Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's Common Position regarding the proposal for a Decision of the European Parliament and of the Council adopting a programme of Community action in the field of public health amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2002-01-23
Institutions: European Commission
Subjects: EU programme, action programme, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 23.1.2002
COM(2002) 29 final

2000/0119 (COD)

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendments
to the Council's Common Position regarding the
proposal for a

DECISION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

adopting a programme of Community action in the field of public health

AMENDING THE PROPOSAL OF THE COMMISSION
pursuant to Article 250 (2) of the EC Treaty

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty,
on the European Parliament's amendments
to the Council's Common Position regarding the
proposal for a

DECISION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
adopting a programme of Community action in the field of public health

1.

INTRODUCTION

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is
to deliver an opinion on the amendments proposed by the European Parliament at second
reading. The Commission sets out its opinion below on the 50 amendments adopted by
Parliament.

2.

BACKGROUND

On 15 June 2000, the Commission submitted to the Council and to the European Parliament a
proposal based on Article 152 of the EC Treaty for a Decision of the European Parliament and
of the Council adopting a programme of Community action in the field of public health –
COM(2000)285 final of 16 May 2000 – COD 2000/0119.

The Economic and Social Committee and the Committee of the Regions delivered their
opinions on 20 November and 14 December 2000 respectively.

On 4 April 2001, the European Parliament delivered a first opinion on the Commission
proposal and adopted a report with 110 amendments.

On 1 June 2001, having examined the amendments proposed by the European Parliament, the
Commission adopted a modified proposal in accordance with Article 250 of the EC Treaty.

At its meeting on 31 July 2001, the Council adopted its Common Position in accordance with
Article 251 of the EC Treaty.

The Commission delivered its opinion on the Common Position on 14 August 2001.

On 12 December 2001, the European Parliament adopted its second reading legislative
resolution, including 50 amendments to the Common Position of the Council.

2

3.

OBJECTIVE OF THE COMMISSION’S PROPOSAL

The proposal is for a decision of the European Parliament and of the Council on a programme
of Community action in the field of public health. It forms part of the European Community's
Health Strategy, as set out in the Commission's communication of 16 May 2000. The
proposed programme takes a horizontal and policy-driven approach. It focuses on three
strands of action:

1.

Improving health information and knowledge

A comprehensive health information system will be put in place which will provide
policy makers, health professionals and the general public with the key health data
and information that they need.

2.

Responding rapidly to health threats

An effective rapid response capability will be created to deal with threats to public
health, for example, arising from communicable diseases.

3.

Addressing health determinants

The programme will help to improve the health status of the population and reduce
premature deaths in the EU by tackling the determinants of health through health
promotion and disease prevention measures.

4.

OPINION OF THE COMMISSION ON THE AMENDMENTS BY THE EUROPEAN
PARLIAMENT

As the second reading report of the European Parliament is based on the Common
Position, the Commission amends its proposal also on the basis of the Common
Position.

Moreover, the Commission is also taking the opportunity to

• put forward a revised financial sheet for the programme which takes account of
the changes introduced by the Council and the European Parliament, especially in
regard to putting in place appropriate structural arrangements to ensuring effective
co-ordination and monitoring; and

• make a technical modification to clarify in Annex 4.1 of the Common Position
that Community assistance can be provided to support the activities referred to in
Article 3, and not just those described in Article 3.2.(a) which concern only the
monitoring and rapid reaction systems.

In the following paragraphs detailed comments are given on each of the amendments.

3

4.1.

Amendments fully accepted by the Commission

• Amendment n° 11 on Recital 15b (new) underlines the importance of education, training
and networking. Such a contribution could be of value to support co-operation between
Member States, and the amendment can therefore be accepted.

• Amendment n° 4 on Recital 10. This amendment underlines the need for effective public
health monitoring at Community level and thus reinforces the need to set up a health
monitoring system. It can thus be accepted by the Commission.

• Amendment n° 5 on Recital 10a refers to the need to co-ordinate actions taken by the
Community and the Member States and to promote co-operation between Member States.
This is acceptable as such co-ordination and co-operation are necessary for effective public
health activities at Community level.

• Amendment n° 8 on Recital 13 refers to the necessity to ensure the effectiveness and
cohesion of measures and actions through ‘appropriate structural arrangements’. Such
arrangements are needed to strengthen the Commission’s capacities to implement and co-
ordinate actions under the programme. The amendment is therefore acceptable.

• Amendment n° 12 on Recital 16 refers to the link to be established with "all Community
policies having an impact on health", and Amendment n° 40 on Article 11a (new) refers to
co-operation with other Community bodies, especially those responsible for food and feed
safety, environmental protection and product safety. These amendments are acceptable in
the framework of developing an integrated, intersectoral strategy.

• Amendment n° 14 on Recital 18 mentions the impact of transnational factors on health
systems and adds environmental pollution and food contamination to examples of threats
of a cross-border nature. These are factual considerations, and the amendment is acceptable
to the Commission.

• Amendment n° 15 on Recital 20a (new) refers to the comparability and compatibility of
data as well as to the interoperability of systems. This amendment is acceptable, as these
characteristics are appropriate to a comprehensive European health information system.

• Amendment n° 16 on Recital 21a (new) refers to the 2000 Feira European Council which
endorsed the eEurope 2002 Action Plan. This is acceptable, since it underlines the need for
further action in this field which has been identified as a priority in the Annex to the
Common Position.

• Amendment n° 17 on Recital 22 refers to the need to develop gender-specific statistics.
This is a useful specification and thus acceptable for the Commission, but the text of this
amendment should be added to Recital 10 on the processing of data.

• Amendment n° 19 on Recital 28 calls for the budget of the programme to be in accordance
with the needs of the programme. This is acceptable since the resources for the
implementation of the programme should be adequate for the objectives to be pursued. For
the same reason the Commission can accept Amendment n° 20 on Recital 30, which calls
for a fair allocation of the budget between the three objectives of the programme.

4

• Amendment n° 21 on Recital 30a (new) underlines the importance of "practical measures"
in order to attain the objectives of the programme. This corresponds to the approach being
taken which stresses the need to achieve concrete results and outcomes. This amendment is
therefore acceptable to the Commission.

• Amendment n° 22 on Recital 37 mentions that the programme must build upon the work of
the network for epidemiological surveillance and control of communicable diseases in the
Community. This network will continue to pursue its activities on the basis of Decision N°
2119/98/EC which will continue in force. The amendment is therefore acceptable to the
Commission insofar as it clarifies that the work of this network must be taken into account.

• Amendment n° 24 on Article 2 (2), which puts an emphasis on health determinants and n°
33 on Article 3.2. (db) (new), which mentions activities of non-profit, non-governmental
European organisations,
incorporate useful clarifications, and are acceptable to the
Commission.

• Amendment n° 38 on Article 8.1(e) deletes the provision in the Common Position for the
Programme Committee to be consulted on ‘the arrangements for the preparation of any
structural arrangements’. This
the
establishment of the structural arrangements is the responsibility of the Commission in the
context of the exercise of its executive powers under the Treaty.

is acceptable since the preparatory work for

• Amendment n° 39 on Article 11 adds the W.T.O. and FAO to the list of international
organisations with which co-operation shall be encouraged. This is acceptable to the
Commission, since both bodies deal with issues having an impact on health.

• Amendment n° 45 on Annex 1.7b calls for a joint action to improve information on
medicines available on the Internet and for considering possibilities for a system of
Community seals of approval for Internet sites. Developing these activities at Community
level is a useful way to contribute to the co-operation between Member States for the
provision of sound information for the Community population, as underlined in the
Common Position. The Commission can therefore accept this amendment.

• Amendment n° 47 on Annex 2.3 refers to developing a vaccination and immunisation
strategy. The Commission accepts
strengthening the overall
Community strategy on public health, particularly in support of Member States’ actions in
preparedness and alert mechanisms.

this amendment as

• Amendment n° 48 on Annex 2.3a (new) covers health threats caused by unforeseen events,
including terrorist acts. The Commission welcomes this in the context of the strengthening
of the Community rapid response capability.

• Amendment n° 51 on Annex 3.1.adds physical activity to the list of life-style determinants
of health. Amendment n° 53 on Annex 3.3. strengthens activities on social and economic
health determinants by focussing on inequalities in access to health and on the assessment
of the impact of social and economic factors. These additions reinforce the action to be
taken on health determinants and are therefore acceptable.

• Amendment n° 60 on Annex 2.6a (new) refers to the development of strategies for
reducing antibiotic resistance. The Commission accepts this amendment as strengthening

5

the overall Community public health strategy in an area of particular concern to all
Member States.

4.2.

Amendments partly accepted by the Commission

• Amendment n° 1 on Recital 2a (new) refers to health as a priority – not a "marketable"
commodity – and to the role of the Community. This statement of principle concerning the
market falls outside the scope of the programme. The amendment should be reworded as:
“Health should be a priority beyond political or financial compromises. Under Article 152
of the Treaty the Community is required to play an active role in this sector by taking
measures which cannot be taken by individual states, in accordance with the principle of
subsidiarity.”

• Amendment n° 3 on Recital 9a says that the programme should contribute to establishing
quality standards in the field of public health and patients' rights, such as data protection
and non-discrimination. This amendment can only be accepted without
the second
sentence. This refers to standards governing patients rights, and there are not such
generally accepted standards. Moreover such a concept would go beyond the scope of the
programme.

• Amendment n° 18 on Recital 22a (new) puts emphasis on experiences acquired in the field
of public health and from applicable charters. This is acceptable with a general reference to
making use of experience already gained: “The experience acquired from different
charters in the field of public in health should be taken into account.”

• Amendment no 26 on Article 3. 1. sets out in detail activities to be taken under the three
strands of the programme. The part dealing with the Community capacity to counter health
threats from various sources, including terrorist acts, is fully acceptable, but this should be
part of Annex 2.3.a, combined with Amendment n° 48. The third indent of the ‘a’ part
dealing with people’s right to be informed about health questions is also acceptable, but it
should be added to Annex 1.3. and reworded as “promoting the right of people to have
sound information on health”. The other parts of this amendment are not acceptable
because they essentially duplicate actions, whose operational part
is described in the
Annex, or activities enumerated in Article 3.2.

• Amendments n° 29 on Article 3.2.d) (4) and 55 on Annex 3.5 a (new) concern promoting
education and training activities in the field of public health. This addition is acceptable,
but it should be reworded to take into account the subsidiarity principle: “Encouraging
education and vocational training in the field of public health.”

• Amendment n° 31 on Article 3.2. (d) (ba) (new) refers to the definition of good practice
and sound guidelines for health. This part of the amendment is acceptable as it lends
support to Member States’ activities in this field. However the second part of this
amendment concerning quality guidelines for medicine based on scientific data cannot be
accepted by the Commission, since this concerns other policies or programmes.

• Amendment n° 32 on Article 3.2. (da) (new) refers to the promotion of an integrated health
strategy by creating links between the public health framework and other policies and
establishing criteria and methodologies for health impact assessment. The first part of this
amendment
is
acceptable but should be incorporated in Article 4 “ ---the objectives of the programme

is not acceptable, since it duplicates Article 2. 3(a). The second part

6

may be implemented as joint strategies and joint actions to create links ---- ” The third part
is unacceptable as it duplicates Annex 1.5.

• Amendment n° 54 on Annex 3.3. focuses on environmental pollution. The amendment is
acceptable subject to some rewording to clarify the scope of action to be taken under the
programme, such as, “Analysing the situation and developing strategies on health
determinants related to the environment and contributing to the identification and
assessment of the health consequences of environmental problems.”

4.3.

Amendments rejected by the Commission

There are 17 amendments that the Commission can not accept: 6, 7, 9, 10, 23, 27, 28, 34, 35,
36, 41, 43, 46, 50, 52, 56 and 57.

• Amendments n° 6 on recital 11, 34 on Article 5.2 and 57 on Annex 4.3.a (new) state that
the Commission shall, within one year, take the preparatory measures to put in place
structural measures. Amendments 34 and 57 require the Commission in addition to set up a
co-ordinating centre. These three amendments are not acceptable to the Commission. A
provision concerning the creation of a specific centre cannot be included in a Decision
establishing an action programme. Moreover it is up to the Commission to determine its
own internal structure and the timing of any measures in conformity with Article 218 of
the EC Treaty.

• Amendment n° 7 on recital 11a(new)

introduces new objectives for the structural
arrangements, which go beyond the scope of the co-ordination of activities foreseen. It is
therefore not acceptable to the Commission.

• Amendments n° 9 on recital 13a(new), calling for the consultation of NGOs through health
fora; n° 10 on recital 15a (new) which mentions the three general objectives of the
programme; and n° 28 on Article 3.2(d)(1) which refers to the need to break down data by
gender, age, geographical location and income bracket are not acceptable as they duplicate
existing provisions of the Common Position (recital 17, Article 2.2, and Annex 1.1. and
1.7.). For the same reason, the Commission cannot accept the following amendments: n°
23 on Article 2(1) which introduces a number of detailed objectives into the operational
part of the programme, duplicating parts of recitals 1, 9 and 15 of the Common Position; n°
35 on Article 5(4) a (new) on the protection of personal data, which duplicates part of
recital 23; and Amendment n° 43 on Annex 1.5. on the impact of the development of an
integrated and intersectoral health strategy which duplicates parts of recital 16 and Articles
2 and 3.

• Amendment n° 27 on Article 3.2.b refers to the development and implementation of health
promotion and disease prevention in all Community policies involving ("as appropriate"
deleted) NGOs, national organisations, institutions and activities. The Commission cannot
accept this amendment. It duplicates parts of Articles 2.3 (a) and 4. Moreover, it removes
the necessary flexibility in the choice of the most relevant partners for actions.

€

• Amendment n° 36 on Article 7.1. sets the financial framework for the implementation of
the programme at
380 million, with each specific objective receiving a minimum of 25%
of the budget. This amendment is unacceptable to the Commission. The imposition of a
percentage to be spent on each objective removes the flexibility necessary for the
programme. With regard to the total budget, the Commission maintains its proposal of
€
in view of the need to ensure adequate resources for the

300 million. However,

7

appropriate structural arrangements,
requested by the Council and the European
Parliament, the Commission is presenting a revised financial sheet, with an increase in
expenditure for technical and administrative assistance.

• Amendment n° 41 on Article 12.1. is not acceptable to the Commission, since to report
annually to the European Parliament on the implementation of the actions goes beyond the
comitology requirements.

• Amendment n° 46 on Annex 2.2a(new) refers to informing the public in Member States
and accession countries on communicable diseases,
in particular resistant pathogens;
Amendment n° 50 on Annex 2.6a introduces activities to assist applicant countries, e.g. by
educating doctors; and Amendment n° 52 on Annex 3.1a(new) refers to campaigns to
improve diet and eating habits. These amendments all raise subsidiarity issues and are not
acceptable to the Commission.

• Amendment n° 56 on Annex 4.1.5 sets limits concerning the financial implementation of
the programme. This is unacceptable since these restrictions would undermine the
flexibility necessary to implement the programme.

5.

CONCLUSION

The Commission is in favour of 33 amendments (9 in part) to the Common Position, out of
the 50 voted by the European Parliament.

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out
above.

8

LEGISLATIVE FINANCIAL STATEMENT

Policy area: Public Health

Activity: PROGRAMME OF COMMUNITY ACTION

TITLE OF ACTION: PROPOSAL FOR A DECISION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL ADOPTING A PROGRAMME OF COMMUNITY ACTION IN THE FIELD OF PUBLIC HEALTH

1.

BUDGET LINE(S) + HEADING(S)

2.

2.1.

2.2.

B3-4308 and B3-4308A

OVERALL FIGURES

Total allocation for action (Part B): 300

€

million for commitment

Period of application:

2002-2007

2.3.

Overall multi-annual estimate on expenditure:

The figures shown are indicative. The actual amounts will be set in the annual
budgetary procedures.

a)

Schedule
commitment
intervention) (see point 6.1.1)

of

appropriations/payment

appropriations

(financial

Commitments

Year
2002
44.774

n + 1

n + 2

n + 3

n + 4

n + 5 and
subs.
years

Total

45.472

45.370

45.470

45.688

45.664

272.438

Payments

38.281

20.135

45.441

45.400

45.535

77.646

272.438

b)

Technical and administrative assistance and support expenditure (see point 6.1.2)

Commitments

1.562

4.740

4.840

5.340

5.540

5.540

27.562

Payments

1.625

1.833

4.780

5.040

5. 420

8.864

27.562

Subtotal a+b

Commitments

46.336

50.212

50.210

50.810

51.228

51.204

300.000

Payments

39.906

21.968

50.221

50.440

50.955

86.510

300.000

9

c)

Overall financial impact of human resources and other administrative expenditure
(see points 7.2 and 7.3)

Commitments

9.906

10.129

10.240

10.352

10.574

10.797

61.998

Payments

9.906

10.129

10.240

10.352

10.574

10.797

61.998

TOTAL a+b+c

Commitments

Payments

56.242

60.341

60.450

61.162

61.802

62.001

361.998

49.812

32.097

60.461

60.792

61.529

97.307

361.998

2.4.

Compatibility with the financial programming and the financial perspective
(cid:1)

Proposal compatible with the existing financial programming

(cid:2)

This proposal will entail reprogramming of the relevant heading in the

financial perspective
(cid:2)

This may entail application of

Agreement.

the provisions of

the Inter-institutional

2.5.

Financial impact on revenue:
(cid:1)

No financial implications (involves technical aspects regarding implementation of

a measure)

OR
(cid:2)

Financial impact – the effect on revenue is as follows:

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
participation

Participation
applicant
countries

Heading
Financial
Perspective

Non-comp

Diff/

NO

YES

YES (1)

3

(1) Under the new framework set out in COM (99) 710, Candidate country (CC) participation
in the programme is subject to a memorandum of understanding determining the terms and
conditions for participation. The Commission will negotiate such a memorandum with each
CC wishing to participate in the programme.

4.

LEGAL BASIS :

Art. 152 of the Treaty establishing the European Community

10

5.

DESCRIPTION AND GROUNDS

5.1.

Need for Community intervention

5.1.1. Objectives pursued

The objective of the decision is to establish a programme of action, the overall aim of which
is to make a contribution towards the attainment of a high level of health protection by
directing action towards improving public health, preventing human illness and diseases and
obviating sources of danger to health.

The general objectives of the programme are:

• To improve information and knowledge for the development of public health

• To enhance the capability to respond rapidly and in a co-ordinated fashion to threats to

health

• To promote health and prevent disease through action on health determinants and across all

policies and activities

5.1.2. Measures taken in connection with ex ante evaluation

The ex ante evaluation was conducted in February/March 2000 by the evaluation cellule of
DG Health and Consumer Protection, supported by two independent consultants. The
evaluation report examined the existing eight programmes and the four mid-term evaluations
carried out so as to assess the modifications and recommendations proposed in the evaluations
and their links to the new programme. Finally, it examined the new draft programme and
other documentation connected with it. Following the ex ante evaluation the proposal was
substantially modified to make more explicit that the lessons learned from past interventions
and approaches had been taken into account, and to respond to the need that had been
identified in the evaluation to define more precisely the main priorities; to ensure that the way
that the programme resources were divided up clearly matched the actions and objectives; and
to strengthen planning and control mechanisms.

5.1.3. Measures taken following monitoring and evaluation

As is set out in Article 12 of the Common Position, in order to ensure the effectiveness of the
programme there will be regular monitoring of its implementation in light of the objectives,
and annual reports will be made to the Committee. After four years there will also be an
external assessment of the programme by independentexperts. It will be possible to adjust or
modify the programme’s priority in the light of the monitoring and of developments that may
take place in the general context of Community action in health and health-related fields.

5.2.

Actions envisaged and arrangements for budget intervention

The 18 action areas are set out in Table 6.1.1. The actions will be pursued by means of a
range of specific activities which will give rise to quantifiable outputs. These include setting
up and operating networks; operation of structural arrangements; development of innovative
or pilot projects; support for preparation of legislative instruments; development of tools for
health impact assessment; preparation of reports,
reviews and analyses; operation of
consultation fora; and development of machinery for dissemination of information.

11

Financial support shall be given to those activities, as set out in the annex to the programme
decision.

The Common Position of the Council and the amendments of the European Parliament both
add to the actions originally proposed for the programme in pursuit of the objectives. In
particular they specify that in view of the need to ensure that there is a properly co-ordinated
EU response, especially in regard to monitoring of health and responding rapidly to health
threats, a significant amount of the efforts of the programme must be put into the co-
ordination of the activities to be undertaken by the Community and the Member States.

The programme must therefore ensure appropriate sustainable co-ordination of the actions to
be taken. In the area of health monitoring this encompasses activities in relation to the
following: definition of information needs, development of indicators, collection of data and
information, comparability issues, exchange of data and information with and between
Member States, continuing development of databases, analyses, and wider dissemination of
information. Quantifiable outputs will be produced, in relation for example to provision of
improved information on the health status of the overall EU population, as well as specific
analyses by population group; health determinants, including the principal social, economic
and environmental determinants; and health policies being pursued in key areas.

In the area of rapid reaction to health threats, such co-ordination should be ensured in respect
of activities in relation to epidemiological surveillance, development of surveillance methods,
exchange of information on guidelines and on prevention and control actions, mechanisms
and procedures. Quantifiable outputs will concern for example common investigations,
training,
the Community network on the
epidemiological
surveillance and control of communicable diseases), exchanges of
information, and operation of vigilance networks…

and quality assurance

assessment

(for

The requirement for effective EU coordination has been reinforced by the conclusions of the
European Council in Göteborg on 15-16 June 2001 on the need to undertake urgent action to
establish an EU response capacity which can react rapidly to health threats, and the
declaration by Heads of State and Government at Ghent on 19 October 2001 on health threats
from the deliberate use of biological, chemical and other means. In this context,
the
Commission committed itself to put in place by 2005 an appropriately financed and effective
in order to analyse and provide scientific guidance on actions to be taken at
facility,
Community level.

Appropriate structural arrangements will therefore be established to ensure the effectiveness
and cohesion of measures and actions of the programme as well as the promotion of co-
operation between the Member States. The structural arrangements to be used will be those
that have been set out
in the context of the Commission’s externalisation initiative
(Communication of 13 December 2000, COM (2000) 788 final).

These latter arrangements cover two kinds of functions.

Administrative and financial tasks

Technical and administrative assistance relating to ancillary tasks (such as collection of data
on project
implementation) and preparatory work (such as preparation of contracts). It
concerns mainly the gathering and processing of factual information, following clear criteria
and methods set out by the Commission and with well-defined results, (such as targets and
specific deliverables) to ensure that there is no use of discretionary powers.

12

Scientific/Technical support

A technical role to support the implementation of the programme and provision of specialised
expertise to the Commission services in relation to identifying and assessing health problems
and developing and refining specific actions in response; monitoring of Community actions;
and assisting in the co-ordination function, for example, concerning the work of networks.

A cost-effectiveness assessment of externalising certain elements of the public health
programme will be used to support possible decisions. This assessment will involve external
consultants chosen by call for tender.

5.2.1.

Arrangements for budget
assistance):

intervention (rate and form of

the required financial

–

–

–

grants to finance projects (including partnerships) intended to help achieve an
objective of the programme with other financing sources in the public and/or private
sector. Grants will be provided to public or private bodies (such as NGOs or
academic institutions) for the implementation of projects proposed in areas under the
programme which produce a real added value for the European Community, such as
the development of innovative approaches for tackling specific health determinants.

operating grants for representative organisations in the health field working at EU
level and pursuing an objective of general European interest, according to criteria set
up in the framework of the programme’s management procedure. The awarding of
these grants will be more limited, and provided in conformity with the financial
regulation.

contracts following calls for tenders. Projects proposed by the various organisations
in the health field must be complemented by initiatives precisely defined and directly
monitored by the Commission, in particular in the field of health monitoring and
rapid reaction to health threats. Appropriate technical specifications will be defined
to buy specific services.

These arrangements for budget intervention and the externalisation of tasks will be done in
accordance with the relevant provisions of the financial regulation applicable to the general
budget of the European Communities.

5.3.

Methods of implementation

Direct management by the Commission using either permanent or temporary staff and by
externalisation which includes several possibilities (outsourcing to private sector, delegating
to national public bodies and executive agencies). The arrangements envisaged for this
externalisation are in the first instance outsourcing of technical and administrative assistance
to private law entities.

This delegation of part of the management of the public health programme will exclude tasks
involving the exercise of discretionary powers or those appropriate to a public authority. It
will make use of specialised staff for implementing work programmes, undertaking analyses
and studies and executing support activities while keeping political orientations, decisions and
control within the Commission services.

The profiles of the specialist staff to be used include epidemiologists, microbiologists, public
health specialists, rapid reaction specialists, IT specialists and social scientists.

13

In the medium-term, once the necessary legal base is available, the aim is to set up an
executive agency in charge of the co-ordination and integration of networks for health
monitoring and rapid response to health threats (Common Position Art. 5.2).

Structural arrangements require a certain capacity to carry out tasks effectively. The necessary
resources will be made available for them out of the total budget for the programme. The
Commission has made an estimation of the tasks required and corresponding resources
needed. This is set out in table 6.1.2. The initial assessment shows that the global cost
required could be of the order of
15.3 Million over the period of the programme. A study
using outside consultants is being launched to refine this calculation.

€

The funding for establishing and operating these structural arrangements, initially by way of
outsourcing of technical and administrative assistance, will necessarily mean some reduction
in the amount available for spending on the operational budget. Therefore the Commission
has had to reconsider the amount to be spent on each of the three strands of the programme. In
doing so, the Commission has taken into account the need to ensure that:

- there is a fair distribution of the budget between the strands;

- an appropriate response is given to the requests of the European Council to strengthen
actions in regard to communicable diseases and health threats;

- the wishes of EP and Council concerning the prioritisation of actions under the programme
are reflected

14

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - (over the entire programming period)

6.1.1.

Financial intervention

EUR million (at current prices)

Year

N

n+1

n+2

N+3

n+4

n+5

Total

1. Improving health information

13.600

17.000

22.176

22.176

22.176

22.082

119.210

and knowledge

1.1.Developing and operating a

7.500

10.600

13.000

13.000

13.000

12.985

70.085

sustainable health
monitoring system

1.2. Developing an information
system on health threats

1.200

1.400

2.600

2.600

2.600

2.585

12.985

1.3. System for transfer and

0.600

0.820

1.170

1.170

1.170

1.155

6.085

sharing of data

1.4. Developing and using

1.400

1.300

1.960

1.960

1.960

1.945

10.525

mechanisms for analysis,
advice, reporting,
information and
consultation on health issues

1.5. Analysis of impact of

1.500

1.576

2.006

2.006

2.006

1.992

11.086

health policy developments
and assessment of health
impact of other policies

1.6. Review and analysis of
health technologies

1.7. Exchange of information
and experience on good
practice

0.700

0.640

0.720

0.720

0.720

0.710

4.210

0.700

0.640

0.720

0.720

0.720

0.710

4.210

2. Responding rapidly to health

18.314

19.000

13.662

13.662

13.760

13.830

92.228

threats

2.1 Enhancing the capacity to
tackle communicable
diseases by supporting the
development of the
Community network on
communicable diseases

8.770

9.536

6.966

6.966

6.966

6.966

46.170

2.2. Supporting the network’s

2.000

1.742

1.742

1.742

1.742

1.742

10.710

operation

15

Year

N

n+1

n+2

N+3

n+4

n+5

Total

4.044

4.518

1.700

1.700

1.718

1.728

15.408

2.3. Strategies and mechanisms
for non-communicable
disease threats, including
rare diseases and threats
arising from unforeseen
events, including terrorist
acts

2.4. Enhance the safety and

2.000

1.742

1.792

1.792

1.792

1.792

10.910

quality of and organs and
substances of human origin
including blood

2.5. Implementing vigilance
networks for human
products

2.6. Protection of health from
environmental agents, and
strategies for reducing
antibiotic resistance

3. Addressing health
determinants

1.000

0.802

0.802

0.802

0.802

0.802

5.010

0.500

0.660

0.660

0.660

0.740

0.800

4.020

12.860

9.472

9.532

9.632

9.752

9.752

61.000

3.1 Lifestyle-related health

8.860

6.946

6.946

6.946

6.946

6.946

43.590

determinants, including age
and gender-specific
strategies on areas such as
Nutrition, Tobacco,
Alcohol, Drug dependence,
Mental health, Sexual
behaviour, Physical activity

3.2 Socio-economic
determinants, and health
inequalities

2.000

0.968

0.968

1.088

1.208

1.208

7.440

3.3. Health determinants related

1.160

0.746

0.756

0.756

0.756

0.756

4.930

to the environment

3.4. Genetic determinants

0.500

0.472

0.522

0.502

0.502

0.502

3.000

3.5. Methods to evaluate health
promotion actions and
approaches

0.340

0.340

0.340

0.340

0.340

0.340

2.040

Total

44.774

45.472

45.370

45.470

45.688

45.664

272.438

The figures given below are indicative. They provide estimates for the level of expenditure
corresponding to the different areas of the programme. The actual amounts will be determined
in accordance with the outcome of the annual budgetary procedures.

16

6.1.2.

Technical and administrative assistance, support expenditure and IT expenditure
(Commitment appropriations)

Commitments in

€

million

Year N

N + 1

N + 2

N + 3

N + 4

Total

N + 5 and
subs.
years

1) Technical and
administrative assistance

a) Technical assistance
offices

b) Other technical and
administrative assistance:

- extra muros :

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

c) Information and
publications

0.460

0.560

0.542

Subtotal 2

1.562

TOTAL 1.562

2.6

2.7

3.2

3.4

3.4

15.3

0.65

0.75

0.74

2.14

4.74

0.65

0.75

0.74

2.14

4.84

0.65

0.75

0.74

2.14

5.34

0.65

0.75

0.74

2.14

5.54

0.65

0.75

0.74

2.14

5.54

3.71

4.31

4.242

12.262

27.562

6.2.

Calculation of costs by measure envisaged in Part B (over the entire
programming period)

Details concerning calculation of costs by measures over the entire period will be defined in
the light of the annual work plans to be adopted under the programme, which will specify for
each of the 18 actions described in table 6.1 the type of outputs, and an estimation of their
number.

The Common Position (see Article 8) 1.a)) explicitly foresees that the annual plan of work
shall be adopted in accordance with the management procedure, “setting out priorities and
actions to be undertaken, including allocation of resources”.

To assist the programme Committee in giving its opinion on the annual work plans and
measures to be taken, the Commission services are developing a number of planning tools to
be used for the implementation of the programme. These will help to set each year’s work
plan in the context of the development of the work of the programme as a whole, and show
how individual activities link with other to constitute the programme’s actions and enable the
overall objectives to be reached.

The tools include:

- for each strand of action, identification of concrete outputs to be achieved, a) by the time of
the initial evaluation of the programme after four years and b) by the end of the programme;

17

-
-
-
-
-
-
-
- for each strand of action, a series of milestones to be reached during the period of
implementation, with indicative dates for achievement. These may include specific networks
to be established, step by step development of the structural arrangements, relevant legislative
instruments, etc; and

- an instrument to manage actions, timetabling and financial planning.

On the basis of these tools, detailed proposals will be drawn up for specific activities under
the actions of the programme for each year, including costs and recommended financial
means which will be incorporated in the annual work programmes to be considered by the
Committee.

A schedule of the indicative costs for each of the 18 actions of the programme by year is
given in table 6.1.1.

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

- 2002

Types of post

Staff to be assigned to management of the
action using existing and/or additional
resources

Number of permanent
posts

Number of
temporary
posts

Description of tasks deriving
from the action

Total

2002

2002

2002

Permanent
officials
Temporary staff

or

A

B

C

Other human resources
(END + AUX)

Total

38
8

20

66

4
4
-

10A/12C

30

42
12
20

22

96

See note 1) below

.

1) - policy conception, formulation and development, including establishment of annual work
technical
implementation,
programmes- policy and budget
specifications, approval of applications for funding, selection of contractors
- policy evaluation in conformity with the legal base

including definition of

18

- 2003 – 2007

The following table indicates changes foreseen in resources in the subsequent years of the
programme.

Increase of permanent staff

2003

2004

2005

2006

2007

Permanent
officials

+1A
+ 1C

+ 1B

+ 1A

+1A
+ 1B

+ 1A
+1C

Other human
resources

Total
permanent staff

Idem 2002

Idem 2002

Idem 2002

Idem 2002

Idem 2002

68

69

70

72

74

These indicative changes are based on an initial assessment of the potential resource
implications of the programme over the first four years. In addition, there will be a mid –term
evaluation which inter alia will look at resource aspects (cf Article 12 of the Common
Position). The entry of candidate countries into the EU will also need to be reflected in the
resources available for the programme in its later years.

Overall financial impact of human resources (2002)
€

Type of human resources

Amount

Method of calculation *

7.2.

Officials

Temporary staff

Other human resources

7 128 000

108 000

864 000

108 000

€

€

X 66

X 8

430 000

504 000

Total

8 926 000

43 000

42 000

€

€

X 10

X 12

* The amounts are total expenditure for twelve months. For years n+(x) : [(increase of
permanent staff x 108 800) + 8 926 000] (see table 7.4)

19

7.3.

Other administrative expenditure deriving from the action

Budget line

(number and heading)

€

Amount

Method of calculation *

Missions: - average costs of: 286.45/month/human
resources

Compulsory Committees: -programme Committee (art.9)

- Committee set up by decision n°98/2119/EC (on the
communicable diseases network)

- Committee set ut by decision n°96/469/EC (on cancer
prevention)

(3 X 2 meetings a year X 15 X 800) = 72 000

Non compulsory Committees (6 Working groups of the
programme Committee)

(6 X 2 meetings a year X 15 X 800) = 144 000

Meetings (experts groups): 14 000

Conferences: 2 X 150 000 on actions defined on
priorities in Annual Work plans.

Initial estimation of the needs over the 6 years of the
programme. This estimation will be refined on an annual
basis in light of priorities and needs. This takes account
of the need for the development and improvement of
systems for the internal management of data and web
sites in support of administration. It is separate from the
actions under
financing the
programme and information systems covered by IDA.
Concrete needs will be justified during each PDB
exercise.

the operational

line

Overall allocation (Title A7)

A0701 – Missions

A07030 – Meetings
A07031 – Compulsory committees (1)
A07032 – Non-compulsory committees(1)

A07040 – Conferences

A0705 – Studies and consultations

… Other expenditure (state which)

A07070 Information systems

330 000

230 000

300 000

120 000

Other expenditure - Part A (state which)

Total

980 000

amounts

* The
n+(x) :
- Missions : [increase of permanent staff x (330 000 / total staff) + 330 000] see table 7.4
- Meetings/Conferences/Information systems : The indicative amounts are stable.

twelve months. For

expenditure

years

total

are

for

20

7.4.

Total cost of action for the 6 years (EUR million)

EUR million

n

n+1

n+2

n+3

n+4

n+5

Total
cost of
action

HUMAN
RESOURCES
(see table 7.1)

Annual total
Financial impact of
human resources

Other
Administrative
expenditure
deriving from the
action

TOTAL

96

(+2
permanent
staff)

(+1
permanent
staff)

(+1
permanent
staff)

(+2
permanent
staff)

(+2
permanent
staff)

8.926

9.142

9.250

9.358

9.574

9.790

56.040

0.980

0.987

0.990

0.994

1.000

1.007

5.958

9.906

10.129

10.240

10.352

10.574

10.797

61.998

The need for human and administrative resources will be covered within the allocation
granted to the managing dg in the framework of the annual allocation procedures.

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

Adequate follow-up information will be collected, from the outset of each action, on the
inputs, outputs and results of the intervention. In practice this means i.) Identification of
indicators for inputs, outputs and results ii.) Putting in place methods for the collection of
data. See point 8.2.

8.2.

Arrangements and schedule for the planned evaluation

Performance indicators selected

*output indicators (measurement of resources employed and efficiency)

The programme provides for annual work plans which will determine quantifiable
deliverables, and on-going monitoring of actions will be undertaken. Relevant indicators will
include reports and analyses undertaken, development of guidelines and establishment of
together with up-take and multiplier effects in Member States by
effective networks,
competent authorities and local groups and associations.

*impact indicators (measurement of performance against objectives)

21

The impact and performance of the programme, including effectiveness against objectives of
the actions, will be subject to detailed evaluation arrangement, using direct, i.e. health-related
indicators and indirect measurements (e.g. setting up and proper operation of mechanisms and
procedures for health monitoring and rapid response).

Specific indicators will be included in the contractual framework to be developed for
outsourcing arrangements.

To facilitate the evaluation process, measurable quantitative and qualitative benchmarks are
being identified for the three strands of the programme. These will be finalised before the
programme comes into effect so that they are available for the development of the annual
the assessments and the
work plans and the establishment of the monitoring process,
evaluations foreseen in Article 12. 1 and 12. 3 of the Common Position.

In addition these benchmarks will be used in relation to the submission of information by the
Member States to the Commission on the implementation and impact of the programme (see
Art 12. 2 of the Common Position).

Details and frequency of planned evaluations

The Commission will have an external assessment of the implementation and achievements
during the four first years of the programme. It will also assess the impact achieved on health
and the efficiency of the use of resources, as well as consistency and complementarity with
other Community programmes and initiatives. The Commission will communicate these
conclusions with its comments, to the European Parliament, the Council, the Economic and
Social Committee and the Committee of the Regions. The Commission will also submit to
them a final report on the implementation of the programme. The evaluation reports will be
made publicly available.

Assessment of the results obtained (where the operation is to be continued or renewed)

In the light of the evaluations mentioned above, the Commission may propose an extension of
the programme, if appropriate.

9.

ANTI-FRAUD MEASURES

All proposals for subsidies will be assessed for technical content and financial criteria which
include adequacy of own resources, sound finances and financial management, past record of
performance or reliability as regards the capability of fulfilling the terms of subsidy,
relationship between partners in a given project and potential for effective accounting and
control. These also apply in cases of service contracts. Specific rules governing the
characteristics and monitoring of outsourcing contracts will be implemented, following the
Commission guide and model contract.

Requests for final payment must be accompanied by an evaluation of the operational and
financial status of the project concerned.

All measures will take account of Article 3(4) of the financial regulation, as well as SANCO
international audit recommendations, in conformity with the International Control Standards
of the Commission, including the UCLAF «Guide to testing for vulnerability to fraud » of
18.4.1997.

22

– Specific control measures envisaged

Checks in situ will be carried out using appropriate selection criteria (scale of subsidy, interim
report, results of on-going monitoring, information on progress with the execution of the
relevant work-plan). In cases of service contracts, the Commission will regularly monitor that
the contractors comply with the rules laid down in the contracts. In cases where there are
reasons to believe that the performance of a project that has received a subsidy, or that of a
service contract, is seriously being compromised, an urgent check will be carried out and, if
there are remaining suspicions, the service concerned will refer the matter to the relevant audit
services and the Anti-Fraud Office.

23