Communication from the Commission to the European Parliament and the Council on the International Health Regulations
Date: 2006-09-26
Institutions: European Commission
Subjects: European Centre for Disease Prevention and Control, World Health Organisation, disease prevention, epidemiology, health legislation, information network, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.9.2006 
COM(2006) 552 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on the International Health Regulations 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on the International Health Regulations 

Blank Line. 

1. 

2. 

2.1. 

2.2. 

3. 

3.1. 

3.2. 

4. 

Introduction .................................................................................................................. 3 

Background to the IHR ................................................................................................ 4 

Brief description........................................................................................................... 4 

Legal competence......................................................................................................... 4 

Reservations ................................................................................................................. 5 

EC & MS reservations ................................................................................................. 5 

EU reactions to third country reservations................................................................... 5 

Voluntary early application of flu-related aspects ....................................................... 5 

4.1. 

Specific aspects identified for early application – EU context .................................... 6 

5. 

5.1. 

5.2. 

5.3. 

5.4. 

6. 

6.1. 

6.2. 

6.3. 

7. 

Full Implementation – EU role .................................................................................... 7 

Memorandum of understanding between the Community & WHO ............................ 7 

Role of existing EU networks, EWRS and the Health Security Committee................ 7 

Role of the ECDC ........................................................................................................ 9 

Roster of Experts, Emergency & Review Committees.............................................. 10 

Restrictions on policy responses affecting international traffic................................. 11 

Border measures......................................................................................................... 11 

Contact tracing ........................................................................................................... 12 

Particular issues in relation to pandemic flu .............................................................. 12 

Operational Conclusions ............................................................................................ 12 

ANNEX - Summary and List of Acronyms…… ................................................................ ….14 

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1. 

INTRODUCTION 

This  Communication  sets  out  the  Commission’s  views  on  implementation  of  the 
revised International Health Regulations (2005) - the IHR1. It is intended to promote 
a structured discussion with the Council and Parliament. 

The IHR is an international legal instrument which aims to prevent, protect against 
and  control  the  spread  of  disease,  and  to  provide  a  public  health  response 
proportionate  to  the  risks,  but  avoiding  unnecessary  interference  with  traffic  and 
trade. 

The IHR enters into force on 15 June 2007, and requires gradual implementation by 
2016  at  the  latest.  The  World  Health  Assembly  (WHA)  of  May  2006  adopted  a 
resolution2 calling for voluntary early application of certain IHR aspects relating to 
pandemic influenza. 

Making  the  IHR  work  in  practice  will  require  close  co-ordination  between  the 
Commission  and  Member  States  (MS).  By  working  together,  the  European  Union 
(EU)  and  MS  can  optimise  implementation,  and  better  protect  EU  citizens  from 
public health emergencies of international concern (PHEICs).  

In particular the European Centre for Disease Prevention and Control (ECDC3), and 
the EU Early Warning and Response System for public health threats (EWRS4), can 
help us to implement the IHR in a stronger, more coherent way. 

In brief, this Communication : 

– 

– 

– 

sets out the Commission’s interpretation of the EU legal position with regard to 
IHR reservations and early implementation of flu-related aspects; 

clarifies  the  EU  role  in  IHR  implementation,  particularly  through  the  ECDC 
and the EWRS; 

reminds MS of the restrictions the IHR places on national measures which can 
be  taken  on  public  health  grounds,  particularly  on  the  types  of  international 
border measures which could be taken in response to pandemic flu; 

– 

stimulates MS to develop and share their own plans for IHR implementation. 

A summary and list of acronyms are annexed to this Communication. 

1 
2 
3 
4 

Report of WHA 58, with IHR text. 
Resolution WHA59.2. 
Established by Regulation 851/2004 of the EP and Council. 
Established by Council and Parliament Decision 2119/98 and Commission Decision 2000/57/EC.  

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2. 

BACKGROUND TO THE IHR 

2.1. 

Brief description5 

In  1951  the  member  states  of  the  World  Health  Organization  (WHO)  adopted  the 
first International Sanitary Regulations. These were renamed the International Health 
Regulations  in  1969;  since  then  they  have  been  amended  and  modified  four  times, 
most recently and most comprehensively in 2005. 

The  IHR  is  an  international  legal  instrument  which  is  legally  binding  on  all  States 
Parties. It does not require ratification by individual states, but any state may reject 
the  IHR  or  make  reservations  on  specific  aspects.  192  states  are  WHO  members, 
including the 25 EU MS, Bulgaria and Romania. 

The  EU  is  not  a  party  to  the  IHR,  but  the  IHR  recognizes  the  role  of  “regional 
economic integration organizations” such as the EU. Specifically, IHR Article 57(3) 
states  that  “Without  prejudice  to  their  obligations  under  these  Regulations,  States 
Parties  that  are  members  of  a  regional  economic  integration  organization  shall 
apply in their mutual relations the common rules in force in that regional economic 
integration organization”.  

This means, for example, that if the WHO were to recommend states to refuse entry 
or departure to certain goods under the IHR (Article 18(2)), the EU would have to act 
collectively,  at  the  initiative  of  the  Commission,  as  EU  single  market  legislation 
prevents MS from taking unilateral action. 

2.2. 

Legal competence 

The IHR is an international instrument which involves matters of mixed competence 
between national governments and the European Community (EC)6. 

Many  IHR  articles  relate  to  issues  covered  by  EC  law.  Depending  on  the  law 
concerned, these are viewed either as a matter of exclusive Community competence, 
or  shared  competence  between  national  governments  and  the  Community.  For 
example  IHR  Article  45  covers  processing  of  personal  data,  which  in  the  EU  is 
addressed by legislation with a single market legal base7, so is a matter of exclusive 
Community competence. 

Other IHR articles are entirely a matter for national governments, because there is no 
related  EC  law.  For  example  IHR  Article  41  covers  charges  for  the  application  of 
health measures to conveyances (ships and aircraft), which are not specifically dealt 
with in EC law and therefore not a Community competence. 

It is not the purpose of this Communication to list which IHR articles are subject to 
national, Community, or shared competence, but to consider how the IHR should be 
implemented in a coordinated manner across the Community. 

5 
6 

7 

For more information see these Frequently Asked Questions. 
The  EC  is  the first  pillar of  the  EU,  and  is  the  part  which  has  legal  identity.  Pillars  2  and 3 relate  to 
political cooperation in foreign policy and justice. 
Directive 95/46/EC of the EP and Council, on data protection. 

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3. 

RESERVATIONS 

Under IHR Article 62, it is open to States Parties to notify reservations to the WHO 
Director-General  until  15  December  2006  under  certain  conditions.  Reservations 
would  generally  be  used  to  indicate  that  states  cannot  or  will  not  implement 
particular aspects of the IHR. 

MS  and  the  Commission  worked  in  close  and  effective  cooperation  throughout  the 
IHR  negotiations  to  ensure  that  the  final  IHR  would  be  consistent  with  EC  and 
national law, so that there would be no need for reservations. 

3.1. 

EC & MS reservations 

A final screening of EC law against the IHR did not find that any reservations were 
needed in respect of IHR aspects under Community competence. 

To date no MS has identified a need for reservations on IHR aspects under national 
competence.  It  is  possible  that  difficulties  with  individual  provisions  might  arise 
during  preparations  for  implementation.  If  so,  a  common  EU  approach  would  be 
necessary  to  formally  enter  reservations  with  the  WHO,  in  order  to  respect  the 
principle of unity of international representation, as recognised by EC case law and 
flowing from Article 10 of the Treaty establishing the European Community. 

The Commission is satisfied there is no need for any IHR reservations on issues of 
Community competence. In the event that a Member State wishes to make an IHR 
reservation on an issue of national competence, EU coordination will be necessary. 
In order to achieve this before the deadline of December 2006, MS wishing to enter 
a  reservation  should  notify  the  Commission  and  other  MS  thereof  at  the  earliest 
possible stage so that a coordinated approach can be agreed. 

3.2. 

EU reactions to third country reservations 

No third country has yet submitted any reservations to the IHR, but some may wish 
to do so. If or when WHO receives a reservation, Article 62 of the IHR requires the 
WHO  Director-General  to  notify  every  other  WHO  State  Party  which  has  not 
rejected the IHR, and allow 6 months for them to react to that reservation. If at least 
one third of those states object to the reservation, WHO will invite the reserving state 
to consider withdrawing its reservation within 3 months. If the state does not agree, 
WHO will seek the view of the IHR Review Committee. 

EU coordination will also be necessary in order to establish a common approach to 
any third country reservations. 

4. 

VOLUNTARY EARLY APPLICATION OF FLU-RELATED ASPECTS 

WHA Resolution 59.2, adopted on 26 May 2006, calls upon States Parties to comply 
immediately, on a voluntary basis, with the IHR provisions considered relevant to the 
risk posed by avian and potential human pandemic influenza.  

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It  is  important  to  clarify  that  from  15  June  2007,  the  IHR  enters  into  force  and  is 
binding on all parties. After that date, different provisions have different timetables 
for implementation, but compliance with the whole instrument is mandatory. 

4.1. 

Specific aspects identified for early application – EU context 

The WHA resolution urges states to  

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

designate IHR national focal points (NFPs) within 90 days of adoption of the 
WHA resolution (ie before end August 2006). This should help establish IHR 
lines of communication in time for the next flu season in the EU. We believe 
the ECDC should work closely with NFPs, especially in the case of disease 
outbreaks occurring in more than one EU MS. See section 5 on the role of the 
ECDC.  

follow mechanisms and procedures in the IHR relating to diseases which may 
constitute a PHEIC. At EU level, this is already being taken into account. For 
example in advice to MS on the implementation of Directive 2004/38 on the 
free movement of EU citizens, “disease with epidemic potential as defined by 
the relevant instruments of the WHO” is defined in relation to IHR Annex 2.  

notify WHO and subsequently communicate with them about any probable or 
confirmed human case of avian influenza. No suspected human cases have so 
far been identified in the EU. 

disseminate  to  WHO  collaborating  centres  information  and  biological 
materials  related  to  highly  pathogenic  avian  influenza  and  other  novel 
influenza strains. Samples from suspect human cases in Turkey were sent to 
WHO  laboratories  in  the  UK  for  testing  earlier  this  year.  Delays  in  sending 
samples have been experienced with some EU airlines; this is being followed 
up with EU Directors General for Civil Aviation. 

develop  domestic  influenza  vaccine  production  capacity  or  work  with 
neighbouring  states  to  establish  regional  capacity.  EU  MS  are  working  on 
this  as  a  high  priority.  Vaccine  capacity  has  been  discussed  in  the  Council, 
along  with  a  Commission  options  paper  on  the  establishment  of  an  EU 
stockpile of antivirals. 

strengthen  collaboration  on  human  and  zoonotic  influenzas  among  national 
organizations.  The  ECDC  and  Commission  6th  Framework  Programme  for 
research are both facilitating EU scientific collaboration in this respect. 

respect  IHR  time  frames  for  activities  and  communications,  particularly  for 
reporting human cases of avian influenza. Experience so far suggests the IHR 
time frames should not be problematic for EU MS, but further assessment of 
MS capacities may be required. 

collaborate,  including  by  mobilizing  financial  support,  to  strengthen 
influenza  surveillance  and  response  in  countries  affected  by  avian  and 
pandemic  influenza.  The  EU  has  provided  financial  contributions  to 
strengthen influenza surveillance and response in the EU, through the ECDC 

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and 
in 
the  public  health  programme  (Decision  1786/2002/EC),  and 
developing countries, through the Beijing Pledging Conference co-hosted by 
the Commission in January 2006. 

4.2. 

Need for common EU approach to voluntary early application 

In  order  to  respect  the  principle  of  unity  of  international  representation  in  the  EC 
Treaty, a common approach is needed.  

The  same  IHR  aspects  should  be  implemented  to  the  same  timetable  across  EU 
Member  States.  This  will  require  coordination  at  EU  level.  The  Commission  will 
take  any  appropriate  initiative  which  could  be  needed  in  order  to  facilitate  this 
implementation. 

5. 

FULL IMPLEMENTATION – EU ROLE 

The IHR has clear EU policy implications, particularly on trade, transport and border 
policies  in  the  single  market,  where  in  the  event  of  a  PHEIC,  EC  law  provides  the 
mechanisms to respond to emergencies.  

As already noted during the negotiations, most  provisions of the IHR concern both 
the  EU  and  the  MS,  so  it  is  necessary  to  coordinate  closely  in  order  to  achieve  an 
optimal implementation. 

The  EU,  its  institutions  and  networks  can  therefore  play  a  positive  role  in  IHR 
implementation, to add value and avoid duplication of effort at national level. 

5.1.  Memorandum of understanding between the Community & WHO 

On the basis of the proposals on working practices and the role of EU institutions and 
networks  set  out  below,  it  would  be  desirable  to  adopt  an  administrative 
memorandum of understanding between the Community and WHO to ensure that 
arrangements are clearly defined in respect of the IHR. The Commission would be 
responsible for drafting, negotiating and signing this memorandum. 

5.2. 

Role of existing EU networks, EWRS and the Health Security Committee 

Decision 2119/98/EC of the European Parliament and the Council set up a network 
for  the  epidemiological  surveillance  and  control  of  communicable  diseases  in  the 
EU. Commission Decision 2000/57 established criteria for the use of EWRS for the 
prevention and control of communicable diseases.  

The  main  role  of  EWRS  is  to  report  communicable  diseases  affecting,  or  with 
potential  risk  of  propagation  to,  more  than  one  MS.  Decision  2119/98/EC  also 
requires MS to report measures taken in response, and to consult each other in liaison 
with  the  Commission  with  a  view  to  coordinating  efforts  for  the  prevention  and 
control of communicable diseases.  

The  scope  of  EWRS  is  limited  to  communicable  diseases,  including  those  of 
unknown  origin.  It  is  therefore  not  as  broad  as  the  IHR,  which  includes  events  of 

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unknown cause or source, and the spread of toxic, infectious or otherwise hazardous 
materials, as potential PHEICs. This is set out in IHR Annex 2.  

But  bearing  in  mind  that  most  potential  PHEICs  are  likely  to  result  from 
communicable  diseases,  it  is  clear  that  there  are  many  similarities  between  the 
information and communication needs MS face with respect to EWRS and the IHR.  

For  potential  PHEICs  caused  by  sources  other  than  communicable  diseases,  there 
may be a complementary role for the EU Health Security Committee (HSC), which 
was  set  up  in  2001  to  promote  cooperation  in  tackling  bioterrorism.  HSC 
representatives  are  co-ordinating  multi-sectoral  responses  to  health  threats  in 
Member States, which are of particular importance in dealing with threats other than 
communicable disease outbreaks. HSC members communicate with one another and 
the  Commission  via  a  secure  information  system  (RAS-BICHAT),  which  allows 
rapid alerting of such events, 24 hours, 7 days a week. 

The  ECDC  Founding  Regulation  states  that the ECDC shall assist  the  Commission 
by operating EWRS. They are currently surveying user requirements with a view to 
improving  the  system,  learning  from  recent  EU  crisis  simulation  exercises  on 
smallpox and flu, organized by the Commission to test EU and MS procedures.  

In  order  to  maximize  efficiency  the  Commission  proposes  the  following  working 
practices: 

(1) 

(2) 

(3) 

(4) 

Nominating the same national focal point for EWRS as for IHR. MS may 
need to make some adjustments in order to fulfil both systems’ requirements, 
but  the  overlap  of  functions  would  justify  this  approach,  especially  as  any 
communicable  disease  notifiable  under  IHR  would  also  be  notifiable  under 
EWRS.  Complementarities  with  the  EU  Rapid  Alert  System  for  Biological 
and Chemical Attacks and Threats could also be explored to define the best 
way to handle IHR notifications on unknown sources or hazardous materials. 

Simultaneously  informing  EWRS  and  WHO  about  events  within  their 
territory  which  are  notifiable  under  IHR  but  which  are  not  potential 
PHEICs.  This  option  is  already  available,  and  used  regularly,  simply  by 
activating  an  option  on  the  EWRS  interface  to  copy  WHO.  This  could 
become  standard  practice,  so  that  all  interested  parties  are  informed 
simultaneously. 

Informing the EU Communicable Disease Network in advance of making a 
formal  IHR  notification  of  a  potential  PHEIC.  This  would  allow  MS  to 
coordinate  notifications,  for  example  in  the  event  of  an  outbreak  of 
communicable disease which occurs simultaneously in more than one MS (a 
multi-state outbreak). 

Particularly  for  multi-state  outbreaks,  using  EWRS  and  /  or  the  Health 
Security  Committee  to  help  coordinate  health  risk  management  and 
response prior to communicating with WHO. Decision 2119/98/EC already 
requires MS to consult each other with a view to coordinating their response 
in the event of an outbreak. A coordinated response to PHEICs under the IHR 
could be prepared through the EWRS and / or the Health Security Committee, 

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depending  on  the  nature  of  the  threat.  This  response  could  then  be 
communicated and coordinated with WHO at EU level, by the Presidency or 
by  the  Commission.  This  would  give  the  EU  a  single  voice,  reduce 
unnecessary  efforts  and  ensure  more  efficient  policy  coordination.  This 
process could be defined on the basis of existing mechanisms.  

5.3. 

Role of the ECDC 

The  ECDC  is  an  independent  agency  charged  with  identifying,  assessing,  and 
communicating  current  and  emerging  threats  to  human  health  from  communicable 
diseases.  The  ECDC  collects  and  processes  relevant  scientific  and  technical  data, 
provides  scientific  opinions  and  technical  assistance,  and  coordinates  European 
networking. The ECDC is also working with the Commission and MS to become the 
EU point of reference for the surveillance of communicable diseases; it is assessing 
and assisting MS in order to strengthen national surveillance capacities. 

The surveillance activities undertaken by the ECDC will be very relevant in the case 
of a public health threat which requires IHR notification. The ECDC can also assist 
MS in national IHR implementation. 

The ECDC is currently preparing guidelines for threat detection and assessment in 
the  EU  which  would  be  useful  in  the  context  of  IHR  Annex  I  on  Core  Capacity 
Requirements.  

The ECDC could provide guidance on how to use IHR Annex 2, which sets out the 
decision instrument for determining which events may constitute a PHEIC.  

The ECDC could facilitate exchange of information and best practice between EU 
MS, possibly by hosting IHR meetings or workshops. 

The  ECDC  can  mobilise  expertise,  by  sending  epidemiological  experts  to  affected 
areas  within  the  EU  and  neighbouring  countries,  to  help  in  risk  assessment  and 
advise  on  the  most  effective  public  health  response.  This  complements  existing 
WHO  mechanisms  for  international  assistance.  Collaboration  between  ECDC  and 
WHO  is  already  working  well  and  will  be  developed  further  in  order  to  ensure 
maximum efficiency within the EU and wider Europe. 

Finally, given WHO’s proposed terms of reference for IHR NFPs8, the Commission 
believes  the  ECDC  could  and  should  perform  a  complementary  role  at  EU  level. 
Formally, the IHR text says only that “Each State Party shall designate or establish a 
National IHR Focal Point”. In practice, however, since the ECDC will be operating 
the EWRS and collating risk assessment data, it will be performing many of the same 
functions at the EU level which are attributed to NFPs at national level. 

The Commission proposes that the ECDC’s role in the IHR should be formalised, 
particularly regarding the collection of data on issues within its mandate. Its role 
should include the following elements referred to in WHO’s guide on IHR NFPs: 

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WHO National IHR Focal Point Guide of July 2006, on the designation and role of NFPs. 

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(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

Remaining accessible at all times for communications with WHO IHR Contact 
Points (via e-mail, telephone, fax). 

Information-sharing  during  unexpected  or  unusual  public  health  events  (IHR 
Article  7):  providing  WHO  IHR  Contact  Points  with  information  on  events 
within the EU which may constitute a PHEIC (subject to MS’ agreement). 

Consultation (Article 8): advising WHO of events within the EU which do not 
require  IHR  notification.  This  would  generally  be  done  by  copying  or 
forwarding EWRS messages to WHO, subject to MS’ agreement. 

Other  reports  (Article  9):  responding  to  WHO  requests  for  consultations,  or 
attempts  to  obtain  verification  of  reports  of  events  occurring  within  the  EU; 
and informing WHO of any evidence of a public health risk identified outside 
the EU that may cause international disease spread. 

Verification  (Article  10):  responding  to  WHO  requests  for  verification  of 
reports from sources other than notifications or consultations of events which 
may constitute a PHEIC allegedly occurring in the EU. 

Provision  of  information  by  WHO  (Article  11):  receiving  information,  in 
confidence,  concerning  notifications,  consultations  and  reports  on  potential 
PHEICs submitted to WHO under Articles 5 - 10 inclusive. WHO could send 
this information via the EWRS. 

Disseminating information to, and consolidating input from, relevant sectors of 
the  EU  administration,  including  those  responsible  for  surveillance  and 
reporting, points of entry, public health, and other departments. The ECDC role 
should  be  limited  to  risk  assessment.  On  risk  management,  the  Commission 
would  lead,  particularly  through  the  Directorates  General  for  Health  & 
Consumer Protection; Justice, Liberty & Security; and Energy & Transport. 

5.4. 

Roster of Experts, Emergency & Review Committees 

IHR  Article  47  provides  for  a  Roster  of  Experts,  to  be  appointed  by  the  WHO 
Director-General, and to include “one member at the request of each State Party and, 
where  appropriate,  experts  proposed  by  relevant  intergovernmental  and  regional 
economic  integration  organizations”.  The  Commission  recently  wrote  to  WHO  to 
propose Commission and ECDC experts for the IHR roster. 

IHR  Articles  48  to  53  relate  to  the  Emergency  and  Review  Committees.  The 
Emergency Committee will advise WHO on whether a particular event constitutes a 
PHEIC, and will also be asked for its views on the appropriate policy response, by 
means  of  WHO  temporary  recommendations.  The  Review  Committee  will  advise 
WHO  on  reservations,  standing  recommendations,  technical  recommendations  on 
possible amendments to the IHR, and the general functioning of the IHR.  

Both  committees  will  be  convened  on  an  ad  hoc  basis  at  the  request  of  WHO,  and 
composed  of  experts  selected  from  the  IHR  Roster,  on  the  basis  of  expertise, 
experience,  and  equitable  geographical  representation.  At  least  one  member  of  the 
Emergency Committee should be an expert from the state in which the event arises. 

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In  the  event  of  a  potential  PHEIC  in  EU  territory,  it  would  be  appropriate  for 
WHO to invite the Commission and / or ECDC expert on the IHR roster to form 
part of the Emergency Committee. 

6. 

RESTRICTIONS ON POLICY RESPONSES AFFECTING INTERNATIONAL TRAFFIC 

IHR  Article  43  makes  clear  that  while  states  may  take  their  own  measures  which 
achieve  the  same  or  greater  level  of  health  protection  as  WHO  recommendations, 
“such measures shall not be more restrictive of international traffic and not more 
invasive or intrusive to persons than reasonably available alternatives that would 
achieve the appropriate level of health protection”. 

The  IHR  places  further  restrictions  on  national  measures  which  “significantly 
interfere” with international traffic. This is defined as refusing, or delaying by more 
than 24 hours, entry or departure of international travellers, baggage or cargo - eg by 
closing  a  border  or  imposing  quarantine.  In  such  cases  states  are  required  to 
demonstrate  the  scientific  information  and  public  health  rationale  behind  the 
measure. 

Any  state  impacted  by  such  a  measure  may  also  request  the  implementing  party  to 
consult  with  it.  If  disputes  were  to  arise  over  measures  restricting  trade,  the  World 
Trade Organization might be called upon to decide the dispute. 

6.1. 

Border measures 

A  key  objective  of  the  revised  IHR,  particularly  Part  V,  is  to  balance  the  need  for 
restrictions  on  arbitrary  border  measures  with  the  right  of  states  to  carry  out 
necessary checks on travellers.  

European  law  further  restricts  unilateral  measures:  at  intra-Community  borders, 
through the Schengen Borders Code9; and at all borders, through Directive 2004/38 
on free movement10, and the European Convention on Human Rights11. 

IHR Article 31 permits States Parties to require medical examination, vaccination or 
other  prophylaxis  of  travellers  as  a  condition  of  entry.  This  is  subject  to  certain 
conditions,  including  that  any  examination  is  the  least  invasive  and  intrusive 
necessary to achieve the public health objective. 

Under  Directive  2004/38,  MS  may  deny  entry  of  EU  citizens  and  their  family 
members  if  they  are  considered  a  threat  to  public  health,  but  only  if  this  is 
proportionate  and  meets  strict  material  and  procedural  safeguards.  Under  the 
Schengen  Borders  Code,  third-country  nationals  may  also  be  refused  entry  if 
considered a threat to public health. In order to define the notion of "threat to public 
health", both documents refer to the relevant instruments of the WHO. 

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10 

11 

Regulation 562/2006 of the EP and Council, on the Schengen Borders Code. 
Directive 2004/38 of the EP and Council, on the right of EU citizens and family members to move and 
reside freely in the EU. 
Protocol 4 to the Convention for the Protection of Human Rights and Fundamental Freedoms.  

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While IHR Article 43 allows States Parties to take their own measures in response 
to international health emergencies, subject to certain conditions, in the EU border 
sures  are  a  matter  of  Community  competence  which  require  EU  coordination. 
Furthermore, as  set out in the Network Decision 2119/1998, where MS intend to 
adopt measures for the control of communicable diseases, they must inform, and 
where  possible  consult,  other  MS  and  the  Commission  in  advance.  This  is  an 
important issue which requires discussion in Council. 

6.2. 

Contact tracing 

Under  IHR  Article  23,  states  may  require  travellers  to  provide  information  about 
their  destination  so  that  they  can  be  contacted  for  public  health  purposes.  There  is 
currently no standard international approach to contact tracing, but provided the rules 
on the protection of personal data are fully complied with, it may be a useful policy 
tool for public health.  

The Commission is working with the aviation industry and Directors General for 
Civil Aviation to discuss a possible EU approach to contact tracing.  

This could be based on a standard passenger locator card to be filled in by passengers 
on board; WHO are already working on a template for use during PHEICs. 

6.3. 

Particular issues in relation to pandemic flu 

The  measures  to  control  international  traffic  described  above  are  traditional  health 
policy tools, addressed under IHR Part V, but their effectiveness is questionable in 
relation to flu, which can be transmitted before symptoms appear, and which spreads 
very  quickly  in  the  pandemic  phase.  National  and  local  measures  for  social 
distancing,  such  as  school  closures  and  internal  travel  restrictions,  may  be  more 
effective, as well as being more practical and less costly. 

According  to  ECDC  advice,  screening  international  passengers  on  departure  or 
arrival  would  be  of  very  limited  use  in  a  flu  pandemic,  except  in  the  early  phase, 
when WHO has indicated exit screening might be worth considering. Still in order to 
be practical and cost-effective, this kind of border measure would benefit from policy 
coordination between countries of arrival and departure. 

7. 

OPERATIONAL CONCLUSIONS 

This  Communication  proposes  a  number  of  working  practices 
for  EU 
implementation  of  the  IHR.  Taking  into  account  the  views  of  the  European 
Parliament  and  Council,  the  Commission  will  develop  these  proposals  further, 
working with Member States and ECDC.  

Specifically, the Commission will: 

– 

develop  coordinated  EU  positions  on  any  IHR  reservations  from  third 
countries, for discussion in Council; 

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– 

– 

draft, negotiate and sign a Memorandum of Understanding on the IHR between 
the  Community  and  the  World  Health  Organization,  clarifying  the  role  of 
EWRS and ECDC in IHR implementation; 

at the request of MS, offer any clarifications necessary on issues of IHR legal 
competence. 

The ECDC will: 

– 

– 

– 

prepare guidelines for threat detection and assessment in the EU, which can be 
applied in the context of IHR Annex I on Core Capacity Requirements; 

if  desired,  develop  guidance  on  how  to  use  IHR  Annex  2,  which  sets  out  the 
decision instrument for determining which events may constitute a PHEIC; 

facilitate  exchange  of  information  and  best  practice  between  EU  MS  on  IHR 
implementation, including by hosting specific IHR workshops if desired. 

The IHR sets implementation deadlines for States Parties to assess and develop core 
capacities  to  meet  its  requirements  in  relation  to  surveillance  and  response.  Within 
five years of entry into force of the IHR in June 2007, States Parties are required to 
have  developed  and  implemented  plans  to  ensure  that  these  core  capacities  are 
present  and  functioning  within  their  territories.  The  Commission  believes  therefore 
that it would be useful to review progress with IHR implementation by 2012. 

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ANNEX – Summary and List of Acronyms 

BLANK LINE. 

Reservations:  The  Commission  is  satisfied  there  is  no  need  for  any  IHR  reservations  on 
issues  of  EC  competence.  No  MS  has  yet  identified  a  need  for  reservations  on  issues  of 
national competence. In the event that any reservations are required, EU coordination will be 
necessary. EU coordination will also be needed in reaction to any third country reservations. 

Voluntary early application. It is important that the same IHR aspects are implemented to 
the same timetable across EU Member States. This will require coordination at EU level. 

Existing  EU  networks,  including  EWRS.  The  Commission  proposes  four  IHR  working 
practices:  nominating  the  same  national  focal  point  for  EWRS  as  for  IHR;  simultaneously 
informing  EWRS  and  WHO  about  public  health  events  on  their  territory  which  do  not 
constitute a PHEIC; informing the EU communicable disease network in advance of making 
a  formal  IHR  notification  of  an  event  which  may  constitute  a  PHEIC;  and  using  EWRS 
and/or  the  Health  Security  Committee  to  help  coordinate  risk  management  and  response 
prior to communicating with WHO.  

Role  of  the  ECDC.  The  ECDC  are  already  preparing  guidelines  on  mapping  national 
surveillance capacity, which should be useful in the context of IHR Annex 1. If desired, they 
could  also  develop  guidance  on  how  to  use  the  decision  instrument  in  IHR  Annex  2,  and 
facilitate exchange of information on IHR implementation, possibly by hosting meetings or 
workshops. The ECDC’s role in relation to the IHR should be formalised, to mirror certain 
aspects of the role of NFPs, including the receipt of information from WHO on notifications 
and consultations (via EWRS). 

IHR  Roster  of  Experts,  Emergency  &  Review  Committees.  The  Commission  recently 
proposed Commission and ECDC experts to the WHO, to be appointed to the IHR roster. In 
the event of a potential PHEIC being notified by an EU MS, it would be appropriate for the 
Commission and/or ECDC expert to be selected to join the Emergency Committee. 

Memorandum of Understanding between the Community & WHO. On the basis of the 
proposals  on  working  practices  set  out  above,  it  is  desirable  to  prepare  a  memorandum  of 
understanding between the Community and WHO to ensure that arrangements in relation to 
the  IHR  are  properly  defined.  The  Commission  would  be  responsible  for  drafting, 
negotiating and signing such a memorandum. 

IHR limits on unilateral policy responses, including border measures. The IHR clarifies 
that  “such  measures  shall  not  be  more  restrictive  of  international  traffic  and  not  more 
invasive or intrusive to persons than reasonably available alternatives that would achieve the 
appropriate  level  of  health  protection”.  Border  measures  are  a  matter  of  Community 
competence which require EU coordination. Furthermore, as set out in the Network Decision 
2119/1998, where  MS  intend  to  adopt  measures  for  the  control  of  communicable  diseases, 
they must inform, and where possible consult, other MS and the Commission in advance.  

Particular  issues  in  relation  to  pandemic  flu.  Measures  at  international  borders  are 
traditional health policy tools, but their effectiveness is questionable in relation to flu, which 
can be transmitted before symptoms appear, and spreads very quickly in the pandemic phase. 

EC: European Community; ECDC: European Centre for Disease Prevention and Control; 
EP:  European  Parliament;  EU:  European  Union;  EWRS:  Early  Warning  &  Response 
System; IHR: International Health Regulations; MS: Member State; NFP: National Focal 
Point;  PHEIC:  Public  Health  Emergency  of  International  Concern;  WHO:  World  Health 
Organization; WHA: World Health Assembly. 

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