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. Introduction

1. 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).

2. 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.

3. 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.

4. 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.

- 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

2. Proposed changes to the International Health Regulations

12. 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.

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

15. 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.

16. 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.

3. Legal Status of the ihr and its Implementation process

17. 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.

18. 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.

19. 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.

20. 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.

22. 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.

23. 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.

4. Basis for community involvement

24. 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.

26. 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.

27. 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.

5. Areas of Community Activity covered by The IHR

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

28. 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.

29. 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.

30. 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.

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).

- 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).

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. 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

2. 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.

3. 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.

4. 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.

5. 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.

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

7. 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.

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

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