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                                                          COMMON POSITION (EC) No 5/2007

                                                        adopted by the Council on 22 March 2007

                    with a view to adopting Decision No .../2007/EC of the European Parliament and of the Council

                        of ... establishing a second programme of Community action in the field of health (2007-2013)

 

                                                                    (Text with EEA relevance)

 

                                                                       (2007/C 103 E/02)

 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-                                        public health. It is therefore appropriate to establish a

PEAN UNION,                                                                                 second programme of Community action on health

                                                                                            (2007-2013) (hereinafter referred to as `the Programme').

Having regard to the Treaty establishing the European Com-

munity, and in particular Article 152 thereof,

 

Having regard to the proposal from the Commission,

 

Having regard to the opinion of the European Economic and

Social Committee (1),

                                                                                   (5)      A number of serious cross-border health threats with a

Having regard to the opinion of the Committee of the                                        possible world-wide dimension exist and new ones are

Regions (2),                                                                                emerging which require further Community action. The

                                                                                            Community should treat serious cross-border health

Acting in accordance with the procedure laid down in                                        threats as a matter of priority. The Programme should

Article 251 of the Treaty (3),                                                              place emphasis on strengthening the Community's

                                                                                            overall capacities by further developing cooperation

Whereas:                                                                                    between the Member States. Monitoring, early warning

                                                                                            and action to combat serious threats to health are impor-

(1)        The Community can contribute to protecting the health                            tant areas where an effective and coordinated response to

           and safety of citizens through actions in the field of                           health threats should be promoted at Community level.

           public health. A high level of health protection should be                       Action to ensure high-quality-diagnostic cooperation

           ensured in the definition and implementation of all Com-                         between laboratories is essential in order to respond to

           munity policies and activities. Under Article 152 of the                         health threats. The Programme should encourage the

           Treaty, the Community is required to play an active role                         establishment of a system of Community reference

           by taking measures which cannot be taken by individual                           laboratories. However, such a system needs to be based

           Member States, in accordance with the principle of subsi-                        on a sound legal base.

           diarity. The Community fully respects the responsibilities

           of the Member States for the organisation and delivery of

           health services and medical care.

 

(2)        The health sector is characterised on the one hand by its

           considerable potential for growth, innovation and dyna-

           mism, and on the other by the challenges it faces in

           terms of financial and social sustainability and efficiency             (6)      According to the World Health Organisation (WHO)

           of the health care systems due, among other things, to                           European Health report 2005, in terms of Disability

           ageing of the population and to medical advances.                                Adjusted Life-Years (DALYs), the most important causes

                                                                                            of the burden of disease in the WHO European Region

(3)        The programme of Community action in the field of                                are non-communicable diseases (NCDs - 77 % of the

           public health (2003-2008), adopted by Decision No 1786/                          total), external causes of injury and poisoning (14 %) and

           2002/EC of the European Parliament and of the                                    communicable diseases (9 %). Seven leading conditions

           Council (4), was the first integrated Community                                  - ischaemic heart disease, unipolar depressive disorders,

           programme in this field, and it has already delivered a                          cerebrovascular disease, alcohol use disorders, chronic

           number of important developments and improvements.                               pulmonary disease, lung cancer and road traffic injuries

                                                                                            - account for 34 % of the DALYs in the Region. Seven

(4)        Continued effort is required in order to meet the objec-                         leading risk factors - tobacco, alcohol, high blood pres-

           tives already established by the Community in the field of                       sure, high cholesterol, overweight, low fruit and vegetable

                                                                                            intake and physical inactivity - account for 60 % of

                                                                                            DALYs. In addition, communicable diseases such as

(1) OJ C 88, 11.4.2006, p. 1.

(2) OJ C 192, 16.8.2006, p. 8.                                                              HIV/AIDS, influenza, tuberculosis and malaria are also

(3) Opinion of the European Parliament of 16 March 2006 (OJ C 291 E,                        becoming a threat to the health of all people in Europe.

       30.11.2006, p. 372), Council Common Position of 22 March 2007                        An important task of the Programme, in cooperation,

       and Position of the European Parliament of ... (not yet published in the             where appropriate, with the Community Statistical

       Official Journal).

(4) OJ L 271, 9.10.2002, p. 1. Decision as amended by Decision No                           Programme, should be to identify better the main health

       786/2004/EC (OJ L 138, 30.4.2004, p. 7).                                             burdens in the Community.

 


 

 

C 103E/12                  EN                        Official Journal of the European Union                                           8.5.2007

 

(7)        Eight leading causes of mortality and morbidity from            (13)    Special efforts should be undertaken to ensure coherence

           NCDs in the WHO European Region are cardiovascular                      and synergies between the Programme and the Commu-

           diseases, neuropsychiatric disorders, cancer, digestive                 nity's external actions, particularly in the areas of avian

           diseases, respiratory diseases, sense organ disorders,                  influenza, HIV/AIDS, tuberculosis and other cross-border

           musculoskeletal diseases and diabetes mellitus.                         health threats. In addition, there should be international

                                                                                   cooperation in order to promote general health reform

                                                                                   and general health institutional issues in third countries.

 

(8)        Microbial resistance to antibiotics and nosocomial infec-

           tions are becoming a threat to health in Europe. Lack of

           new effective antibiotics as well as the means to ensure

           the proper use of existing antibiotics are major concerns.      (14)    Increasing Healthy Life Years (HLY), also called disability-

           Therefore it is important to collect and analyse relevant               free life expectancy indicator, by preventing disease and

           data.                                                                   promoting policies that lead to a healthier way of life is

                                                                                   important for the well-being of EU citizens and helps to

                                                                                   meet the challenges of the Lisbon process as regards the

                                                                                   knowledge society and the sustainability of public

                                                                                   finances, which are under pressure from rising health

(9)        Strengthening the role of the European Centre for                       care and social security costs.

           Disease Prevention and Control established by Regulation

           (EC) No 851/2004 of the European Parliament and of

           the Council (1) is important in the fight against commu-

           nicable diseases.

                                                                           (15)    The enlargement of the European Union has brought

                                                                                   additional concerns in terms of health inequalities within

                                                                                   the EU and this is likely to be accentuated by further

(10)       The Programme should build on the achievements of the                   enlargements. This issue should, therefore, be one of the

           previous Programme for Community action in the field                    priorities of the Programme.

           of public health (2003-2008). It should contribute

           towards the attainment of a high level of physical and

           mental health and greater equality in health matters

           throughout the Community by directing actions towards

           improving public health, preventing human diseases and          (16)    The Programme should help to identify the causes of

           disorders, and obviating sources of danger to health with               health inequalities and encourage, among other things,

           a view to combating morbidity and premature mortality.                  the exchange of best practice to tackle them.

 

 

 

(11)       The Programme should place emphasis on improving the            (17)    It is essential systematically to collect, process and

           health condition and promoting a healthy lifestyle and a                analyse comparable data, within national constraints, for

           culture of prevention among children and young people.                  an effective monitoring of the state of health in the

                                                                                   European Union. This would enable the Commission and

                                                                                   the Member States to improve information to the public

                                                                                   and formulate appropriate strategies, policies and actions

(12)       The Programme should support the mainstreaming of                       to achieve a high level of human health protection.

           health objectives in all Community policies and activities,             Compatibility and interoperability of the systems and

           without duplicating work carried out under other Com-                   networks for exchanging information and data for the

           munity policies. Coordination with other Community                      development of public health should be pursued in the

           policies and programmes is a key part of the objective of               actions and support measures. Gender, socio-economic

           mainstreaming health in other policies. In order to                     status and age are important health considerations. Data

           promote synergies and avoid duplication, joint actions                  collection should wherever possible build on existing

           may be undertaken with related Community programmes                     work, and proposals for new collections should be costed

           and actions and appropriate use should be made of other                 and based on a clear need. The collection of data should

           Community funds and programmes, including the                           be in compliance with the relevant legal provisions on

           current and future Community framework programmes                       the protection of personal data.

           for research and their outcomes, the Structural Funds, the

           European Solidarity Fund, the European strategy for

           health at work, the programme of Community action in

           the field of consumer policy (2007-2013) (2), the

           programme `Drugs prevention and information', the               (18)    Best practice is important because health promotion and

           programme `Fight against violence (Daphne)' and the                     prevention should be measured on the basis of efficiency

           Community Statistical Programme within their respective                 and effectiveness and not purely in economic terms. Best

           activities.                                                             practice and latest treatment methods for diseases and

                                                                                   injuries should be promoted in order to prevent further

                                                                                   deterioration of health, and European networks of

(1) OJ L 142, 30.4.2004, p. 1.

(2) Decision No 1926/2006/EC of the European Parliament and of the                 centres of reference for specific conditions should be

       Council (OJ L 404, 30.12.2006, p. 39).                                      developed.

 


 

 

8.5.2007                EN                        Official Journal of the European Union                                         C 103E/13

 

(19)    Action should be taken in order to prevent injuries by          (25)    This Decision establishes, for the entire duration of the

        collecting data, analysing injury determinants and disse-               programme, a financial envelope which constitutes the

        minating relevant information.                                          prime reference within the meaning of point 37 of the

                                                                                Interinstitutional Agreement of 17 May 2006 between

                                                                                the European Parliament, the Council and the Commis-

                                                                                sion on budgetary discipline and sound financial manage-

                                                                                ment (2), for the budgetary authority during the annual

(20)    Health services are primarily the responsibility of                     budgetary procedure.

        Member States but cooperation at Community level can

        benefit both patients and health systems. Activities

        funded by the Programme as well as new proposals

        developed as a result of these should have due regard to        (26)    In order to ensure a high level of coordination between

        the Council Conclusions on common values and princi-                    actions and initiatives taken by the Community and

        ples in European Union Health Systems (1) adopted in                    Member States in the implementation of the Programme,

        June 2006 that endorse a statement on the common                        it is necessary to promote cooperation between Member

        values and principles of EU Health Systems and invite the               States and to enhance the effectiveness of existing and

        institutions of the European Union to respect them in                   future networks in the field of public health. The partici-

        their work. The Programme should take due account of                    pation of national, regional and local authorities at the

        future developments as regards Community action on                      appropriate level in accordance with the national systems

        health services as well as the work of the High Level                   should be taken into account in regard to the implemen-

        Group on Health Services and Medical Care which                         tation of the Programme.

        provides an important forum for collaboration and

        exchange of best practice between Member States' health

        systems.

                                                                        (27)    It is necessary to increase EU investment in health and

                                                                                health-related projects. In this regard, Member States

                                                                                should be encouraged to identify health improvements as

(21)    The Programme should contribute to the collection of                    a priority in their national programmes. Better awareness

        data, the promotion and development of methods and                      about the possibilities of EU funding for health is needed.

        tools, the establishment of networks and various kinds of               Exchange of experience between the Member States on

        cooperation and the promotion of relevant policies on                   funding health through the Structural Funds should be

        patient mobility as well as on the mobility of health                   encouraged.

        professionals. It should facilitate the further development

        of the European e-Health Area, through joint European

        initiatives with other EU policy areas, including regional

        policy, while contributing towards work on quality              (28)    Non-governmental bodies and specialised networks can

        criteria for health-related websites and towards a Euro-                also play an important role in meeting the objectives of

        pean health insurance card. Telemedicine should be taken                the Programme. In pursuing one or more objectives of

        into account as telemedicine applications may contribute                the Programme, they may require Community contribu-

        to cross-border care while ensuring medical care at                     tions to enable them to function. Hence, detailed elig-

        home.                                                                   ibility criteria, provisions regarding financial transparency

                                                                                and the duration of Community contributions for non-

                                                                                governmental bodies and specialised networks qualifying

                                                                                for Community support should be set out in accordance

                                                                                with Council Decision 1999/468/EC of 28 June 1999

(22)    Environmental pollution is a serious risk to health and a               laying down the procedures for the exercise of imple-

        major source of concern for European citizens. Special                  menting powers conferred on the Commission (3). Such

        action should focus on children and other groups which                  criteria should include the obligations of such bodies and

        are particularly vulnerable to hazardous environmental                  networks in establishing clear objectives, action plans and

        conditions. The Programme should complement the                         measurable results representing a strong European

        actions taken within the European Environment and                       dimension and a real added value for the objectives of

        Health Action Plan 2004-2010.                                           the Programme. Given the particular nature of the orga-

                                                                                nisations concerned and in cases of exceptional utility, it

                                                                                should be possible for the renewal of Community support

                                                                                to the functioning of such bodies and specialised

                                                                                networks to be exempted from the principle of gradual

(23)    The Programme should address gender-related and                         decrease of the extent of Community support.

        ageing-related health issues.

 

 

                                                                        (29)    Implementation of the Programme should be carried out

                                                                                in close cooperation with relevant organisations and

(24)    The precautionary principle and risk assessment are key                 agencies, in particular with the European Centre for

        factors for the protection of human health and should                   Disease Prevention and Control.

        therefore be part of further integration into other

        Community policies and activities.                              (2) OJ C 139, 14.6.2006, p. 1.

                                                                        (3) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

(1) OJ C 146, 22.6.2006, p. 1.                                             2006/512/EC (OJ L 200, 22.7.2006, p. 11).

 


 

 

C 103E/14             EN                            Official Journal of the European Union                                               8.5.2007

 

(30)    The measures necessary for the implementation of this             (36)       Since the objectives of this Decision cannot be suffi-

        Decision should be adopted in accordance with Decision                       ciently achieved by the Member States due to the trans-

        1999/468/EC, respecting the need for transparency as                         national nature of the issues involved, and can therefore,

        well as a reasonable balance between the different objec-                    by reason of the potential for Community action to be

        tives of the Programme.                                                      more efficient and effective than national action alone in

                                                                                     protecting the health and safety of citizens, be better

                                                                                     achieved at Community level, the Community may adopt

                                                                                     measures, in accordance with the principle of subsidiarity

(31)    The Agreement on the European Economic Area (herein-                         set out in Article 5 of the Treaty. In accordance with the

        after referred to as the EEA Agreement) provides for                         principle of proportionality, as set out in that Article, this

        cooperation in the field of health between the European                      Decision does not go beyond what is necessary in order

        Community and its Member States, on the one hand, and                        to achieve those objectives.

        the countries of the European Free Trade Association

        participating in the European Economic Area (hereinafter

        referred to as the EFTA/EEA countries), on the other.             (37)       In accordance with Article 2 of the Treaty, which

        Provision should also be made to open the Programme                          provides that equality between men and women is a prin-

        to participation by other countries, in particular the                       ciple of the Community, and in accordance with Article 3

        neighbouring countries of the Community and countries                        (2) thereof, which provides that the Community shall aim

        that are applying for, are candidates for, or are acceding                   to eliminate inequalities, and to promote equality

        to, membership of the Community, taking particular                           between men and women in all Community activities

        account of the potential for health threats arising in other                 including the attainment of a high level of health protec-

        countries to have an impact within the Community.                            tion, all objectives and actions covered by the Programme

                                                                                     contribute to promoting a better understanding and

                                                                                     recognition of men's and women's respective needs and

                                                                                     approaches to health.

(32)    Appropriate relations with third countries not partici-

        pating in the Programme should be facilitated in order to         (38)       It is appropriate to ensure a transition between the

        help achieve the objectives of the Programme, taking                         Programme and the previous programme it replaces, in

        account of any relevant agreements between those coun-                       particular regarding the continuation of multiannual

        tries and the Community. This may involve third coun-                        arrangements for its management, such as the financing

        tries taking forward complementary activities to those                       of technical and administrative assistance. As of 1 January

        financed through the Programme on areas of mutual                            2014, the technical and administrative assistance appro-

        interest, but should not involve a financial contribution                    priations should cover, if necessary, the expenditure

        under the Programme.                                                         related to the management of actions not yet completed

                                                                                     by the end of 2013.

 

(33)    It is appropriate to develop cooperation with relevant            (39)       This Decision replaces Decision No 1786/2002/EC. That

        international organisations such as the United Nations                       Decision should therefore be repealed,

        and its specialised agencies, in particular the WHO, as

        well as with the Council of Europe and the Organisation

        for Economic Cooperation and Development, with a view

        to implementing the Programme through maximising the

        effectiveness and efficiency of actions relating to health at     HAVE DECIDED AS FOLLOWS:

        Community and international level, taking into account

        the particular capacities and roles of the different organi-

        sations.                                                                                              Article 1

 

                                                                                             Establishment of the Programme

(34)    The successful implementation of the objectives under

        the Programme should be based on good coverage of the             The second programme of `Community action in the field of

        issues included in the annual work plans, on selection of         health (2007-2013)' covering the period from ... (*) to 31

        appropriate actions and funding of projects, which all            December 2013 (hereinafter referred to as the Programme) is

        have an inbuilt appropriate monitoring and evaluation             hereby established.

        process in place, and on regular monitoring and evalua-

        tion, including independent external evaluations, which

        should measure the impact of actions and demonstrate

        their contribution to the overall objectives of the                                                   Article 2

        Programme. Programme evaluation should take into

        account the fact that the achievement of the Programme                                       Aim and objectives

        objectives may require a longer time period than the

        duration of the Programme.                                        1.      The Programme shall complement, support and add value

                                                                          to the policies of the Member States and contribute to increased

                                                                          solidarity and prosperity in the European Union by protecting

(35)    The annual work plans should cover the main foreseeable           and promoting human health and safety and improving public

        activities to be funded from the Programme through all            health.

        the different funding mechanisms, including calls for

        tender.                                                           (*) The date of entry into force of this Decision.

 


 

 

8.5.2007               EN                           Official Journal of the European Union                                        C 103E/15

 

2.       The objectives to be pursued through the actions set out         through a transparent procedure by the Member State or the

in the Annex shall be:                                                    competent authority concerned and agreed by the Commission.

 

- to improve citizens' health security,                                   4.     Financial contributions by the Community may also be

- to promote health,                                                      given in the form of a lump sum and flat-rate financing where

                                                                          this is suited to the nature of the actions concerned. For such

- to generate and disseminate health information and knowl-               financial contributions, the percentage limits stipulated in para-

      edge.                                                               graphs 1 and 3 shall not apply, although co-financing is still

                                                                          required.

The actions referred to in the first subparagraph shall, where

appropriate, support the prevention of major diseases and

contribute to reducing their incidence as well as the morbidity                                           Article 5

and mortality caused by them.

                                                                                       Administrative and technical assistance

 

                                Article 3                                 1.     The financial allocation of the Programme may also cover

                                                                          expenses pertaining to preparatory, monitoring, control, audit

                                Funding                                   and evaluation activities, required directly for the management

                                                                          of the Programme and the realisation of its objectives, in par-

                                                                          ticular studies, meetings, information and publication actions,

1.       The financial envelope for the implementation of the             expenses linked to informatic networks focusing on information

Programme for the period specified in Article 1 is hereby set at          exchange, as well as all other technical and administrative assis-

EUR 365 600 000.                                                          tance expense that the Commission may have recourse to for

                                                                          the management of the Programme.

2.       Annual appropriations shall be authorised by the

budgetary authority within the limits of the financial frame-             2.     The financial allocation may also cover the technical and

work.                                                                     administrative assistance expenses necessary to ensure the tran-

                                                                          sition between the Programme and the measures adopted under

                                                                          Decision No 1786/2002/EC. If necessary, appropriations could

                                                                          be entered in the budget beyond 2013 to cover similar

                                Article 4                                 expenses, in order to enable the management of actions not yet

                                                                          completed by 31 December 2013.

                      Financial contributions

 

1.       Financial contributions by the Community shall not                                               Article 6

exceed the following levels:

                                                                                                Methods of implementation

(a) 60 % of costs for an action intended to help achieve an

      objective forming part of the Programme, except in cases of

      exceptional utility, where the Community contribution shall         Actions in pursuit of the aim and objectives set out in Article 2

      not exceed 80 %; and                                                shall make full use of appropriate available methods of imple-

                                                                          mentation, including in particular:

(b) 60 % of costs for the functioning of a non-governmental

      body or a specialised network, which is non-profit-making           (a) direct or indirect implementation by the Commission on a

      and independent of industry, commercial and business or                   centralised basis; and

      other conflicting interests, has members in at least half of        (b) joint management with international organisations, where

      the Member States, with a balanced geographical coverage,                 appropriate.

      and pursues as its primary goal one or more objectives of

      the Programme, where such support is necessary to pursue

      those objectives. In cases of exceptional utility, the Com-

      munity contribution shall not exceed 80 %.                                                          Article 7

2.       The renewal of financial contributions set out in para-                          Implementation of the Programme

graph 1(b) to non-governmental bodies and specialised

networks may be exempted from the principle of gradual                    1.     The Commission shall ensure the implementation, in close

decrease.                                                                 cooperation with the Member States, of the actions and

                                                                          measures set out in the Programme in accordance with Articles 3

3.       Financial contributions by the Community may, where              and 8.

appropriate given the nature of the objective to be achieved,

include joint financing by the Community and one or more                  2.     The Commission and the Member States shall take appro-

Member States or by the Community and the competent autho-                priate action, within their respective areas of competence, to

rities of other participating countries. In this case, the Com-           ensure the efficient running of the Programme and to develop

munity contribution shall not exceed 50 %, except in cases of             mechanisms at Community and Member State level to achieve

exceptional utility, where the Community contribution shall not           the objectives of the Programme. They shall ensure that appro-

exceed 70 %. These Community contributions may be awarded                 priate information is provided about actions supported by the

to a public body or a non-profit-making body designated                   Programme and that appropriate participation is obtained.

 


 

 

C 103E/16                 EN                           Official Journal of the European Union                                              8.5.2007

 

3.     For the attainment of the objectives of the Programme,                                                Article 10

the Commission shall, in close cooperation with the Member

States:                                                                                                     Committee

 

(a) pursue the comparability of data and information, and the                1.     The Commission shall be assisted by a committee (herein-

      compatibility and interoperability of the systems and                  after referred to as the Committee).

      networks for exchange of data and information on health;

      and                                                                    2.     Where reference is made to this paragraph, Articles 4 and

(b) ensure the necessary cooperation and communication with                  7 of Decision 1999/468/EC shall apply, having regard to the

      the European Centre for Disease Prevention and Control and             provisions of Article 8 thereof.

      other relevant EU agencies in order to optimise the use of

      Community funds.                                                       The period laid down in Article 4(3) of Decision 1999/468/EC

                                                                             shall be set at two months.

4.     In implementing the Programme, the Commission,

together with the Member States, shall ensure compliance with                3.     Where reference is made to this paragraph, Articles 3 and

all relevant legal provisions regarding personal data protection             7 of Decision 1999/468/EC shall apply, having regard to the

and, where appropriate, the introduction of mechanisms to                    provisions of Article 8 thereof.

ensure the confidentiality and safety of such data.

                                                                             4.     The Committee shall adopt its rules of procedure.

 

 

                                  Article 8                                                                  Article 11

 

                       Implementation measures                                                   Participation of third countries

 

1.     The measures necessary for the implementation of this                 The Programme shall be open to the participation of:

Decision relating to the following shall be adopted in accord-

ance with the procedure referred to in Article 10(2):                        (a) the EFTA/EEA countries in accordance with the conditions

                                                                                   established in the EEA Agreement; and

(a) the annual work plan for the implementation of the                       (b) third countries, in particular countries to which the Euro-

      Programme, setting out:                                                      pean Neighbourhood Policy applies, countries that are

                                                                                   applying for, are candidates for, or are acceding to, member-

       (i) priorities and actions to be undertaken, including the                  ship of the European Union, and the western Balkan coun-

             allocation of financial resources;                                    tries included in the stabilisation and association process, in

                                                                                   accordance with the conditions laid down in the respective

      (ii) criteria for the percentage of Community financial                      bilateral or multilateral agreements establishing the general

             contribution, including criteria for assessing whether or             principles     for    their    participation    in    Community

             not exceptional utility applies;                                      programmes.

      (iii) the arrangements for implementing the joint strategies

             and actions referred to in Article 9;                                                           Article 12

(b) selection, award and other criteria for financial contributions

      to the actions of the Programme covered by Article 4.                                        International cooperation

2.     Any other measures necessary for the implementation of                In the course of implementing the Programme, relations and

this Decision shall be adopted in accordance with the procedure              cooperation with third countries that are not participating in

referred to in Article 10(3).                                                the Programme and relevant international organisations, in par-

                                                                             ticular the WHO, shall be encouraged.

 

 

                                  Article 9                                                                  Article 13

 

                       Joint strategies and actions                                Monitoring, evaluation and dissemination of results

 

                                                                             1.     The Commission, in close cooperation with the Member

1.     To ensure a high level of human health protection in the              States, shall monitor the implementation of the actions of the

definition and implementation of all Community policies and                  Programme in the light of its objectives. It shall report yearly to

activities and to promote the mainstreaming of health, the                   the Committee on all actions and projects funded through the

objectives of the Programme may be implemented as joint stra-                Programme, and shall keep the European Parliament and the

tegies and joint actions by creating links with relevant Com-                Council informed.

munity programmes, actions and funds.

                                                                             2.     At the request of the Commission, which shall avoid a

2.     The Commission shall ensure the optimal synergy of the                disproportionate increase in the administrative burden of the

Programme with other Community programmes, actions and                       Member States, Member States shall submit any available infor-

funds.                                                                       mation on the implementation and impact of the Programme.

 


 

 

8.5.2007                 EN                                Official Journal of the European Union                                            C 103E/17

 

3.     The Commission shall submit to the European Parliament,                                                 Article 14

the Council, the European Economic and Social Committee and

the Committee of the Regions:                                                                                   Repeal

(a) not later than ... (*), an external and independent interim                  Decision No 1786/2002/EC shall be repealed.

      evaluation report on the results obtained in relation to the

      objectives of the Programme and the qualitative and quanti-

      tative aspects of its implementation as well as its consistency                                          Article 15

      and complementarity with other relevant Community

      programmes, actions and funds. The report shall in particu-                                           Entry into force

      lar make it possible to assess the impact of measures on all

      countries. The report shall contain a summary of the main                  This Decision shall enter into force on the day following that of

      conclusions, and it shall be accompanied by remarks by the                 its publication in the Official Journal of the European Union.

      Commission;

(b) not later than ... (**), a Communication on the continua-

      tion of the Programme;

(c) not later than 31 December 2015, an external and indepen-                    Done at Brussels,

      dent ex post evaluation report covering the implementation

      and results of the Programme.                                                 For the European Parliament                 For the Council

4.     The Commission shall make the results of actions under-

taken pursuant to this Decision publicly available and shall                               The President                         The President

ensure their dissemination.                                                                      ...                                  ...

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(*) Three years after the entry into force of this Decision.

(**) Four years after the entry into force of this Decision.

 


 

 

C 103E/18            EN                               Official Journal of the European Union                                                 8.5.2007

 

 

                                                                         ANNEX

 

                                                     ACTIONS REFERRED TO IN ARTICLE 2(2)

 

 

             1. Improve citizens' health security

 

                1.1. Protect citizens against health threats

 

                     1.1.1. Develop strategies and mechanisms for preventing, exchanging information on and responding to health

                            threats from communicable and non-communicable diseases and health threats from physical, chemical or

                            biological sources, including deliberate release acts; take action to assure high-quality-diagnostic coopera-

                            tion between Member States' laboratories; support the work of existing laboratories carrying out work

                            with relevance to the Community; work on the setting up of a network of Community reference labora-

                            tories.

 

                     1.1.2. Support the development of prevention, vaccination and immunisation policies; improve partnerships,

                            networks, tools and reporting systems for immunisation status and adverse events monitoring.

 

                     1.1.3. Develop risk management capacity and procedures; improve preparedness and planning for health emer-

                            gencies, including preparing for coordinated EU and international responses to health emergencies; develop

                            risk communication and consultation procedures on counter-measures.

 

                     1.1.4. Promote the cooperation and improvement of existing response capacity and assets, including protective

                            equipment, isolation facilities and mobile laboratories to deploy rapidly in emergencies.

 

                     1.1.5. Develop strategies and procedures for drawing up, improving surge capacity of, conducting exercises and

                            tests of, evaluating and revising general contingency and specific health emergency plans and their inter-

                            operability between Member States.

 

                1.2. Improve citizens' safety

 

                     1.2.1. Support and enhance scientific advice and risk assessment by promoting the early identification of risks;

                            analyse their potential impact; exchange information on hazards and exposure; foster integrated and

                            harmonised approaches.

 

                     1.2.2. Help to enhance the safety and quality of organs and substances of human origin, blood, and blood deriva-

                            tives; promote their availability, traceability and accessibility for medical use while respecting Member

                            States' responsibilities as set out in Article 152(5) of the Treaty.

 

                     1.2.3. Promote measures to improve patient safety through high-quality and safe healthcare, including in relation

                            to antibiotic resistance and nosocomial infections.

 

             2. Promote health

 

                2.1. Foster healthier ways of life and help bridge health inequalities

 

                     2.1.1. Promote initiatives to increase healthy life years and promote healthy ageing; support measures to promote

                            and explore the impact of health on productivity and labour participation as a contribution to meeting the

                            Lisbon goals; support measures to study the impact on health of other policies.

 

                     2.1.2. Support initiatives to identify the causes of, address and reduce health inequalities within and between

                            Member States, including those related to gender differences, in order to contribute to prosperity and cohe-

                            sion; promote investment in health in cooperation with other Community policies and funds; improve soli-

                            darity between national health systems by supporting cooperation on issues of cross-border care.

 

                2.2. Promote healthier ways of life and reduce major diseases and injuries by tackling health determinants

 

                     2.2.1. Address health determinants to promote and improve physical and mental health, creating supportive

                            environments for healthy lifestyles and preventing disease; take action on key factors such as nutrition and

                            physical activity and sexual health, and on addiction-related determinants such as tobacco, alcohol and

                            drugs, focusing on key settings such as education and the workplace, and across the life cycle.

 


 

 

8.5.2007           EN                              Official Journal of the European Union                                                 C 103E/19

 

                    2.2.2. Promote action on the prevention of major diseases of particular significance in view of the overall burden

                          of diseases in the Community, and on rare diseases, where Community action by tackling their determi-

                          nants can provide significant added value to national efforts.

                    2.2.3. Support action on the health effects of wider environmental and socio-economic determinants.

                    2.2.4. Promote actions to help reduce accidents and injuries.

            3. Generate and disseminate health information and knowledge

               3.1. Exchange knowledge and best practice

                    3.1.1. Exchange knowledge and best practice on health issues within the scope of the Programme.

               3.2. Collect, analyse and disseminate health information

                    3.2.1. Develop further a sustainable health monitoring system with mechanisms for collection of data and infor-

                          mation, with appropriate indicators; collect data on health status and policies; develop, with the Com-

                          munity Statistical Programme, the statistical element of this system.

                    3.2.2. Develop mechanisms for analysis and dissemination, including Community health reports, the Health

                          portal and conferences; provide information to citizens, stakeholders and policy makers, develop consulta-

                          tion mechanisms and participatory processes; establish regular reports on health status in the European

                          Union based on all data and indicators and including a qualitative and quantitative analysis.

                    3.2.3. Provide analysis and technical assistance in support of the development or implementation of policies or

                          legislation related to the scope of the Programme.

 


 

 

C 103E/20            EN                            Official Journal of the European Union                                       8.5.2007

 

 

                                                STATEMENT OF THE COUNCIL'S REASONS

 

              I. INTRODUCTION

 

                 1. On 15 April 2005, the Commission forwarded to the Council and to the European Parliament a

                     proposal (1) for a Decision of the European Parliament and of the Council establishing a Programme

                     of Community action in the field of Health and Consumer protection 2007-2013.

 

                 2. The opinions of the European Economic and Social Committee and the Committee of the Regions

                     were adopted respectively on 14-15 February 2006 (2) and 16 February 2006 (3) while the European

                     Parliament's first reading opinion was adopted on 16 March 2006 (4).

 

                 3. Following the adoption on 17 May 2006 of the Interinstitutional Agreement between the European

                     Parliament, the Council and the Commission on budgetary discipline and sound financial manage-

                     ment (including the multiannual financial framework 2007-2013), the Commission submitted on

                     29 May 2006 an amended proposal (5) (hereinafter second Public Health Programme) which incorpo-

                     rated a number of European Parliament amendments, notably on the split of the proposal into two

                     separate programmes (one in the field of health and one in the field of consumer protection), as well

                     as the revised budget allocations.

 

                 4. On 22 March 2007, the Council adopted its Common Position in accordance with Article 251(2) of

                     the Treaty.

 

 

              II. OBJECTIVE

 

                 The second Public Health Programme for the period 2007-2013 is to replace the current programme

                 established by the Decision No 1786/2002/EC (6).

                 The main objectives of the second Public Health Programme are to:

                 - improve citizen's health security,

                 - promote health, and

                 - generate and disseminate health information and knowledge.

                 These objectives will be pursued through the actions listed in the Annex to the Decision that represent a

                 continuation with respect to the current programme, while at the same time adapting them to new stra-

                 tegic issues, such as the need to promote healthy ageing, further address health inequalities and improve

                 preparedness and planning for health emergencies.

 

                 Concrete priorities and actions, as well as other aspects of the programme's implementation (e.g. alloca-

                 tion of financial resources, selection and award criteria for financial contributions, the arrangements for

                 implementing the joint strategies and actions), will be decided in the annual work-plans in consultation

                 with the programme's management Committee. The broad objectives of the Public Health Programme

                 give room to deal with new emerging issues, if needed, during its implementation period.

 

                 The total amount of the budget allocated to the programme stands at EUR 365,6 million in current

                 prices.

 

 

             III. ANALYSIS OF THE COMMON POSITION

 

                 1. General remarks

 

                     In general, the Council has followed the European Parliament's first reading Opinion that was incor-

                     porated to a considerable extent in the Commission's amended proposal. In particular, the Council

                     agreed to the split of the Commission's original proposal into two separate programmes (one in the

                     field of health and one in the field of consumer protection). The Council agreed to the revised budget

                     allocations as mentioned in section II above and set out in the Interinstitutional agreement of 17 May

                     2006. It should be noted that the European Parliament's first reading opinion was adopted on

                     16 March 2006, i.e. before the Interinstitutional agreement of 17 May 2006.

 

             (1) OJ C 172, 12.7.2005, p. 25.

             (2) OJ C 88, 11.4.2006, p. 1.

             (3) OJ C 192, 16.8.2006, p. 8.

             (4) 7537/06.

             (5) 9905/06.

             (6) OJ L 271, 9.10.2002, p. 1.

 


 

 

8.5.2007      EN                             Official Journal of the European Union                                C 103E/21

 

            2. European Parliament Amendments

 

              In its plenary vote on 16 March 2006, the European Parliament adopted 145 Amendments to the

              Commission's initial proposal. The majority of these amendments were integrated in the Commis-

              sion's amended proposal, with respect of which the Council has accepted further amendments in its

              common position.

 

              The Council:

 

              (a) Introduced in the common position 22 Amendments related to the split of the Commission's

                    original proposal into two separate programmes, as follows:

 

                    (i) Amendments accepted in full:

 

                       Amendment 1 (on Title): the new title;

 

                       Amendment 2 (on Citation 1);

 

                       Amendment 15 (on Recital 2): the additional part not related to the split is accepted in

                       Recital 4;

 

                       Amendment 37 (on Recital 4): deleted;

 

                       Amendment 42 (on Recital 9); this Recital is now Recital 31;

 

                       Amendment 52 (on Article 3); this Article is now Article 4;

 

                       Amendment 74 (on Article 11); this Article is now Article 14;

 

                       Amendment 75 (on Article 12); this Article is now Article 5.2;

 

                       Amendment 76 (on Annex 1); Annex 1 was deleted;

 

                       Amendments 77, 78, 84, 86, 101: (on Annex 2); this Annex 2 is now Annex;

 

                       Amendment 140 (on Annex 3); this Annex became the annex to the programme of Com-

                       munity action in the field of Consumer policy (2007-2013).

 

                    (ii) Amendments reworded or accepted in part:

 

                       Amendment 3 (on Recital 1); accepted concerning the splitting;

 

                       Amendment 18 (on Recital 3): accepted concerning the splitting;

 

                       Amendment 38 (on Recital 5): partly also accepted in Recital 12;

 

                       Amendment 41 (on Recital 7): accepted concerning the splitting;

 

                       Amendment 43 (on Recital 11): reworded in Recital 33;

 

                       Amendment 48 (on Article 1);

 

                       Amendment 49 (on Article 2): partly also accepted in Article 2.1.

 

              (b) did not accept Amendment 113 as a result of the reduced number of actions in the Commis-

                    sion's amended proposal.

 

              (c) Introduced in the common position 91 Amendments which were not related to the split of the

                    proposal, as follows:

 

                    (i) Amendments accepted in full:

 

                       On the recitals:

 

                       Amendment 7 (on Recital 1 d (new)): is now in Recital 3;

 

                       Amendment 9 (on Recital 1 f (new)): is now in Recital 6;

 

                       Amendment 19 (on Recital 3 a (new)): is now in Recital 12;

 

                       Amendment 20 (on Recital 3 b (new)): is now in Recital 14;

 

                       Amendment 21 (on Recital 3 c (new)): is now in Recital 15;

 

                       Amendment 22 (on Recital 3 d (new)): is now in Recital 16;

 


 

 

C 103E/22    EN                           Official Journal of the European Union                      8.5.2007

 

                      Amendment 24 (on Recital 3 f (new)): is now in Recital 17;

 

                      Amendment 30 (on Recital 3 l (new)): is now in Recital 22;

 

                      Amendment 34 (on Recital 3 p (new)): is now in Recital 24;

 

                      Amendment 35 (on Recital 3 q (new)): is now in Recital 26;

 

                      Amendment 36 (on Recital 3 r (new)): is now in Recital 26;

 

                      On the Articles:

 

                      Amendment 59 (on Article 4 paragraph 1 d (new)): is now in Article 7.3(a);

 

                      Amendment 60 (on Article 4 paragraph 1 e (new)): is now Article 7.3(b);

 

                      Amendment 61 (on Article 4 paragraph 1 f (new)): is now Article 7.4;

 

                      Amendment 66 (on Article 7 paragraph 1 point (a)): is now Article 8.1(a)(i);

 

                      Amendment 69 (on Article 7 paragraph 2): is now Article 8.2;

 

                      Amendment 70 (on Article 9): is now Article 12;

 

                      Amendment 72 (on Article 10, paragraph 3); deleted;

 

                   (ii) Amendments reworded or accepted in part:

 

                      On the recitals:

 

                      Amendment 4 (on Recital 1): partly accepted in Recital 1;

 

                      Amendment 6 (on Recital 1 c (new)): reworded in Recital 2;

 

                      Amendment 8 (on Recital 1 e (new)): partly accepted in Recital 5;

 

                      Amendment 10 (on Recital 1 g (new)): partly accepted in Recital 7;

 

                      Amendment 13 (on Recital 1 k (new)): partly accepted in Recital 8;

 

                      Amendment 14 (on Recital 11 (new)): reworded in Recital 9;

 

                      Amendment 16 (on Recital 2 a (new)): partly accepted in Recital 10;

 

                      Amendment 17 (on Recital 2 b (new)): partly accepted in Recital 11;

 

                      Amendment 23 (on Recital 3 e (new)): partly accepted in Recital 17;

 

                      Amendment 25 (on Recital 3 g (new)): partly accepted in Recital 18;

 

                      Amendment 26 (on Recital 3 h (new)): partly accepted in Recital 18;

 

                      Amendment 27 (on Recital 3 g (new)): reworded in Recital 19;

 

                      Amendment 28 (on Recital 3 j (new)): reworded in Recital 21;

 

                      Amendment 29 (on Recital 3 k (new)): partly accepted in Recital 21;

 


 

 

8.5.2007    EN                            Official Journal of the European Union                                C 103E/23

 

                  Amendment 31 (on Recital 3 m (new)): partly accepted in Recital 23;

 

                  Amendment 39 (on Recital 5 a (new)): reworded in Recital 27;

 

                  Amendment 40 (on Recital 6): partly accepted in Recital 28;

 

                  Amendment 44 (on Recital 12): partly accepted in Recital 34;

 

                  Amendment 45 (on Recital 13): partly accepted in Recital 36;

 

                  Amendment 46 (on Recital 13 a (new)): reworded in Recital 37;

 

                  Amendment 47 (on Recital 14): reworded in Recital 38 and Article 5.2;

 

                  On the Articles:

 

                  Amendment 50 (on Article 2 paragraph 2, point (a) new): partly accepted in Recital 1 and

                  Annex Objective 2.1;

 

                  Amendment 53 (on Article 3 paragraph 2, point (b)): partly accepted in Article 4.1(b);

 

                  Amendment 55 (on Article 4): partly accepted in Article 7.1;

 

                  Amendment 56 (on Article 4 paragraph 1 a (new)): partly accepted in Article 7.3(a);

 

                  Amendment 57 (on Article 4 paragraph 1 b (new)): partly accepted in Article 7.2;

 

                  Amendment 62 (on Article 4, paragraph 1 g (new)): partly accepted in Article 5.2;

 

                  Amendment 63 (on Article 4 a (new)): partly accepted in Article 9;

 

                  Amendment 67 (on Article 7, paragraph 1 point (aa) (new)): partly accepted in

                  Article 8.1(a)(iii);

 

                  Amendment 71 (on Article 10 paragraph 2): partly accepted in Article 13.3;

 

                  Amendment 73 (on Article 10, paragraph 3 a (new)): partly accepted in Article 13.3(a);

 

                  Amendment 146 (on Article 7, paragraph 1 point a c (new)): partly accepted in Article 8.1;

 

                  Amendment 147 (on Article 10, paragraph 1): partly accepted in Art. 13.3(a);

 

                  On the Annex:

 

                  Amendments 79 and 80 (on Annex 2): partly accepted in Article 7.3(b);

 

                  Amendment 81 (on Annex 2): partly accepted in the Annex, Objective 1.2.3;

 

                  Amendment 85 (on Annex 2): partly accepted in Annex Objective 1.1.3;

 

                  Amendment 88 (on Annex 2): partly accepted in Recitals 11 and 22;

 

                  Amendment 89 (on Annex 2): partly accepted in Annex Objective 2.2.1;

 

                  Amendment 90 (on Annex 2): partly accepted in Recital 19;

 

                  Amendment 91 (on Annex 2): partly accepted in Annex Objective 2.1.2;

 


 

 

C 103E/24    EN                        Official Journal of the European Union                                  8.5.2007

 

                   Amendment 92 (on Annex 2): partly accepted in Recitals 16 and 37, and Annex Objec-

                   tive 2.1;

 

                   Amendment 93 (on Annex 2): partly accepted in Annex Objective 1.1.1;

 

                   Amendment 98 (on Annex 2): partly accepted in Recitals 17, 23 and Annex Objective 2.1.1;

 

                   Amendment 99 (on Annex 2): partly accepted in Recitals 17, 23 and Annex Objective 2.1.2;

 

                   Amendment 100 (on Annex 2): partly accepted in Article 2.2 and Annex Objective 2.2;

 

                   Amendment 104 (on Annex 2): partly accepted in Annex Objective 2.1;

 

                   Amendment 106 (on Annex 2): partly accepted in Annex Objective 1.1.2;

 

                   Amendment 107 (on Annex 2): partly accepted in Recitals 16 and 37, and Annex Objec-

                   tive 2.1;

 

                   Amendment 108 (on Annex 2): partly accepted in Recital 18 and Annex Objective 3.1;

 

                   Amendment 109 (on Annex 2): partly accepted in Recital 21;

 

                   Amendment 110 (on Annex 2): partly accepted in Recital 19;

 

                   Amendment 111 (on Annex 2): partly accepted in Recitals 18, 19 and Annex Objective 2.2;

 

                   Amendment 112 (on Annex 2): partly accepted in Article 2.2 and Annex Objective 2.2;

 

                   Amendment 115 (on Annex 2): partly accepted in Recital 21;

 

                   Amendment 116 (on Annex 2): partly accepted in Annex Objective 3.1;

 

                   Amendment 117 (on Annex 2): partly accepted in Recitals 17 and 23, and Annex Objec-

                   tive 2.1.2;

 

                   Amendment 118 (on Annex 2): partly accepted in Recital 21;

 

                   Amendment 119 (on Annex 2): partly accepted in Annex Objective 2.1.1;

 

                   Amendment 120 (on Annex 2): partly accepted in Annex Objective 1.2.2;

 

                   Amendment 121 (on Annex 2): partly accepted in Recital 12, Articles 2.2 and 9, and Annex

                   Objective 3;

 

                   Amendment 123 (on Annex 2): reworded in Annex Objective 3;

 

                   Amendment 124 (on Annex 2): partly accepted in Annex Objective 3.2;

 

                   Amendment 125 (on Annex 2): partly accepted in Recital 17 and Annex Objective 3.2.1;

 

                   Amendment 126 (on Annex 2): partly accepted in Annex Objective 3.2.1;

 

                   Amendment 132 (on Annex 2): partly accepted in Annex Objective 1.1.1;

 

                   Amendment 133 (on Annex 2): partly accepted in Annex Objective 3.2.2;

 

                   Amendment 134 (on Annex 2): partly accepted in Recitals 12 and 13, Article 9.1 and Annex

                   Objective 2.1.1;

 


 

 

8.5.2007         EN                          Official Journal of the European Union                                      C 103E/25

 

                          Amendment 135 (on Annex 2): partly accepted in the Annex;

                          Amendment 136 (on Annex 2): partly accepted in Article 12;

                          Amendment 137 (on Annex 2): partly accepted in Annex Objective 1.2.1;

                          Amendment 138 (on Annex 2): partly accepted in Annex Objective 1.2.2;

                          Amendment 139 (on Annex 2): partly accepted in Annex Objective 3.2.3;

                 (d) Did not include 26 Amendments (5, 11, 12, 32, 33, 51, 54, 58, 65, 68, 82, 83, 87, 95, 96,

                       102, 103, 105, 122, 128, 130, 131, 145, 148, 152 and 153) in the common position.

                       The Council cannot accept the following five amendments due to resource-related constrains

                       following the adoption of the Interinstitutional agreement of 17 May 2006: 64, 97, 114, 127

                       and 129.

 

            IV. CONCLUSION

              The Council considers that its common position, which incorporates the Amendments mentioned in

              Sections III.2.(a) and (c), takes good account of the first reading opinion of the European Parliament.

              The common position represents a balance of concerns and interests ensuring that the objectives of the

              programme could be implemented through a tightened number of actions and instruments as well as

              more accurate methods and procedures, which have been reformulated in line with the European Parlia-

              ment's first reading opinion and the Commission's amended proposal. The Decision will improve the

              effectiveness of Community actions in the field of public health and raise awareness about status of

              health in the European Union, thus contributing to the improvement and protection of health of the

              European Union' citizens.