51996AC1068

Opinion of the Economic and Social Committee on the 'Proposal for a European Parliament and Council Decision creating a network for the epidemiological surveillance and control of communicable diseases in the European Community` () (97/C 30/01)

On 11 April 1996, the Council decided to consult the Economic and Social Committee, under Article 129 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 16 July 1996. The Rapporteur was Mr Fuchs.

At its 338th Plenary Session (meeting of 25 September 1996), the Economic and Social Committee adopted the following Opinion, by 82 votes to four with three abstentions.

1. Introduction

Background to the Commission proposal

1.1. As the Communication and Explanatory Memorandum which precede it indicate, this proposal follows on from the Commission Communication on the framework for action in the field of public health () and, more particularly, from that on the prevention of AIDS and certain other communicable diseases (), which called for the creation and development of communicable disease surveillance networks.

1.2. In different Opinions on public health, including the most recent on health monitoring (), the ESC has stressed the need to develop a preventative approach coordinated at Community level, to improve the exchange of information and to harmonize data-processing methods.

1.3. More particularly, in the Opinion on the prevention of AIDS and other communicable diseases, it recommended that European monitoring networks should not duplicate the work of existing coordination networks; the evaluation and formal organization of these networks should make it possible to identify centres of excellence or reference centres that are well suited to carrying out pilot studies (Point 3.7).

1.4. The ESC also called for particular attention to be paid to 'new types of infection` and the organization of ad hoc epidemiological surveys (Point 3.8), and identified a need to set up a European rapid intervention unit to respond to health emergencies (Point 3.9).

2. General comments

2.1. Whilst the action programme on the prevention of AIDS and certain other communicable diseases makes it possible to initiate and test specific coordinated measures for a limited period, the Commission proposal seeks to lay the foundations for a permanent EU surveillance and control network covering a wide range of communicable diseases.

2.2. The ESC would point out that such a network can only be made up of compatible national networks and that the institutions and experts responsible for the surveillance and control of communicable diseases at national level should therefore play a central role in the development and creation of the EU network.

2.3. The ESC would stress that communicable diseases know no frontiers. As a result, other non-EU surveillance and control initiatives have been launched. For example, the WHO is active on an international scale. Cooperation with the USA aimed at the establishment of an early-warning and response system has been initiated under the joint EU/US action plan. International data exchange on communicable diseases is a central element in the G7 Global Healthcare Applications Project in which Canada and Japan are participating. These activities exhibit points of contact, and some even overlap, with the network outlined in the Commission proposal. The USA is anxious to avoid any duplication of activities and structures and to make the measures in question broadly complementary. This will require a comprehensive and up-to-date evaluation of all bi- and multi-lateral action aimed at the surveillance and control of communicable diseases.

2.4. The ESC observes that the Commission Communication on communicable disease surveillance networks in the European Community provides a fundamental basis for the draft decision. The Communication gives a broader definition of 'surveillance`, stressing the epidemiological, as opposed to the regulatory, nature of the concept. The definition of 'control of communicable diseases` in the draft decision emphasizes this epidemiological aspect of the measures in addition to '... the range of measures taken by the competent public health authorities to stop the spread of communicable diseases ...`. The ESC welcomes this emphasis, since more far-reaching protective measures can only be adequately formulated if due account is taken of particular national conditions and circumstances. It therefore thinks that the Member States should continue to be responsible for formulating specific protective measures. The Commission should primarily act as a coordinator with regard to control measures in the narrower sense, especially since, on the basis of Article 129(4) of the Maastricht, Treaty, measures adopted pursuant to the decision can be regarded as binding on the Member States.

2.5. In the light of these general comments and its earlier remarks on the content of the draft decision, the ESC feels able to endorse the Commission proposal in principle, since many of its aims coincide with the ESC's own suggestions. At the same time, the ESC reserves the right to comment further on the content of the proposal.

3. Gist of the proposal

3.1. The proposal comes under the principle of shared competence between the Community and the Member States and seeks to create a network for the epidemiological surveillance and control of communicable diseases. Full participation by the Member States in the organization and implementation of the network should help to ensure coordination and mutual cooperation in the collection, processing and exchange of necessary information.

3.2. This action is therefore geared towards disease prevention in the broad sense and will follow the principles of subsidiarity and proportionality.

3.3. The communicable disease data will be collected in aggregated form or completely anonymously and will in no case enable individuals to be identified. So, there would be no conflict with Community instruments concerning the protection of personal data.

3.4. The setting-up of this network is based on the situation already existing in this field at European level and aims to avoid unnecessary duplication of work by ensuring that all Member States have the same conception of surveillance, as a result of defining with them the type of information required and the arrangements appropriate for each group of communicable diseases.

3.5. Finally, other parties will be associated with the network, under arrangements yet to be worked out. These will include the competent international organizations, non-EU countries such as the USA, with whom cooperation is already planned, and the surveillance networks to which Member States already belong.

3.6. The Annex contains an indicative list of diseases and their categories. The Commission will regularly update this list and review the classification which is at present based on corresponding control measures. The Annex currently divides the communicable diseases covered by the surveillance network into the two following groups:

1) - diseases preventable by vaccination (tuberculosis, tetanus, poliomyelitis, diphtheria, meningitis, measles, mumps, rubella, influenza syndromes, etc.);

- sexually-transmitted diseases (hepatitis B, AIDS/HIV, chlamydiasis, etc.);

- viral hepatitis (including hepatitis C and other as yet unclassified categories of hepatitis);

- food-borne diseases (listeriosis, salmonellosis, etc.);

- water-borne diseases and diseases of environmental origin (legionellosis, etc.);

- nosocomial infections;

- other diseases transmissible by non-conventional agents (including Creutzfeldt-Jakob disease, etc.).

2) - diseases covered by the International Health Regulations (yellow fever, cholera, plague);

- other diseases (rabies, typhus fever, African haemorrhagic fevers, malaria and any other as yet unclassified serious epidemic disease, etc.).

4. Specific comments

The establishment of a transnational EU epidemiological network for communicable diseases is essentially to be welcomed as a means of effective prevention and control which also offers synergistic benefits.

At the same time, the ESC feels impelled to raise certain questions and to ask for clarification and suggestions with regard to the following points:

4.1. Article 1

4.1.1. Article 1 clearly defines the proposed Community network as a horizontal structure, since it will be created by establishing permanent communication between the relevant national structures. In addition, the financial statement - which merely outlines the costs of this 'permanent communication` - states that implementation of the individual measures and provision of the necessary resources are the exclusive responsibility of the Member States.

In view of the prevailing situation in the different Member States, however, it seems necessary to examine whether EU (co-)financing going beyond the currently planned funding of 'permanent communication` might be required during the start-up phase of the general surveillance network.

4.1.2. The ESC would point out that existing national structures vary greatly in their surveillance and control objectives and possibilities. The Commission proposal must not be interpreted to mean that Community-level measures and requirements represent a fundamental criticism of individual national structures, without simultaneously providing EU resources to set up the necessary national structures.

4.1.3. A general EU-wide network will promote greater harmonization in the surveillance and control of communicable diseases throughout the EU. This development is essentially to be welcomed. From the standpoint of possible scenarios, however, it would seem advisable, particularly in the case of harbours, airports and frontiers with non-EU countries, not to lay down uniform protective measures but always to take account of the special geopolitical, spatial, socio-cultural and other features of individual Member States. The ESC therefore concludes that such EU measures should generally take the form of recommendations.

4.1.4. In its recent Opinion on BSE (), the Committee expressed concern at the delays affecting research and health protection policy with regard to possible links between BSE and the new strain of Creutzfeldt-Jakob disease, and welcomed the fact that the programme in question would also cover CJD monitoring. At the same time, the urgent need for action in this area and the need to mobilize all appropriate financial resources raise the question of whether the present programme, which lacks sufficient own resources, is adequate to the situation. The Committee therefore thinks that the programme's appropriation should be reconsidered in the light of these new developments.

4.2. Article 2

The definition of 'control of communicable diseases` must stress the preventative aspect, i.e. control should be interpreted as the 'formulation of common guidelines and the coordination or harmonization of counter-measures`. This interpretation should be embodied in the text, so as to ensure that all sectors are covered by these preventative objectives.

4.3. Article 3

4.3.1. By analogy with Article 2, the preventative dimension of 'control` must be stressed. The ESC would emphasize that Community-level control must be planned and put into effect with due regard for the EU subsidiarity principle and must be coordinated with national control measures.

4.3.2. Addressed to every Member State, Article 3 limits the scope of the draft decision to serious and/or rare communicable diseases classified according to their 'appearance or resurgence on its territory` or 'importation` on to its territory. It should also state that different surveillance and control measures are required for less serious communicable diseases or infections whose occurrence in the disease patterns of a society is somewhat more predictable. There is, therefore, a need to examine whether the range of diseases listed in the Annex to the draft decision is sufficient and whether their classification with reference to corresponding categories of measures is appropriate. The diseases listed and the classification criteria adopted offer a possible basis for planning counter-measures. Other diseases can be included in the list as an indication, just as other classification criteria involving corresponding control categories are conceivable. Thus, a classification based on 'transmission by blood` would correlate with specific transfusion measures and blood-processing techniques. Adoption of an 'emerging diseases` category would lead to emphasis on preventative measures or phased crisis planning. At all events, such important diseases as hepatitis A, psittacosis, Queensland fever, bacillary dysentery or leprosy should be listed, even if the Annex is expanded as proposed. National experts should participate fully in any such expansion.

4.3.3. Lastly, we ought to look at whether action criteria other than the proposed disease categories need to be identified. This would include preparatory measures in the context of laboratory diagnosis and the provision of transport and nursing facilities, including the necessary qualified staff.

4.4. Article 4

4.4.1. This Article describes the specific decision-making structures and procedures required for the drafting and implementation of measures. The ESC would stress that it expects the Community committee procedure to be strictly observed in this connection.

4.4.2. Reference has already been made to the potentially binding nature of the measures and its implications for resources in individual Member States (see points 4.1.1 and 4.1.2). This makes it imperative for the Member States to be represented on this preparatory committee, especially by national 'surveillance experts`. This being the case, the proposed level of representation, namely two members per Member State, must be seen as an absolute minimum.

4.4.3. The ESC wonders whether proposals for action should not, essentially, be drawn up by a group of representatives of the national surveillance and control bodies. Such a body should make use of the horizontal communications and operational structures already established between the Member States.

4.5. Article 5

4.5.1. The first three indents of Article 5 list epidemiological and sero-epidemiological types of measure. The ESC unreservedly welcomes a greater degree of comparability in the activities of the Member States and a Community overview of the information thus acquired.

4.5.2. In addition to the development of EU epidemiological rules of procedure, it is necessary to ensure comparable compliance therewith. The ESC therefore thinks that the Member States must guarantee comparable quality assurance.

4.5.3. Reference has already been made to the problems associated with the protective measures referred to in the fourth indent (see point 4.1.3). The Committee thinks that the Commission's role should be expressly restricted to the coordination of protective measures in this context.

4.5.4. Article 5 essentially covers primary preventative measures. The particular socio-cultural context of each Member State is extremely important in this connection. Individual measures of this type may be more effective if they are chiefly devised and implemented at national level.

4.6. Article 6

4.6.1. Article 6 specifies in highly abstract fashion the information to be communicated to the Commission by the Member States. Whether this information relates to individuals, patients or procedural rules depends on the type of measure taken. Nor is it stated whether personal data are to be communicated solely in aggregate form, along the lines of the HIV/AIDS monitoring data collected in Paris, or on an individualized basis. A solution acceptable to all Member States must be found in this connection.

4.6.2. In the case of epidemiological or anamnesic data, there is a need to clarify who, and pursuant to what rules, can be granted access to this information for the purpose of further scientific analysis. In principle, all national data-suppliers should be entitled to participate in further analyses as originators.

4.7. Modern information and communications technology combined with a modern approach to cooperation will ensure, or at least make it likely, that the decentralized or horizontal network structure highlighted in this Opinion is adequately realized. A structure should be created which will allow all the participating national bodies direct access to the total information pool. Commission filtering of this information would be superfluous.

4.8. The ESC would also stress that cooperation and the division of activities which have already proved successful must be revived and turned to advantage. Thus, units attached to national epidemiological centres and engaged in the collection, documentation and information-/action-orientated processing of data for the whole of Europe have made a valuable contribution to the monitoring of HIV/AIDS (Paris), salmonella (London) and legionella (London). Similar centres could be established for other disease categories in other Member States.

Brussels, 25 September 1996.

The President of the Economic and Social Committee

Carlos FERRER

() OJ No C 123, 26. 4. 1996, p. 10.

() OJ No C 338, 31. 12. 1994.

() OJ No C 133, 31. 5. 1995.

() OJ No C 174, 17. 6. 1996.

() OJ No C 295, 7. 10. 1996, p. 53.