Explanatory Memorandum to COM(2007)46 - Community statistics on public health and health and safety at work

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1) CONTEXT OF THE PROPOSAL

• Grounds for and objectives of the proposal

This proposal for a Regulation (EC) of the European Parliament and of the Council concerning Community statistics on public health and health and safety at work aims at establishing the framework for the systematic production of statistics in these two areas, in the form of a minimum data set, carried out by the European Statistical System, i.e. Eurostat, the national statistical institutes and all other national authorities responsible for the provision of official statistics in these areas. Consequently, this Regulation is only focused on statistical activities developed under article 285 of the Treaty establishing the European Community. Its aim is not on policy developments for the two areas of public health and health and safety at work, which are carried out respectively under articles 152 and 137 of the Treaty. The production of Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council.

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 making it applicable to the Community institutions and bodies allow the processing of personal data on health for reasons of substantial public interest subject to provision of appropriate safeguards. The Community and national political actions and strategies in the areas of public health and health and safety at work constitute a substantial public interest and the provisions of the Council Regulations (EC) No 322/97 and (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (Eurostat) provide the appropriate safeguards for the protection of individuals in the case of the production of Community statistics on public health and health and safety at work.

• General context

The methodological developments for Eurostat statistical activities in both areas of public health and health and safety at work started in the first half of the 90's, with first data collection starting with reference years 1993-1994. The sustainability and quality improvement of these data collections already in place as well as a successful implementation of new statistical data collections for which methodologies have been or are being developed in both areas are clearly needed by the relevant European policies. Actually, the Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health 2003-2008, the Council Resolution No 2002/C 161/01 of 3 June 2002 on a new Community strategy on health and safety at work 2002-2006 and the Commission Communication of 20 April 2004 on "modernising social protection for the development of high-quality, accessible and sustainable health care and long-term care: support for the national strategies using the open method of coordination", require a high standard statistical information system for assessing achievements of policies and developing and monitoring further actions in both areas. This will be continued and developed under successor programmes and strategies.

Until now, statistical data collections were carried out on the basis of 'gentlemen agreements' with the Member States in the framework of the five years Community Statistical Programmes (currently Decision 2367/2002/EC of the European Parliament and Council of 16 December 2002 on the Community statistical programme 2003 to 2007) and its annual components. In particular in the area of public health statistics, the developments and implementations in the three strands (causes of deaths, health care and health interview surveys, disability and morbidity) are steered and organised according to a partnership structure between Eurostat, together with leading countries (currently United Kingdom as general coordinator and respective domain leaders from Estonia, Luxembourg and Denmark), and Member States. In this framework, a lot of methodological work, including preparation of guidelines, has been already achieved and the implementation of data collections has started.

However, the current situation is characterised by the following limitations. First, for data collection already implemented, though a certain increase in data quality and comparability has been achieved, Member States should be given a firm basis for implementation. A legal framework would allow a consolidation of the progress towards better quality and comparability standards for all related routine data collections. It will ensure a better sustainability and stability of the European requirements for the medium term and would give clear targets in terms of standards to be achieved for comparability at EU level. Moreover, a high majority of the new Member States stated that, for the implementation of both the full statistical 'acquis communautaire' and new statistical collections to be set up in near future, they will not be able to comply with the EU requirements in the areas of public health and health and safety at work statistics without a European legal framework. Finally, all Member States need a clearer view on the time schedule and milestones for the implementation of the new statistical tools, currently being developed, and of the actions being prepared for quality improvement. The proposed regulation will be an appropriate framework for drawing up detailed roadmaps in the various areas and strands of health and safety statistics.

This is why the Commission (Eurostat) considers it is necessary now to give a firm basis through providing a basic legal act in the areas of public health and health and safety at work statistics. The domains covered by the proposal for a European Parliament and Council Regulation relate to ongoing activities and developments carried out together with the Member States in the relevant groups of Eurostat or, in the area of public health, of the Partnership on public health statistics. The main goal is to give a consolidated and firm basis for collections already implemented or which methodology is currently being developed or implementation prepared.

• Existing provisions in the area of the proposal

There are no existing provisions in the area of the proposal.

• Consistency with other policies and objectives of the Union

The Programme of Community action in the field of public health (2003-2008), stated that the statistical element of the information system on public health will be developed, in collaboration with Member States, using as necessary the Community statistical programme to promote synergy and avoid duplication. The amended proposal for a Decision of the European Parliament and of the Council establishing a second programme of Community action in the field of health 2007-2013 (COM (2006) 234 final), stated that the existing work to develop an EU health monitoring system shall be expanded, using the Community Statistical Programme as necessary. For its part, the Community strategy on health and safety at work 2002-2006 called on the Commission and the Member States to step up work in hand on harmonisation of statistics on accidents at work and occupational illnesses, so as to have available comparable data from which to make an objective assessment of the impact and effectiveness of the measures taken under the Community strategy.

3.

2) CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT


• Consultation of interested parties

4.

Consultation methods, main sectors targeted and general profile of respondents


- Meetings with the Core Groups in charge of steering developments and implementations in each of the three strands of the Partnership on public health statistics - first quarter 2005.

- Meetings with the Eurostat Technical Groups in the area of health and safety at work statistics (one group on accidents at work and another one on occupational diseases) - February and April 2005.

- Written consultation of all Member States in the framework of the two Eurostat public health statistics and health and safety at work statistics Working Groups - May to September 2005.

- Meeting of the Directors of Social Statistics of the National Statistical Institutes on 28-29 September 2005.

- Meeting of the Statistical Programme Committee on 29-30 November 2005.

In addition an information was provided to the following groups:

- Meetings of the Technical Groups in each of the three strands of the Partnership on public health statistics - May to September 2005.

- Meeting of the Network of Competent Authorities of the Health Information strand of the Community action in the field of public health 2003-2008 - 5-6 July 2005.

- Public Health Working Group of the Council - 7 November 2005.

- Tripartite Advisory Committee on Safety and Health at Work - 25 November 2005.

- High Level Committee on Health - 14-15 December 2005.

5.

Summary of responses and how they have been taken into account


In the framework of the Partnership on public health statistics groups, the experts supported the proposal and provided detailed comments for improvements of technical contents which were taken into consideration in the final drafting. In the framework of the other meetings and written consultation of the Eurostat Working Groups, the majority of the Member States also supported the proposal. However, some Member States considered the gentlemen agreement procedure as more flexible for this area, some others required to concentrate on the achievement of a minimum statistical data set in these areas (taken into consideration in the final drafting) and others required to consult the demand side groups (actually an information was provided to various groups including the Council Working Group on Public Health). Finally, Member States required that an impact assessment will be provided at the time of the adoption of the proposal by the Commission; Eurostat is preparing the 'analysis of the consequences' of the proposal. Finally detailed comments from Member States and Commission services were taken into consideration.

• Collection and use of expertise

6.

Scientific/expertise domains concerned


For public health: Partnership on Public Health statistics, general coordinator, domain leaders and core groups members.

For health and safety at work: members of the Eurostat Technical Groups of the European Statistics on Accidents at Work (ESAW) and the European Occupational Diseases Statistics (EODS).

7.

Methodology used


Discussion at meetings.

8.

Main organisations/experts consulted


For public health: Office for National statistics of UK, Inspection Générale de la Sécurité Sociale of Luxembourg, Central Statistical Office of Ireland until June 2005 and since then National Statistical Institute of Estonia, National Institute of Public Health of Denmark.

For health and safety at work: members of the respective technical groups (all Member States).

9.

Summary of advice received and used


The existence of potentially serious risks with irreversible consequences has not been mentioned.

They provided support in drafting some articles of the proposal and the detailed contents of the five annexes.

10.

Means used to make the expert advice publicly available


Working documents and minutes of the following meetings, available on the respective Eurostat Circa sites:

- Directors of Social Statistics 28-29/09/2005;

- Eurostat Public Health Statistics Working Group 28-29/11/2005;

- Eurostat Technical Groups in on accidents at work statistics 25/02/2005 and on occupational diseases 26/04/2005 as well as Eurostat Health and Safety at Work Working Group 6-7/10/2005.

• Impact assessment

An 'Analyses of the consequences' (impact assessment in the case of Community statistics legislation) has been carried out. The three options considered are :

- No action, i.e. continue to develop statistics in the areas of public health and health and safety at work using a 'gentlemen agreements' with the Member States in the framework of the five years Community Statistical Programmes;

- The development and adoption of various proposals for Regulations (EC) of the European Parliament and of the Council concerning either public health statistics and health and safety at work separately or each domain and related statistical tool separately;

- The development and adoption of the current proposal for a Regulation (EC) of the European Parliament and of the Council concerning Community statistics on public health and health and safety at work.

3)

1.

LEGAL ELEMENTS OF THE PROPOSAL



• Summary of the proposed action

The proposal for a Regulation (EC) of the European Parliament and of the Council on public health and health and safety at work statistics aims at establishing the framework for all current and foreseeable activities in the field of Public health and Health and Safety at Work statistics carried out by the European Statistical System. It is proposed to formulate a general Regulation on all domains concerned together. The reason is to have a global and coherent approach to responding to policy needs and to promote synergies as heath issues at work and outside workplace, and their different elements, are linked; when relevant, some statistical collections can usefully be carried out for both areas together, using common tools such as population surveys. The proposed regulation sets the general principles and describes the main contents of the related data collections in Annexes I to V for the 5 domains concerned, namely statistics on health status and health determinants, health care, causes of death, accidents at work as well as occupational diseases and other work-related health problems and illnesses. The elements on the statistical methodologies and data collection will be set up by Commission implementing regulations and specified into details in manuals and guidelines.

• Legal basis

Article 285 of the Treaty establishing the European Community provides the legal basis for Community statistics. The Council, acting in accordance with the codecision procedure, shall adopt measures for the production of statistics where necessary for the performance of the activities of the Community. This Article sets out requirements relating to the production of Community statistics and requires conformity to standards of impartiality, reliability, objectivity, scientific independence, cost-effectiveness and statistical confidentiality. This Article implies that measures for the production of statistics are of exclusive competence at Community level.

• Subsidiarity principle

Since the objectives of the proposed action, namely the production of Community statistics on public health and health and safety at work, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level on the basis of a Community legal act because only the Commission can coordinate the necessary harmonisation of statistical information at Community level, while the collection of data and compilation of comparable statistics on public health and health and safety at work can be organised by the Member Sates, the Community may adopt measures, in accordance with the principle of subsidiary as set out in Article 5 of the Treaty.

• Proportionality principle

The proposal complies with the proportionality principle for the following reason(s).

In the framework of the proposed Regulation, only measures that have an important impact for the implementation and quality of the statistical data collections, such as the definition of variables, breakdowns, dates of implementation and frequency, etc., in priority domains or part of domains to be selected with the Member States, should be included in implementing measures. Main elements on sources may be also included but a high level of flexibility will be let for decisions at national level. Similarly, decisions of a more technical or very detailed nature, as guidelines, detailed classifications, etc., will be decided and included only in methodological manuals in order to allow a flexible and proportionate implementation in the Member States.

For example, in the field of surveys, the future European Health Interview Survey (EHIS) will be carried out every five years at the same time in all Member States. The subjects and breakdowns, for which questions are developed at EU level and are translated into all EU official languages (in order to avoid as much as possible linguistic and cultural biases), will be defined in an implementing regulation. However, Member States will have the choice either to set up a new survey or to include the EHIS questions in the national health or population surveys they consider appropriate.

The Commission (Eurostat) does not aim at adding new general requirements to the agreements already achieved but to support quality, comparability and timeliness improvements.

• Choice of instruments

11.

Proposed instruments: regulation


Other means would not be adequate for the following reason(s).

Gentlemen agreement procedures do not allow achieving sufficient comparability, coverage and timeliness. They will not give sufficient priority and resources for the preparation and implementation of statistical data collections on health and safety. In particular financing will not be ensured. This is why a European legal framework is necessary. A Regulation of the European Parliament and Council is the legal instrument most appropriate for statistical actions which require detailed and uniformed application throughout the Community.

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2.

BUDGETARY IMPLICATION



Main financing of actions for statistics in the areas of public health and health and safety at work will be covered by the Community statistical programme 2003 to 2007 (Decision no 2367/2002/EC of the European Parliament and of the Council) and the future Community statistical programme 2008-2012.

Complementary financing shall be provided from operational resources made available by Directorates General Health and Consumer Protection and Employment and Social Affairs in the framework of the:

- second Programme of Community action in the field of health 2007-2013 (COM (2006) 234 final, amended proposal for a Decision of the European Parliament and of the Council);

- Community programme for employment and social solidarity – PROGRESS (COM (2005) 536 final, amended proposal for a Decision of the European Parliament and of the Council).

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5) ADDITIONAL INFORMATION


• European Economic Area

The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.

• Detailed explanation of the proposal

The text follows the standard model act for statistical Regulations of the European Parliament and Council.