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
Date: 2008-10-08
Institutions: European Commission
Subjects: EU statistics, occupational health, occupational safety, public health

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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 

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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 

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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.  

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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 

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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. 

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