REPORT on the proposal 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) - Health aspects

    9.2.2006 - (COM(2005)0115 – C6‑0097/2005 – 2005/0042A(COD)) - ***I

    Committee on the Environment, Public Health and Food Safety
    Rapporteur: Antonios Trakatellis


    Procedure : 2005/0042A(COD)
    Document stages in plenary
    Document selected :  
    A6-0030/2006

    DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

    on the proposal 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) - Health aspects

    (COM(2005)0115 – C6‑0097/2005 – 2005/0042A(COD))

    (Codecision procedure: first reading)

    The European Parliament,

    –   having regard to the Commission proposal to the European Parliament and the Council (COM(2005)0115)[1],

    –   having regard to Article 251(2) and Article 152 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6‑0097/2005),

    –   having regard to the decision by the Conference of Presidents on 30 June 2005 to split the Proposal 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) in order to assign it to both the Committee on the Environment, Public Health and Food Safety and the Committee on the Internal Market and Consumer Protection for the drawing-up of two separate reports;

    –   having regard to Rule 51 of its Rules of Procedure,

    –   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Budgets (A6-0030/2005),

    1.  Approves the Commission proposal as amended;

    2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;

    3.  Instructs its President to forward its position to the Council and Commission.

    Text proposed by the CommissionAmendments by Parliament

    Amendment 1

    Title

    Proposal 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)

    Proposal for a decision of the European Parliament and of the Council establishing a second programme of Community action in the field of health (2007-2013)

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection Programme. This programme constitutes a continuation and development of the first integrated Community action programme in the field of public health (2003-2008).

    Amendment 2

    Citation 1

    Having regard to the Treaty establishing the European Community, and in particular Articles 152 and 153 thereof,

    Having regard to the Treaty establishing the European Community, and in particular Article 152 thereof,

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection Programme.

    Amendment 3

    Recital 1

    (1) The Community can contribute to protecting the health, safety and economic interests of citizens through actions in the fields of public health and consumer protection.

    (1) The Community is committed to promoting and improving health, preventing and reducing disease, and countering potential threats to health. It must address in a coordinated and coherent way public concerns and expectations. The Community can contribute to protecting the health and safety of citizens through actions in the field of public health which add value to those of Member States.

    Justification

    Public health is a common good of prime importance and its protection concerns everyone without exception. Article 152 of the EC Treaty commits the Community to the promotion and improvement of health, the prevention of human illness and obviating sources of danger to human health. Meeting the challenges in the field of health calls for coordinated and cohesive measures to ensure a high level of protection of public health. A sound public health policy adapted to the challenges of the 21st Century must strive for a reduction of disease to avoid further health loss.

    Amendment 4

    Recital 1 a (new)

     

    (1a) A high level of health protection should be ensured in the definition and implementation of all Community policies and activities. Under Article 152 of the Treaty, the Community is required to play an active role by taking measures which cannot be taken by individual Member States and in coordinating measures taken by Member States, in accordance with the principle of subsidiarity. The Community fully respects the prerogatives of Member States in the organisation and delivery of health services and medical care.

    Justification

    The Treaties require the Community to play an active role, by taking measures which cannot be taken by the Member States. The strengthened provisions of Article 152 of the Treaty of Amsterdam constituted a quantitative and qualitative leap forward in containing the three-fold objectives of improving public health, preventing disease in all its forms and obviating sources of danger. It should be noted that competence and responsibility for health services (hospitals etc.), lie with the Member States (subsidiarity principle).

    Amendment 5

    Recital 1 b (new)

     

    (1b) Whilst being committed to preserving and improving the health of its citizens, the Community should also take ethical values into consideration, so as not to breach the existing codes of conduct.

    Justification

    A sentence in the preamble to the decision N:3.1 "Making European citizens healthier is the ultimate goal of all health activities pursued under the Treaty" needed clarification, since, legally and ethically, the goal cannot be pursued by all available means, which would ultimately lead to the improvement of citizens' health.

    Amendment 6

    Recital 1 c (new)

     

    (1c) The health sector is characterised on the one hand by its considerable potential for growth, innovation and dynamism and on the other by the challenges it faces in terms of financial and social sustainability and efficiency of the health care systems due, among other things, to the rise in life expectancy and medical advances.

     

    Justification

    There have been rapid developments in the health sector in financial terms with an increase in investment and rising employment, as well as the introduction of technology and innovation, particularly in the developed countries. At the same time, there has been an increase in spending on health and health care of almost 10% of GDP of the Member States, taking into account the increase in life expectancy and the fact that the health sector constitutes an important part of the Member States' social security systems.

    Amendment 7

    Recital 1 d (new)

     

    (1d) The programme of Community action in the field of public health (2003-2008) was the first integrated European Community programme in this field, and has already delivered a number of important developments and improvements.

    Justification

    Τhe first integrated Community action programme in the field of public health is the programme in force for 2003-2008 and there is a clear difference in its entire philosophy compared with previous such initiatives in that, although in the past important health issues, such as the anti-cancer programme, health promotion, AIDS, drug addiction, health monitoring, injuries, rare diseases, pollution-related diseases, were being addressed, they were dealt with in a piecemeal manner, mainly in isolation from one another. This programme has three general objectives - (a) improving information, (b) strengthening the capacity for a rapid coordinated response to health threats and (c) the promotion of health and prevention of disease through addressing health determinants - and after two years of implementation, the first positive results have already been obtained with Community measures and the development of mechanisms on the basis of an integrated approach to public health.


    Amendment 8

    Recital 1 e (new)

     

    (1e) A number of serious cross-border health threats with a possible world-wide dimension exist and new ones are emerging which require further Community action. The Community should treat serious cross-border health threats as a matter of priority. Monitoring, early warning and action to combat serious threats to health require a capacity of the Community to respond in an effective and coordinated fashion.

    Justification

    The successive food crises, the worldwide panic caused by SARS, which first appeared in China, avian influenza and the possibility of an influenza pandemic in the immediate future, which may claim millions of lives, and the environmental problems affecting public health highlight the exceptional importance of public health and, consequently, the importance of protecting it for citizens who are calling for effective action at Union level. Moreover, the mobility of European citizens and the freedom of movement of individuals within the EU call for vigilance in order to be alert to serious cross-border threats, and to give early warning of and combat such threats.

    Amendment 9

    Recital 1 f (new)

     

    (1f) According to the WHO European Health Report 2005, in terms of Disability Adjusted Life-Years (DALYs) the most important causes of the burden of disease in the Region are non-communicable diseases (NCDs – 77% of the total), external causes of injury and poisoning (14%) and communicable diseases (9%). Seven leading conditions – ischaemic heart disease, unipolar depressive disorders, cerebrovascular disease, alcohol use disorders, chronic pulmonary disease, lung cancer and road traffic injuries – account for 34% of the DALYs in the Region. Seven leading risk factors – tobacco, alcohol, high blood pressure, high cholesterol, overweight, low fruit and vegetable intake and physical inactivity – account for 60% of DALYs. In addition, communicable diseases, such as HIV/AIDS, influenza, tuberculosis and malaria are also becoming a threat to the health of all people in Europe. An important task of the programme would be to identify better the main health burdens in the Community.

    Justification

    It is absolutely essential to take account of the WHO's authoritative data in drawing up the public health programme in the Union.

    Amendment 10

    Recital 1 g (new)

     

    (1g) Eight leading causes of death from NCDs in the WHO European Region are cardiovascular disease, neuropsychiatric disorders, cancer, digestive diseases, respiratory diseases, sense organ disorders, musculoskeletal diseases and diabetes mellitus. Furthermore, findings of a recent study, based on a disease model used by the WHO, suggest that mortality attributable to diabetes is likely to be considerably higher than previous global estimates based on death certificates, because individuals with diabetes most often die of cardiovascular and renal disease.

     

    Justification

    This amendment is related to the previous amendment.

    Amendment 11

    Recital 1 h (new)

     

    (1h) Diabetes and obesity are serious threats to European Union citizens and therefore the Programme should also address this important issue on the basis inter alia of collection and analysis of relevant data.

    Amendment 12

    Recital 1 i (new)

     

    (1i) A great percentage of all cancers are preventable. Continued effort is required to strengthen and accelerate the translation of cancer prevention and control knowledge into public health action.

    Justification

    According to WHO, cancer rates are set to increase dramatically due to Europe’s ageing population and the rise of the cancer epidemic is attributed to increased exposure to tobacco use, unhealthy diet, physical inactivity, some infections and carcinogens. One in 3 Europeans is diagnosed with cancer and the disease kills 1 in 4 people in Europe. Prevention offers the most effective long-term strategy for the control of cancer.

    For example the European Cancer Code could provide a new impetus to tackling cancer in new Member States which have the greatest cancer survival deficits.

    Amendment 13

    Recital 1 j (new)

     

    (1j) Microbial resistance to antibiotics and nosocomial infections are becoming a threat to health in Europe. Lack of research into new antibiotics as well as the proper use of the existing ones are major concerns. Therefore it is important to collect and analyse relevant data.

    Amendment 14

    Recital 1 k (new)

     

    (1k) Strengthening the role of the European Centre for Disease Prevention and Control is important to centrally reduce the impact of communicable diseases.

    Justification

    This amendment seeks to underline the important role of the ECDC.

    Amendment 15

    Recital 2

    (2) It is therefore appropriate to establish a programme of Community action on health and consumer protection, replacing Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) and Decision No 20/2004/EC of the European Parliament and of the Council of 8 December 2003 establishing a general framework for financing Community actions in support of consumer policy for the years 2004 to 2007 These Decisions should therefore be repealed.

    (2) Continued effort is required in order to meet the objectives and targets already established by the Community in the field of public health. It is therefore appropriate to establish a second programme of Community action on health (2007-2013, "the Programme") as set out in this Decision, replacing Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008), which should therefore be repealed.

    Justification

    This amendment is in accordance with the decision by the Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection Programme. The Community is facing serious challenges in the health sector which call for a response at Community level and, consequently, Community action is required in the form of a second programme in the field of health (2007-2013) which will constitute a continuation and development of the first integrated Community action programme in the field of public health (2003-2008).

    Amendment 16

    Recital 2 a (new)

     

    (2a) The Programme builds on the structure, mechanisms and activities of the previous programme for Community action in the field of public health (2003-2008), adds new objectives and benefits from the experience and knowledge gained through the implemented actions and measures. It will 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 disorders, and obviating sources of danger to health with a view to combating morbidity and premature mortality, while taking gender, ethnic origin and age into consideration.

    Justification

    The second programme will build on the structures, mechanisms and activities of the first programme, the experience gained and the addition of new objectives, contributing to combating health threats, attaining a high level of physical and mental health and well-being and greater equality in health matters.

    Amendment 17

    Recital 2 b (new)

     

    (2b) The Programme will place emphasis on improving the health condition and promoting a healthy lifestyle among children and young people.

    Justification

    Regarding the fact that the prevention of illnesses in adults can most effectively be achieved by adopting a healthy lifestyle from the early stages of life, it seems necessary to concentrate the resources of the Programme on improving the health of the young generations.

    Amendment 18

    Recital 3

    (3) Whilst maintaining the core elements and specificities of actions on health and consumer protection, a single integrated programme should help to maximise synergies in objectives and efficiency in administration of actions in these areas. Combining health and consumer protection activities in a single programme should help to meet joint objectives on protecting citizens from risks and threats, increasing the ability for citizens to have the knowledge and opportunity to make decisions in their interests and supporting mainstreaming of health and consumer objectives in all Community policies and activities. Combining administrative structures and systems should enable more efficient implementation of the programme and help to make best use of available Community resources for health and consumer protection.

    (3) The Programme should help to meet objectives on protecting citizens from health risks and threats, including those that are beyond the control of individuals, such as addiction to prescription drugs, and to help them to optimise their level of physical and mental health, provide them with better access to information on such risks and threats, and thereby increase their ability to make decisions which cater best for their interests.

    Justification

    Τhe programme should strengthen the capacity to provide citizens with information on health matters, broadening the scope of knowledge and choice.

    Amendment 19

    Recital 3 a (new)

     

    (3a)The Programme should support the mainstreaming of health objectives in all Community policies and activities.

    Justification

    The programme will cover and support the mainstreaming of health objectives in all Community policies and activities.

    Amendment 20

    Recital 3 b (new)

     

    (3b) Increasing Healthy Life Years (HLY), also called disability-free life expectancy indicator, by preventing disease and promoting ageing with good health 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 care and social security costs.

    Justification

    Health contributes to productivity, employment and consequently to economic growth. Investment in prevention improves not only health, but also the economy. The categories of health indicator (negative and positive) help to measure the population's level of health. According to the conclusions of the Lisbon Process, 'a major challenge will be to reduce the important differences between Member States in terms of life expectancy, incidence of major diseases and health capability. Modernising the health sector (…) can make a substantial contribution to sustain labour supply'.

    Amendment 21

    Recital 3 c (new)

     

    (3c)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 enlargements. This issue should, therefore, be one of the priorities of the Programme.

    Justification

    Enlargement has exacerbated inequalities in the health sector. There are currently major differences between the Member States and within them in terms of average lifespan of citizens, their state of health and their access to care. These inequalities in turn lead to inequalities in growth and, consequently, it is essential that the programme takes measures to reduce them.

    Amendment 22

    Recital 3 d (new)

     

    (3d) The Programme should help to identify the causes of health inequalities and encourage, among other things, the exchange of best practice to tackle them.

     

    Justification

    The programme should focus, inter alia, on measures which help to reduce inequalities.

    Amendment 23

    Recital 3 e (new)

     

    (3e) It is essential to systematically collect, process and analyse comparable data for 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 to achieve a high level of human health protection. Compatibility and interoperability of the systems and networks for exchanging information and data for the development of public health should be pursued in the actions and support measures. Gender, age, and ethnic origin are important health considerations. Therefore, relevant data should be analysed accordingly.

    Justification

    Without systematic collection, processing and analysis of data at Community level, there can be no effective monitoring of health. It is therefore essential to draw on objective, reliable, compatible, comparable and exchangeable information at Community level. It is equally important that compatible and interoperable systems and networks are operating in the health sector.

    Amendment 24

    Recital 3 f (new)

     

    (3f) The collection of data must be in compliance with the relevant legal provisions on the protection of personal data.

    Amendment 25

    Recital 3 g (new)

     

    (3g) Best practice is the most appropriate option because health promotion, prevention and the treatment of diseases and injuries should be measured on the basis of efficiency and effectiveness and not purely in economic terms. It is, therefore, of primary importance to establish guidelines and indicators and organise the exchange of best practice.

    Justification

    The development of best practice and guidelines is the best option for prevention measures in the field of health, treatment of diseases and injuries and is in keeping with the subsidiarity principle.

    Amendment 26

    Recital 3 h (new)

     

    (3h) It is important to promote best practice and latest treatment methods for diseases and injuries in order to prevent further deterioration of health, and to develop centres of reference for specific conditions. It is also important to promote sound alternatives, which may be preferable for social, ethical and other individual reasons.

     

    Justification

    It is important to take into account that medical care is so good now that someone may choose a method of treatment, because of social, religious or other individual preferences, which is not, objectively, exactly as good as another. For instance, someone dying of cancer may prefer to be close to relatives rather than prolong his/her life; someone may choose, on religious grounds, not to accept a blood donation.

    Amendment 27

    Recital 3 i (new)

     

    (3i) Action should be taken in order to prevent injuries by collecting data, developing injury determinants and disseminating relevant information.

    Amendment 28

    Recital 3 j (new)

     

    (3j) The Programme should contribute to the collection of data and the promotion of relevant policies on patient mobility as well as on the mobility of health professionals. It should facilitate the further development of the European e- Health Area, and especially the European health insurance card through joint European initiatives with other EU policy areas, while establishing strict quality criteria for health-related websites.

    Justification

    The mobility of patients and health professionals is a basic challenge in the health sector in the Union. In the light of the case law of the Court of Justice of the European Communities, which recognises the right of patients to the refund of medical expenses incurred in another Member State but distinguishes between hospital and non-hospital care and links the exercise of this right with certain conditions to ensure financial balance and social security with the aim of safeguarding a high level of health protection, Community action is required to deal with the issues associated with patient mobility and the promotion of the e-health initiatives and, in particular the further development of the ‘European health insurance card’.

    The internet may have considerable added value in offering a platform providing for complementary health related information and services. However, the programme should provide for the necessary measures establishing quality criteria for health related websites in order to assure that the European e-Health area provides reliable and safe health related information and services.

    Amendment 29

    Recital 3 k (new)

     

    (3k) The promotion of telemedicine applications may contribute to patient mobility and to medical care at home, thereby relieving the pressure on primary care and reducing the burden caused by disease and injury.

    Justification

    Telemedicine applications promote patients' mobility, facilitating their prompt and appropriate access to health services while, at the same time, helping to reduce the impact of disease and injury, and rationalising expenditure in the health sector.

    Amendment 30

    Recital 3 l (new)

     

    (3l) Environmental pollution is a serious risk to health and a major source of concern for European citizens. Special action should focus on children and other groups which are particularly vulnerable to hazardous environmental conditions. The Programme should complement the actions taken within the Environment and Health Action Plan 2004-2010.

    Amendment 31

    Recital 3 m (new)

     

    (3m) The Programme should also address illnesses related to gender (such as breast and prostate cancer, osteoporosis, etc.).

    Justification

    Many illnesses of high prevalence are gender-specific, therefore it is necessary to address these specifically.

    Amendment 32

    Recital 3n (new)

     

    (3n) The Programme should help to combat prejudices on grounds of gender and age in the clinical treatment of patients, in health care systems, in research and in government policy.

    Justification

    One of the common objectives of the programme should be to reduce inequality between men and women in health care.

    Amendment 33

    Recital 3 o (new)

     

    (3o) Health factors contributing to Europe’s falling birth rates should also be adequately addressed.

     

    Justification

    The age-related decline in fertility, along with a lack of access to adequate intervention for those who may benefit, is likely to exacerbate the impact on populations in Europe, and further contribute to the associated problems of Europe’s changing demographics. The Community should commit to recommending and supporting fair and equitable access to appropriate services across Europe in an effort to reverse the trend in falling birth rates and avert this pending population crisis.

    Amendment 34

    Recital 3 p (new)

     

    (3p) The precautionary principle and risk assessment are key factors for the protection of human health and should therefore be part of further integration into other Community policies and activities.

    Amendment 35

    Recital 3 q (new)

     

    (3q) In order to ensure a high level of coordination between actions and initiatives taken by the Community and Member States in the implementation of the Programme, it is necessary to promote cooperation between Member States and to enhance the effectiveness of existing and future networks in the field of public health.

    Justification

    Coordination and cooperation between the Commission and the Member States is absolutely essential for effective implementation of the programme.

    Amendment 36

    Recital 3 r (new)

     

    (3r) The participation of national, regional and local authorities at the appropriate level in accordance with the national systems should be taken into account in regard to the implementation of the Programme.

    Amendment 37

    Recital 4

    (4) Health and consumer protection policies share common objectives relating to protection against risks, improving decision-making of citizens and integrating health and consumer protection interests in all Community policies, as well as common instruments such as communication, capacity-building for civil society regarding health and consumer protection issues, and promoting international cooperation on these issues. Issues such as diet and obesity, tobacco and other consumption-related choices related to health are examples of cross cutting issues affecting both health and consumer protection. Taking a joint approach to these common objectives and instruments will enable activities common to both health and consumer protection to be undertaken more efficiently and effectively. There are also separate objectives relating to each of the two areas of health and consumer protection which should be addressed through actions and instruments specific to each of the two areas.

    deleted

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme.

    Amendment 38

    Recital 5

    (5) Coordination with other Community policies and programmes is a key part of the joint objective of mainstreaming health and consumer policies in other policies. In order to promote synergies and avoid duplication, appropriate use will be made of other Community funds and programmes including the Community framework programmes for research and their outcomes, the Structural Funds, and the Community Statistical Programme.

    (5) Coordination with other Community policies and programmes is a key part of the objective of mainstreaming health in other policies. In order to promote synergies and avoid duplication, joint actions will be undertaken with related Community programmes and actions and appropriate use will be made of other Community funds and programmes including the Community framework programmes for research and their outcomes, the Structural Funds, the Cohesion Fund, the European Agricultural Guidance and Guarantee Fund, the European Solidarity Fund and the Community Statistical Programme. It should also be ensured that they all incorporate the health aspect.

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection programme. It is essential to aim for synergy between the actions under the programme and other Community programmes, actions and funds.

    Amendment 39

    Recital 5 a (new)

     

    (5a) It is necessary to increase EU investment in health and health-related projects. In this regard, Member States should identify health improvements as a priority in their national programmes. Better awareness about the possibilities of EU funding for health is needed. Exchange of experience between the Member States on funding health through the Structural Funds must be encouraged.

    Justification

    In order to finance health through structural funds health has to be included as a priority in Member States' national programmes. Awareness among the population needs to be raised as there is not enough information about this possibility.

    Amendment 40

    Recital 6

    (6) It is of general European interest that the health, safety and economic interests of citizens, as well as consumer interests in the development of standards for products and services, be represented at Community level. Key objectives of the programme may also depend on the existence of specialised networks that also require Community contributions to enable them to develop and function. Given the particular nature of the organisations concerned and in cases of exceptional utility, the renewal of Community support to the functioning of such organisations should not be subject to the principle of gradual decrease of the extent of Community support.

     

    (6) Non-governmental organisations and specialised networks also play an important role in promoting public health and representing citizens' interests in health policy in the Community. They require Community contributions to enable them to develop and function. Eligibility criteria and provisions regarding financial transparency for non-governmental organisations and specialised networks qualifying for Community support should be established under this Decision. Given the particular nature of the organisations concerned and in cases of exceptional utility, the renewal of Community support to the functioning of such organisations should not be subject to the principle of gradual decrease of the extent of Community support.

    Justification

    NGOs and specialised networks play an important role in promoting health and, consequently should take part in the programme.

    Amendment 41

    Recital 7

    (7) Implementation of the programme should build upon and extend existing actions and structural arrangements in the fields of public health and consumer protection, including the Executive Agency for the Public Health Programme set up by Commission Decision 2004/858/EC. Implementation should be carried out in close cooperation with relevant organisations and agencies, in particular with the European Centre for Disease Prevention and Control established by Regulation (EC) No 851/2004 of the European Parliament and of the Council.

    (7) Implementation of the Programme should include the Executive Agency for the Public Health Programme set up by Commission Decision 2004/858/EC as well as close cooperation with relevant organisations and agencies, in particular with the European Centre for Disease Prevention and Control (ECDC) established by Regulation (EC) No 851/2004 of the European Parliament and of the Council. The Commission should communicate to the ECDC all information and data collected under the Programme which are relevant to its mission.

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection programme. It is important that the Commission should cooperate and communicate with the European Centre for Disease Prevention and Control.

    Amendment 42

    Recital 9

    (9) The Agreement on the European Economic Area (hereinafter referred to as the EEA Agreement) provides for cooperation in the fields of health and consumer protection between the European Community and its Member States, on the one hand, and 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. Provision should also be made to open the programme to participation by other countries, in particular the neighbouring countries of the Community, countries that are applying for, candidates for or acceding to membership of the Community, taking particular account of the potential for threats to health arising in other countries to have an impact within the Community.

    (9) The Agreement on the European Economic Area (hereinafter referred to as the EEA Agreement) provides for cooperation in the field of health between the European Community and its Member States, on the one hand, and 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. Provision should also be made to open the Programme to participation by other countries, in particular the neighbouring countries of the Community, countries that are applying for, candidates for or acceding to membership of the Community, taking particular account of the potential for threats to health arising in other countries to have an impact within the Community.

     

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection Programme.

    Amendment 43

    Recital 11

    (11) It is appropriate to develop cooperation with relevant international organisations such as the United Nations and its specialised agencies including the World Health Organisation, 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 and consumer protection at Community and international level, taking account of the particular capacities and roles of the different organisations.

    (11) In order to maximise the effectiveness and efficiency of actions relating to health at Community and international level, it is appropriate to develop cooperation with relevant international organisations such as the United Nations and its specialised agencies including the World Health Organisation, as well as with the Council of Europe and the Organisation for Economic Cooperation and Development.

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme.

    Amendment 44

    Recital 12

    (12) In order to increase the value and impact of the programme there should be regular monitoring and evaluation, including independent external evaluations, of the measures taken.

    (12) Progress towards meeting the health objectives under this Programme needs to be measured and evaluated in order to increase the value and impact of the Programme. There should be regular monitoring and evaluation, including independent external evaluations, of the measures taken.

    Amendment 45

    Recital 13

    (13) Since the objectives of the action to be taken on health and consumer protection cannot be sufficiently achieved by the Member States due to the trans-national nature of the issues involved, and can therefore by reason of the potential for Community action to be more efficient and effective than national action alone in protecting the health, safety and economic interests of citizens, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this decision does not go beyond what is necessary in order to achieve those objectives.

    (13) In accordance with the principles of subsidiarity and proportionality set out in Article 5 of the Treaty, Community action on matters which do not fall within the exclusive competence of the Community, such as those in the field of public health, should be undertaken only if and in so far as, by reason of its scale or effects, its objective can be better achieved by the Community. The objectives of the Programme cannot be sufficiently achieved by the Member States because of the complexity, transnational character and lack of complete control at Member State level over the factors affecting health, and therefore the Programme should support and complement the Member States' actions and measures. The Programme can provide significant added value to health promotion and to health systems in the Community through the support of structures and programmes which enhance the capabilities of individuals, institutions, associations, organisations and bodies in the health field by facilitating the exchange of experience and best practices and by providing a basis for a common analysis of the factors affecting public health. Also, the Programme may have added value in the event of threats to public health of a cross-border nature, such as infectious diseases, environmental pollution or food contamination, to the extent that they prompt joint strategies and actions with a view to protecting health and safety, promoting health-related economic interests of citizens and alleviating the economic burden to European citizens as patients.

    Justification

    This amendment is in accordance with the decision by the Conference of Presidents to split the programme. The Health Programme should also deal with aspects relating to the role of citizens as patients in the reception of health services. The actions under the programme may encourage cooperation between the Member States on cross-border care in order to ensure effective or urgent treatment and the promotion of patients’ health with a view to improving the complementarity of health services in border regions.

    Amendment 46

    Recital 13 a (new)

     

    (13a) In accordance with Article 2 of the Treaty providing that equality between men and women is a principle of the European Community and in accordance with Article 3(2) thereof providing that the Community shall aim to eliminate inequalities, and to promote equality between men and women in all Community activities including the attainment of a high level of health protection, all objectives and actions covered by the programme of Community action in the field of health will promote a better understanding and recognition of men’s and women’s respective needs and approaches to health.

    Justification

    By Treaty provision [Articles 2 and 3(2) EC] and according to the Community commitments for gender mainstreaming, gender must be explicitly referred to in the programme which objective is to contribute to a high level of health protection. Therefore, the proposed Recital should be introduced on the same level as the subsidiarity and proportionality EC Treaty principles.

    Amendment 47

    Recital 14

    (14) The Commission should ensure an appropriate transition between this programme and the two programmes it replaces, in particular regarding the continuation of multi-annual measures and administrative support structures such as the Executive Agency for the Public Health Programme.

    (14) The Commission should ensure an appropriate transition between the Programme and the first programme it replaces, in particular regarding the completion of the financing obligations undertaken.

     

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme.

    Amendment 48

    Article 1

    Establishment of the programme

    Establishment of the Second programme

    A programme of Community action in the field of health and consumer protection covering the period from 1 January 2007 to 31 December 2013, hereinafter referred to as ‘the programme’ is hereby established.

    The second programme of Community action in the field of health covering the period from 1 January 2007 to 31 December 2013, hereinafter referred to as ‘the Programme’, is hereby established.

     

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection programme.

    Amendment 49

    Article 2

    1. The programme shall complement and support the policies of the Member States and shall contribute to protecting the health, safety and economic interests of citizens.

    The Programme shall complement, support and add value to the policies of the Community and Member States and shall contribute to protecting and promoting human health and safety, preventing human illness, diseases and injuries and improving public health.

    2. The aim referred to in paragraph 1 shall be pursued through common objectives together with specific objectives in the fields of health and consumer protection.

     

    (a) The common objectives for health and consumer protection to be pursued through the actions and instruments set out in Annex 1 to this Decision shall be:

     

    – to protect citizens from risks and threats that are beyond the control of individuals;

     

    – to increase the ability of citizens to take better decisions about their health and consumer interests;

     

    – and to mainstream health and consumer policy objectives.

     

    (b) The specific health objectives to be pursued through the actions and instruments set out in Annex 2 to this Decision shall be:

    The objectives to be pursued through the actions and instruments set out in the Annex to this Decision shall be:

    – to protect citizens against health threats;

    - to protect citizens against health threats

    - to promote policies that lead to a healthier way of life;

    - to promote policies that lead to a healthier way of life;

    – to contribute to reducing the incidence of major diseases;

    – to contribute to reducing the incidence, morbidity and mortality of major diseases and injuries;

    and to improve efficiency and effectiveness in health systems.

    - to improve efficiency and effectiveness in health systems; and

     

    - to improve information and knowledge for the development of public health and to contribute to mainstreaming of health objectives.

    (c) The specific consumer protection objectives to be pursued through the actions and instruments set out in Annex 3 to this Decision shall be:

    – a better understanding of consumers and markets;

    – better consumer protection regulation;

    – better enforcement, monitoring and redress;

    – and better informed and educated and responsible consumers.

     

    Justification

    This amendment is in accordance with the decision by the Conference of Presidents to split the programme. Consequently, it is necessary to modify the aims and objectives of the programme to correspond to Article 152 of the EC Treaty. The actions corresponding to the objectives are presented in the Annex. This is an essential addendum in order to clarify the definition of the aims and objectives of the programme. A notable addendum is the reduction in the mortality and morbidity of major diseases and injuries.

    Amendment 50

    Article 2, paragraph 2 a (new)

     

    2a. The programme shall further contribute to:

     

    (a) ensuring a high level of human health protection in the definition and implementation of all Community policies and activities, through the promotion of a multi-faceted approach to health;

     

    (b) tackling inequalities of all kinds in the field of health which exist amongst and within Member States so that all EU citizens have access to health care of a comparable standard, irrespective of sex, age, ethnic origin, education or place of residence;

     

    (c) encouraging cooperation between Member States in the areas covered by Article 152 of the Treaty and empowering citizens by facilitating patient mobility and increasing transparency between the various countries' health systems;

    Amendment 51

    Article 3, paragraph 1, introductory part

    1. Actions in pursuit of the aims and objectives set out in Article 2 shall make full use of appropriate available methods of implementation including in particular:

    1. Actions in pursuit of the aims and objectives set out in Article 2 shall make full use of appropriate methods of implementation and funding adopted in accordance with the management procedure referred to in Article 6(2), including in particular:

    Justification

    This amendment is in accordance with the decision by the Conference of Presidents to split the programme. The methods of implementing the programme and the terms of funding will be defined by the programme’s management committee.

    Amendment 52

    Article 3, paragraph 2, point (a)

     

     

    (a) 60% for an action intended to help achieve an objective forming part of a Community policy within the field of health and consumer protection, except in cases of exceptional utility where the Community contribution shall not exceed 80%; and,

     

    (a) 60% for an action intended to help achieve an objective forming part of a Community policy within the field of health, except in cases of exceptional utility where the Community contribution shall not exceed 80%; and,

     

     

     

    Justification

    This amendment is in accordance with the decision of Conference of Presidents to split the programme into two parts.

    Amendment 53

    Article 3, paragraph 2, point (b)

    (b) 60% of expenditure for the functioning of a body pursuing an aim of general European interest where such support is necessary to ensure representation of health or consumer interests at Community level or to implement key objectives of the programme, except in cases of exceptional utility where the Community contribution shall not exceed 95%. The renewal of such financial contributions may be exempted from the principle of gradual decrease.

    (b) 75% of expenditure for the functioning of a body or a specialised network, which is non-governmental, non-profit making, independent of industry, commercial and business or other conflicting interests, and has members in at least half of the Member States, where such NGO or specialised network has as its primary objective the promotion of health or the prevention or treatment of diseases in the European Community, where such support is necessary to ensure representation of interests at Community level or to implement key objectives of the Programme. Applicants must provide to the Commission full and updated accounts of their membership, internal rules and sources of funding. In cases of exceptional utility, the Community contribution shall not exceed 95%. The criteria for assessing whether or not exceptional utility applies shall be established in advance in the annual work plan referred to in Article 7(1)(a) and published. The renewal of such financial contributions to NGOs and specialised networks may be exempted from the principle of gradual decrease.

     

    The Commission can, as the general rule, seek to grant core funding on a two-year basis by means of a network partnership convention. In accordance with Article 163 of the Implementing Rules of the Financial Regulation such a partnership establishes a long-term cooperation between the recipient and the Commission, but shall not exceed two years.

    Justification

    Participation of civil society is vitally important for the formulation and implementation of European health policy. The EU provides core funding so that health interests could be effectively represented at the Community level. The specification of NGOs, which play an important role in promoting health and are able to take part in the programme, will provide greater legal certainty for funding the measures under the programme. Further, establishing in advance the criteria for assessing whether or not exceptional utility applies should also give more legal certainty for funding.

    The application of Article 163 of the Implementing Rules of the Financial Regulation will provide the relevant health organisations with more financial certainty and reduce the administrative burden of both the Commission and the European health organisations. Core financing is, contrary to project funding, by nature distributed to organisations which pursue long term objectives. Therefore, the possibility of establishing a long-term co-operation is especially suited to applicants for core funding.

    Amendment 54

    Article 3, paragraph 3

    3. For the purpose of paragraph 1(a) above, financial contributions by the Community may, where appropriate given the nature of the objective to be achieved, include joint financing by the Community and one or more Member States or by the Community and the competent authorities of other participating countries. In this case, the Community contribution shall not exceed 50%, except in cases of exceptional utility, where the Community contribution shall not exceed 70%. These Community contributions may be awarded to a public body or a non-profit-making body designated by the Member State or the competent authority concerned and agreed by the Commission.

     

    3. For the purpose of paragraph 1(a) above, financial contributions by the Community may, where appropriate given the nature of the objective to be achieved, include joint financing by the Community and one or more Member States or by the Community and the competent authorities of other participating countries. In this case, the Community contribution shall not exceed 50%, except in cases of exceptional utility, where the Community contribution shall not exceed 70%. These Community contributions may be awarded to a public body or a non-profit-making body designated by the Member State or the competent authority concerned and agreed by the Commission. These Community contributions should be granted on the basis of the criteria for patients’ and consumers’ organisations adopted by the European Medicines Agency (September 2005).

    Justification

    It is in the public interest that these Community contributions to patients’ and consumers’ organisations can be made available as soon as possible after the adoption of the programme of community action in the field of health (2007-2013). Relevant criteria already exists and have been officially adopted by the European Medicines Agency (EMEA) in September 2005. Where both the European Commission and the EMEA use the same criteria in consistency will be ensured at the EU level.

    Amendment 55

    Article 4

    The Commission shall ensure the implementation of the programme in accordance with the provisions of Article 7.

    1. The Commission shall ensure the implementation, in close cooperation with the Member States, of the actions and measures set out in the Programme in accordance with the provisions of Articles 6 and 7 and ensuring its harmonious and balanced development.

    Justification

    Cooperation between the Commission and the Member States is a precondition for effective implementation of the programme.

    Amendment 56

    Article 4, paragraph 1 a (new)

     

    1a. In order to assist the implementation, the Commission shall ensure the coordination and, if necessary, the integration of networks for health monitoring and rapid reaction to health threats.

    Amendment 57

    Article 4, paragraph 1 b (new)

     

    1b. The Commission and the Member States shall take appropriate action, within their respective areas of competence, to ensure the efficient running of the Programme and to develop mechanisms at Community and Member State level to achieve the objectives of the Programme. They shall ensure that appropriate information is provided about actions supported by the Programme and that the widest possible participation is obtained in actions requiring implementation through local and regional authorities and non-governmental organisations.

    Justification

    Coordination and cooperation between the Commission and the Member States is absolutely essential for effective implementation of the programme.

    Amendment 58

    Article 4, subparagraph 1 c (new)

     

    1c. The Commission shall ensure that all activities pertaining to the recording, processing and communication of data comply with the overall approach of the 'Open Method of Coordination in Health Care'.

    Justification

    It should be made clear that avoiding duplication of effort must receive ample attention. In particular, however, it seems important to put in order the terminology relating to the recording, processing and communication of data and to render it semantically unambiguous.

    Amendment 59

    Article 4, paragraph 1 d (new)

     

    1d. The Commission shall, in close cooperation with the Member States, pursue the comparability of data and information, and the compatibility and interoperability of the systems and networks for exchange of data and information on health.

    Amendment 60

    Article 4, paragraph 1 e (new)

     

    1e. The Commission shall ensure, in close cooperation with the Member States, for the attainment of the objectives of the Programme the necessary cooperation and communication with the European Centre for Disease Prevention and Control.

    Justification

    Coordination and cooperation between the Commission, the Member States and the ECDC is absolutely necessary for the effective implementation of the objectives of the programme.

    Amendment 61

    Article 4, paragraph 1 f (new)

     

    1f. In implementing the Programme, the Commission, together with the Member States, shall ensure compliance with all relevant legal provisions regarding personal data protection and, where appropriate, the introduction of mechanisms to ensure the confidentiality and safety of such data.

    Justification

    Collection of relevant data is an essential part of the programme. In order to guarantee its legitimacy and credibility, it must comply with all relevant legal provisions on data protection.

    Amendment 62

    Article 4, paragraph 1 g (new)

     

    1g. The Commission, in close cooperation with the Member States, shall ensure the transition between those actions developed within the first programme adopted by the Decision referred to in Article 11 which contribute to the priorities set out in this programme, and those to be implemented under this programme.

    Amendment 63

    Article 4 a (new)

     

    Article 4a

     

    Joint strategies and actions

     

     

    1. To ensure a high level of human health protection in the definition and implementation of all Community policies and activities and to promote the mainstreaming of health, the objectives of the Programme may be implemented as joint strategies and joint actions by creating links with relevant Community programmes, actions and funds.

     

     

    2. The Commission shall ensure that the Programme ties in optimally with other Community programmes, actions and funds. In particular, cooperation with the 7th Framework Programme of Research should reinforce the impact of the health programme.

    Justification

    It is necessary to develop joint strategies and actions by promoting Community synergy and maximising the impact of the programme on other Community measures, actions and funds.

    Amendment 64

    Article 5, paragraph 1

    1. The financial framework for the implementation of the programme for the period specified in Article 1 is EUR 1 203 million.

     

    1. The indicative financial framework for the implementation of the Programme is set at EUR 1 500 million for the seven-year period starting on 1 January 2007.

     

    Justification

    The budget for the programme should be increased to cover the addition of new actions and measures and to ensure its integrated and effective implementation.
    The amendment emphazises that the amount proposed is subject to confirmation by a possible multiannual financial framework.

    Amendment 65

    Article 5, paragraph 2 a (new)

     

    2a. The Commission shall ensure that the financial provisions for the funding of the Programme comply with the provisions of the Financial Regulation applicable to the general budget of the European Communities.

    Justification

    Any derogation within the basic act should be in line with the provisions the Financial Regulation.

    Amendment 66

    Article 7, paragraph 1, point (a)

    (a) the annual plan of work for the implementation of the programme, setting out priorities and actions to be undertaken, including the allocation of resources and relevant criteria;

    (a) the annual plan of work for the implementation of the Programme, setting out priorities and actions to be undertaken, including the allocation of resources;

    Justification

    This amendment together with subsequent amendments aims to make the provisions on implementation clearer and more precise.

    Amendment 67

    Article 7, paragraph 1, point (a a) (new)

     

    (aa) the arrangements, criteria, transparency measures and procedures for selecting and financing the actions of the Programme;

    Justification

    These matters call, in procedural terms, for the adoption of implementing measures by the management committee.

    Amendment 68

    Article 7, paragraph 1, point (a b) (new)

     

    (ab) the arrangements for the coordination, transmission, exchange and dissemination of information and intellectual property and the detention of data relating to actions and measures referred to in the Annex.

    Justification

    These matters call, in procedural terms, for the adoption of implementing measures by the management committee.

    Amendment 69

    Article 7, paragraph 2

    2. The Commission shall adopt any other measures necessary for the implementation of this Decision. The Committee shall be informed of them.

    2. The Commission shall adopt any other measures necessary for the implementation of this Decision in accordance with the advisory procedure referred to in Article 6(3).

    Justification

    Provides greater clarity.

    Amendment 70

    Article 9

    In the course of implementing the programme, relations with third countries that are not participating in the programme and relevant international organisations shall be encouraged.

    In the course of implementing the Programme, relations with third countries that are not participating in the Programme and relevant international organisations, in particular the WHO, shall be encouraged.

    Justification

    The World Health Organisation should be specifically named here, as it is the most important international organisation in the field of health.

    Amendment 71

    Article 10, paragraph 2

    2. At the request of the Commission, Member States shall submit information on the implementation and impact of this programme.

    2. The Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions:

     

    (a) an external and independent interim evaluation report on the results obtained and on the qualitative and quantitative aspects of the implementation of the Programme three years after its adoption; the report shall in particular make it possible to assess the impact of measures on all countries; the report shall contain a summary of the main conclusions and remarks by the Commission;

     

    (b) a Communication on the continuation of the Programme no later than four years after its adoption;

     

    (c) no later than 31 December 2015, a detailed external and independent ex-post evaluation report covering the implementation and results of the Programme, to be drawn up on completion of its implementation.

    Justification

    An independent evaluation of the results of the programme is considered essential.

    Amendment 72

    Article 10, paragraph 3

    3. The Commission shall ensure that the programme is evaluated three years after its start and following the end of the programme. The Commission shall communicate the conclusions thereof, accompanied by its comments, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

    deleted

    Justification

    The contents of this paragraph are incorporated in a clearer and more precise form in amendment to Article 10, paragraph 2.

    Amendment 73

    Article 10, paragraph 3 a (new)

     

    3a. The Commission shall publish every two years after the adoption of the Programme a report on Health Status in the European Union based on all data and indicators and including a qualitative and quantitative analysis.

    Justification

    A periodical report should be published on health in the Union based on data and indicators derived from implementation of the measures under the programme.

    Amendment 74

    Article 11

    Decisions No 1786/2002/EC and No 20/2004/EC are repealed.

     

    Decision No 1786/2002/EC is repealed.

     

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection Programme.

    Amendment 75

    Article 12

    The Commission shall adopt any measures necessary to ensure the transition between the measures adopted under Decisions No 1786/2002/EC and No 20/2004/EC and those to be implemented under this programme.

    The Commission shall adopt any measures necessary to ensure the transition between the measures adopted under Decision No 1786/2002/EC and those to be implemented under the Programme.

     

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. The deleted parts are covered by the report on the Consumer Protection programme.

    Amendment 76

    Annex 1

     

    This annex deleted

    Justification

    All the elements relevant to the Health Programme should be included in Annex 2, so that the programme would contain only one single Annex.

    Amendment 77

    Annex 2, title

    ANNEX 2 - HEALTH

    ANNEX

    Justification

    As Annex 1 is merged with Annex 2 and Annex 3 covers the Consumer Protection programme, there will only be one annex in the Public Health Programme.

    Amendment 78

    Annex 2, Objective 1, point 1

    1. Enhance surveillance and control of health threats by

     

    1.1. Enhance surveillance and control of health threats by

     

     

    (The numbering of the sub-points should be altered accordingly, i.e. 1.1.1., 1.1.2, etc.)

    Justification

    Change of numbering.

    Amendment 79

    Annex 2, Objective 1, point 1, sub-point 1.1.

    1.1. Enhancing the capacity to tackle communicable diseases by supporting the further implementation of Decision No 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases;

    1.1. Enhancing the capacity to tackle communicable diseases by supporting the further implementation of Decision No 2119/98/EC on the Community network on the epidemiological surveillance and control of communicable diseases, taking into account the activities of the European Centre for Disease Prevention and Control;

    Justification

    It is important that the role already performed by the European Centre for Disease Prevention and Control is not duplicated through the implementation of this programme.

    Amendment 80

    Annex 2, Objective 1, point 1, sub-point 1.3.

    1.3. Exchanging information on strategies and developing joint strategies to detect and obtain reliable information on health threats from physical, chemical or biological sources, including those relating to deliberate release acts, and developing and using, when appropriate, Community approaches and mechanisms;

    1.3. Exchanging information on strategies and developing joint strategies to detect and obtain reliable information on health threats from physical, chemical or biological sources, including those relating to deliberate release acts, and developing and using, when appropriate, Community approaches and mechanisms in coordination with the European Centre for Disease Prevention and Control;

    Amendment 81

    Annex 2, Objective 1, point 1, sub-point 1.5.a (new)

     

    1.5.a Monitoring the resistance of bacteria to antibiotics and of nosocomial infections, and developing strategies to prevent and treat them.

    Justification

    The increase in resistance to antibiotics and the increase in nosocomial infections are of particular concern at the present time. There is, therefore, a need to collect data, to monitor and to develop strategies to treat them.

    Amendment 82

    Annex 2, Objective 1, point 1, sub-point 1.6.a (new)

     

    1.6.a Developing measures to prevent disease and injury in socially isolated individuals and to raise the awareness of immigrants in matters of health.

    Amendment 83

    Annex 2, Objective 1, point 1, sub-point 1.6.b (new)

     

    1.6.b Encouraging Member States to establish genuinely independent drug scrutiny boards to monitor the usage and effects of all new prescription drugs from the date of their approval.

     

    Justification

    Self-explanatory. Stress should be placed on the need for such boards to be genuinely independent and free from influence by pharmaceuticals companies.

    Amendment 84

    Annex 2, Objective 1, point 2

    2. Deliver response to health threats by

    1.2. Deliver response to health threats by

     

     

    (The numbering of the subpoints should be altered accordingly, i.e. 1.2.1., 1.2.2, etc.)

    Justification

    Change of numbering.

    Amendment 85

    Annex 2, Objective 1, point 2, sub-point 2.1.

    2.1. Elaborating risk management procedures for health emergencies and enhancing capability for coordinated responses to health emergencies;

    2.1. Elaborating risk management procedures for health emergencies, including procedures for mutual assistance in the event of pandemics, and enhancing capability for coordinated responses to health emergencies;

    Justification

    Flu pandemics and the growing threat of other diseases exposes the gap between the richer and poorer countries in the Union. Some can cope with the challenge posed by diseases, while others cannot. It is therefore proposed that provision be made for procedures and assistance in such cases.

    Amendment 86

    Annex 2, Objective 2, point 3

    3. Promote health by tackling determinants

    2. Promote health by tackling determinants

     

    (The numbering of the subpoints should be altered accordingly, i.e. 2.1., 2.2., etc.)

    Justification

    Change of numbering.

    Amendment 87

    Annex 2, Objective 2, point 3, sub-point 3.1.

    3.1. Health determinants linked to addictions, notably tobacco, alcohol and drugs and other addictive substances;

     

    3.1. Health determinants linked to addictions, notably tobacco, alcohol, medical prescription drugs, illegal drugs and other addictive substances;

     

    Justification

    Decision No 1786/2002/EC adopting a programme of Community action in the field of public health (2003- 2008) includes drug prevention under the health determinants strand of the public health programme. It is important to acknowledge here the problem of drugs- related health damage caused by addiction to (legal) prescription drugs by identifying the latter as health determinants. The consequences for individuals can be akin to those created by heroin and alcohol addiction.

    Amendment 88

    Annex 2, Objective 2, point 3, sub-point 3.1. a (new)

     

    3.1.a Practices which lead to a healthier life, in order to improve children's health;

     

    Amendment 89

    Annex 2, Objective 2, point 3, sub-point 3.2.

    3.2. Lifestyle related health determinants, notably nutrition and physical activity, sexual health and reproductive health;

    3.2. Lifestyle related health determinants, notably nutrition and physical activity, sexual health and reproductive health and mental health;

    Justification

    Lifestyle determinants are having an increasing impact on mental health, for example occupational stress and depression.

    Amendment 90

    Annex 2, Objective 2, point 3, sub-point 3.2. a (new)

     

    3.2.a Injury-related health determinants;

    Justification

    The identification of injury-related determinants could improve their prevention and medical care.

    Amendment 91

    Annex 2, Objective 2, point 3, sub-point 3.3.

    3.3. Social and economic determinants of health, with a particular focus on inequalities in health and on the impact of social and economic factors on health;

    3.3. Social and economic determinants of health, with a particular focus on inequalities in health, on the impact of social and economic factors on health, and on discrimination against vulnerable groups;

    Justification

    It is essential to include measures to reduce discrimination against vulnerable groups in matters of health, such as the disabled.

    Amendment 92

    Annex 2, Objective 2, point 3, sub-point 3.3. a (new)

     

    3.3.a Identification of the causes of health inequalities, which have an impact on prevention and optimal health care, with particular attention to health inequalities in the new Member States.

     

    Justification

    There are currently major differences between the Member States and within them in terms of average lifespan of citizens, their state of health and their access to care. This is particularly true for the new Member States. Consequently, it is essential that the programme takes measures to reduce them and involve the new Member States.

    Amendment 93

    Annex 2, Objective 2, point 3, sub-point 3.4.

    3.4. Environmental determinants of health, with a particular emphasis on the health impact of environmental factors;

    3.4. Environmental determinants of health, with a particular emphasis on the health impact of environmental factors, including indoor air quality and the exposure to toxic chemicals, such as carcinogenic, mutagenic, reprotoxic and allergenic substances;

    Amendment 94

    Annex 2, Objective 2, point 3, sub-point 3.4. a (new)

     

    3.4.a Analysis of genetic determinants and personal and biological factors of major diseases and development of prevention strategies, including genetic screening;

    Justification

    These issues were specifically listed in the legal text of the current Public Health Programme but are missing in the text of the new Health Programme.

    Amendment 95

    Annex 2, Objective 2, point 3, sub-point 3.5.a (new)

     

    3.5.a The development of strategies and the exchange of correct practices in order to prevent disability, where possible, and promote the health of people with disabilities;

    Justification

    It is essential to include measures to develop strategies and exchange correct practices to prevent disability, where feasible, and to promote the health of people with disabilities.

    Amendment 96

    Annex 2, Objective 2, point 3, sub-point 3.5. b (new)

     

    3.5.b Support for the development of education units on nutrition for parents and children, with actions which also reach strata remote from education.

    Justification

    Overweight and obesity among children, who are likely to carry the condition on into adulthood, due to wrong diets, is a growing problem in Europe. Targeted measures, which are also perceived by strata remote from education, should tackle the problem.

    Amendment 97

    Annex 2, Objective 2, point 3, sub-point 3.5. c (new)

     

    3.5.c Support for strategies for health promotion in businesses;

    Justification

    'Health promotion building blocks' should be made available to businesses which they can use to provide health education for their employees and to protect their health.

    Amendment 98

    Annex 2, Objective 2, point 3, sub-point 3.5. d (new)

     

    3.5.d Support for actions to improve diagnosis and therapy for older persons;

    Justification

    The field of geriatric medicine should receive support in the EU Member States. Diagnosis and therapy for older persons suffering from so-called diseases of old age require separate attention and separate methods.

    Amendment 99

    Annex 2, Objective 2, point 3, sub-point 3.5.e (new)

     

    3.5.e Gender and age aspects of health.

    Justification

    Gender aspects of health are not acknowledged despite recent work to highlight the gender differences and inequalities in health of both women and men. Ageing appears in the introduction of the proposal but is absent in the draft legal text.

    Amendment 100

    Annex 2, Objective 3

    Objective 3: contribute to reducing the incidence of major diseases

     

    Objective 3: contribute to reducing the incidence, morbidity and mortality of major diseases and injuries

    Justification

    Amendment for consistency with amendment of part of Article 2 concerning the objectives of the programme.

    Amendment 101

    Annex 2, Objective 3, point 4

    4. Prevent diseases and injuries

    3. Prevent diseases and injuries

     

     

    (The numbering of the subpoints should be altered accordingly, i.e. 3.1., 3.2., etc.)

    Justification

    Change of numbering.

    Amendment 102

    Annex 2, Objective 3, introductory phrase

    In coordination with work on health determinants, the programme shall support:

    In coordination with work on determinants, the Programme shall support:

    Justification

    Provides greater clarity.

    Amendment 103

    Annex 2, Objective 3, point 4, sub-point 4.1.

    4.1. Development and implementation of actions on major diseases of particular significance in view of the overall burden of disease in the Community where Community action can provide significant added value to national efforts;

    4.1. Development and implementation of actions on major diseases of particular significance in view of the overall burden of disease and of the main causes of potential life years lost and incapacities in the Community where Community action can provide significant added value to national efforts;

    Justification

    The emphasis is placed on the diseases themselves but also on their causes.

    Amendment 104

    Annex 2, Objective 3, point 4, sub-point 4.2.

    4.2. Preparation and implementation of strategies and measures on disease prevention, in particular by identifying best practice and developing guidelines and recommendations, including on secondary prevention, screening and early detection;

    4.2. Preparation and implementation of strategies and measures on disease prevention and rehabilitation, in particular in the case of major diseases, by:

    - focusing on primordial prevention (to prevent the development of disease risk in the next generations),

    - developing primary prevention in asymptomatic adults including mass prevention and high risk strategies,

    - identifying best practice and developing guidelines and recommendations (with particular emphasis on strategies aiming at closing the gap between guidelines, recommendations and actual practice), including on secondary prevention, for example screening and early detection,

    -promoting and developing risk-assessment tools, and

    -addressing gender differences and population ageing.

    Justification

    Prevention is to be addressed globally, i.e. early and late in life, in the male and female population not at risk as well as in the population having suffered from disease in the past. This can be done simply by giving primary care professionals and general practitioners access to risk-assessment tools. A special focus on the medical profession education is needed.

    Amendment 105

    Annex 2, Objective 3, point 4, sub-point 4.2, subparagraph 1 a (new)

     

    Accordingly, the Commission will submit, during the course of this Framework Programme, proposals for Council Recommendations on the prevention, diagnosis and control of major diseases.

    Justification

    The transferring of best practice across Europe for major diseases will undoubtedly add value to national health strategies. EU actions are also justified in terms of efficiency as well as addressing inequalities between Member States by reducing inconsistency in national policies. The diseases have already, to varying degrees, attracted EU attention but incoherently it follows that Europe should contribute now to prevention, diagnosis and control in these areas.

    Amendment 106

    Annex 2, Objective 3, point 4, sub-point 4.2.a (new)

     

    4.2.a Preparation of strategies and measures on immunisation and vaccination and recommendations for their implementation.

    Amendment 107

    Annex 2, Objective 3, point 4, sub-point 4.3.a (new)

     

    4.3.a Development of strategies and measures to address and rectify the causes of health inequalities;

    Justification

    Self-explanatory as a reduction in inequalities is one of the priorities of the programme.

    Amendment 108

    Annex 2, Objective 3, point 4, sub-point 4.3.b (new)

     

    4.3.b Promotion of best practice for diseases and injuries in order to prevent further deterioration of health;

    Justification

    Self-explanatory as a reduction in inequalities is one of the priorities of the programme.

    Amendment 109

    Annex 2, Objective 3, point 4, sub-point 4.3.c (new)

     

    4.3.c Promotion of telemedicine with a view to the networking of health services, facilitating patient mobility and the provision of care at home, principally for the elderly, the disabled or isolated individuals;

    Justification

    Telemedicine applications promote patients' mobility, facilitating their prompt and appropriate access to health services. At the same time, providing care at home, also by way of telemedicine, to elderly, disabled or isolated individuals helps to reduce the impact of disease and injury, and rationalise expenditure in the health sector.

    Amendment 110

    Annex 2, Objective 3, point 4, sub-point 4.4.

    4.4. Preparation and implementation of strategies and measures on prevention of injuries;

    4.4. Preparation and implementation of strategies and measures on prevention of injuries, based on injury determinants;

    Justification

    Action must be based on injury determinants identified by the analysis of injury data.

    Amendment 111

    Annex 2, Objective 3, point 4, sub-point 4.4.a (new)

     

    4.4.a Development of best practice and guidelines on injuries based on the analysis of collected data;

    Justification

    Development of best practice and guidelines is the best option for preventive measures and medical care of injuries.

    Amendment 112

    Annex 2, Objective 3, point 4, sub-point 4.5.a (new)

     

    4.5.a Identification of knowledge gaps in order to combat major diseases and provide incentives for research in EU research programmes.

    Justification

    The EU should also join forces to identify knowledge gaps and there should be a link to FP7 programme. A more pro-active research policy and public expenditure may reduce the treatment gaps that still exists in diseases areas that are not profitable for the pharmaceutical industry to develop.

    Amendment 113

    Annex 2, Objective 4, point 5

    5. Achieve synergies between national health systems by

    4. Achieve synergies between national health systems by

     

    (The numbering of the subpoints should be altered accordingly, i.e. 4.1., 4.2., etc.)

    Justification

    Change of numbering.

    Amendment 114

    Annex 2, Objective 4, point 5, sub-point 5.1.

    5.1. Facilitating cross-border healthcare purchasing and provision, including information gathering and exchange to enable sharing of capacity and use of cross-border care;

    5.1. Facilitating cross-border healthcare purchasing and provision through cooperation between the Member States to improve the complementarity of their health service in cross-border areas and patient mobility, including, inter alia :

     

    - information gathering and exchange to enable sharing of capacity and use of cross-border care especially in the case of rare and extremely rare diseases;

     

    - information about healthcare providers and services available abroad as well as rules regarding the reimbursement of healthcare costs;

     

    - information on treatments which are not available in the patient's Member State of origin and in regard to access to treatments which, though urgent, cannot be provided immediately in the patient's Member State of origin;

    Amendment 115

    Annex 2, Objective 4, point 5, sub-point 5.2.

    5.2. Sharing information on and managing the consequences of the mobility of health professionals;

     

    5.2. Collecting data and sharing information on and managing the consequences of the mobility of health professionals and promoting policies on patient mobility;

     

    Amendment 116

    Annex 2, Objective 4, point 5, sub-point 5.3.

    5.3. Establishing a Community system for cooperation on centres of reference and other collaborative structures between health systems of more than one Member State;

    5.3. Establishing a Community system for cooperation on centres of reference and other collaborative structures between health systems of more than one Member State which would enable doctors and other healthcare practitioners to apply best practices and best knowledge on prevention and treatment available within the EU;

    Justification

    Establishment of European centres of reference for each important diseases area (for instance, cardio-vascular, diabetes, lung diseases, mental health, ...) can spread knowledge and best practices both for prevention and treatment throughout the Union. These centres may also contribute to inform citizens/patients on diseases, thus creating more awareness on the possibilities of prevention.

    Amendment 117

    Annex 2, Objective 4, point 5, sub-point 5.3. a (new)

     

    5.3.a The use by the EU Institutions of standardised data and common indicators to measure gender inequalities in medical and health services in the EU;

    Justification

    Gathering knowledge and building up health systems which are specifically geared to the needs of those groups which suffer greatest disadvantage and discrimination help to generate standardised data, although it is essential to apply the subsidiarity principle strictly and take account of the specific characteristics of the health systems of the Member States.

    Amendment 118

    Annex 2, Objective 4, point 5, sub-point 5.5.

    5.5. Providing information for patients, professionals and policy-makers, on health systems and medical care in liaison with overall health information actions, and including mechanisms for sharing and disseminating information with the action plan for a European e-health area;

    5.5. Providing information for patients, professionals and policy-makers on health systems and medical care in liaison with overall health information actions, and including mechanisms for sharing and disseminating information with the action plan for a European e-health area, while establishing strict quality criteria for health-related websites;

    Justification

    The internet can play an important role in offering medical information. However, public funding should only go to e-health information that is subject to strict quality criteria.

    Amendment 119

    Annex 2, Objective 4, point 5, sub-point 5.6.

    5.6. Developing instruments for assessing the impact of Community policies on health systems;

    5.6. Developing instruments for assessing the impact of Community policies on health systems, including the consequences of enlargement and the Lisbon strategy;

    Justification

    Enlargement as well as the Lisbon strategy are likely to have very significant impact on health systems and should therefore be mentioned specifically.

    Amendment 120

    Annex 2, Objective 4, point 5, sub-point 5.7.a (new)

     

    5.7.a Promoting the availability and accessibility across the Community of organs and substances of human origin of high quality and safety for medical use.

    Justification

    Paragraph 6.4 of the original Annex 1 is better placed after Objective 4.

    Amendment 121

    Annex 2, Objective 5 (new)

     

    Objective 5: To improve health information and knowledge for the development of public health and to contribute to mainstreaming of health objectives

    Justification

    A new objective following the reformulation of Article 2.

    Amendment 122

    Annex 2, Objective 5, introductory part

    Actions contributing to all the above objectives:

    Actions and instruments contributing to all the above objectives:

    Justification

    Provides greater clarity and is in keeping with the amended text of the Annex.

    Amendment 123

    Annex 2, Objective 5, subtitle 1 (new) after introductory part

     

    DATA COLLECTION, HEALTH MONITORING AND INFORMATION

     

    Amendment 124

    Annex 2, Objective 5, point 6

    6. To improve health information and knowledge for the development of public health by:

    5.1. Data collection, health monitoring and dissemination of information

    (The numbering of sub-points should be altered accordingly, i.e. 5.1.1., 5.1.2, 5.1.3, etc.

    Justification

    Change of numbering.

    Amendment 125

    Annex 2, point 6, sub-point 6.1.a (new)

     

    6.1.a Increasing understanding of the health status of various groups and of how they have their needs for care met in society by, for instance, collecting, processing and analysing statistics broken down by social group, ethnic background and gender;

    Justification

    Greater understanding of the health of various groups is required to form a sound basis for measures to promote more equal health.

    Amendment 126

    Annex 2, Objective 5, point 6, sub-point 6.1. b (new)

     

    6.1.b Collection and analysis of data on lifestyle-related factors (e.g. nutrition and tobacco and alcohol consumption) and injuries, establishment of Europe-wide registries for major diseases (e.g. cancer), and development of methodologies and database maintenance.

    Amendment 127

    Annex 2, Objective 5, point 6, sub-point 6.7.

    6.7. Focusing on providing a regular and reliable source of information to citizens, to decision makers, to patients, carers, health professionals and to other interested parties;

    6.7. Focusing on providing a regular and reliable source of information to citizens, including in formats accessible to disabled persons, and to decision makers, to patients, carers, health professionals and to other interested parties;

    Justification

    It is crucial that the most vulnerable groups, which are often the ones also excluded from access to mainstream information, are provided with health information as elaborated within this programme.

    Amendment 128

    Annex 2, Objective 5, point 6, sub-point 6.7.a (new)

     

    6.7.a Collecting and analysing data on disabilities as well as combating and preventing them;

    Justification

    It is essential to include actions relating to the collection and analysis of data concerning disabled people.

    Amendment 129

    Annex 2, Objective 5, point 6, sub-point 6.8.a (new)

     

    6.8.a Collecting and analysing data on sub-fertility;

    Justification

    One in six couples at the present time have fertility problems. It is therefore worth studying the situation and identifying the factors which affect fertility, which could also be attributable to environmental factors.

    Amendment 130

    Annex 2, Objective 5, point 6, sub-point 6.8.b (new)

     

    6.8.b Providing updated information on the price in the different Member States of individual pharmaceutical products, based on the active ingredient;

    Justification

    Prices of similar pharmaceutical products with the same active ingredient vary to a very large extent from one Member State to another. EU citizens should be able to inform themselves about these price differences as a means to increase competition in the pharmaceutical sector.

    Amendment 131

    Annex 2, Objective 5, point 5.2. (new)

     

    5.2.     IMPROVE COMMUNICATION WITH EU CITIZENS ON HEALTH ISSUES BY ADDING VALUE TO THE INITIATIVES OF THE COMMUNITY AND MEMBER STATES

     

    5.2.1.  Awareness-raising campaigns.

     

    5.2.2.  Surveys.

     

    5.2.3.  Conferences, seminars, experts' and stakeholders' meetings.

     

    5.2.4.  Publications on issues of interest for health.

     

    5.2.5.  Provision of online information.

     

    5.2.6.  Development and use of information points.

    Justification

    Change of numbering. Modified version of the point 1 of original Annex. Member States are best placed to communicate directly to citizens in their countries. The Commission can add value by encouraging exchange of good practice and comparing successful public health initiatives.

    Amendment 132

    Annex 2, Objective 5, subtitle 2 (new) after point 5.2. (new)

     

    COOPERATION AND INTEGRATION

    Amendment 133

    Annex 2, Objective 5, point 5.3. (new)

     

    5.3.     Increase civil society and stakeholders’ participation in policy-making related to health

     

    5.3.1.  Promote and strengthen Community level health organisations.

     

    5.3.2.  Training and capacity-building for health organisations.

     

    5.3.3.  Networking of non-governmental health organisations and other stakeholders.

     

    5.3.4.  Strengthening of Community-level consultative bodies and mechanisms.

     

    5.3.5 Recognising that patients have rights also as healthcare consumers;

    Justification

    Change of numbering. Modified version of the point 2 of original Annex 1.
    Patients in the EU today are healthier and better informed than ever. Health care has changed and become more professional, embracing a broader spectrum of players. Patients now need not only protection but also the ability to make use of the medical advances and differentiation in the health sector, which should be reflected in the legislation, particularly in terms of information and the right to freedom of choice in health care.

    Amendment 134

    Annex 2, Objective 5, point 5.4. (new)

     

    5.4. DEVELOP AN APPROACH FOR

    INTEGRATING HEALTH CONCERNS INTO OTHER COMMUNITY POLICIES

     

     

    5.4.1. Development and application of methods to assess the impact of Community policies and activities on health.

     

    5.4.2. Exchange best practice with Member States on national policies.

     

    5.4.3. Studies on impact of other policies on health.

     

    5.4.4. Develop joint strategies and joint actions by creating links and synergies with relevant Community programmes, actions and funds.

     

    Justification

    Replaces amendment 86.There must be close coordination between health actions and other community policies.

    Amendment 135

    Annex 2, Objective 5, subtitle 3 (new) after point 5.5.

     

    RISKS, SAFETY AND HORIZONTAL ISSUES

    Amendment 136

    Annex 2, Objective 5, point 5.5. (new)

     

    5.5.     Promote international co-operation related to health

     

    5.5.1.  Co-operation measures with international organisations.

     

    5.5.2.  Co-operation measures with third countries who are not participating in the programme.

     

    5.5.3.  Encourage health organisations’ dialogue.

    Justification

    Change of numbering. Modified version of the point 4 of original Annex 1.

    Amendment 137

    Annex 2, Objective 5, point 5.6.(new)

     

    5.6.      Improve the early detection, evaluation and communication of risks by:

     

    5.6.1.   Supporting scientific advice and risk evaluation, including the tasks of the independent scientific committees established by Commission Decision 2004/210/EC1.

     

    5.6.2.   The collection and collation of information and establishment of networks of specialists and institutes.

     

    5.6.3.   Promoting the development and harmonisation of risk assessment methodologies.

     

    5.6.4.   Actions for collecting and assessing information on the exposure of populations and sub-groups to chemical, biological and physical hazards to health, including the effects of such hazards.

     

    5.6.5.   Establishing mechanisms concerning early detection of emerging risks and action on newly identified risks.

     

    5.6.6.   Strategies to improve risk communication.

     

    5.6.7.   Training in risk assessment.

     

    ________

    1 OJ L 66, 4.3.2004, p. 45.

    Justification

    Change of numbering. Modified version of the point 5 of original Annex 1.

    Amendment 138

    Annex 2, Objective 5, point 5.7. (new)

     

    5.7.     Promote the safety of organs, substances of human origin, blood and blood derivatives

     

     

    5.7.1.  Activities to help enhance the safety and quality of organs and substances of human origin, including blood, blood components and blood precursors.

     

     

    5.7.2.  Supporting strategies and mechanisms for the promotion of living donor transplantation and for tackling the issue of organ shortage taking into account ethical considerations.

     

     

    5.7.3.  Developing and operating common platforms between donors and recipients for establishing best practice on organs and substances of human origin.

     

    5.7.4.  Creating a European organ donor card.

    Justification

    First sub-point originally in Annex 1, point 6.5. The two new sub-points complement the first one. Additional improvement and development of measures in the field of organ transplants.
    Creating an organ donor card valid throughout Europe will help to make valuable and safe organs and substances of human origin available for purposes of medical treatment throughout Europe and afford access to them everywhere in the Community.

    Amendment 139

    Annex 2, Objective 5, point 5.8. (new)

     

    5.8. Horizontal issues

     

    Technical assistance for the analysis of issues related to the development and implementation of policies and legislation.

     

     

     

     

    Justification

    Additional improvement and development of joint actions to promote Community synergy.

    Amendment 140

    Annex 3

     

    This annex deleted

    Justification

    This amendment is in accordance with the decision by Conference of Presidents to split the programme. Annex 3 is covered by the report on the Consumer Protection Programme.

    EXPLANATORY STATEMENT

    Introduction

    Public health is a commodity of prime importance and its protection concerns everyone without exception. The introduction of health protection into the Charter of Fundamental Rights (Article 11-35) officially sets out this generally held conviction and, at the same time, the obligation to give it prominence as a major priority of the European Union.

    In particular, the Treaties require the Community to play an active role in the field of public health by taking measures which cannot be taken by the Member States. Article 152 of the Treaty sets out three objectives for Community action - improving public health, preventing disease in all its forms and obviating sources of danger. It also provides for Community coordination and cooperation with the Member States to support actions in the field of public health, while competence and responsibility for health services (hospitals etc.), lie with the Member States (subsidiarity principle). Drawing up action programmes allows the Commission to shape and develop policy and action in the field of public health in order to achieve the objectives of the Treaty.

    1.        Background to the proposal for a decision

    On 6 April 2005, the Commission submitted a proposal for a decision of the European Parliament and of the Council[2] establishing a programme of Community action in the field of health and consumer protection 2007-2013; Article 251 was specified as the procedure under which that decision would be taken, i.e. the co-decision procedure between the European Parliament and the Council. In specific terms, the proposal for a decision concerns the establishment of a programme covering two separate articles of the EC Treaty, Article 152 concerning public health and Article 153 concerning consumer protection. The Community has in fact previously adopted two separate programmes on the basis of these articles, viz. the general framework for financing Community actions in support of consumer policy for the years 2004-2007[3], with a budget of € 81.8 million (annual average € 20.45 million), and the current Community action programme in the field of public health 2003-2008[4], with a budget of € 354 million (annual average of € 59 million), which is the first integrated programme in the field of public health.

    2.        Remarks on procedure - decision to split the programme

    In the explanatory memorandum to the proposal for a decision, the Commission points out that the programmes in the Union are fragmented and that the actions in the fields of consumer protection and public health share common objectives. Although the simplification and rationalisation of Community programmes may be an objective, the merger of the two areas of policy into a single programme cannot disguise the different nature of those areas of policy and the different level of involvement of the Union.

    On 30 June 2005, the Conference of Presidents of the European Parliament approved splitting the proposal into two parts, while the two committees responsible (the Committee on the Environment and the Committee on the Internal Market) were asked to ensure that the reports to be submitted would not contain contradictory amendments to one or the other part of the legislative proposal, and that the splitting of the proposal would enable the Committee on Budgets to examine the budgetary aspects of all elements of the proposal.

    Your rapporteur must also stress that each area, i.e. public health and consumer protection, has its own priorities and specific features, and each is both multi-faceted and complex. Consequently, when we address both of these vast and sensitive areas simultaneously, there is a risk that we focus our attention only on their common points and do not cover all of the aspects involved. Everything therefore points to two separate programmes so that each subject can be dealt with fully. This does not prevent the Commission's departments from managing the two programmes jointly, in particular on points where they overlap.

    Review of the Union's second health programme

    The split into two programmes has prompted your rapporteur to submit a number of amendments to produce a cohesive and substantive health programmes which meets the requirements of the EU and the aspirations as well as the needs of the public for better health for all. Without a doubt, the experience gained from the first programme, for which it was my honour to be the EP's rapporteur, has made an instrumental contribution to my proposal.

    Two additional points in the second programme, ensuing from the experience already gained from implementation of the first programme, distinguish it from the first: (a) synergy between the national health systems with a view to improving efficiency and effectiveness as an individual objective and (b) additional actions to consolidate further the capacity to achieve the individual objectives.

    As with the first programme, the new programme is characterised by a holistic approach both towards health and towards the means, mechanisms and practices for tackling health problems. It is the approach which must be adopted in order to improve, at Community level, not only the quantity of information disseminated but also its quality and, at the same time achieve more effective support and coordination for everyone involved in the health sector. Whether in the private or public sector, help must be given to stakeholders to draw up and develop the priorities of the programme, focusing throughout on the cohesion and coordination of its actions.

    Among those actions, prominence should be given to the correct treatment of diseases and injuries through information about best medical practice in order to prevent further loss of health status. However, even in the case of chronic diseases and disabilities, care should be available which enables sufferers to have a better quality of life. Consequently, a significant part of the actions should concern medical care and treatment.

    The programme is an invitation and, at the same time, a challenge to all to contribute to ensuring more effective prevention, improved health services, and a better quality of life. It should not be overlooked in this respect that there are existing differences in health services between the Member States and between areas within the same Member State as well as inequalities in access to good health services for citizens. Bridging these gaps, in combination with synergy between the national health services, is therefore an important aspect of the programme.

    The objectives of the programme

    The objectives of the programme as set out in my proposal are as follows:

    -  to protect citizens against health threats,

    -  to promote policies that lead to a healthier way of life,

    -  to contribute to reducing the incidence, morbidity and morality of major diseases and injuries,

    -  to contribute to the development of more effective and efficient health systems,

    -  to improve information and knowledge in order to further the development of health and to incorporate the objectives of the policy implemented in the fields of health in other Community policies (mainstreaming)..

    The programme will also contribute to:

    -  ensuring a high level of protection for human health when formulating and implementing all Community policies and activities,

    -  promoting a holistic approach to health,

    -  tackling health inequalities,

    -  encouraging cooperation between the Member States in the fields covered by Article 152 of the Treaty.

    Actions and support measures for the objectives

    The new programme includes the following actions:

    - promoting health and access to information so that European citizens are in a position to make beneficial choices for health,

    - responding to health threats in a coordinated manner at European level, as in the case of epidemics, diseases such as HIV/AIDS, bioterrorism etc.,

    - preventing disease by tackling health determinants such as those related to lifestyle (diet, smoking, consumption of alcohol) as well as to additional factors, genetic, environmental, socio-economic etc. which demonstrably affect both physical and mental health,

    - preventing further loss of health status of an individual by means of applying sound medical practice and the most modern methods of treating diseases. It is also obvious that the criterion for evaluating treatment cannot be the financial cost but the effectiveness, which is also a long-term financial consideration.

    - ensuring, by means of information, the best possible treatment for sufferers of chronic disease and disabilities, which will offer them a corresponding quality of life,

    - bridging the gaps at the level of Member States' health systems and the inequalities faced by European citizens in gaining access to good health services, and the appropriate treatment. These inequalities as a rule affect social groups with shared characteristics, be they unemployed, isolated, with personal and family difficulties, often immigrants, with chronic diseases, often mental illness and/or disability,

    - collecting and analysing data through the programme in order accurately to inventory 'health status' in the European Union and to promote actions to restore a converging tendency in the Member States in this field by means of information, information campaigns, synergy with other Community actions and funds, through non-governmental organisations and the promotion of best practice,

    - improving communication with citizens by providing them with the necessary information on how to stay in good health, the effects of lifestyle, appropriate treatment options when they are ill and how to lead a better life with a chronic disease or a disability.

    Implementation and coordination

    The cooperation of the Commission both with the Member States and international organisations, such as the World Health Organisation, and specialised centres, such as the European Centre for Disease Prevention and Control, is essential for exchanges of views and the promotion of health measures. The Member States are also required to play an important role given that much of the data will come from them. Their cooperation is essential for the collection and processing of data and potential implementation of new policies and approaches with appropriate coordination on health-related matters, as important mechanisms and instruments are available to them. Your rapporteur considers that coordination of the programme is a substantial and essential factor in its success and that the 'open coordination method' may help in matters relating to subsidiarity by strengthening strategies in the field of health and healthcare, such as patient mobility.

    Budget

    One aspect which your rapporteur considers to be extremely important is the budget. The objectives must always be matched by the resources available to achieve them. In your rapporteur's view, there is no guaranteed match between these two in the proposed programme. The actions under the programme, as described, are extremely wide-ranging and ambitious and therefore cannot be achieved with a limited budget. Moreover, the Commission's proposal contained another two new objectives in addition to the three declared objectives of the first programme.

    Your rapporteur therefore proposes the amount of € 1, 200 million in the certainty that the Council and the Commission will realise that this proposal is perfectly reasonable and will facilitate the smooth implementation of the 2007-2013 health programme. Neither should we overlook for one moment the fact that public health is one of the EU's major priorities compared with all other policies. This development demonstrates the exceptional importance of public health and, therefore, its protection as a response to existing needs and challenges as well as the great interest shown by European citizens who are also demanding effective action in this field.

    • [1]  OJ C ... / Not yet published in OJ.
    • [2]  COM(2005) 115 final.
    • [3]  Decision No. 20/2004, OJ L5, 09.01.2004.
    • [4]  Decision No 1786/2002/EC, OJ L 271, 9.10.2002.

    OPINION OF THE COMMITTEE ON BUDGETS (27.1.2006)

    for the Committee on the Environment, Public Health and Food Safety

    on the proposal 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) - Health aspects
    (COM(2005)0115 – C6‑0097/2005 – 2005/0042A(COD))

    Draftsman: Anders Samuelsen

    SHORT JUSTIFICATION

    BACKGROUND

    On April 6 2005, the Commission submitted a proposal for a decision establishing a programme for Community action in the field of Health and Consumer Protection.

    Merging the two previous and distinct programmes for health and consumer protection into one common framework based on different legal bases, the Commission estimates that a common framework would create synergies between the two policy areas because there are considerable overlaps in objectives, strategies and tools.

    On June 30 2005, the Conference of Presidents of the European Parliament decided to split up the programme anew. The health related part was directed to the Environment Committee as lead.

    In both responsible Committees, the rapporteurs favoured a permanent separation of the programme.

    The total financial framework including human resources proposed by the Commission for the period January 1 2007 to December 31 2013 is EUR 1 203 million. The schedule of commitments/appropriations proposed concerning the Health part including cost of human resources is as follows:

     

    2007

    2008

    2009

    2010

    2011

    2012

    2013 and later

    TOTAL

    Operational Expenditure

    Common objectives Health and consumers CA

    7,606

    9,532

    11,146

    13,890

    18,767

    24,146

    25,895

    110,981

    Operational Expenditure

    Health Part -CA

    49,928

    64,34

    76,042

    96,411

    135,62

    183,495

    199,159

    804,995

    Administrative Expenditure

    8,945

    10,681

    12,543

    14,102

    15,332

    15,535

    16,046

    93,185

    C.A. + Admin. Expenditure

    66,479

    84,553

    99,731

    124,403

    169,719

    223,176

    241,1

    1009,161

    With respect to the allocation of resources, the Commission proposes the following breakdown of the total EUR 1 109 815 million budgeted for operational expenditures from 2007-2013:

    · EUR 110 981 million (10%) are to be spent on common objectives,

    · EUR 804 995 million (72,5%) are to be spent on protecting citizens against health threats,

    · EUR 193 818 million (17,5%) are to be spent on consumer protection.

    DRAFTSMAN PROPOSAL

    The two responsible rapporteurs suggest substantial increases in the financial framework (EUR 1 200 million for the Health Protection Programme and EUR 233,46 million for the Consumer Protection Programme). Your draftsman wants to point out that the appropriations indicated in the proposal for a decision are purely for guidance until an agreement is reached on the financial perspective for the period 2007-2013. Regarding this particular point, two amendments are tabled to the draft legislative resolution and one to Article 5.

    Your draftsman supports the request to separate the programme and underlines that separate programmes do not prevent the Commission from managing the two programmes jointly, in particular on points where they overlap.

    There are well founded concerns that the expected synergies will not be as substantial as expected and relevant stakeholders have made a strong case that health and consumer interests are served best in a separate framework. Whilst it is commonly agreed that actions in the fields of consumer protection and public health share common objectives, it is also true that the areas are different in nature and characterised by a different level of involvement of the Union. Hence, a program that addresses the two complex areas simultaneously has a built-in risk of ignoring aspects that are unique to one of the two areas:

    · On the macro level, the policy-areas rely on a different legal basis within the European Community. On the micro level users of public health services cannot in every respect be treated as 'pure' consumers. This might constrain rather than evoke mutual benefits.

    · Each sector has greater certainty when it has its own budget. For instance, the 'consumer side' has voiced concern that it - already the budgetary minor - will lose funding because savings on health protection could be argued to have more dramatic (short term) consequences than savings on consumer policy.

    · The economics of scale suggested by the Commission are not sufficiently substantiated by the extended impact assessment (SEC(2005)0425).

    AMENDMENTS

    The Committee on Budgets calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:

    I. Drafts legislative resolution

    Amendment 1

    Paragraph 1 a (new)

    1a.      Stresses that the appropriations mentioned in the legislative proposal for the period after 2006 are object to the decision on the next multiannual financial framework;

    Amendment 2

    Paragraph 1 b (new)

    1b.      Calls on the Commission to submit, where appropriate, a proposal to adjust the financial reference amount for this programme once the next multiannual financial framework has been adopted;

    Justification

    Amendments emphasizing that the amounts proposed are subject to confirmation by a possible multiannual financial framework.

    II. Proposal for a decision

    Text proposed by the Commission[1]Amendments by Parliament

    Amendment 3

    Recital 3

    (3) Whilst maintaining the core elements and specificities of actions on health and consumer protection, a single integrated programme should help to maximise synergies in objectives and efficiency in administration of actions in these areas. Combining health and consumer protection activities in a single programme should help to meet joint objectives on protecting citizens from risks and threats, increasing the ability for citizens to have the knowledge and opportunity to make decisions in their interest and supporting mainstreaming of health and consumer objectives in all community policies and activities. Combining administrative structures and systems should enable more efficient implementation of the programme and help to make best use of available Community resources for health and consumer protection.

    (3) Whilst maintaining the core elements and specificities of actions on health and consumer protection, a single integrated programme should help to maximise synergies in objectives and efficiency in administration of actions in these areas. Combining administrative structures and systems should enable more efficient implementation of the programme and help to make best use of available Community resources for health and consumer protection.

    Justification

    The economics of scale suggested by the Commission when merging Health and Consumer programme are not substantial.

    Amendment 4

    Recital 4

    (4) Health and consumer protection policies share common objectives relating to protection against risks, improving decision-making of citizens and integrating health and consumer protection interests in all Community policies, as well as common instruments such as communication, capacity-building for civil society regarding health and consumer protection issues, and promoting international cooperation on these issues. Issues such as diet and obesity, tobacco and other consumption-related choices related to health are examples of cross-cutting issues affecting both health and consumer protection. Taking a joint approach to these common objectives and instruments will enable activities common to both health and consumer protection to be undertaken more efficiently and effectively. There are also separate objectives relating to each of the two areas of health and consumer protection which should be addressed through actions and instruments specific to each of the two areas.

    (4) Health and consumer protection policies share common objectives relating to protection against risks, improving decision-making of citizens and integrating health and consumer protection interests in all Community policies. Issues such as diet and obesity, tobacco and other consumption-related choices related to health, and high-risk behaviours are examples of cross-cutting issues affecting both health and consumer protection. Counterfeiting, which both deceives consumers and is a danger to their health, should also be vigorously combated at European level. There are also separate objectives relating to each of the two areas of health and consumer protection which should be addressed through actions and instruments specific to each of the two areas.

    Justification

    Action to combat counterfeiting, which is tantamount to the theft of products and trade-marks, should be stepped up at European and international level. Counterfeiting deceives consumers, is a danger to health and destroys jobs (it is estimated that 100 000 jobs in the European Union are lost every year as a result of counterfeiting).

    Amendment 5

    Recital 6

    (6) It is of general European interest that the health, safety and economic interests of citizens, as well as consumer interests in the development of standards for products and services, be represented at Community level. Key objectives of the programme may also depend on the existence of specialised network that also require Community contributions to enable them to develop and function. Given the particular nature of the organisations concerned and in cases of exceptional utility, the renewal of Community support to the functioning of such organisations should not be subjected to the principle of gradual decrease of the extent of Community support.

    (6) It is of general European interest that the health, safety and economic interests of citizens, as well as consumer interests in the development of standards for products and services, be represented at Community level. Key objectives of the programme may also depend on the existence of specialised network that also require Community contributions to enable them to develop and function. Therefore, full use of the tool of a "Framework Partnership agreement" proposed by the Implementing Rules to the Financial Regulation must be made. Given the particular nature of the organisations concerned and in cases of exceptional utility, the renewal of Community support to the functioning of such organisations should not be subjected to the principle of gradual decrease of the extent of Community support.

    Justification

    Article 163 of the Implementing Rules of the Financial Regulation enables the Commission to establish a longer term partnership with a given organisation. Full use of this tool will provide the relevant health organisations with more financial certainty and reduce the administrative burden of both the Commission and the European health organisations

    Amendment 6

    Article 3 paragraph 2, point (b)

    (b) 60 % of expenditure for the functioning of a body pursuing an aim of general European interest where such support is necessary to ensure representation of health or consumer interests at Community level or to implement key objectives of the programme, except in case of exceptional utility where the Community contribution shall not exceed 95 %. The renewal of such financial contributions may be exempted from the principle of gradual decrease.

    (b) 60 % of expenditure for the functioning of a body pursuing an aim of General European interest where such support is necessary to ensure representation of health or consumer interests at Community level or to implement key objectives of the programme, except in cases of exceptional utility where the Community contribution shall not exceed 95 %.

     

    The Commission can, as the general rule, seek to grant core funding on a two years basis by means of a network partnership convention. In accordance with Article 163 of the Implementing Rules of the Financial Regulation such a partnership establishes a long-term cooperation between the recipient and the Commission, but shall not exceed two years.

    Justification

    The application of Article 163 of the Implementing Rules of the Financial Regulation will provide the relevant health organisations with more financial certainty and reduce the administrative burden of both the Commission and the European health organisations. Core financing is, contrary to project funding, by nature distributed to organisations which pursue long term objectives. Therefore, the possibility of establishing a long-term co-operation is especially suited to applicants for core funding.

    Amendment 7

    Article 5, paragraph 1

    1. The financial framework for the implementation of the programme for the period specified in Article 1 is EUR 1 203 million

    1. The indicative financial framework for the implementation of this instrument is set at EUR 1 203 million for the period of 7 years as from 1 January 2007

    Justification

    Amendments emphazising that the amounts proposed are subject to confirmation by a possible multiannual financial framework. Once decided, the Commisssion shall present a legislative proposal in order to determine the final reference amount.

    Amendment 8

    Article 5, paragraph 1 a (new)

     

    1a. The overall administrative expenditure of the programme including internal and management expenditure for the Executive Agency referred to in Article 3, paragraph 1a should be proportionate to the tasks provided for in the programme concerned and is subject to the decision of the budgetary and legislative authorities.

    Justification

    The appropriations allocated to the Agency should comply with the overall ceiling established for the Agencies. this will ensure availability of resources for the financing of the actions of the programme.

    Amendment 9

    Article 5, paragraph 2 a (new)

     

    2a. The Commission shall ensure that the financial provisions for the funding of the programme comply with the provisions of the Financial Regulation applicable to the general budget of the European Communities.

    Justification

    Any derogation within the basic act should be in line with the provisions the Financial Regulation.

    Amendment 10

    Article 5, paragraph 2 b (new)

     

    2b. Access to financial contributions shall be facilitated by the application of the principle of proportionality as regards the documents to be supplied and by the creation of a database for the submission of applications.

    Justification

    The methods and the procedures need to be simplified in order to speeding up the transparency of the selection procedure and facilitate access to the programme.

    Amendment 11

    Article 10, paragraph 3

    3. The Commission shall ensure that the programme is evaluated three years after its start and following the end of the programme. The Commission shall communicate the conclusions hereof, accompanied by its comments, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

    3. The Commission shall ensure that the programme is evaluated three years after its start, two years before its end and following the end of the programme. The Commission shall communicate the conclusions hereof, accompanied by its comments, to the European Parliament, the Council, the European Economic and Social Committee and of the Regions.

    Justification

    Consideration of the programme's future should be made in due time to ensure careful planning and democratic discussion of possible reforms.

    Amendment 12

    Annex 1, point 1.1 a (new)

     

    1.1a. Better provision of information to consumers on the risks posed to their health by counterfeit medicinal and other products.

    Justification

    Counterfeiting deceives consumers and is a danger to their health.

    PROCEDURE

    Title

    Proposal 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) - Health aspects

    References

    COM(2005)0115 – C6-0097/2005 – 2005/0042A(COD)

    Committee responsible

    Environment, Public Health and Food Safety

    Opinion by
      Date announced in plenary

    BUDG
    9.6.2005

    Enhanced cooperation – date announced in plenary

    No

    Draftsman
      Date appointed

    Anders Samuelsen
    9.6.2005

    Previous draftsman

     

    Discussed in committee

    24.1.2006

    25.1.2006

     

     

     

    Date adopted

    25.1.2006

    Result of final vote

    +:

    –:

    0:

    unanimity

     

    Members present for the final vote

    Herbert Bösch, Simon Busuttil, Paulo Casaca, Brigitte Douay, Bárbara Dührkop Dührkop, Markus Ferber, Neena Gill, Ingeborg Gräßle, Louis Grech, Catherine Guy-Quint, Jutta D. Haug, Anne E. Jensen, Wiesław Stefan Kuc, Alain Lamassoure, Janusz Lewandowski, Vladimír Maňka, Mario Mauro, Giovanni Pittella, Wojciech Roszkowski, Anders Samuelsen, Esko Seppänen, Nina Škottová, László Surján, Helga Trüpel, Yannick Vaugrenard, Kyösti Tapio Virrankoski, Marilisa Xenogiannakopoulou

    Substitute(s) present for the final vote

    Lidia Joanna Geringer de Oedenberg, Margarita Starkevičiūtė

    Substitute(s) under Rule 178(2) present for the final vote

     

    Comments (available in one language only)

     

    • [1]  OJ C .., 8.12.2005, p. ….

    PROCEDURE

    Title

    Proposal 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) - Health aspects

    References

    COM(2005)0115 – C6-0097/2005 – 2005/0042A(COD)

    Date submitted to Parliament

    6.4.2005

    Committee responsible
      Date announced in plenary

    ENVI
    9.6.2005

    Committee(s) asked for opinion(s)
      Date announced

    BUDG
    9.6.2005

     

     

     

     

    Not delivering opinion(s)
      Date of decision

    IMCO
    4.7.2005

     

     

     

     

    Rapporteur(
      Date appointed

    Antonios Trakatellis
    24.5.2005

     

    Discussed in committee

    10.10.2005

    28.11.2005

    23.1.2006

    31.1.2006

     

    Date adopted

    31.01.2006

    Result of final vote

    +:

    –:

    0:

    53
    1
    1

    Members present for the final vote

    Adamos Adamou, Liam Aylward, Johannes Blokland, John Bowis, Frederika Brepoels, Hiltrud Breyer, Dorette Corbey, Chris Davies, Mojca Drčar Murko, Edite Estrela, Jillian Evans, Karl-Heinz Florenz, Matthias Groote, Françoise Grossetête, Satu Hassi, Gyula Hegyi, Caroline Jackson, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Urszula Krupa, Peter Liese, Jules Maaten, Linda McAvan, Roberto Musacchio, Riitta Myller, Péter Olajos, Miroslav Ouzký, Vittorio Prodi, Frédérique Ries, Dagmar Roth-Behrendt, Guido Sacconi, Karin Scheele, Horst Schnellhardt, Kathy Sinnott, Jonas Sjöstedt, Bogusław Sonik, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Marcello Vernola, Anja Weisgerber, Åsa Westlund

    Substitute(s) present for the final vote

    Margrete Auken, María del Pilar Ayuso González, Philip Bushill-Matthews, Bairbre de Brún, Milan Gaľa, Genowefa Grabowska, Jutta D. Haug, Karin Jöns, Caroline Lucas, Miroslav Mikolášik, Ria Oomen-Ruijten, Alojz Peterle

    Substitute(s) under Rule 178(2) present for the final vote

     

    Date tabled

    9.2.2006

    Comments (available in one language only)