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 compulsory licensing for crisis management and amending Regulation (EC) 816/2006
Date: 2025-10-29
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: coronavirus disease, epidemic, export monitoring, health aid, intellectual property, pharmaceutical product, risk management, rule under emergency powers, security of supply

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   EUROPEAN COMMISSION  Brussels, 29.10.2025  COM(2025) 661 final 2023/0129 (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 compulsory licensing for crisis management and amending Regulation (EC) 816/2006  
 
2023/0129 (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 compulsory licensing for crisis management and amending Regulation 
(EC) 816/2006 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council (document COM(2023) 224 final – 2023/0129COD): 

27 April 2023. 

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

20 September 2023. 

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

13 March 2024. 

Date of transmission of the amended proposal: 

N/A. 

Date  of  adoption  by  the  Permanent  Representatives  Committee  of 
the Council’s mandate for interinstitutional negotiations: 

26 June 2024. 

Date of provisional agreement between the co-legislators: 

21 May 2025. 

Date  of  confirmation  of  the  final  compromise  text  of  the  proposal 
by the Permanent Representatives Committee:  

13 June 2025. 

Date  of  approval  of 
negotiations by the European Parliament's JURI Committee: 

the  outcome  of 

the 

interinstitutional 

24 June 2025. 

Date of adoption of the position of the Council, first reading: 

27 October 2025. 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The  aim  of  this  proposal  is  to  provide  the  Internal  Market  with  an  efficient  compulsory 
licensing  scheme  for  crisis  management.  The  initiative  therefore  has  two  main  objectives. 
First, it aims to enable the EU to rely on compulsory licensing during crises under certain EU 
crisis  instruments.  Second,  it  introduces  an  efficient  compulsory  licensing  scheme,  with 
appropriate features and safeguards, to allow a swift and appropriate response to crises, with a 
functioning Internal Market, guaranteeing the supply and the free movement of crisis-critical 
products subject to compulsory licencing in the internal market. 

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3. 

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 May 2025. The Commission 
supports this agreement. The main points of this agreement, which is reflected in the position 
of the Council, are the following: 

On  the  disclosure  of  trade  secrets:  It  is  clarified  that  the  proposal  does  not  impose  any 
obligation  to  disclose  trade  secrets,  while  acknowledging  the  possibility  of  voluntary 
conclusion of agreements on trade secrets. 

On  the  scope:  The  list  of  crisis  instruments  triggering  the  compulsory  licensing  scheme  no 
longer  includes  the  Chips  Act  and  the  Gas  Supply  Security  Regulation.  Defence-related 
products1  are  now  explicitly  excluded  from  the  scope  of  the  proposal.  An evaluation  clause 
was included for the list of relevant crisis instruments, with the possibility of assessing new 
and  existing  instruments  and  with  a  specific  reference  to  semiconductors  for  medical 
equipment. 

Addition of conditions to grant a compulsory licence: The granting of a Union compulsory 
licence is now subject to four cumulative conditions, namely (i) a crisis or emergency mode 
has been declared, (ii) the use of a protected invention which concerns crisis-relevant products 
is required to secure the supply of those products in the Union, (iii) means other than a Union 
compulsory  licence,  including  voluntary  agreements,  could  not  be  achieved  within  a 
reasonable  timeframe  and  could  not  ensure  access  to  the  products,  (iv)  the  rightsholder 
concerned  was  given  the  opportunity  to  provide  comments  to  the  Commission  and  the 
competent advisory body. 

Changes  to  the  procedure  for  granting  a  compulsory  licence:  The  role  of  the  advisory 
body to assist and advise the Commission largely remains the same, although the tasks have 
been restructured and further specified. In particular, experts from intellectual property offices 
and national authorities responsible for granting compulsory licences must now be involved in 
advisory body discussions on intellectual property. In addition, the EP can also participate, as 
an  observer,  in  the  relevant  meetings  of  the  competent  advisory  body,  including  the  ad  hoc 
advisory  body.  Changes  made  to  Article 7  include  a  reference  to  preliminary  information 
gathered  under  the  relevant  Union  crisis  or  emergency  mechanism,  which  the  Commission 
should  consider  when  deciding  whether  to  initiate  the  procedure  for  granting  a  Union 
compulsory  licence.  In  addition,  the  procedure  is  to  be  formally  initiated  by  publishing  a 
notice on the Commission’s website. It is now stated that where the Commission’s decision to 
grant  a  Union  compulsory  licence  departs  from  the  opinion  of  the  advisory  body,  it  must 
indicate the reasons for this. Furthermore, where the Commission decides not to grant a Union 
compulsory licence, a notice must be published in the Official Journal of the European Union 
to provide information about the end of the procedure. Finally, the possibility of concluding 
voluntary licensing agreements at any time during or after the procedure for granting a Union 
compulsory licence is explicitly set out in the text. 

On  comitology:  the  advisory  procedure  was  replaced  by  the  examination  procedure  for 
implementing  acts  adopting,  modifying  and  terminating  a  Union  compulsory  licence.  A  no-
opinion clause was included for the adoption of the implementing act. A recital justifying the 
use  of  the  examination  procedure  in  light  of  the  spirit  of  the  Comitology  Regulation  was 
added. 

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As  defined  in  Article 3(1)  of  Directive  2009/43/EC  simplifying  terms  and  conditions  of  transfers  of 
defence-related products within the Community. 

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4. 

CONCLUSION 

The Commission supports the outcome of the interinstitutional negotiations and can therefore 
accept the Council’s position at first reading. 

5. 

STATEMENT FROM THE COMMISSION 

The Commission has made one unilateral statement, which can be found in the appendix. 

APPENDIX 

Statement from the Commission 

Commission statement on Regulation 816/2006: 

The Commission commits to present a report to the European Parliament, the Council, and 
the European Economic  and Social Committee on Regulation  816/2006, in  line with  Article 
19 of this Regulation. 

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