COMMON POSITION (EC) No 10/95 adopted by the Council on 2 June 1995 with a view to adopting a European Parliament and Council Decision of . . . adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (1996 to 2000) (95/C 216/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 129 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure referred to in Article 189b of the Treaty (4),

(1) Whereas the Council, in its resolution of 2 June 1994 (5), in response to the Commission communication of 24 November 1993 on a framework for Community action in the field of public health, included AIDS and other communicable diseases among the priority areas for Community action for which the Commission was invited to bring forward proposals for action;

(2) Whereas AIDS is at present an incurable disease regarded as a major scourge, to combat which coordinated action is required in the areas both of research and of prevention;

(3) Whereas AIDS is a phenomenon that poses a dilemma not only for those parts of human relationships of most intimate concern to individuals, but also for modes of collective behaviour; whereas its implications extend to law and the economy, to politics, public health, education and culture, as well as to medicine, sociology and research;

(4) Whereas the plan of action adopted by Decision 91/317/EEC of the Council and the Ministers for Health of the Member States, meeting within the Council (6), in the framework of the 'Europe against AIDS' programme expired at the end of 1993;

(5) Whereas the 'Europe against AIDS' programme has been extended until the end of 1995 by the European Parliament and Council Decision No 1729/95/EC of 19 June 1995 (7);

(6) Whereas the Council, in its conclusions of 13 December 1993 (8) and the European Parliament in its resolutions of 26 May 1989 (9), 15 May 1991 (10) and 19 November 1993 (11) took the view that it was essential to acquire a better knowledge of diseases on the basis of their causes and their epidemiological context; whereas, accordingly, the two institutions have called on the Commission to submit proposals for the setting up of an epidemiological network in the Community;

(7) Whereas the European Parliament and the Council emphasized that the smooth running of a network for gathering epidemiological data requires that the comparability and compatibility of data be ensured and that theoretical training in epidemiology and practical preparation in epidemiology in the field be developed for the teams participating in the network;

(8) Whereas the European Community can make a contribution towards the organization of exchanges of experience and the dissemination of information with regard to the specific training of health professionals and the information of all the social players involved, such as teachers, families, authorities and heads of undertakings;

(9) Whereas, in their resolution of 13 November 1992 (12), the Council and the Ministers for Health meeting within the Council invited the Commission to consider the existing arrangements which provide for cooperation between Member States in the field of monitoring and control of communicable diseases;

(10) Whereas the actions undertaken at Community level in the field of AIDS need to be continued, extended to cover certain other communicable diseases, in particular sexually transmissible diseases (STDs) and consolidated within the framework of the action in the field of public health set out by the Commission (13);

(11) Whereas these actions must take into account, as the Council requested in its resolution of 27 May 1993 (14), other actions undertaken by the Community in the field of public health or having an impact on public health;

(12) Whereas, by reason of its scale and effects, Community action in support of the prevention of AIDS and other communicable diseases enables the designed objectives to be reached more effectively;

(13) Whereas policies and programmes formulated and implemented at Community level should be compatible with the targets and objectives of Community action on the prevention of AIDS and other communicable diseases; whereas, in particular, implementation of actions under the Community's biomedical and health research programme must be closely coordinated with the implementation of Community actions on prevention of these diseases;

(14) Whereas it is necessary to promote studies in the Member States to identify the most effective methods of prevention and to publish the most significant results of this work;

(15) Whereas cooperation with the competent international organizations and with non-member countries should be strengthened;

(16) Whereas a multiannual programme is required, defining the objectives of Community action, the priority actions for the prevention of AIDS and other communicable diseases, and the appropriate evaluation mechanisms;

(17) Whereas it is important that the Commission ensures implementation of the programme in close cooperation with the Member States; whereas, to that end, provision must be made for a procedure to ensure that Member States are fully involved in implementing the programme;

(18) Whereas agreement on a modus vivendi between the European Parliament, the Council and the Commission concerning measures implementing acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994;

(19) Whereas, from an operational point of view, the investment made under the preceding action plans in terms of both the European pilot networks and of the mobilization of all those involved in combating AIDS and other communicable diseases should be safeguarded and developed;

(20) Whereas, however, possible duplication of effort should be avoided by the promotion of exchanges of experience and by the joint development of basic information modules for the general public, for health education and for training members of the health professions, which may be targeted on specific groups and on non-governmental organizations, including patients' associations;

(21) Whereas the objective of this programme must be to contribute towards stemming the spread of AIDS and other communicable diseases in the Community by improving knowledge concerning their prevalence and patterns, improving recognition of risk situations and practices and improving early detection and social, health and medical support, with a view to preventing the transmission of AIDS and other communicable diseases and thus reducing the associated mortality and morbidity as well as combating all forms of discrimination against people suffering from AIDS or infected with the HIV virus;

(22) Whereas in order to increase the value and impact of this programme a continuous assessment of the measures undertaken should be carried out, with particular reference to their effectiveness and the achievement of objectives at both national and Community level, and the necessary adjustments should be made where appropriate;

(23) Whereas the objectives of this programme and of the measures undertaken to implement it form part of the health protection requirements referred to in the third paragraph of Article 129 (1) of the Treaty establishing the European Community and as such form a constituent part of the Community' other policies;

(24) Whereas access to this programme should be facilitated, with especial stress on reaching organizations which lack means of easy access to information on Community programmes;

(25) Whereas the procedures for granting financial aid should be simple and accessible, and there should be guarantees of total transparency of these procedures and the relevant controls;

(26) Whereas this Decision lays down, for the entire duration of the programme, a financial framework constituting the principal point of reference, within the meaning of point 1 of the Declaration of the European Parliament, the Council and Commission of 6 March 1995, for the budgetary authority during the annual budgetary procedure;

(27) Whereas this programme should be of five-year duration in order to allow sufficient time for actions to be implemented to achieve the objectives set,

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the programme

1. A programme of Community action on the prevention of AIDS and certain other communicable diseases, hereinafter referred to as 'this programme', is hereby adopted for the period 1 January 1996 to 31 December 2000 within the framework for action in the field of public health.

2. The aim of this programme is to help in reducing mortality and morbidity due to communicable diseases and reducing he risk of infection by the AIDS virus or other infectious agents, by encouraging cooperation between Member States, supporting their operations and promoting coordination between their prevention policies and programmes.

3. The actions to be implemented under this programme and their specific objectives are set out in the Annex under the following headings:

A. Surveillance and monitoring of communicable diseases

B. Combating transmission

C. Information, education and training

D. Support for persons with HIV/AIDS and combating discrimination.

Article 2

Implementation

1. The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions set out in the Annex in accordance with Article 5.

2. The Commission shall cooperate with institutions and organizations active in preventing AIDS and other communicable diseases.

3. Member States are called upon to take the measures they judge necessary to coordinate and organize the implementation of this programme at national level.

Article 3

Budget

1. The total appropriation for implementation of this programme for the period referred to in Article 1 shall be ECU 49,6 million.

2. The annual appropriations shall be authorized by the budget authority within the limits of the financial perspective.

Article 4

Consistency and complementarity

The Commission and the Member States shall ensure that there is consistency and complementarity between actions to be implemented under this programme and other relevant Community programmes and initiatives, including the biomedical and health research programme under the Community's framework programme for research and Community action in developing countries.

Article 5

Committee

1. The Commission shall be assisted by a committee hereinafter referred to as 'the committee' consisting of two members designated by each Member State and chaired by a representative of the Commission.

2. The representative of the Commission shall submit to the committee draft measures concerning:

(a) the committee's rules of procedure;

(b) an annual work programme indicating the priorities for action;

(c) the arrangements, criteria and procedures for selecting and financing projects under this programme, including those involving cooperation with international organizations competent in the field of public health and participation of the countries referred to in Article 6 (2);

(d) the evaluation procedure;

(e) the arrangements for dissemination and transfer of results;

(f) the arrangements for cooperating with the institutions and organizations referred to in Article 2 (2).

The committee shall deliver its opinion on the draft measures referred to above within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the committee, they shall forthwith be communicated by the Commission to the Council. In that event, the Commission shall defer application of the measures which it has decided upon for a period of two months from the date of such communication.

The Council, acting by a qualified majority, may take a different decision within the time limit referred to in the preceding subparagraph.

3. In addition, the Commission may consult the committee on any other matter concerning he implementation of this programme.

The repesentative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its opinion recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into acount.

4. The representative of the Commission shall keep the committee regularly informed about:

- financial assistance granted under this programme (amounts, duration, breakdown and beneficiaries),

- Commission proposals or Community initiatives and the implementation of programmes in other policy areas which are of direct relevance to achievement of the objectives of this programme, with a view to ensuring the consistency and complementarity required pursuant to Article 4.

Article 6

International cooperation

1. In the course of implementing this programme, cooperation with non-member countries and with international organizations competent in the field of public health, in particular the United Nations, the World Health Organization and the Council of Europe, shall be encouraged and implemented in accordance with the procedure laid down in Article 5.

2. This programme shall be open to participation by the associated countries of central and eastern Europe (CCEE), in accordance with the conditions laid down in the Additional Protocols to the Association Agreements relating to participation in Community programmes, to be concluded with those countries. This programme shall be open to participation by Cyprus and Malta on the basis of additional appropriations in accordance with the same rules as those applied to the EFTA countries, in accordance with procedures to be agreed with those countries.

Article 7

Monitoring and evaluation

1. The Commission, taking into account the reports drawn up by the Member States and with the participation, where necessary, of independent experts, shall ensure that an evaluation is made of the actions undertaken.

2. The Commission shall submit to the European Parliament and the Council an interim report halfway through this programme and a final report on completion of this programme. It shall incorporate into these reports the results of the evaluations. It shall also send the reports to the Economic and Social Committee and the Committee of the Regions.

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ No C 333, 29. 11. 1994, p. 34.

(2) OJ No C 133, 31. 5. 1995, p. 23.

(3) Opinion delivered on 21 April 1995 (not yet published in the Official Journal).

(4) Opinion of the European Parliament of 27 April 1995 (OJ No C 126, 22. 5. 1995), Council common position of . . . (not yet published in the Official Journal) and European Parliament Decision of . . . (not yet published in the Official Journal).

(5) OJ No C 165, 17. 6. 1994, p. 1.

(6) OJ No L 175, 4. 7. 1991, p. 26.

(7) OJ No L 168, 18. 7. 1995, p. 1.

(8) OJ No C 15, 18. 1. 1994, p. 6.

(9) OJ No C 158, 26. 6. 1989, p. 477.

(10) OJ No C 158, 17. 6. 1991, p. 45.

(11) OJ No C 329, 6. 12. 1993, p. 375.

(12) OJ No C 326, 11. 12. 1992, p. 1.

(13) COM(93) 559 final, 24. 11. 1993.

(14) OJ No C 174, 25. 6. 1993, p. 1.

ANNEX

PROGRAMME OF COMMUNITY ACTION ON THE PREVENTION OF AIDS AND CERTAIN OTHER COMMUNICABLE DISEASES (1996 to 2000)

A. Surveillance and monitoring of communicable diseases

Objective

To help to improve knowledge and dissemination of information and data concerning HIV/AIDS and other communicable diseases, taking into account international disease-classification provisions, and to improve the coordination of systems for monitoring these diseases and coordinating Community-level responses, particularly in the event of an epidemic outbreak.

Actions

1. Exploration with Member States of ways to increase the amount and improve the quality, comparability and availability of data and provide support for strengthening national or regional monitoring systems and implementing them as part of a network and, in the case of HIV/AIDS and connected diseases, support for the European Centre for the Epidemiological Monitoring of AIDS.

2. Contribution towards improving the quality and coordination of Member States' epidemiological monitoring systems and participation in the development of surveillance networks on the basis of the jointly-defined methodologies and conditions for data transmission, prior consultation and coordination of replies.

3. Setting up of a Community network of public health epidemiologists for the purpose of defining common surveillance methods and tools and enhancing the ability to respond in a coordinated way to the development of communicable diseases, especially in the case of epidemic outbreaks.

4. Contributing, in particular by the provision of the logistical support necessary, to the production and dissemination of a regular information notice and of a Community bulletin on communicable diseases surveillance, comprising both routine surveillance data and reports on specific epidemiological investigations.

5. Encouraging action aimed at increasing awareness of the problems and including comparable and reliable data on nosocomial infections particularly in routine surveys of hospital conditions; promoting knowledge and exchanges of experience on the ways in which surveillance results for infections caused by germs resistant to normal treatment (antibiotics) are analysed, processed and used by the actors in the field.

6. Promotion of investigations of the effectiveness and feasibility of screening for certain types of communicable diseases (tuberculosis, hepatitis, etc.), in particular among pregnant women. Coordination of research to minimalize transmission of diseases from mother to child.

B. Combating transmission

Objectives

To assist efforts to prevent the transmission of HIV and other sexually transmitted diseases (STDs), particularly as regards risk environments and behaviour and ensure optimum vaccination cover in the Community for certain communicable diseases.

Actions

7. Examination of and exchanges of information on the problems and situations of persons engaging in risk behaviour (parenteral drug use, prostitution and at-risk sexual relations, etc.), or placed in particular situations (travel, penal institutions, etc.) and modes of transmission; exchange of experience on preventive action and risk-reduction measures; promotion of appropriate preventive measures and of pilot projects.

8. Exchange of views and experience on information, advice and counselling for women who are pregnant or wanting to have children and who may be at risk of transmitting HIV to their babies.

9. Exchanges of information on messages and promotion of appropriate measures for the dissemination of effective messages aimed at the general public and at target groups, notably through campaigns to inform, educate and raise awareness concerning means of protection against the risk of sexual transmission of diseases, the problems they raise and their use.

10. Promotion of cooperation and of exchange of information between Member States on their vaccination policies and programmes as well as their arrangements for implementing them and their results among the general population and especially among children, groups exposed to risk and persons living in certain risk situations. Promotion of exchange of experience and information as regards determining vaccination cover, vigilance concerning vaccines and encouragement of measures and initiatives to ensure optimum vaccination cover.

C. Information, education and training

Objective

To help to increase awareness and improve public information and education and provide, including with regard to the early detection of communicable diseases, better training for health professionals and relevant personnel.

Actions

11. Evaluation of the impact of information campaigns on communicable diseases and their prevention; encouragement of exchanges between Member States on information campaigns at all levels; development of ways of linking and reinforcing campaigns in the Member States, such as provision of specific materials; utilization of telephone and other response mechanisms, and development and promotion of activities to complement national efforts, including the setting up or strengthening of networks and the exchange of experience and expertise.

12. Gathering, analysis and promotion of the dissemination of information concerning preventive measures; promotion of the development and use of assessment methods to determine the effectiveness of preventive measures and information campaigns aimed at the general public and target groups.

13. Encouragement of initiatives to ascertain and disseminate existing information about the knowledge, attitudes and behaviour of the general public and certain target groups, particularly children and young people, regarding HIV/AIDS and other STDs and about the preventive measures taken in the European Community; examination and evaluation of current practice in providing information both within and outside formal structures such as schools, training institutions and sports clubs, promotion of the exchange of educational and training material and methods, and support for pilot projects, especially those centred on groups of young people without any specific organizational framework or formed educational structure; development of training suited to every stage of the individual's development and exchange of educational material for this purpose.

Carrying out new Eurobarometer surveys on trends in knowledge and behaviour with regard to HIV/AIDS, where existing information is inadequate.

14. Encouragement of initiatives relating to messages intended to inform and educate migrants in the countries of the Member States, taking particular account of cultural and linguistic differences.

15. Surveys and exchange of experience on training given to health professionals and those who, through their work, are brought into contact with certain communicable diseases or can act to prevent them, including workers responsible for social support and counselling for HIV-infected persons and those living with them, in order to identify weaknesses and gaps in them and to help in devising and promoting new further training programmes; promotion of exchanges among the health professionals involved, where such action is not covered by existing Community programmes.

16. Support for the training of health personnel, in particular in the context of epidemiology and early detection of and screening for communicable diseases, including personal advice at the time of screening.

D. Support for persons with HIV/AIDS and combating discrimination

Objective

To assist efforts to ensure that persons living with HIV/AIDS receive assistance in line with their needs and are not discriminated against in any way.

Actions

17. Exchanges of experience and information concerning modes of assistance and support for those testing seropositive, those infected with AIDS and persons living with them. Promotion of studies, pilot projects and actions on the psycho-social aspects of HIV/AIDS.

18. Production and dissemination of information bulletins and directories giving the latest information on organizations providing information and support; encouragement of networks of associations providing information and psycho-social support.

19. Examination of actual or potential discriminatory situations in the Member States. Exchange of information on measures taken in the Member States to avoid or combat discrimination, particularly as regards employment, insurance, credit, housing, education and health care. Exchange of information and experience on HIV-testing policies and practices.

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 9 November 1994 the Commission submitted a proposal, based on Article 129 of the EC Treaty, relating to a Decision adopting a programme of action (1996 to 2000) on the prevention of AIDS and other communicable diseases within the framework for action in the field of public health.

2. The European Parliament, the Economic and Social Committee and the Committee of the Regions delivered their opinions on 27 April 1995 (1), 30 March 1995 (2) and 21 April 1995 (3) respectively.

In the light of those opinions, the Commission submitted an amended proposal for a Decision on 30 May 1995 (4).

3. On 2 June 1995 the Council adopted its common position in accordance with Article 189b of the Treaty.

II. OBJECTIVE OF THE PROPOSAL

The proposal forms part of the priority measures to be carried out in the framework for action in the field of public health pursuant to Article 129 of the EC Treaty. Its purpose is to ensure the continuation of the activities undertaken to prevent AIDS in the framework of the 'Europe against AIDS' programme, the second plan of which expires at the end of 1995, and to extend the programme to other communicable diseases.

The action, scheduled over five years, defines:

- in the Articles, the general framework for action (general provisions on the establishment, operation, implementation and monitoring of the programme),

- in the Annex, the actions to be implemented:

- on the one hand, for HIV/AIDS and sexually transmitted diseases (collection of data, measures concerning children and young people, prevention of transmission, social and psychological assistance and fight against discrimination),

- on the other hand, for certain communicable diseases in general (measures linked to vaccination, creation and development of networks, information, education and training, early detection and screening).

III. ANALYSIS OF THE COMMON POSITION

1. General remarks:

In its common position the Council, while making the amendments it regarded as indispensable to the general aspects of the lay-out, implementation and structure of the programme, retained the main substance of the proposal.

2. Specific remarks:

2.1. Amendments made by the Council to the Commission's amended proposal

The main amendments to the proposal, which are, as regards the general aspects, similar to those used for the other programmes proposed in the field of health, concern:

(a) Establishment of the programme (Article 1)

The purpose of the amendments is to make more specific and clarify the general objective of the programme (paragraph 2) and its structure and the specific objectives of the various fields of action (paragraph 3).

(b) Implementation (Article 2) and committee procedure (Article 5)

The main purpose of the amendments to the provisions and procedures for implementing the programme is to:

- identify more clearly the respective roles of the various participants in implementing the programme (Article 2),

- reconcile the requirement of flexibility in the management of the programme with that of more active involvement of Member States in certain important decisions, by means of a mixed procedure: management committee procedure for such decisions and the advisory committee procedure for others (Article 5 (2) and (3) - in accordance with the interinstitutional modus vivendi referred to in recital 18),

- bolster the transparency and effectiveness requirement through regular information on financial assistance granted and on activities in other areas which are directly relevant to achievement of the objectives of the programme, in accordance with Article 4 (Article 5 (4)).

(c) Total appropriation (Article 3 (1))

The Council amended Article 3, in accordance with the Parliament/Council/Commission statement of 6 March 1995 on the inclusion of financial provisions in legislative acts, by entering in this Article the amount of the total appropriation to be earmarked for implementation of the programme. It took over the amount envisaged by the Commission in the financial statement, taking into account the extension of the proposed scope and the need to continue to provide appropriate support for activities concerning HIV/AIDS. An appropriate penultimate recital was also added.

(d) International cooperation (Article 6)

The Council confined itself to adjustments to ensure that those provisions were consistent with the provision in Article 5 (2) (f) (paragraph 1) and with agreements in existence or negotiated with the countries concerned (paragraph 2).

(e) Monitoring and evaluation

The amendments to the text do not alter its substance and have the sole purpose of clarifying the conditions for monitoring in general and evaluation in particular.

(f) Annex

In order to avoid any overlapping as a result of the structure proposed, the Council recast the main headings, which it based on four fields of action - with an indication of their specific objectives - as indicated in Article 1 (3) - specifying, where appropriate, the scope of the actions.

2.2. European Parliament amendments

(a) Amendments taken over by the Commission

The Commission accepted, in whole or in part, 33 amendments (5). The Council took over most of those amendments, in some instances in substance, in another form, or in part (in particular amendments 64, 10, 11, 15 - see recitals 16 and 19 of the common position - and 35).

Only three amendments, which introduced more specific aspects into the recitals, were not taken over, namely amendments 64, 14 and 18, although their substance was covered in general, either elsewhere or in part.

Amendment 60 (accepted in substance) has become redundant owing to the amendments to the headings (heading deleted - substance reproduced in A (6) and C (16)).

(b) Amendments not taken over by the Commission

On the basis of three different types of consideration, the Commission stated that it could not accept the other amendments (6).

In most cases the Council endorsed the Commission view.

However, the Council text incorporates several of those amendments, namely:

- amendments 1 and 29, in another form (recital 18),

- amendments 55 and 59, in part, under heading A.

CONCLUSIONS

The Council has retained the substance of the proposed programme, taking into account the Parliament's opinion. It has endeavoured to clarify the lay-out and to strengthen the conditions whereby it can be implemented and monitored with maximum transparency and efficiency.

(1) OJ No C 126, 22. 5. 1995.

(2) OJ No C 133, 31. 5. 1995, p. 23.

(3) Not yet published in the Official Journal.

(4) COM(95) 209 final.

(5) Amendments 2, 64, 4, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 18, 19, 23, 24, 25, 28, 31, 32, 35, 37, 38, 39, 40, 65, 42, 50, 56, 60 and 61, in some cases (notably amendments 24, 32 and 65) in part or indirectly.

(6) Amendments 1, 5, 12, 17, 20, 21, 22, 26, 29, 30, 33, 34, 36, 43, 62, 63, 46, 47, 48, 49, 51, 52, 53, 66, 54, 55, 57 and 59.