Communication from the Commission to the Council on the Revision of the International Health Regulations under the framework of the World Health Organisation
Date: 2003-09-19
Institutions: European Commission
Subjects: World Health Organisation, amendment of a law, health legislation, health policy

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 19.9.2003
COM(2003) 545 final

COMMUNICATION FROM THE COMMISSION
TO THE COUNCIL

ON THE REVISION OF THE INTERNATIONAL HEALTH REGULATIONS
UNDER THE FRAMEWORK OF THE WORLD HEALTH ORGANISATION

COMMUNICATION FROM THE COMMISSION
TO THE COUNCIL

ON THE REVISION OF THE INTERNATIONAL HEALTH REGULATIONS
UNDER THE FRAMEWORK OF THE WORLD HEALTH ORGANISATION

A. EXPLANATORY MEMORANDUM

1.

1.

2.

3.

4.

INTRODUCTION

The  International  Health  Regulations  (IHR)  were  adopted  by  the  Twenty-second
World  Health  Assembly  in  1969,  amended  by  the  Twenty-sixth  World  Health
Assembly in 1973 and the Thirty-fourth World Health Assembly in 1981, consist of
provisions for the reporting to WHO of cases of three diseases (cholera, plague and
yellow  fever)  and  a  series  of  articles  setting  out  measures  to  be  implemented  at
points of arrival and departure (ports, airports and frontiers posts) and in international
conveyances (ships, aircraft, etc).

The  current  regulations  are  a  multilateral  initiative  to  develop  an  effective  global
surveillance  tool  for  cross-border  transmission  of  specific  diseases  of  global
significance.  The  IHR  strive  to  harmonise  the  protection  of  public  health  with  the
need  to  avoid  unnecessary  disruption  of  trade  and  travel.  They  remain  the  only
legally  binding  set  of  regulations,  for  WHO  member  states,  on  global  alert  and
response for infectious diseases.

The  IHR  are  a  mechanism  for  the  sharing  of  epidemiological  information  on  the
transboundary  spread  of  infectious  diseases.  Their  purpose  is  to  ensure  maximum
security  against  the  international  spread  of  diseases  with  a  minimum  interference
with world trade and travel. The current IHR contain provisions for the application of
both  non-urgent  and  reactive  public  health  measures  to  international  travellers,
conveyances  and  goods,  and  require  countries  to  report  three  infectious  diseases
when they occur in humans: cholera, plague, and yellow fever.

The  WHO  is  concerned  that  the  present  Regulations,  as  a  global  tool  for  disease
surveillance and public health protection, have the following major constraints:

– 

– 

– 

– 

limited coverage. The IHR require reporting of cholera, plague and yellow fe-
ver only.

dependence  on  country  notification.  The  IHR  wholly  depend  on  the  affected
country to make an official notification to WHO once cases are diagnosed.

lack  of  mechanisms  for  collaboration.  At  present,  little  exists  in  the  IHR  to
foster collaboration between WHO and a country in which infections diseases
with a potential for international spread are occurring.

lack of incentives. The present IHR lack effective incentives to encourage com-
pliance by Member States.

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5.

6.

7.

8.

9.

10.

11.

2.

12.

– 

lack  of  risk-specific  measures.  WHO  lacks  the  capacity  to  proscribe  specific
measures,  tailored  to  the  actual  threat  posed  by  an  outbreak  that  will  prevent
international spread of disease.

The SARS outbreak, the first severe infectious disease to emerge in the twenty first
century,  has  taken  advantage  of  opportunities  for  rapid  international  spread  made
possible  by  the  unprecedented  volume  and  speed  of  air  travel  The  disease  has
affected  the  health  and  the  livelihood  of  populations,  and  the  functioning  of  health
systems and the stability and growth of economies has proven that intensive regional
and global collaboration is required to respond to new emerging threats. The SARS
outbreak  highlights  the  principal  challenges  that  have  to  be  met  in  revising  the
International  Health  Regulations  and  the  importance  of  coherence  at  Community
level.

In 1995, the World Health Assembly adopted Resolution WHA48.7 on the “Revision
and  Updating  of  the  International  Health  Regulations”  requesting  that  the  IHR  be
revised to take more effective account of the threat posed by the international spread
of new and re-emerging diseases.

In 2001, the World Health Assembly adopted Resolution WHA 54.14 on the “Global
health  security:  epidemic  alert  and  response”.  The  Resolution  explicitly  links  the
IHR to WHO’s activities to support its Member States in identifying, verifying and
responding  to  “health  emergencies  of  international  concern”  and  the  need  for
surveillance of communicable diseases by Member States.

In 2002, the World Health Assembly adopted Resolution WHA 55.16 on the “Global
public health response to natural occurrence, accidental release, or deliberate use of
biological  and  chemical  agents  or  radionuclear  material  that  affect  health”,  urging
Member  States  and  international  organisations,  to  strengthen  global  surveillance  of
infectious  diseases.  The  Resolution  identified  with  different  activities  including  the
revision of the IHR.

In 2003, the 56th World Health Assembly, decided by means of Resolution 56.28, to
establish an Intergovernmental Working Group open to all Member States of WHO,
to review and recommend a draft revision of the International Health Regulations.

The main objectives of the revised IHR as envisaged are to ensure maximum security
against the spread of diseases with a minimum interference with world trade.

Several areas of Community activity are concerned with these two pillars of activity
and  these  form  the  basis,  and  give  rise  to  the  need,  for  strong  Community
involvement and action in a coherent and effective way.

PROPOSED CHANGES TO THE INTERNATIONAL HEALTH REGULATIONS

The  IHR  are  being  developed  and  fine-tuned  to  adapt  to  contemporary  needs  for
surveillance  for  the  control  of  public  health  emergencies  of  international  concern,
although  many  of  the  core  concepts  proposed  for  the  revision  of  the  IHR  are  new,
some of their elements already exist in the present IHR, which are outdated.

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13.

It would  appear that the proposed WHO structure for the revised IHR will take  the
form of:

– 

– 

a framework document containing (i) general principles on appropriate public
health  measures  and  (ii)  legal  provisions  relating  to  the  operation  and
amendment of the IHR incorporating by reference the technical annexes; and

a series of  annexes  describing  technical provisions and  specific requirements,
which  -  because  of  the  reference  in  the  framework  part  to  the  annexes  -  will
form an integral part of IHR.

In addition, there will be operational guidelines to accompany the IHR and assist in
their application. (E.g. on ships and aircraft)

14.

The proposed core concepts in the revised IHR are expected to cover the following
criteria:

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

the reporting of all public health emergencies of international concern.

the establishment of a national focal point for the IHR revision and subsequent
implementation.

national  capacity  to  quickly  analyse  and  report  national  disease  risks  and,  in
collaboration with WHO, to determine their potential to spread internationally
and to affect other countries.

the  option  for  countries  of  making  confidential,  provisional  notifications  to
WHO.  This  option  is  not  available  within  the  existing  IHR,  which
automatically  list  notified  cases  of  cholera,  plague  or  yellow  fever  in  the
Weekly epidemiological record (WER).

information other than official notifications which might be  used by WHO to
help  identify  and  control  public  health  emergencies  of  international  concern.
There  would  be  an  obligation  on  countries  to  respond  to  requests  from  the
Organisation to verify the reliability of such information.

the  measures  on  how  to  offset  the  risk  of  economic  losses  associated  with
public  health  emergencies  of  international  concern  by  issuing  time  limited
recommendations that in effect  establish  a  template  (norms)  for  the  measures
required for the protection of other countries.

the obligation on WHO to rapidly assist countries in assessing and controlling
outbreaks.

the setting up of a transparent process within WHO to issue recommendations.

the provisions of a non-exhaustive list of key measures that could be used in a
WHO recommendation.

the establishment of a permanent IHR review body to secure continuity within
the IHR process

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15.

16.

3.

17.

18.

19.

20.

The  initial  WHO  consultation  documents  have  been  circulated  to  a  few  selected
countries,  including  some  EU  Member  States.  These  documents  describe  how  an
outbreak in a country might be communicated to the WHO, and how the WHO might
provide  assistance  and  assessment  of  the  situation.  WHO  would  also  try  to  put  in
place  a  procedure  which  would  identify  actions,  which  would  be  potentially
applicable  at  point  of  entry  into  a  country  of  produce  or  persons  from  the  country,
affected  by  the  epidemic.  This  would  mean  that  during  an  actual  public  health
emergency of international concern, WHO and the concerned State(s) would choose
the appropriate measures to be taken from the complete list, and use these as a basis
for  recommendations  for  use  by  countries.  These  recommendations  would  be
time-limited, and may need to be changed during the risk period. A clear protocol for
ending recommended measures would be included in the IHR.

For  travellers  these  range  from  “No  measures  required”  to  “Refusal  of  entry  of
persons from affected areas”. For  goods and conveyances the draft initial measures
range  from  “No  measures  required”  to  “  Refusal  of  entry  of  conveyance,  cargo  or
goods”. Clearly as far as EU is concerned there should be coherence of actions.

LEGAL STATUS OF THE IHR AND ITS IMPLEMENTATION PROCESS

The  IHR  revision  process  strives  to  build  broad  consensus  with  WHO  Member
States.  The  first  non-regulatory  draft,  which  reflects  the  consensus  reached  by
Member States of the organisation ‘participating’ in the revision, should be available
late in 2003. This draft will then be shared with Member States and the Commission.
The  draft  will  provide  the  basis  for  the  legally  worded  text  and  an  extensive
consultation process through a series of regional consensus meetings to be convened
in late 2003 and 2004.

The  draft  revised  Regulations  will  then  be  agreed  and  finalised  within  the
Intergovernmental Working Group, which is foreseen to take place in 2004 to which
Member States and the Commission will be invited. The final text will be submitted
to the 2005 World Health Assembly for adoption.

The  governments  of  all  Member  States  were  invited  to  designate  an  official  focal
point  for  liaison  with  WHO  on  the  IHR  revision.  According  to  WHO  over  108
Member  States  have  now  done  so  including  several  EU  Member  States.  Many
interested  intergovernmental  and  non-governmental  organisations  were  also  invited
to designate focal points for this purpose and several have done so.

The  56th  World  Health  Assembly,  decided  by  means  of  Resolution  56.28  that
regional  economic  integration  organisations  constituted  by  sovereign  States,
Members of WHO, to which their Member States have transferred competence over
matters  governed  by  this  resolution,  including  the  competence  to  enter  into  legally
binding  regulations,  may  participate,  in  accordance  with  Rule  55  of  the  Rules  of
Procedure  of  the  World  Health  Assembly,  in  the  work  of  the  Intergovernmental
Working  Group  referred  to  under  point  9.  This  implies  the  participation  of  the
Commission as representative of the Community in accordance with the Treaty

21.

The legal status  of  the  new  Regulations  will  remain  unchanged  as  Article  21of  the
WHO Constitution.

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22.

23.

4.

24.

With  regard  the  legal  status  and  the  implementation  process  of  the  Regulations,
taking  into  account  its  legal  status,  WHO  considers  that  a  WHA  Resolution  will
suffice  to  adopt  the  new  Regulations.  Countries  thereafter  will  be  provided  with
some time for their internal procedures for its ratification, and/or notify to WHO any
reservation they may have to  any of the articles of the new Regulations.  If no such
notification/reservation takes place during an agreed period, it will be assumed that
the Regulations will be applied to the country concerned.

Currently  the  Community  as  such  may  not  ratify  the  Regulations,  which  are  to  be
considered  as  an  internal  act  of  WHO.  However  when  ratified  they  become  as
international  regulations,  binding  on  concerned  countries.  Therefore  in  due  course
the Community will need to decide how to address this issue in order to participate
fully in the final negotiations in 2005.

BASIS FOR COMMUNITY INVOLVEMENT

Globalisation  is  blurring  the  discussion  between  national  and  international  public
health  concerns;  people  move  freely  and  goods,  as  well  as  microorganisms,  cross
national borders without limitations. The best way to prevent the international spread
of diseases is to detect public health threats early and effectively respond when  the
problem is small. This is only possible if national surveillance systems are effective
in  detecting  the  threats  early  and  capable  of  rapidly  implementing  effective
responses.  At  the  international  level,  there  must  be  co-ordination  for  coherent  and
effective  global  response.  The  proposals  for  the  revised  IHR  seek  to  apply  these
principles  within  a  multilateral  framework  with  an  emphasis  on  partnership  and
collaboration  at  national  and  regional  level  to  achieve  global  surveillance  and
response capacity.

The main objectives of the revised IHR as envisaged are to ensure maximum security
against the spread of diseases with a minimum interference with world trade.

Several areas of Community activity are concerned with these two pillars of activity
and  these  form  the  basis,  and  give  rise  to  the  need,  for  strong  Community
involvement and action in a coherent and effective way.

Particular  areas  of  direct  concern  are  the  Community  instruments  and  activities
dealing with the epidemiological surveillance and control of communicable diseases.
Several other associated areas such as food safety, restrictions on trade, transport and
civil protection could also be concerned by the IHR revision.

25.

In  fact  the  ideas  now  discussed  in  WHO  are  very  similar  to  those  in  the  existing
Community network for epidemiological surveillance  and control  of communicable
diseases  set  up  under  Decision  2119/98/EC.  In  the  Network  the  Commission  co-
ordinates actions with single contact points (authorities and structures) designated by
Member  States  in  surveillance,  and  in  the  early  warning  and  response  system
(EWRS).  All  public  health  threats  as  well  as  measures  taken  should  be
communicated into the network according to Decision 2119/98/EC.

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26.

27.

5.

5.1.

28.

29.

30.

The revision of IHR will support the actions of EU Member States in responding to
the  requirements  of  Decision  2119/98/EC  providing  a  framework  for  better  co-
ordination  at  international  level,  in  coherence  with  WHO,  especially  where  third
countries are involved.

The European Commission has the 23rd of July 2003, adopted a proposal for Council
and Parliament Regulation proposal aiming creating a European  Centre  for Disease
Prevention and Control. If the Council and the Parliament adopt the Regulation, the
Centre will have a big role  in  a  assisting the  Commission and  Member  States  with
technical  and  scientific  advice  in  the  application  and  implementation  of  the  new
Regulations, particularly with WHO’s Global Alert Network.

AREAS OF COMMUNITY ACTIVITY COVERED BY THE IHR

Community  activity  in  the  field  of  epidemiological  surveillance  and  control  of
communicable diseases;

The objectives of the revised IHR and the organisation foreseen – that of addressing
communicable  diseases  in  general  by  epidemiological  surveillance  and  an  early
warning  system  between  government  departments  –  will  introduce  at  worldwide
level a system which is very close in structure to that introduced by the Parliament
and Council at EU level.

WHO and the EU must have strong co-operation and links in this area to ensure that
the  Member  States  common  to  both  organisations  can  benefit  from  synergy  and
avoid duplication of effort.

The  Commission,  which  itself  works  closely  with  WHO,  both  informally,  and
formally  through  an  exchange  of  letters  between  the  WHO  and  the  Commission
concerning the  consolidation and  intensification of  co-operation (OJ  C  1,  4.1.2001,
p. 1),  must  therefore  have  a  key  role  to  play  in  translating  this  co-operation  into
dynamic activity. Legal provisions of particular relevance are:

– 

– 

– 

procedures for information exchange in the context of the Community network
for  the  epidemiological  surveillance  and  control  of  communicable  disease  as
set  out  in  European  Parliament  and  the  Council  Decision  2119/98/EC  of
24.09.1998 (OJ L 268 of 3.10.1998, p. 1);

the  early  warning  and  response  system  for  the  prevention  and  control  of
communicable  diseases  set  out  in  Commission  Decision  2000/57/EC  of
22.12.1999 (OJ L 21 of 26.01.2000, p. 32);

diseases  to  be  covered  by  the  Community  network  for  the  epidemiological
surveillance  and  control  of  communicable  disease  as  set  out  in  Commission
Decision 2000/96/EC (OJ L 28 of 03.02.2000, p. 50).

It  is  necessary  to  ensure  that  the  new  IHR  will  be  compatible,  complementary  and
coherent with EC legislation in particular to that included in the above mentioned EC
Decisions developed under European Parliament and Council Decision 2119/98/EC.

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5.2.

Food Safety:

The  following  selection  illustrates  the  extensive  Community  competence  on  food
safety:

– 

– 

– 

– 

– 

– 

– 

– 

– 

Regulation (EC) No 178/2002 of the European Parliament and of the Council
of  28  January  2002  laying  down  the  general  principles  and  requirements  of
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down
procedures in matters of food safety (Official Journal L 31 , 01/02/2002, p. 1).

Council Directive 92/67/EEC of 14 July 1992 amending Directive 89/662/EEC
concerning  veterinary  checks  in  intra-  Community  trade  with  a  view  to  the
completion of the internal market (Official Journal L 268 , 14/09/1992, p. 73).

Council  Directive  96/90/EC  of  17  December  1996  amending  Directive
92/118/EEC  laying  down  animal  health  and  public  health  requirements
governing trade in and imports into the Community of products not subject to
the  said  requirements  laid  down  in  specific  Community  rules  referred  to  in
Annex A (I) to Directive 89/662/EEC and,  as regards pathogens, to Directive
90/425/EEC (Official Journal L 13 , 16/01/1997, p. 24).

Commission Decision 2002/477/EC of 20 June 2002 laying down public health
requirements  for  fresh  meat  and  fresh  poultry  meat  imported  from  third
countries, and amending Decision 94/984/EC C(2002) 2196) (Official Journal
L 164 , 22/06/2002, p. 39).

Council Directive 97/78/EC of 18 December 1997 laying down the principles
governing  the  organisation  of  veterinary  checks  on  products  entering  the
Community from third countries (Official Journal L 24 , 30/01/1998, p. 9).

Council  Directive  93/43/EEC  on  the  hygiene  of  foodstuffs  (Official  Journal
L 175 , 19/07/1993, p. 1)

Council Directive 95/23/EC of 22 June 1995 amending Directive 64/433/EEC
on conditions for the production and marketing of fresh meat (Official Journal
L 243 , 11/10/1995, p. 7) .

Council  Directive  83/91/EEC  of  7  February  1983  amending  Directive
72/462/EEC on health and veterinary inspection problems upon importation of
bovine  animals  and  swine  and  fresh  meat  from  third  countries  and  Directive
77/96/EEC  on  the  examination  for  trichinae  (trichinella  spiralis)  upon
importation  from  third  countries  of  fresh  meat  derived  from  domestic  swine
(Official Journal L 59 , 05/03/1983, p.34).

Council Directive 97/22/EC of 22 April 1997 amending Directive 92/117/EEC
concerning  measures  for  protection  against  specified  zoonoses  and  specified
zoonotic  agents  in  animals  and  products  of  animal  origin  in  order  to  prevent
outbreaks of food-borne infections and intoxications (Official Journal L  113 ,
30/04/1997, p.9).

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– 

– 

Council Directive 96/23/EC  of  29  April  1996  on measures  to  monitor certain
substances  and  residues  thereof  in  live  animals  and  animal  products  and
repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC
and 91/664/EEC (Official Journal L 125 , 23/05/1996, p. 10).

Council  Directive  96/43/EC  of  26  June  1996  amending  and  consolidating
Directive 85/73/EEC in order to ensure financing of veterinary inspections and
controls on live animals and certain animal products and amending Directives
90/675/EEC and 91/496/EEC (Official Journal L 162 , 01/07/1996, p. 1).

5.3.

Trade:

– 

Application of the new  IHR ‘s main objectives - to ensure maximum security
against the international spread of diseases with a minimum interference with
world trade  and travel –  will have to be considered  and put  into  effect  in  the
framework  of  articles  28,  29  and  30  of  the  EC  Treaty  which  deal  with
prohibition of quantitative restrictions of goods between Members States, and
(article 30) with the possibility of restriction based on the protection of health.

5.4.

Other activities and legislation:

– 

– 

– 

– 

Council  Decision  2001/792/EC,Euratom  of  23  October  2001  establishing  a
Community mechanism to facilitate reinforced co-operation in civil protection
assistance interventions (Official Journal L 297, 15/11/2001, p. 7).

Commission  Directive  97/58/EC  of  26  September  1997  amending  Council
Directive  94/57/EC  on  common  rules  and  standards  for  ship  inspection  and
survey organisations and for the relevant activities of maritime administrations
(Official Journal L 274 , 07/10/1997, p. 8).

Directive  2000/61/EC  of  the  European  Parliament  and  of  the  Council  of  10
October 2000  amending Council Directive 94/55/EC on  the  approximation of
the laws of the Member States with regard to the transport of dangerous goods
by road. (Official Journal L 279, 01/11/2000, p.40).

Directive  2000/62/EC  of  the  European  Parliament  and  of  the  Council  of  10
October 2000  amending Council Directive 96/49/EC on  the  approximation of
the laws of the Member States with regard to the transport of dangerous goods
by rail. (Official Journal L 279, 01/11/2000, p.44).

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B. CONCLUSIONS

An effective revision of the IHR will reinforce international co-operation in the field of public
health  protection  and  thus  will  strengthen  the  capacity  of  the  Community  and  its  Member
States in preventing outbreaks of disease and in responding in the most effective way. Whilst
at the same time interfering as little as possible with international obligations on trade.

The new text of  the  IHR should enable  Member  States,  through  an  appropriate  Community
process, to endorse and implement its provisions as widely as possible.

It is in the interest of the Community that the revision process is concluded as expeditiously
as possible and, therefore that the Member States and the Commission work in co-operation
and co-ordination to this end.

“When it appears that the subject-matter of an agreement or contract falls in part within the
competence of the Community and in part within that of the Member States, it is important to
ensure  that  there  is  a  close  association  between  the  institutions  of  the  Community  and  the
Member States both in the process of negotiation and conclusion and in the fulfilment of the
obligations  entered  into.  This  duty  of  co-operation,  to  which  attention  was  drawn  in  the
context of the EAEC Treaty, must also apply in the context of the EEC Treaty since it results
from the requirement of unity in the international representation of the Community". (Opinion
of the Court of 19 March 1993. Page I-1061. Point 36)

Consequently:

1.

2.

3.

4.

5.

6.

As  many  of  the  areas  covered  in  the  proposed  IHR  Regulations  framework  and  its
annexes  fall  within  the  scope  of  Community  legislation,  the  Commission  and
Member  States  must  take  part  in  these  deliberations,  playing  an  active  and  leading
role in the revision process to obtain a conclusion of the Revision of the International
Health Regulations in accordance with the Community acquis

In application of the World Health Assembly Resolution 56.28, the Community must
contribute  effectively  the  works  of  the  Intergovernmental  Working  Group.  This
implies active participation by Member States, and of the Commission in accordance
with the Treaty.

The Commission will co-ordinate with the technical experts from Member States in
the  areas  of  Community  competence,  in  particular  communicable  disease  control,
and also food safety, trade, transport, and civil protection, to ensure concerted action
at Community level.

The Commission will co-ordinate with Member States, so that the Community point
of view is considered in the preliminary technical drafts of the revised texts, and its
opinion  is  taken  into  account  while  agreeing  the  negotiating  procedure  for  the
revision process within the WHO context.

The Commission will participate with Member States, during the regional meetings
organised  by  WHO,  to  ensure  a  co-ordinated  Community  position  both  prior  and
during the meetings.

The Commission will regularly inform the Council of the progress achieved through
the Health Group.

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7.

8.

9.

The  Commission  will  regularly  consult  Member  States  on  the  progress  achieved
through the Community network for the epidemiological surveillance and control of
communicable diseases set up by Decision 2119/98/EC.

The  Commission  will  pursue  with  Acceding,  Candidate,  and  EEA  countries  a
consistent and coherent approach in the revision process.

The  Commission  invites  the  Council  to  endorse  these  conclusions  and  support  the
Commission in their implementation.

11