Common Position (EC) No 26/2008 of 2 October 2008 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to 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 (Text with EEA relevance)
Date: 2008-10-02
Institutions: Council of the European Union
Subjects: EU statistics, occupational health, occupational safety, public health

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III

(Preparatory Acts)

COUNCIL

COMMON POSITION (EC) No 26/2008

adopted by the Connsil on 2 October 2008

with a view to adopting Regulation (EC) No …/2008 of the European Parliament and of the Council
… on Community statistics on public health and health and safety at work

(Text with EEA relevance)

(2008/C 280 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

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

Having regard to the proposal from the Commission,

and of the Council of 23 October 2007 establishing a
second programme of Community action in the field of
health (2008-13) (4) indicated that its objective of gener-
ating and disseminating health information and know-
ledge would be pursued by actions to develop further a
sustainable health monitoring system with mechanisms
for collection of comparable data and information, with
appropriate indicators, and to develop, with the Com-
munity Statistical Programme, the statistical element of
this system.

Having regard to the opinion of the European Economic and
Social Committee (1),

(2)

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

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

(1)

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) (3), stated that the statistical element
of the information system on public health was to be
developed in collaboration with Member States using, as
the Community Statistical Programme to
necessary,
duplication.
and
promote
Decision No 1350/2007/EC of the European Parliament

synergy

avoid

(1) OJ C 44, 16.2.2008, p. 103.
(2) Opinion of the European Parliament of 13 November 2007 (not yet
published in the Official Journal), Council Common Position of 2
October 2008 and Position of the European Parliament of … (not yet
published in the Official Journal).

(3) OJ L 271, 9.10.2002, p. 1. Decision repealed by Decision

No 1350/2007/EC.

(3)

Council Resolution of 3 June 2002 on a new Community
strategy on health and safety at work (2002-2006) (5)
called on the Commission and the Member States to step
up work in hand on harmonisation of statistics on acci-
dents at work and occupational illnesses, so as to have
available comparable data from which to make an objec-
tive assessment of the impact and effectiveness of the
measures taken under the new Community strategy, as
well as emphasised, in a specific section, the need to take
into account the increase in the proportion of women

(4) OJ L 301, 20.11.2007, p. 3.
(5) OJ C 161, 5.7.2002, p. 1.

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on the labour market and to respond to their specific
needs in relation to policies on health and safety at work.
In addition, in its Resolution of 25 June 2007 on a new
Community strategy on health and safety at work (2007-
2012) (1) the Council called on the Commission to coop-
erate with the legislative authorities in establishing an
appropriate European statistical system in the area of
occupational safety and health, which takes account of
the different national systems and avoids imposing addi-
tional administrative burdens. Finally, in its Recommen-
dation of 19 September 2003 concerning the European
schedule of occupational diseases (2),
the Commission
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 the system of harmonising European
statistics on occupational diseases.

of

15

Council

European

Barcelona

The
and
16 March 2002 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 of 20 April 2004
entitled ‘Modernising social protection for the develop-
ment of high-quality, accessible and sustainable health
care and long-term care: support for the national strate-
gies using the 'open method of coordination'’, proposed
starting work to identify possible indicators for joint
objectives for developing care systems on the basis of
activities undertaken in the context of the Community
action programme for health, of Eurostat's health statis-
tics and of cooperation with international organisations.
In establishing such indicators, specific attention should
be devoted to the use and comparability of self-assessed
health as reported in surveys.

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 (3)
includes an action on environment and health and
quality of life as a key environmental priority, calling for
the definition and development of indicators of health
and environment. In addition, the Council Conclusions
on Structural Indicators 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 Euro-
pean Council; health and safety at work indicators are
also included in this database, under the title ‘employ-
ment’. The set of sustainable development
indicators
adopted by the Commission in 2005 also contains a
theme on public health indicators.

(4)

(5)

(1) OJ C 145, 30.6.2007, p. 1.
(2) OJ L 238, 25.9.2003, p. 28.
(3) OJ L 242, 10.9.2002, p. 1.

(6)

(7)

(8)

(9)

The Environment and Health Action Plan 2004-2010
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 Com-
munity Statistical Programme.

Council Resolution of 15 July 2003 on promoting the
employment and social integration of people with disabil-
ities (4) 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 entitled
‘Equal
disabilities:
A European Action Plan’, 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 par-
ticular
through development of harmonised survey
modules, to acquire the internationally comparable statis-
tical information needed for monitoring progress.

people with

opportunities

for

In order to ensure relevance and comparability of the
data and avoid duplication of work, the statistical activ-
ities of the Commission (Eurostat) in the area of public
health and health and safety at work should be carried
in cooperation with the United Nations and its
out
special organisations, such as the World Health Organisa-
tion (WHO) and the International Labour Organisation
(ILO), as well as the Organisation for Economic Coopera-
(OECD), when relevant and
tion and Development
possible.

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. 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, develop-
ment and implementation are steered and organised
according to a partnership structure between the
Commission (Eurostat) and Member States. However,
greater accuracy and reliability, coherence and compar-
the
ability,
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
in the areas of public
necessary at Community level
health and health and safety at work.

timeliness and punctuality of

coverage,

(4) OJ C 175, 24.7.2003, p. 1.

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(10)

(11)

specific Community statistics

The production of
is
governed by the rules set out in Council Regulation (EC)
No 322/97 of 17 February 1997 on Community Statis-
tics (1).

This 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 (2).

(12) 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 (3) and Regu-
lation (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 (4) apply in the 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 gives rise, as well as require-
ments arising in connection with structural
indicators,
sustainable development indicators and ECHI 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 confidenti-
ality 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 (5). 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 Com-
munity statistical authorities should take account of the
principles set out in the European Statistics Code of Prac-
tice, which was adopted by the Statistical Programme
Committee on 24 February 2005.

(15)

Since the objective of this Regulation, namely the estab-
lishment 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.

Recognising that the organisation and management of
health care systems are matters of national competence
and that the implementation of Community legislation
on workplaces and labour conditions is primarily the
responsibility of Member States, this Regulation ensures
full respect for Member States' competence for public
health and health and safety at work.

It is important that gender and age be included in the
breakdown variables as this allows the impact of gender
and age differences on health and safety at work to be
taken into account.

The measures necessary for the implementation of this
adopted in accordance with
Regulation should be
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (6).

In particular, the Commission should be empowered to
adopt the implementing measures covering characteristics
of certain subjects and their breakdown, the reference
periods,
intervals and time limits for data provision as
well as provision of metadata. Since those measures are
of general scope and are designed to amend non-essential
elements of this Regulation, inter alia by supplementing
it with new non-essential elements, they must be adopted
in accordance with the regulatory procedure with scru-
tiny provided for in Article 5a of Decision 1999/468/EC.

Complementary financing for the collection of data in
the fields of public health and health and safety at work
are to be provided respectively within the frameworks of
the second programme of Community action in the field
of health (2008-13) and of the Community Programme
for Employment and Social Solidarity — Progress (7).
Within those frameworks, financial resources should be
used to help Member States in further building up
national capacities to implement improvements and new
tools for statistical data collection in the fields of public
health and health and safety at work.

(16)

(17)

(18)

(19)

(20)

(1) OJ L 52, 22.2.1997, p. 1.
(2) OJ C 303, 14.12.2007, p. 1.
(3) OJ L 281, 23.11.1995, p. 31.
(4) OJ L 8, 12.1.2001, p. 1.
(5) OJ L 151, 15.6.1990, p. 1.

(6) OJ L 184, 17.7.1999, p. 23.
(7) Decision No 1672/2006/EC of the European Parliament and of the
Council of 24 October 2006 establishing a Community Programme for
Employment and Social Solidarity — Progress (OJ L 315, 15.11.2006,
p. 1).

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(21)

(22)

The European Data Protection Supervisor has been
consulted.

The Statistical Programme Committee has been consulted
in accordance with Article 3(1) of Decision 89/382/EEC,
Euratom (1),

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation establishes a common framework for the
1.
systematic production of Community statistics on public health
and health and safety at work. The statistics shall be produced
in compliance with standards on impartiality, reliability, objec-
tivity, cost-effectiveness and statistical confidentiality.

The statistics shall include, in the form of a harmonised
2.
and common data set,
information required for Community
action in the field of public health, for supporting national stra-
tegies for the development of high-quality, universally accessible
and sustainable health care as well as for Community action in
the field of health and safety at work.

3.
The statistics shall provide data for structural indicators,
sustainable development indicators and European Community
Health Indicators (ECHI), as well as for the other sets of indica-
tors which it is necessary to develop for the purpose of moni-
toring 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) statis-
tics on the following domains:

— health status and health determinants, as defined in Annex I,

— health care, as defined in Annex II,

— causes of death, as defined in Annex III,

— accidents at work, as defined in Annex IV,

— occupational

diseases

and

other work-related health

problems and illnesses, as defined in Annex V.

Article 3

Definitions

For the purpose of this Regulation:

(a) ‘Community statistics’ shall have the meaning assigned to it
by the first indent of Article 2 of Regulation (EC) No 322/
97;

(1) Council Decision 89/382/EEC, Euratom of 19 June 1989 establishing a
Committee on the Statistical Programmes of the European Commu-
nities (OJ L 181, 28.6.1989, p. 47).

(b) ‘production of statistics’ shall have the meaning assigned to
it by the second indent of Article 2 of Regulation (EC)
No 322/97;

(c) ‘public health’ shall mean all elements related to health,
namely health status, including morbidity and disability, the
determinants having an effect on that health status, health
care needs, resources allocated to health care, the provision
of, and universal access to, health care as well as health care
expenditure and financing, and the causes of mortality;

(d) ‘health and safety at work’ shall mean all elements related to
the prevention and protection of the health and safety of
workers at work in their current or past activities, in particu-
lar accidents at work, occupational diseases and other work-
related health problems and illnesses;

(e) ‘microdata’ shall mean individual statistical records;

(f) ‘transmission of confidential data’ shall mean transmission
between national authorities and the Community authority
of confidential data which do not permit direct identifica-
tion,
in accordance with Article 14 of Regulation (EC)
No 322/97 and with Regulation (Euratom, EEC) No 1588/
90;

(g) ‘personal data’ shall mean any information relating to an
identified or identifiable natural person, in accordance with
the Article 2(a) of Directive 95/46/EC.

Article 4

Sources

Member States shall compile data concerning public health and
health and safety at work from sources which shall, depending
on the domains and subjects and on the characteristics of the
national systems, consist of either household or similar surveys
or survey modules, or national administrative or reporting
sources.

Article 5

Methodology

1.
The methods used for the implementation of the data
collections shall take into consideration, including in the case of
preparatory activities, national experience and expertise, and
national specificities, capacities and existing data collections, in
the framework of the collaborative networks and other Euro-
pean Statistical System (ESS) structures with Member States set
up by the Commission (Eurostat). The methodologies
for
regular data collections which result from projects with a statis-
other Community
tical
out
programmes
research
programmes shall also be taken into consideration.

the public health or

dimension

such as

carried

under

the

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2.
The statistical methodologies and data collections to be
developed for the compilation of statistics on public health and
health and safety at work at Community level shall take into
consideration the need for coordination, whenever relevant,
with the activities of international organisations in the field,
with a view to ensuring international comparability of statistics
and consistency of data collections as well as avoiding duplica-
tion of effort and of deliveries of data by Member States.

Article 6

Pilot studies and cost-benefit analyses

1. Whenever data are required in addition to those already
collected and to those for which methodologies already exist, or
when insufficient quality of data is identified in the domains
referred to in Article 2, the Commission (Eurostat) shall institute
pilot studies to be completed on a voluntary basis by the
Member States. The purpose of such pilot studies shall be to test
the concepts and methods and to assess the feasibility of the
related data collections,
including statistical quality, compar-
ability and cost effectiveness, in accordance with the principles
set up by the European Statistics Code of Practice.

2. Whenever preparation of an implementing measure is
envisaged in accordance with the regulatory procedure with
scrutiny referred to in Article 10(2), a cost-benefit analysis,
taking into account the benefits of the availability of the data in
relation to the cost of the data collection and the burden on
Member States, shall be carried out.

The Commission (Eurostat) shall prepare a report evalu-
3.
ating the findings of
the pilot studies and/or cost benefit
analysis, including the effects and implications of national speci-
ficities, in cooperation with Member States, in the framework of
the collaborative networks and other ESS structures.

Article 7

Transmission, treatment and dissemination of data

1. When necessary for the production of Community statis-
tics, Member States shall transmit the confidential microdata or,
depending on the domain and subject concerned, the aggregated
data, in accordance with the provisions on transmission of data
subject to confidentiality set out in Regulation (EC) No 322/97
and in Regulation (Euratom, EEC) No 1588/90. Those provi-
sions shall apply to the treatment of the data by the Commis-
sion (Eurostat), in so far as the data are considered confidential
within the meaning of Article 13 of Regulation (EC) No 322/
97. Member States shall ensure that the transmitted data do not
permit the direct identification of the statistical units (indivi-
duals) and that personal data are protected in compliance with
the principles laid down in Directive 95/46/EC.

2. Member States shall
required by this Regulation in electronic form,

the data and metadata
in accordance

transmit

with an interchange standard agreed between the Commission
(Eurostat) and the Member States. The data shall be provided in
accordance with the time limits set out, at the intervals provided
for, and in respect of the reference periods indicated in the
Annexes or in the implementing measures adopted in accord-
ance with the regulatory procedure with scrutiny referred to in
Article 10(2).

3.
The Commission (Eurostat) shall take the necessary steps
to improve the dissemination, accessibility and documentation
of the statistical information, in accordance with the principles
of comparability, reliability and statistical confidentiality laid
down in Regulation (EC) No 322/97 and with Regulation (EC)
No 45/2001.

Article 8

Quality assessment

1.
For the purpose of this Regulation, the following quality
assessment dimensions shall apply to the data to be transmitted:

(a) ‘relevance’ shall refer to the degree to which statistics meet

the current and potential needs of users;

(b) ‘accuracy’ shall refer to the closeness of estimates to the

unknown true values;

(c) ‘timeliness’ shall refer to the time lag between the availability
the information and the event or phenomenon it

of
describes;

(d) ‘punctuality’ shall refer to the time lag between the date of
the release of the data and the target date when it should
have been delivered;

(e) ‘accessibility’ and ‘clarity’ shall refer to the conditions and
modalities by which users can obtain, use and interpret data;

(f) ‘comparability’ shall refer to the measurement of the impact
of differences in applied statistical concepts and measure-
ment tools and procedures when statistics are compared
between geographical areas, sectoral domains or over time;

(g) ‘coherence’ shall refer to the adequacy of the data to be reli-

ably combined in different ways and for various uses.

Every five years each Member State shall provide the
2.
Commission (Eurostat) with a report on the quality of the data
transmitted. The Commission (Eurostat) shall assess the quality
of data transmitted and publish the reports.

Article 9

Implementing measures

1.

The implementing measures shall cover:

(a) the characteristics, namely variables, definitions and classifi-

cations of the subjects, covered in Annexes I to V;

(b) the breakdown of characteristics;

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(c) the reference periods,

intervals and time limits for data

provision;

(d) the provision of metadata.

These measures shall take account of, in particular, the provi-
sions of Article 5, Article 6(2) and (3) and Article 7(1), as well
as the availability, suitability and the legal context of existing
Community data sources after examination of all sources related
to the respective domains and subjects.

These measures designed to amend non-essential elements of
this Regulation, inter alia, by supplementing it, shall be adopted
in accordance with the regulatory procedure with scrutiny
referred to in Article 10(2).

If necessary, derogations

2.
for
Member States, both to be based upon objective grounds, shall
be adopted in accordance with the regulatory procedure referred
to in Article 10(3).

and transition periods

Article 10

Committee

The Commission shall be assisted by the Statistical
set up by Decision 89/382/EEC,

1.
Programme Committee
Euratom.

2. Where reference is made to this paragraph, Articles 5a(1)
to (4) and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

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

Article 11

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

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 provision of statistics on health status and determinants.

(b) Scope

This domain covers the statistics on health status and health determinants that are based on self-assessment and
compiled from population surveys such as the European Health Interview Survey (EHIS), as well as other statistics
compiled from administrative sources such as those on morbidity or accidents and injuries. Persons living in institu-
tions as well as children aged 0-14 years shall be included, when appropriate and at the relevant ad hoc intervals,
subject to successful prior pilot studies.

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

Statistics shall be provided every five years from the EHIS; a different frequency may be needed for other data collec-
tions, such as those on morbidity or accidents and injuries, as well as for some specific survey modules; the measures
relating to the first reference year, the interval and the time limit for provision of the data shall be adopted in accord-
ance with the regulatory procedure with scrutiny referred to in Article 10(2).

(d) Subjects covered

The harmonised and common data set to be provided shall cover the following list of subjects:

— health status, including health perceptions, physical and mental functioning, limitations and disability,

— diagnosis-specific morbidity,

— protection against possible pandemics and transmissible diseases,

— accidents and injuries, including those related to consumer safety, and, whenever possible, alcohol- and drug-

related harm,

— lifestyle, such as physical activity, diet, smoking, alcohol consumption and drug-use, and environmental, social and

occupational factors,

— access and use of preventive and curative health care facilities, as well as of long-term care services (population

survey),

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

Not all subjects are necessarily to be covered at the time of each data provision. The measures relating to the charac-
teristics, namely variables, definitions and classifications of the subjects listed above, and the breakdown of characteris-
tics, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

The implementation of Health Examination Surveys shall be optional
in the framework of this Regulation. The
average length of the interview per household shall not exceed one hour for the EHIS and 20 minutes for the other
survey modules.

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning characteristics of surveys and
other sources used, population covered and information about any national specificity essential for the interpretation
and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 10(2).

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ANNEX II

DOMAIN: HEALTH CARE

(a) Aims

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

(b) Scope

This domain covers the sum of activities performed either by institutions or individuals pursuing, through the applica-
tion of medical, paramedical and nursing knowledge and technology, the goal of health, including long-term care, as
well as related administration and management activities.

The data shall be compiled mainly from administrative sources.

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

Statistics shall be provided annually. The measures relating to the first reference year, the interval and the time limit
for provision of the data shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 10(2).

(d) Subjects covered

The harmonised and common data set to be provided shall cover the following list of subjects:

— health care facilities,

— health care human resources,

— health care utilisation, individual and collective services,

— health care expenditure and financing.

Not all subjects are necessarily to be covered at the time of each data provision. The data set shall be established
following the relevant international classifications and taking into consideration the circumstances and practices in
Member States.

The mobility of patients, namely their use of health care facilities in a country other than their country of residence,
and of health professionals, such as those practising their profession outside the country where they obtained their
first licence, shall be considered in the data collections. The quality of health care shall also be considered in the data
collection.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed
above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning characteristics of sources and
compilations used, population covered and information about any national specificity essential for the interpretation
and compilation of comparable statistics and indicators, shall be adopted in accordance with the regulatory procedure
with scrutiny referred to in Article 10(2).

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ANNEX III

DOMAIN: CAUSES OF DEATH

(a) Aims

The aim of this domain is the provision of 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 circum-
stances of the accident or violence which produced the fatal injury’. The statistics shall be compiled for all deaths and
stillbirths occurring in each Member State, distinguishing residents and non-residents. Whenever possible, data on
causes of death for residents dying abroad shall be included in the statistics of their country of residence.

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

Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than
24 months after the end of the reference year. Provisional or estimated data can be provided earlier. In the case of
public-health incidents, additional special data collections may be established, either for all deaths or for specific
causes of death.

(d) Subjects covered

The harmonised and common 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 causes of death data set shall be established in the framework of the WHO International Classification of Diseases
and shall follow the Eurostat rules and the UN and WHO recommendations for population statistics. The provision of
data relating to the characteristics of stillbirths shall be on a voluntary basis. 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 measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed
above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered and informa-
tion about any national specificity essential for the interpretation and compilation of comparable statistics and indica-
tors, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

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ANNEX IV

DOMAIN: ACCIDENTS AT WORK

(a) Aims

The aim of this domain is the 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 three days of absence from work, using administrative sources complemented with relevant additional
sources whenever necessary and feasible for specific groups of workers or specific national situations. A limited subset
of basic data on accidents with less than four days of absence may be collected, when available and on an optional
basis, in the framework of the collaboration with the ILO.

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

Statistics shall be provided annually. The measures relating to the first reference year shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in Article 10(2). The data shall be submitted no later than
18 months after the end of the reference year.

(d) Subjects covered

The harmonised and common microdata set to be provided shall cover the following list of subjects:

— characteristics of the injured person,

— characteristics of the injury, including severity (days lost),

— characteristics of the enterprise including economic activity,

— characteristics of the workplace,

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

accident.

The accidents-at-work data set shall be established in the framework of the specifications laid down by the European
Statistics on Accidents at Work (ESAW) methodology, taking into consideration the circumstances and practices in
Member States.

The provision of data relating to the nationality of the injured person, the size of the enterprise and the time of the
accident shall be on a voluntary basis. Concerning the ESAW-methodology Phase III subjects, namely the workplace
and the sequence of events characterising the causes and circumstances of the accident, a minimum of three variables
shall be provided. Member States should also supply more data conforming to the ESAW Phase III specifications on a
voluntary basis.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed
above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered, the declara-
tion rates for accidents at work and, when relevant, sampling characteristics, as well as information about any national
specificity essential for the interpretation and compilation of comparable statistics and indicators, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

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ANNEX V

DOMAIN: OCCUPATIONAL DISEASES AND OTHER WORK-RELATED HEALTH PROBLEMS AND ILLNESSES

(a) Aims

The aim of this domain is the 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 recogni-
tion of occupational diseases. The data shall be collected for incident occupational diseases and deaths due to occu-
pational disease.

— Work-related health problems and illnesses are those health problems and illnesses which can be caused, worsened
or jointly caused by working conditions. This includes physical and psychosocial health problems. 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 from existing population surveys such as the European Health Interview Survey (EHIS) or other
social surveys.

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

For occupational diseases, statistics shall be provided annually and submitted no later than 15 months after the end of
the reference year. The measures relating to the reference periods, the intervals and the time limits for provision of the
other data collections shall be adopted in accordance with the regulatory procedure with scrutiny referred to in
Article 10(2).

(d) Subjects covered

The harmonised and common data set to be provided for occupational diseases shall cover the following list of
subjects:

— characteristics of the diseased person, including gender and age,

— characteristics of the disease, including severity,

— characteristics of the enterprise and workplace, including economic activity,

— characteristics of the causative agent or factor.

The occupational diseases data set shall be established in the framework of the specifications laid down by the Euro-
pean Occupational Diseases Statistics (EODS) methodology, taking into consideration the circumstances and practices
in Member States.

The harmonised and common data set to be provided for work-related health problems shall cover the following list
of subjects:

— characteristics of the person suffering the health problem, including gender, age and employment status,

— characteristics of the work-related health problem, including severity,

— characteristics of the enterprise and workplace, including size and economic activity,

— characteristics of the agent or factor that caused the health problem or made it worse.

Not all subjects are necessarily to be covered at the time of each data provision.

The measures relating to the characteristics, namely variables, definitions and classifications of the subjects listed
above, and the breakdown of characteristics, shall be adopted in accordance with the regulatory procedure with scru-
tiny referred to in Article 10(2).

(e) Metadata

The measures relating to the provision of metadata, including metadata concerning population covered and informa-
tion about any national specificity essential for the interpretation and compilation of comparable statistics and indica-
tors, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 10(2).

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 7 February 2007, the Commission adopted its proposal (1) for a new regulation on Community
statistics on public health and health and safety at work, based on Article 285(1) of the Treaty estab-
lishing the European Community.

2. The European Parliament adopted its first-reading opinion (2) on 13 November 2007.

3. The European Data Protection Supervisor gave his opinion on 5 September 2007 (3) and the Euro-

pean Economic and Social Committee gave its opinion on 25 October 2007 (4).

4. The Council adopted its common position on 2 October 2008 pursuant to Article 251 of the Treaty.

II. OBJECTIVE

1. The objective of the regulation is to establish a framework for the systematic production of Com-

munity statistics in two areas:

(i) public health; and

(ii) health and safety at work.

2. The statistics should take the form of a harmonised and common data set and would be produced by
the European Statistical System (i.e. Eurostat together with the national statistical institutes and all
other national authorities responsible for the provision of official statistics in these areas).

3. The draft Regulation focuses exclusively on statistical activities developed under Article 285 of the
Treaty. It is not concerned with policy developments for the two above mentioned areas, which fall
under Articles 152 and 137 of the Treaty.

III. ANALYSIS OF THE COMMON POSITION

(a) General

1. In its Plenary vote on 13 November 2007, the European Parliament adopted twelve first-reading
amendments. The Council's common position incorporates ten of them entirely and one partly.
It includes in particular the amendments made to the Commission's original proposal, which aim
at
including gender and age in the breakdown variables in order to obtain information
concerning any gender and age differences with regard to public health and health and safety at
work.

2. Only one amendment (Amendment 8) concerning the inclusion of the tracking of any disease
whose incidence is increasing or decreasing in the list of subjects covered was not taken into
account as the Council considered, like the Commission, that a change in incidence of a disease
was by definition an important aspect of the analysis and dissemination of morbidity data and
could not form a separate subject.

3. The common position also contains a number of substantive amendments other than those
contained in the European Parliament's first-reading opinion. Drafting changes have also been
made to render the text more precise or ensure consistency throughout the regulation.

4. The Commission has accepted the common position agreed by the Council.

(1) OJ C 138, 22.6.2007, p. 9.
(2) European Parliament opinion of 13 November 2007 (not yet published in the Official Journal).
(3) OJ C 295, 7.12.2007, p. 1.
(4) OJ C 44, 16.2.2008, p. 103.

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(b) European Parliament amendments

1. The Council incorporated the following eleven amendments into the common position:

Recitals

Amendments l (in full) and 2 (last part) concerning the inclusions of gender and age in the break-
down variables in the two areas covered by the regulation (public health and health and safety at
work) have been added in order to obtain information concerning any gender and age differences
in these two areas.

Amendment 3 (in full) has been accepted with a view to help Member States to build up capacity
to introduce new tools for collecting statistical data using additional and complementary financial
resources provided by the Community programmes in the two areas covered by the regulation.

Articles

Amendment 4 (in full) has been incorporated into the common position in order to lay down
the conditions and standards governing the production of Community statistics.

Amendments 5 (in full) and 6 (in full) have been included to emphasise the importance of data
collection for supporting national strategies to guarantee universal access to public health services
in the Member States.

Account has been taken of Amendment 7 (in substance — to be read in conjunction with Article
9(1)) on the coordination of Community statistical activities with those of other international
organisations, in order to limit the burden on Member States. The Council has adopted a more
general approach without listing all the international or European organisations active in the
fields covered by the Regulation. A reference to the sources of existing Community data is made
in Article 9.

Annexes

Amendments 11 (in full) and 12 (in full) have been added to include protection against possible
pandemics and transmissible diseases and alcohol- and drug-related harm among the subjects
covered by the ‘Health status and health determinants’ domain.

Amendment 9 (in full) concerning the scope of the ‘Occupational diseases and other work-related
health problems and illnesses’ domain (Annex V) has been taken into consideration in order to
cover both physical and mental and social illnesses and problems caused, worsened or jointly
caused by the working environment.

Amendment 10 (in full) has been accepted to include gender, age and employment status of the
person and the size and economic activity of the enterprise among the subjects covered by
Annex V.

(c) Other changes made by the Council

The other major changes introduced by the common position relate to:

— a new recital 16 concerning full respect for national competence for public health and health

and safety at work;

— Article 5 that has been split into two articles (5 and 6) to better define the different stages of the

development of methodology, pilot studies and cost-benefit analyses;

— inclusion of a reference to Regulation (EC) No 1588/90 in Article 3 to increase the protection of

confidential data transmitted between national authorities and the Community authority;

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— inclusion of a reference to Regulation (EC) No 45/2001 in Article 7 in order to clearly establish
the obligations of the Commission (Eurostat) towards individuals and to protect personal statis-
tical information;

— Article 8 which now includes quality assessment of the data to be transmitted;

— more precise details in the annexes concerning intervals and time limits for data provision and

the subjects covered.

IV. CONCLUSION

1. The Council considers that its common position is a balanced and realistic response to a number of
concerns expressed by Member States in relation to the Commission proposal, while taking account
of the European Parliament's opinion to a considerable extent.

2. The Council looks forward to confirmation of the European Parliament's agreement to this common

position at the earliest opportunity so that the regulation can be adopted rapidly.