Article 1 Subject matter
1. This Regulation establishes a common framework for the systematic production of Community statistics on public health and health and safety at work. The statistics shall be produced in compliance with standards on impartiality, reliability, objectivity, cost-effectiveness and statistical confidentiality. 2. The statistics shall include, in the form of a harmonised and common data set, information required for Community action in the field of public health, for supporting national strategies for the development of high-quality, universally accessible and sustainable health care as well as for Community action in the field of health and safety at work. 3. The statistics shall provide data for structural indicators, sustainable development indicators and European Community Health Indicators (ECHI), as well as for the other sets of indicators which it is necessary to develop for the purpose of monitoring Community actions in the fields of public health and health and safety at work.
Article 2 Scope
Member States shall supply to the Commission (Eurostat) statistics on the following domains: — health status and health determinants, as defined in Annex I, — health care, as defined in Annex II, — causes of death, as defined in Annex III, — accidents at work, as defined in Annex IV, — occupational diseases and other work-related health problems and illnesses, as defined in Annex V.
Article 3 Definitions
For the purpose of this Regulation: (a) ‘Community statistics’ shall have the meaning assigned to it by the first indent of Article 2 of Regulation (EC) No 322/97; (b) ‘production of statistics’ shall have the meaning assigned to it by the second indent of Article 2 of Regulation (EC) No 322/97; (c) ‘public health’ shall mean all elements related to health, namely health status, including morbidity and disability, the determinants having an effect on that health status, health care needs, resources allocated to health care, the provision of, and universal access to, health care as well as health care expenditure and financing, and the causes of mortality; (d) ‘health and safety at work’ shall mean all elements related to the prevention and protection of the health and safety of workers at work in their current or past activities, in particular accidents at work, occupational diseases and other work-related health problems and illnesses; (e) ‘microdata’ shall mean individual statistical records; (f) ‘transmission of confidential data’ shall mean transmission between national authorities and the Community authority of confidential data which do not permit direct identification, in accordance with Article 14 of Regulation (EC) No 322/97 and with Regulation (Euratom, EEC) No 1588/90; (g) ‘personal data’ shall mean any information relating to an identified or identifiable natural person, in accordance with the Article 2(a) of Directive 95/46/EC.
Article 4 Sources
Member States shall compile data concerning public health and health and safety at work from sources which shall, depending on the domains and subjects and on the characteristics of the national systems, consist of either household or similar surveys or survey modules, or national administrative or reporting sources.
Article 5 Methodology
1. The methods used for the implementation of the data collections shall take into consideration, including in the case of preparatory activities, national experience and expertise, and national specificities, capacities and existing data collections, in the framework of the collaborative networks and other European Statistical System (ESS) structures with Member States set up by the Commission (Eurostat). The methodologies for regular data collections which result from projects with a statistical dimension carried out under other Community programmes such as the public health or the research programmes shall also be taken into consideration. 2. The statistical methodologies and data collections to be developed for the compilation of statistics on public health and health and safety at work at Community level shall take into consideration the need for coordination, whenever relevant, with the activities of international organisations in the field, with a view to ensuring international comparability of statistics and consistency of data collections as well as avoiding duplication of effort and of deliveries of data by Member States.
Article 6 Pilot studies and cost-benefit analyses
1. Whenever data are required in addition to those already collected and to those for which methodologies already exist, or when insufficient quality of data is identified in the domains referred to in Article 2, the Commission (Eurostat) shall institute pilot studies to be completed on a voluntary basis by the Member States. The purpose of such pilot studies shall be to test the concepts and methods and to assess the feasibility of the related data collections, including statistical quality, comparability and cost effectiveness, in accordance with the principles set up by the European Statistics Code of Practice. 2. Whenever preparation of an implementing measure is envisaged in accordance with the regulatory procedure with scrutiny referred to in Article 10(2), a cost-benefit analysis, taking into account the benefits of the availability of the data in relation to the cost of the data collection and the burden on Member States, shall be carried out. 3. The Commission (Eurostat) shall prepare a report evaluating the findings of the pilot studies and/or cost benefit analysis, including the effects and implications of national specificities, in cooperation with Member States, in the framework of the collaborative networks and other ESS structures.
Article 7 Transmission, treatment and dissemination of data
1. When necessary for the production of Community statistics, Member States shall transmit the confidential microdata or, depending on the domain and subject concerned, the aggregated data, in accordance with the provisions on transmission of data subject to confidentiality set out in Regulation (EC) No 322/97 and in Regulation (Euratom, EEC) No 1588/90. Those provisions shall apply to the treatment of the data by the Commission (Eurostat), in so far as the data are considered confidential within the meaning of Article 13 of Regulation (EC) No 322/97. Member States shall ensure that the transmitted data do not permit the direct identification of the statistical units (individuals) and that personal data are protected in compliance with the principles laid down in Directive 95/46/EC. 2. Member States shall transmit the data and metadata required by this Regulation in electronic form, in accordance with an interchange standard agreed between the Commission (Eurostat) and the Member States. The data shall be provided in accordance with the time limits set out, at the intervals provided for, and in respect of the reference periods indicated in the Annexes or in the implementing measures adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). 3. The Commission (Eurostat) shall take the necessary steps to improve the dissemination, accessibility and documentation of the statistical information, in accordance with the principles of comparability, reliability and statistical confidentiality laid down in Regulation (EC) No 322/97 and with Regulation (EC) No 45/2001.
Article 8 Quality assessment
1. For the purpose of this Regulation, the following quality assessment dimensions shall apply to the data to be transmitted: (a) ‘relevance’ shall refer to the degree to which statistics meet the current and potential needs of users; (b) ‘accuracy’ shall refer to the closeness of estimates to the unknown true values; (c) ‘timeliness’ shall refer to the time lag between the availability of the information and the event or phenomenon it describes; (d) ‘punctuality’ shall refer to the time lag between the date of the release of the data and the target date when it should have been delivered; (e) ‘accessibility’ and ‘clarity’ shall refer to the conditions and modalities by which users can obtain, use and interpret data; (f) ‘comparability’ shall refer to the measurement of the impact of differences in applied statistical concepts and measurement tools and procedures when statistics are compared between geographical areas, sectoral domains or over time; (g) ‘coherence’ shall refer to the adequacy of the data to be reliably combined in different ways and for various uses. 2. Every five years each Member State shall provide the Commission (Eurostat) with a report on the quality of the data transmitted. The Commission (Eurostat) shall assess the quality of data transmitted and publish the reports.
Article 9 Implementing measures
1. The implementing measures shall cover: (a) the characteristics, namely variables, definitions and classifications of the subjects, covered in Annexes I to V; (b) the breakdown of characteristics; (c) the reference periods, intervals and time limits for data provision; (d) the provision of metadata. These measures shall take account of, in particular, the provisions of Article 5, Article 6(2) and (3) and Article 7(1), as well as the availability, suitability and the legal context of existing Community data sources after examination of all sources related to the respective domains and subjects. These measures designed to amend non-essential elements of this Regulation, inter alia , by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2). 2. If necessary, derogations and transition periods for Member States, both to be based upon objective grounds, shall be adopted in accordance with the regulatory procedure referred to in Article 10(3).
Article 10 Committee
1. The Commission shall be assisted by the Statistical Programme Committee set up by Decision 89/382/EEC, Euratom. 2. Where reference is made to this paragraph, Articles 5a(1) to (4) and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 11 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .