[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 8.10.2008

COM(2008) 649 final

2007/0020 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the

common position of the Council on the adoption of a Regulation of the European Parliament and of the Council on Community statistics on public health and health and safety at work

2007/0020 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251(2) of the EC Treaty concerning the

common position of the Council on the adoption of a Regulation of the European Parliament and of the Council on Community statistics on public health and health and safety at work

1. BACKGROUND

Date of transmission of the proposal to the EP and the Council (document COM (2007) 46 final – 2007/0020 (COD) | 7 February 2007 |

Date of the opinion of the European Data Protection Supervisor | 5 September 2007 |

Date of the opinion of the European Economic and Social Committee: | 25 October 2007 |

Date of the opinion of the European Parliament, first reading: | 13 November 2007 |

Date of adoption of the common position: | 2 October 2008 |

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The proposed Regulation aims at establishing a legal framework for the systematic production of Community statistics in two areas: 'public health' and 'health and safety at work'. The statistics shall provide a harmonised and common data set for five domains concerned, namely Health status and health determinants; Health care; Causes of death; Accidents at work, and Occupational diseases and other work-related health problems and illnesses. |

- These statistics are carried out by the European Statistical System, i.e. Eurostat together with the national statistical institutes and other national authorities responsible for the provision of official statistics. The proposed Regulation aims at consolidating the progress made for routine data collections in the two areas concerned, and to set the frame for improving quality and comparability standards by common methodologies. It will provide a clearer planning, sustainability and stability of the European requirements for health and safety statistics.

3. COMMENTS ON THE COMMON POSITION

3.1 General comments

The European Parliament gave its opinion at first reading on 13 November 2007 and adopted twelve amendments. The Commission accepted those amendments.

The common position incorporates ten of them entirely and one of them partly. Only one amendment concerning Annex I (amendment 8) was not taken into account.

Furthermore the common position contains a number of amendments – made by the Council - in view of clarifying the text and making it more readable and precise.

The Commission considers that the common position does not alter the approach or aims of the proposal and can thus support it as it stands.

3.2. Detailed comments

3.2.1. Parliamentary amendments accepted by the Commission and incorporated in full or in part in the common position

Recitals 3, 17 and 20: Amendments 1 (in full) and 2 (last part) have been incorporated with a slightly different wording. They underline the key role of gender and age in the breakdown variables for the different domains of health and safety statistics, which was already included in the gentlemen's agreements. Amendment 3 (in full) underlines the provision of financial support through Community programmes in view of additional costs for data collections as specified in the proposed regulation.

Article 1, paragraph 1: Amendment 4 (in full) refers to main principles of the European Statistics Code of Practice, which are expressively mentioned under Article 8 on quality assessment. Article 1 paragraph 2 and Article 3 point c: Amendments 5 (in full) and 6 (in full) have been incorporated to ensure that the data collected should provide the necessary information for supporting national strategies for the development of universally accessible health care. Article 5 paragraph 2: Amendment 7 (to be read in conjunction with Article 9 paragraph 1) has been incorporated in substance in order to adopt a more general approach with emphasis on ‘avoiding duplication of effort’, but in a comprehensive way without listing specific institutions or organisations in the field.

Annex I point (d), indent 3 (new) and 4 (new): Amendments 11 (in full) and 12 (in full) have been incorporated in order to ensure data collection on these subjects in view of their importance in the context of health and its determinants. Annex V point (b): Amendment 9 (in full) allows a clear distinction between occupational diseases and work-related health problems and illnesses by defining them in two separate paragraphs and by stating that the data on work-related health problems and illnesses ‘shall be collected from existing population surveys’. Annex V point (d): Amendment 10 (in full) has been incorporated in line with amendment 2 for recital 17 in view of ensuring that the relevant characteristics of the person (diseased or suffering from a health problem) and of the enterprise/ workplace are included.

3.2.2. Parliamentary amendments rejected by the Commission but incorporated in full, in part or in principle in the common position

None.

3.2.3. Parliamentary amendments accepted in full, in part or in principle by the Commission but not incorporated in the common position

Annex I, point (d), indent 1a (new): Amendment 8 on 'tracking of any disease whose incidence is increasing or decreasing' was not taken into account. At the European Parliament first reading the Commission had emphasised that it is potentially repetitive with indent one which already includes 'morbidity', but accepted it in view of giving a specific focus on those diseases in health monitoring. However, as the Council considered that it is by definition an element of the analysis and dissemination of the morbidity data and consequently does not add anything to the text, the Commission could agree.

3.2.4. Parliamentary amendments rejected by the Commission and the Council and not incorporated in the common position

None.

3.2.5. Changes made by the Council to the Proposal

The Council proposed the following main changes to the Commission proposal:

Recital 1 : The reference to the second programme of Community action in the field of health (2008-2013) now adopted by the EP and Council is added, in parallel to the reference made in Recital 3 to the second Community strategy on health and safety at work (2007-2012); this is also necessary in order to mention possibilities of complementary financing via these two programmes (see whereas (20) to help Member States in further building up national capacities to implement statistical data collections on public health and on health and safety at work. The Commission agrees on this addition.

Recital 3: The reference to the Council Resolution No 2007/C 145/01 of 25 June 2007 on a second Community strategy on health and safety at work (2007-2012) was added. The Commission can agree on such changes.

Recital 16 (new): The new recital underlines the national competences for organisation and management of health care systems and the responsibility of the Member States for the implementation of Community legislation on workplaces and labour conditions. The Commission can support these clarifications.

Article 3 points (e), (f), (g): Definitions were added on ‘microdata’, ‘transmission of confidential data’ and ‘personal data’ for more coherence with other legal texts which ensure appropriate protection of those data. The Commission can support these additional definitions.

Articles 5 and 6 (new): From the former Article 5 on ‘Methodology, manuals and pilot studies’ paragraphs 1 to 3 were revised for clarification and re-grouped to 2 paragraphs under the header ‘Methodology’, while paragraph 4 was separately put under a new article 6 ‘Pilot studies and cost-benefit analysis’ as paragraph 1. It was complemented with 2 new paragraphs on the need for a cost-benefit analysis and a Commission evaluation on the findings of the pilot studies and the cost-benefit analysis before developing implementing measures on the subjects of those pilots. Those clarifications are in line with the European Statistics Code of Practice and can be supported by the Commission.

Article 7: Paragraph 1 was revised for clarification, and to paragraph 3 a reference to Regulation (EC) No 45/2001 was added in order to emphasise the Commission's obligations for ensuring the protection of individuals in view of the processing of personal data. The Commission can support these changes.

Article 8: Under a revised header ‘Quality assessment’ the former 4 paragraphs were grouped to 2. While paragraph 1 defines explicitly the quality assessment dimensions for data to be transmitted by following the principles of the European Statistics Code of Practice, the second paragraph is clarifying the rules on reporting on data quality. The Commission can support that clarification.

Annex I (d): A final paragraph was added in order to give precisions on the maximum length of the interview and to ensure the optional aspect of the Health Examination Surveys ‘in the framework of this Regulation’, which can be agreed by the Commission.

Annex II (d): The "mobility of patients", "mobility of health professionals" and "quality of health care" are particularly included as horizontal issues to be considered in the data collections for the subjects listed. The Commission supports that clarification.

Annex III (b) and (d): Clarifications were made under ‘scope’, that data should distinguish residents from non-residents, and data on residents dying abroad should be considered to be included in the data collections. In addition, under ‘subjects covered’, the data for stillbirths shall be provided for the total figure, however, the provision of data relating to the characteristics (causes) of stillbirths shall be on a voluntary basis. The "Provision of data relating to neonatal deaths (deaths up to the age of 28 days) shall recognise national differences in practice, regarding the recording of multiple causes of death". The Commission can agree on these clarifications.

Annex IV (d): The modifications made are clarifications that refer to the current ESAW methodology and are in line with the ESAW data as provided by the Member States to the Commission (Eurostat) under gentlemen’s agreement. The Commission can accept these changes.

For the Annexes in general more details were given, such as on intervals and time limits for data delivery, on measures relating to metadata and on subjects covered. The Commission can agree on those changes.

4. CONCLUSION

The changes introduced by the Council's common position are acceptable to the Commission as they lead to a realistic compromise between, on the one hand, the need for reliable and comparable data for key domains of the areas of public health and health and safety at work in order to support evidence based policy and, on the other hand, the difficulty for most of the Member States to improve ongoing or start new data collection systems and collect sufficiently detailed and comparable data for the needs of this Regulation.

In general, the Council changes build upon the Commission's proposal and therefore the Commission can accept the common position.