Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU
Date: 2018-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: cross-border cooperation, exchange of information, health care, innovation, medical device, medical science, patient's rights, public health, scientific cooperation, technology assessment

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   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}  
 
 
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  seek  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 healthcare. 

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 
Member 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)  compared  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  made  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. Participation 
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  on  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 technical 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 cooperation 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 States 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 national processes and 
methodologies  also  lead  to  differences  in  how  evidence  is  considered  in 

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assessments, which can contribute to delays and inequalities in availabilities of 
innovative health technologies for patients. 

Problem 2. Duplication of work for national 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 means 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  time  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 functioning 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 long-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 facilitate 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 

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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 Actions).  

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 in 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 market,  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  Regulations  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 devices, 
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 timelines 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  proposal, 
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 robust 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  sharing  on  registries  of  real 
world  evidence,  and  by  supporting  the  development  of  a  Union-level  IT 
infrastructure supporting EU cooperation on HTA.  

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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. 
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". 

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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-exclusive 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 
unlikely  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 duplication 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  which  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 

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discrepancies. At the same time, the proposal will avoid 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  duplication  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 proposal 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  differences  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  the  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  set 
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 repeated, 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 assessments 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  for  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  of  a  Regulation  would  be  a 
more adequate and proportionate approach than the transposition needed for a 

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Directive,  in  ensuring  use  of  joint  clinical  assessments  and  common  rules  at 
national level. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

 

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 consultation 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 reach 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  needed  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  ensure  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 continuing 
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  jointly  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 them 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  reports  publicly  available,  including  criteria  and  rationale 

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https://ec.europa.eu/health/technology_assessment/events_en#anchor3 

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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  associations  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  described  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 common  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  of  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 scope 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 

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http://ec.europa.eu/smart-
regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf 

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methodologies,  reducing  duplication  (e.g.  of  clinical  assessments)  and 
therefore  the  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  decision-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 result 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  December  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 particular, 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  on  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 simplification 

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  role  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  particular,  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  dedicated 
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 impact 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 developed 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  Union  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.  

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4. 

BUDGETARY IMPLICATIONS 

The  implementation  of  this  proposal  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  next  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. organisation 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 
the  documentation,  manage  procedures  for 
sub-groups,  preparation  of 
including  scientific 
involving  stakeholders,  ensure  quality  management 
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/repositories  of 
secure 
communication etc.).  

and  national  HTA 

reports, 

joint 

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  Member  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  reporting 
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 States 
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. 

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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 
framework 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  in  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 Commission 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 
qualitative  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 Article 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  provide 
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  assessments,  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 

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approve the joint reports which will then be published 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  work 
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  voluntary  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 transitional 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  carried  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 extended 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 
views  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, transformative 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 
proportionate 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. 

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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  shortly  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 
devices,  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  point  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, and 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 increase 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 based 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 step-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  report  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 drafting 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 other 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  detailed  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 clinical assessments, ensuring a consistent approach 

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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 of 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 
(e.g.  economic, 
assessments 
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.  

the  non-clinical  HTA  domains 

i.e.  on 

Section 2 - Joint scientific consultations 

The  proposal  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 development 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  scientific 
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) clinical 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 input 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 the 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 

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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  use  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 care). 

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 carrying 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 Commission 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  outlines  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 delegated 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  undertaken 
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.  for  only  one  category  of  health 
technology or for only one part of the joint work. 

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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. 

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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 UNION, 

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) 

(2) 

(3) 

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. 

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

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

(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 
7 

OJ C , , p. . 
OJ C , , p. . 

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pricing  or  reimbursement  levels  of  health  technologies.  HTA  can  therefore  assist 
Member  States  in  creating  and  maintaining  sustainable  healthcare  systems  and  to 
stimulate innovation that delivers better outcomes for patients. 

(5) 

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

(6)  While Member States have carried out some joint assessments within the framework 
of  the  EU  co-funded  joint  actions,  the  production  of  output  has  been  inefficient, 
relying  on  project-based  cooperation  in  the  absence  of  a  sustainable  model  of 
cooperation.  Use  of  the  results  of  the  joint  actions,  including  their  joint  clinical 
assessments, at Member State-level has remained low, meaning that the duplication of 
assessments on the same health technology by HTA authorities and bodies in different 
Member  States  within  identical  or  similar  timeframes  has  not  been  sufficiently 
addressed. 
The  Council  in  its  Conclusions  of  December  20148  acknowledged  the  key  role  of 
health  technology  assessment  and  called  on  the  Commission  to  continue  to  support 
cooperation in a sustainable manner. 

(7) 

(8) 

(9) 

(10) 

(11) 

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.  
In  its  2015  Communication  on  upgrading  the  single  market,10  the  Commission 
declared  its  intention  to  introduce  an  initiative  on  HTA  to  increase  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. 

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

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

8 
9 

10 

OJ C 438, 6.12.2014, p. 12. 
European Parliament resolution of 2 March 2017 on EU options for improving access to medicines  – 
2016/2057(INI). 
COM(2015) 550 final p. 19. 

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(12) 

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. 

In order to ensure a wide application of harmonised rules on clinical aspects of HTA 
and enable pooling of expertise and resources across HTA bodies, it is appropriate to 
require  joint  clinical  assessments  to  be  carried  out  for  all  medicinal  products 
undergoing  the  central  marketing  authorisation  procedure  provided  for  under 
Regulation (EC) No 726/2004 of the European Parliament and of the Council,11 which 
incorporate  a  new  active  substance,  and  where  those  medicinal  products  are 
subsequently  authorised  for  a  new  therapeutic  indication.  Joint  clinical  assessments 
should  also  be  carried  out  on  certain  medical  devices  within  the  meaning  of 
Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are 
in the highest risk classes and for which the relevant expert panels have provided their 
opinions or views. A selection of medical devices for joint clinical assessment should 
be made based on specific criteria. 

(13) 

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

(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) 

(16) 

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

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

(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 

12 

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

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

(19) 

(20) 

(21) 

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

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

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

(22) 

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

(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  inclusiveness  and  transparency  of  the  joint  work,  the 
Coordination  Group  should  engage  and  consult  widely  with  interested  parties  and 
stakeholders.  However,  in  order  to  preserve  the  integrity  of  the  joint  work,  rules 

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(25) 

(26) 

(27) 

(28) 

should be developed to ensure the independence and impartiality of the joint work and 
ensure that such consultation does not give rise to any conflicts of interest.  

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

In order to ensure that this Regulation is fully operational and to adapt it to technical 
and scientific development, the power to adopt acts in accordance with Article 290 of 
the  Treaty  on  the  Functioning  of  the  European  Union  should  be  delegated  to  the 
Commission  in  respect  of  the  contents  of  documents  to  be  submitted,  reports,  and 
summary reports of clinical assessments, the contents of documents for requests, and 
reports of joint scientific consultations, and the rules for selecting stakeholders. It is of 
particular importance that the Commission carries out appropriate consultations during 
its  preparatory  work,  including  at  expert  level,  and  that  those  consultations  be 
conducted  in  accordance  with  the  principles  laid  down  in  the  Interinstitutional 
Agreement  on  Better  Law-Making  of  13  April  2016.14  In  particular,  to  ensure  equal 
participation  in  the  preparation  of  delegated  acts,  the  European  Parliament  and  the 
Council should receive all documents at the same time as Member States' experts, and 
their  experts  systematically  should  be  granted  access  to  meetings  of  Commission 
expert groups dealing with the preparation of delegated acts. 

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

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

(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  allowing  a  progressive  expansion  of  the  number  of  joint 

13 

14 

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

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

(31) 

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

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

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

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). 

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HAVE ADOPTED 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.  

For the purposes of this Regulation, the following definitions shall apply: 

Article 2 
Definitions 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

16 

'medicinal product' means a medicinal product for human use as defined in Directive 
2001/83/EC16; 

'medical device' means a medical device as defined in Regulation (EU) 2017/745;  

'health technology' means a health technology as defined in Directive 2011/24/EU; 

'health  technology  assessment'  means  a  multidisciplinary  comparative  assessment 
process, based on clinical and non-clinical assessment domains, which compiles and 
evaluates the available evidence about the clinical and non-clinical issues related to 
the use of a health technology; 

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

'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; 

'collaborative  assessment'  means  a  clinical  assessment  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. 

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). 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Article 3 
The Member State Coordination Group on Health Technology Assessment 

The  Member  State  Coordination  Group  on  Health  Technology  Assessment  (the 
'Coordination Group') is hereby established. 

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

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

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. 

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. 

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

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

The Coordination Group shall: 

(a) 

adopt rules of procedure for the conduct of its meetings and update them where 
necessary; 

(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.  

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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. 

2. 

The sub-group designated in accordance with Article 3(8)(e) shall prepare an annual 
work programme for approval by the Coordination Group by December 31st of each 
year.  

The  annual  work  programme  shall  set  out  the  joint  work  to  be  carried  out  in  the 
calendar year following its approval, covering: 

(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) 

(c) 

take  into  account  the  resources  available  to  the  Coordination  Group  for  the 
joint work; 

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

4. 

5. 

The  designated  sub-group  shall  prepare  an  annual  report  for  approval  by  the 
Coordination Group by February 28th of each year. 

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 Clinical 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  Decision  to  grant  a  marketing  authorisation  based  on  a 
change  in  the  therapeutic  indication  or  indications  for  which  the  original 

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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 Article 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. 

1. 

2. 

3. 

4. 

5. 

17 

Article 6 
Preparation of Joint Clinical Assessment Reports 

The  Coordination  Group  shall 
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. 

initiate 

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

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

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

The  assessor,  with  the  assistance  of  the  co-assessor,  shall  prepare  the  draft  joint 
clinical assessment report and the summary report.  

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. 

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

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6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

1. 

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

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

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

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

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

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.  

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. 

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

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

Article 7 
The List of Assessed Health Technologies  

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

2. 

Where, within 30 days of receipt of the approved joint clinical assessment report and 
the  summary  report,  the  Commission  concludes  that  the  approved  joint  clinical 

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26 

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3. 

4. 

5. 

6. 

assessment  report  and  summary  report  do  not  comply  with  the  substantive  and 
procedural  requirements  laid  down  in  this  Regulation,  it  shall  inform  the 
Coordination  Group  of  the  reasons  for  its  conclusions  and  request  it  to  review  the 
report and summary report. 

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

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

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

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

Article 8 
Use of Joint Clinical Assessment Reports at Member State Level 

1. 

Member States shall: 

2. 

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

(b) 

apply joint clinical assessment reports, in their health technology assessments 
at Member State level. 

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

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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 
additional post-authorisation requirements; 

(b) 

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

2. 

3. 

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

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 period referred to in Article 33(1): 

(a) 

the Coordination Group shall: 

(i) 

(ii) 

base the annual number of planned joint clinical assessments on the number of 
Member States participating and the resources available to it; 

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) 

(iv) 

take  part  in  the  approval  process  of  the  final  joint  clinical  assessment  reports 
and summary reports; 

take  part  in  the  preparation  and  approval  process  on  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 Rules for Joint Clinical Assessments 

1. 

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

(a) 

submissions  of 
developers; 

information,  data  and  evidence  by  health 

technology 

(b) 

the appointment of assessors and co-assessors; 

(c)  determining  the  detailed  procedural  steps  and  their  timing,  and  the  overall 

duration of joint clinical assessments; 

(d)  updates of joint clinical assessments; 

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(e) 

(f) 

cooperation  with  the  European  Medicines  Agency  on  the  preparation  and 
update of joint clinical assessments of medicinal products; 

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 scientific 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 receiving 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 accordance 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. 

1. 

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

Article 13 
Preparation of Joint Scientific Consultation Reports 

Following the acceptance of a request for a joint scientific consultation in accordance 
with  Article  12  and  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.  

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2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

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

The 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.  

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

The  assessor,  with  the  assistance  of  the  co-assessor,  shall  prepare  the  draft  joint 
scientific consultation report. 

Where, at any stage 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 from the assessor shall specify the number of working days for 
which the preparation shall be suspended.  

The  members  of  the  designated  sub-group  shall  provide  their  comments  during  the 
preparation of the draft joint scientific consultation report. 

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. 

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

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

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

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 Coordination Group.  

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.  

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Article 14 
Joint Scientific Consultation Reports 

1. 

2. 

3. 

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.  

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

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

Article 15 
Transitional Arrangements for Joint Scientific Consultations 

During the transitional period referred to in Article 33(1): 

(a) 

(b) 

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; 

members  of  the  Coordination  Group  from  Member  States  not  participating  in  joint 
scientific consultations shall not: 

(i) 

be appointed as assessors or co-assessors; 

(ii) 

comment on the draft joint scientific consultation reports; 

(iii) 

(iv) 

take  part  in  the  approval  process  of  the  final  joint  scientific  consultation 
reports; 

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 means of implementing acts, procedural rules for: 

(a) 

submissions  of  requests  from  health 
involvement in the preparation of joint scientific consultation reports; 

technology  developers  and 

their 

(b) 

the appointment of assessors and co-assessors; 

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

(d) 

(e) 

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

cooperation  with 
joint  scientific 
the  European  Medicines  Agency  on 
consultations  on  medicinal  products  where  a  health  technology  developer 
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 devices. 

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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 empowered 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 developers 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, the Coordination Group shall consult: 

(a)  health technology developers; 

(b)  patient organisations;  

(c) 

(d) 

(e) 

clinical experts; 

the European Medicines Agency including on the pre-notification of medicinal 
products prior to marketing authorisation applications; 

the  Medical  Devices  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. 

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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.  

The  Coordination  Group  shall  be  used  to  facilitate  the  cooperation  referred  to  in 
paragraph 1. 

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.  

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 reports and the IT platform referred to in Article 27. 

2. 

3. 

4. 

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) 

(b) 

1. 

joint clinical assessments carried out in accordance with Chapter II; 

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

Article 21 
Clinical Assessment Reports 

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 
assessment.  

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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 Procedural 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 
conflicts 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)  methodologies  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 Report 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 Framework 

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 network referred to 
in Article 26 shall be ensured by the Union. The Union's financial assistance to the 

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2. 

activities under this Regulation shall be implemented in accordance with Regulation 
(EU, Euratom) No 966/2012 of the European Parliament and of the Council.18 

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 Coordination Group  

The  Commission  shall  support  the  work  of  the  Coordination  Group.  In  particular  the 
Commission shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

1. 

2. 

3. 

18 

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

provide  the  secretariat  for  the  Coordination  Group  and  provide  administrative, 
scientific and IT support; 

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; 

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

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

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  

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

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

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. 

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). 

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4. 

5. 

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

On the request of the Coordination Group, the stakeholder network shall 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, and completed joint clinical assessments and Member State 

health technology assessments; 

joint scientific consultations; 

studies on the identification of emerging health technologies; 

results of the voluntary cooperation between Member States. 

(b) 

(c) 

(d) 

2. 

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

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. 

2. 

3. 

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. 

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. 

The annual reports of the Coordination Group shall be used as part of the monitoring 
programme. 

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1. 

2. 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

Article 30 
Committee Procedure  

The  Commission  shall  be  assisted  by  a  committee.  That  committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011.  

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply.  

Article 31 
Exercise of the Delegation 

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

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]. 

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

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

the  principles 

laid  down 

in 

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

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

Article 32 
Preparation of Implementing and Delegated Acts 

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. 

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

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Article 33 
Transitional Provisions  

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].  

Member  States  shall  notify  the  Commission  where  they  intend  to  make  use  of  the 
transitional  period  set  out  in  paragraph  1  at  the  latest  one  year  before  the  date  of 
application of this Regulation.  

Member States which have delayed their participation in accordance with paragraph 
1  may  begin  participating  with  effect  from  the  next  financial  year  after  having 
notified the Commission at least three months before the beginning of that financial 
year.  

Article 34 
Safeguard Clause 

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

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

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  

Article 15 of Directive 2011/24/EU is deleted.  

References to the deleted Article shall be construed as references to this Regulation.  

Article 36 
Entry into Force and Date of Application 

This  Regulation  shall  enter  into  force  on  the  twentieth  day  following  that  of  its 
publication in the Official Journal of the European Union. 

It shall apply from [insert date 3 years after date of entry into force]. 

1. 

2. 

3. 

1. 

2. 

3. 

1. 

2. 

1. 

2. 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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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. 

MANAGEMENT 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  expenditure  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 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

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 
project/preparatory action19  

relates 

to  a  new  action 

following  a  pilot 

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 objectives 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. 

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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  quality  and 
timely 
joint 
joint  clinical  assessment  reports).  Furthermore,  focusing 
assessments  on  clinical  data  makes  them  relevant  to  all  decision-makers, 
without  affecting  national  competences  on  pricing  and  reimbursement 
decisions.  

Cost savings and optimisation 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 both 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 relation 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  predictable  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 assessments 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  investment  in  health  technologies  which  would  for  instance 
address  unmet  medical  needs  and  lead  to  the  improvement  of  health  outcomes  for 
patients. 

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1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

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 consultations 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  identified  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  sustainable  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 ensures 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  the 
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. 

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1.5.3.  Lessons learned from similar experiences in the past 

for 

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 
increasing  knowledge  of  working  procedures  and 
and  stakeholders, 
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  addressed  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  quality  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  needs  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  objectives,  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  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). Moreover, the joint scientific 
consultations foreseen in this proposal will contribute 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  Single  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 innovation for the 
benefit  of  patients  by  influencing  longer-term  R&D  investment  decisions  by 
industry. 

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1.6. 

Duration and financial impact  

 Proposal/initiative of limited duration  

–    Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial 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 designated; 

–    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 guarantees; 

–    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. 

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2. 

MANAGEMENT MEASURES  

2.1.  Monitoring 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  supporting  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 disclosed 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  by  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. 

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2.2.3.  Estimate of the costs and benefits of the controls 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 Commission. 

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 
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:  

line  with 

in 

‒ 

‒ 

‒ 

‒ 

the  financing  of 
decisions,  agreements  and  contracts  resulting  from 
implementing  activities  under 
the 
Commission,  including  the  Anti-Fraud  Office  (OLAF),  and  the  Court  of 
Auditors, to conduct audits, on-the-spot checks and inspections; 

this  proposal  will  expressly  entitle 

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 provisions 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 Commission will oversee a strict application of the rules on conflicts 
of interests provided for in the proposal. 

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3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL 

As the budgetary consequences of the proposal are expected to take effect from 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 the MFF post-2020. 

The proposal is compatible with the current MFF. 

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