Brussels, 23.10.2007

SEC(2007) 1374

COMMISSION STAFF WORKING DOCUMENT Accompanying document to the

WHITE PAPER Together for Health: A Strategic Approach for the EU 2008-2013 Impact Assessment

{COM(2007) 630 final}{SEC(2007) 1375}{SEC(2007) 1376}

TABLE OF CONTENTS

Executive Summary 4

1. Procedural Issues and Consultation of Interested Parties 5

1.1. Organisation and Timing 5

1.2. Consultation Processes 5

1.3. Consultation Meetings 6

1.4. Consultation Results 6

2. Problem definition 7

Introduction 7

2.1. Changing Health Challenges 9

(1) Enlarged EU with Greater Inequities in Health 10

(2) Current and Emerging Threats to Health 14

(3) Sustainable Health Systems 16

(4) Globalisation and Health 18

2.2. Advancing Good Governance 20

(5) Creating a Coherent Framework 20

(6) Increasing 'Health In All Policies' Cooperation 22

(7) Improving Visibility and Transparency 24

2.3. Subsidiarity Test 25

Conclusion 29

3. Objectives 29

4. Policy Options 32

Option 1: Status Quo: No new Health Strategy 32

Option 2: Health Strategy with Enhanced Intersectoral Action at EU level 33

Option 3: Health Strategy with Enhanced Intersectoral Action and Structured Cooperation with Member States and Other Stakeholders 34

Option 4: Health Strategy with Enhanced Intersectoral Action, Structured Cooperation with Member States and Other Stakeholders, and Binding Targets 35

5. Analysis of Impacts 36

Option 1: Status Quo: No new Health Strategy 36

Option 2: Health Strategy with Enhanced Intersectoral Action at EU level 38

Option 3: Health Strategy with Enhanced Intersectoral Action and Structured Cooperation with Member States and Other Stakeholders 40

Option 4: Health Strategy with Enhanced Intersectoral Action, Structured Cooperation with Member States and Other Stakeholders, and Binding Targets 44

6. Comparing the Options 47

7. Monitoring and Evaluation 51

Annexes 53

Annex 1: Health Strategy Consultation Meetings 53

Annex 2: Health Activities Across the European Community 57

Annex 3: Key Health Determinants 61

Annex 4: Health and its relationship to the Economy 70

Annex 5: ECHI Indicators – 'First Set' 77

Annex 6: Glossary 79

EXECUTIVE SUMMARY

This Impact Assessment considers the need for and potential impact of a new European Community Health Strategy. The strategy would aim to take a new approach to key health challenges by putting in place a strategic framework with clear objectives, setting the direction of travel for the coming years.

The EU has a clear role to play in health. Working towards the EU's fundamental mission, to enable free movement of people, goods and services, and to cooperate on cross-border issues, requires the consideration of health issues. From common standards for health-related products to ensuring healthcare for travellers, the EU has a role to play, while at the same time respecting the subsidiarity principle. In some cases, such as coordination for pandemic preparedness, the EU's role is clearly indispensable. In other cases, the EU is able to add value to actions at national level by means such as facilitating the sharing of best practice, developing networks, and funding projects. Much valuable work has been done in the field of health at EU level, not only in the health sector but in many other sectors such as research, regional policy, enterprise, employment and environment. However, there are growing calls for more health action at EU level. As the Union has enlarged since 2004, health gaps have widened. Threats from communicable and non-communicable disease continue, alongside globalisation and increasing concern about the future sustainability of health systems, particularly given the predicted ageing of the population. A new strategic approach to EU health policy is needed to address these challenges.

This IA does not examine a list of specific actions to take on health. Rather, it looks at options for a strategic framework that will set the direction of travel for work on health across the European Community for the next ten years. The objectives comprise both governance and health objectives. In terms of governance, the strategy aims to develop and put in place strategic objectives, increase Health In All Policies cooperation and improve the visibility of work on health at EU level. In terms of health objectives, four key areas are identified, fostering healthy lifestyles and reducing inequities in health, tackling threats to health, supporting sustainable health systems and strengthening the EU's voice in global health. These broad objectives will be achieved through the continuation of current action and through new actions at EU, national and local level, supported by an appropriate implementation mechanism to drive real change.

The policy options considered were firstly to continue as present, without a new Health Strategy. Options 2-4 consider different methods for putting a strategy in place. These options set out cumulative levels of action in relation to such a Strategy. Option 2 describes a Strategy with increased intersectoral action at the EU level only, Option 3 adds to this Structured Cooperation with Member States and Stakeholders, and Option 4 adds legislation for Binding Targets.

Option 3 was identified as the preferred option because it allows for ownership and engagement on the Strategy by Member States and Stakeholders, but is a proportionate approach. Through a Structured Cooperation mechanism, Member States would agree indicators through which to measure the broad objectives set out in the Strategy. These indicators would be expected to be taken from the existing indicators used at EU level to prevent imposing an additional burden on Member States. The Structured Cooperation mechanism would then lead work towards the achievement of the objectives alongside a renewed focus on health across all sectors and working with all partners.

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES

Organisation and Timing

A White Paper on Health Strategy was included as a strategic initiative in the Commission's Legislative Work Programme for 2007[1], with DG SANCO as the lead Directorate General. Work on the Impact Assessment began after the completion of the Roadmap in late October 2006, and was finished ahead of Interservice Consultation in July 2007 .

The Impact Assessment Board was consulted on 16 May 2007. The Board's recommendations reflected the challenges of producing an Impact Assessment for a broad, overarching strategy spanning multiple different elements, where the impact of each individual action cannot be analysed. The main recommendations of the Board were that the internal logic of the IA should be clarified, that the added value of action at EU level should be more clearly brought out, that the analysis of options section should focus more clearly on economic, social and environmental impacts, and that justification for the 10 year time-span of the strategy should be included. Following the recommendations of the Board, a structure based on the set of seven 'health' and 'governance' objectives of the IA was developed, to run throughout the document, simplifying the presentation of the issue and clarifying the areas where added value was achievable. The analysis of environmental, social and economic impacts was more clearly defined in the analysis section, and a paragraph was added more clearly explaining the reasoning behind the 10 year timescale. The second opinion of the Board recognised the improvements made. Suggestions to further enhance the IA included a stronger focus on the shortcomings of current activities and more detailed objectives. As, in most areas, the Strategy aims to build on effective current work, only minor changes were made in relation to the first point. In relation to the second point, the aim is that the Commission and Member States should work together to develop precise objectives, so they will not be fully defined at this stage. However, some priorities in the areas of demographic change, climate change, and new technologies have been suggested in the text.

An Interservice steering group was set up for the Strategy and met on 17 November 2006, 31 January 2007, and 27 March 2007. DGs participating were AGRI, AIDCO, COMP, DEV, EAC, ECFIN, ECHO, ELARG, EMPL, ENTR, ENVI, EUROSTAT, INFSO, JLS, JRC, MARKT, REGIO, RELEX, RTD, SG, SJ, TAXUD, and TRADE. As well as offering input into the development of this Impact Assessment, the group members contributed to a mapping exercise on their work on health, which will be included as an Annex to the White Paper.

Consultation Processes

In late 2004, the Commission consulted stakeholders on what future action the EU should take in the field of health through the initiative ‘Enabling Good Health for All – A Reflection Process for a new EU Health Strategy’. The reflection process generated a broad debate amongst stakeholders, national and regional authorities, NGOs, universities, individual citizens and the private sector[2].

On 11 December 2006 a Discussion Document was released to enable stakeholders to comment further on plans for a new Health Strategy, this time with a focus on objective-setting and implementation mechanisms. This process ended on 12 February 2007.

Members of the High Level Committee on Public Health (all Member States) also received a supplementary questionnaire requesting their views on objective-setting and implementation mechanisms in relation to developing a new Health Strategy. Responses were received from 12 of the 27 Member States.

Comments from all consultation processes have been reflected in this Impact Assessment. Regarding the consultation process, the requirements of the Commission's minimum standards for consultation have been respected[3].

Consultation Meetings

Alongside the two processes described above, consultation took place through a wide range of meetings. Annex 1 sets out a list of consultation meetings that took place between October 2006 and March 2007. This list includes consultation with Member States, in particular at the biannual High Level Committee on Public Health in October 2006, and also with regional groups. It includes consultation with other Commission services, including 3 meetings of the Interservice Steering Group (see above), as well as bilaterals with services with a particular interest in health, including INFSO, EMPL, ENTR, RTD, REGIO, MARKT and EUROSTAT. Meetings were held with NGOs, in particular the Health Policy Forum which meets regularly and has a membership of 49 health-related NGOs. Meetings were also held with a wide range of experts and other stakeholders, including industry representatives and three meetings with a small discussion group of health strategy experts.

Consultation Results

193 responses were received to the 2004 reflection process, including 12 Member States. Key outcomes[4] were that stakeholders want a comprehensive approach to health that mainstreams health concerns into all Community policies; that they see a need to bridge inequalities in health across the EU; that the EU should take a much stronger role in global health; that the EU should focus on health promotion; that it should tackle key issues such as mental health and cross-border matters, and that the EU, its Member States and stakeholders should work together to deliver concrete results. This input has formed the basis of the proposed Strategy as set out in section 2.

156 responses were received for the 2006-2007 consultation process, including 16 Member States. Key outcomes[5] were general support for a new overarching, strategic and coherent framework for health policy in the coming decade. The vast majority supported the three broad priorities proposed by the Commission: working on core issues, ensuring health considerations in all policies and engaging global considerations. The respondents advised that policy coherence should be ensured through an enhanced use of health Impact Assessment and that European as well as national administrations should ensure internal coordination in their activities impacting on health.

There was broad support for enhancing European cooperation in a number of fields including health threats, reducing inequalities in health, health information and promotion of healthy lifestyles. Respondents from all level stressed the need for the development of a European health information system with an open access to comparable data.

In terms of implementation mechanisms, there was broad support for the establishment of a Structured Cooperation mechanism, similar to the Open Method of Coordination which was developed to measure the progress towards Lisbon goals. In parallel, alternative approaches were proposed, including development of legislation or enhancement of existing structures with centralised expertise. Finally, it was highlighted that the success of the strategy would also be linked to the sense of ownership at local, regional and national level. To that end, action plans at European and National level were recommended by respondents with the establishment of a regular reporting system and a mid term review.

Key outcomes of the consultation meetings have also been fed into this paper[6].

Problem definition

INTRODUCTION

This document is an assessment of the potential impact of the proposed White Paper 'Together for Health: A Strategic Approach for the EU 2008-17', a new Community Strategy which aims to bring together all sectors in working towards common health objectives. Developing a useful Impact Assessment for something as broad as an overarching Strategy is a challenge. It is not possible to evaluate the impact of individual actions, and the link between strategic actions and concrete results is very difficult to quantify. This Impact Assessment therefore sets out a broad-ranging 'problem definition' section (Section 1) looking at current health challenges, good governance challenges, and conducting a subsidiarity test. The 'policy options' and 'analysis of impacts' sections (Section 3 and 4) estimate, in broad terms, the impact of a number of different methods of putting in place a Community strategic framework for health.

Health is important for individuals and for society. People expect to be protected against illness and disease. They want to bring up their children in a healthy environment, and demand that their workplace is safe and hygienic. They need access to reliable and high-quality health services. At the same time, improving the health and well-being of European citizens is also important for the European Union. The EU's core aims to enable free movement of people, goods and services, and cooperation on cross-border issues, means that work at EU level has always had, and will continue to have a health dimension, at the same time as the subsidiarity principle is respected. From the movement of health products to providing a safe environment, from ensuring the production and processing of safe and nutritious food, to responding to people's need for healthcare when travelling, it is impossible to avoid health in policy at the EU level. The importance of health for the EU has been reaffirmed by the agreement at the European Council meeting of 21-22 June 2007 on the framework for a Reform Treaty, which proposes to reinforce health as a major focus of the EU's work.

The achievement of the Commission's strategic objectives of Prosperity, Solidarity, Security and Europe in the World is clearly linked to health. In terms of security , EU action on cross-border health threats from communicable diseases such as avian flu, and on bioterrorism continues to be vital. In relation to solidarity , reducing inequities across the enlarged EU in terms of life expectancy, health status and provision of high-quality health services is part of achieving the goal of a more cohesive Europe. In relation to prosperity , population health is a key factor for productivity and growth, and this is reflected in the inclusion of the Healthy Life Years indicator as a Lisbon agenda indicator[7] and in relation to Europe in the world, the EU has an important role in international health governance as well as in terms of trade in health products and responses to humanitarian crises and development aid.

Table 1: Key Health Challenges and Objectives linked to current Commission Objectives

Key Health Challenges | Key Health Objectives | Commission Objectives |

Communicable disease e.g. Pandemic, bioterrorism | Increase Capacity to Tackle Health Threats | Security |

Enlarged EU with 27 Member States – Wider Health Gaps | Promote Health and Reduce Health Inequities | Solidarity |

Population Ageing, Rise of new Technologies | Increase Sustainability of Health Systems | Prosperity |

Consequences of Globalisation | Improve EU Effectiveness on the Global Stage | Europe in the World |

Much has been achieved in health policy at the EU level in a range of areas, based on different parts of the Treaty, for example in health and safety at work, pharmaceuticals, public health, food safety, research and environment. Following the introduction of specific public health provisions into the EU Treaty[8], in the 1990s the EU worked on several ‘sectoral’ health programmes, looking at individual issues such as cancer, communicable diseases, rare diseases and health promotion. In 2000 the Commission adopted a first public health strategy[9] which gave rise to the Public Health Programme (2003-2008), setting out a framework for action on health determinants, health threats, information and monitoring within the health sector at EU level.

However, the EU is now facing new challenges , which require a new approach. Europe is changing as globalisation continues and innovative technologies are developed every day. The ageing population is changing disease patterns and putting pressure on health systems, new disease threats such as avian flu and the risk of bioterrorist attacks are emerging. Lifestyle-related illness, particularly linked to obesity and smoking, are a major part of the disease burden. Table 1 shows some of the key health challenges facing the EU, linked the Commission's overarching objectives, and to key health objectives. A new strategy will aim to maximise the EU's ability to tackle these health challenges, while supporting the Commission's broader objectives.

In order to address these increasing health challenges, the Strategy aims to advance good governance methods, by putting an overarching strategic framework in place with effective objectives and an implementation mechanism, building Health In All Policies cooperation, and increasing visibility and understanding about health at EU level.

The proposed Strategy would set out a first stage to 2013, the end of the current financial perspectives, when an evaluation will take place to support the definition of further work towards strategic objectives.

Changing Health Challenges

The EU is currently facing new challenges. Four key health challenges for the EU, which relate to the Commission's objectives of prosperity, security, solidarity and Europe in the world, are the increased health inequities caused by EU enlargement, current and emerging threats to health, the challenge of supporting sustainable health systems, and the opportunity to increase EU activity in the field of global health. Within the scope of this document it is impossible to describe all the actions that are currently undertaken or will be undertaken in the future. Therefore a short introduction to key concerns is included, describing the added value of current and future EU action in that area. The overall subsidiarity test addressing the necessity and added-value of EU policies in the area of health is then summarized in section 2.3.

These four areas are not discrete but overlap with one another. For example, tackling inequities means reducing inequities in access to health systems and in treatment of disease. Increasing the focus on global health means recognising the global element in all areas of health, e.g. the employment of health professionals, which is an issue for sustainable health systems , and tackling health threats like communicable disease. Setting objectives in these areas would therefore provide a dynamic and inclusive framework for focusing on protecting and improving health across the EU.

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(1) Enlarged EU with Greater Inequities in Health

Although most Europeans today enjoy the prospect of a longer and healthier life than previous generations, major inequities still exist. Health inequities are inequalities in health (differences in health status, and differences in access to treatment and care) that are avoidable and unfair.

A major reason for inequity comes from conditions related to socio-economic factors, lifestyle and environmental conditions. Poverty, low levels of education, differences in gender, membership of some minority ethnic groups, and disability are some of the factors that are associated with poorer health. Inequalities will always exist within and between countries. The EU has a role to address areas where change can be made and where added value is achievable, for example by facilitating the sharing of best practice and taking action where issues have a cross border impact.

Key Facts

The difference in life expectancy at birth between people living in different countries within the EU is more than 7 years for females and 12 years for males. A baby is more than 6 times more likely to die before their first birthday in Romania than in Sweden.[10] Graph 1 shows the differences in life expectancy including the clear gap between EU-15 and EU-12 Member States. In the majority of EU Member States life expectancy has improved consistently over the last 50 years but this general trend masks major differences between countries. Some Member States experienced a decline in life expectancy during the mid 1990s and in Latvia and Lithuania life expectancy at birth has dropped significantly in the latest figures (2005)[11].

Graph 1: Life Expectancy at Birth (1970 to 2005) in EU Members before 1 May 2004, EU Members after 2004, and selected countries

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The Healthy Life Years indicator, an indicator of the Lisbon agenda, is used to measure how much time people are spending in good health. This varies widely across the EU. In 2003 Healthy Life Years ranged from 71 years in Italy to 53 in Hungary for men, and 74 in Italy to 57 in Finland for women.

Inequities in health are closely linked to the economic prosperity of a country. Increasing economic prosperity through initiatives like the Lisbon agenda will therefore support improvements in health. However, specific health interventions are also effective. Promoting health, addressing health determinants, improving health literacy and health information, increasing the availability of healthy choices and improving the efficiency and responsiveness of health services can help to narrow the health gaps.

The predicted trend of population ageing , resulting from low birth rates, increasing longevity, and the ageing of the 'baby boom' generation is now well established on political agendas across Europe. The additional health expenditure that this will entail, and other consequences, such as the likely shortage of healthcare professionals, will clearly pose a major challenge to the sustainability of health systems. By 2050 the number of people in the EU aged 65+ will increase by 70% and the 80+ age group will increase by 170% in the same period. DG ECFIN projections have estimated that if healthy life expectancy evolves broadly in line with change in age-specific life expectancy, then the projected increase in spending on healthcare due to ageing would be halved. [12] A healthy, active ageing population can be supported through effective health policy across the lifecycle, in particular in relation to offering more healthy choices and tackling non-communicable disease.

Non-communicable diseases contribute to a substantial part of the burden of disease in the EU. Modern patterns of living are having a complex effect on risk factors for health. Physical activity is in decline due to reductions in the physical requirements for work, increased motorised transport and more passive leisure activities. There is clear evidence that overweight and obesity are rapidly increasing. Patterns of smoking and harmful alcohol consumption are also increasing in some groups, particularly amongst young people. Chart 1 shows that tobacco use, high blood pressure, nutritional factors such as obesity and high cholesterol, alcohol abuse, low levels of physical activity, illicit drugs and unsafe sex are some of the most important risk factors for poor health in Europe. Many of these causes or 'determinants' of ill-health are preventable by means of ensuring that healthy choices are available to citizens. Annex 3 sets out more information on key determinants of health.

[pic]Chart 1: Source WHO[13]

Current Actions

Much work has been done to tackle inequities in health. In its Resolution of 29 June 2000 on health determinants, the Council considered that the increasing differences in health status and health outcomes between and within Member States called for renewed and coordinated efforts at national and Community level.[14] Additional attention on the link between social inequalities and health inequalities has arisen since the establishment by the World Health Organisation in 2004 of a Commission on Social Determinants and there is increasing appreciation as part of the review of the Lisbon process, that reducing the social impact on health can lead to improved health of the population with corresponding increases in human capital, reductions in social payments and economic growth. In particular, the use of Structural Funds for health through EU regional policy can lead to concrete improvements, as demonstrated in the broad-ranging Portuguese 'Saúde' project.[15] DG EMPL's Open Method of Coordination on Social Protection and Social Inclusion is a key policy tackling social and health inequalities.

In the area of non-communicable disease, strategies have been developed in the areas of alcohol, mental health and nutrition and physical activity. Further information is included in Annex 3. Policies with an impact on the determinants of health include agriculture, including the promotion of healthy foods, and decoupling of subsidies for unhealthy products such as tobacco. Close links also exist in the tobacco area between health objectives and taxation policies. There are synergies with JLS in terms of illegal drugs, including work on indicators for drugs along with Eurostat and expert agency EMCDDA. Synergies are also found in relation to health promotion in workplace and schools settings with EMPL and EAC. As with all areas, research projects support better understanding of the issues.

Added Value of a New Strategic Approach at EU level

As described above, EU is already actively involved in tackling inequities in health. However, there is clearly scope for further work in this area. Added value would be found in particular in a new focus towards raising awareness at Member State level in relation to the potential for Regional Policy to contribute to the health sector, both through health-related investments and through systematic sharing of the successful experiences of some Member States and regions with others. This would be particularly beneficial for new Member States and regions. EU added value would be found in measures (such as facilitating the sharing of best practice) to support Member States to improve health literacy, to enable people to have better access to information and services, to make more healthy choices available, and to support 'lifecycle' approaches to health focusing on the need for effective health promotion and interventions from childhood through to old age. The experience of some Member States has shown that effective low-cost preventative measures, such as cancer screening can have a real impact on health outcomes for a population. Studies have shown that screening people aged over 50 for breast cancer and colon cancer can reduce mortality by 35% and 16% respectively[16]. Therefore clear EU added value could be found in a renewed approach to disseminating best practice in these areas, thus helping to narrow the health gaps within and between EU-27 countries. A new strategic approach would also mean enhanced networks to encourage communication between Member States, experts, and stakeholders on the issues.

Reducing inequities in health was considered by many consultation respondents from all backgrounds as an important objective of the strategy. In a questionnaire to the High Level Committee on Public Health[17], several Member States identified mental illness, cancer and cardiovascular disease as key issues on which the EU should focus, and named physical activity, smoking and alcohol/drugs as top priority risk factors to tackle. They also identified the workplace and schools as key settings to promote health.

(2) Current and Emerging Threats to Health

Key Facts

Communicable disease remains an important health threat to European citizens. Parts of Europe have the fastest rate of new HIV/AIDS cases in the world. In 2005, 77,553 newly diagnosed cases of HIV infection (104 per million population) were reported in the European Region of the World Health Organization,[18] while rates of Tuberculosis (TB) increased by 8% in Sweden and 5% in the UK, with new more resistant strains of TB a growing concern[19]. In recent years threats from SARS and avian influenza, and the increased risks of a bioterrorist attack since September 11th have shown the need for good coordination between Member States on surveillance, preparedness and response.

Climate change is also a looming threat with the potential for a severe impact on health. In recent years, extreme weather conditions have proved harmful and fatal particularly among the elderly and other vulnerable groups. France suffered an estimated 15,000 deaths due to an August heat-wave in 2003. Climate change may also change the areas affected by communicable diseases, such as malaria and tick-bourne diseases, reduce the predictability of communicable disease threats such as pandemics, and worsen the consequences of these.

Threats to health also occur in healthcare settings and patient safety is an important area of concern. Studies have shown that 10% of patients admitted to a hospital in the UK encounter an adverse effect[20]. These range from healthcare acquired infections to prescribing errors and unsafe devices. In the Netherlands, research has shown that around 800,000 Dutch people over the age of 18 have been subject, in their own perception, to errors based on the inadequate transfer of medical information[21]. It is likely that this problem exists at a similar scale in other EU Member States.

Current Actions

In terms of communicable disease, work on this area by the EU has included actions to improve preparedness and response to epidemics or deliberate acts of threat such as bioterrorism, to support Member States in addressing communicable disease threats such as HIV/AIDS and TB, anti-microbial resistance, patient safety issues, pharmaceuticals and medical devices safety, and the quality and safety of blood, tissues and cells. Many communicable disease threats require close EU-level cooperation and coordination between Member States and international actors. The European Centre for Disease Control was set up in 2004-2005 in response to the need for a more coordinated approach to communicable disease, and its mandate will be reviewed in 2008 to reflect what has been learned in the first years of the Centre, and to ensure that the system for responding to threats is as effective as possible in the light of current and emerging challenges, with the optimum use of resources. The existing legal instruments for communicable disease surveillance and reporting will also be reviewed. The introduction and implementation of the International Health Regulations is currently a major priority, aiming to make alert and information systems at the EU level and through WHO more compatible and coherent.

In the area of patient safety a working group of the High Level Group on Health Services and Medical Care has developed a recommendation to describing the areas of patient safety where action could be taken at Member State level and/or at the EU level. These include developing the knowledge base, establishing reporting mechanisms, instituting training for staff, and developing a culture of safe care in healthcare management and leadership. Based on these recommendations, action on patient safety at the EU level is planned for 2008.

Other sectors involved in protecting citizens from a wide range of health threats include the employment sector, in the area of health and safety at work and coordination in relation to social security schemes, the enterprise sector in the regulation of pharmaceuticals, medical devices, chemicals, cosmetics etc, the EC Research Framework Programmes on health, food, environment and other health-related areas, Consumer Safety, Food Safety, Animal Health, Environmental issues such as air quality, water quality, noise, climate change, industrial emissions, and chemicals, and Transport in relation to accidents, in particular road safety. The Joint Research Centre currently supports a range of research from the migration of chemicals into food products to detecting genetically-modified organisms in imported food, which support policy responses.

Added Value of a New Strategic Approach at EU level

Although much work has been done, the growing challenges presented by health threats to EU citizens mean that a new focus is needed. There is a risk, given the seriousness of emerging health threats that the usual pace of evolution of mechanisms, institutions and programmes may prove insufficient to respond to these challenges in an effective and timely manner. Experience in recent years with health threats such as avian influenza and SARS has demonstrated that a priority area for development is improving surveillance and alert systems across the EU and international lines of communication, as well as making links with existing surveillance and alert systems for events which may have a public health impact, such as pharmaceutical or nuclear safety systems. In addition, further information is needed on how to address the consequences of climate change on health and health systems. Issues of vaccination are another major area needing increased attention, including vaccinations for pandemic and seasonal influenza, but also childhood vaccinations. For example, the EU can add value to the issue of the introduction of HPV vaccination for cervical cancer by providing opportunities for Member States to exchange best practice and experience.

Renewed support for these efforts led by a new strategic approach could add value by driving forward improvements, as well as implementing new initiatives building on cross-sectoral synergies, such as virtual mapping of disease, increased cooperation on organ donation and transplantation, and the potential health risks of climate change. In addition, health threats, including the need to ensure preparedness and protection of European citizens through cooperation among Member States were identified as one of the main priority areas for the Health Strategy by many consultation respondents. Patient safety, including work on hospital acquired infection and epidemiology safety, was clearly identified as a key challenge, especially by the Member States.

(3) Sustainable Health Systems

The sustainability of health systems in the future is a challenge where the EU can add value due to cross border issues such as patient and health professional mobility, and in facilitating exchange of knowledge and good practice on issues such as demographic change and the increase in new technologies[22].

Key Facts

The impact of the single market on health, with the increasing mobility of patients, services and health professionals, coupled with more general issues that confront national health systems such as the growing pressures from new technology, demographic change and popular expectations, call for adequate Community responses in the field of health services and co-operation between health systems at European level. Current economic projections show that the future cost of healthcare between now and 2050 will depend crucially on efficiency in provision; this will be as significant a factor as population ageing itself. Ensuring sufficient capacity in the field of healthcare and public health is an issue needing consideration, in particular in the new Member States.

Innovation and the development of new technologies are key issues that affect EU health systems. For example, e-health (which has been identified as one of the 6 most promising markets in the EU by the Lead Market Initiative) through electronic health records, personal health devices for the elderly, the chronically sick, and disabled, and as a means to reduce medical errors through recording adverse incidents, and biotechnologies which combine disciplines such as genetics, molecular biology, biochemistry and cell biology, show great potential to contribute to improved healthcare.

Furthermore, the growing use of life sciences and biotechnology, for the development of drugs, vaccines and innovative therapies, as well as the applications of "nanomedicine", represent huge potential for innovation and growth[23]. The health sector must take advantage of innovation and technology where this will lead to greater efficiency and health improvements. A balance must, however, be struck in terms of cost-effectiveness. Developing means for Health Technology Assessment (HTA) is one area where the EU can add value by enabling the exchange of knowledge and best practice, and this was supported in the consultation.

Current Actions

To aid investment towards modernised and efficient health systems and better healthcare, health has already been integrated into instruments aimed at enhancing growth and employment in Europe: the Lisbon Strategy, Regional Policy and the EC Research Framework Programmes. The complexities around cross-border healthcare have been demonstrated in a number of judgments by the European Court of Justice concerning the right of patients to benefit from medical treatment in another Member State. An initiative on health services to help clarify these and other health services issues is therefore under development at EU level. Since 2004, the High Level Group on Health Services and Medical Care has brought experts together to discuss issues such as cross border care, the training and mobility of health professionals, health and health systems Impact Assessment, patient safety, networks of centres of reference, health technology assessment, and e-health.

Sectors with clear links to health services at European Commission level include DG MARKT, who lead on infringement issues including relating to health professional mobility, pharmacy restrictions, etc, DG TRADE who facilitates cross border trade with health services and access for health professionals in and from third countries, and DG REGIO who, in cooperation with Member States, regions and regional partners, implement Regional Policy, including health-related aspects. DG EMPL's Open Method of Coordination on Social Protection and Social Inclusion relates to health and long term care systems, and DG EMPL also work on coordination in relation to social security schemes in relation to patient mobility[24] and on demographic change issues. Further examples are DG ENTR who lead on pharmaceuticals, DG COMP who support competition between healthcare products and services, DG INFSO who work with technologies in relation to health and healthcare, and DG RTD who support health research on issues affecting health systems under the 7th Framework Programme for Research. DG ECFIN has put a particular focus on ageing in recent reports, given its huge potential impact on public finances. [25]

Added Value of a New Strategic Approach at EU level

The planned Community framework for safe and efficient health services would be put in place as an element of the overarching Health Strategy, with the aim of responding to current inefficiencies that could undermine Europe’s potential to maintain sustainable health systems in future years, in particular with regard to population ageing. Facing these challenges and in particular their cross-border dimension calls for adequate support to national systems at European level, while respecting the subsidiarity principle. Individual Member States are already tackling these issues although some are doing more than others. As cross-border economic activities within the EU continue to increase, there are rising numbers of patients seeking treatment and health professionals working abroad. An EU approach is needed to support closer cooperation at EU-level to ensure a coherent approach to these cross-border issues, and this is where the added-value of a new strategy can be the most significant. Similarly, EU level work on healthcare systems, especially in relation to cross-border activities, was considered to be an important area of work in the consultation responses. Some contributors stressed that the Strategy should ensure that patients and professionals are aware of their rights in relation to mobility between EU Member States, including in relation to services offered, health insurance, and costs. The consultation on the health services itself showed general consensus in favour of a clear Community framework on health systems[26].

Added value can also be found in boosting the health capacity of the regions , which are primary actors in delivering healthcare, which would be supported by a coherent new EU level health strategy with a strong implementation mechanism at Member State level. A more focused approach through a new health strategy could lead to better cooperation between healthcare systems , particularly benefiting border regions or places where there are capacity constraints or the need for particular concentrations of resources or expertise. Current variations across the EU in terms of techniques, resources and outcomes show that there is enormous scope to improve the results obtained from existing resources by bringing healthcare across the Union towards the standard of the best. For example, for bladder cancer, although survival rates are improving in general, there are substantial differences in survival among countries in Europe, with five-year survival rates ranging from highs of 78% in Austria to 47% in Poland and Estonia.[27]

(4) Globalisation and Health

In today's globalised world it is increasingly difficult to separate national or EU wide actions from global policy. Decisions affecting EU citizens directly are often made at global level, and EU's internal policy can have consequences outside the EU borders. The EU can therefore add value through showing leadership in global aspects of health policy. This is essential both for the protection of the European population and for the respect of people living outside the EU. The EU has a Treaty obligation in article 152 to, 'foster cooperation with third countries and the competent international organisations in the sphere of public health,' and it is likely that a new Reform Treaty will also include a new objective for the EU, in its relations with the wider world, to uphold and promote the Union's values and interests and contribute to the protection of its citizens.

Key Facts

The 57th World Health Assembly on May 2005, called Member States to work towards universal coverage of basic healthcare, and attaining internationally agreed development goals including those contained in the United Nations Millennium Declaration . Public financing for basic health services is essential, especially for pro-poor fair financing[28]. Specific preventive and treatment interventions can reduce the burden of disease in the short and middle term, alongside longer term measures to support the wide economy and improve socioeconomic conditions. It has been estimated that a comprehensive package of essential services[29] costs € 20-30 per capita and year[30]. Developing countries face a gap in public financing for health. If countries were to allocate 15% of their government's budgets to health (Abuja target, OECD average), then the additional public funding from domestic sources would be over € 25 billion.

Although investment in health is expected to increase in countries experiencing economic growth, the need for more investment is also expected to rise, particularly in high-HIV prevalence countries. The commitments of the EU at Monterrey and Barcelona to gradually increase the level of aid, together with the adherence to the Paris principles of alignment and coordination, provide the EU with a historic opportunity to champion the global right to health, through supporting equitable access to basic healthcare. EU action in this field can help to tackle major ongoing problems, including over 20 million preventable premature deaths, the global threats of pandemics, resistant strains of micro-organisms, emerging and re-emerging diseases and growing levels of insecurity, unrest and massive migration flows. Global HIV/AIDS deaths are projected to rise from 2.8 million in 2002 to 6.5 million in 2030[31] The global proportion of deaths due to non-communicable diseases is projected to rise from 59% in 2002 to 69% in 2030 and total tobacco-attributable deaths are foreseen to rise from 5.4 million in 2005 to 8.3 million in 2030. [32]

New actors are emerging on the global health arena and new forms of interactions are taking place. For instance, new public-private-partnerships have multiplied to over 100 and gained importance and foundations are playing a significant role in financing of global health[33]. At the same time, the Paris principles call for greater respect to ownership in the recipient countries and more predictable budget support so as to allow countries to set their national strategies, including universal access to basic healthcare and education.

Globalisation has increased cross-border flows of people and products. A key global health threat is the severe shortage of health professionals, particularly in developing countries. This is a problem of cross-border nature requiring actions at the global level, as a major contributing factor is the migration of health workers to wealthier countries, causing "brain drain" in many developing countries. The global shortage of health workers is estimated to be 4.3 million workers and the situation is most critical in developing countries. In Sub-Saharan Africa the average ratio of physicians and nurses per 100 000 people is 15.5 and 73.4 respectively, compared to a ratio of 311 and 737.5 in developed countries.[34] This is likely to get worse as demographic changes in developed counties mean that more health workers are needed and less are available.

Current Actions

The EU as a whole is the world's largest development and humanitarian aid donor, and health is an important component in the EU's assistance to world-wide efforts to save and preserve lives, to combat poverty and to work towards the Millennium Development Goals. The EU has also played a key role in negotiations on the WHO Framework Convention on Tobacco Control, on the International Health Regulations and on G8 discussions on health. The WHO is a main player in global health, but the EU is also working with other UN and international organisations active in health as well as with other bilateral and regional partners and civil society. Close cooperation with other international actors, for example the partnership between the EU and the Global Fund to fight AIDS, Tuberculosis and Malaria, and other public-private-partnerships[35] dedicated to global health issues, is also a vital part of EU's work on global health.

Global health is linked to work by the RELEX 'family' of DGs of which DG DEV and AIDCO work towards health elements of the Millenium Development Goals. DG ECHO responds to health threats in third countries and towards saving and preserving lives in emergency and immediate post-emergency situations. DG RELEX deals with relations to third countries, including European Neighbourhood policy and DG ENLARG with candidate and potential candidate countries. Global health policy is also part of the work of DG TRADE in terms of international trade with health goods and services and JLS on the issue of migration. Amongst many other sectors with links to global health issues, food safety is a key area with a clear global dimension, as food is imported into the EU from over 200 countries, and ensuring the safety of these imports is an ongoing challenge.

Added Value of a New Strategic Approach at EU level

As described above, the EU is active on the international health stage. However, this activity could be strengthened to give the EU a stronger voice to represent Member States on health issues. The increased globalisation of health is presenting challenges in governance . A large number of bilateral and international organisations and public-private partnerships are active in global health. To avoid conflicting messages and duplication of work, and to clearly define the roles of actors on the global health stage, close collaboration between these organisations is crucial. Effective coordination and a coherent intersectoral approach are necessary components of global health governance, and a new strategic focus on global health issues would add value by supporting this more fully.

The EU is committed to take a leading role in the fight against poverty, hunger and disease in the world.[36] This has not yet been fully exploited. The EU can add value in its contributions to global health by sharing its common European values as well as its experience in implementing health policy that reduces health inequalities, strengthens health systems and promotes access to basic healthcare, and improves health indicators.

Engaging more strongly in global health policy would aim to make health a key issue on the agenda in the EU's relations with third countries – bilaterally, regionally and globally. A key message from the new development consensus and the Paris principles is the importance of shifting from international cooperation based on development aid to partnerships based on solidarity and guided by the needs of the beneficiary countries.

Two additional key issues where EU added value was foreseen by a number of consultation respondents were addressing the severe shortage of health professionals globally, and improving access to medicines including research and development of new medicines and health technologies, especially for neglected diseases.

Advancing Good Governance

A new governance approach is needed to better support effective work at EU level given the changes taking place in the EU. These include setting clear objectives for work on health at the EU level; achieving greater inter-sectoral cooperation on health, (also known as mainstreaming, or Health in all Policies); and achieving greater transparency and visibility of work on health at the EU level.

(5) Creating a Coherent Framework

Currently no overarching strategic framework for health exists at the EU level. Health is clearly an important element in many areas of work; within the health sector itself the Public Health Programme provides a framework for health spending, while the European Environment and Health Action Plan[37], ongoing E-health initiatives[38] and the health themes under the EC Research Framework Programme[39] are three examples in other sectors. The expansion of the EU and emerging health challenges as set out in the previous section mean that it is now time to build on these successful initiatives with a more inclusive framework to set the direction of travel for health policy for the coming decade. The need for a strategic approach, setting measurable objectives, is supported by past evaluations of the Public Health Programme (see Box 1.)

Box 1: Evaluations of Previous Health Programmes Evaluations of previous health programmes support a more coherent approach to EU health policy, including setting clear and well-defined objectives and goals. In the evaluation of the eight separate programmes run in the field of health from 1996-2002 (health promotion, information, education and training, rare diseases, pollution-related diseases, AIDS and communicable diseases, cancer, drug prevention, injury prevention, and health monitoring), one comment was that 'the implementation of the programmes seems to have been rather compartmentalised. There were few bridges between programmes'. It recommends 'the development of a complete and coherent theory of action for the general public health framework, identifying the levels of (quantified) objectives, the target groups, and possible monitoring indicators. This strategic thinking should be accompanied by a long-term perspective of where the Commission wants to go in the field of public health in the 15 or 20 coming years'.[40] The evaluation of the Public Health Programme 2003-2008 (PHP) recommends development of, 'more quantitative intermediary outcome measures to support milestones which could chart progress towards more general public health measures (e.g. comparable health indicators such as the Healthy Life Years indicator).'[41] It notes that measuring the effectiveness of the PHP faced considerable barriers due in part to a lack of measurable performance indicators,[42] stating, 'we recommend making the objectives and success indicators of the PHP more explicit and ensure the dissemination of these to stakeholders…monitoring progress against these and communicating progress transparently. |

Added Value of a Coherent Framework at EU level

A coherent framework for health policy would encompass the broad range of work on health across the European Community. Setting objectives to which all sectors agree, which build upon the aims of existing sectoral strategies and programmes and serve to bring them together and underpin them, can act as a 'beacon' to encourage progress towards key health objectives. If those objectives are supported by measurable indicators, this provides a means for monitoring of progress and a driver for achieving the objectives .

A new framework would also add value in terms of rationalising and simplifying, where appropriate, groups and initiatives currently ongoing in the health field at EU level. An implementation mechanism for the Strategy could replace a number of current groups where energies could be channelled towards achieving the Strategy's objectives.

While the Strategy's broad aims are expected to be compatible with national health strategies in those Member States which have a broad health strategy in place, they should also support the development of health strategies in all Member States and more generally support strengthened health action at national, regional and local level . This is supported by responses to the consultation in which some Member States, regional and local administrations saw the Strategy as a potential guide for their own activities. Member States including regions and local areas would be responsible for delivering progress towards the objectives, and a small number of broad objectives set by the Commission as part of a new health strategy would therefore be supported by more specific objectives developed with Member States. Member States would also agree on indicators to measure progress against the objectives. Other stakeholders, including health professionals, academic bodies, non-governmental organisations, industry and others should also be aware of the Strategy's objectives and support them through their own activities.

Objectives set by the European Community on health would complement other international goals and objectives for health including the WHO Europe's Health 21[43] and the Millennium Development Goals[44] to which EU Member States have already committed themselves, as well as EU objectives (see section 3). The goals set by international bodies are focused on tackling similar health challenges, but the EU has a unique role to play in health and added value is found in the definition of a framework to guide the use of EU policies, programmes, instruments and actions in tackling these health challenges as well as other areas where the EU can add value.

(6) Increasing 'Health In All Policies' Cooperation

Health in all Policies (HIAP) is a concept that underpins work on health at the European Level. Under article 152 of the Treaty, the EU is required to make sure that a high level of health protection is ensured in ‘the definition and implementation of all Community Policies and Activities’. Many sectors take actions that have an impact on health, for example regional development, environment, research, economic policy, social policy, etc. Policy partnerships are ongoing, for example in the fields of pharmaceuticals; demographic change and ageing; Regional policy health-related actions (infrastructure, research, training), health research in the RTD Framework Programmes, and health in the information society. Annex 2 contains a list of health-related actions across many different sectors at the European level. It is necessary not only to acknowledge this fact but to encourage active coordination between sectors to develop long-term strategic approaches to health problems.

Significant work to increase HIAP cooperation has been undertaken at EU level in recent years; methodologies have been developed for Health Impact Assessment (HIA) and Health Systems Impact Assessment (HSIA), a number of projects have been funded[45]. An interservice group meets several times each year to share information on health-related initiatives. Council Conclusions on Health In All Policies were agreed under the Finnish Presidency on 30 November 2006, which, inter alia, invited the Commission to set out a plan for work in Health in All Policies with a specific emphasis on equity in health and to consider including such activities in its new Health Strategy. A recent evaluation found that use of the key Healthy Life Years indicator 'is not (yet) widespread, especially within Commission Services and by National and Regional Non-Health Ministries'. It recommends improving dissemination activities, supporting HIAP aims within the proposed new health strategy, and developing further coordinated action plans linking health with other policy areas.[46]

There is therefore potential to strengthen the current approach by putting in place a mechanism that links actions across all sectors to the achievement of strategic health objectives. A cross sectoral approach is a vital element of the proposed new strategic framework, as work in the health sector alone would limit the possible achievements. Increasing HIAP cooperation at EU level in relation to the strategic health objectives will mean that the value of action on health in other policy areas is fully recognised and that possibilities for partnerships to share knowledge and expertise are fully exploited, and this will be reflected within Member States.

Added Value of a Renewed Health in All Policies Approach (HIAP)

While some countries are active in working towards HIAP, in many Member States health policy is not linked up to other sectors. Building on current achievements in HIAP at EU level will support the development of a cross-sectoral approach for more effective health policy at national, regional and local level . For example, enhanced HIAP cooperation to support the objective to reduce inequities in health could lead to better understanding of the links between health and economics and an increase of the use of the full scope of Regional Policy for health-related actions by Member States and regions. Similarly, an enhanced cooperation between health, employment and education sectors to promote health in the workplace and schools would encourage Member States to make similar cross-sectoral links and achieve related health gains.

Increasingly, real change is being made by involving partners outside the health sector in achieving health improvements. The Platform for Action on Diet, Nutrition and Physical Activity has successfully engaged the food and broadcasting industry on issues relating to improving population health. This can be replicated in other sectors, and a similar platform is being developed in relation to alcohol misuse. A new strategy would build on this approach, expanding it to other areas and encouraging similar approaches at national, regional and local levels to achieve health gains in key areas.

By setting a governance objective on HIAP the Strategy can also add value through a more focused dissemination of practical information and tools in relation to HIAP, for example in relation to Health Impact Assessment and Health Systems Impact Assessment for new initiatives. Added value could also be found in improved coordination in working between the different sets of health indicators managed for different policies, including ECHI indicators, Social Protection indicators, and Sustainable Development indicators in relation to health.

Consultation responses in both the 2004 reflection process and the 2006-2007 process were strongly in favour of strengthening HIAP, including at national, regional and local level. There was also a large consensus on the importance of ensuring the application of Health Impact Assessment at all policy levels and in all sectors.

(7) Improving Visibility and Transparency

The rejection of the EU Constitution in 2005 by referenda in two Member States has led to the EU reflecting on how it can better connect with its citizens. The Commission's White Paper on European Governance[47] stresses the need for greater attention to five key principles of governance, 'openness, participation, accountability, effectiveness and coherence'. An overall health strategy can support these five aims.

The evaluation of the Public Health Programme 2003-2008 recommended giving 'sharper definition'[48] to the Programme to build on its visibility within the health community, and recommended better coordination and effective information across the European Community to avoid overlaps and improve synergies between EC programmes and policies.[49]

Added Value of Greater Visibility and Transparency of EU Health Action

A new health strategy can support openness and accountability by clarifying the role of the EU in health to Member States and stakeholders, and therefore decrease the chance of the EU being misunderstood and undervalued in this field. A health strategy will help to define the role of the EU, Member States and other stakeholders in improving and protecting health, and encouraging participation. A health strategy will offer a coherent, transparent vision of what the EU's aims are in terms of health, and what actions it may take, leading to greater effectiveness through a focus on key areas where added value is achievable. Developing an EU health strategy will, in itself, send a strong political message about the important role of the EU in health to all stakeholders including European citizens and international organizations, and lead to greater understanding of the rationale for and legitimacy of action on health at the EU level. This clarification of the EU's role may lead to more effective partnerships with Member States and other stakeholders who may be more willing to work closely with the EU on those issues where EU added value is demonstrated.

As great social and technological change has taken place in recent years, citizens are seeking to understand and take greater control of their own healthcare. Although Member States have a clear role to advise citizens on health issues, citizens also have the right to information on what is happening at EU level. The Commission has a role in offering information directly to citizens, for example through the Health Portal, which aims to provide European citizens with easy access to comprehensive information on Public Health initiatives and programmes at EU level, and to promote the improvement of public health in the EU.[50] Added value can be found in building on this approach to make EU health policy more accessible to citizens including through the communication of a coherent, strategic EU approach to health.

The EU's ability to collect comparable data and information to provide an overview across Member States is invaluable for policymakers at the national level, and can also be useful for hospital managers, health professionals, health research centres, universities and others. This can range from information on best practice and techniques, to data on the prevalence of diseases, to information on cross-border issues relating to the mobility of patients and health professionals. Providing this information helps to share knowledge across the EU while at the same time respecting the Member States' prerogative on the establishment and organisation of their health systems. One example of a successful information tool supported by the European Commission is the Orphanet website which offers free information on rare diseases for patients, families, industry, health professionals and researchers.[51] A new strategy would build on the success of current practices by offering accessible and coherent comparable data on progress towards the strategic health objectives that can act as benchmarks across the EU and drive improvements towards the level of the best performers. At the same time, the visibility and accessibility of health information in general will be enhanced at both EU and national levels through, for example, sharing best practice in promoting health in a wide range of settings such as schools and workplaces, exploiting new media to communicate health messages, and clarifying rights for patients and professionals when crossing borders for treatment or employment.

Subsidiarity Test

The subsidiarity test asks whether EU action is really necessary (the 'necessity test'), or whether action by Member States is sufficient to solve the problem. It asks whether action at EU level add value to the work done by Member States (the 'added value test'), and it asks if the measures chosen are proportionate to the objectives (the 'boundary test'). This section looks at the first two tests. The subsidiarity test, in particular the boundary test, is also applied to options under Section 4. This section also draws from the analysis of the added value of a new strategic approach presented within the description of each of seven challenges in Sections 2.1 and 2.2.

EU Member States have the prime responsibility for protecting and improving the health of their citizens. As part of that responsibility, it is for them to decide on the organisation and delivery of health services and medical care. However, the fundamental aims of the EU in terms of free movement of goods and services, and working together on cross-border issues, necessarily have a health dimension. It is recognised that there are many areas relating to health where, to be effective, action needs to involve cooperation and coordination between countries. The prevention of the major health scourges and issues with a cross-border or international impact, such as pandemic preparedness or movement of patients or health professionals within the single market, where Member States cannot act alone effectively, are areas where cooperative action at EU level is indispensable. In addition, applying the single market and striving for EU integration must include health issues because health is affected by many different policy areas, and is provided for in many areas of the Treaty (see below).

There are also a wide range of health issues where the EU has a key role in undertaking actions which add value to and complement the work done by Member States in making European Citizens healthier and safer. In recent years the EU, in partnership with Member States, has made important progress in improving and protecting health. Important achievements have included, for example, legislation on tobacco advertising and on blood products, and the launch of the European Centre for Disease Control (ECDC). Through the EU Public Health Programme and other funding mechanisms, work has been developed on a EU health information and knowledge system including the creation of a comparable system of indicators to monitor health statuts of Europeans, the European Health Indicators (ECHI) system, a comparable system of tools to collect health information (health interview surveys, health examination surveys, hospital information system, etc) in cooperation with the EU Statistical Programme, and a series of health reports. Policy initiatives have been launched on mental health, and accidents and injuries. Networks have been developed in the rare diseases, major and chronic diseases, lifestyle, health and environment and health systems areas.

The EU can add value through a wide range of activities. These may include working to reach critical mass or obtain economies of scale , for example sharing information on rare diseases where only a small number people are affected in each Member State. It may mean working with Member States to enlarge the internal market and increasing the international competitiveness of health services. Added value can be found in health promotion campaigns (such as the 'Help' tobacco campaign[52]), in devising common standards such as food labelling, in the support of pharmaceutical research, in e-health development and deployment, and in research in a wide range of areas. Sharing best practice and benchmarking activities in many areas can play a major role for the efficient and effective use of scarce resources and therefore the European coordination of MS action can prove particularly important in terms of future financial sustainability.

Importantly, the Community as a whole has a major role to play in creating the conditions which support and maintain health, such as employment, health and safety at work, sustainable economic growth, technology, high quality environment, effective energy and transport infrastructure, and safe products. Many "non-health" sectors have a major, direct role in improving and protecting health, for example, in the field of environmental health, health and safety at work, pharmaceuticals, and research. This role is recognised in the Treaty (see Box 2) which situates what has become known as 'Health in All Policies' (HIAP) at the heart of work on health at the EU level.

The EU therefore clearly adds value in a wide range of areas relating to health. Given the need to tackle current and emerging health challenges in the most effective manner and to advance good governance in health at the EU level, there is also an important added value resulting from taking a new strategic approach in relation to the seven challenges identified. As set out in Sections 2.1 and 2.2, clear added value examples can be identified in the seven areas:

- 1) Enlarged EU with Greater Inequities in Health

Added value of a new strategic EU approach is found in, e.g. utilising the potential of Regional Policy for health-related actions; a renewed focus on making healthy choices available and enabling more access to information on health

- 2) Current and Emerging Threats to Health

Added value of a new strategic EU approach is found in, e.g. improving surveillance and alert systems; increasing cooperation on issues such as vaccination, organ donation, and climate change

- 3) Sustainable Health Systems

Added value of a new strategic EU approach is found in, e.g. taking forward a new Community framework for health services; greater support for improving health capacity in the regions; supporting greater cooperation between health systems

- 4) Globalisation and Health

Added value of a new strategic EU approach is found in, e.g. a stronger voice for the EU in global health governance; raising health on the agenda of work with third countries; an increased global perspective for all health issues (e.g. communicable disease threats, etc.)

- 5) Creating a Coherent Framework

Added value of a new strategic EU framework for health is to drive forward positive change; rationalise current mechanisms; support strategic action on health at national level; strengthen cooperation between Member States at EU level

- 6) Increasing Health In All Policies Cooperation

Added value of increasing HIAP cooperation at EU level is to ensure optimal policy approaches to protecting and improving health; to support multisectoral approaches at national and international levels; involve more partners leading to more effective initiatives; development and dissemination of tools for HIAP

- 7) Improving Visibility and Transparency of EU Health Action

Added value of improving visibility of EU Health Action is to clarify the role of the EU in health to all stakeholders, to make EU health policy more accessible to citizens, and to improve availability of comparable data and information to support progress towards objectives.

Box 2: Health in the Treaty Establishing the European Community The Treaty clearly states that the activities of the Community shall include 'a contribution to the attainment of a high level of health protection' Article 3 (1) (p) EU action on health is also explicitly provided for in Treaty Article 152[53], which states that 'a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities'. Article 152 also states that "The Community shall encourage cooperation between the Member States in the areas referred to in this Article, and if necessary, lend support to their action. Member States shall, in liaison with the Commission, coordinate among themselves their policies and programmes………The Commission may, in close contact with Member States, take any initiative to promote such coordination", bearing in mind that, "Community action in the field of public health shall fully respect the responsibilities of the Member States for the organization and delivery of health services and medical care." However, health is also mentioned in other articles throughout the Treaty. For example, Article 95 (3), (6) and (8) concerning health in relation to the internal market Article 133 (6) concerning common commercial policy, stating that health services "…shall fall within the shared competence of the Community and its Member States…". Article 137 (1) (a) "1.'The Community shall support and complement the activities of the Member States in the following fields: a) improvement in particular of the working environment to protect workers' health and safety" Article 153 "The Community shall contribute to protecting the health, safety and economic interests of consumers" Article 174 (1) "Community policy on the environment shall contribute to pursuit of the following objectives: (…)- protecting human health. Articles 18(1), 39(3), 46(1) and 55 concerning the right to limit free movement of persons if necessary on the grounds of public health Article 163 concerning the objective to promote 'all the research activities deemed necessary by virtue of other chapters of this Treaty'. Following agreement at the European Council meeting of 21-22 June, it is likely that a new Reform Treaty will introduce amendments strengthening scope for EU action in the field of health. |

In response to the consultation, many Member States acknowledged the substantial achievements of the Commission in the field of health over the recent years including the aspects of health promotion and prevention, management of health threats and combating communicable disease. Many also highlighted the importance of designing a strategy that would respond to the actual challenges while respecting the principle of subsidiarity, by focusing on issues that had cross-border aspects or European added-value. Some respondents also called for more clarity on the respective competencies and responsibilities of Member States and the EU in the field of health.

The EU's legal right and obligation to take action on cross-border health issues, and its demonstration of success in taking relevant and effective action on health, while respecting Member States' prerogative, is clear. The ability of the EU to add value to work done by Member States in the field of health is also demonstrated. As a new health strategy will cover the broad range of work on health at EU level, providing a more coherent framework for this work, we can assume that the necessity test and added value test have been passed. (The subsidiarity test, in particular the boundary test, will also be applied under section 4 in relation to each option).

CONCLUSION

In conclusion, therefore, this Problem Definition section of the Impact Assessment has argued that new health challenges facing the EU action in four key areas of inequities in health, current and emerging threats to health, the need to support the sustainability of health systems, and the need to better address global health issues, require a new focus at EU level. The EU can provide important added value in all these areas, which can be maximised through employing a new overarching EU health strategy.

It was also argued that to ensure the effectiveness of a new Strategy, three governance challenges need to be addressed: a coherent overarching framework including strategic objectives should be put in place, Health In All Policies cooperation should be reinforced, and visibility of the EU approach should be increased. A focused approach reflecting these three elements will produce clear added value.

The subsidiarity test concluded that the EU has a clear mandate for action and can add value in many areas in the field of health, including playing a role in addressing key existing and emerging health challenges in the EU. Member States are responsible for national health services, but the EU has a wide range of roles to play, and the EU's potential for helping to address health challenges in the EU should be optimised through the development of a new strategic framework.

OBJECTIVES

The objectives for the Health Strategy relate to the problems defined in section 2.1 and 2.2.

It is not possible in the context of this Impact Assessment to cover the detailed content of the proposed Health Strategy. This will contain multiple actions, many of which are already ongoing both in DG SANCO and other services, which will address a range of challenges. The Strategy does not aim to replace actions currently undertaken on health at EU level, but to put in place a new overarching strategic framework to focus on key challenges and guide current and future actions in all sectors (see diagram below).

[pic]

Health Objectives:

Four broad health objectives are defined, relating to the Changing Health Challenges identified in Section 2.1. These general objectives will be supported by specific and operational objectives which will be defined in cooperation with Member States in the initial phase of the implementation process. Some of these individual actions would require a specific Impact Assessment and monitoring process. These areas will need to remain flexible enough to cover work in relation to existing challenges and to avoid excluding any new challenges that may not have been foreseen.

These four objectives relate closely to the Commission's existing objectives of Solidarity, Security, Prosperity, and Europe in the World, as well as with key European strategies. Objective 1 relates to the solidarity objective, in assisting all Member States to achieve the health standards of the best, and it also relates to the Open Method of Coordination on Social Protection and Social Exclusion. Objective 2 relates to security and the protection of citizens from heath threats. Objective 3 relates particularly to prosperity and the Sustainable Development Strategy, as sustainable and cost-effective health systems support a health population and therefore a strong economy. Objective 4 relates to the objective of Europe in the World. All four objectives are in line with the Lisbon Strategy, as all aim for better health and healthcare which is clearly linked to economic prosperity.

The four health objectives are as follows:

Objective 1 – To Foster Healthier Lifestyles and Reduce Inequities In Health Across The EU – particularly in relation to supporting healthy ageing Objective 2 – To Protect Citizens and Patients from Known and Unknown Threats to Health Objective 3 – To Increase The Sustainability Of Health Systems with a focus on New Technologies Objective 4 – Strengthening the EU's Voice in Global Health |

- Good Governance Objectives:

Three good governance objectives are defined, relating to the issues identified in Section 2.2 These will be supported by operational objectives that are linked to the implementation of an effective strategy.

Objective 5 – to set a Strategic Framework with objectives and measurable indicators |

- The Strategy would identify clear objectives measurable by indicators for progress at EU level in the field of health over the coming 10 year period. This will enable a focused approach to tackling health objectives 1-4. Further specific and operational objectives would be developed with Member States and would need to be in line with the Lisbon Strategy, the Sustainable Development Strategy, the Open Method of Coordination on Social Protection and Social Exclusion and other key EU policies.

Objective 6 – To Achieve Greater Health In All Policies Cooperation |

- Health is affected, and has the potential to be affected in both positive and negative ways, by a wide range of non-health policies. This general objective is central to supporting health objectives 1-4 as health policy alone will not fulfil potential for positive change without partnerships in other sectors.

Objective 7 – To Achieve Greater Visibility for work on health at European level |

- A key objective for the Health Strategy, which will be a clear measure of its success, is that it creates greater visibility and understanding of work done on health at the EU level, and supports the enhanced communication of health information.

POLICY OPTIONS

It is not the function of this Impact Assessment to set out in detail the lists of actions that will support the health objectives. Many actions are already ongoing, and new actions will have their own Impact Assessment where necessary. The purpose of the strategy is rather to put in place a new framework to set the direction of travel. The options therefore look at different ways of putting such a framework in place.

Overview of Options |

Option 1 | Status Quo: No new Health Strategy |

Option 2 | Health Strategy with Enhanced Intersectoral Action at EU level |

Option 3 | Health Strategy with Enhanced Intersectoral Action and Structured Cooperation with Member States and Other Stakeholders |

Option 4 | Health Strategy with Enhanced Intersectoral Action, Structured Cooperation with Member States and Other Stakeholders, and Binding Targets |

Option 1: Status Quo: No new Health Strategy

Continue with existing and planned work without setting overarching objectives or developing a coherent, strategic approach for key actions in the health sector, cross sectoral actions and global issues.

Instruments: continue as present using a range of tools as appropriate.

Option 2: Health Strategy with Enhanced Intersectoral Action at EU level

This would include:

a) Setting 4 health objectives to guide future actions, supported by specific and operational objectives, and observing the 3 good governance objectives.

b) Selecting quantitative indicators to measure progress against these objectives where appropriate. These might be, for example, increase cancer screening, increase numbers of networks of centres of reference, or increase numbers of Member States with e-medical records. Under Option 2, these indicators would be selected by the Commission.

c) Development of an enhanced 'Health in all Policies' Intersectoral Approach to support action to achieve the objectives of the Strategy alongside other sectors and specialised EU agencies, for example in relation to the Lisbon Agenda and competitiveness, technology and innovation, young people’s health, health prevention/life-long learning, ageing and health, health and the world of work, health and regional development.

Instruments: White Paper Communication, Commission interservice monitoring mechanism

Diagram: Option 2

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Option 3: Health Strategy with Enhanced Intersectoral Action and Structured Cooperation with Member States and Other Stakeholders

In addition to Option 2, Option 3 would include:

a) Setting up a new consensus mechanism of ' Structured Cooperation' with Member States. The new mechanism would use methods that have been tried and tested under the Open Method of Coordination which is used for work towards the Lisbon goals, and would involve agreeing indicators in relation to the objectives of the Strategy, developing specific and operational objectives to support the achievement of the 4 health objectives, sharing information to support national, regional and local policy development to support the objectives, mutual learning processes, and other relevant activities. This new structured cooperation would also establish a process for monitoring the Strategy. [54]

b) A Health In All Policies approach which goes beyond EU level to support greater intersectoral cooperation at national, regional and local levels.

c) Building closer links with regions through, for example, greater cooperation with the Committee of the Regions and through the Structural Funds mechanism.

d) Strengthening existing mechanisms of dialogue and cooperation with health partners, with a particular focus on civil society, through a new advisory board or forum.

Instruments: White Paper Communication, Commission interservice monitoring mechanism, coordination and partnership mechanisms

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Option 4: Health Strategy with Enhanced Intersectoral Action, Structured Cooperation with Member States and Other Stakeholders, and Binding Targets

Option 4 would be a strengthened version of Option 3. As in Options 2 and 3, a set of indicators would be agreed. However, this option would include legislation to set binding targets to drive forward work towards the objectives by close scrutiny of progress across Member States. Other stakeholders could report in line with Member State reporting, on a voluntary basis.

Instruments: White Paper Communication, Commission interservice monitoring mechanism, other coordination and partnership mechanisms, legislation for binding targets

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ANALYSIS OF IMPACTS

This section looks at the possible impacts of each of the four policy options set out in the last section. Given the broad nature of the Strategy, it is not possible to provide detailed and quantifiable estimates of the impact of the options. Instead, general estimates of the impact of each approach have been made.

Before analysing Options 1-4, it is worth briefly considering the negative impacts of not having any EU-level work on health. Under 1.2 above, the justification for EU action on health is set out; some issues are of a cross border nature, and EU action is indispensable. For other issues, the EU can clearly add value. Box 4 sets out some concrete examples of the 'impact' of no action on health at EU level. This acts as a baseline for the consideration of Options 1-4.

Box 4 – Negative Consequences of No Health Action at EU level No coordination of pandemic influenza planning; lines of communication would be confused, and mutual agreements between Member States bilateral or fragmented. No projects within the Health Programme; many projects on key health issues are funded each year, with 353.77 million euros available for projects between 2003 – 2008. Without EU mutual recognition of qualifications, movement of health professionals between countries would be much more difficult. No transnational health research in Framework Programmes to improve understanding of health issues while increasing EU competitiveness and innovative capacity. No ban on tobacco advertising across the EU, leading to the continued promotion of a product which causes more than 79,000 deaths per year in the EU[55]. No advice from EU health-related scientific committees on issues like nanotechnologies or exposure to electromagnetic radiation or environmental pollutants. No European Health Insurance Card, covering EU citizens for necessary medical care when travelling within the European Economic Area. Less interchange of knowledge, ideas, and best practice in the field of health between national health administrations and experts from across the EU. |

Option 1: Status Quo: No new Health Strategy |

- Introduction

Current work on health at EU level is valuable and will lead to positive benefits in terms of Economic, Social and Environmental aspects. Although these are too complex and numerous to mention in detail, this section sets out some examples and analysis, with a particular focus on the relationship between health and economic prosperity. The aim of a new Health Strategy is not necessarily to do more (although some new actions will be identified) but to give health policy at EU level more focus, coherence, direction, and prioritisation and thus enable it to be more effective and efficient. Continuing as at present would mean that potential benefits of this approach will not be realised.

Economic Impact of Option 1

There is a clear link between health and economic prosperity, both in terms of costs of health systems and of illness to the economy, and in terms of the facts that effective investment in health can support future sustainability particularly given the demographic ageing of the population, and that the health market is a key sector for growth and innovation. Annex 3 contains a more detailed analysis of the relationship between health and the economy. It is becoming more widely accepted that work done at EU level on health contributes to economic prosperity and sustainability. This is recognised in the inclusion of the Healthy Life Years indicator (a measure of the number of years that a person can expect to live in good health) in the Lisbon agenda, and in the fact that Structural Funds can be broadly used for improving health infrastructure and workforce and supporting actions on health prevention and promotion so that they contribute to the overall cohesion and economic development of the EU's regions. However, continuing with the Status Quo option makes it likely that the full potential for supporting the economy through health is not achieved, particularly in relation to Objective 3, to increase the sustainability of health systems with a focus on New Technologies , because the lack of a visible, strategic framework means that the link between health and the economy is not fully taken into account in all areas, and this may lead to a less sustainable economic future for Europe.

Social Impact of Option 1

As health itself falls into the category of social impacts, it is clear that a broad range of positive impacts can be expected from the 'no new action' option, which cannot be enumerated here, but include current initiatives to protect citizens including pandemic preparedness planning, work to prevent ill-health such as the Commission's initiative on smoke-free environments, mental health and the adopted EU strategy to reduce alcohol related harm[56], work in the area of health services including the proposed new initiative on health services, and the Pharmaceutical Forum which brings together industry, Member States and stakeholders, work to increase knowledge on health issues including using DG Research framework programme projects, and many other actions including those done in non-health policy areas.

There are, however, limitations in continuing as present as there is potential for better cooperation, coherence and objective setting. As set out in the problem definition section of this Impact Assessment, new challenges to health mean that the EU needs to refocus on key priorities where added value is achievable, building on current actions. Continuing with the Status Quo would mean that the benefits of a renewed focus on the four health objectives, (1 -to foster healthier lifestyles and reduce inequities in health across the EU, 2 - to protect citizens and patients from known and unknown threats to health, 3 - to increase the sustainability of health systems with a focus on New Technologies and 4 - to stenghten the EU's voice in global health), would be lost.

Similarly, positive social impacts in relation to the three governance objectives (5 - to set a strategic framework with objectives and measurable indicators, 6 - to achieve greater Health In All Policies cooperation, and 7 - to achieve greater visibility for work on health at European level) would be lost. No clear direction of travel would be set for the EU in terms of a strategic framework, leading to less focus on key areas. Synergies between sectors at all levels may not be exploited fully leading to a limited impact of health initiatives, and citizens and stakeholders would not have improved clarity on, and participation in, the EU's work on health.

Environmental Impact of Option 1

In terms of environmental impacts, ongoing positive work will take place on environment and health under the European Environment and Health Action Plan 2004-2010[57], which aims to reduce the disease burden caused by environmental factors in the EU, to identify and prevent new health threats caused by environmental factors and to strengthen EU capacity for policymaking in this area. Positive impact on health is also expected by the ongoing work done in the sectoral health related environmental policies such as REACH[58] legislation for chemicals, the thematic Strategy on the Sustainable Use of Pesticides[59], the 2005[60] strategy on Mercury, Thematic Strategy on Air Pollution[61], policy on water quality[62], noise[63], etc. However, more visibility of environment and health actions could be achieved Objective 7 to achieve greater visibility for work on health at European level. Further, integration across the EU in line with Objective 6 to achieve greater Health In All Policies cooperation could lead to the development of actions in other areas where synergies between health and environment are to be found. For example, environmental problems have often a global dimension where only initiatives coordinated at local, national and international level can ensure that the actions taken are effective and will deliver expected health and environmental benefits (e.g. greenhouse gas emissions and climate change which are key concerns for the coming years) and there is potential for these to be further developed (see Annex 3d).

Conclusion

Although positive impacts will be achieved by continuing with current work on health at the EU level, choosing Option 1 would not, however, refocus on significant new challenges within and beyond the EU and would therefore not address these challenges in the optimum way. Options 2-4 refer to the introduction of a new Health Strategy which sets clear objectives, identifies priorities and gives a clear sense of direction.

Option 2: Health Strategy with Enhanced Intersectoral Action at EU level |

Option 2 aims to draw together the work done on health at EU level in all sectors. The Health Strategy will not be a 'DG SANCO' strategy but a Community-wide Strategy. The achievement of common objectives by all sectors working in partnership will require a new cross-sectoral 'Health in all Policies' approach including an improved mechanism for monitoring progress.

Economic Impact of Option 2

Under Option 2, the relationship between health and economic growth and prosperity could be more fully exploited than under Option 1 through more focused development of cross-sectoral synergies in a wide range of fields, building on the significant progress being made in relation to, for example, the impact of a healthy population on the labour force, innovation in the field of health, e-health technology, taxation policy on products such as tobacco, supporting efficient health systems to ensure effective public spending, and health in regional policy and the Structural Funds, many of these contributing in particular to Objective 3 - to increase the sustainability of health systems with a focus on New Technologies . This is turn may help to stimulate greater understanding EU-wide of the importance of investments in health and health systems. However, without the full engagement of Member States and other stakeholders as foreseen in Options 3 and 4, the impact on economic prosperity would be limited, and beyond the use of European Funding mechanisms there might be little change at national level.

Social Impact of Option 2

In terms of social impact, Option 2 would build on existing cross-sectoral synergies, particularly in the fields of employment and education, which are increasingly recognised as settings for health promotion and prevention of disease and ill-health, supporting the achievement in particular of Objective 1 - to foster healthier lifestyles and reduce inequities in health across the EU . One benefit would be strengthened health links with the Open Method of Coordination for social protection and social inclusion, which already works with Member States on key issues affecting Lisbon agenda goals. In comparison with Option 1, therefore, Option 2 could lead to improved clarification of key health issues at the EU level which could lead to some health gains. Enhanced HIAP cooperation at EU level might also stimulate greater HIAP cooperation at national, regional and local levels, supporting Objective 6 - to achieve greater Health In All Policies cooperation . However, without the full engagement of Member States and other stakeholders as foreseen in Options 3 and 4, changes in health status and other positive social impacts would be unlikely to be significant. In particular, the fact that indicators to measure progress against the health objectives would be selected at Commission level would mean that the 'buy-in' required to drive changes in health policy and therefore changes in outcomes at national, regional and local level would be unlikely to be achieved. Other stakeholders such as NGOs representing a wide range of health groups, as well as academia and industry may benefit from the clarity given by the EU health strategy but as no new mechanism is set up under Option 2, the possibilities for their involvement and therefore their contribution to positive social and economic impacts may not be maximised.

Environmental Impact of Option 2

In terms of environmental impact, Option 2 would build on existing work in relation to the European Environment and Health Action Plan as under Option 1. Cross-sectoral work could be further developed in fields like the health impact of climate change, health impacts within the built environment, etc, in order to work