Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union in the first meeting of the States Parties Committee for the Implementation of the International Health Regulations (2005)
Date: 2026-07-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: World Health Organisation, cross-border cooperation, disease prevention, epidemic, health care, health legislation, international cooperation, joint body (EU), multilateral agreement

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   EUROPEAN COMMISSION  Brussels, 20.7.2026  COM(2026) 406 final 2026/0226 (NLE)  Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union in the first meeting of the States Parties Committee for the Implementation of the International Health Regulations (2005)  
 
EXPLANATORY MEMORANDUM 

1. 

SUBJECT MATTER OF THE PROPOSAL 

This proposal concerns the decision establishing the position to be taken on the Union's behalf 
in  the  first  meeting  of  the  States  Parties  Committee  for  the  Implementation  of  the 
International  Health  Regulations  (2005)  in  connection  with  the  envisaged  adoption  of  the 
terms  of reference  for the Committee and its Subcommittee, which is  to  be established also 
during the meeting. 

2. 

CONTEXT OF THE PROPOSAL 

2.1. 

The International Health Regulations (2005) 

The  International  Health  Regulations  (2005)  constitute  an  instrument  of  international  law, 
adopted pursuant to Article 21 of the Constitution of the World Health Organization (WHO) 
in  2005,  replacing  the  Regulations  adopted  in  1969.  They  entered  into  force  in  June  2007. 
They are legally binding on all WHO Member States, as well as the Holy See, Liechtenstein 
and Palestine. The Regulations provide an overarching legal framework in the field of global 
health security and define the Parties’ rights and obligations in handling public health events 
and emergencies that have a cross-border potential. 

The International Health Regulations (2005) have been amended in 2014, 2022 and 2024. The 
amendments adopted by the World Health Assembly on 1 June 2024, which led to the most 
substantial  revision  of  the  instrument  since  its  entering  into  force,  aim  at  strengthening  the 
International  Health  Regulations  (2005)  in  light  of  the  lessons  learned  from  the  COVID-19 
crisis, as well as from previous outbreaks. They focus on improving international cooperation 
and collaboration in response to health threats and provide a framework for enhanced support 
to ensure stronger implementation of the International Health Regulations (2005). 

The  Commission  negotiated  the  2024  amendments  to  the  International  Health  Regulations 
(2005)  on  behalf  of  the  Union,  for  matters  falling  within  Union  competence,  based  on  an 
authorisation from the Council set out in Council Decision (EU) 2022/451 of 3 March 20221. 
On  26  May  2025,  the  Council  adopted  a  Decision  inviting  Member  States  to  accept,  in  the 
interest  of  the  European  Union,  the  amendments  to  the  International  Health  Regulations 
(2005) contained in the Annex to Resolution WHA77.17 and adopted on 1 June 20242. 

The Union is not a party to the International Health Regulations (2005), as the Regulations do 
not provide for the possibility of accession by regional economic integration organisations3. 

All Member States are parties to the International Health Regulations (2005). The Netherlands 
and  Slovakia  have  however  rejected  both the  2022  and  2024  amendments to  the  International 

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OJ L92, 21.3.2022, p. 1. 
OJ L, 2025/1129, 4.6.2025. 
It  should  be  noted  that  the  Commission  had  put  forward  in  2022  a  proposal  to  amend  Article  64  of  the 
International  Health  Regulations  (2005)  to  allow  regional  economic  integration  organisation  to  become 
parties.  Such  proposal  did  not  meet  the  agreement  of  some  EU  Member  States  and  was  therefore  not 
included in the package of proposed amendments to the International Health Regulations (2005) submitted 
by the Czech Republic to the WHO on behalf of the Union and its Member States, on 30 September 2022.  

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Health Regulations (2005), while Italy, the Czech Republic and Austria4 rejected only the 2024 
amendments.  

2.2. 

The States Parties Committee for the Implementation of the International Health 
Regulations (2005) 

The States Parties Committee for the Implementation of the International Health Regulations 
(2005)  is  established  by  Article  54  bis  of  the  International  Health  Regulations  (2005)  to 
facilitate  the  effective  implementation  of  the  Regulations,  in  particular  of  Article  44  on 
Collaboration,  assistance  and  financing  and  Article  44  bis  on  the  Coordinating  Financial 
Mechanism.  Article  54  bis  is  a  new  article,  introduced  by  the  2024  amendments  to  the 
International Health Regulations (2005). 

Pursuant  to  Article  54  bis,  paragraphs  1  and  2,  the  Committee  shall,  at  its  first  meeting, 
establish  a  Subcommittee  to  provide  technical  advice  and  report  to  the  Committee  itself.  In 
addition, the Committee shall adopt, by consensus, its terms of reference, including the way 
that the Committee conducts its business, and the terms of reference for its Subcommittee. 

Pursuant to Article 54 bis, paragraph 4, the Committee shall also adopt, at its first meeting, by 
consensus,  the  terms  of  reference  for  the  Coordinating  Financial  Mechanism,  established  in 
Article  44  bis  of  the  Regulations,  and  modalities  for  its  operationalization  and  governance. 
The  Committee  may  also  adopt  necessary  working  arrangements  with  relevant  international 
bodies, which may support the operation of the Coordinating Financial Mechanism. 

No proposal for any such terms of reference is available. The first session of the Committee is 
scheduled to start on 31 August 2026. 

2.3. 

The envisaged act of the States Parties Committee for the Implementation of the 
International Health Regulations (2005) 

During  its  first  meeting,  the  States  Parties  Committee  for  the  Implementation  of  the 
International  Health Regulations  (2005)  is to adopt its own terms of reference, including the 
way  that  the  Committee  conducts  its  business,  as  well  as  the  terms  of  reference  for  its 
Subcommittee (‘the envisaged acts’). 

The  terms  of  reference  of  the  Committee  and  of  its Subcommittee  are  envisaged  to  address 
various  issues,  such  as  the  organisation  and  conduct  of  the  meetings,  the  participation  of 
observers, the preparation of the agendas, representation, or decision-making modalities, and 
as such they will encompass the rules of procedure for the Committee and its Subcommittee. 

3. 

POSITION TO BE TAKEN ON THE UNION'S BEHALF 

To support the proper functioning of the States Parties Committee for the Implementation of the 
International  Health  Regulations  (2005)  and  of  its  Subcommittee,  the  Union  should  support  the 
adoption of terms of reference that provide for the efficient, cost effective, transparent and orderly 
functioning and organisation of the meetings of the Committee and Subcommittee and that allow 
for the participation of the Union as an observer.  

Allowing for the participation of the Union as an observer to the meetings of the States Parties 
Committee for the Implementation of the International Health Regulations (2005), and of its 

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The Netherlands, the Czech Republic and Austria indicated that they were not in a position to finalise their 
domestic procedure for the acceptation of the amendments by the time of their entering into force. 

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Subcommittee  is  of  particular  importance,  as  the  International  Health  Regulations  include  a 
significant number of provisions that fall within matters for which the Union has competence 
on  the  basis  of  Article  168(5)  of  the  Treaty  on  the  Functioning  of  the  European  Union 
(TFEU),  read  together  with  Article  6  and  Article  168(1)  TFEU,  to  support,  coordinate  or 
supplement  the  actions  of  the  Member  States  and  in  relation  to  which  Union  rules  exist,  in 
particular  in  the  field  of  serious  cross-border  threats  to  health  under  Regulation  (EU) 
2022/2371.  

4. 

LEGAL BASIS 

4.1. 

Procedural legal basis 

The States Parties Committee for the Implementation of the International Health Regulations 
is a body set up by an agreement, namely the International Health Regulations (2005). 

The  envisaged  acts  which  the  States  Parties  Committee  for  the  Implementation  of  the 
International  Health  Regulations  (2005)  is  called  upon  to  adopt  will  produce  legal  effects 
under the International Health Regulations (2005) for the Union. 

They will in particular determine whether regional economic integration organisations such as 
the Union can participate as observers to the States Parties Committee for the Implementation 
of the International Health Regulations (2005) and to its Subcommittee. Such organisational 
acts  determining  the  participation  of  the  Union  in  the  meetings  of  the  Committee  and 
Subcommittee produce legal effects within the meaning of Article 218(9) TFEU. 

In  addition,  the  terms  of  reference  to  be  adopted  by  the  States  Parties  Committee  for  the 
Implementation of the International Health Regulations (2005), whose role is to facilitate the 
effective  implementation  of  the  International  Health  Regulations  (2005),  will  determine  the 
way  in  which  decisions  or  recommendations  will  be  adopted.  Such  decisions  or 
recommendations are capable of affecting the interpretation or application of the provisions of 
the  International  Health  Regulations  (2005).  In  this  regard,  an  important  part  of  these 
provisions,  which  are  legally  binding  for  all  Union  Member  States  under  international  law, 
falls within matters for which the Union has exercised its competences on the basis of Article 
168(5) TFEU, read together with Article 6 and Article 168(1) TFEU, to support, coordinate or 
supplement  the  actions  of  the  Member  States  and  in  relation  to  which  Union  rules  exist,  in 
particular  in  the  field  of  serious  cross-border  threats  to  health  under  Regulation  (EU) 
2022/2371. The States Parties Committee for the Implementation of the International Health 
Regulations (2005)  and its  Subcommittee have the  competence to  take decisions, which  are 
capable  to  have  an  influence  on  the  content  of  Union  rules,  in  particular  Regulation  (EU) 
2022/2371.  Thus,  the  envisaged  acts  produce  legal  effects  within  the  meaning  of  Article 
218(9) TFEU.  

The  envisaged  acts  do  not  supplement  or  amend  the  institutional  framework  of  the 
International Health Regulations (2005). 

Therefore, the procedural legal basis for the proposed decision is Article 218(9) TFEU. 

4.2. 

Substantive legal basis 

The  main  objective  and  content  of  the  envisaged  acts  relate  to  the  establishment  of  a 
structured framework and relevant methods of work for the States Parties Committee for the 
Implementation of the International Health (2005) and its Subcommittee. 

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The  purpose  and  scope  of  the  International  Health  Regulations  (2005)  are  “to  prevent, 
prepare for, protect against, control and provide a public health response to the international 
spread  of  disease  in  ways  that  are  commensurate  and  restricted  to  public  health  risks,  and 
which avoid unnecessary interference with international traffic and trade”.  

Considering the objectives and substantive provisions of the International Health Regulations 
(2005),  the  substantive  legal  basis  of  the  proposed  decision  is  Article  168(5)  TFEU,  which 
provides  that  “the  European  Parliament  and  the  Council,  acting  in  accordance  with  the 
ordinary  legislative  procedure,  may  also  adopt  incentive  measures  designed  to  protect  and 
improve human health and in  particular to  combat the major  cross-border health scourges, 
measures  concerning  monitoring,  early  warning  of  and  combating  serious  cross-border 
threats to health”.  

4.3. 

Conclusion 

The legal basis of the proposed decision should be Article 168(5) TFEU, in conjunction with 
Article 218(9) TFEU. 

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2026/0226 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the position to be taken on behalf of the European Union in the first meeting of the 
States Parties Committee for the Implementation of the International Health 
Regulations (2005) 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(5) TFEU, in conjunction with Article 218(9), thereof, 

Having regard to the proposal from the European Commission,  

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

The International Health Regulations (2005) entered into force in June 2007, while the 
amendments to the International Health Regulations (2005) adopted on 1 June 2024 by 
the World Health Assembly entered into force on 19 September 2025, except for the 
States Parties that rejected those amendments. 

The Union is not party to the International Health Regulations (2005), as only States 
can  be  Parties  thereto.  All  Member  States  are  parties  to  the  International  Health 
Regulations (2005). 
Council Decision (EU) 2025/11291 invited Member States to accept, in the interest of 
the  Union,  without  reservations,  the  amendments  to  the  International  Health 
Regulations (2005) adopted on 1 June 2024, to the extent that the Union has adopted 
common rules regarding the matters addressed in those amendments.  

Those  amendments  led,  among  others,  to  the  establishment  of  the  States  Parties 
Committee  for  the  Implementation  of  the  International  Health  Regulations  (2005), 
with the objective of facilitating the effective implementation of the Regulations. 

The  States  Parties  Committee  for  the  Implementation  of  the  International  Health 
Regulations (2005) is scheduled to adopt at its first meeting its terms of reference and 
the terms of reference for its Subcommittee. 

The  envisaged  acts  of  the  States  Parties  Committee  for  the  Implementation  of  the 
International Health Regulations (2005) will, if adopted, produce legal effects for the 
Union,  as  they  will  determine  whether  regional  economic  integration  organisations 
such as the Union can participate as observers to the States Parties Committee and to 
its Subcommittee. In addition, the envisaged acts will, if adopted, produce legal effects 
by determining the way in which future decisions of the States Parties Committee for 
the  Implementation  of 
its 
Subcommittee  are  taken.  Decisions  and  recommendations  of  the  States  Parties 

the  International  Health  Regulations  (2005)  and 

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Council Decision (EU) 2025/1129 of 26 May 2025 inviting Member States to accept, in the interest of 
the  European  Union,  the  amendments  to  the  International Health  Regulations  (2005)  contained  in  the 
Annex  to  Resolution  WHA77.17  and  adopted  on  1  June  2024  (OJ  L,  2025/1129,  4.6.2025, 
ELI: http://data.europa.eu/eli/dec/2025/1129/oj). 

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Committee for the Implementation of the International Health Regulations (2005) and 
its  Subcommittee  concerning  the  application  and  interpretation  of  the  International 
Health  Regulations  (2005),  in  particular  of  those  amended  provisions  which  were 
authorised  pursuant  to  Council  Decision  (EU)  2025/1129,  are  capable  of  decisively 
influencing the content of Union rules, and in particular Regulation (EU) 2022/2371 of 
the  European  Parliament  and  of  the  Council2,  which  provides  the  framework  and 
mechanisms at  the level  of the Union for coordinating and strengthening prevention, 
preparedness  and  response  to  serious  cross-border  threats  to  health  of  biological, 
chemical, environmental and unknown origin.  

(7) 

(8) 

It  is  therefore appropriate to  establish  the position to  be taken on the Union’s behalf 
during the States Parties Committee for the Implementation of the International Health 
Regulations  (2005)  with  regard  to  the  terms  of  reference  for  the  Committee  and  its 
Subcommittee. 

The Union's position is to be expressed by the Member States that are represented in 
the  States  Parties  Committee  for  the  Implementation  of  the  International  Health 
Regulations (2005), acting jointly, in the interest of the Union, 

HAS ADOPTED THIS DECISION:  

Article 1 

The  position  to  be  taken  on  the  Union's  behalf  in  the  first  meeting  of  the  States  Parties 
Committee for the Implementation of the International Health Regulations (2005) shall be to 
support the adoption of the terms of reference for that Committee and for its Subcommittee 
provided that the final texts fulfil the following conditions: 

(a) 

(b) 

they provide for the efficient, cost effective, transparent and orderly functioning and 
organisation of meetings of the Committee and its Subcommittee,  

they  allow  for  the  participation  of  the  Union  to  the  Committee  and  to  its 
Subcommittee as an observer.  

The  position  set  out  in  Article  1  shall  be  expressed  by  the  Member  States  that  are 
represented in the States Parties Committee for the Implementation of the International Health 
Regulations (2005), acting jointly, in the interest of the Union. 

Article 2 

Minor  technical  changes  to  the  position  set  out  in  Article  1  may  be  agreed  upon  without  a 
further decision of the Council. 

Article 3 

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Regulation (EU) 2022/2371 of the European Parliament and of  the Council of 23 November 2022 on 
serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, 
p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj). 

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This Decision is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the Council 
The President 

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