COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on Health Technology Assessment and amending Directive 2011/24/EU
Date: 2021-11-17
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, 17.11.2021  COM(2021) 696 final 2018/0018 (COD)  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT  pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on Health Technology Assessment and amending Directive 2011/24/EU (Text with EEA relevance)  
 
 
2018/0018 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council on Health Technology Assessment and amending Directive 2011/24/EU 

(Text with EEA relevance) 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council 
(document COM (2018) 51 final, 2018/0018 (COD)): 

31 January 2018. 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee on the proposal: 

23 May 2018. 

Date of the position of the European Parliament, first reading: 

14 February 2019. 

Date of the opinion the European Economic and Social Committee 
on the amended proposal: 

27 April 2021. 

Date of transmission of the amended proposal: 

N/A. 

Date of adoption of the position of the Council: 

9 November 2021. 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The  proposal  aims  to  replace  the  current  system  of  EU-funded  project-based  cooperation 
between  Member  States  on  health  technology  assessment  with  a  permanent  framework  for 
joint work at EU-level. This framework would cover work on joint clinical assessments, joint 
scientific  consultations,  the  identification  of  emerging  health  technologies,  and  voluntary 
cooperation. The proposal seeks to address a number of identified weaknesses in the current 
system through the following objectives: 

Specific objectives: 

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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: 

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Promote convergence in HTA tools, procedures and methodologies; 

Reduce duplication of efforts for HTA bodies and industry; 

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Ensure the use of joint outputs in Member States; 

Ensure the long-term sustainability of EU HTA cooperation. 

COMMENTS ON THE POSITION OF THE COUNCIL 

The  position  of  the Council  as  adopted  at  first  reading  fully  reflects  the  political  agreement 
reached between the European Parliament and the Council on 21 June 2021. The Commission 
can accept this agreement. The main points of this agreement are the following: 

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Progressive  implementation:  A  phase-in  period  of  five  years  has  been  introduced, 
during  which  the  volume  of  joint  clinical  assessments  for  medicinal  products  is 
increased  in  a  step-wise  manner,  based  on  particular  product  categories.  As  of  the 
date  of  application,  in  a  first  step,  joint  clinical  assessments  will  be  carried  out  on 
medicinal  products  containing  new  active  substances  for  which  the  therapeutic 
indication is the treatment of cancer and on medicinal products which are regulated 
as  advanced  therapy  medicinal  products.  This  approach  fully  supports  Europe’s 
Beating Cancer Plan. Interim dates for each step are set out in the agreed text. This is 
acceptable considering that the Commission proposal also included the concept of a 
gradual  phase-in  (via  a  transitional  period  envisaged  in  the  Commission  proposal) 
and  the  definition  of  clear  product  categories  and  their  interim  steps  provide 
predictability for health technology developers.  

Obligations  on  Member  States:  Member  States  will  be  required  to  “give  due 
consideration” to the joint clinical assessment reports. This wording is less stringent 
than  that  of  the  original  Commission  proposal.  However,  this  approach  can  be 
accepted  taking  into  account  that  a  number  of  safeguards  were  introduced  to 
strengthen obligations on Member States, namely the requirement to annex the joint 
clinical assessment report to the national health technology assessment and to report 
on  how  each  joint  clinical  assessment  report  was  given  due  consideration  in  the 
health  technology  assessment  at  national  level.  Further  additions  include  the 
strengthened level of obligations on health technology developers to provide all data 
and evidence necessary for the assessment, and the requirement for Member States to 
not  duplicate  requests  for  data  and  evidence  to  be  used  for  the  joint  clinical 
assessments.  

Quality,  transparency,  timeliness  and  enhanced  level  of  involvement  of  external 
experts and stakeholder organisations: A number of changes were introduced in the 
agreed  text  to  further detail  the provisions in the Commission's proposal  on quality 
and  transparency.  These  include  the  addition  of  specific  provisions  on  quality 
assurance, transparency and conflicts of interest. More details were also added to the 
text on the level of involvement of external experts and stakeholder organisations, on 
the procedures for joint clinical assessments, including the timing of the submissions 
of data and the end of the assessment, and on submission dossier requirements that 
are  set  out  in  the  agreed  text.  While  in  the  Commission  proposal,  most  of  these 
aspects  were  to  be  further  developed  in  tertiary  legislation,  specifying  some 
important elements already in the main text is acceptable.  

Voting  regime  of  the  Coordination  Group  and  finalisation  of  joint  clinical 
assessments:  The  Coordination  Group  of  Member  States  authorities  and  bodies 
responsible for HTA shall take its decisions by simple majority based on a principle 
of  one  vote  per  Member  State,  as  foreseen  by  the  Commission  proposal.  An 
exception  was  introduced  in  the  agreed  text  for  the  adoption  by  the  Coordination 

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Group of its annual work programme and its annual report, which will be adopted by 
a  qualified  majority  of  Member  States.  By  way  of  derogation  from  the  simple 
majority  voting  system,  the  joint  clinical  assessment  report  shall,  where  consensus 
cannot  be  reached,  include  the  diverging  scientific  opinions  and  the  scientific 
grounds  on  which  these  are  based.  In  addition,  according  to  the  agreed  text  the 
Commission  shall conduct  procedural  reviews and publish joint  clinical  assessment 
reports  considered  to  be  compliant  with  the  procedural  rules.  The  agreed  text  is 
acceptable  as  it  preserves  the  approach  that  scientific  reports  (such  as  the  joint 
clinical  assessments)  are  agreed  by  consensus.  The  role  of  the  Commission  in  the 
procedural  review  as  well  as  the  publication  and  finalisation  of  the  reports  ensures 
legal certainty in the process and is acceptable.  

4. 

CONCLUSION 

The Commission supports the results of the inter-institutional negotiations and can therefore 
accept the Council's position at first reading. 

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