Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union in the seventy-fourth session of the World Health Assembly
Date: 2021-05-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: UN convention, World Health Organisation, coronavirus disease, crisis management, epidemic, epidemiology, health policy, international cooperation, international negotiations

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   EUROPEAN COMMISSION  Brussels, 3.5.2021  COM(2021) 233 final 2021/0120 (NLE)  Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union in the seventy-fourth session of the World Health Assembly  
 
EXPLANATORY MEMORANDUM 

1. 

SUBJECT MATTER OF THE PROPOSAL 

This proposal concerns the establishment of the position to be taken on the Union’s behalf at 
the  seventy-fourth  session  of  the  World  Health  Assembly  (WHA)  in  connection  with  the 
envisaged  adoption  of  a  Decision  regarding  the  modalities/process  for  establishing  an 
international treaty on the fight against pandemics.  

2. 

CONTEXT OF THE PROPOSAL 

2.1. 

The World Health Organisation 

The  World  Health  Organisation  (WHO)  was  established  as  a  specialized  United  Nations 
health  agency  within  the  terms  of  Article  57  of  the  Charter  of  the  United  Nations.  The 
Constitution1 of the World Health Organisation entered into force on 7 April 1948 and defines 
the  main  objective  of  the  organization  to  be  the  “attainment  by  all  peoples  of  the  highest 
possible level of health”. 

The  European  Union  has  an  informal  observer  status  at  the  WHO.  This  status  has  been 
established  through  an  exchange  of  letters  published  in  the  Official  Journal  on  4  January 
20012. The exchange included a “Memorandum concerning the framework and arrangements 
for cooperation between the World Health Organization and the Commission of the European 
Communities”. All EU Member States are members of the WHO.  

2.2. 

The World Health Assembly 

The World Health Assembly is the main governing body of the WHO. The main functions of 
the World Health Assembly are to determine the policies of the WHO, appoint the Director-
General,  supervise  financial  policies,  and  review  and  approve  the  proposed  programme 
budget.  

The  World  Health  Assembly  is  held  annually  in  Geneva,  Switzerland.  The  seventy-fourth 
session of the Assembly will take place virtually from 24 May to 1 June 2021.  

According to Article 59 of the WHO Constitution, each Member has one vote in the World 
Health Assembly. Decisions are made by a majority of Members present and voting, except a 
few  situations  as  outlined  in  Article  60  of  the  Constitution,  where  a  two-thirds  majority  is 
needed.  In  practice,  every  effort  is  to  be  made  to  reach  agreement  by  consensus.  The 
European Union has no voting rights.  

Under Article 19 of the WHO Constitution, the World Health Assembly is given the authority 
to adopt conventions or agreements with respect to any matter within the competence of the 
Organization. 

2.3. 

The envisaged act of the seventy-fourth session of the World Health Assembly 

In  May  2021,  during  its  seventy-fourth  session,  the  World  Health  Assembly  is  expected  to 
adopt  a  procedural  Decision  regarding  modalities/process  for  establishing  an  international 
treaty  on  the  fight  against  pandemics.  More  specifically,  the  purpose  of  the  Decision  is  to 
establish an Intergovernmental Meeting to draft and negotiate a WHO Framework Convention 
on  Pandemic  Preparedness  and  Response  for  consideration  by  the  Health  Assembly  under 
Article 19 of the WHO Constitution.  

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BASIC DOCUMENTS (who.int) 
https://ec.europa.eu/health/sites/health/files/eu_world/docs/exchange_of_letters_2001.pdf 

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3. 

POSITION TO BE TAKEN ON THE UNION'S BEHALF 

The  EU  and  its  Member  States  are  leading  international  efforts  to  strengthen  global  health 
security  and  the  World  Health  Organisation,  in  particular  on  preparedness  and  response  to 
health emergencies, on the basis inter alia of Council Conclusions3 of November 2020 on the 
EU’s role in strengthening the WHO.  

The  proposal  to  conclude  an  international  treaty  on  pandemics  is  currently  discussed  in  the 
context of ongoing international efforts to reinforce global health security in light of lessons 
learnt from the pandemic. The overall aim of such a Treaty should be to secure political and 
legal commitment to an improved global health architecture. 

Taking part in the development of such a treaty would be in line with Article 21(1) TEU that 
affirms  that  “The  Union  shall  seek  to  develop  relations  and  build  partnerships  with  third 
countries,  and  inter-national,  regional  or  global  organisations  which  share  the  principles 
referred  to  in  the  first  subparagraph.  It  shall  promote  multilateral  solutions  to  common 
problems, in  particular in the framework of the  United Nations”. The European Council4 in 
February  2021  reiterated  its  commitment  to  ‘advancing  global  health  security,  including  by 
strengthening the World Health Organization and working towards an international treaty on 
pandemics within its framework’.  

Although its exact scope is still not decided, the envisaged international Treaty is to address 
serious cross-border health threats. Such objective is likely to concern policy areas, which are 
rooted under Title XIV of Part III of the TFEU but also may possibly concern several other 
articles of the Treaty on the Functioning of the EU, for example: 

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Prevention  and  management  of  zoonotic  risks  as  part  of  a  one-health  approach, 
which  requires  linkages  with  environmental  treaties  on  issues  such  as  biodiversity 
and  trade  in  endangered  species,  which  could  affect  among  others  Council 
Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild 
fauna and flora by regulating trade therein; 

A structured system for the sharing of pathogens, genetic sequences and the resulting 
benefits  for  public  health  purposes  (relevant  EU  legislation  being  Regulation  (EU) 
No  511/2014  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on 
compliance  measures  for  users  from  the  Nagoya  Protocol  on  Access  to  Genetic 
Resources  and  the  Fair  and  Equitable  Sharing  of  Benefits  Arising  from  their 
Utilization in the Union); 

Human rights and privacy protection, particularly in light of surveillance technology, 
artificial  intelligence  and  big  data  use  for  public  health  purposes  (e.g.  Regulation 
(EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on 
the protection of natural persons with regard to the processing of personal data and 
on the free movement of such data); and 

Measures  to  promote  implementation  and  compliance,  e.g.,  peer  and  expert  review 
processes,  mutual  accountability  mechanisms,  verification  and 
inspection 
arrangements, and dispute settlement processes. 

The Decision No 1082/2013/EU of the European Parliament and of the Council of 22 
October 2013 on serious cross-border threats to health and also the future Regulation 
on Cross-Border Health threats will also be affected by the future Treaty. 

https://data.consilium.europa.eu/doc/document/ST-12276-2020-INIT/en/pdf 
Statement of the members of the European Council, 25-26 February 2021 

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In view of the above and the likely affectation of the existing EU legislation in different areas 
of the EU’s action, it is essential that the participation of the Union is assured alongside the 
Member States. The following principles should guide their position in the upcoming World 
Health  Assembly  discussions  on  a  possible  Decision  establishing  a  process  to  draft  and 
negotiate a WHO Framework Convention on Pandemic Preparedness and Response: 

a. 

b. 

c. 

d. 

The EU should be allowed to participate as contracting party to the Treaty in order to 
fully support the establishment of a WHO process for a new Framework Convention 
on Pandemic Preparedness and Response. 

The decision of the World Health Assembly setting out the procedural aspects of the 
negotiations  should  allow  for  the  full  participation  of  the  EU  in  the  negotiating 
process. 

A  new  Framework  Convention  must  strengthen,  be  complementary  to,  and  bring 
added value to the existing international framework for preventing and responding to 
health  emergencies,  taking  into  account  the  outcome  of  the  forthcoming  Global 
Health Summit on 21 May. In line with this, any new Framework Convention should 
complement  and  reinforce 
the  International  Health 
Regulations (IHR), and address effectively any gaps in those Regulations. 

implementation  of 

the 

Discussions on a Framework Convention should take into account the outcome of the 
independent  panels5  reviewing  the  WHO-led  international  pandemic  response,  to 
ensure that it is firmly evidence-based and reflects the lessons learnt from the global 
experience in tackling the COVID-19 pandemic. 

4. 

LEGAL BASIS 

4.1. 

Procedural legal basis 

4.1.1.  Principles 

Article 218(9) of the Treaty on the Functioning of the European Union (TFEU) provides for 
decisions establishing ‘the positions to be adopted on the Union’s behalf in a body set up by 
an  agreement,  when  that  body  is  called  upon  to  adopt  acts  having  legal  effects,  with  the 
exception of acts supplementing or amending the institutional framework of the agreement.’ 

Article 218(9) TFEU applies regardless of whether the Union is a member of the body or a 
party to the agreement6. 

The concept of ‘acts having legal effects’ includes acts that have legal effects by virtue of the 
rules of international law governing the body in question. It also includes instruments that do 
not  have  a  binding  effect  under  international  law,  but  that  are  ‘capable  of  decisively 
influencing the content of the legislation adopted by the EU legislature’7. 

4.1.2.  Application to the present case 

The World Health Assembly is a body set up by an agreement, namely the Constitution of the 
World Health Organization, signed at New York on 22 July 1946. 

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Notably the Independent Panel on Pandemic Preparedness and Response, the IHR Review Committee 
and the Independent Oversight and Advisory Committee of the WHO Health Emergencies Programme 
Judgment  of 
ECLI:EU:C:2014:2258, paragraph 64.  
Judgment  of 
ECLI:EU:C:2014:2258, paragraphs 61 to 64.  

the  Court  of  Justice  of  7  October  2014,  Germany  v  Council,  C-399/12, 

the  Court  of  Justice  of  7  October  2014,  Germany  v  Council,  C-399/12, 

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The  decision  on  modalities  which  the  World  Health  Assembly  is  called  upon  to  adopt 
constitutes an act having legal effects. The envisaged act will be binding under international 
law for the Members of the World Health Organization in accordance with Articles 18 and 60 
of the Constitution of the World Health Organization. The envisaged act also has legal effects 
because it will determine the ability of the European Union to participate fully in the drafting 
and negotiation of a WHO framework convention on pandemic preparedness and response for 
consideration by the World Health Assembly under Article 19 of the WHO Constitution and 
to become party to this Convention as a Regional Economic Integration Organization.  

The Framework Convention will have an impact on the exercise of Union competences and, 
depending on its scope, on the EU legislation in areas such as health, trade, free movement, 
data  protection,  internal  market,  development  cooperation,  all  of  which  might  become 
relevant under the Framework Convention. 

The  envisaged  act  does  not  supplement  or  amend  the  institutional  framework  of  the 
Agreement. 

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

4.2. 

Substantive legal basis 

4.2.1.  Principles 

The  substantive  legal  basis  for  a  decision  under  Article  218(9)  TFEU  depends  primarily  on 
the objective and content of the envisaged act in respect of which a position is taken on the 
Union's behalf.  If the  envisaged act  pursues two  aims or has two components  and if one of 
those  aims  or  components  is  identifiable  as  the  main  one,  whereas  the  other  is  merely 
incidental, the decision under Article 218(9) TFEU must be founded on a single substantive 
legal basis, namely that required by the main or predominant aim or component. 

4.2.2.  Application to the present case 

The  main  objective  and  content  of  the  envisaged  act  relate  to  increasing  international 
cooperation  in  the  field  of  pandemic  preparedness  and  response  within  the  United  Nation 
system, with the aim to “promote multilateral solutions to common problems, in particular in 
the  framework  of  the  United  Nations.”  In  particular,  its  principal  aim  is  to  combat  major 
cross-border health scourges and serious cross-border threats to health. 

Therefore,  the  substantive  legal  basis  of  the  proposed  decision  is  Article  168(3)  and  (5) 
TFEU. 

4.3. 

Conclusion 

The  legal  basis  of  the  proposed  decision  should  be  Article  168(3)  and  (5)  TFEU,  in 
conjunction with Article 218(9) TFEU. 

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2021/0120 (NLE) 

Proposal for a 

COUNCIL DECISION 

on the position to be taken on behalf of the European Union in the seventy-fourth 
session of the World Health Assembly 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 168(3) and (5), in conjunction with Article 218(9) thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

Article 21, paragraph 1, TEU, states that the Union shall seek to develop relations and 
build  partnerships  with  third  countries,  and  international,  regional  or  global 
organisations which share the principles referred to in the first subparagraph. It shall 
promote multilateral solutions to common problems, in particular in the framework of 
the United Nations. 

The  Constitution  of  the  World  Health  Organization  (‘the  Agreement’)  entered  into 
force on 7 April 1948. 

Pursuant  to  Article  60  of  the  Agreement,  the  World  Health  Assembly  may  adopt 
decisions  by  a  majority  of  the  World  Health  Organisation  (WHO)  Members  present 
and voting. 

The  World  Health  Assembly,  during  its  seventy-fourth  session  starting  on  24  May 
2021, is to adopt a decision on the establishment of an Intergovernmental Meeting to 
draft  and  negotiate  a  WHO  Framework  Convention  on  Pandemic  Preparedness  and 
Response. 

It is appropriate to establish the position to be taken on the Union's behalf in the World 
Health  Assembly,  as  the  decision  of  the  World  Health  Assembly  will  determine  the 
ability of the European Union to participate in the drafting and negotiation of a WHO 
Framework  Convention  on  Pandemic  Preparedness  and  Response  and  to  potentially 
become a party to it as a Regional Economic Integration Organisation. 

The  European  Union’s  full  participation  in  the  drafting  and  negotiation  of  a  WHO 
Framework  Convention  on  Pandemic  Preparedness  and  Response  and  its  possible 
accession to the Convention will contribute to increasing international cooperation in 
response to pandemics within the United Nations system. 

(7) 

The  Union's  position  is  to  be  expressed  by  the  Member  States  of  the  Union  that  are 
members of the World Health Assembly, 

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HAS ADOPTED THIS DECISION:  

Article 1 

The  position  to  be  taken  on  the  Union's  behalf  in  the  seventy-fourth  session  of  the  World 
Health Assembly shall be the following: 

The European Union supports the establishment of a World Health Organisation process for a 
new Framework Convention on Pandemic Preparedness and Response and must be allowed to 
participate as contracting party to such a treaty. 

The  decision  of  the  World  Health  Assembly  setting  out  the  procedural  aspects  of  the 
negotiations must allow for the full participation of the Union in the negotiating process,  in 
view of the Union’s possible accession to the Convention as a Regional Economic Integration 
Organisation.  

This  should be achieved through the inclusion of specific  references in  the body text  of the 
decision  clarifying  that  any  intergovernmental  body  set  up  to  draft  and  negotiate  the 
the  participation  of  Regional  Economic  Integration 
Convention  shall  be  open 
Organisations.   

to 

The  position  referred  to  in  Article  1  shall  be  expressed  by  the  Member  States  of  the  Union 
that are members of the World Health Organization, acting jointly on behalf of the Union.  

Article 2 

This Decision is addressed to the Member States. 

Done at Brussels, 

Article 3 

For the Council 
The President 

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