COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Date: 2022-07-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: artificial reproduction, blood transfusion, cytology, health control, quality standard, safety standard, stem cell, substance of human origin, therapeutics

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   EUROPEAN COMMISSION  Brussels, 14.7.2022  SWD(2022) 191 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council  on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC {COM(2022) 338 final} - {SEC(2022) 304 final} - {SWD(2022) 189 final} - {SWD(2022) 190 final}  
 
 
Executive Summary Sheet 

Impact assessment on the revision of the EU legislation on blood, tissues and cells (BTC) 

A.  Need for action 

What is the problem and why is it a problem at EU level? 

The evaluation of the Blood and Tissues and Cells Directives showed that patients, donors and children 
born from donated eggs, sperm or embryos are not fully protected from avoidable risks, as the legislation 
has not kept up to date with scientific and epidemiological developments; there are divergent approaches 
to  oversight  among  Member  States,  leading  to  barriers  for  cross-border  exchange  of  BTC;  the  full 
potential of innovative therapies is not reached for patients, who are also vulnerable to interruptions of 
BTC supply. There are also some undue burdens due to the absence of common IT systems. 

What should be achieved? 

The  overall  objective  of  this initiative  is  to  ensure  a high  level of health  protection,  by  providing  safe 
access  to  BTC  therapies  for  EU  citizens.  As  new  technologies  or  risks  will  continue  to  emerge,  it  is 
necessary for the framework to be future-proof, resilient and agile enough to accommodate new trends 
and continue providing appropriate safety and quality requirements. 

What is the value added of action at EU level (subsidiarity)? 

By  providing  a  framework  for  cross-border  cooperation,  based  on  a  common  set  of  rules,  EU-level 
measures  are  best placed to  address the above  issues  effectively,  with  EU  expertise.  Establishing  high 
standards of quality and safety for BTC at an EU level brings equal levels of access to safe therapies.  

B.  Solutions 

What are the various options to achieve the objectives? Is there a preferred option or not? If not, 
why? 

Three options to set and update technical standards were assessed: 
  Option 1 - Decentralised regulation: blood and tissue establishments make reference to a variety of 
national and international guidance to set their internal technical standards for their own activities. 
  Option 2 - Joint regulation: blood and tissue establishments have to follow the technical standards 

defined in guidance developed and maintained by nominated EU expert bodies.  

  Option  3  -  Central  Regulation:  blood  and  tissue  establishments  have  to  follow  the  technical 

standards defined in EU law. 

The preferred option is Option 2, which brings the highest effectiveness and efficiency as it builds on 
established BTC expertise to get timely standards that are applied across the EU.  
In addition, a series of common measures was assessed, to fill some legal gaps in the BTC framework, 
strengthen  oversight,  facilitate  innovation,  with  advice  on  when  the  BTC  legislation  is  applicable  (the 
delineation  with  other  frameworks  will  not  change),  a  (risk-)  proportionate  authorisation  for  new 
processes,  and  (crisis)  management  of  BTC  supply.  Regarding  digital  aspects,  the  preferred 
implementation is a new single IT system.  
What are different stakeholders' views? Who supports which option? 

There  is  broad  support  among  stakeholders  for  option  2,  and  for  the  common  measures.  However, 
national  competent  authorities  flagged  concerns  on  the  resources  needed  for  the  implementation  of 
measures  to  strengthen  oversight.  Also,  while  supported,  stakeholders  pointed  out  that  crisis 
preparedness  measures  will  bring  significant  efforts  without  direct  impact  in  reducing  the  risks  of 
shortages of critical BTC. 
C.  Impacts of the preferred option 

 
 
What are the benefits of the preferred option (if any, otherwise of main ones)? 

The preferred option would ensure that citizens are better protected when donating, or being treated with 
a  substance  of  human  origin,  with  more  harmonised  safety  and  quality  rules  across  EU.  It  would  also 
bring  a  positive  impact  for  healthcare  professionals,  in  particular  in  blood  and  tissue  establishments. 
Outdated, and sometimes costly, technical rules for safety and quality will be removed and replaced with 
standards based on the best scientific evidence and expertise available, and updated in a timely manner. 
The common measures will also strengthen oversight by national competent authorities. Digitalisation 
will allow for further efficiencies in administrative processes, and the possibility for sharing information 
will limit duplication of work across Member States. 
What are the costs of the preferred option (if any; otherwise of main ones)? 

The  main  costs  relate  to  monitoring  measures  (donors,  offspring,  supply),  to  registration  of  bedside 
preparations of BTC and to the risk-proportionate pathway to authorise BTC processed or used in new 
ways. Those costs mostly fall on professionals in blood and tissues establishments, hospitals and clinics 
and, to a lesser degree, on national competent authorities. For EU institutions,  the set-up of a common 
EU IT platform brings an important  cost, but will allow to lighten (administrative) burden for  national 
authorities and  professionals.  Further  EU  costs relate  to  coordination  and  co-funding  of expert  bodies. 
The overall costs for the measures under the preferred option are expected to be around EUR 38 million 
per year, above the baseline. 
What are the impacts on small and medium-sized enterprises (SMEs)? 

Only  a  small  amount  of  for-profit  ‘small  and  medium-sized  enterprises’  (SMEs)  will  be  directly 
impacted  by  the  initiative;  it  concerns  mostly  establishments  found  in  the  sub-sector  of  medically 
assisted  reproduction  (private  IVF  clinics).  The  BTC  sector  is  also  dependent  from  developments  in 
medical device technologies (e.g., test kits) and ICT (e.g., data-registries), two SME-rich sectors. 
Will there be significant impacts on national budgets and administrations? 

New measures such as authorisation of novel BTC preparations, oversight of bedside BTC preparations 
and of new SoHOs will require additional resources. The introduction of some risk-based measures will 
however enable a more efficient oversight with limited resources. Authorities will be further supported 
with measures like training, audits, common guidance and a dedicated EU IT platform. 
Will there be other significant impacts? 

There  will  be  positive  impacts  on  some  fundamental  rights  of  citizen  (health  protection,  non-
discrimination),  although  for  most  of  the  ethical  aspects, in  particular  the  rights  of  children  born  from 
medically assisted reproduction, the decisions are taken by Member States at national level. 
Digital impacts are expected: a single IT system can host flexible solutions, allowing Member States and 
blood  and  tissue  establishments  to  maintain  and  connect  with  their  own  system  or  re-use  existing 
components. It could become an important node in the European Health Data Space and more broadly 
the EU digital ecosystem. 
Proportionality? 

The overall initiative is limited to aspects that Member States cannot achieve satisfactorily on their own, 
and where there is an EU added value. The added value of the EU approach is to ensure the full use of 
the high level of scientific and technical expertise already available in expert bodies such as the ECDC 
and the EDQM. 
D. Follow up 

When will the policy be reviewed? 

The  Commission  will  review  the  monitoring  indicators  periodically  and  evaluate  the  impacts  of  the 
legislative act after 5 years. 

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