Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action on healht monitoring in the context of the framework for action in the field of public health
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 15. 05. 1996 COM(96) 222 final 95/0238 (COD) Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action on health monitoring in the context of the framework for action in the field of public health (presented by the Commission pursuant to Article 189 a (2) of the EC-Treaty) EXPLANATORY STATEMENT Amended proposal for a European Parliament and Council decision adopting a programme of Community action on health monitoring in the context of the framework for action in the field of public health (1997-2001) 1. 2. 3. 4. 5. The initial proposal for a European Parliament and Council decision adopting a programme of Community action on health monitoring was adopted by the Commission on 16 October 1995. The Economic and Social Committee1 and the Committee of the Regions2 delivered favourable opinions on this initial Commission proposal. In light of the European Parliament's opinion after its first reading on 17 April 1996, an amended proposal for a decision was submitted by the Commission in accordance with Article 189A of the Treaty. The text incorporates essentially two types of amendments: amendments that clarify or broaden the recitals amendments that clarify and broaden the actions covered by the programme. In particular, a feasibility study of a health observatory has been included, and an Annex (II) has been added, containing a list of potential domains in which the health indicators may be established. The European Parliament adopted 44 amendments when it voted on 17 April 1996, of which 28 were acceptable in toto (12, 16-18, 20, 23, and 29) or in part (1, 3, 4, 6-11, 13, 19, 25, 33-40, and 42) by the Commission. The amendments which are not acceptable by the Commission can be divided into 5 groups: amendments that pose legal problems because they do not conform with the wording or intent of Art. 129 (15, 21, 31), or because they are inconsistent with the analogous provisions of the other public health programmes (43, 46, 47) amendments that propose changes which fall outside the scope of the proposed programme (2, 32) amendments that propose a less flexible wording than that proposed by the Commission and/or which unduly limite-the scope of the proposed programme (5, 14, 30, and 45) amendments that are covered elsewhere (26-28) one amendment (22) that would result in difficulties over budgetary matters. 1 Opinion delivered on 27 March 1996. 2 Opinion delivered on 18 January 1996. Amended proposal for a European Parliament and Council decision adopting a programme of Community action on health monitoring in the context of the framework for action in the field of public health COM(95) 449 AMENDED PROPOSAL 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 Commission1, Having regard to the opinion of the Economic and Social Committee2, Having regard to the opinion of the Committee of the Regions3, Acting in according with the procedures referred to in Article 189b of the Treaty, 1. Whereas, in accordance with point (o) of Article 3 of the Treaty, Community action must the include a contribution of Community towards the achievement of a high level of health protection; whereas Article 129 expressly provides for Community competence in this field, in particular by encouraging cooperation between if necessary, lending support to their action; the Member States and, collection, 2. Whereas the Council, in its resolution4 of 27 May 1993 on future action in the field of public health, considered that and improved distribution of health data, as well as an improvement and compatibility of available data, are essential for the preparation of future programmes; analysis quality the in i 2 3 4 OJNo. OJNo. OJ No. OJNo. C 174, 25. 6. 1993, p. l for 3. Whereas, the European Parliament, in its resolution on public health policy after Maastricht5, has stressed the importance of having sufficient and relevant information the development of as a basis Community actions in the field of public health; whereas the it Commission to collect and examine health data from the Member States in order to assess the effects of public health policies, as well as the impact of other policies, on in the European the state of health Community. called on for 3. Whereas, the European Parliament, in its report on public health policy after Maastricht5, has stressed the importance of having sufficient and relevant information the development of as a basis Community actions in the field of public health; whereas the European Parliament called on the Commission to collect and examine health data from Member States and analyse trends and assess the effects of public health policies, as well as the impact of other policies; in the Commission, health6, on identified standardisation 4. Whereas its Communication of 24 November 1993 on the framework for action in the field of increased public and cooperation collection of comparable/compatible data on health, and the promotion of systems of health monitoring and surveillance as a prerequesite for the establishment of a framework for supporting Member States' policies and programmes; and whereas the area of health monitoring, including health data and indicators, has been identified as a priority area for proposals on multi- annual Community programmmes in the field of public health; OJ No. C 329, 6. 12. 1993, p. 375 COM(93) 559 final OJNo. C 329, 6. 12. 1993, p. 375 and invited indicators used 5. Whereas in its resolution of 2 June 1994, the Council7 indicated that the collection of health data should be the accorded priority Commission to present relevant proposals; whereas the Council considered that data and include measures relating to the quality of life of the population, accurate assessments of health needs, estimations of the avoidable deaths from the prevention of diseases, socio-economic factors in health among different population groups, and, where appropriate and if the Member States judge it necessary, health aid, medical practices, and the impact of reforms; should level 6. Whereas health monitoring at the Community is essential for the planning, monitoring, and assessment of Community actions in the field of public health, and the monitoring and assessment of the health impact of other Community policies; 6a. (new) Whereas on the basis, inter alia, of knowledge of the facts of public health in Europe, obtained by setting up a Community health monitoring system, it will be possible to monitor public health trends and define public health priorities and objectives; 7. Whereas health monitoring, in this context, encompasses the establishment of the Community collection, dissemination, and analysis of Community health data and indicators; indicators, health OJNo. C 165, 17. 6. 94, p. 1 in 8. Whereas its Decision on the framework programme for priority actions in the field of statistical information 1993 to 1997 the Council8 has identified under the heading "health and safety" analysis of mortality and morbidity by cause as one of the fields of priority actions under the sectoral programmes for social policy, for economic cohesion and social consumer protection; and 9. Whereas the Council9 in its Decision adopting a specific programme on research and technological development, including demonstration, in the field of biomedicine and health (1994-1998) identified a specific and research comparison of European health data, including nutritional data, the Member States, and whereas this was taken research work the in up programme; coordination relevant from task on should 10. Whereas health monitoring at enable level Community measurements of health status, trends and determinants to be carried out, facilitate the planning, monitoring and evaluation of Community programmes and actions, and provide Member States with health information supporting the development and evaluation of their health policies; 11. Whereas, in order to give full effect to requirements and expectations in this area a Community health monitoring system should be developed, comprising the establishment of health indicators and the collection of health data, a network for transmission and sharing of health data and indicators, and a capacity for analysis and dissemination of health information; OJNo. L219, 28. 8. 93, p. 1 OJNo. L361, 31. 12. 94, p. 40 to options 12. Whereas and available possibilities for developing the various parts of a Community health monitoring system should be carefully assessed with respect performance, the desired flexibility and the costs and benefits involved; whereas a Community health the monitoring system should definition of sets of Community health indicators and the collection of the data necessary for the establishment of such indicators; include from should draw 13. Whereas, Community health data and indicators readily available European data and indicators, such as those held by Member States or transmitted by international them organisations, so as to avoid unnecessary duplication of work; to a Community 14. Whereas health monitoring system would benefit from the establishment of a network, the backbone of which relies on telematics, for the collection and distribution of Community health data and indicators; a Community 15. Whereas health monitoring system should be capable of encouraging and assisting in the production of analyses of health status, trends, and health the Community, and in the availability and dissemination of health information; throughout problems that of including 12. Whereas available options and possibilities for developing the various parts of a Community health monitoring enhancing system, existing capabilities and/or setting up an observatory, should be examined with respect to the desired performance, and the costs and benefits involved; and whereas a flexible system is required which can incorporate features which are valuable at present while adapting to new requirements or other priorities; whereas a Community health monitoring system should include the definition of sets of Community health indicators and the collection of the data necessary for the establishment of such indicators; 13. Whereas Community health data and indicators should draw from existing European data and indicators, such as those held by Member States and/or transmitted by international them organisations, so as to avoid unnecessary duplication; to 13a. (new) Whereas the situation with regard to the collection of data varies from Member State to Member State: the Community health 14. Whereas monitoring system would benefit from being based on a network, the backbone of which the collection and distribution of Community health data and indicators; telematics, relies on for 15. Whereas the health monitoring system should provide material for regular reports on health status in the European Community, analyses of trends, and health problems, and assist in the availability and dissemination of health information; 15a. (new) Whereas importance must be attached to cooperation in the field of health and occupational health and safety, from which a picture of the prevalence of occupational diseases and accidents at work can be built up; 16. Whereas it is necessary to ensure the respect of legislative provisions on data protection, and the implementation of appropriate confidentiality and security arrangements; 16. Whereas overriding considerations in the development of a Community health monitoring system are the respect of legislative provisions on data protection, and the implementation of appropriate confidentiality and security arrangements; 17. Whereas a multiannual programme should be launched within the context of the framework for action in the field of public health, in order to permit the development of a Community health monitoring system and of appropriate mechanisms for its evaluation; 18. Whereas, by reason of its scale and effects, Community action in support of health monitoring enables the desired objectives to be reached more effectively; the 19. Whereas policies and programmes formulated and implemented at Community level, in particular those undertaken in the context of the framework for action in the field of public health, should be compatible with targets and objectives of Community action on health monitoring; whereas the implementation of Community actions on health monitoring should be coordinated with and take account of relevant research activities under the Community's Framework Programme for Research and Technological Development; whereas projects on telematics applications in the health field under the Community's RTD Framework must be closely coordinated with Community actions on health monitoring; whereas actions under the Community's framework programme for statistical information, the Community telematic projects field of the in closely coordinated with interchange of data between administrations (IDA) and G-7 health-related projects must be the implementation of Community actions on the work health monitoring; whereas undertaken by the specialised European agencies, such as the EMCDDA and the European Environment Agency, should be taken into account; 20. Whereas cooperation in this area with the competent international organisations and with third countries should be fostered; it is important the 21. Whereas Commission ensure implementation of the programme in close cooperation with the Member States; that point of view, 20a. (previously recital 23) Whereas, from an operational the investments made in the past both in terms of the development of Community networks and cooperation with international organisations competent in this field should be safeguarded and further developed; 21. Whereas it is important that the Commission implement this programme in close cooperation with the Member States; 22. Whereas an agreement on a "modus vivendi" between the European Parliament, the Commission the Council concerning measures implementing acts adopted in accordance with the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994; and 23. Whereas, from an operational point of view, the investments made in the past both in terms of the development of Community networks and cooperation with international organisations competent in this field should be safeguarded and further developed; 23. Deleted 10 24. Whereas at present data are insufficiently comparable, and unnecessary duplication of effort should be avoided by the joint development of methodologies, comparison and conversion criteria and techniques, progressively harmonized data collection surveys, questionnaires or parts thereof, and content specifications for health information to be shared using in particular a telematics network; tools such as 24. Whereas unnecessary duplication of effort should be avoided by the joint development of methodologies, comparison and conversion criteria and techniques, progressively harmonised data collection tools such as surveys, questionnaires or parts thereof, and content specifications for health information to be shared using in particular a telematics network; 25. Whereas, in order to increase the value and impact of the programme, a continuous assessment of the measures undertaken should be carried out, with particular regard to their effectiveness and the achievement of objectives both at national and Community and, where the necessary adjustments appropriate, should be made; level framework constituting 26. Whereas this Decision lays down, for the entire duration of the programme, a financial 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 must be of in order to allow five-year duration sufficient to be for implemented to achieve the objectives set, actions time HAVE DECIDED AS FOLLOWS: Article 1 Establishment of the programme 1. A programme of Community action on health monitoring, hereinafter referred to as "this programme", is hereby adopted for the period 1 January 1997 to 31 December 2001 within the framework for action in the field of public health. 11 is to 2. The aim of this programme establish a Community health monitoring system which allows the measuring of health status, trends and determinants throughout the Community, facilitates the planning, monitoring, and evaluation of Community programmes and actions, and provides Member States with appropriate health information to make comparisions and their national health policies. to support programme 3. The actions to be implemented under this specific objectives are set out in the Annex under the headings: their and The actions to be 3. implemented under this programme and their specific objectives are set out in Annex 1 under the headings: A. B. C. Establishment of Community health indicators Development of a Community-wide network for sharing health data Analyses and reporting Article 2 Implementation ensure 1. The Commission implementation, in close cooperation with the Member States, of the actions set out in the Annex in accordance with Article 5. shall ensure 1. The Commission implementation, in close cooperation with the Member States, of the actions set out in Annex I in accordance with Article 5. shall 2. The Commission shall cooperate with institutions and organisations active in the field of health monitoring. Article 3 Budget total appropriation for 1. The implementation of this programme for the period referred to in Article 1 shall be ECU 13. 8 Million. 12 The Commission 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 statistical framework programme information, the projects in the field of interchange of data between telematic administrations, framework the and programme for research and technological development the in particular and telematics applications of the latter. for of 1. The Commission shall be assisted by a Committee an advisory nature. composed of two members designated by each Member State and chaired by a the Commission, representative hereinafter referred to as "the Committee". of 2. The annual appropriations shall be established by the Budgetary Authority in accordance with the financial perspectives. Article 4 Consistency and complementarity including 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 framework initiatives, programme for statistical information, the projects telematic interchange between of framework and administrations, programme for research and technological development the in particular and telematics applications of the latter. field of data the the the in Article 5 Committee 1. The Commission shall be assisted by a Committee composed of two members designated by each Member State and chaired by a representative of the Commission, hereinafter referred to as "the Committee". 2. The representative of the Commission shall submit to the Committee draft measures concerning, in particular: (a) the Committee's rules of procedure; (b) annual work an programme indicating the priorities for action; 13 (c) including the arrangements, criteria, and and procedures selecting for this financing projects under programme, those cooperation with involving international organisations competent in the field of public health and participation of the countries mentioned in Article 6(2); (d) the evaluation procedure; (e) (f) (g) the arrangements for reporting, conversion, and harmonisation of the data; the arrangements for the definition and selection of indicators; the arrangements for the content specifications necessary for the development and operation of the relevant networks. 3. In addition, the Commission may consult the Committee on any other matter implementation of this concerning the programme. The representative 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 chairperson 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 account. 14 4. The representative of the Commission shall keep the Committee regularly informed about: financial assistance granted under this programme (amounts, duration, breakdown, and recipients); proposals initiatives and or Commission Community the implementation of programmes in other policy areas which are relevant to the achievement of the objectives of this programme, with a view to ensure the consistency and complementarity required under Article 4. Article 6 International cooperation and with 1. In the course of implementing this programme, cooperation with non-member countries international organisations competent in the field of public health, in particular the World Health Organization and the Organization and for Economic Cooperation Development fostered and shall be implemented in accordance with Article 5. and with In the course of implementing this 1. third cooperation with programme, countries international organisations competent in the field of public health, in particular the World Health Organization and the Organization and for Economic Cooperation Development, fostered and shall be implemented in accordance with Article 5. to relating the Additional Protocols 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 the in Association Agreements 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 in accordance with EFTA countries, procedures those countries. to be agreed with 15 Article 7 Monitoring and evaluation 1. The Community, 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 the actions undertaken. is made of into these incorporate 2. The Commission shall submit to the European Parliament and the Council an interim report halfway through, and a final report on completion of this programme. It shall reports information on Community financing in the on various complementarity with the other actions referred to in Article 4, as well as the results of the evaluations. It shall also send the Economic and Social them Committee and the Committee of the Regions. action fields and to of ANNEX ANNEX I SPECIFIC OBJECTIVES AND ACTIONS A. OF E S T A B L I S H M E NT C O M M U N I TY H E A L TH INDICATORS Objective: To establish Community health indicators by a critical review of existing health data and indicators, and develop appropriate methods for the collection and of progressively harmonised health data. comparable 16 1. Carrying out an identification, review and critical analysis of existing health indicators and data at the European and Member States' level in order to identify their relevance, quality and coverage with regard to the establishment of Community indicators. for the monitoring 2. Creation of a set of Community health indicators, including a sub-set of core indicators of Community programmes actions in public health, and a sub-set of background indicators for the monitoring of other Community policies programmes and actions, and for providing Member States with common measures for making comparisons. and/or 3. Development of the routine collection of comparable progressively harmonised data in the Member States, including support for the elaboration of data dictionaries, and the establishment of appropriate conversion methods and rules. Creation of a set of Community 2. health indicators, including a sub-set of core indicators for the monitoring of Community programmes actions in public health, and a sub-set of background indicators for the monitoring of other Community policies programmes and actions, and for providing Member States with common measures for making comparisons. Details of these indicators are given in Annex II to this programme. of to the collection of 4. Contributing the supporting comparable data by elaboration including Community-wide surveys in support of Community policies, or modules or agreed forms of words for questions in existing surveys. surveys 5. Foster co-operation with international organizations competent in the field of European health data and indicators and networks for the exchange of health data covering specific areas in public health, in order to enhance comparability of data. 17 and cost-effectiveness 6. Support for the assessment of the of feasibility developing standardised health resource statistics with the aim of including them in a future Community health monitoring system. B. D E V E L O P M E NT OF A COMMUNITY-WIDE NETWORK FOR SHARING HEALTH DATA Objective: To enable the establishment of effective and reliable transfer and sharing of health data and indicators using telematic interchange of data as the principal means. 7. Encourage and support the development of a network for sharing health data, mainly using telematic interchanges and a system of distributed databases, in particular by the establishment of data specifications and of procedures with the access, retrieval, regard confidentiality and security for the different types of information to be included in the system. the to assessment of the feasibility and cost- effectiveness of developing standardised health resource statistics with the aim of including them in the Community health monitoring system. Encouragement of and support for 7. the development of a network for transferring and sharing health data, mainly using telematic interchanges and a system of distributed databases, in particular by the establishment of data specifications and of procedures with regard to the access, retrieval, confidentiality and security for the different types of information to be included in the system. C. ANALYSES AND REPORTING Objective: To develop methods and tools necessary for analysis and reporting, and support analyses and reporting on health trends, status, determinants, and the effect of policies on health. 18 8. Encourage the development of a capacity for analyses, including comparative and predictive methodologies and tools, the testing of hypotheses and models and the and evaluation outcomes. of health scenarios 8. Encouragement of and support for the development of a capacity for analyses, enhancing existing capabilities, and for feasibility for possible new structures, comparative and predictive methodologies and tools, the testing of hypotheses and models and the evaluation of health scenarios and outcomes. studies 9. Support for the analysis and evaluation of the impact of Community actions and programmes in public health. for of the production and 10. Support dissemination other and reports information material on health status and trends, health determinants and the impact on health of other policies. the Support 9. analysis,. for preparation, and dissemination of reports evaluating the impact of Community action and programmes in the field of public health. for the Support preparation. 10. production and dissemination of reports and other information material on health status and trends, health determinants and the impact on health of other policies. ANNEX II Non-Exhaustive list of domains in which health indicators may be established under the Community health monitoring system Health Status 1. Life expectancy: - life expectancy at certain ages - health expectancies 2. Mortality: - overall - causes of death - disease-specific survival 3. Morbidity: - disease-specific morbidity - co-morbidity 4. Functioning and quality of life: self-perceived health - - physical disability - activity limitations - functional status/ability - health-related work loss 19 - mental health 5. Anthropometric characteristics B. Life Style and Health Habits Illicit drug consumption 1. Tobacco consumption 2. Alcohol consumption 3. 4. Physical activities 5. Diet 6. Sexual behaviour 7. Other health promotion-related activities C. Living and working conditions 1. Employment/unemployment: - occupation 2. Work environment: - accidents - exposure and substances other to carcinogenic dangerous - occupational health 3. Housing conditions 4. Home and leisure activities: - accidents at home - leisure 5. Transport: - automobile accidents 6. External environment: - air pollution - water pollution - other types of pollution - radiation to carcinogenic - exposure and dangerous substances outside the work environment other D. Health Protection 1. Sources of financing 2. Facilities / Manpower 20 - Health resource utilisation - Health care personnel Cost / Expenditure - In patient care - Out patient care - Pharmaceutical products Consumption / uses - In patient care - Out patient care - Pharmaceutical products Health promotion and disease prevention £. Demographic and Other Social Factors 1. Gender 2. Age 3. Civil status 4. Region of residence 5. Education 6. Income 7. Population subgroups 8. Health insurance status F. Miscellaneous 1. Product safety 2. Others 21 ISSN 0254-1475 COM(96) 222 final DOCUMENTS EN 05 Catalogue number : CB-CO-96-232-EN-C ISBN 92-78-04220-X Office for Officiai Publications of the European Communities L-2985 Luxembourg 2<L