joint Action focuses on developing common assessment 
methodologies, piloting and producing joint clinical assessments and full HTA 
reports, and o n developing and maintaining common ICT tools. In addition, 
following the adoption of the Cross -Border Healthcare Directive (Directive 
2011/24/EU), the HTA Network was established in 2013 to provide strategic and 
political guidance to the scientific and te chnical cooperation at Union -level.  
 Reasons for and objectives of the proposal  
Despite the achievements of the current EU cooperation, a number of problems 
have been identified, which cannot be sufficiently addressed by continued 
project -based voluntary co operation on HTA.  
Problem 1. Impeded and distorted market access  
The different national processes and methodologies of national and regional 
HTA bodies mean that health technology developers who want to introduce a 
health technology in multiple Member Sta tes are confronted with various data 
and evidence requests. This in turn contributes to impeded and distorted market 
access, leading to a lack of business predictability, higher costs, and, in the 
long run, negative effects on innovation. Differences in na tional processes and 
methodologies also lead to differences in how evidence is considered in  
EN 2  EN assessments, which can contribute to delays and inequalities in availabilities of 
innovative health technologies for patients.  
Problem 2. Duplication of work for n ational HTA bodies  
Clinical assessments of the same technologies are being conducted in parallel 
or within a similar time -frame by HTA bodies in different Member States, 
resulting in duplication of work and inefficient use of resources. In addition, 
the current low levels of  use at national level of the joint clinical assessments 
produced through the Union -level cooperation result in duplication and incur 
additional work and costs. The duplication may be associated with different 
outcomes/conclusions, which negatively affect business predictability and 
contribute to delays and inequalities in availabilities to patients of the most 
innovative health technologies.  
Problem 3. Unsustainability of HTA cooperation  
The current Union -level cooperation on HTA is project -based. This me ans its 
funding is short -term, needs to be secured and renegotiated in every financial 
cycle, and there is no guarantee for the continuation of activities in the long -
term. During the initiation and closing of each such large -scale project, 
substantial tim e and resources are spent on organisational issues leading to 
disruption in the output of the scientific cooperation.  
With regard to the problems identified, the objectives of the current proposal 
are the following:  
General objectives:  
– Ensure a better fun ctioning of the internal market;  
– Contribute to a high level of human health protection.  
Specific objectives:  
– Improve the availability of innovative health technologies for EU 
patients;  
– Ensure efficient use of resources and strengthen the quality of HTA 
across the EU;  
– Improve business predictability.  
Operational objectives:  
– Promote convergence in HTA tools, procedures and methodologies;  
– Reduce duplication of efforts for HTA bodies and industry;  
– Ensure the use of joint outputs in Member States;  
– Ensure the lon g-term sustainability of EU HTA cooperation.  
 Consistency with existing policy provisions in the policy area  
Currently the Union -level HTA cooperation is facilitated through Article 15 of 
the Cross -Border Healthcare Directive (Directive 2011/24/EU). This Directive 
provides for the establishment of a network of Member States' HTA authorities 
and bodies to facilita te cooperation and the exchange of scientific information 
among Member States. The objectives of the HTA Network are, inter alia,  to 
support cooperation between national HTA bodies, support the provision and  
EN 3  EN exchange between Member States of information on  the relative efficacy of 
health technologies and to avoid duplication of assessments. The network thus 
provides a strategic steer to the scientific cooperation carried out under it and 
through the EU -funded initiatives described above (i.e. the Joint Acti ons).  
This proposal incorporates the provisions of Article 15 of Directive 
2011/24/EU and builds upon these through reinforced cooperation at Union -
level. The proposal thus deletes Article 15 of that Directive. The definition of 
'health technology' used i n Directive 2011/24/EU is also used in this proposal, 
ensuring a consistent approach across the two texts.  
 Consistency with other Union policies  
The proposal is in line with the EU's overarching objectives, including a 
smooth functioning of the internal ma rket, sustainable health systems, and an 
ambitious research and innovation agenda. In addition to coherence with these 
EU policy objectives, the proposal is also consistent with and complementary 
to existing EU legislation related to medicinal products and  medical devices1. 
For example, while the regulatory process and the HTA process will remain 
well separated as they have different purposes, there are opportunities to create 
synergies, through mutual information -sharing and better alignment of the 
timing of procedures between the proposed joint clinical assessments and the 
centralised marketing authorisation for medicinal products2. Synergies are also 
expected between joint clinical assessments of medical devices and some of the 
provisions in the new EU Re gulations for medical devices and in vitro  
diagnostics (e.g. strengthened rules on clinical evaluation and clinical 
investigation; EU -level expert panels for high -risk medical devices).  
Given the recent entry into force of the new Regulations on medical d evices, 
their on -going implementation, and the impact of this on medical device 
authorities and manufacturers, a coherent approach has been taken to ensure 
that the implementation of the provisions in this proposal will be phased in, to 
avoid overlapping t imelines and to ensure that the implementation of both sets 
of legislation meet their respective objectives without creating uncertainty or 
undue administrative burden in the sector.  
Moreover, the joint scientific consultations provided for by this propos al, 
through which advice can be given to health technology developers in the 
development phase of a technology, will contribute to the objectives of related 
EU legislation on clinical trials to ensure that the evidence generated in clinical 
studies is robu st and benefits patients and public health.  
In addition, the proposal will provide useful input to and synergies with the EU 
Digital Single Market agenda by encouraging innovation and research of high -
tech health technologies, facilitate information shari ng on registries of real 
world evidence, and by supporting the development of a Union -level IT 
infrastructure supporting EU cooperation on HTA.  
                                                 
1 Relevant legislation includes Directive 2001/83/EC, Regulation (EC) No 726/2004), Regulation (EU) 
536/2014, Regulation (EU) 2017/745 and Regulation (EU) 2017/746.  
2 Note that the need for improved synergies has been recognised by Member States in the HTA Network 
Reflection Paper "Synergies between regulatory and HTA issues on pharmaceuticals" as well as by 
EUnetHTA and EMA in their joint "Report on the implementation of the EMA -EUnetHTA  three -year 
work plan 2012 -2015".   
EN 4  EN 2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
 Legal basis  
The proposal is based on Article 114 of the Treaty  on the Functioning of the 
European Union (TFEU).  
Article 114 TFEU allows for the adoption of measures for the approximation of 
the provisions laid down by law, regulation or administrative action in the 
Member States, provided they are necessary for the establishment or 
functioning of the internal market, whilst at the same time ensuring a high level 
of public health protection. Article 114 TFEU provides an appropriate legal 
basis given the objectives of the proposal, namely to remove some of the 
existing  divergences in the internal market for health technologies caused by 
procedural and methodological differences in clinical assessments carried out 
in Member States along with the considerable duplication of such assessments 
across the EU.  
In line with Article 114(3) (TFEU), a high level of human health protection has 
been considered in the preparation of the proposal which is expected to 
improve the availability of innovative health technologies for EU patients.  
 Subsidiarity (for non -exclu sive competence)  
The diversity and multitude of approaches to clinical assessments across the 
Member States means that, due to their scale and effect, only action at Union -
level can eliminate the obstacles described. Without action at EU -level it is 
unlik ely that national rules on how HTAs are carried out would be further 
aligned and thus the current fragmentation of the internal market would persist.  
While the on -going cooperation, namely the Joint Actions and the HTA 
Network, has illustrated benefits of EU cooperation, in terms of establishing 
the professional network, the tools and methodologies for cooperation and 
piloting joint assessments, this cooperation model has not contributed to the 
removal of the fragmentation of national systems and the duplic ation of efforts.  
The impact assessment report accompanying this proposal identified a 
distinction between clinical assessments where there is considerable scope for 
alignment in the Member States' procedures for carrying out such assessments, 
assessment methods and the types of data requested and non -clinical 
assessments which focus more on domains (e.g. economic, organisational, 
ethical) which are linked more to national contexts, and which are closer to the 
final decisions on pricing and reimbursement w hich remain strictly in the 
hands of Member States. By thus focusing on clinical assessments, the 
proposal targets the domains of HTA where EU added value is considered to 
be strongest.  
The aims of this initiative cannot therefore be achieved sufficiently  without 
strengthened HTA cooperation at EU -level.  
 Proportionality  
The proposal constitutes a proportionate and necessary response to addressing 
the problems described in section 1. In particular, the proposed requirement of 
not repeating at national level  joint clinical assessments performed at Union -
level and the nature of the joint clinical assessment, which will be limited to 
the assessment of the evidence, is necessary to reduce duplication and avoid  
EN 5  EN discrepancies. At the same time, the proposal will a void any interference with 
Member States competences in decisions concerning access to the health 
technologies assessed at Union -level. By focusing the joint work on clinical 
aspects of HTA, where EU cooperation can bring both quality and efficiency 
gains,  the proposal does not go beyond what is necessary. The assessment of 
more context -specific HTA domains (e.g. economic, organisational, ethical) 
and decision -making on pricing and reimbursement remain at Member State -
level.  
By reducing the current duplicat ion and fragmentation, the proposal will 
optimise resources in Member States and also reduce the administrative burden 
for health technology developers currently undergoing assessments on the 
same health technology in multiple national systems.  
The propos al is proportionate in that it limits the scope of joint work to specific 
types of medicinal products and medical devices and allows flexibility 
concerning the timing of joint clinical assessments for medical devices. This 
takes into account the difference s between medicinal product and medical 
device sectors and their market access pathways. By focusing on the type of 
health technologies where current duplication of work among HTA bodies is 
most prominent and the benefit of joint assessment is strongest th e proposal 
brings clear added value.  
The proportionality of the proposal is also well reflected in the approach 
adopted for medical devices. The proposal does not introduce any new 
requirements on health technology developers when these are not already se t 
out in national legislation. On the other hand, the proposal will ensure that 
when HTA is performed, the methodologies and procedures applied are more 
predictable across the EU and when subject to joint clinical assessment such 
assessments are not repeat ed, avoiding duplication and discrepancies.  
Finally, the proposal respects the principle of proportionality by allowing 
sufficient time for both Member States and industry to adapt to the new EU 
system through a phase -in approach for the number of assessme nts carried out 
at Union -level and a transitional period for Member State participation.  
 Choice of the instrument  
The proposal takes the form of a new Regulation. This type of instrument is 
considered to be the most suitable considering that a key element  of the 
proposal is the establishment of procedures and structures for cooperation on 
joint work at Union -level. While inevitably such a transition to a Union -wide 
approach will require some adjustments to national rules, for example, as 
regards allowing f or the use of joint clinical assessments at national level as 
part of the overall HTA, that transition does not result in a need for significant 
implementing measures establishing those procedures and structures at national 
level.  
In addition, the majority  of detailed national rules on how HTA is actually 
carried out are contained in the administrative provisions of Member States’ 
HTA bodies rather than in national legislation. This suggests that a suitable 
adaptation period before the date of application o f a Regulation would be a 
more adequate and proportionate approach than the transposition needed for a  
EN 6  EN Directive, in ensuring use of joint clinical assessments and common rules at 
national level.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
 Stakeholder  consultations  
Extensive consultation with stakeholders took place in the preparation of this 
proposal. In order to reach all interested stakeholders and to ensure a high 
quality and balanced input, a combination of consu ltation methods was used:  
 Besides the feedback received in response to the publication of the 
Inception Impact Assessment, the Commission held a broad online public 
consultation  between October 2016 and January 2017. In addition, 
position statements from different interest groups were received by 
email;  
 Bilateral meetings with interested stakeholder representatives were 
organised throughout the preparation phase to allow in -depth  discussion 
on specific topics and the expression of non -organised interests;3 
 Consultation of experts was carried out through the existing cooperation 
mechanisms, EUnetHTA Joint Action 3 and the HTA Network. 
Presentations at external events were used to r each out to stakeholders, to 
explain the main elements of the initiative, to invite them to participate in 
the public consultation, and listen to their views and opinions.  
A large majority of stakeholders emphasised that EU cooperation beyond 2020 
is need ed to ensure a constant exchange of information and knowledge 
between HTA institutions in Europe, to increase synergies between Member 
States, to streamline HTA methodologies, to increase transparency and 
evidence -based decision -making, as well as to ensur e business predictability. 
The possibility to access a larger number of HTA reports with less duplication 
of work and better allocation of resources by HTA bodies was highlighted.  
While all representatives of public administrations are in favour of contin uing 
EU cooperation on HTA beyond 2020, some indicated a preference for 
voluntary cooperation while others supported a system with mandatory 
elements (i.e. a legal framework for EU cooperation on HTA to streamline 
interoperability of HTA national systems).  Most contributors highlighted that 
in case of a mandatory system, use of joint work should be limited to clinical 
and technical matters, whereas assessment of non -clinical domains (e.g. 
economic, legal, ethical) should be carried out individually or joint ly by 
interested Member States/HTA bodies on a voluntary basis. The idea of 
progressive implementation was also raised.  
Citizens, patients and consumers representatives, as well as healthcare 
providers and academia were extremely positive, with most of th em in favour 
of a collaboration covering both the clinical and economic parts of 
assessments. They underlined the need for involving patients and healthcare 
professionals in the HTA process, the need for transparency (e.g. making the 
summaries of HTA repor ts publicly available, including criteria and rationale 
                                                 
3 https://ec.europa.eu/health/technology_assessment/events_en#anchor3   
EN 7  EN for evaluation), and the need to ensure the independence of HTA bodies from 
industry and other interests.  
As regards health technology developers, the pharmaceutical industry and their 
trade associati ons supported the harmonisation of clinical assessments at the 
time of the launch of their health technologies. It was stressed that the 
economic part of assessments should remain the responsibility of Member 
States. Medical device manufacturers and their trade associations reiterated the 
importance of taking into account the particularities of their sector and the need 
for a Member State -driven approach. It was underlined that HTA should focus 
on products that are innovative and address high unmet patient needs in disease 
areas where appropriate clinical and economic evidence has been or can be 
generated (e.g. transformative in vitro  diagnostics and medical devices).  
 Collection and use of expertise  
In addition to the extensive stakeholder consultation descr ibed in previous 
sections, the following three external studies were conducted to support 
assessing the impacts of this initiative:  
– Mapping of HTA National Organisations, Programmes and Processes in 
EU and Norway. 2017, Contract No. 17010402/2016/734820  
– Mapping of HTA Methodologies in EU and Norway. 2017, DG SANTE 
Contract No. 17010402/2016/736040  
– Study on Impact Analysis of Policy Options for Strengthened EU 
Cooperation on HTA. 2017. Sogeti, Austrian Public Health Institute, 
London School of Economics. ( CHAFEA/2016/Health/16)  
The Commission has also used and benefitted from, the vast pool of expertise 
available in the HTA Network and EUnetHTA Joint Action 3.  
 Impact assessment  
The impact assessment report4 provides an in -depth analysis of four policy 
options: No Joint Actions after 2020 (policy option 1, baseline scenario); 
Project -based cooperation on HTA activities (policy option 2); Permanent 
cooperation on common tools, procedures and early dialogues (policy option 
3); and Permanent cooperation on comm on tools, procedures, early dialogues 
and joint clinical assessments (policy option 4). Based on this analysis, the 
impact assessment report presents a preferred policy option, which has 
provided the basis for the contents of this proposal (see section 8 o f Impact 
Assessment). This preferred option builds primarily on policy option 4, but 
also integrates elements of policy option 2 as well as some adjustments (e.g. 
transitional arrangements for Member States and progressive implementation 
of the product sco pe for joint clinical assessments).  
As described in more detail in the impact assessment report, the preferred 
option is considered to provide for the best combination of effectiveness and 
efficiency in reaching the policy objectives, while also respecting  the principles 
of subsidiarity and proportionality. It allows for the best possible achievement 
of the internal market objectives by promoting convergence in procedures and 
                                                 
4 http://ec.europa.eu/smart -
regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf   
EN 8  EN methodologies, reducing duplication (e.g. of clinical assessments) and 
therefore t he risk of divergent outcomes, thus contributing to improving the 
availability of innovative health technologies for patients. Moreover, it 
provides Member States with a sustainable framework, allowing them to pool 
expertise, reinforce evidence -based decis ion-making, and supporting them in 
their efforts to ensure the sustainability of national health systems. The 
preferred option is also cost efficient in the sense that the costs are significantly 
outweighed by savings for Member States and industry, as a r esult of pooling 
of resources, avoiding duplication and improving business predictability.  
The Regulatory Scrutiny Board gave its initial opinion on the impact 
assessment report on 27 October 2017 and asked for resubmission of a revised 
version. On 4 Decem ber 2017, the Regulatory Scrutiny Board delivered its 
second opinion (positive with reservations), indicating a number of points 
where further changes to the report were needed. The necessary changes have 
been made in the final version of the report. In pa rticular, the final version of 
the report provides further clarifications on the proportionality of the preferred 
option and describes in more detail the rationale for and implications of 
mandatory use of the joint work. Further details are also provided o n how 
views expressed by Member States have been taken into account in the 
preferred option. Finally, the report describes in more detail how possible risks 
and implementation challenges are addressed by the preferred option.  
 Regulatory fitness and simplif ication  
The proposal is relevant for small and medium -sized enterprises (SMEs), 
which are particularly prominent in the medical device sector. However, no 
specific provisions are foreseen for micro -enterprises, as these are not expected 
to play a major rol e in bringing new health technologies to the market. The 
proposal is expected to benefit SMEs by reducing the current administrative 
burden and compliance costs linked to submissions of multiple dossiers to meet 
different national HTA requirements. In part icular, joint clinical assessments 
and joint scientific consultations foreseen by the proposal would increase 
business predictability for industry. This is particularly relevant for SMEs, as 
they tend to have a smaller product portfolios and more limited d edicated 
resources and capacities for HTA. Of note, the proposal does not provide for 
fees for joint clinical assessments or joint scientific consultations. Improved 
business predictability due to joint work on HTA across the EU is expected to 
positively i mpact on the competitiveness of the EU health technology sector.  
The IT infrastructure foreseen by the proposal relies on standard IT tools (e.g. 
for databases, document exchange, internet -based publication), building on 
tools that have already been develo ped by the EUnetHTA Joint Actions.  
 Fundamental rights  
The proposal has limited consequences for the protection of fundamental 
rights. Where personal data is processed to fulfil the provisions of the proposal 
this will be done in line with the relevant Unio n legislation on personal data 
protection. The proposal contributes to achieving a high level of human health 
protection and is thus consistent with the Charter of Fundamental Rights in this 
regard.   
EN 9  EN 4. BUDGETARY  IMPLICATIONS  
The implementation of this pro posal has no impact on the current Multiannual 
Financial Framework 2014 -2020 as the current cooperation on HTA is financed by 
the Public Health Programme. The financial impact on the EU budget post -2020 will 
be part of the Commission's proposals for the ne xt Multiannual Financial 
Framework.  
The budgetary implications are mainly related to the support framework provided for 
in this proposal, namely a central secretariat hosted by the European Commission, 
which will provide:  
– administrative support (e.g. organ isation of meetings, travel arrangements etc.) 
to the Coordination Group and its sub -groups including HTA experts 
nominated by the Member States' authorities who will carry out the joint work 
(e.g. joint clinical assessments, joint scientific consultations , studies on 
emerging health technologies, and provide expertise for the development and 
update of common rules and methodologies);  
– scientific support (e.g. advice for the meetings of the coordination group and 
sub-groups, preparation of the documentation , manage procedures for 
involving stakeholders, ensure quality management including scientific 
scrutiny of reports and support the implementation of the joint work etc.);  
– IT support (e.g. establish, host, and maintain an IT platform, including 
databases/re positories of joint and national HTA reports, secure 
communication etc.).  
The proposal foresees remuneration in the form of special allowance to Member 
States' HTA bodies carrying out the joint work as assessors and co -assessors and 
travel expenses for Me mber State experts contributing to the activities of the 
coordination group and its sub -groups.  
In-kind contribution from the Member States is foreseen in the form of seconded 
national experts5 to the central secretariat and by national experts who will 
participate in the meetings and contribute to the activities of the Coordination Group 
and relevant sub -groups (e.g. on joint clinical assessments and joint scientific 
consultations).  
5. OTHER  ELEMENTS  
 Implementation plans and monitoring, evaluation and repo rting 
arrangements  
The proposal provides for regular Commission monitoring and reporting on the 
implementation of the proposed Regulation starting, at the latest, one year after 
its date of application. To facilitate monitoring and reporting, Members State s 
would be required to provide the Commission with the information necessary 
for the monitoring programme which will also benefit from the annual reports 
of the Coordination Group which will summarise the outputs of the joint work. 
                                                 
5 Seconded national experts are national civil servants or persons employed in the public sector who are 
working temporarily for an EU Institution. They remain in the service of that employer throughout the 
period of secondment and receive a daily allowance from the European Commission in line with the  
provisions in the Staff Regulation.   
EN 10  EN The Commission will also  carry out a formal evaluation of the Regulation and 
report on the conclusions of this evaluation.  
An obligation is also placed on the Commission to report specifically on the 
implementation of the scope of the joint clinical assessments and support 
framew ork no later than five years after the date of application. This will allow 
the Commission to consider whether the proposed Regulation ensures that the 
most innovative health technologies are being assessed, taking into account 
technological developments i n the sector. The report will also allow for an 
assessment of whether the support framework provided by the Commission 
continues to provide the most efficient and cost -effective governance 
mechanism for the joint work.  
The proposal would place on the Comm ission an obligation to verify the joint 
clinical assessment reports prior to their publication. This will allow the 
Commission to ensure that the reports have been prepared in accordance with 
the requirements proposed and help to build trust in the system . The 
Commission will also monitor both the implementation of the common rules 
and the use of the joint work at Member State -level. In order to facilitate this 
task and also allow for the exchange of information between Member States, 
the proposal provides  for specific reporting obligations on the Member States 
where they use joint clinical assessment reports at Member State -level and 
where they carry out clinical assessments based on the common rules.  
In addition, monitoring and evaluation of the specific  objectives will use 
several means of data collection, including a number of quantitative indicators 
to assess effectiveness, as outlined in section 9 of the Impact Assessment 
Report, evaluation of the wider impacts will also require a number of 
qualitativ e tools such as desk research, surveys, focus groups and Delphi 
surveys.  
 Detailed explanation of the specific provisions of the proposal  
The proposal consists of five chapters comprising a total of 36 articles.  
Chapter I – General provisions  
This chapter outlines the subject matter of the proposal and defines the key 
terms used in the proposed Regulation. To ensure consistency with other Union 
legislation, the definitions of 'medicinal product', 'medical device', and 'health 
technology' in the  proposal are aligned with those applied in Directive 
2001/83/EC, Regulation (EU) No 2017/745, and Directive 2011/24/EU 
respectively. The Member State Coordination Group on Health Technology 
Assessment (the Coordination Group) is formally established in Ar ticle 3 along 
with its composition, roles and responsibilities to oversee the joint work 
referred to in Chapter II.  
The Coordination Group will be Member State -led and manage the overall 
governance of the joint work. The Group will meet regularly to provi de 
guidance and steer the cooperation. Under the authority of the Coordination 
Group, a number of sub -groups consisting of experts nominated by Member 
States will carry out the joint work foreseen in this proposal. For example, for 
the joint clinical asses sments, Member States' HTA bodies acting as assessor 
and co -assessor will carry out the clinical assessment, prepare a draft report 
and consult relevant stakeholders. The Coordination Group will thereafter  
EN 11  EN approve the joint reports which will then be publi shed by the Commission and 
included in a list of health technologies having undergone joint clinical 
assessments.  
This joint work is based on the annual work programme of the Coordination 
Group which is outlined in Article 4 of the proposal. The annual wo rk 
programme provides clarity on the planned work of the Group and allows 
health technology developers to foresee any expected involvement they may 
have in the joint work for the year ahead.  
Chapter II - Joint work on health technology assessment at Union -level  
This chapter establishes the four pillars of the future cooperation between 
Member States at Union -level (the joint work) namely, joint clinical 
assessments, joint scientific consultations, the identification of emerging health 
technologies, and volu ntary cooperation. The work will be Member State -led 
through the Coordination Group.  
Section 1 - Joint clinical assessments  
The joint clinical assessments will be one of the main proponents of the future 
joint work and, following the end of the transitio nal period, participation in the 
assessments and use of the joint clinical assessment reports at Member State -
level will be mandatory. As described below, there will be a progressive phase -
in approach to the annual number of joint clinical assessments carr ied out 
during the transitional period.  
Scope  
Joint clinical assessments are limited to:  
 medicinal products undergoing the central marketing authorisation 
procedure, new active substances and existing products for which the 
marketing authorisation is exten ded to a new therapeutic indication; and  
 certain classes of medical devices and in vitro  diagnostic medical devices 
for which the relevant expert panels established in accordance with 
Regulations (EU) 2017/745 and 2017/746 have given their opinions or 
view s and which have been selected by the Coordination Group set up 
under this Regulation based on the following criteria:  
 unmet medical need;  
 potential impact on patients, public health, or healthcare systems 
(e.g. burden of disease, budget impact, transforma tive technology);  
 significant cross -border dimension;  
 Union -wide added value (e.g. relevance to a large number of 
Member States);  
 the resources available to it.  
This relatively limited scope and the selection criteria reflect the need to take a 
proportiona te approach concerning the type and amount of health technologies 
assessed at Union level. By focusing on the most innovative technologies and 
selecting those with the most Union -wide and public health impact, the EU 
added value of the assessments will be maximised.   
EN 12  EN The timing of the procedure for joint clinical assessments for medicinal 
products will be coordinated with that of the central marketing authorisation 
procedure (i.e. the joint clinical assessment report will be available at the time 
of or short ly after the final Commission Decision granting marketing 
authorisation), ensuring its timeliness for supporting Member States decision -
making at the time of market launch.  
Taking into account the more decentralised market access pathway for medical 
device s, the timing of the joint clinical assessment will not necessarily be 
aligned with the timing of the conformity assessment i.e. it will not always be 
at the time of market launch. Instead, the Coordination Group will consider the 
most appropriate time poi nt for a joint clinical assessment in line with the 
abovementioned selection criteria.  
The identified scope and phase -in approach take into account the current level 
of duplication among Member States' HTA bodies, the EU added value of a 
joint approach, a nd stakeholder views and concerns.  
Progressive implementation  
The proposal provides for progressive implementation of the amount of joint 
clinical assessments during the transitional period. This means that the number 
of joint clinical assessments will in crease gradually during the first three years 
after the date of application, taking into account specific selection criteria 
(same as those used permanently for medical devices, described above). The 
Coordination Group will select the health technologies b ased on these criteria 
and include them in the annual work programme. Following the end of the 
transitional period, all medicinal products falling within the scope and granted 
marketing authorisation in a given year will be assessed, while a selection of 
medical devices falling within the scope will undergo assessment.  
Preparation of joint clinical assessment reports  
The joint clinical assessments will cover the four assessment domains 
described in the definition of 'clinical assessment' in Chapter I. A st ep-by-step 
procedure on how the joint clinical assessment reports will be prepared is 
outlined in this section. Member States, through their HTA authorities and 
bodies, will be in the lead, selecting the assessor authority or body which will 
draft the repo rt providing support and comments throughout the drafting 
process, and approving the final reports. The selection of the assessors and co -
assessors will be a particularly important step in ensuring the quality of the 
report and the independence of the draf ting process and this selection will thus 
be made based on specific procedural rules to be developed in tertiary 
legislation. The health technology developer whose health technology is the 
subject of the report, as well as patients, clinical experts and ot her stakeholders 
will also be given opportunities to provide input in order to ensure a thorough, 
independent and transparent assessment process. Once verified by the 
Commission, the final reports will be published and then used by the Member 
States.  
The d etailed procedural rules for each step in the process will be further 
developed in tertiary legislation while the common rules and documentation 
developed in tertiary legislation for clinical assessments at Member State -level 
will also be used for joint cl inical assessments, ensuring a consistent approach  
EN 13  EN across national and Union -level clinical assessments. The development of the 
tertiary legislation will take as a basis the work on common procedures, 
methodologies and documents already being developed in the EUnetHTA Joint 
Action 3.  
Use of joint clinical assessment reports by Member States  
The proposal does not oblige Member States to carry out a HTA on health 
technologies which are the subject of joint clinical assessments. However, 
where Member States do carry out HTAs on such health technologies, there is 
a requirement for mandatory use o f the joint clinical assessment report and no 
repetition of the clinical assessment in Member States' overall HTA processes. 
This means that Member States will continue to carry out non -clinical 
assessments i.e. on the non -clinical HTA domains (e.g. econom ic, 
organisational, ethical) and will draw conclusions on the overall added value of 
the assessed health technology based on the joint clinical assessment report and 
their own non -clinical assessment.  
Section 2 - Joint scientific consultations  
The proposa l provides for the possibility for health technology developers to 
make a request to the Coordination Group for a joint scientific consultation. 
The joint scientific consultations, commonly referred to as 'early dialogues', 
allow a developer in the develop ment phase of a health technology to seek the 
advice of HTA authorities and bodies on the data and evidence likely to be 
required as part of a potential future joint clinical assessment. The 
Coordination Group will carry out an annual number of joint scien tific 
consultations based on its annual work programme, taking into account the 
resources available to it.  
The preparation of joint scientific consultation reports will mirror the approach 
taken for joint clinical assessments as described above. The main difference 
will be that the joint scientific consultation reports approved by the 
Coordination Group will be addressed to the health technology developer, will 
not be published, nor will they bind the developer or the Member States at the 
time of (joint) c linical assessment. To ensure transparency, information on the 
consultations will be included in the Coordination Group's annual reports.  
Section 3 - Emerging health technologies  
The joint work would also encompass an annual study to be carried out under 
the responsibility of the Coordination Group on the identification of emerging 
health technologies. This exercise, commonly referred to as 'horizon scanning', 
will act as a key inp ut for the annual work programmes, helping to ensure that 
the health technologies expected to have a major impact on patients, public 
health or healthcare systems are identified at an early stage in their 
development and are included in the joint work of t he Coordination Group. The 
proposal requires the Coordination Group to fully consult with all relevant 
interest groups during this exercise.  
Section 4 - Voluntary cooperation  
Under this section, the proposal provides for the possibility for Member States  
to continue to cooperate on a voluntary basis at Union -level. This voluntary 
cooperation would allow for HTA on health technologies other than medicinal 
products or medical devices, non -clinical assessments, collaborative  
EN 14  EN assessments on medical devices i. e. on medical devices not selected for joint 
clinical assessment, and cooperation on the provision of additional evidence 
which can facilitate HTA.  
Voluntary cooperation should take advantage of the outputs from research on 
HTA, such as methods for the us e of real world evidence to reduce the 
uncertainty on effectiveness, the evaluation of innovative technologies (e.g. 
'eHealth', personalised medicine) and the assessment of non -clinical domains 
(e.g. the impact of medical devices on the organisation of car e). 
This cooperation will benefit from the support framework set up under this 
proposal while participation in it and use of the results would be fully 
voluntary.  
Chapter III - Rules for clinical assessments  
This Chapter lays down common rules for carryin g out clinical assessments at 
Member State -level which will then be developed in detail in tertiary 
legislation. These rules will ensure a harmonised approach to clinical 
assessment across EU Member States. In the development of the rules, use will 
be made  of the tools already developed under the EUnetHTA Joint Actions as a 
base and the common rules will also be used for the joint clinical assessments 
at EU -level. An important part of these rules will be to ensure that clinical 
assessments, whether carried out at EU or Member State level, are done in an 
independent and transparent manner, free from conflicts of interest.  
Chapter IV - Support framework  
This chapter sets out the support framework which will support the joint work 
at EU -level. It provides for  its funding and support from the Commission 
acting as its secretariat and providing its IT infrastructure. A stakeholder 
network is also established under this chapter along with reporting and 
monitoring obligations placed on the Commission.  
The Commissi on will support the work of the Coordination Group and the sub -
groups, in particular by providing scientific, administrative and IT support (as 
described in detail in the section on budgetary implications).  
Chapter V - Final provisions  
This chapter outline s the timeline for the implementation of the Regulation. 
Following the entry into force, a three -year period before the date of 
application is proposed which will allow for the development and adoption of 
all tertiary legislation (the implementing and dele gated acts) provided for in the 
proposal as well as the preparatory steps necessary for the joint work. 
Following the date of application, a further three -year transitional period is 
envisaged to allow for a phase -in approach in terms of the work undertake n 
and to allow Member States to fully adapt to the new system. During this 
transitional period, Member States would have the option to delay their 
participation in the joint work on joint clinical assessments and joint scientific 
consultations. Under such circumstances they would not be obliged to use the 
output of this joint work at Member State -level but would be obliged to use the 
common rules for their own clinical assessments. Member States will not be 
able to delay their participation partially i.e. f or only one category of health 
technology or for only one part of the joint work.   
EN 15  EN The proposal also includes a safeguard clause allowing clinical assessments to 
be carried out at national level using means other than the common rules, on 
grounds related to  the need to protect public health specific to the Member 
State wishing to invoke the clause. Such measures would need to be justified 
and notified to the Commission for an assessment of the justifications 
presented.   
EN 16  EN 2018/0018 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on health technology assessment and amending Directive 2011/24/EU  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN U NION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof,  
Having regard to the proposal from the European Commission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee6,  
Having regard to the opinion of the Committee of the Regions7,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(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.  
(2) Health Technology Assessment (HTA) is an evidence -based process that allows 
competent authorities to determine the relative effectiveness of new or existing 
technologies. H TA focuses specifically on the added value of a health technology in 
comparison with other new or existing health technologies.  
(3) HTA covers both clinical and non -clinical aspects of a health technology. The EU co -
funded joint actions on HTA (EUnetHTA J oint 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 an d 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 tech nology, 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.  
(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 
                                                 
6 OJ C , , p. .  
7 OJ C , , p. .   
EN 17  EN pricing or reimbursement levels of h ealth technologies. HTA can therefore assist 
Member States in creating and maintaining sustainable healthcare systems and to 
stimulate innovation that delivers better outcomes for patients.  
(5) The carrying out of parallel assessments by multiple Member St ates 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 le ad 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.  
(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 resu lts 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 identica l or similar timeframes has not been sufficiently 
addressed.  
(7) The Council in its Conclusions of December 20148 acknowledged the key role of 
health technology assessment and called on the Commission to continue to support 
cooperation in a sustainable man ner. 
(8) The European Parliament, in its resolution of 2 March 2017 on EU options for 
improving access to medicines,9 called on the Commission to propose legislation on a 
European system for health technology assessment as soon as possible and to 
harmonise  transparent health technology assessment criteria in order to assess the 
added therapeutic value of medicines.  
(9) In its 2015 Communication on upgrading the single market,10 the Commission 
declared its intention to introduce an initiative on HTA to incre ase coordination in 
order to avoid multiple assessments of a product in different Member States and 
improve the functioning of the Single Market for health technologies.  
(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 vol untary 
cooperation between Member States on certain aspects of HTA.  
(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 healt hcare. 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 
                                                 
8 OJ C 438, 6.12.2014, p. 12.  
9 European Parliament resolution of 2 March 2017 on EU options for improving access to medicines – 
2016/2057(INI).  
10 COM(2015) 550 final p. 19.   
EN 18  EN 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.  
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HT A 
and enable pooling of expertise and resources across HTA bodies, it is appropriate to 
require joint clinical assessments to be carried out for all medicinal products 
undergoing the central marketing authorisation procedure provided for under 
Regulation ( EC) No 726/2004 of the European Parliament and of the Council,11 which 
incorporate a new active substance, and where those medicinal products are 
subsequently authorised for a new therapeutic indication.  Joint clinical assessments 
should also be carried out  on certain medical devices within the meaning of 
Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are 
in the highest risk classes and for which the relevant expert panels have provided their 
opinions or views. A selection of m edical devices for joint clinical assessment should 
be made based on specific criteria.  
(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 t he updating 
of assessments, in particular where additional data available subsequent to the initial 
assessment has the potential to increase the accuracy of the assessment.  
(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.  
(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 
representati on 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.  
(16) In order that the harmonised procedures fulfil their internal market object ive, 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 formi ng 
their own recommendations or decisions on pricing or reimbursement.  
(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 
                                                 
11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down Community procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency (OJ L 136 , 30.4.2004, p. 1).  
12 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90 /385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1).   
EN 19  EN technologies for pat ients. As a rule, the process should be completed by the time of the 
publication of the Commission decision granting marketing authorisation.  
(18) The establishment of a time -frame for the joint clinical assessments for medical 
devices should take into acc ount 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.  
(19) In al l 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 
technologie s. 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.  
(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 de velopers or HTA authorities 
and bodies.  
(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 prot ection 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 an y 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 . 
(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 prioriti sation of technologies 
that are to be selected for joint clinical assessment.  
(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.  
(24) In order to ensure the inclus iveness 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  
EN 20  EN should be developed to ensure the independenc e and impartiality of the joint work and 
ensure that such consultation does not give rise to any conflicts of interest.  
(25) In order to ensure a uniform approach to the joint work provided for in this 
Regulation, implementing powers should be conferred o n 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 t he 
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 
Coun cil.13 
(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 delegat ed 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 stakehold ers. 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 Interinstitut ional 
Agreement on Better Law -Making of 13 April 2016.14 In particular, to ensure equal 
participation in the preparation of delegated acts, the European Parliament and the 
Council should receive all documents at the same time as Member States' experts, and 
their experts systematically should be granted access to meetings of Commission 
expert groups dealing with the preparation of delegated acts.  
(27) In order to ensure that sufficient resources are available for the joint work provided for 
under this Regulat ion, 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 repor ts. Member States should also have the possibility to 
second national experts to the Commission in order to support the secretariat of the 
Coordination Group.   
(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 fo r the purposes of HTA such as registries of real world data.   
(29) In order to ensure the smooth establishment and operation of Union -level joint 
assessments, as well as to safeguard their quality, it is appropriate to provide for a 
transitional period all owing a progressive expansion of the number of joint 
                                                 
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 Co mmission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).  
14 Interinstitutional Agreement between the European Parliament, the Council of the European Union and 
the European Commission of 13 April 2016 on Better Law -Making ( OJ L 123, 12.5.2016 , p. 1).   
EN 21  EN assessments carried out annually. The number of assessments to be carried out should 
be determined with due regard for the resources available and the number of Member 
States participating with a view to  reaching full capacity by the end of the transitional 
period. The establishment of such a transitional period should also afford Member 
States an opportunity to fully align their national systems with the framework for joint 
work in terms of resource allo cation, timing, and prioritisation of assessments.  
(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 Memb er 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 org anisation 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.  
(31) In order to ensure that the support framework continues to be a s 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 tra nsitional 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 j oint work.  
(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, effec tiveness, 
relevance, coherence and EU added value and should be supported by a monitoring 
programme.  
(33) Directive 2011/24/EU of the European Parliament and of the Council15 provides that 
the Union is to support and facilitate cooperation and the exchange of scientific 
information among Member States within a voluntary network connecting national 
authorities or bodies responsible for health technology assessment designated by the 
Member States. As those matters are governed by this Regulation, Directive 
2011/24/EU should be amended accordingly.  
(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 assessmen ts 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 o f 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,  
                                                 
15 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the 
application of patients’ rights in cross -border healthcare (OJ L 88, 4.4.2011, p. 45).   
EN 22  EN HAVE ADOPT ED THIS REGULATION:  
Chapter I  
General Provisions  
Article 1  
Subject Matter  
1. This Regulation establishes:  
(a) a support framework and procedures for cooperation on health technology 
assessment at Union level;  
(b) common rules for the clinical assessment of health technologies.  
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.  
Article 2  
Definitions  
For the purposes of this Regulation, the following definitions shall apply:  
(a) 'medicinal product' means a medicinal product for human use as defined in Directive 
2001/83/EC16; 
(b) 'medical device' means a medical device as defined in Regulation (EU) 2017/745;  
(c) 'health technology' means a health technology as defined in Directive 2011/24/EU;  
(d) 'health technology assessment' means a multidisciplinary comparative assessment 
process, based on clinical and non -clinical assessment domains, which compiles and 
evalu ates the available evidence about the clinical and non -clinical issues related to 
the use of a health technology;  
(e) 'clinical assessment' means a compilation and evaluation of the available scientific 
evidence on a health technology in comparison with on e 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 pr oblem, the 
description and technical characterisation of the health technology, the relative 
clinical effectiveness, and the relative safety of the health technology;  
(f) 'non-clinical assessment' means the part of a health technology assessment based on 
the following non -clinical domains of health technology assessment: the cost and 
economic evaluation of a health technology, and ethical, organisational, social, and 
legal aspects related to its use;  
(g) 'collaborative assessment' means a clinical assessme nt of a medical device carried 
out at Union level by a number of interested health technology assessment authorities 
and bodies participating on a voluntary basis.  
                                                 
16 Directive 2001/83/EC of the European Parliament and of the Council  of 6 November 2001 on the 
Community code relating to medicinal products for human use ( OJ L 311, 28.11.2001, p. 67).   
EN 23  EN Article 3  
The Member State Coordination Group on Health Technology Assessment  
1. The Member State Coordination Group on Health Technology Assessment (the 
'Coordination Group') is hereby established.  
2. Member States shall designate their national authorities and bodies responsible for 
health technology assessment as members of the Coordination Gr oup 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.  
3. The Coordination Group shall act by consensus, or, where necessary, vote by simple 
majority. There shall be one vote per Member State.  
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.  
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.  
6. Members of the Coordination Group, and their appointed representatives shall 
respect the principles of independence, impartiality, and confidentiality.  
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.  
8. The Coordination Group shall:  
(a) adopt rules of procedure for the conduct of its meetings and update them where 
necessa ry; 
(b) coordinate and approve the work of its sub -groups;  
(c) ensure cooperation with relevant Union level bodies to facilitate additional 
evidence generation necessary for its work;  
(d) ensure appropriate involvement of stakeholders in its work;  
(e) establish sub -groups for the following:  
(i) joint clinical assessments;  
(ii) joint scientific consultations;  
(iii) identification of emerging health technologies;  
(iv) voluntary cooperation;  
(v) preparation of the annual work programmes and annual reports, and  
updates of the common rules and working documents.  
9. The Coordination Group may meet in different configurations for the following 
categories of health technology: medicinal products, medical devices, and other 
health technologies.   
EN 24  EN 10. The Coordination  Group may establish separate sub -groups for the following 
categories of health technology: medicinal products, medical devices, and other 
health technologies.  
Article 4  
Annual Work Programme and Annual Report  
1. The sub -group designated in accordance wit h Article 3(8)(e) shall prepare an annual 
work programme for approval by the Coordination Group by December 31st of each 
year.  
2. The annual work programme shall set out the joint work to be carried out in the 
calendar year following its approval, coverin g: 
(a) the planned number of joint clinical assessments and the types of health 
technologies to be assessed;  
(b) the planned number of joint scientific consultations;  
(c) voluntary cooperation.  
3. In the preparation of the annual work programme, the designated sub -group shall:  
(a) have regard to the annual study on emerging health technologies referred to in 
Article 18;  
(b) take into account the resources available to the Coordination Group for the 
joint w ork; 
(c) consult the Commission on the draft annual work programme and take into 
account its opinion.  
4. The designated sub -group shall prepare an annual report for approval by the 
Coordination Group by February 28th of each year.  
5. The annual report shall provide information on the joint work carried out in the 
calendar year preceding its approval.  
Chapter II  
Joint Work on Health Technology Assessment at Union Level  
SECTION 1 
JOINT CLINICAL ASSESSMENTS  
Article 5  
Scope of Joint Clini cal Assessments  
1. The Coordination Group shall carry out joint clinical assessments on:  
(a) medicinal products subject to the authorisation procedure provided for in 
Regulation (EC) No 726/2004, including where an amendment has been made 
to the Commission Dec ision to grant a marketing authorisation based on a 
change in the therapeutic indication or indications for which the original  
EN 25  EN authorisation was granted, with the exception of medicinal products authorised 
under Articles 10 and 10a of Directive 2001/83/EC;  
(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 Artic le 54 of that Regulation;  
(c) in vitro  diagnostic medical devices classified as class D pursuant to Article 47 
of Regulation (EU) 2017/74617 for which the relevant expert panels have 
provided their views in the framework of the procedure pursuant to Article 
48(6) of that Regulation.  
2. The Coordination Group shall select the medical devices referred to in paragraph 1 
points (b) and (c) for joint clinical assessment based on the following criteria:  
(a) unmet medical needs;  
(b) potential impact on patients, public health , or healthcare systems;  
(c) significant cross -border dimension;  
(d) major Union -wide added value;  
(e) the available resources.  
Article 6  
Preparation of Joint Clinical Assessment Reports  
1. The Coordination Group shall initiate joint clinical assessments of health 
technologies on the basis of its annual work programme by designating a sub -group 
to oversee the preparation of the joint clinical assessment report on behalf of the 
Coordination Group.  
The joint clinical assessment report shall be accompanied by a summary re port and 
they shall be prepared in accordance with the requirements in this Article and the 
requirements established pursuant to Articles 11, 22, and 23.  
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.  
3. The designated sub -group shall appoint, from among its membe rs, 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.  
4. The assessor, with the assistance of the co -assessor, shall prepare the draft jo int 
clinical assessment report and the summary report.  
5. The conclusions of the joint clinical assessment report shall be limited to the 
following:  
(a) an analysis of the relative effects of the health technology being assessed on 
the patient -relevant health  outcomes chosen for the assessment;  
(b) the degree of certainty on the relative effects based on the available evidence.  
                                                 
17 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repeal ing Directive 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117, 5.5.2017, p. 176).   
EN 26  EN 6. Where, at any stage in the preparation of the draft joint clinical assessment report, the 
assessor considers that additional evidence f rom 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 technol ogy 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.  
7. The mem bers 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.  
8. The assessor shall provide the draft joint clinical asse ssment report and the summary 
report to the submitting health technology developer and set a time -frame in which 
the developer may submit comments.  
9. The designated sub -group shall ensure that stakeholders, including patients and 
clinical experts, are gi ven 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.  
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 comme nts. 
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.  
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.  
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.  
14. The Coordination Group shall provide the approved joint clinical assessment report 
and the summary report to the submitting healt h technology developer and the 
Commission.  
Article 7  
The List of Assessed Health Technologies  
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 
Techno logies" or the "List") at the latest 30 days after receipt of the approved report 
and summary report from the Coordination Group.  
2. Where, within 30 days of receipt of the approved joint clinical assessment report and 
the summary report, the Commission c oncludes that the approved joint clinical  
EN 27  EN 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 reques t it to review the 
report and summary report.  
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 repor t accordingly and 
submit them to the Coordination Group. Article 6, paragraphs 12 to 14 shall apply.  
4. Following the submission of the modified approved joint clinical assessment report 
and summary report, and where the Commission considers that the modi fied 
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.  
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 th e 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.  
6. For those health technologies included on the List of Assess ed 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 workin g days following 
their inclusion in the List.  
Article 8  
Use of Joint Clinical Assessment Reports at Member State Level  
1. Member States shall:  
(a) not carry out a clinical assessment or an equivalent assessment process on a 
health technology included in the Li st of Assessed Health Technologies or for 
which a joint clinical assessment has been initiated;  
(b) apply joint clinical assessment reports, in their health technology assessments 
at Member State level.  
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 as sessment 
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.   
EN 28  EN Article 9  
Updates of Joint Clinical Assessments  
1. The Coordination Group shall carry out updates of joint clinical assessments where:  
(a) the Commission Decision to grant the marketing authorisation of a medicinal 
product referred to in Article 5(1)(a) was conditional on the fulfilment of 
addit ional post -authorisation requirements;  
(b) the initial joint clinical assessment report specified the need for an update once 
additional evidence for further assessment is available.  
2. The Coordination Group may carry out updates of joint clinical assessments  where 
requested by one or more of its members.  
3. Updates shall be carried out in accordance with the procedural rules established 
pursuant to Article 11(1)(d).  
Article 10  
Transitional Arrangements for Joint Clinical Assessments  
During the transitional p eriod referred to in Article 33(1):  
(a) the Coordination Group shall:  
(i) base the annual number of planned joint clinical assessments on the number of 
Member States participating and the resources available to it;  
(ii) select medicinal products referred to in  Article 5(1)(a) for joint clinical 
assessment based on the selection criteria referred to in Article 5(2).  
(b) members of the Coordination Group from Member States not participating in joint 
clinical assessments shall not:  
(i) be appointed as assessors or co -assessors;  
(ii) comment on the draft joint clinical assessment reports and summary reports;  
(iii) take part in the approval process of the final joint clinical assessment reports 
and summary reports;  
(iv) take part in the preparation and approval process o n the parts of the annual 
work programmes on joint clinical assessments;  
(v) be subject to the obligations set out in Article 8 as regards the health 
technologies which have undergone joint clinical assessment.  
Article 11  
Adoption of Detailed Procedural Ru les for Joint Clinical Assessments  
1. The Commission shall develop, by means of implementing acts, procedural rules for:  
(a) submissions of information, data and evidence by health technology 
developers;  
(b) the appointment of assessors and co -assessors;  
(c) determini ng the detailed procedural steps and their timing, and the overall 
duration of joint clinical assessments;  
(d) updates of joint clinical assessments;   
EN 29  EN (e) cooperation with the European Medicines Agency on the preparation and 
update of joint clinical assessments of medicinal products;  
(f) cooperation with the notified bodies and expert panels on the preparation and 
update of joint clinical assessments of medical devices.  
2. Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article 30(2).  
SECTION 2 
JOINT SCIENTIFIC CONSULTATIONS  
Article 12  
Requests for Joint Scientific Consultations  
1. Health technology developers may request a joint scientific consultation with the 
Coordination Group for the purposes of obtaining scientif ic advice concerning data 
and evidence likely to be required as part of a joint clinical assessment.  
Health technology developers of medicinal products may request that the joint 
scientific consultation takes place in parallel with the process of receivin g scientific 
advice from the European Medicines Agency pursuant to Article 57(1)(n) of 
Regulation (EC) No 726/2004. In such a case, it shall make that request at the time of 
submitting an application for scientific advice to the European Medicines Agency.  
2. In considering the request for joint scientific consultation, the Coordination Group 
shall take into account the following criteria:  
(a) the likelihood that the health technology under development will be the subject 
of a joint clinical assessment in accor dance with Article 5(1);  
(b) unmet medical needs;  
(c) potential impact on patients, public health, or healthcare systems;  
(d) significant cross -border dimension;  
(e) major Union -wide added value;  
(f) the available resources.  
3. Within 15 working days after receipt of the requ est, 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 thereo f and explain the reasons having 
regard to the criteria laid down in paragraph 2.  
Article 13  
Preparation of Joint Scientific Consultation Reports  
1. Following the acceptance of a request for a joint scientific consultation in accordance 
with Article 12 an d on the basis of its annual work programme, the Coordination 
Group shall designate a sub -group to oversee the preparation of the joint scientific 
consultation report on behalf of the Coordination Group.   
EN 30  EN The joint scientific consultation report shall be p repared in accordance with the 
requirements in this Article and in accordance with the procedural rules and 
documentation established pursuant to Articles 16 and 17.  
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.  
3. The designated sub -group shall appoint from among its members, an assessor and a 
co-assessor, with responsibility for conducting the joint scient ific consultation. The 
appointments shall take into account the scientific expertise necessary for the 
assessment.  
4. The assessor, with the assistance of the co -assessor, shall prepare the draft joint 
scientific consultation report.  
5. Where, at any stag e in the preparation of the draft joint scientific consultation report, 
the assessor considers that additional evidence from a 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 the 
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 fro m the assessor shall specify the number of working days for 
which the preparation shall be suspended.  
6. The members of the designated sub -group shall provide their comments during the 
preparation of the draft joint scientific consultation report.  
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.  
8. The designated sub -group shall ensure that stakeholders, including patie nts 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.  
9. Following receipt and consideration of any comments p rovided 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.  
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 repo rt with those of the scientific advice.  
11. The assessor, with the assistance of the co -assessor, shall take into account the 
comments of the members of the designated sub -group and submit the final draft 
joint scientific consultation report to the Coordin ation Group.  
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.   
EN 31  EN Article 14  
Joint Scientific Consultation Reports  
1. The Coordination Group shall communicate the approved joint scientific consultation 
report to the requesting health technology developer at the latest 10 working days 
following its approval.  
2. The Coordination Group shall include anonymised summary infor mation on the joint 
scientific consultations in its annual reports and the IT platform referred to in Article 
27. 
3. Member States shall not carry out a scientific consultation or an equivalent 
consultation on a health technology for which a joint scientif ic consultation has been 
initiated and where the contents of the request are the same as those covered by the 
joint scientific consultation.  
Article 15  
Transitional Arrangements for Joint Scientific Consultations  
During the transitional period referred to  in Article 33(1):  
(a) the Coordination Group shall base the annual number of planned joint scientific 
consultations on the number of Member States participating and the resources 
available to it;  
(b) members of the Coordination Group from Member States not partic ipating in joint 
scientific consultations shall not:  
(i) be appointed as assessors or co -assessors;  
(ii) comment on the draft joint scientific consultation reports;  
(iii) take part in the approval process of the final joint scientific consultation 
reports;  
(iv) take part in the preparation and approval process on the parts of the annual 
work programmes on joint scientific consultations.  
Article 16  
Adoption of Detailed Procedural Rules for Joint Scientific Consultations  
1. The Commission shall develop, by me ans of implementing acts, procedural rules for:  
(a) submissions of requests from health technology developers and their 
involvement in the preparation of joint scientific consultation reports;  
(b) the appointment of assessors and co -assessors;  
(c) determining the deta iled procedural steps and their timing;  
(d) the consultation of patients, clinical experts and other relevant stakeholders;  
(e) cooperation with the European Medicines Agency on joint scientific 
consultations on medicinal products where a health technology develop er 
requests the consultation to be carried out in parallel with a process for 
scientific advice from the Agency;  
(f) cooperation with the expert panels referred to in Article 106(1) of Regulation 
(EU) 2017/745 on the joint scientific consultations on medical d evices.   
EN 32  EN 2. Those implementing acts shall be adopted in accordance with the examination 
procedure referred to in Article 30(2).  
Article 17  
Documentation and Rules for Selecting Stakeholders for Joint Scientific Consultations  
The Commission shall be empowere d to adopt delegated acts in accordance with Article 31 
concerning:  
(a) the contents of:  
(i) requests from health technology developers for joint scientific consultations;  
(ii) dossiers of information, data and evidence to be submitted by health 
technology de velopers for joint scientific consultations;  
(iii) joint scientific consultation reports.  
(b) the rules for determining the stakeholders to be consulted for the purpose of this 
Section.  
SECTION 3 
EMERGING HEALTH TECHNOLOGIES  
Article 18  
Identification of Emerging Health Technologies  
1. The Coordination Group shall annually prepare a study on emerging health 
technologies expected to have a major impact on patients, public health or healthcare 
systems.  
2. In the preparation of the study, t he Coordination Group shall consult:  
(a) health technology developers;  
(b) patient organisations;  
(c) clinical experts;  
(d) the European Medicines Agency including on the pre -notification of medicinal 
products prior to marketing authorisation applications;  
(e) the Medical De vices Coordination Group established in Article 103 of 
Regulation (EU) 2017/745.  
3. The conclusions of the study shall be summarised in the Coordination Group's annual 
report and shall be taken into account in the preparation of its annual work 
programmes.   
EN 33  EN SECTION 4  
VOLUNTARY COOPERATION ON HEALTH TECHNOLOGY ASSESSMENT  
Article 19  
Voluntary Cooperation  
1. The Commission shall support cooperation and the exchange of scientific 
information among Member States on:  
(a) non-clinical assessments on health technologies;  
(b) collaborative assessments on medical devices;  
(c) health technology assessments on health technologies other than medicinal 
products or medical devices;  
(d) the provision of additional evidence necessary to support health technology 
assessments.  
2. The Coordination Group shall be used to facilitate the cooperation referred to in 
paragraph 1.  
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.  
4. The cooperation referred to in paragraph 1 shall be included in the annual work 
programmes of the Coordination Group and the results of the cooperation shall be 
included in its annual repo rts and the IT platform referred to in Article 27.  
Chapter III  
Rules for Clinical Assessments  
Article 20  
Harmonised Rules for Clinical Assessments  
The common procedural rules and methodology established in accordance with Article 22 and 
the requirements established in accordance with Article 23 shall apply to:  
(a) joint clinical assessments carried out in accordance with Chapter II;  
(b) clinical assessments of medicinal products and medical devices carried out by 
Member States.  
Article 21  
Clinical Assessment Rep orts 
1. Where a clinical assessment is carried out by a Member State, that Member State 
shall provide the Commission with the clinical assessment report and summary 
report at the latest 30 working days after the completion of the health technology 
assessme nt.   
EN 34  EN 2. The Commission shall publish the summary reports referred to in paragraph 1 in the 
IT platform referred to in Article 27 and make the clinical assessment reports 
available to other Member States through that IT platform.  
Article 22  
Common Procedura l Rules and Methodology  
1. The Commission shall adopt implementing acts concerning:  
(a) procedural rules for:  
(i) ensuring that health technology authorities and bodies carry out clinical 
assessments in an independent and transparent manner, free from 
conflict s of interest;  
(ii) the mechanisms for the interaction between health technology bodies and 
health technology developers during clinical assessments;  
(iii) the consultation of patients, clinical experts, and other stakeholders in 
clinical assessments.  
(b) meth odologies used to formulate the contents and design of clinical 
assessments.  
2. Implementing acts referred to in paragraph 1 shall be adopted in accordance with the 
examination procedure referred to in Article 30(2).  
Article 23  
Contents of Submission and R eport Documents and Rules for Selecting Stakeholders  
The Commission shall be empowered to adopt delegated acts in accordance with Article 31  
concerning:  
(a) the contents of:  
(i) dossiers of information, data and evidence to be provided by health technology 
developers for clinical assessments;  
(ii) clinical assessment reports;  
(iii) summary clinical assessment reports.  
(b) the rules for determining the stakeholders to be consulted for the purposes of Section 
1 of Chapter II and of this Chapter.  
Chapter IV  
Support Fr amework  
Article 24  
Union Funding  
1. The financing of the work of the Coordination Group and its sub -groups and 
activities in support of that work involving its cooperation with the Commission, 
with the European Medicines Agency, and with the stakeholder ne twork referred to 
in Article 26 shall be ensured by the Union. The Union's financial assistance to the  
EN 35  EN activities under this Regulation shall be implemented in accordance with Regulation 
(EU, Euratom) No 966/2012 of the European Parliament and of the Counc il.18 
2. The funding referred to in paragraph 1 shall include funding for the participation of 
Member States' designated health technology authorities and bodies in support of the 
work on joint clinical assessments and joint scientific consultations. Assessor and co -
assessors shall be entitled to a special allowance compensating them for their work 
on joint clinical assessments and joint scientific consultations in accordance with 
internal Commission provisions.  
Article 25  
Commission Support for the Co ordination Group  
The Commission shall support the work of the Coordination Group. In particular the 
Commission shall:  
(a) host on its premises and co -chair the meetings of the Coordination Group;  
(b) provide the secretariat for the Coordination Group and provide administrative, 
scientific and IT support;  
(c) publish on the IT platform referred to in Article 27 the Coordination Group's annual 
work programmes, annual reports, summary minutes of its meetings, and reports and 
summary reports of joint clinical assessments;  
(d) verify that the work of the Coordination Group is carried out in an independent and 
transparent manner;  
(e) facilitate cooperation with the European Medicines Agency on the joint work on 
medicinal products 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 confidential information.  
Article 26  
Stakeholder Network  
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.  
2. The Commission shall publish the list of stakeholder organisations included in the 
stakeholder network.  
3. The Commission shall organise ad -hoc meetings between the stakeholder network 
and the Coordination Group in order to:  
(a) update stakeholders on the work of the group;  
(b) provide for an exchange of information on the work of the Coordination 
Group.  
                                                 
18 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 
2012 on the financial rules applicable to the general budget of the  Union and repealing Council 
Regulation (EC, Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1).   
EN 36  EN 4. On the req uest 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.  
5. On the request of the Coordination Group, the stakeholder network s hall support the 
Coordination Group in the identification of patient and clinical expertise for the work 
of its sub -groups.  
Article 27  
IT Platform  
1. The Commission shall develop and maintain an IT platform containing information 
on: 
(a) planned, on -going, a nd completed joint clinical assessments and Member State 
health technology assessments;  
(b) joint scientific consultations;  
(c) studies on the identification of emerging health technologies;  
(d) results of the voluntary cooperation between Member States.  
2. The Commis sion 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.  
Article 28  
Implementation Report  
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.  
Chapter V  
Final Provisions  
Article 29  
Evaluation and Monitoring  
1. No later than five years after the publication of the report referred to in Article 28, 
the Commission shall carry out an evaluation of this Regulation, and report on its 
conclusions.  
2. By … [ insert  date one year after the date of application ] at the latest, the 
Commission shall establish a programme for monitoring the implementation of this 
Regulation. The monitoring programme shall set out the means by which and the 
intervals at which the data and other necessary evidence will be collected. The 
monitoring programme shall specify the action to be taken by the Commission and 
by the Member States in collecting and analysing the data and other evidence.  
3. The annual reports of the Coordination Group sh all be used as part of the monitoring 
programme.   
EN 37  EN Article 30  
Committee Procedure  
1. The Commission shall be assisted by a committee. That committee shall be a 
committee within the meaning of Regulation (EU) No 182/2011.  
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 
182/2011 shall apply.  
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 Europ ean 
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 princip les 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 pursua nt 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 t he 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.  
Article 32  
Preparatio n of Implementing and Delegated Acts  
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.  
2. When preparing those implementing and del egated acts, the Commission shall take 
into account the distinctive characteristics of the medicinal product and medical 
device sectors.   
EN 38  EN Article 33  
Transitional Provisions  
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] .  
2. Member States shall notify the Commission where they intend to make use of the 
transitional period s et out in paragraph 1 at the latest one year before the date of 
application of this Regulation.  
3. Member States which have delayed their participation in accordance with paragraph 
1 may begin participating with effect from the next financial year after h aving 
notified the Commission at least three months before the beginning of that financial 
year.  
Article 34  
Safeguard Clause  
1. Member States may carry out a clinical assessment using means other than the rules 
provided for in Chapter III of this Regulati on, 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.  
2. Member States shall notify the Commission of their intention to c arry out a clinical 
assessment using other means together with the justifications for doing so.  
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.  
Article 35  
Amendment of Directive 2011/24/EU  
1. Article 15 of Directive 2011/24/EU is deleted.  
2. References to the deleted Article shall be construed as references to this Regulation.  
Article 36  
Entry into Force and Date of Application  
1. This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of the European Union . 
2. It shall apply from [insert date 3 years after date of entry into force].   
EN 39  EN This Regulation shall be binding in it s entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President   
EN 40  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
1.2. Policy area(s) concerned in the ABM/ABB structure  
1.3. Nature of the proposal/initiative  
1.4. Objective(s)  
1.5. Grounds for the proposal/initiative  
1.6. Duration and financial impact  
1.7. Management mode(s) planned  
2. MANAGEM ENT  MEASURES   
2.1. Monitoring and reporting rules  
2.2. Management and control system  
2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financial framework and e xpenditure budget 
line(s) affected  
3.2. Estimated impact on expenditure  
3.2.1.  Summary of estimated impact on expenditure  
3.2.2.  Estimated impact on operational appropriations  
3.2.3.  Estimated impact on appropriations of an administrative nature  
3.2.4.  Compatibility with the current multiannual financial framework  
3.2.5.  Third -party contributions  
3.3. Estimated impact on revenue   
EN 41  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/i nitiative  
Proposal for a Regulation of the European Parliament and of the Council on Health 
Technology Assessment, and amending Directive 2011/24/EU  
1.2. Policy area(s) concerned in the ABM/ABB structure   
Public Health (Possibly to be amended depending on  MFF negotiations)  
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to a new action   
 The proposal/initiative relates to a new action following a pilot 
project/preparatory action19  
 The proposal/initiative relates to the extension of an existing action   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objective(s)  
1.4.1.  The Commission's multiannual strategic objective(s) targeted by the 
proposal/initiative  
The Commission's strategic ob jectives targeted by this proposal are:  
• To ensure a better functioning of the internal market;  
• To contribute to a high level of human health protection.  
1.4.2.  Specific objective(s) and ABM/ABB activity(ies) concerned  
The specific objectives  of the proposal are:  
• Improve the availability of innovative health technologies for EU patients;  
• Ensure efficient use of resources and strengthen the quality of HTA across the 
EU; 
• Improve business predictability.  
ABM/ABB activity(ies) concerned  
Health 
                                                 
19 As referred to in Article 54(2)(a) or (b) of the Financial Regulation.   
EN 42  EN 1.4.3.  Expected result(s) and impact  
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.  
Member States authorities will benefit from:  
• Better evidence for national decision -makers (i.e. due to high qual ity and 
timely joint clinical assessment reports). Furthermore, focusing joint 
assessments on clinical data makes them relevant to all decision -makers, 
without affecting national competences on pricing and reimbursement 
decisions.  
• Cost savings and optim isation of resources.  
• Pooling expertise and enhanced capacity to address more health technologies. 
HTA bodies in the EU will be able to specialise in different topics (e.g. orphan 
medicines, medical devices), rather than to keep a general profile of bot h their 
tasks and staff.  
As regards patients, an EU HTA system would provide for a framework for the 
involvement of patients in the HTA processes. Additionally, the publication of the 
joint clinical assessment reports will also increase the transparency of decision -
making in relat ion to the availability of health technologies.  
For healthcare professionals and academia, an EU HTA system would provide for a 
framework for their involvement in the HTA process (i.e. common procedures for 
involving healthcare professionals and providers ), while the publication of the joint 
assessment reports would facilitate access to reliable, timely and objective 
information on health technologies allowing for better informed decisions on the best 
treatment for their patients.  
For industry the proposal  has a clear potential to improve business predictability and 
provide for savings.  
It may also have a potential positive impact on time to market and it will reduce 
duplication of work through harmonisation of tools and methodologies. Overall, a 
more predi ctable HTA system has the potential to increase investments in R&D 
activities in Europe.  
The proposal takes into account the more decentralised market access pathway for 
medical devices and does not link the timing of the joint clinical assessments to the 
timing of the conformity assessment, thus avoiding putting an additional burden on 
the manufacturers at market launch. In addition the selection/priority mechanism 
foreseen in the proposal to decide which medical devices will be subject to joint 
clinical a ssessments aims at focusing on devices where cooperation brings the most 
added value to Member States and the sector as a whole. Overall, a predictable HTA 
system is expected to re -direct medical device industry resources towards the 
development of and inv estment in health technologies which would for instance 
address unmet medical needs and lead to the improvement of health outcomes for 
patients.   
EN 43  EN 1.4.4.  Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/i nitiative.  
• Number of Member States joining the Coordination Group in the transitional 
period;  
• Number of HTA authorities and bodies and their areas of expertise;  
• Number of national assessments carried out using the joint clinical assessment 
reports;  
• Number of assessments carried out at national level using the common clinical 
assessment rules and methodologies;  
• Number of national HTA reports (carried out at national level using the 
common clinical assessment rules and methodologies) reused by HTA bodies 
in other Member States;  
• Number of joint clinical assessments on medicinal products;  
• Number of joint clinical assessments on medical devices;  
• Number of joint scientific consultations on medicinal products;  
• Number of joint scientific consultat ions on medical devices;  
• Number of days to carry out a joint clinical assessment by the assessor and co -
assessor;  
• Number of days to carry out a joint scientific consultation by the assessor and 
co-assessor;  
• Number of emerging health technologies iden tified as candidate health 
technologies for joint clinical assessments.  
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term  
The proposal addresses the shortcomings of the current model of EU cooperation on 
HTA (impeded and distorted market access for health technologies due to various 
HTA processes and methodologies across the EU, duplication of work for national 
HTA bodies and industry, unsustainability of the current cooperation) by providing a 
long-term su stainable solution which enables Member States' HTA authorities and 
bodies to use their HTA resources more efficiently. It promotes convergence of HTA 
tools, procedures and methodologies, reduces duplication of efforts for HTA bodies 
and industry, and ensu res the adequate uptake of joint outputs in Member States.  
1.5.2.  Added value of EU involvement  
The diversity and multitude of approaches to HTA across the Member States means 
that, due to their scale and effect, only action at Union level can eliminate th e 
obstacles described. Without action at EU level it is unlikely that national rules on 
how HTAs are carried out would be harmonised and thus the current fragmentation 
of the internal market would persist.   
EN 44  EN 1.5.3.  Lessons learned from similar experiences in  the past  
As proven by the public consultation, the existing EU cooperation on HTA including 
the HTA Network (the strategic arm) and the EUnetHTA Joint Action (as the 
scientific and technical arm) has been useful for building trust between HTA bodies 
and stakeholders, for increasing knowledge of working procedures and 
methodologies in Member States, and for the sharing of best practices and capacity 
building. The public consultations also confirmed the existence of important 
shortcomings which cannot be ad dressed by the current cooperation model (e.g. 
changes in human resources with important consequences on the progress of the 
activities, delayed recruitment of staff and implementation of an efficient and reliable 
IT infrastructure, inconsistency of qualit y and timely delivery of joint outputs, low 
uptake at national level).  
While this proposal builds on the tools, methodologies and experience from the 
EUnetHTA Joint Actions, it addresses the abovementioned shortcomings, taking into 
account not only the nee ds of the Member States authorities but also those of 
industry, healthcare professionals and patients (See section 1.4.3. Expected result(s) 
and impact).  
1.5.4.  Compatibility and possible synergy with other appropriate instruments  
The proposal constitutes a coherent approach, well in line with the EU's overarching 
objectives, including a smooth functioning of the internal market, sustainable health 
systems and an ambitious research and innovation agenda. In addition to coherence 
with these EU policy objecti ves, the proposal is compatible, coherent and 
complementary to existing EU legislation related to medicinal products and medical 
devices.  
For example, there are opportunities for mutual information -sharing and better 
alignment of the timing of procedures between the joint clinical assessment and the 
centralised marketing authorisation for medicinal products. Synergies are also 
expected between joint clinical assessments for medical devices and some of the 
provisions foreseen by the new EU Regulations for m edical devices and in vitro  
diagnostics (e.g. strengthened rules on clinical evaluation and clinical investigation; 
EU-level expert panels for high -risk medical devices). Moreover, the joint scientific 
consultations foreseen in this proposal will contribut e to the objectives of related EU 
legislation on clinical trials to ensure that the evidence generated in clinical studies is 
robust and benefits patients and public health. The proposal could also provide useful 
input to and synergies with the Digital Sin gle Market agenda by encouraging 
innovation and research of high -tech health technologies and by supporting the 
development of a European IT infrastructure supporting EU cooperation on HTA. 
The proposal is expected to play an important role in supporting i nnovation for the 
benefit of patients by influencing longer -term R&D investment decisions by 
industry.   
EN 45  EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  
–  Financ ial impact from YYYY to YYYY  
 Proposal/initiative of unlimited duration  
– Implementation with a start -up period from 2023 to 2026,  
– followed by full -scale operation.  
1.7. Management mode(s) planned  
Direct management  by the Commission  
–  by its departments, including by its staff in the Union delegations;  
–  by the executive agencies  
 Shared management  with the Member States  
 Indirect management  by entrusting budget implementation tasks to:  
–  third countries or the bodies they have des ignated;  
–  international organisations and their agencies (to be specified);  
–  the EIB and the European Investment Fund;  
–  bodies referred to in Articles 208 and 209 of the Financial Regulation;  
–  public law bodies;  
–  bodies governed by private law with a public service mission to the extent that 
they provide adequate financial guarantees;  
–  bodies governed by the private law of a Member State that are entrusted with 
the implementation of a public -private partnership and that provide adequate 
financial guar antees;  
–  persons entrusted with the implementation of specific actions in the CFSP 
pursuant to Title V of the TEU, and identified in the relevant basic act.  
– If more than one management mode is indicated, please provide details in the ‘Comments’ section.  
Comments  
The Commission intends to ensure the provision of the services concerned via centralised 
direct management through its own services, including technical, scientific and logistic 
support.   
EN 46  EN 2. MANAGEMENT  MEASURES   
2.1. Monitor ing and reporting rules  
Specify frequency and conditions.  
The Coordination Group and sub -groups will provide a regular platform to discuss 
issues related to the implementation of the new regulatory framework. Monitoring of 
the implementation will also be facilitated by the IT Platform to be set up.  
No later than two years after the end of the transitional period foreseen by this 
proposal, the Commission will report on the implementation of the scope and support 
framework. The proposal also lays down a requirement for regular monitoring and 
reporting by the Commission on the implementation of the Regulation.  
2.2. Management and control system  
2.2.1.  Risk(s) identified  
Risks related to the number of joint outputs:  
‒ The number of health technologies receiving central marketing authorisation 
(for medicinal products)/CE marking (for medical devices) may vary from one 
year to another;  
‒ Challenges to achieve scientific consensus on the joint clinical assessments.  
Risks related to the IT platform supporti ng the strengthened EU cooperation on 
HTA:  
‒ Besides an interface open to the general public, the IT infrastructure will have 
an intranet, which will contain confidential information (i.e. commercially 
sensitive data, personal information) which could be d isclosed due to hacking 
or software failure.  
2.2.2.  Information concerning the internal control system set up  
Control methods regarding the risks related to the number of joint outputs:  
‒ As regards the risk of variable output, this risk can be mitigated b y a 
methodical study to identify emerging health technologies before the adoption 
of the annual work programme by the Coordination Group;  
‒ Cooperation with the European Medicines Agency will help to ensure the 
identification of emerging medicinal products  to be assessed, especially in the 
transitional phase;  
‒ Cooperation with the Medical Devices Coordination Group will help to ensure 
the identification of emerging medical devices;  
‒ The strong involvement of Member States in selection, preparation and 
approval of clinical assessments and the expected format of the clinical 
assessment report will facilitate consensus building.  
Control methods related to the risks related to the IT platform supporting the 
strengthened EU cooperation on HTA:  
‒ The Commission  has experience with IT tools requiring a high level of 
sensitivity regards its functioning. Control methods and audits regarding IT 
procedures and handling of confidential information will be implemented.   
EN 47  EN 2.2.3.  Estimate of the costs and benefits of the c ontrols and assessment of the expected level 
of risk of error  
Control methods regarding the risks related to the number of joint outputs:  
‒ The costs of the controls are included in the costs allocated to the exercise on 
the identification of emerging new  technologies to be assessed at EU -level and 
the joint clinical assessments. Cooperation with the relevant bodies for 
medicinal products and medical devices will minimise the risks of errors when 
drawing up the work programme of the Coordination Group.  
Control methods related to the risks related to the IT platform supporting the 
strengthened EU cooperation on HTA:  
‒ The costs of the controls are included in the IT costs. The risk of error is 
similar to the risk for other IT platforms hosted by the Commissi on. 
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection measures.  
In addition to the application of all regulatory control mechanisms, the Commission's 
responsible service(s) will devise an anti -fraud strategy in line with the 
Commission's anti -fraud strategy (CAFS) adopted on 24 June 2011, in order to 
ensure, inter alia , that its internal anti -fraud related controls are fully aligned with the 
CAFS and that its fraud risk management approach is geared to identify fraud risk 
areas and adequate responses. Where necessary, networking groups and adequate IT 
tools dedicated to  analysing fraud cases related to the financing of implementing 
activities under this proposal will be set up. In particular a series of measures will be 
put in place such as:  
‒ decisions, agreements and contracts resulting from the financing of 
implement ing activities under this proposal will expressly entitle the 
Commission, including the Anti -Fraud Office (OLAF), and the Court of 
Auditors, to conduct audits, on -the-spot checks and inspections;  
‒ during the evaluation phase of a call for proposals/tender , the proposers and 
tenderers are checked against the published exclusion criteria based on 
declarations and the Early Detection and Exclusion System (EDES);  
‒ the rules governing the eligibility of costs will be simplified in accordance with 
the provisio ns of the Financial Regulation;  
‒ regular training on issues related to fraud and irregularities for all staff 
involved in contract management as well as to auditors and controllers who 
verify the beneficiaries' declarations on the spot.  
Moreover, the Comm ission will oversee a strict application of the rules on conflicts 
of interests provided for in the proposal.   
EN 48  EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL  
As the budgetary consequences of the proposal are expected to take effect fr om 2023 
onwards, the contribution from the EU budget post -2020 will be discussed within the 
framework of the preparation of the Commission's proposals for the next 
Multiannual Financial Framework (MFF) and will reflect the outcome of the 
negotiations on th e MFF post -2020.  
The proposal is compatible with the current MFF.