52000PC0448

Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL extending certain programmes of Community action in the field of public health adopted by Decisions No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC and amending those Decisions

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. The present proposal for a decision of the European Parliament and of the Council on the extension of the programme of Community action on health promotion, information, education and training, the action plan to combat cancer, and the programmes on the prevention of AIDS and certain other communicable diseases, the prevention of drug dependence, health monitoring and pollution-related diseases forms part of the health strategy that the Commission presented in its communication COM(2000) 285 of 16 May 2000.

2. The new health strategy comprises a framework for action in the field of public health and inter-linked and mutually-supportive components in other Community policies and activities that have an influence on factors that affect health. As part of the public health framework, a new, overall, programme for action in the field of public health has been proposed by the Commission for adoption by the European Parliament and the Council pursuant to Article 152 of the EC Treaty. The new programme will replace the current programmes of action in the public health field.

3. In view of the need for completion of the co-decision procedure concerning the proposal for the new public health programme, it is possible that adoption of the relevant decision of the European Parliament and of the Council will not take place before the end of some of the existing programmes. The programmes on health promotion, cancer, AIDS and certain other communicable diseases, and drug dependence come to an end on 31 December 2000. The programmes on health monitoring and on pollution-related diseases come to an end on 31 December 2001.

4. Actions under the existing programmes are vital for pursuing the public health objectives of the Community and damage will be caused, in policy and field activity terms, if they are discontinued. The proposed new programme builds on such actions. The interim reports by the Commission (COM(1999) 408 of 8 September 1999, COM (1999) 463 of 14 October 1999), and COM (2000) 165 of 22 March 2000) on the programmes on cancer, AIDS and certain other communicable diseases, drug dependence and health promotion, information, education and training, are based on independent assessments of the actions taken under these programmes and their added value.

5. If the programmes that are due to end in 2000 and 2001 are extended, the potential damage from a discontinuity in the Community action will be averted and the difficulties above will not arise. However, their extension should only be limited in time and cover the transitional period until the new public health programme comes into force. For this reason, it is proposed to extend these six programmes until 31 December 2002. At the same time, the proposal for the new public health programme provides for the repeal of all the decisions concerning the current public health programmes. In this way there will be continuation and roll-over of actions from the current programmes to the new without interruption to key Community public health activities. Since EFTA/EEA countries and associated Central and Eastern European countries participate in the existing programmes, their extension will allow the continuation of such participation.

6. To ensure appropriate transition from the existing programmes to the new public health programme, the present proposal for decision calls for proper account to be taken in their implementation of the results of the independent evaluations that have been carried out. It also provides the frame for the activities in the transitional period by making explicit reference to the new strategy orientations contained in Communication COM(1998) 230 of 15 April 1998 from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions, on the development of public health policy in the European Community, the Council Conclusions of 26 November 1998 on the future framework for Community action in the field of public health [1], the Council Resolution of 8.6.1999 on the future Community action in the field of public health [2], the European Parliament Resolution A4-0082/99 of 12 March 1999, the opinion of the Economic and Social Committee of 9 September 1998 [3], the opinion of the Committee of the Regions of 19 November 1998 [4] and in Communication COM(2000) 285 of 16 May 2000 on the health strategy of the European Community.

[1] OJ C 390, 15.12.1998, p. 1.

[2] OJ C 200, 15.7.1999, p. 1.

[3] OJ C 407, 28.12.1998, p. 21.

[4] OJ C 51, 22.2.1999, p. 53.

7. In accordance with Article 152 of the EC Treaty, this proposal concerns incentive measures to be carried out under the six programmes mentioned above. The decisions that established these programmes confirm the respect of the principles of subsidiarity and proportionality with respect to the measures undertaken. The overall goal of such measures is to contribute towards ensuring a high level of human health protection by encouraging cooperation between the Member States, lending support to their action, promoting coordination of their policies and programmes, and fostering cooperation with third countries and the international organisations competent in the sphere of public health.

8. The objectives of these programmes, cannot, as has been shown in the decisions that adopted them, be sufficiently accomplished by the Member States. The proposed decision does not go beyond what is necessary to achieve the aforementioned objectives and respects fully the responsibilities of the Member States for the organisation and delivery of health services and medical care.

9. The actions envisaged aim at the development of and support to activities of health promotion and prevention of specific diseases, the development of a health monitoring system, the collection and dissemination of information and the production of reports, which require cooperation with the Member States and lending support to their action. According to Article 152, no harmonisation measures are being proposed.

10. The proposal for extension of the programmes on health promotion, cancer, AIDS and certain other communicable diseases, drug dependence, health monitoring, and pollution-related diseases contains:

* A preamble, setting out the legal context, the justification for the proposal, and monitoring and evaluation arrangements;

* An operative part which extends the six programmes in line with the provisions concerning the objectives, actions, implementation responsibility, consistency and complementarity and committee procedure and international co-operation laid down under the corresponding decisions that launched them (Article 1), and contains clauses on budgetary provision (Article 2), on adaptation of the committee procedure (Article 3), on the participation of the EFTA/EEA countries, the associated Central and Eastern European Countries, Cyprus, Malta and Turkey (Article 4), on monitoring and evaluation (Article 5), and on entry into force of the extension decision (Article 6).

2000/192 (COD)

Proposal for a DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL extending certain programmes of Community action in the field of public health adopted by Decisions No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC and amending those Decisions

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152 thereof,

Having regard to the proposal from the Commission [5],

[5] OJ C

Having regard to the opinion of the Economic and Social Committee [6],

[6] OJ C

Having regard to the opinion of the Committee of the Regions [7],

[7] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [8],

[8] Opinion of the European Parliament.

Whereas:

(1) A number of programmes of Community action within the framework for action in the field of public health are to expire shortly.

(2) The following expire at the end of 2000:

- the programme of Community action on health promotion, information, education and training, adopted by Decision No 645/96/EC of the European Parliament and of the Council [9],

[9] OJ L 95, 16.4.1996, p. 1.

- the action plan to combat cancer, adopted by Decision No 646/96/EC of the European Parliament and of the Council [10],

[10] OJ L 95, 16.4.1996, p. 9.

- the programme of Community action on the prevention of AIDS and certain other communicable diseases, adopted by Decision No 647/96/EC of the European Parliament and of the Council [11],

[11] OJ L 95, 16.4.1996, p. 16.

- the programme of Community action on the prevention of drug dependence, adopted by Decision No 102/97/EC of the European Parliament and of the Council [12].

[12] OJ L 19, 22.1.1997, p. 25.

(3) The following expire at the end of 2001:

- the programme of Community action on health monitoring, adopted by Decision No 1400/97/EC of the European Parliament and of the Council [13],

[13] OJ L 193 22.7.1997, p. 1.

- the programme of Community action on pollution-related diseases, adopted by Decision No 1296/1999/EC of the European Parliament and of the Council [14].

[14] OJ L 155, 22.6.1999, p. 7.

(4) The Council, in its Resolution of 8 June 1999 on the future Community action in the field of public health [15], stressed the need for continuity of Community action in the field of public health in the light of the perspective of expiry of existing programmes.

[15] OJ C 200, 15.7.1999, p. 1.

(5) The Commission, in its Communication of 15 April 1998 to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the development of public health policy in the European Community [16], indicated that existing public health programmes will be coming to an end from the end of year 2000 onwards and stressed that there is a need to ensure that there is no vacuum in Community policy in this important field. The subsequent debate on that communication resulted in a consensus among the Community Institutions in favour of developing a new health strategy with an overall public health programme of action in the field of public health.

[16] COM(1998) 230 final.

(6) While a new strategy and proposals for a new, overall, public health programme are being considered, the present programmes in the public health area should be extended until the end of 2002 in order to avoid any interruption in the Community action concerned.

(7) The Agreement on the European Economic Area (EEA) provides for greater cooperation in the field of public health between the Community and its Member States, on the one hand, and the countries of the European Free Trade Association participating in the EEA (EFTA/EEA countries), on the other. Provision should also be made to open the programmes in the field of public health to participation of the associated Central and Eastern European countries in accordance with the conditions established in the Europe Agreements, in their additional protocols and in the decisions of the respective Association Councils, of Cyprus, funded by additional appropriations in accordance with the procedures to be agreed with that country, as well as of Malta and Turkey, funded by additional appropriations, in accordance with the provisions of the Treaty.

(8) In extending the programmes, account should be taken of the Communication of 15 June 2000 from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions, on the health strategy of the European Community [17], the Council Conclusions of 26 November.1998 on the future framework for Community action in the field of public health [18], the Council Resolution of 8 June 1999 on the future Community action in the field of public health, the European Parliament Resolution of 12 March 1999 [19], the opinion of the Economic and Social Committee of 9 September 1998 [20] and the opinion of the Committee of the Regions of 19 November 1998 [21]. Account should also be taken of the interim report from the Commission of 14 October 1999 to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on the implementation of the programmes of Community action on the prevention of cancer, AIDS and certain other communicable diseases, and drug dependence within the framework for action in the field of public health [22], and the interim report from the Commission of 22 March 2000 to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions on the implementation of the programme of Community action on health promotion, information, education and training [23].

[17] COM(2000) 285 final.

[18] OJ C 390, 15.12.1998, p. 1.

[19] OJ C 175, 21.6.1999, p.135.

[20] OJ C 407, 28.12.1998, p. 21.

[21] OJ C 51, 22.2.1999, p. 53.

[22] COM(1999) 463 final.

[23] COM(2000) 165 final.

(9) The present Decision lays down, for the period of extension of the action programmes, the financial framework constituting the prime reference, within the meaning of point 33 of the Interinstitutional Agreement of 6 May 1999 between the European Parliament, the Council and the Commission on budgetary discipline and improvement of the budgetary procedure [24], for the budgetary authority during the annual budgetary procedure.

[24] OJ C 172, 18.6.1999, p. 1.

(10) Decisions No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC, No 1400/97/EC and No 1296/1999/EC should be amended to take account of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers of the Commission [25].

[25] OJ L 184, 17.7.1999, p. 23.

(11) The action programmes should be monitored and continuously evaluated in cooperation between the Commission and the Member States,

HAVE DECIDED AS FOLLOWS:

Article 1

Extension

1. The following shall be extended from 1 January 2001 until 31 December 2002:

(a) the programme of Community action on health promotion, information, education and training adopted by Decision No 645/96/EC,

(b) the plan of action to combat cancer adopted by Decision No 646/96/EC,

(c) the programme of action for the prevention of AIDS and certain other communicable diseases adopted by Decision No 647/96/EC,

(d) the programme of action for the prevention of drug dependence adopted by Decision No 102/97/EC.

2. The following shall be extended from 1 January 2002 until 31 December 2002:

(a) the programme of action on health monitoring adopted by Decision No 1400/97EC,

(b) the programme of action on pollution-related diseases adopted by Decision No 1296/1999/EC.

Article 2

Budget

1. The total financial framework for the implementation of the programmes and plan referred to in Article 1 for the period 1 January 2001 to 31 December 2002 shall be EUR 79.1 million.

2. The financial framework for the implementation for the period 1 January 2001 to 31 December 2002 of the programme of action on health promotion, information, education and training shall be EUR 8.5 million, that of the plan of action on cancer shall be EUR 31.142 million, that of the programme of action on the prevention of drug dependence shall be EUR 11.434 million and that of the programme of action on the prevention of AIDS and certain other communicable diseases shall be EUR 22.324 million.

3. The financial framework for the implementation for the period 1 January 2002 to 31 December 2002 of the programme of action on health monitoring shall be EUR 4.4 million and that of the programme of action on pollution-related diseases shall be EUR 1.3 million.

4. Annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspective.

Article 3

Adaptation of the committee procedure

1. Article 5 of Decisions No 645/96/EC, No 646/96/EC, No 647/96/EC, No 102/97/EC and No 1400/97/EC is amended as follows:

(a) Paragraph 1 is replaced by the following:

"1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission."

(b) In paragraph 2, the second and third subparagraphs are replaced by the following:

"The management procedure laid down in Article 4 of Decision 1999/468/EC shall apply for the adoption of the measures referred to in the first sub-paragraph of this paragraph, in compliance with Article 7 and Article 8 of Decision 1999/468/EC. The period provided for in Article 4(3) of Decision 1999/468/EC shall be two months."

(c) Paragraph 3 is replaced by the following:

"3. In addition, the Commission may consult the Committee on any other matter concerning the implementation of this decision. In this case, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof."

2. Article 5 of Decision No 1296/1999/EC is amended as follows:

(a) Paragraph 1 is replaced by the following:

"1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by the representative of the Commission."

(b) In paragraph 2, the second, third and fourth subparagraphs are replaced by the following:

"The advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply for the adoption of the measures referred to in the first subparagraph of this paragraph, in compliance with Article 7 and Article 8 of Decision 1999/468/EC."

Article 4

Participation of the EFTA/EEA countries, the associated Central and Eastern European countries, Cyprus, Malta and Turkey

The programmes referred to in Article 1 shall be open to the participation of:

(a) The EFTA/EEA, countries in accordance with the conditions established in the EEA Agreement;

(b) The associated countries of Central and Eastern Europe, in accordance with the conditions laid down in the Europe Agreements, in their Additional Protocols and in the Decisions of the respective Association Councils;

(c) Cyprus, funded by additional appropriations in accordance with the procedures to be agreed with that country;

(d) Malta and Turkey, funded by additional appropriations in accordance with the provisions of the Treaty.

Article 5

Monitoring and evaluation

1. In the implementation of this Decision, the Commission in co-operation with the Member States shall take the necessary measures to ensure the monitoring and evaluation of the activities provided under the programmes and plan referred to in Article 1.

2. The Commission shall submit a report to the European Parliament and to the Council upon completion of the programmes and plan referred to in Article 1. It shall include in this report the results of the evaluation mentioned in the first paragraph of this Article. The report shall also be submitted to the Economic and Social Committee and to the Committee of the Regions.

Article 6

Entry into force

This Decision shall enter into force on the date of its publication in the Official Journal of the European Communities.

It shall apply from 1 January 2001.

Done at Brussels,

For the European Parliament For the Council

The President The President

FINANCIAL STATEMENT

1. Title of operation

Proposal for a decision of the European Parliament and of the Council on the extension of the programme of Community action on health promotion, information, education and training, the action plan to combat cancer, the programme on the prevention of AIDS and certain other communicable diseases, the programme on the prevention of drug dependence, the programme on health monitoring and the programme on pollution-related diseases.

2. Budget heading(s) involved

B3-4308 and B3-4308A

(ex budget lines B3-4300 and B3-4300A, B3-4301 and B3-4301A, B3-4302 and B3-4302A, B3-4303 and B3-4303A, B3-4304 and B3-4304A, B3-4306 and B3-4306A.).

3. Legal basis

Proposal for a decision of the European Parliament and of the Council on the extension of the programme of Community action on health promotion, information, education and training, the action plan to combat cancer, the programme on the prevention of AIDS and certain other communicable diseases, the programme on the prevention of drug dependence, the programme on health monitoring and the programme on pollution-related diseases.

4. Description of operation

4.1 General objective

The objective is to permit the continuation of actions under the six public health programmes referred to under point 1 above. These programmes are vital for pursuing the public health objectives of the Community until a new, overall, public health programme is adopted, and at any rate, no later than 31 December 2002. Therefore, the following programmes shall be extended:

- the programme of Community action on health promotion, information, education and training;

- the action plan to combat cancer;

- the programme on the prevention of AIDS and certain other communicable diseases;

- the programme on the prevention of drug dependence;

- the programme on health monitoring;

- the programme on pollution-related diseases.

These actions aim at encouraging cooperation between the Member States, lending support to their action, promoting coordination of their policies and programmes, and fostering cooperation with third countries and international organisations competent in the sphere of public health.

4.2 Period covered and arrangements for renewal

* The extension covers the period of two years beginning on 1.1.2001 for:

- the programme on health promotion, information, education and training;

- the action plan to combat cancer;

- the programme on the prevention of AIDS and certain other communicable diseases;

- the programme on the prevention of drug dependence.

* The extension covers the period of one year beginning on 1.1.2002 for:

- the programme on health monitoring;

- programme on pollution-related diseases.

5. Classification of expenditure or revenue

5.1 Compulsory/Non-compulsory expenditure

NCE

5.2 Differentiated/Non-differentiated appropriations

6. Type of expenditure or revenue

- Subsidy for joint financing with other sources in the public and/or private sector. The Commission's participation will, in general, be limited up to 70% of the total cost of the subsidised projects;

- Service contracts following calls for tender.

7. Financial impact

7.1 Method of calculating total cost of operation (relation between individual and total costs)

Commitment appropriations EUR million (at current prices)

>TABLE POSITION>

7.2 Itemised breakdown of cost

>TABLE POSITION>

>TABLE POSITION>

>TABLE POSITION>

* Excluding technical and/or administrative assistance and support expenditure (see 7.3).

7.3 Technical and/or administrative assistance and support expenditure included in Part B of the budget (B3-4308A)

Commitment appropriations EUR million (at current prices)

>TABLE POSITION>

7.4 Schedule of commitment and payment appropriations

EUR million

>TABLE POSITION>

8. Fraud prevention measures

All proposals for subsidies will be assessed for technical content and financial criteria already in place in accordance with the provisions laid down by Commission implementing decisions on each of the programme being extended. These include criteria on own resources, sound finances and financial management, past record of performance or reliability as regards the capability of fulfilling the terms of subsidy, relationship between partners in a given project and potential for effective accounting and control.

Requests for final payment must be accompanied by an evaluation of the operational and financial status of the project concerned.

In accordance with the decision adopting the extension of the programmes, an ex-post evaluation will take place and its results will be included in a report by the Commission to the European Parliament, Council, Economic and Social Committee and the Committee of the Regions.

- Specific control measures envisaged

Checks in situ will be carried out using appropriate selection criteria (scale of subsidy, interim report, results of on-going monitoring, information on progress with the execution of the relevant work-plan). In cases where there are reasons to believe that the performance of a project that has received a subsidy, or that of a service contract, is seriously being compromised, an urgent check will be carried out and, if there are remaining suspicions, the service concerned will refer the matter to the relevant audit services and the Anti-fraud Office.

9. Elements of cost-effectiveness analysis

9.1 Specific and quantified objectives; target population

- Specific objectives: links with general objective

Each of the programmes being extended has particular objectives laid down in the corresponding decision of the European Parliament and Council. Moreover, in accordance with implementing provisions adopted by the Commission for each of the programmes, work-plans with specific objectives and priorities are adopted each year and reports made on their execution.

- Target population:

Depending on the programme, the general population (programme of health monitoring and health promotion, surveillance of certain communicable diseases) or target population sub-groups (e.g. groups more susceptible to skin cancer, youths taking up smoking, risk-taking sexual behaviour among youth, homosexuals, drug use among groups in deprived environments, health promotion at work and at school, etc.), are the ultimate beneficiaries of the actions being undertaken.

The direct beneficiaries of the Community's financial contribution are NGOs active in the field of prevention of diseases and health promotion, governmental or quasi-governmental agencies and institutes competent in health matters, and associations of health professionals and learned institutions. Criteria for eligibility have been laid down by implementing provisions adopted by the Commission for each of the programmes, the main ones being the involvement of partners from several Member States and added value.

9.2 Grounds for the operation

- Need for Community financial aid, with particular regard for the principle of subsidiarity

Actions under the programmes the extension of which is being proposed are indispensable for pursuing the public health objectives of the Community in accordance with the requirements of the Treaty. Each of the programmes had been confirmed by the corresponding European Parliament and Council decision as fulfilling the requirements of subsidiarity.

- Choice of ways and means

The implementing provisions adopted by the Commission for each of the programmes require a work-plan to be drawn up each year following consultation of the relevant management committee. This is followed by calls for proposals and a specific timetable for the submission of applications using a standard application form. The latter serves as the principal tool by which financial and technical appropriateness and quality in respect of the objectives of the programme and the relevant selection criteria and financial regulations are judged prior to obtaining the opinion of the relevant committee on overall soundness of the proposal, added value and comparative merit.

9.3 Monitoring and evaluation of the operation

- Performance indicators selected

* output indicators (measurement of resources employed)

Each programme is the object of on-going monitoring using as indicators the number and quality of networks established, recommendations and guidelines issued, communications and reports adopted or published by the Commission, ad hoc surveys such as Eurobarometer surveys on attitudes and behaviours, effectiveness of campaigns and information dissemination exercises, and up-take, emulation and multiplier effects in Member States by competent authorities and local groups and associations.

* impact indicators (measurement of performance against objectives)

Each programme is the object of evaluation, especially on performance against objectives for each of the action involved, by Commission staff and by independent experts using direct (e.g. change in behaviour or smoking or drug use) and indirect measurements (e.g. efficiency in reaching and distributing health promoting material, recall of messages or participation rates). The Commission will submit an overall report at the end of the extension period on each of the programmes and their effectiveness

10. Administrative expenditure (Section III, Part A of the budget)

The staff which is currently managing the existing programmes will be involved in the management of the extensions. No additional staff required on the part A of the budget.

Human resources and administrative means are to be covered by the credits already allocated to the managing service.

10.1 Effect on the number of posts

>TABLE POSITION>

10.2 Overall financial impact of human resources

No additional human resources to those already allocated to the public health programmes are envisaged.

EUR million

>TABLE POSITION>

10.3 Increase in other administrative expenditure as a result of the operation

Administrative expenditure for missions, meetings, committees, and conferences will be financed from the global envelope under title A-7 of the budget allocated to DGSANCO.

IMPACT ASSESSMENT FORM THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

Title of proposal

Proposal for a decision of the European Parliament and of the Council on the extension of the programme of Community action on health promotion, information, education and training, the action plan to combat cancer, the programme on the prevention of AIDS and certain other communicable diseases, the programme on the prevention of drug dependence, the programme on health monitoring and the programme on pollution-related diseases.

Document reference number

The proposal

1. Taking account of the principle of subsidiarity, why is Community legislation necessary in this area and what are its main aims-

In accordance with Article 152 of the EC Treaty, the Commission is presenting this proposal for incentive measures under the programmes the extension of which is sought for adoption by the European Parliament and the Council. The decisions that established these programmes confirm the respect of the principles of subsidiarity and proportionality with respect to the measures undertaken. The overall goal of such measures is to contribute towards ensuring a high level of human health protection by encouraging cooperation between the Member States, lending support to their action, promoting coordination of their policies and programmes, and fostering cooperation with third countries and the international organisations competent in the sphere of public health.

The impact on business

2. Who will be affected by the proposal-

There will be no effects on business by this proposal. The programmes provides for the financing of actions encouraging cooperation between Member States, promoting coordination of their policies and programmes, promoting the exchange of information on disease prevention and the sharing of experience on strategies to counter threats to health.

3. What will business have to do to comply with the proposal-

There are no requirements placed on business.

4. What economic effects is the proposal likely to have-

There are no economic effects on employment, investment and the creation of new business or on the competitiveness of business by this proposal.

5. Does the proposal contain measures to take account of the specific situation of small and medium-sized firms (reduced or different requirements etc)-

As there are no effects on business, there is no need for such measures.

Consultation

6. List the organisations which have been consulted about the proposal and outline their main views.

No organisation has been consulted about this proposal. The proposal forms part of the Commission strategy on health on which there is consensus among and support from all Community Institutions following an in-depth debate launched by the Commission with its communication COM (1998) 230 of 15 April 1998.