REGULATORY SCRUTINY BOARD OPINIO REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF REGIONS on the interim evaluation of the EU4Health Programme 2021-2024
Date: 2025-11-25
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU financing, EU programme, cross-border cooperation, disease prevention, health care, health care system, illness, multiannual financial framework, project evaluation, public health

EUROPEAN COMMISSION 

Brussels, 15.11.2024 
SEC(2025) 304 final 

 REGULATORY SCRUTINY BOARD OPINION 

REPORT FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND 
SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS  
on the interim evaluation of the EU4Health Programme 2021-2024 

{COM(2025) 709 final} 
{SWD(2025) 369 final} 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EUROPEAN COMMISSION 
Regulatory Scrutiny Board 

Brussels,  
Ares(2024) 

Opinion 

Title: Evaluation / Interim evaluation of the EU4Health Programme 
2021-2027 

Overall opinion: NEGATIVE 

(A) Policy context 

Regulation  (EU)  2021/522,  adopted  in  March  2021,  established  the  EUR  5.7  billion 
EU4Health Programme  (2021-2027).  It has four  general objectives:  (i) to improve  and 
foster health in the Union; (ii) to protect people from serious cross-border threats to health; 
(iii) to improve access to medicinal products, medical devices and crisis-relevant products; 
and (iv) to strengthen health systems.  

The interim evaluation aims to measure the Programme’s progress up to April 2024, across 
the 27 Member States and the six non-EU countries associated. 

(B) Key issues 

The  Board  notes  the  additional  information  provided  and  commitments  to  make 
changes to the report. 

However,  the  Board  gives  a  negative  opinion  because  the  report  contains  the 
following serious shortcomings:  

(1)  The intervention logic is not clear on the causality between investment, outputs, 
results  and  impacts.  The  monitoring  system  and  available  indicators  are  not 
sufficiently  analysed  to  support  the  evaluation  and  to  identify  areas  for  their 
improvement.  

(2)  The report makes statements not supported by evidence and analysis. The report 
is not clear about the additionality of the Programme. The effectiveness analysis 
is incomplete. The approach to assessing efficiency is conceptually incorrect. The 
potential for simplification and administrative cost reduction is not sufficiently 
assessed.  

(3)  The conclusions do not fully reflect the key findings of the analysis. The lessons 
learned  are  not  sufficiently  developed  to  improve  the  implementation  of  the 
Programme and to allow for final evaluation. 

  ________________________________   
This opinion concerns a draft evaluation/fitness check which may differ from the final version. 

Commission européenne, B-1049 Bruxelles - Belgium. Office: BERL 08/010. E-mail: regulatory-scrutiny-board@ec.europa.eu 

 
 
 
 
 
 
(C) What to improve 

(1)  The explanation of the intervention logic should be further  developed to  identify the 
causal link between inputs, actions, outputs, results and impacts. The causal link should be 
clear  and  specific  for  all  areas  of  intervention  in  view  of  its  importance  for  the  entire 
assessment. If the causality cannot be established, the report should explain how it accounts 
for  the  absence  of  causality,  be  clear  throughout  whether  the  analysis  refers  to  causal 
relationships or not and explicitly state limitations. As this is the interim evaluation the report 
should  draw  lessons  regarding  methodology  and  data  collection  to  overcome  causality 
limitations so that the impact of the Programme can be assessed in the final evaluation.  

(2)  The report should explain how the specific objectives could be further operationalised 
in terms of their specificity and measurability to allow evaluation and measurement of the 
performance of the intervention. 

(3)  The report should further analyse the available indicators from the existing monitoring 
system,  including  the  Programme  Performance  Monitoring  and  Evaluation  Framework 
(PPMEF), and reflect on their usefulness for this evaluation as well as for a final evaluation. 
In this respect, it should critically assess the findings of support study.  

(4)  Given that at present, some indicators cover areas with multiple investment and policy 
activities, in particular at national level, and that there is only one impact indicator, the report 
should  reflect  on  how  the  results  would  be  measured,  the  causal  links  established,  and 
impacts assessed and appropriated to the Programme in the final evaluation. It should explore 
what data and indicators may be needed to provide robust and meaningful input to assess the 
results and impacts of the Programme. In this context, the report should elaborate on how an 
improved and revised methodology and PPMEF would address those issues.  

(5)  The  report  should  clearly  establish  the  appropriate  points  of  comparison.  It  should 
attempt to create a chart or a table illustrating the baseline (i.e. the pre-Programme situation 
in  2020),  the  expected  achievements  (i.e.  what  was  expected  at  time  of  adoption  to  be 
achieved by 2024), and  the actual situation in  2024.  In terms of inputs, the report  should 
present a reflection of the consequences of the reduction of the Programme budget. It should 
include a description on how the Programme operates, how much money has been spent, and 
who are the beneficiaries. In terms of completeness of the analysis, the assessment should be 
performed on all programs and activities under each strand.  

(6)  The report should provide more explicit analysis of the additionality of the Programme. 
In this context, the report should isolate the effects of the Programme from possible effects 
due  to  other  interventions  or  draw  conclusions  where  it  is  not  possible  due  to  PPMEF 
limitations. The EU added value and relevance analysis should be further strengthened and 
focused  on  the  added  value  that  goes  beyond  what  could  reasonable  be  achieved  from 
Member States acting independently and considering the size of the Programme. 

(7)  The report should better explain the limitations of the effectiveness analysis. It should 
clarify  whether  the  analysis  at  the  level  of  outputs  is  complete,  i.e.  whether  it  covers  all 
actions  and  activities,  or  is  based  on  selection  of  those.  It  should  identify  and  present 
shortcomings or underperforming elements in the intervention, if any.  The flow of analysis-
conclusions  is  not  always  evident,  and  the  report  often  makes  statements  without  clear 
support  from  the  preceding  analysis.  Statements,  not  supported  by  the  analysis  or  the 
available evidence, should be avoided. The report should not imply causality between the 
intervention and the observed effects unless supported by the analysis of available data. The 

2 

 
 
 
 
 
 
conclusions from the effectiveness assessment should clearly follow from the analysis and 
the available evidence.  

(8)  Given that the estimates of Return on Investment (ROI) included in the report neither 
present the actual ROI of the Programme, nor are specific to the Programme, these estimates 
should not be used in the efficiency analysis and in the related conclusions.  The report should 
clearly explain the limitations of the efficiency analysis at this stage of the implementation 
of the Programme. It should be clear upfront and consistent throughout that the analysis is 
based on the outputs and to the limited extent on the results, not the impacts.  Any conclusions 
on efficiency of the Programme should be adjusted to  reflect  the underlying  analysis and 
limited available evidence. The report should further assess the potential for simplification 
and reduction of administrative burden. In this context, it should better use the findings from 
the customer journey case studies. It should compare the administrative costs related to the 
implementation  of  the  Programme  with  the  administrative  costs  of  implementing  other 
programmes.  

(9)  The  Cost/Benefit  Table  should  be  amended  to  include  all  relevant  costs,  both 
investments and administrative costs, as well as benefits to the extent possible, and to remove 
any inconsistences with the proceeding analysis. The Table on Potential Simplification and 
Burden  Reduction  should  be  further  developed  once  the  analysis  mentioned  above  is 
completed. 

(10) The conclusions and lessons learned should be revised to better reflect the analysis and 
better  inform  for  future  action  in  particular  on  improving  the  implementation  and  the 
monitoring of the Programme. The conclusions should be objective, clearly supported by the 
analysis  and  the  available  evidence,  and  taking  into  account  all  identified  potential 
underperforming  elements.  The  conclusions  should  summarise  the  findings  of  the 
assessments  for  all  evaluation  criteria.    Lessons  learned  should  make  better  use  of 
conclusions  from  the  support  study  to  inform  on  future  actions.  They  should  be  further 
elaborated to focus on improving the implementation of the Programme and should reflect 
on necessary methods and data for the final evaluation.  

Some more technical comments have been sent directly to the author Service. 

(D) Conclusion 

The lead Service must revise the report before launching the interservice consultation. 

The lead Service may resubmit to the Board a revised version of this report.  

Full title 

Interim evaluation of the EU4Health Programme 2021-2027 

Reference number 

PLAN/2023/1633 

Submitted to RSB on 

17 October 2024 

Date of RSB meeting 

13 November 2024 

3 

Electronically signed on 15/11/2024 12:12 (UTC+01) in accordance with Article 11 of Commission Decision (EU) 2021/2121