Proposal for a Regulation of the European Parliament and of the Council on Community statistics on public health and health and safety at work
Date: 2007-02-07
Institutions: European Commission
Subjects: EU statistics, occupational health, occupational safety, public health

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 7.2.2007 
COM(2007) 46 final 

2007/0020 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Community statistics on public health and health and safety at work 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

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. 

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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 

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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. 

2) 

• 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

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. 

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 

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consequences"  of  the  proposal.  Finally  detailed  comments  from  Member  States  and 
Commission services were taken into consideration. 

• 

Collection and use of expertise 

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). 

Methodology used 

Discussion at meetings. 

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). 

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. 

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 : 

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-  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) 

• 

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 

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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 
timeliness 
improvements. 

to  support  quality,  comparability  and 

• 

Choice of instruments 

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. 

4) 

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: 

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- 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). 

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. 

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2007/0020 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Community statistics on public health and health and safety at work 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
285(1) thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

After consulting the European Data Protection Supervisor, 

After consulting the Statistical Programme Committee (SPC) in accordance with Art. 3(1) of 
Council Decision No 89/382/EEC, Euratom3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

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) (5), stated that the statistical element of the information system on 
public  health  is  to  be  developed,  in  collaboration  with  Member  States,  using  as 
necessary  the  Community  statistical  programme  to  promote  synergy  and  avoid 
duplication.  

Community  information  on  public  health  has  been  developed  systematically  through 
the Community public-health programmes. Building on this work, a list of European 
Community  Health  Indicators  (ECHI)  has  now  emerged  providing  an  overview  of 
health status, determinants of health and health systems. In order to make available the 
minimum  statistical  data  set  needed  for  the  calculation  of  ECHI  indicators, 
Community statistics on health should be consistent, when relevant and possible, with 
the developments and achievements resulting  from Community action in the field of 
public health. 

(1) 
(2) 
(3) 
(4) 
(5) 

OJ C , , p. . 
OJ C , , p. . 
OJ L 181, 28.06.1989, p. 47. 
OJ C , , p. . 
OJ L 271, 09.10.2002, p. 1. 

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(3) 

(4) 

(5) 

(6) 

(7) 

Council Resolution No 2002/C 161/01 of 3 June 2002 on a new Community strategy 
on  health  and  safety  at  work  (2002-2006)  (6)  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  new  Community  strategy.  In  addition,  Commission  Recommendation 
C(2003)  3297  final  of  19  September  2003  concerning  the  European  schedule  of 
occupational diseases recommended that the Member States progressively make their 
statistics  on  occupational  diseases  compatible  with  the  European  schedule,  in 
accordance  with  the  work  being  done  on  harmonising  European  statistics  on 
occupational diseases. 

In  2002  the  Barcelona  European  Council  recognised  three  guiding  principles  for  the 
reform  of  health  care  systems:  accessibility  for  all,  high  quality  care  and  long-term 
financial sustainability. The Commission Communication (7) of 20 April 2004 to the 
Council, the European Parliament, the European Economic and Social Committee and 
the Committee of the Regions 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’”,  proposed  starting 
work to identify possible indicators for joint objectives to develop care systems on the 
basis of activities undertaken in the context of the Community action programme on 
health, of Eurostat health statistics and cooperation with international organisations.  

Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 
2002 laying down the sixth Community Environment Action Programme (8) includes 
an action on environment and health and quality of life as a key priority, calling for the 
definition  and  development  of  indicators  of  health  and  environment.  In  addition,  the 
Council conclusions of 8 December 2003 requested that indicators on biodiversity and 
health be included, under the title “environment”, in the structural indicators database 
used for the annual Spring Report to the European Council; health and safety at work 
indicators are also included in this database, under the title “employment”. The set of 
sustainable development indicators adopted by the Commission in 2005 also contains 
a theme on public health indicators. 

The  Environment  and  Health  Action  Plan  2004-2010  (9)  recognises  the  need  to 
improve  the  quality,  comparability  and  accessibility  of  data  on  health  status  for 
diseases  and  disorders  linked  to  the  environment,  using  the  Community  Statistical 
Programme. 

Council Resolution No 2003/C 175/01 of 15 July 2003 on promoting the employment 
and social integration of people with disabilities (10), called on the Member States and 
the  Commission  to  collect  statistical  material  on  the  situation  of  people  with 
disabilities,  including  on  the  development  of  services  and  benefits  for  this  group.  In 
addition,  the  Commission  in  its  Communication  of  30  October  2003  to  the  Council, 
the  European  Parliament,  the  European  Economic  and  Social  Committee  and  the 

(6) 
(7) 
(8) 
(9) 
(10) 

OJ C 161, 5.7.2002, p. 1 
COM(2004) 304 final 
OJ L 242, 10.9.2002, p. 1. 
COM(2004) 416 final . 
OJ C 175, 24.7.2003, p. 1. 

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(8) 

(9) 

Committee  of  the  Regions  on  Equal  opportunities  for  people  with  disabilities  -  A 
European action plan (11), decided to develop context indicators which are comparable 
across  Member  States  in  order  to  assess  the  effectiveness  of  disability  policies.  It 
indicated that maximum use should be made of sources and structures of the European 
Statistical System, in particular through development of harmonised survey modules, 
to acquire the internationally comparable statistical information needed for monitoring 
progress. 

In  order  to  ensure  relevance  and  comparability  of  the  data  and  avoid  duplication  of 
work,  the  statistical  activities  of  Eurostat  in  the  area  of  public  health  and  health  and 
safety  at  work  need  to  be  carried  out  in  cooperation  with  the  United  Nations  and  its 
special  organisations,  such  as  the  World  Health  Organisation  (WHO)  and  the 
International  Labour  Organisation  (ILO),  as  well  as  the  Organisation  for  Economic 
Cooperation  and  Development  (OECD),  when  relevant  and  possible.  In  particular,  a 
common  statistical  data  collection  on  the  Systems  of  Health  Accounts  has  been 
recently implemented together with OECD and WHO. 

The Commission (Eurostat) already collects on a regular basis statistical data on public 
health and health and safety at work from the Member States which provide such data 
on  a  voluntary  basis.  In  addition,  it  also  collects  data  on  those  areas  through  other 
sources. Those activities are developed in close collaboration with Member States. In 
the area of public health statistics in particular, development and implementation are 
steered  and  organised  according  to  a  partnership  structure  between  Eurostat  and 
reliability,  coherence  and 
Member  States.  However,  greater  accuracy  and 
comparability,  coverage,  timeliness  and  punctuality  of  the  existing  statistical  data 
collections  are  still  needed  and  it  is  also  necessary  to  ensure  that  further  collections 
agreed and developed with the Member States are implemented in order to achieve the 
minimum  statistical  data  set  necessary  at  Community  level  in  the  areas  of  public 
health and health and safety at work. 

(10)  The  production  of  specific  Community  statistics  is  governed  by  the  rules  set  out  in 
Council  Regulation  (EC)  No  322/97  of  17  February  1997  on  Community  Statistics 
(12). 

(11)  The present Regulation ensures full respect for the right to the protection of personal 
data as provided for in Article 8 of the Charter of Fundamental Rights of the European 
Union. 

(12)  Directive No 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  (13)  and  Regulation  (EC)  No  45/2001  of  the 
European  Parliament  and  of  the  Council  of  18  December  2000  on  the  protection  of 
individuals  with  regard  to  the  processing  of  personal  data  by  the  Community 
institutions and bodies and on the free movement of such data (14) shall apply in the 

(11) 
(12) 

(13) 

(14) 

COM(2003) 650 final. 
OJ L 52, 22.2.1997, p. 61. Regulation as amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ  L  281,  23.11.1995,  p.  31.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1).  
OJ L 8, 12.1.2001, p. 1. 

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context of this Regulation. The statistical requirements to which Community action in 
the  field  of  public  health,  national  strategies  for  the  development  of  high-quality, 
accessible and sustainable health care and Community strategy on health and safety at 
work give rise, as well as requirements arising in connection with structural indicators, 
sustainable  development  indicators  and  European  Community  health  indicators  and 
other sets of indicators which it is necessary to develop for the purpose of monitoring 
Community  and  national  political actions  and  strategies  in the  areas  of  public  health 
and health and safety at work, constitute a substantial public interest.  

(13)  The transmission of data subject to statistical confidentiality is governed by the rules 
set out in Regulation (EC) No 322/97 and in Council Regulation (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  (15).  Measures 
which are taken in accordance with those Regulations ensure the physical and logical 
protection  of  confidential  data  and  ensure  that  no  unlawful  disclosure  and  non-
statistical use occur when Community statistics are produced and disseminated. 

(14) 

In the production and dissemination of Community statistics under this Regulation, the 
national and Community statistical authorities should take account of the principles set 
out in the European Statistics Code of Practice, which was adopted by the Statistical 
Programme  Committee  on  24  February  2005  and  attached  to  the  Commission 
Communication  to  the  European  Parliament  and  to  the  Council  and  promulgated  by 
the  Recommendation  of  the  Commission  of  25  May  2005  on  the  independence, 
integrity and accountability of the national and Community statistical authorities(16). 

(15)  Since  the  objectives  of  this  Regulation,  namely  the  establishment  of  a  common 
framework for the systematic 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,  the  Community  may  adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty. In accordance with the principle of proportionality, as set out in that Article, 
this  Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  that 
objective. 

(16)  The measures necessary for the implementation of this Regulation should be adopted 
in accordance with Council Decision No 1999/468/EC of 28 June 1999 laying down 
the procedures for the exercise of implementing powers conferred on the Commission 
(17). 

(17) 

In particular, the Commission should be empowered to determine definitions, subjects 
and  breakdown  (including  variables  and  classifications),  sources  whenever  relevant 
and  provision  of  data  and  metadata  (including  reference  periods,  intervals  and  time 
limits) as regards the domains referred to in Article 2 and in the Annexes 1 to 5 to this 
Regulation.  Since  these  are  measures  of  general  scope  designed  to  amend  or  delete 
non-essential  elements  of  this  Regulation,  or  to  supplement  this  Regulation  by  the 
addition of new non-essential elements, they should be adopted in accordance with the 

(15) 
(16) 

(17) 

OJ L 151, 15.6.1990, p. 1, Regulation as amended by Regulation (EC) No. 322/97. 
COM(2005)  217  final  and  Recommendation  of  the  Commission  on  the  independence,  integrity  and 
accountability of the national and Community statistical authorities.  
OJ L 184, 17.7.1999, p. 23. 

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regulatory  procedure  with  scrutiny  provided  for 
1999/468/EEC. 

in  Article  5a  of  Decision 

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HAVE ADOPTED THIS REGULATION: 

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. 

2.  The  statistics  shall  include,  in  the  form  of  a  minimum  data  set,  information  required  for 
Community  action  in  the  field  of  public  health,  for  supporting  national  strategies  for  the 
development of high-quality, 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 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” has the meaning assigned to it by the first indent of Article 2 of 
Regulation (EC) No 322/97;  

(b) “production of statistics” has the meaning assigned to it by the second indent of Article 2 
of Regulation (EC) No 322/97;  

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(c) “public health” means all elements related to the health of European citizens and residents, 
namely  their  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  access  to,  health  care  as  well  as  the  health  care  expenditure  and  financing,  and  the 
causes of mortality;  

(d) “health and safety at work” means all elements related to the prevention and protection of 
the health and safety of European Union workers at work in their current or past activities, in 
particular  accidents  at  work,  occupational  diseases  and  other  work-related  health  problems 
and illnesses.  

Article 4 

Sources 

Member  States  shall  compile  data  concerning  public  health  and  health  and  safety  at  work 
from  sources  which  shall  consist  in,  depending  on  the  domains  and  subjects  and  on  the 
characteristics of the national systems, either: 

(a) existing or planned household or similar surveys or survey modules, or 

(b) existing or planned national administrative or reporting sources. 

Article 5 

Methodology, manuals and pilot studies 

1.  The  Commission  (Eurostat)  shall  draw  up,  or  as  the  case  may  be  improve  or  update, 
manuals,  guidelines  or  recommendations  on  frameworks,  concepts  and  methodologies 
concerning the Community statistics produced pursuant to this Regulation. 

2. National experience and expertise shall be used in the development referred to in paragraph 
1.  The  methods  used  for  the  implementation  of  the  data  collections  shall  take  into 
consideration, including in the case of preparatory activities, national specificities, capacities 
and existing data collections, in the framework of collaborative structures with Member States 
set  up  by  the  Commission  (Eurostat).  The  methodologies  for  regular  data  collections  which 
result of 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. 

3. 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,  in  order  to  ensure  international  comparability  of  statistics  and 
consistency of data collections. 

4.  Whenever  new  data  requirements  or  insufficient  quality  of  data  are  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, according to the principles 

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set up by the European Statistics Code of Practice. The approaches used in such studies shall 
be agreed in the framework of collaborative structures with Member States. 

Article 6 

Transmission, treatment, dissemination and publication of data 

1.  Member  States  shall  transmit  the  microdata  or,  depending  on  the  domain  and  subject 
concerned, the aggregated data, including confidential data as defined by article 13 of Council 
Regulation  (EC)  No  322/97,  and  the  metadata,  required  by  this  Regulation  and  measures 
implementing  it,  to  the  Commission  (Eurostat)  in  accordance  with  the  existing  Community 
provisions on transmission  of  data subject to statistical  confidentiality laid down in Council 
Regulations (EC) No 322/97 and (Euratom, EEC) No 1588/90. Those Community provisions 
shall  apply  to  the  treatment  of  the  data  by  Eurostat,  in  so  far  as  the  data  are  considered 
confidential as defined by article 13 of Council Regulation (EC) No 322/97. 

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 
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. 

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  Council 
Regulation (EC) No 322/97. 

Article 7 

Quality criteria and reports 

1. The Commission (Eurostat) shall assess the quality of the data transmitted. 

2.  The  Commission  (Eurostat),  in  close  cooperation  with  Member  States,  shall  develop 
recommended common standards designed to ensure the quality and comparability of the data 
provided, according to the principles set up by the European Statistics Code of Practice. These 
standards shall be published in the methodological manuals or guidelines. 

3. Member States shall take all measures necessary to ensure the best possible quality of the 
data transmitted. 

4. Every five years Member States shall supply the Commission (Eurostat) with two reports, 
prepared in conformity with the standards referred to in paragraph 2, on the quality of the data 
transmitted and the sources of the data. The first report shall concern public health statistics 
and  the  second  health  and  safety  at  work  statistics.  Every  five  years  the  Commission 
(Eurostat) shall draw up a report on the comparability of the data disseminated. 

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Article 8 

Implementing measures 

The  measures  necessary  for  the  implementation  of  this  Regulation  shall  be  adopted  in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article  9(2).  The 
measures shall cover for the domains referred to in Article 2: 

- definitions, 

- subjects and breakdown, including variables and classifications, 

- sources whenever relevant, 

- provision of data and metadata, including reference periods, intervals and time limits. 

Article 9 

Committee 

1.  The  Commission  shall  be  assisted  by  the  Statistical  Programme  Committee  set  up  by 
Council Decision 89/382/EEC, Euratom, hereinafter referred to as “the Committee”. 

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. 

The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months. 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 10 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I  

Domain: Health status and health determinants 

(a) Aims 

The aim of this domain is the timely provision of statistics on health status and determinants. 

(b) Scope 

This domain shall be compiled mainly from population surveys or survey modules on health. 
Register  data  or  other  administrative  sources  may  also  be  used  when  providing  a 
complementary coverage and information or for some specific subjects such as morbidity or 
accidents and injuries. When relevant, persons living in institutions as well as children 0-14 
years shall be included, when appropriate subject to successful prior pilot studies. 

(c) Reference periods, intervals and time limits of data provision 

Statistics  shall  be  provided  at  least  every  five  years;  a  more  frequent  periodicity  may  be 
needed for some specific data collections such as on morbidity or accidents and injuries; the 
first reference year, the interval and the time limit of provision of the data for each source and 
subject shall be specified and agreed upon as part of the implementing measures referred to in 
article 8. 

(d) Subjects covered 

The minimum data set to be provided shall cover the following list of subjects: 

-  health  status,  including  health  perceptions,  physical  and  mental  functioning  and  disability, 
and morbidity, 

- accidents and injuries, including those related to consumer safety, 

- lifestyle and environmental, social and occupational factors, 

- access and use of preventive and curative health care facilities (population survey), 

- background demographic and socio-economic information on the individuals. 

Not  all  subjects  are  necessarily  to  be  provided  at  the  time  of  each  data  provision.  The 
variables, breakdowns and micro data required shall be drawn from the above list.  

If survey sources are used, the development of the health survey instruments and the drawing 
up of recommended characteristics and quality assessment for the survey design, sample and 
weighting, and realisation shall be carried out according to guidelines drawn up with Member 
States.  These  specifications  on  data  collected  and  surveys  used  shall  be  agreed  upon  in  the 
context of the relevant implementing measures and stated in detail in manuals and guidelines.  

(e) Metadata 

When submitting the statistical data covered by this domain, the Member States shall provide 
the required metadata to be agreed upon as part of the implementing measures (including on 

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survey characteristics) as well as information about any national specificity essential for the 
interpretation and compilation of comparable statistics and indicators. 

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ANNEX II 

Domain: Health care 

(a) Aims 

The aim of this domain is the timely provision of statistics on health care. 

(b) Scope 

This  domain  covers  the  sum  of  activities  performed  either  by  institutions  or  individuals 
pursuing,  through  the  application  of  medical,  paramedical  and  nursing  knowledge  and 
technology, the goal of health as well as related administration and management activities. 

The data shall be compiled mainly from administrative sources. 

(c) Reference periods, intervals and time limits of data provision 

Statistics shall be provided annually; the first reference year, the interval and the time limit of 
provision of the data for each source and subject shall be specified and agreed upon as part of 
the implementing measures referred to in article 8. 

(d) Subjects covered 

The minimum data set to be provided shall cover the following list of subjects: 

- health care institutions and resources, 

- health care utilisation, individual and collective services, 

- health care expenditures and financing, 

-  and  other  elements  for  supporting  national  strategies  for  the  development  of  high-quality, 
accessible and sustainable health care and long-term care. 

Not  all  subjects  are  necessarily  to  be  provided  at  the  time  of  each  data  provision.  The 
variables and breakdowns required shall be drawn from the above lists. The data set shall be 
laid down following the International Classification of Health Accounts of the OECD and the 
International  Shortlist  for  Hospital  Morbidity  Tabulation  of  the  WHO.  These  specifications 
shall be agreed upon in the context of the relevant implementing measures and stated in detail 
in manuals and guidelines.  

(e) Metadata 

When submitting the statistical data covered by this domain, the Member States shall provide 
the  required  metadata  to  be  agreed  upon  as  part  of  the  implementing  measures  (including 
sources,  definitions  and  compilations)  as  well  as  information  about  any  national  specificity 
essential for the interpretation and compilation of comparable statistics and indicators. 

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ANNEX III 

Domain: Causes of deaths 

a) Aims 

The aim of this domain is the timely provision of comparable statistics on the causes of death. 

b) Scope 

This  domain  covers  the  causes  of  death  statistics  as  derived  from  national  medical  death 
certificates taking into account WHO recommendations. The statistics to be compiled refer to 
the underlying cause which is defined by WHO as “the disease or injury which initiated the 
train  of  morbid  events  leading  directly  to  death,  or  the  circumstances  of  the  accident  or 
violence  which  produced  the  fatal  injury”.  The  statistics  shall  be  compiled  for  European 
residents and stillbirths. 

c) Reference periods, intervals and time limits of data provision 

Statistics  shall  be  provided  annually.  The  first  reference  year  shall  be  specified  and  agreed 
upon as part of the implementing measures referred to in article 8. The data shall be submitted 
by the latest in the second year following the reference year. Provisional or estimated data can 
be  provided  earlier.  In  the  case  of  public  health  incidents,  special  data  collections  may  be 
additionally established, either for all deaths or for specific causes of death. 

d) Subjects covered 

The minimum data set to be provided shall cover the following list of subjects: 

- characteristics of the deceased, 

- region, 

- characteristics of the death, including the underlying cause of death. 

The  variables  and  breakdowns  required  shall  be  drawn  from  the  above  list.  The  causes  of 
death  data  set  shall  be  laid  down  in  the  framework  of  the  International  Classification  of 
Diseases  of  WHO  and  shall  follow  the  Eurostat  rules  and  the  recommendations  of  UN  and 
WHO for population statistics. These specifications shall be agreed upon in the context of the 
relevant implementing measures and stated in detail in manuals and guidelines. 

e) Metadata 

When submitting the statistical data covered by this domain, the Member States shall provide 
the  required  metadata  to  be  agreed  upon  as  part  of  the  implementing  measures  as  well  as 
information about any national specificity essential for the interpretation and compilation of 
comparable statistics and indicators. 

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ANNEX IV 

Domain: Accidents at work 

a) Aims 

The aim of this domain is the timely provision of statistics on accidents at work. 

b) Scope 

An accident at work is defined as “a discrete occurrence in the course of work which leads to 
physical  or  mental  harm”.  The  data  shall  be  collected,  for  the  entire  workforce,  for  fatal 
accidents at work and accidents at work resulting in more than 3 days of absence from work, 
using administrative sources complemented with relevant additional sources. A limited subset 
of basic data on accidents with less than 4 day’s absence may be collected, when available, in 
the framework of the collaboration with ILO. 

c) Reference periods, intervals and time limits of data provision 

Statistics  shall  be  provided  annually.  The  first  reference  year  shall  be  specified  and  agreed 
upon as part of the implementing measures referred to in article 8. The data shall be submitted 
by  the  latest  in  June  the  second  year  following  the  reference  year.  Provisional  data  can  be 
submitted earlier. 

d) Subjects covered 

The minimum micro data set to be provided shall cover the following list of subjects: 

- characteristics of the injured person and the injury, 

- characteristics of the enterprise and workplace, 

- characteristics of the working environment, 

-  characteristics  of  the  accident,  including  the  sequence  of  events  characterising  the  causes 
and circumstances of the accident. 

The  variables  and  breakdowns  required,  as  well  as  their  related  options  and  sample 
weightings, shall be drawn from the above list in the framework of the ESAW methodology. 
They shall be agreed upon in the context of the relevant implementing measures and stated in 
detail in manuals and guidelines. 

e) Metadata 

When submitting the statistical data covered by this domain, the Member states shall provide 
the required metadata regarding population covered by the statistics, the declaration rates for 
the  accidents  at  work  defined  in  b)  and,  when  relevant,  sample  characteristics,  as  well  as 
information about any national specificity essential for the interpretation and compilation of 
comparable statistics and indicators. 

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Domain: Occupational diseases and other work-related health problems and illnesses 

ANNEX V 

a) Aims 

The  aim  of  this  domain  is  the  timely  provision  of  statistics  on  recognised  cases  of 
occupational disease and other work-related health problems and illnesses. 

b) Scope 

A  case  of  occupational  disease  is  defined  as  a  case  recognised  by  the  national  authorities 
responsible for recognition of occupational diseases. The data shall be collected for incident 
occupational diseases and deaths due to occupational disease. A case of work-related health 
problem and illness does not necessarily refer to recognition by an authority and the related 
data shall be collected mainly from population surveys. 

c) Reference periods, intervals and time limits of data provision 

For occupational diseases, statistics shall be provided annually and submitted by the latest in 
the  first  quarter  of  the  second  year  following  the  reference  year.  The  reference  periods, 
intervals and the time limits of provision of the other data collections shall be specified and 
agreed upon with Member States. 

d) Subjects covered 

The minimum data set to be provided shall cover the following list of subjects: 

- characteristics of the diseased person and the disease or health-related problems, 

- characteristics of the enterprise and workplace, 

- characteristics of the causative agent or factor. 

Not  all  subjects  are  necessarily  to  be  provided  at  the  time  of  each  data  provision.  The 
variables and breakdowns required shall be drawn from the above list and agreed upon with 
Member States. 

e) Metadata 

When submitting the statistical data covered by this domain, the Member states shall provide 
the  required  metadata  regarding  population  covered  by  the  statistics,  as  well  as  information 
about any national specificity essential for the interpretation and compilation of comparable 
statistics and indicators. 

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