COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document 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  SWD(2018) 42 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU {COM(2018) 51 final} - {SWD(2018) 41 final}  
 
 
Impact assessment on Strengthening EU cooperation on Health Technology Assessment (HTA)   

Executive Summary Sheet 

A. Need for action 

Why? What is the problem being addressed?  
HTA is considered a valuable tool for ensuring the sustainability of health systems and stimulating innovation at 
EU level, but a series of shortcomings have prevented the full potential of HTA being reached for Member States 
and  economic  operators  with  subsequent  negative  consequences  also  for  EU  patients  and  healthcare 
professionals:  1)  Impeded  and  distorted  market  access,  results  from  different  national  HTA  processes  and 
methodologies meaning that economic operators who want to introduce a health technology in multiple Member 
States are confronted with various data requests. 2) Duplication of work for national HTA bodies means that 
they carry out in parallel or within a similar time-frame, clinical assessments on the same health technologies. In 
addition,  the  results  of  joint  clinical  assessments  (relative  effectiveness  assessments  -  REA)  carried  out  by  a 
group of HTA bodies in the framework of the current Union-funded cooperation (EUnetHTA Joint Action 3) have 
not  been  used  at  national  level  ("low  uptake"),  which  has  resulted  in  additional  duplication,  extra  work  and 
supplementary  costs.3)  Unsustainability  of  the  current  HTA  cooperation.  The  current  EU  cooperation  on 
HTA is project-based with no guarantee for the continuation of activities or their financing in the long-term.  

What is this initiative expected to achieve?  
The  general  objectives  of  the  initiative  are  to  ensure  a  better  functioning  of  the  internal  market  of  health 
technologies and to contribute to a high level of human health protection.  
The  specific  objectives  of  the  initiative  are:  to  promote  convergence  in  HTA  tools,  procedures  and 
methodologies;  to  ensure  efficient  use  of  resources  and  strengthen  the  quality  of  HTA  across  the  EU  and  to 
improve business predictability. 

What is the value added of action at the EU level?  
While  the on-going  cooperation  (i.e.  EUnetHTA Joint  Actions  and HTA Network)  has  illustrated  benefits  of  EU 
cooperation, the current model has not contributed to the removal of the fragmentation of the internal market, or 
the  duplication  of  assessments.  Without  an  EU  initiative,  it  is  unlikely  that  long-term  cooperation  on  HTA 
between Member States would be strengthened, with a potential risk of losing the results achieved until now. By 
carrying  joint  clinical  assessments,  economies  of  scale,  greater  business  predictability,  increased  quality  and 
consistency and improved transparency for patients would be achieved in the long run. 

B. Solutions 

What  legislative  and  non-legislative  policy  options  have  been  considered?  Is  there  a  preferred 
choice or not? Why?  
Two non-legislative options were considered. Policy option 1 supposes that when EUnetHTA Joint Action 3 
ends in 2020 the EU funding for the scientific and technical cooperation is discontinued. The cooperation would 
be voluntary, relying on national resources and is expected to remain sporadic. Policy option 2 provides for a 
voluntary cooperation model, implemented through EU-funded projects other than Joint Actions. It is dependent 
on  the  willingness  of  HTA  bodies  to  participate,  with  no  guarantee  for  the  implementation  of  joint  outputs. 
Additionally,  three  legislative  policy  options  were  considered.  Policy  option  3  provides  for  a  permanent 
cooperation  mechanism  allowing  for  the  harmonisation  of  common  HTA  tools,  procedures,  methodology  and 
joint Early Dialogues with health technology developers. Policy option 4 builds on option 3, to which joint clinical 
assessments  (i.e.  joint REA)  are  added.  This policy option could be  applied  through  an  'opt-in' system  (option 
4.1) or to all Member States with no possibilities to opt-in later or stay out (option 4.2). Policy option 5 which 
extends option 4 by including the joint full HTA (i.e. REA plus an economic assessment and other non-clinical 
domains) was not considered feasible and was discarded at the start of the process. The preferred option is a 
revised  Option  4.2  which  integrates  elements  from  other  policy  options  (i.e.  2  and  4.1)  and  also  some 
adjustments  (i.e.  progressive  implementation  of  the  product  scope,  inclusion  of  transitional  arrangements  for 
Member  States  and  specific  approach  for  medical  technologies).    The  preferred  governance  option  includes a 
central secretariat to be hosted by the European Commission.  

Who supports which option?  
Most Member States' public administrations  support options 3-4, favouring a stepwise approach/transitional 
regime.  Payers  expressed  concerns  about  mandatory  use  of  economic  assessments.  Patients  are  strong 
supporters of option 5, or at least option 4. Healthcare professionals and academia advocate for options 4-5, and 

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together  with  patients'  representatives  support  a  legal  framework  to  secure  their  participation  in  the  HTA 
process. The pharmaceutical industry supports option 4 advocating for a legal framework to guarantee uptake 
of  joint  clinical  assessments  by  Member  States.  The  medical  technologies  industry  expressed  concerns 
regarding  a  "one  size  fits  all"  solution  and  a  legally  mandated  joint  clinical  assessment  (REA)  at  the  time  for 
market launch. 

C. Impacts of the preferred option 

What are the benefits of the preferred option (if any, otherwise main ones)?                                  
The preferred option is considered to provide for the best combination of effectiveness and efficiency and is the 
most proportionate one: 
-  It  allows  for  the  best  possible  achievement  of  the  internal  market  objective  by  promoting  convergence  in 
procedures and methodologies, reducing duplications/parallel REA and thereby the risk of divergent outcomes, 
thus contributing to improving the availability of innovative health technologies for patients;  
- It provides Member States with a sustainable framework allowing them to pool expertise, reinforce evidence-
based decision making, supporting them in their efforts to ensure sustainability of national health systems; 
-  It  respects  the  subsidiarity  principle,  taking  into  account  the  time  needed  for  adapting/aligning  to  the  system 
and leaving the economic/non-clinical assessment to national or regional level; 
- It is  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 duplications and improving business predictability;   
- It provides useful input to and  synergies with the Digital Single Market agenda and  play an important role in 
supporting innovation by influencing longer-term R&D investment decisions by industry. It is fully coherent with 
other EU legislation in the field of medicinal products and medical devices. 

What are the costs of the preferred option (if any, otherwise main ones)?  
Economic  impacts.  The  cost  savings  related  to  the  joint  clinical  assessments  (REA)  could  reach  over  time 
EUR  2  670  000  per  year  for  HTA  bodies.  A  high  quality  joint  REA  is  also  expected  to  contribute  to  better 
allocation  of  resources  and  more  efficient  healthcare  investments  decisions,  but  these  benefits  are  difficult  to 
quantify  at  this  stage.  For  industry,  the  most  important  economic  impact  is  related  to  the  expected  benefits  in 
terms  of  predictability,  leading  to  better  innovation  and  increased  competitiveness.  Social  impacts.  The 
availability  of  timely  and  good  quality  joint  REAs  mean  better  evidence  available  for  national  decision-making, 
sustainability  of  health  systems,  and  ultimately  improved  public  health.  The  joint  REA  will  further  improve  the 
participation  of  patients  and  transparency.  It  has  the  potential  to  speed  up  assessment  timelines  and  thereby 
reduce delays in the availability of innovative medicines. 
Costs.  The  overall  costs  of  the  preferred  option  were  estimated  at  approximately  EUR  16  million,  of  which  7 
million represent the running costs and the rest the costs of the joint outputs.   

How will businesses, SMEs and micro-enterprises be affected?  

In the area of pharmaceuticals SMEs are mostly engaged in the discovery phase of new molecules, and a very 
low  number  apply  for  central  marketing  authorisation.  The  number  of  applications  for  joint  REA  from  SMEs  is 
expected to be very low, and since no fees are foreseen for this type of joint output, the compliance costs are 
expected  to  be  low.  Similar  treatment  would  be  applied  for  SMEs  in  the  field  of  medical  technologies  (no 
compliance fee in case of a joint REA).  

Will there be significant impacts on national budgets and administrations?  
The  planned  work-sharing  is  expected  to  result  in  cost  savings  for  public  administrations.  It  is  expected, 
however, that in the short run national administrations would be faced with limited administrative costs/burden as 
they have to adapt to the joint system.  

Will there be other significant impacts?  
No other significant impacts have been identified. 

D. Follow up 

When will the policy be reviewed?  
Continuous monitoring and evaluation is planned. A review of the scope and governance structure, including the 
possibility of introducing fees for joint clinical assessments is planned. 

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