[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 6.4.2005

COM(2005) 115 final

2005/0042 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Healthier, safer, more confident citizens: a Health and Consumer protection Strategy

Proposal for a

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a Programme of Community action in the field of Health and Consumer protection 2007-2013 (Text with EEA relevance)

(presented by the Commission) {SEC(2005) 425}

1. INTRODUCTION

1.1. What do our citizens want?

EU citizens want to live healthily and safely wherever and whoever they are and to have confidence in the products and services they consume. They also want a say in the decisions that affect their health and their consumer interests. The EU, national and regional authorities, businesses and civil society must play a part to respond to these concerns, but there are common health and consumer policy challenges that only EU level action can tackle.

This Communication sets out how the EU intends to improve health and consumer confidence using the Treaty provisions[1]. By doing so it will help to bring Europe closer to its citizens and contribute to enhancing its competitiveness. Better health contributes to Europe’s productivity, labour force participation and sustainable growth. Bad health drives up costs and is a burden on the economy. Equally, achieving an Internal Market in goods and services that responds to consumer needs and demands will improve competitiveness.

1.2. Why a joint approach

This Communication and the attached programme proposal bring together Public Health and Consumer protection policies and programmes under one framework to make EU policy work better for citizens. Many objectives of health and consumer actions under Treaty articles 152 and 153 are shared: promoting health protection, information and education, safety and integration of health and consumer concerns into all policies. Health and consumer policies also use many similar types of actions to pursue their objectives e.g. information to citizens, consultation of stakeholders, mainstreaming activities, risk assessment. Bringing the two areas together will thus lead to greater policy coherence, economies of scale and increased visibility.

Finally, the joint programme will offer savings and synergies in terms of streamlined administrative and budgetary procedures, common tools and a common executive agency.

While exploiting synergies, the programme will maintain and develop the core specificities of actions on health and consumer protection so as to respond to stakeholders’ concerns.

2. Making Europe’s citizens Healthier, safer and more confident

The goal of EU Health and Consumer Policy is to improve EU citizens’ quality of life in terms of their health and their consumer interests. For health, progress will be assessed with the Healthy Life Years (HLY) Structural Indicator (the number of years a person can expect to live in good health) and the EC Health Indicators. For consumer policy, a range of indicators is being developed.

2.1. Joint Health and Consumer protection objectives

EU Health and Consumer policies have three core joint objectives:

1. Protect citizens from risks and threats which are beyond the control of individuals and that cannot be effectively tackled by individual Member States alone (e.g. health threats, unsafe products, unfair commercial practices).

2. Increase the ability of citizens to take better decisions about their health and consumer interests.

3. Mainstream health and consumer policy objectives across all Community policies in order to put health and consumer issues at the centre of policy-making.

2.2. Common actions

There are several areas of synergy between EU Health and Consumer policies and thus much scope for complementary action as follows:

( Improve communication with citizens to provide information they need for their health and consumer interests, and feed their concerns into policy-making better e.g. by developing web portals, awareness-raising campaigns, surveys, conferences, and information points.

( Increase the participation of consumer and health organisations in EU policy-making e.g. by promoting their networking, wider public consultations and better representation in consultation bodies. Consumer and health organisations need active, expert and articulate voices. There is still a lack of a credible EU consumer movement and a need to strengthen health networks.

( Develop a Commission approach to integrate health and consumer concerns into other policies and share best practice with the Member States. In the health area, Health Impact Assessment will be developed and synergies built with policies such as food safety, social policy, environment, customs, research, and regional policy. In the consumer area, policies that regulate markets or citizens’ rights (e.g. copyright, access to justice), competition, services of general interest, standardisation and the information society are key.

( Enhance scientific advice and expert risk assessment e.g. by promoting the early identification of risks; analysing their potential impact; information exchange on hazards and exposure; fostering harmonised approaches to risk assessment and promoting training for assessors.

( Promote the safety of products and substances of human origin (blood, tissues and cells) e.g. with best practice exchange, awareness raising, implementation guidelines, training and networking, surveillance and development of standards.

( Promote international cooperation with international organisations and third countries in health and consumer protection. The EU must play a bigger role in international health e.g. by strengthening co-operation with the WHO and the OECD and by supporting third countries on major health issues, in particular candidate and neighbourhood countries and the Western Balkans. On consumer affairs, international regulatory cooperation is needed e.g. on product safety and dealing with rogue traders.

The proposed programme budget is EUR 1 203 million, which represents a substantial increase vis-à-vis current expenditure. The executive agency set up for the Public Health Programme[2] will be extended to support the new programme (see annex 1).

3. Making European citizens healthier

3.1. Where we are

Health is a basic human right. Making European citizens healthier is the ultimate goal of all health activities pursued under the Treaty.

EU citizens are living longer and in better health than ever before. However, Europe faces serious health challenges requiring EU response.

The open consultation on health pointed to the need to boost EU action[3] e.g. on mainstreaming health, tackling determinants, preventing diseases, investing in health research, improving information, addressing inequalities, enhancing international co-operation, involving stakeholders in policy-making and the need for more resources. The evaluation of the health programmes 1996-2002[4] also recommended more focus on prevention and dissemination of information and exchange of knowledge.

First, there are major inequalities within and between Member States in life expectancy, health status and access to healthcare. In turn this leads to inequalities in growth and competitiveness. Health contributes to productivity, labour participation and economic growth. Cost-efficiency actions and investment in prevention are thus needed to improve both health and the economy. This was concluded in the Lisbon process, which also stressed that “ a major challenge will be to reduce the important differences between Member States in terms of life expectancy, incidence of major diseases and health capability. Modernising the health sector (…) can make a substantial contribution to sustain labour supply ”[5]. The EU can add value in helping bridge the health gap and in positioning health as a factor of competitiveness e.g. with awareness raising, gathering and dissemination of evidence and exchange of good practice.

The Report to the Spring Council stresses that increasing Healthy Life Years (HLY) is crucial in attracting more people into employment[6]. Increasing HLY by preventing disease and promoting active ageing is important for the sustainability of public finances under pressure from rising healthcare and social security costs, a pressure growing as the population ages and the proportion of the population of working age falls.

Meeting the challenges posed by health inequalities and ageing requires a range of cross-sector actions. Also the rise in childhood diseases linked, e.g. with obesity, demands a special focus on the childhood dimension of health promotion.

Health inequalities, ageing and children’s health are thus underlying themes of all health activities under the current programme.

Second, lessons from global health threats such as avian influenza show the need for increased EU capacity to protect citizens against threats requiring a coordinated response, including bioterrorism. In line with its Strategic objectives for 2005-2009[7], which stress the importance of countering threats to citizens’ health and safety at EU level, the Commission proposes that the programme has a new strand on response to threats.

Third, Member States face common challenges that require promoting health and preventing illness . The growing burden of avoidable diseases related to life-style and addiction (e.g. tobacco, alcohol, drug use, nutrition), diseases such as HIV and mental illness, all call for EU level action. To help meet these challenges, the health determinants strand will be reinforced and complemented by a new strand on disease prevention.

Fourth, the EU can help health systems respond to the challenges they face. The Lisbon process concluded that EU support to healthcare systems can provide important added value. A new strand on health systems co-operation is thus proposed.

Fifth, health policy must be based on sound information . The existing health information strand will be expanded, with a stronger focus on analysis and dissemination to citizens.

Lastly, health policies will be shaped in closer partnership with citizens and stakeholders e.g. by providing support to develop organisations representing patients’ interests or which take forward the health agenda.

The programme thus reinforces the three strands of the Public Health Programme (information, threats and determinants), and creates three new ones: response to threats, disease prevention and co-operation between health systems.

3.2. What we do next

The EU will seek to improve citizens’ health throughout their lives, to promote health as a human right and to encourage health investment by pursuing the following objectives.

First, to protect citizens against health threats.

Second, to promote policies that lead to a healthier way of life.

Third, to contribute to reducing the incidence of major diseases in the EU.

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

Fifth, to support the objectives above by providing health information and analysis.

The following strands of action are foreseen. Annex II to the attached proposal for a Decision provides an exhaustive list of actions planned under each strand.

3.2.1. Enhance surveillance and control of health threats

Protecting EU citizens against health threats is a Treaty obligation. The creation of the European Centre for Disease Prevention and Control (ECDC)[8] is a key step. It will analyse, assess and advise on risks from communicable diseases, and enhance capacity. Action under the programme and ECDC activities will be complementary and will boost Member States’ efforts. It will also support the work of international organisations on communicable disease control.

The programme will cover monitoring and surveillance of threats not in the ECDC remit, in association with the “information strand”, in particular on physical and chemical agents; translate research into practical methodologies; and implement the decision creating a EU surveillance network[9], Directives on blood, tissues and cells, and vaccination policies. To develop EU diagnostic capabilities for pathogens requires a European reference laboratory structure for rare or high-risk pathogens. Criteria to evaluate the performance of these laboratories will be set. Lastly, action will aim to help Member States and candidate countries to implement the International Health Regulations.

3.2.2. Deliver response to health threats (new strand)

To protect citizens effectively, the EU needs technical and operational capability to prepare for and respond to health threats. Capacity is needed to respond to health risks from an event (inside or outside the EU) to minimise the potential impact on the EU.

Work under this strand of the programme will enhance the effectiveness of national structures and resources with action to improve risk management and plans for health emergencies; facilitate alert and follow–up communication and co-ordination of actions in health emergencies; improve preparedness and intervention capacities for health emergencies focusing on concrete mechanisms and provision of health assets; facilitate networking and exchange of expertise and best practice.

It will thus help Member States develop their infrastructure, capacity and co-ordination arrangements needed to respond to a threat, e.g. setting up networks, training experts and developing health contingency planning. In addition, natural or man-made disasters with health consequences require e.g. dispatching health experts and medical equipment. This involves planning and co-ordination mechanisms to mobilise, deploy and use health resources in health emergencies and crises.

3.2.3. Promote health by tackling determinants

Promoting good health requires tackling both the life style factors and addictions that undermine health (e.g. smoking, alcohol, unhealthy diets) and broader socio-economic and environmental health determinants. The overall approach to pursue this objective consists of a series of Community strategies to tackle the most important determinants, such as nutrition and obesity, alcohol abuse, tobacco smoking and drugs[10] as well as HIV/AIDS[11] and reproductive health.

Socio-economic factors such as poverty and working conditions will be addressed by actions to disseminate best practice and to integrate health inequality issues in other policies. Environmental actions will build on the environment and health action plan 2004-2010, and focus on indoor air quality, environmental tobacco smoke and health outcomes linked to the environment.

As many problems originate in childhood, a life-cycle approach will be used to focus on young people’s health. In addition, actions on the impact of ageing on health and healthcare demand will be proposed.

Lastly, the Commission will develop thematic platforms bringing together Member States and stakeholders and different actions on specific determinants.

3.2.4. Prevent diseases and injuries (new strand)

Some diseases, including mental illnesses, cancer and cardio-vascular diseases, represent a major share of the EU disease burden. Action on determinants must be complemented by action to tackle such diseases, when this provides added value or when cross-border action is justified in terms of efficiency, as with rare diseases. Actions include support for secondary prevention e.g. screening and early detection through exchange of good practice, platforms, studies and networking. Synergies are envisaged with the 7th Framework Programme for Research.

To help reduce accidents and injuries, preventive actions, campaigns and a strategy focusing on particular risk groups and situations will be proposed.

3.2.5. Achieve synergies between national health systems (new strand)

Health services are primarily Member States’ responsibility but EU-level cooperation can benefit patients and health systems facing common challenges e.g. medical advances, ageing, mobility of patients and professionals. The Commission is facilitating cooperation through the meetings of the High Level Group on Health Services and Medical care and the open method of coordination[12]. Effective cooperation requires resources e.g. to set up and operate networks and carry out analysis.

Community support would include facilitating cross-border healthcare provision, information exchange, promoting patient safety, support to set up an EU system for centres of reference and providing information on health services. There will be complementarities with the 7th Framework Programme for Research and the action plan for eHealth.

3.2.6. Generate and disseminate more and better health information to citizens, health experts and policy-makers

An EU-wide knowledge base is needed for the collection, analysis, and dissemination of comparable and reliable health information to citizens and policy makers. To generate and disseminate better information means expanding existing work to develop a EU health monitoring system that feeds into all health activities, using the Community Statistical Programme as necessary.

To implement this objective means developing existing indicators and new tools to collect data, a European health survey, more dissemination to citizens with an EU health portal, campaigns targeting young people, networking and information on rare diseases. It also includes strengthening health analysis and supporting e-Health tools.

4. Towards a European Market for European Consumers

4.1. Where we are

Consumer confidence as a basic requirement of markets is better understood; but it has not been reflected enough in all policy areas.

Member States now give more priority to consumer protection. Business recognises the value of European consumer protection legislation to develop the internal market, reinforce consumer confidence and exclude rogue traders. The importance of strong, credible consumer representation is also recognised.

As the impact assessment demonstrates, we need more progress in those areas recognised as priorities for consumer policy. Our current goals: a common high level of consumer protection, proper enforcement of legislation and a stronger voice for consumers in policy making therefore remain still valid, as is the target of integrating consumer interests in other policies. Similarly, developing data to understand consumers’ problems and needs remains a challenge, despite recent progress.

Market integration results in economic benefits for consumers (greater choice of goods and services, competition on merit; lower prices; higher standards of living). Internal Market policies must ensure that these benefits are realised, including on the quality of goods and services, and their accessibility and inclusiveness. The Internal Market cannot function properly without consumer confidence. Adequate consumer protection is necessary for growth and competitiveness.

4.2. What we do next

Consumer policy must, however, continue to keep up with developments.

Challenges that face consumer policy….

Such as:

( an ageing population, as well as the need for inclusiveness (particularly in the context of the information society) with regard to special needs. These include problems regarding the safety of goods and services, vulnerability to scams and rogue traders; easy access to essential goods and services.

( combined with the challenges posed to all consumers by more complex and sophisticated modern markets, that allow more choice, but also bring greater risks including crime.

( realising the potential for cross-border shopping by eliminating remaining barriers to the completion of the retail dimension of the internal market.

( the combined challenge of improving the application and enforcement of legislation, in particular across borders.

….require additional efforts and new ideas, which will be dealt with through action in these two priority areas:

( ensuring a common high level of protection for all EU consumers, wherever they live, travel to or buy from in the EU, from risks and threats to their safety and economic interests.

( increasing consumers’ capacity to promote their own interests, i.e. helping consumers help themselves.

In addition, a European Consumer Institute created within the single executive agency of the programme will be the cornerstone for implementing these actions (see annex 1).

Four strands of actions are foreseen:

4.2.1. Better understanding of consumers and markets

This includes:

( Developing and updating its scientific knowledge base and assessment tools on consumer exposure to chemicals, including with respect to general product safety, and to contribute to the application of REACH.

( Developing comparable consumer policy indicators and benchmarks: measure success of the market in delivering results for consumers, e.g. on prices, levels of cross-border B2C purchases, cross-border marketing, consumer fraud, accidents and injuries, consumer complaints – with particular emphasis on Services of General Interest.

( Deepening knowledge of consumer demand and behaviour and interaction with businesses, and market impacts of regulation e.g. through work on information provided to consumers and consumer satisfaction using the Community Statistical Programme as necessary.

Some of this work can be accommodated under the 7th Framework Programme for Research.

4.2.2. Better consumer protection regulation

This includes:

( Completing the review of consumer law directives, developing a Common Frame of Reference for European contract law.

( Analysis of the safety aspects of the growing cross-border market in services , full analysis of the General Product Safety directive, and more systematic use of standards.

( Understand better national consumer policies: identify and promote best practice; setting benchmarks and recommendations; training policy makers and enforcers.

( Examining how consumer interests are taken into account in standardisation, identify improvement needs.

( Ensuring consumers are heard in EU policy-making, support effective consumer organisations at EU level and their participation in consultative bodies, forum groups, and specialist panels.

4.2.3. Better enforcement, monitoring and redress

This includes:

( Strengthening cross-border enforcement: implementation of relevant legislation and coordinating the work of all actors, and in particular customs, including on General Product Safety, RAPEX, and taking into account the international dimension.

( Improving transposition and implementation of EU directives, focusing more resources on monitoring transposition and implementation, to ensure consistent interpretation.

( Improving consumer organisations’ ability to assist consumers, act as an early warning system to identify rogue traders, and monitor national policies.

( Improve consumers’ means of redress, notably in cross-border cases, including access to Alternative Dispute Resolution; developing the network of European Consumer Centres.

4.2.4. Better informed and educated consumers

This includes:

( Informing consumers, jointly with Member States, e.g. about rights and means of redress. This includes comparative testing, price comparisons and better awareness of offers available throughout the EU.

( Developing consumer education, building on the pilot work on education carried out thus far; with national authorities, support consumer education activities incorporating an EU dimension, actions targeted at young consumers.

( Ensuring that consumers, through better information, are able to make informed, environmentally and socially responsible choices on food, the most advantageous products and services, and those that correspond most to their lifestyle objectives thus building up trust and confidence.

( Capacity building of consumer organisations: training to develop skills, knowledge, networking and pooling of efforts.

The impact assessment shows the need for more and sustained action in all these areas. This requires more resources than currently available.

Developing a knowledge base e.g. on consumer detriment, safety of services, satisfaction and confidence of consumers on the market, on services of general interest, or the information society, requires considerably stepping up research carried out so far.

Training of consumer organisations and information to citizens requires sustained efforts which go beyond what current resources allow. Enforcement cooperation, including developing networks, training enforcers, to ensure optimal implementation and on-the-ground cross-border enforcement, is necessary but has a cost. Continued efforts to support consumer organisations require additional means in an enlarged EU. Financial resources far above current levels are thus needed to follow-up on the 2002-2007 Strategy, and to take on the outlined challenges.

Implementing the programme and managing these additional resources means efficient and structured organisation. The extension of the Health Executive Agency to include a consumer department is the most cost effective way of proceeding.

5. CONCLUSION

The proposals outlined represent a major departure for the EU. They build on the work developed in the health and consumer areas and enable new links to be made thus creating synergies. This will improve efficiency and effectiveness of EU actions and make them more visible. More fundamentally, health and consumer interests lie at the centre of people’s daily lives. By bringing these issues to centre stage and proposing concrete action to meet citizens’ needs and concerns, the programme will help to bring a focus on citizenship to the centre of policy-making and will help to reconnect the EU with its citizens.

A nnex 1: The Executive agency of the joint Health and Consumer Programme

To implement the joint Health and Consumer programme, the Commission will be assisted by one single executive agency, which will consist of an extended version of the existing Public Health Programme’s executive agency encompassing the “Consumer Institute”.

To this end, the Commission will propose a modification to Commission Decision 2004/858 of 15 December 2004 creating the Executive agency for the Public Health Programme in order to enlarge its scope of action to supporting the operation of the whole new joint programme.

Without prejudice to this future Decision, it is envisaged that the agency would be organised in two “departments”: the “Health Department” and the “Consumer Institute”. Common actions would be managed jointly by the “two departments”.

The scope of action of the Public Health Programme executive agency created by Decision 2004/858 is limited to “ implementing tasks concerning Community aid under the programme, except for programme evaluation, monitoring of legislation or any other actions which could come under the exclusive competence of the Commission ”. In particular, the agency manages specific projects, deals with procedures linked to the award of contracts and grants and provides “ logistic, scientific and technical support in particular by organising meetings, preparatory studies, seminars and conferences ”.

The “Consumer Institute” part of the agency is intended to support the Commission in carrying out the financial and administrative work on all consumer policy actions envisaged in the Health and Consumer protection Strategy. This would include the organisation of calls for tender and data collection and related work to bolster research and data collection; organisation and practical day-to-day running of programmes to educate and train Member State experts, consumer organisations and their experts; and the dissemination of data and information. The Consumer Institute should actively seek co-operation with other Community bodies and programmes, and notably the Joint Research Centre and the Statistical Office of the European Communities with a view to reinforce synergies in all relevant areas of consumer protection (e.g. exposure, consumer safety, method validation).

As is the case with all executive agencies, the Commission will remain in charge of all policy decisions related to defining and managing policy priorities and action, including the definition of the annual work plan (following the procedure specified in the draft Decision of the European Parliament and of the Council establishing a programme of Community action in the field of health and consumer protection (2007-2013). This would enable the Commission services to focus on policy-related tasks.

Annex 2: Examples of Policy areas and issues where synergies with health and consumer policies can be developed further

Policies | Issues and programmes where synergies should be developed further |

Safety of the food chain | Labelling, alert mechanisms, inspection and control Synergies with Research, Transport, Environment, Agriculture, Education, action on nutrition |

Social policy | Social policy agenda Social security benefits: Regulation 1408/71 and related regulations; European Health Insurance Card Social protection: Open Method of Co-ordination in Health care and long-term care services (within OMC for Social Inclusion and Protection) European Social Fund (ESF) projects to train health professionals Social and health services of general interest Health and safety at work |

Research | Health and consumer research in the 7th framework programme for Research (theme Health research of FP7) Closer co-operation to be built with the Research programme, in particular as regards the following strands of the Health and Consumer programme: “Promote health by tackling determinants”, “Prevent diseases and injuries” (including research on infectious diseases); “Synergies between national health systems”. |

Environment | Environment and Health action plan 2004-2010 |

Information society and Media | eHealth Action Plan (eHealth applications, eHealth conferences) e-communication and consumer rights (Services of General Interest) e-Inclusion and citizenship i2010 – A European Information Society for growth and employment eAccessibility (Policy and Research activities) |

Regional policy | Solidarity Fund Health under the Structural Funds’ new convergence objective 2007-13 Health as a driver of regional development/health infrastructure projects |

Economic policy | Work on long-term budgetary projections of healthcare costs Work with OECD on health studies Macro-economic trends affecting consumer confidence Health and consumer policies as drivers of competitiveness |

Enterprise Policy | Follow-up to the G10 medicines process and implementing the G10 recommendations Joint action on pharmaceuticals and medical devices REACH Pedestrian safety Cosmetics Consumer interests in standardisation |

Internal Market | Services in the Internal Market Recognition of professional qualifications Health insurance Retail financial services Postal services and Services of General Interest Data on consumers in the Internal Market Consumer detriment E-commerce directive |

Transport | European Road Safety Action Programme Transport of dangerous goods Passenger Rights |

Energy | Radiation protection Policy Liberalisation, consumer rights and safety |

Competition | Health services markets Consumer benefits and detriment |

Trade | Position of health services within trade negotiations TRIPS, anti-retroviral drugs, trade in tobacco products Integration of consumer views in the WTO, including the GATS Regulatory dialogues |

External policy | Co-operation with neighbourhood countries |

Development and Aid policies | Action to confront HIV/AIDS, Malaria and Tuberculosis (external action). Shortages of health personnel in developing countries Promotion of civil society input |

Enlargement | Promotion of convergence with the EU acquis on Health and Consumer protection Promotion of economic and social cohesion Strengthening public administrations and institutions in the fields of Health and Consumer protection |

Taxation and Customs Union | Taxes and duties on specific products relevant to health and consumers Custom policies (ensuring provisions on health and safety for third countries’ products entering the EU) |

Agriculture | Quality policy Cross compliance rural development programmes |

Education / Culture | Youth programme, sports/promotion of physical activity Life-long learning, consumer education |

Statistical Programme | Statistics on health, health determinants, health services and food safety Statistics on consumer protection including buying patterns, price comparisons and price convergence for goods and services |

Justice, Freedom and Security | Access to Justice International private law and mediation Action on Drugs abuse: EU Drugs Strategy (2005-2012) and the EU Action Plan on Drugs (2005-2008). Enhancing consumer awareness of crime risks associated with products and services (“crime proofing”) Bioterrorism Trafficking in Human Organs Data protection |

Horizontal policies

Better regulation EU communication Strategy Services of General Interest | Full involvement of health and consumer representatives in the EU policy process Communication strategy includes health and consumer interests Consumer rights in SGIs |

2005/aaaa (COD)

Proposal for a

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

establishing a programme of Community action in the field of health and consumer protection (2007-2013) (Text with EEA relevance )

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission[13],

Having regard to the opinion of the European Economic and Social Committee[14],

Having regard to the opinion of the Committee of the Regions[15],

Acting in accordance with the procedure laid down in Article 251 of the Treaty[16],

Whereas:

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

2. It is therefore appropriate to establish a programme of Community action on health and consumer protection, replacing Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008)[17] and Decision No 20/2004/EC of the European Parliament and of the Council of 8 December 2003 establishing a general framework for financing Community actions in support of consumer policy for the years 2004 to 2007[18]. These Decisions should therefore be repealed.

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

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

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

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

7. Implementation of the programme should build upon and extend existing actions and structural arrangements in the fields of public health and consumer protection, including the Executive Agency for the Public Health Programme set up by Commission Decision 2004/858/EC[19]. Implementation should be carried out in close cooperation with relevant organisations and agencies, in particular with the European Centre for Disease Prevention and Control[20] established by Regulation (EC) No 851/2004 of the European Parliament and of the Council.

8. The measures necessary for the implementation of this Decision should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[21], respecting the need for transparency as well as a reasonable balance between the different objectives of the programme.

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

10. Appropriate relations with third countries not participating in the programme should be facilitated in order to help achieve the objectives of the programme, taking account of any relevant agreements between those countries and the Community. This may involve third countries taking forward complementary activities to those financed through this programme on areas of mutual interest, but will not involve a financial contribution under this programme.

11. It is appropriate to develop cooperation with relevant international organisations such as the United Nations and its specialised agencies including the World Health Organisation, as well as with the Council of Europe and the Organisation for Economic Cooperation and Development with a view to implementing the programme through maximising the effectiveness and efficiency of actions relating to health and consumer protection at Community and international level, taking account of the particular capacities and roles of the different organisations.

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

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

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

HAVE ADOPTED THIS DECISION:

Article 1

Establishment of the programme

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

Article 2

Aim and objectives

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

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

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

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

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

- and to mainstream health and consumer policy objectives.

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

- to protect citizens against health threats;

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

- to contribute to reducing the incidence of major diseases;

- and to improve efficiency and effectiveness in health systems.

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

- a better understanding of consumers and markets;

- better consumer protection regulation;

- better enforcement, monitoring and redress;

- and better informed and educated and responsible consumers.

Article 3

Methods of implementation

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

(a) direct or indirect implementation by the Commission on a centralised basis;

(b) and joint management with international organisations.

2. For the purpose of paragraph 1(a) above, financial contributions by the Community shall not exceed the following levels:

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

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

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

4. For the purpose of paragraph 1(a) above, financial contributions by the Community may also be given in the form of flat-rate financing where this is suited to the nature of the actions concerned. For such financial contributions the percentage limits stipulated in paragraphs 2 and 3 above shall not apply. The criteria for selecting, monitoring and evaluating such actions shall be adapted as necessary.

Article 4

Implementation of the programme

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

Article 5

Funding

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

2. Annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspective.

Article 6

Committee

1. The Commission shall be assisted by a Committee (hereinafter ‘the Committee’).

2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at two months.

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

4. The Committee shall adopt its rules of procedure.

Article 7

Implementation measures

1. The measures necessary for the implementation of this Decision relating to the following shall be adopted in accordance with the management procedure referred to in Article 6(2):

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

(b) the arrangements for evaluating the programme referred to in Article 10.

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

Article 8

Participation of third countries

The programme shall be open to the participation of:

(a) the EFTA/EEA countries in accordance with the conditions established in the EEA Agreement;

(b) and third countries, in particular countries in the European neighbourhood, countries that are applying for, candidates for or acceding to membership of the Union, and the western Balkan countries included in the stabilisation and association process, in accordance with the conditions laid down in the respective bilateral or multilateral agreements establishing the general principles for their participation in Community programmes.

Article 9

International cooperation

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

Article 10

Monitoring, evaluation and dissemination of results

1. The Commission, in close cooperation with the Member States, shall monitor the implementation of the actions of the programme in the light of its objectives. It shall report to the Committee, and shall keep the Council and Parliament informed.

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

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

4. The Commission shall make the results of actions undertaken in accordance with this Decision publicly available and shall ensure their dissemination.

Article 11

Repeal

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

Article 12

Transitional measures

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

Article 13

Final provision

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union .

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX 1 – Strengthening synergies through common actions and instruments

Objectives

1. To protect citizens from risks and threats that are beyond the control of individuals (e.g. health threats which affect the society as a whole, unsafe products, unfair commercial practices).

2. To increase the ability of citizens to take better decisions about their health and consumer interests.

3. To mainstream health and consumer policy objectives.

Actions and instruments

1. IMPROVE COMMUNICATION WITH EU CITIZENS ON HEALTH AND CONSUMER ISSUES

1.1. Awareness-raising campaigns.

1.2. Surveys.

1.3. Conferences, seminars, experts and stakeholders meetings.

1.4. Publications on issues of interest for health and for consumer policy.

1.5. Provision of online information.

1.6. Developing and use of information points.

2. INCREASE CIVIL SOCIETY AND STAKEHOLDERS’ PARTICIPATION IN POLICY-MAKING RELATED TO HEALTH AND CONSUMER PROTECTION

2.1. Promote and strengthen Community level consumer and health organisations.

2.2. Training and capacity-building for consumer and health organisations.

2.3. Networking of non-governmental consumer and health organisations and other stakeholders.

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

3. DEVELOP A COMMON APPROACH FOR INTEGRATING HEALTH AND CONSUMER CONCERNS INTO OTHER COMMUNITY POLICIES

3.1. Development and application of methods to assess the impact of Community policies and activities on health and consumer interests.

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

3.3. Studies on impact of other policies on health and consumer protection.

4. PROMOTE INTERNATIONAL CO-OPERATION RELATED TO HEALTH AND CONSUMER PROTECTION

4.1. Co-operation measures with international organisations.

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

4.3. Encourage health and consumer organisations’ dialogue.

5. IMPROVE THE EARLY DETECTION, EVALUATION AND COMMUNICATION OF RISKS BY:

5.1. Supporting scientific advice and risk evaluation, including the tasks of the independent scientific committees established by Commission Decision 2004/210/EC[22].

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

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

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

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

5.6. Strategies to improve risk communication.

5.7. Training in risk assessment.

6. PROMOTE THE SAFETY OF GOODS AND OF SUBSTANCES OF HUMAN ORIGIN

6.1. Analysis of injury data and development of best practice guidelines in relation to the safety of consumer products and services.

6.2. Development of methodologies and database maintenance for the purpose of data collection on injuries in relation to the safety of consumer products.

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

6.4. Promoting the availability and accessibility across the Community of organs and substances of human origin of high quality and safety for medical treatments.

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

ANNEX 2 - HEALTH

ACTIONS AND SUPPORT MEASURES

Objective one: protect citizens against health threats

1. ENHANCE SURVEILLANCE AND CONTROL OF HEALTH THREATS BY

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

1.2. Developing strategies and mechanisms for preventing, exchanging information on and responding to non-communicable disease threats;

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

1.4. Improving laboratory co-operation to assure high quality diagnostic capabilities for pathogens across the Community, including a Community reference laboratory structure for pathogens requiring enhanced Community collaboration;

1.5. Developing new and improved prevention, vaccination and immunisation policies , partnerships and tools and monitoring immunisation status;

1.6. Developing and implementing vigilance networks and reporting systems for adverse events when using preventive health measures and substances of human origin;

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

2. DELIVER RESPONSE TO HEALTH THREATS BY

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

2.2. Developing and maintaining capacity for appraising and addressing the needs and gaps in preparedness and response and for rapid and reliable communications and consultation on counter-measures;

2.3. Developing risk communication strategies and tools for information and guidance to the public, and health professionals, and improving awareness and interaction among actors;

2.4. Developing strategies and procedures for drawing up, testing, evaluating and revising general contingency and specific health emergency plans and their inter-operability between Member States and conducting exercises and tests;

2.5. Developing strategies and mechanisms for reviewing and improving the availability and adequacy of, and access to facilities (e.g. laboratories) and equipment (detectors etc), as well as readiness, surge capacity and infrastructure of the health sector to react rapidly;

2.6. Developing strategies and mechanisms for assessing the need for and promoting the establishment of public health assets that can be deployed rapidly in emergencies and setting-up mechanisms and procedures for health assets transfer to requesting states and international organisations;

2.7. Establishment and maintenance of a trained and permanently available core group of public health experts for global rapid deployment to places of major health crises together with mobile laboratories, protective equipment and isolation facilities.

Objective 2: promote policies that lead to a healthier way of life

3. PROMOTE HEALTH BY TACKLING DETERMINANTS

Actions will support the preparation, development and implementation of activities, strategies and measures on health determinants by addressing:

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

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

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

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

3.5. The quality, efficiency and cost effectiveness of public health interventions;

3.6. Support for public awareness activities, training and capacity building actions related to the priorities set out in the previous paragraphs;

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

Objective 3: contribute to reducing the incidence of major diseases

4. PREVENT DISEASES AND INJURIES

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

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

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

4.3. Exchange of best practice and knowledge as well as the coordination of strategies to promote mental health and to prevent mental illness;

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

4.5. Support for knowledge exchange, training and capacity building actions related to the diseases addressed and injury prevention.

Objective 4: improving effectiveness and efficiency in health systems

5. ACHIEVE SYNERGIES BETWEEN NATIONAL HEALTH SYSTEMS BY

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

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

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

5.4. Developing a network for strengthening the capacity to develop and share information and assessments regarding health technologies and techniques (health technology assessment);

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

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

5.7. Developing and implementing actions to promote patient safety and high-quality care;

5.8. Supporting health systems policy development, in particular linked to the open method of coordination on healthcare and long-term care.

Actions contributing to all the above objectives:

6. TO IMPROVE HEALTH INFORMATION AND KNOWLEDGE FOR THE DEVELOPMENT OF PUBLIC HEALTH BY:

6.1. Continue further developing a sustainable health monitoring system, paying special attention to health inequalities and covering data on health status, health determinants, health systems and injuries; the statistical element of this system will be further developed, using as necessary the Community Statistical Programme.

6.2. Providing other relevant health related knowledge;

6.3. Defining relevant additional indicators;

6.4. Developing appropriate mechanisms of reporting;

6.5. Arranging for regular collection of such information, together with the Statistical Programme, international organisations, agencies and through projects;

6.6. Supporting analysis of Community health issues through regular Community health reports, the maintenance of diffusion mechanisms such as the Health Portal, support for consensus conferences and targeted information campaigns coordinated between concerned parties;

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

6.8. Developing strategies and mechanisms for preventing, exchanging information on and responding to rare diseases.

ANNEX 3: Consumer Policy – Actions and Support Measures

Objective I - A better understanding of consumers and markets

Action 1: Monitoring and assessment of market developments with an impact on the economic and other interests of consumers, including price surveys, inventory and analysis of consumer complaints, analysis of cross-border marketing and business-to-consumer purchases, and surveys of changes in the structure of markets.

Action 2: The collection and exchange of data and information that provide an evidence base for the development of consumer policy and for the integration of consumer interests in other Community policies, including, surveys of consumer and business attitudes, consumer-related and other market research in the financial services area, collection and analysis of statistical and other relevant data, the statistical element of which will be developed using as necessary the Community Statistical Programme.

Action 3: The collection, exchange, analysis of data and development of assessment tools that provide a scientific evidence base on consumer exposure to chemicals released from products.

Objective II - Better consumer protection regulation

Action 4: Preparation of legislative and other regulatory initiatives and promotion of self-regulatory initiatives, including:

4.1. Comparative analysis of markets and regulatory systems

4.2. Legal and technical expertise for policy making on the safety of services

4.3 Technical expertise in relation to assessment of the need for product safety standards and the drafting of CEN standardisation mandates for products and services

4.4 Legal and technical expertise for policy development on the economic interests of consumers

4.5 Workshops with stakeholders and experts.

Objective III - Better enforcement, monitoring and redress

Action 5: Coordination of surveillance and enforcement actions linked to the application of consumer protection legislation, including:

5.1 Development and maintenance of IT tools (e.g. databases, information and communication systems)

5.2. Training, seminars, conferences on enforcement

5.3. Planning and development of joint enforcement actions

5.4. Pilot joint enforcement actions

5.5. Analysis of enforcement problems and solutions

Action 6: Financial contributions for specific joint surveillance and enforcement actions to improve administrative and enforcement cooperation on Community consumer protection legislation, including the General Product Safety Directive, and other actions in the context of administrative cooperation.

Action 7: Monitoring and assessment of the safety of non-food products and services, including:

7.1. Reinforcement and extension of the scope and operation of the RAPEX alert system, taking developments in market surveillance information exchange into account

7.2. Technical analysis of alert notifications

7.3. Collection and assessment of data on the risks posed by specific consumer products and services

7.4. Further development of the consumer product safety network as provided for in Directive 2001/95/EC of the European Parliament and of the Council[23].

Action 8: Monitoring of the functioning and assessment of the impact of alternative dispute resolution schemes on consumers.

Action 9: Monitoring of the transposition and implementation of consumer protection legislation by Member States, notably the Unfair Commercial Practices Directive, and of national consumer policies.

Action 10: Provision of specific technical and legal expertise to consumer organisations to support their contribution to enforcement and surveillance actions.

Objective IV. Better informed and educated and responsible consumers

Action 11: Development and maintenance of easily and publicly accessible databases covering the application of and case-law on Community consumer protection legislation.

Action 12: Information actions about consumer protection measures, particularly in the new Member States, in cooperation with their consumer organisations.

Action 13: Consumer education, including the actions targeted at young consumers, and the development of interactive consumer education tools.

Action 14: Representation of the interests of Community consumers in international forums, including international standardisation bodies and international trade organisations.

Action 15: Training for staff members of regional, national and Community consumer organisations and other capacity building actions.

Action 16: Financial contributions for joint actions with public or non-profit bodies constituting Community networks that provide information and assistance to consumers to help them exercise their rights and obtain access to appropriate dispute resolution (the European Consumer Centres Network).

Action 17: Financial contributions to the functioning of Community consumer organisations representing consumer interests in the development of standards for products and services at Community level.

Action 18: Financial contributions to the functioning of Community consumer organisations.

Action 19: Provision of specific technical and legal expertise to consumer organisations to support their participation in, and input into, consultation processes on Community legislative and non-legislative policy initiatives, in relevant policy areas, such as internal market policies, services of general interest and the 10-year framework programme on sustainable production and consumption.

Common to all objectives

Action 20: Financial contributions for specific projects at Community or national level in support of other consumer policy objectives.

LEGISLATIVE FINANCIAL STATEMENT

1. NAME OF THE PROPOSAL :

Health and consumer protection programme 2007-2013

2. ABM / ABB FRAMEWORK

Policy area: Health and Consumer Protection (SANCO, Title 17)

Activities: Public health / Consumer protection:

3. BUDGET LINES

3.1. Budget lines (operational lines and related technical and administrative assistance lines (ex- B..A lines)) including headings :

Current budget lines:

ABB 17 03 01 01 Public health (2003-2008)

ABB 17 01 04 02 : Public Health – Expenditure for Administrative management

ABB 17 01 04 30 : Public health –Operating subsidy to the Executive Agency for the Public Health Programme. This line should to be renamed and should receive appropriations from the lines ABB 17 01 04 02 : Public Health – Expenditure for Administrative management and ABB 17 01 04 03 : Community activities in favour of consumers – Expenditure for Administrative management.

ABB 17 02 01 : Community activities in favour of consumers

ABB 17 01 04 03 : Community activities in favour of consumers – Expenditure for Administrative management

A new budget structure will be defined after approval of the Interinstitutional Agreement on Financial Perspective 2007-2013.

3.2. Duration of the action and of the financial impact:

Total allocation for action : 1203 € million for commitment

Period of application:1 January 2007 – 31 December 2013

3.3. Budgetary characteristics:

Budget lines | Type of expenditure | New | EFTA contribution | Contributions from associated countries | Heading in financial perspectives |

17 03 01 01 | Non-comp | diff | NO | YES | YES | No 3 |

17 01 04 02 | Non-comp | Non-diff | NO | YES | YES | No 3 |

17 01 04 30 | Non-comp | Non-diff[24] | YES | YES | YES | No 3 |

17 02 01 | Non-comp | diff[25] | NO | YES | YES | No 3 |

17 01 04 03 | Non-comp | Non-diff[26] | NO | YES | YES | No 3 |

4. SUMMARY OF RESOURCES

4.1. Financial Resources

4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA)

EUR million (to 3 decimal places)

Total number of human resources* | 79 | 83 | 87 | 91 | 95 | 95 | 95 |

* of which 20 new posts with a breakdown of 4 new posts each year from 2007 to 2011

5. CHARACTERISTICS AND OBJECTIVES:

5.1. Need to be met in the short or long term

The Communication and the programme proposal bring together Public Health and Consumer protection policies and programmes under one framework to make EU policy work better for citizens. Many objectives of health and consumer actions under Treaty articles 152 and 153 are shared: promoting health protection, information and education, safety and integration of health and consumer concerns into all policies. Health and consumer policies also use many similar types of actions to pursue their objectives e.g. information to citizens, consultation of stakeholders, mainstreaming activities, risk assessment. Bringing the two areas together will thus lead to greater policy coherence, economies of scale and increased visibility.

5.2. Value added of Community involvement and coherence of the proposal with other financial instruments and possible synergy

The EU, national and regional authorities, citizens, businesses and civil society have a role to play in improving the health, wellbeing and welfare of European citizens. There are however several shared health and consumer policy challenges that only action at EU level can tackle. Greater mobility and more communication have benefited citizens. But they have also increased the risk of spreading health threats such as SARS and other communicable diseases (which cannot be addressed by individual Member States alone) and scams e.g. from bogus lotteries. The complexity of modern life has brought more choice for citizens. But it has also made it harder for them to make the best choices.

The proposed strategy and programme aim to implement articles 152 and 153 of the Treaty as regards Community action on health and consumer protection, by complementing national action with value-added measures which cannot be taken at national level .

Bringing health and consumer protection under a common framework will lead to important synergies in terms of objectives and actions, and enhance policy coherence . Merging the two programmes will also streamline administrative procedures (with a common set of tools and a unified budget) and increase visibility of policy actions vis-à-vis European citizens and within the EU institutions.

The joint Health and Consumer programme builds on the two existing programmes and maintains their core elements. It also expands health and consumer protection activities and builds bridges between the two in order to respond to stakeholders’ concerns.

Clearly, EU action on food safety also has an important contribution to making citizens healthier, safer and more confident. The Commission will build synergies with food safety policy which is not explicitly covered in this strategy, for example when working on nutrition.

Synergies will be ensured with other major instruments. One of the common objectives of the proposed health and consumer programme is to mainstream health and consumer interests in other policies to reflect the obligations of articles 152 and 153 of the Treaty. Actions will be developed building on and extending current activities.

For example health has been more closely associated to the Structural Funds and the research programme when designing the new legal bases. Particular attention has also been given to ensure synergies with the Solidarity Fund. Similarly, consumer interests have to be integrated into areas of policy such as the development of the internal market, competition or services of general interest.

5.3. Objectives and expected results of the proposal in the context of the ABM framework

The overall goal of the EU Health and Consumer Policy is to improve the quality of life for EU citizens, in terms of their health and their consumer interests. This will contribute to making Europe’s citizens healthier, safer and more confident, providing the means for economic and social inclusion, and thus giving substance to EU citizenship. As regards health, progress towards meeting this goal will be assessed with the Healthy Life Years Structural Indicator .

Protection and promotion of health and consumer interests depends on many factors. Citizens themselves, through their own choices, can improve their health and protect their interests as consumers. But much depends on external factors that public policy needs to address.

5.3.1. Core joint objectives

•EU Health and Consumer policies have three core joint objectives :

1. Protect citizens from risks and threats which are beyond the control of individuals and that cannot be effectively and completely tackled by individual Member States alone.

2. Increase the ability of citizens to take better decisions about their health and consumer interests. This means increasing the opportunities they have to exercise real choice and also equipping them with the knowledge they need.

3. Mainstream health and consumer policy objectives across all Community policies in order to put health and consumer issues at the centre of policy-making. The EU Treaty recognises this by requiring that all policies take health and consumer interests into account[27].

5.3.2. Areas of synergy

There are a number of areas of synergy between EU Health and Consumer policies. There is therefore much scope for complementary actions with common objectives to be undertaken as outlined below.

• Improve communication with EU citizens. The aim is to improve the delivery of information citizens need to manage their health and consumer interests and to listen better to their concerns and feed this into policy-making.

• Increase civil society and stakeholders’ participation in EU policy-making. The aim is to improve consultation to ensure their close participation in policy-making. Activities would include promoting civil society networking, wider public consultations and better representation in consultation bodies. Civil society needs active, expert and articulate voices for health and consumer interests at EU level. There is still a lack of a stable and credible EU consumer movement with grassroots, resources and voice, and this cannot be ignored in the Member States. Similarly, on health there is a need to increase stakeholders’ input into policy-making.

• Develop a common approach for integrating health and consumer concerns into other EU policies , i.e., to deliver within the Commission the integration of health concerns and consumer interests into other policies and to develop ideas and share best practice with Member States on how to develop this at national level. In the health area , there is a need to develop Health Impact Assessment as an evaluation tool. There is also much scope for achieving synergies with other policies, including social policy (Health Insurance card, health and safety at work); Information society (eHealth applications); Environment (Environment and health action plan); Research (health research in the framework programmes); Development (HIV/AIDS); Regional policy (health in the Structural Funds) and many others.

In the consumer area, most EU policies that regulate or intervene in markets or which affect citizens’ rights (data protection, copyright, access to justice) have a profound effect on consumer outcomes. The main current areas are competition policy, information society and essential services (or services of general interest), where core universal services need be established and maintained. Issues related to standardisation and developing of information society are also of key importance to consumers.

• Enhance scientific advice and risk assessment. Tackling problems that might impact on health and safety requires good independent scientific advice and thorough risk assessment. Risk assessment is therefore a fundamental element of the joint programme. Proactive risk management measures will be taken by encouraging the early identification of emerging risks; analysing their potential impact; promoting information exchange on hazards and exposure; fostering harmonised approaches to risk assessment across different sectors; promoting training and exchange schemes for assessors; and improving communication between risk assessors and stakeholders.

• Promote the safety of products and substances of human origin. Activities would include best practice exchange, awareness raising, implementation guidelines, training and networking, joint surveillance and enforcement projects and systematic development of product safety standards, as regards the following two categories:

• General product safety, which is a common thread running through consumer actions.

• Safety of products that impact directly on health, including those derived from substances of human origin (such as blood, tissues and cells) that are not tradable for profit. The aim is to support Member States’ implementation of Community legislation and to promote the accessibility of these products.

• To promote international cooperation, including co-operation with international organisations and third countries in the areas of health and consumer protection.

The EU must take a bigger role in international health and tackle global health issues more. Measures foreseen include taking steps to strengthen co-operation with the WHO and with the OECD. The EU must also support candidate countries as well as neighbouring countries on key public health issues and in developing their health systems. Measures foreseen include bilateral initiatives with enlargement and neighbouring countries, exchange of good practices and assistance in tackling health crises.

On consumer affairs , international regulatory cooperation is increasingly necessary in areas such as product safety and in dealing with rogue traders. At the multilateral level, the relationship between trade and consumer interests is growing. International Regulatory cooperation also needs to be complemented by dialogue between civil society and their involvement (e.g. in standardisation).

5.3.3. Public health objectives

First, to protect citizens against health threats .

Second, to promote policies that lead to a healthier way of life.

Third, to contribute to reducing the incidence of major diseases in the EU.

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

Fifth, to support the objectives above by providing health information and analysis .

Progress towards these objectives will lead to enabling European citizens across the EU to enjoy healthier and longer lives and will contribute to reducing the gap in life expectancy and health status between Member States. Improvements will be monitored through the short list of Community health indicators[28] and the “healthy life years” structural indicator.

5.3.4. Consumer policy priority areas:

• Better understanding of consumers and markets,

• Better consumer protection regulation

• Better enforcement, monitoring and redress,

• Better informed and educated consumers

Actions will contribute to ensure an equally high level of protection for all EU consumers, wherever they live, travel to or buy from in the EU, from risks and threats to their interests. Action covers the safety of goods and services; the fairness of commercial practices and contractual rights for consumers; affordable access to essential services, protection from rogue traders and access to effective means of redress. This should result in reducing the lack of confidence of consumers in the internal market and enabling them to make free and informed choices from an appropriate range of products . This, in turn, will boost competition and make a significant contribution to the competitiveness of EU businesses .

Actions will also contribute to increase the capacity of consumers to promote their own interests, as individuals or though consumer organisations, i.e., helping consumers help themselves. This means equipping consumers with the tools they need to take better and more rational decisions in the internal market. This includes the provision of information to consumers about their rights, means of redress but also products and the opportunities of the internal market. This also implies a clear role for the representatives of consumers, properly resourced and with sufficient expertise.

5.4. Method of Implementation (indicative)

Show below the method(s)[29] chosen for the implementation of the action.

X Centralised Management

X Directly by the Commission

ٱ Indirectly by delegation to:

X Executive Agency

ٱ Bodies set up by the Communities as referred to in art. 185 of the Financial Regulation

ٱ National public-sector bodies/bodies with public-service mission

ٱ Shared or decentralised management

ٱ With Member states

ٱ With Third countries

X Joint management with international organisations (relevant organisations in the areas of health and consumers)

6. MONITORING AND EVALUATION

6.1. Monitoring system

The Commission monitors the most pertinent indicators throughout the implementation of the new joint programme. The indicators hereunder listed are related to the objectives described under part 5.3 .

Objectives | Indicators |

Strengthening synergies for policy delivery |

Improve communication with EU citizens | number of campaigns number of conferences & participants number of publications satisfaction with portal, n. of users number information points’ users |

Increase civil society and stakeholders’ participation in EU policy-making | number of public consultations, meetings, number of conferences and participants number of responses to open consultations number of members of consultation bodies, number and regularity o meetings |

Develop a common approach for integrating health and consumer concerns into other EU policies | Number of joint measures with other DGs Number of ISC on which DG SANCO is consulted/Number of SANCO responses to other DGs Health Impact assessments undertaken Explicit references to health policy objectives in other policies |

Enhance scientific advice and risk assessment | Number of scientific opinions given Community guidelines or decisions embodying the scientific opinions |

Promote the safety of products and substances of human origin | Number of product safety standards developed |

Promote international cooperation | Number of initiatives with International organisations Number of initiatives with third countries |

Health |

protect citizens against health threats | ECDC becomes operational European co-ordination capacity for responding rapidly to threats is in place Number of projects in this area |

promote policies that lead to a healthier way of life | Number of new measures proposed and carried out in new strategies Number of projects in this area Number of events Number of thematic platforms created Number of information/awareness raising publications and target audience reached |

contribute to reducing the incidence of major diseases | Number of new measures proposed and carried out in new strategies Number of projects in this area Number of information/awareness raising publications and events and target audience reached |

improving effectiveness and efficiency in European health systems | Number of centres of reference identified Number of countries participating in HTA network Number of assessment reports |

For all health objectives : Health information and knowledge | Number of projects in this area Number of information/awareness raising publications and events and target audience reached Number of hits in health portal Number of Health reports |

Consumer policy |

A better understanding of consumers and markets | Level of knowledge-base activity (number of reports and data analysis) integration of the data and analyses into consumer-related Commission initiatives |

Better consumer protection regulation | Level of consumer satisfaction on legislation, opinions on infrigements. Businesses’ opinions on the impact of legislation |

Better enforcement, monitoring and redress | Measure of consumers’ satisfaction evaluation of the efficiency of the different tools, instruments and networks |

Better informed and educated consumers | Measure of knowledge and satisfaction of consumers on consumer policy and consumer protection |

The implementation of the Community programme entrusted to the executive agency is subject to the control of the Commission and this control is exerted according to the methods, the conditions, the criteria and the parameters which it lays down in the act of delegation defined by Council Regulation (EC) N° 58/2003 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes[30], Article 6 (3).

6.2. Evaluation

6.2.1. Ex-ante evaluation

This programme proposal is built on a series of existing Community programmes and measures, some of which have been operational for many years, and which have been the subject of a comprehensive sequence of evaluations, as well as a substantial corpus of experience of administering and implementing the programmes in the Commission (and a former technical assistance office) and within the Member States and other participating countries (particularly the candidate countries).

The new programme was designed taking into account in particular the experience gained through implementing the programmes on public health 2003-2008 and the Consumer Policy Strategy 2002-2006.

The hypothesis of taking no action was considered:

• No action means failure to meet the provisions of articles 152 and 153 of the Treaty.

• No action means that the Commission would not meet the requirement of having a proper legal basis for consumer protection and for health actions during the period 2007-2013 as imposed by the new financial perspectives. (The Health Programme expires at the end of 2008; the consumer programme at the end of 2007). This would make it very difficult to fulfil various legal obligations.

• No action would mean that it would not be possible to take action to increase consumers’ confidence in goods and services from other Member States with consequent implications for the effectiveness of the single market. This would cause problems for business which would continue to be confronted with a fragmented market.

• No action would mean that the Commission would not fulfil its commitment to present a health strategy, following an open consultation in 2004, intended to help prepare the ground for a new strategy. In terms of effects on health, some serious negative impact would arise following the expiry of the current health programme. Health protection in Europe would be undermined as essential health threat surveillance systems and alert mecanisms would find it difficult to operate. There would be inadequate information about important health trends and developments as mechanisms to collect and analyse the data would not function effectively. This would make it harder for health authorities to plan and develop policies and for citizens to take decisions. There would also be a great reduction in actions against trans-frontier health threats eg HIV/AIDS and bioterrorism.

• No action would also mean that the Commission stopped work in areas of central concern to its citizens daily lives and thus lost the possibility to increase visibility and to demonstrate the relevance of its action to them.

Building a joint programme will:

• help bring citizens’ issues to the forefront of the EU agenda by providing a joint framework for two policies that impact on citizens’ day-to-day life.

• generate synergies , exploiting the common objectives of articles 152 (public health) and 153 (consumer protection) of the Treaty (e.g. health protection, citizens’ information and education, mainstreaming) and common elements of work under health and consumer policies (e.g. co-operation with Member States, contacts with civil society, risk assessment, international dimension).

• enhance the coherence of EU policies , in response to Treaty articles 152 and 153, which require the integration of health and consumer interests in other policy areas.

• streamline and simplify administrative and budgetary procedures making Community action more visible, transparent, operational, effective and also flexible (one single programme, one set of procedures, common set of tools, one budget line).

In addition the existing executive agency for the public health programme could have its current mandate adapted to be able to ensure the management tasks of the new programme, including budgetary tasks, which would constitute the best management instrument at the disposal of the Commission[31]. This will in particular ensure :

- Multiplier effect (leverage) enabling the Commission to concentrate on its core competencies;

- Effectiveness and flexibility in the implementation of outsourced tasks;

- Simplification of the procedures used;

- Proximity of the outsourced action to the final beneficiaries.

(a) In the public health area

The public health programme 2003-2008, adopted in September 2002,[32] represents a major step forward for the implementation of the provisions of Article 152 of the EC Treaty. It provides for the integrated development of a strategy aimed on the one hand at ensuring a high level of health protection in all Community policies and actions and, on the other, at supplementing and coordinating policies and actions carried out by the Member States in the field of health surveillance and information systems, combating transmissible diseases and disease prevention.

In designing the new joint programme proposal, special attention was given to building upon the experience acquired during the first years of operation of the 2003-2008 programme, as well as to integrating the work carried out in various consultations, fora and groups.

Preparatory work on the health strategy

An open consultation on the future Health Strategy was launched in July 2004. The consultation was carried out on the basis of a public consultation document published on the web-site. All interested parties from the public health area, public bodies, interest groups and individual citizens, were invited to participate in the consultation, by means of a written contribution. Almost 200 contributions from national and regional authorities, NGOs, universities, individual citizens and companies have reached the Commission, Following the analysis of the results, a number of policy priority areas have been identified making it necessary to re-orient existing work in order to refine the policy priorities. The result is available in the Commission website[33].

Approximately 1/4 of all respondents including Ireland, Sweden, the Netherlands, Germany, the UK, Lithuania Malta and Poland urged the EU to pro-actively promote health and prevent illness. Measures proposed include the need to focus on children and teenagers, to implement a nutrition/obesity strategy, to tackle smoking and alcohol, to address a wide range of issues affecting health and to act on important diseases including cancer, respiratory and cardiovascular diseases.

Approximately 1/5 of all respondents including France, Germany, Ireland, the Netherlands, Sweden, Finland and Lithuania asked the EU to mainstream health . Respondents urged the Commission to implement a comprehensive and coherent EU approach to health, encompassing policies as diverse as Education, Trade, Internal Market, Social, Environment, Agriculture, External, Transport and Regional development. Several respondents including France, Ireland, Sweden and Finland raised the need for a Health Impact Assessment system.

The need to position health as a driver of economic growth and to disseminate evidence was raised by Ireland, France, the Netherlands, Malta and the UK. Some NGOs and Germany, Ireland and Sweden asked for health to become part of the Lisbon agenda .

Many stressed the need to address health inequalities by increasing funding for health. Respondents also urged the EU to involve stakeholders more closely in policy-making , to support the civil society, to take a stronger role on international health and to step up efforts in the analysis and dissemination of data.

Finally, many respondents also urged the EU to increase resources allocated to health, for the Public Health Programme to better serve policy priorities, to improve dissemination of project results, to cover neighbouring countries and to increase co-funding.

Respondents raise a large number of additional specific issues including the need to focus more on mental health, the challenges posed by an ageing population, the need to increase quality in healthcare, to secure patients’ rights and safety, to set clear rules for patient and professional mobility, for health technology assessment and research.

Health systems

In 2003, a high level reflection process on patient mobility and healthcare developments in the EU was launched at ministerial level. Working groups composed of Member State health ministers or senior representatives, and stakeholders met throughout the year. In December 2003, a ministerial level meeting including ministers from acceding countries, adopted a report containing 19 recommendations for action at EU level. The Commission responded in presenting three Communications[34] in April 2004. To take forward these recommendations, a High Level Group on health services and medical care was established with working groups on the following areas : cross-border healthcare purchasing and provision, health professionals, centres of reference, health technology assessment, information and e-health, health impact assessment and health systems, patient safety. A report setting out progress at this stage and orientations for future work was endorsed by the Council in December 2004. The need to take forward work on the cooperation of health systems justifies the creation of a new action strand under the selected option.

Involvement of stakeholders

Health policy making must respond to the needs and concerns of citizens. It is necessary to build up the organisations representing patients and those developing the public health agenda so that civil society is able to make the constructive contribution needed to public health policy.

Currently, patient groups and non governmental organisations in the health field can find it difficult to develop initiatives at EU level and to stabilise their organisations because they have inadequate resources.

For example active participation in the EU Health policy forum, which brings stakeholders together to discuss policy issues, requires a level of organisational capacity and resources that many NGOs lack. Associations are not funded for their core work as such, because the legal basis of the Public Health Programme 2003-2008 does not allow such direct funding. The Commission is therefore proposing operational grants as well as project grants to provide core funding to certain NGOs, including patient groups, in order to help them develop their organisational capacity and put themselves on a sound basis.

Need for additional budget and added-value

The programme proposal reinforces the existing three strands of the Public Health Programme (Information, Health threats and promoting health through addressing health determinants). The programme also includes three new action areas which are essential to respond to the needs identified: response to health threats, prevention of diseases and co-operation between health systems. Below are the main reasons why an additional budget is needed and the added value of Community action:

First, the current health budget is too limited to fully comply with Treaty provisions . For example, the Community has a Treaty obligation to protect citizens against health threats . Threats such as SARS show the need for increased EU capacity to help Member States react to such threats and to co-ordinate a response in order to minimise the risk of spread of infection within the EU. The current budget does not enable the Community to effectively pursue this obligation. The Treaty also foresees Community action to encourage Members States’ co-operation on health. However, so far, co-operation has been limited to the High Level Group on health services which has no operational budget.

Second, the three new strands also reflect existing Commission engagements and policy developments. The Commission strategic objectives for 2005-2009 stress the importance of countering threats to citizens’ health and safety at EU level: hence a new strand on reaction to threats which requires substantial resources. The new strand on health systems co-operation responds to Member States’ requests and the Lisbon process conclusion that European support to improve health systems is “ envisaged and can provide important added value”. The strand on preventing specific diseases responds to repeated requests and to the outcome of the open consultation on health. In addition, the first two strands (reaction to threats and health systems co-operation) also correspond to two areas where the Community Health mandate would be expanded in the Constitution.

Third, as underlined in the Lisbon process , there is a need to reduce the major differences between Member States in terms of life expectancy, health status and health systems capability. Following enlargement, supporting in particular the new Member States to develop their health systems requires additional resources. In addition to infrastructure investment to which the Community Structural Funds can contribute, there is a need for the Community to help these countries in terms of training, expertise, capacity building, preparedness, prevention and promotion, as well as a need for analysis on their health investment needs.

Finally, the EU population ageing and its potential impact on the sustainability of public finances, not least from the relative decline in the working population, requires EU action to help Member States cope with this challenge.

Cost-effectiveness

Improving cost-efficiency is one of the main reasons for bringing together the existing Health and Consumer programmes into a single framework. The overall programme will benefit from economies of scale and from the streamlining of administrative and budgetary procedures, including common tools. Using the same tools and procedures on common actions will lead to savings in terms of organisation and management tasks and will therefore translate into a cost/input reduction. The extension of the existing Public Health Programme executive agency to support the whole of the proposed programme will also lead to savings in terms of input as regards tasks related with tendering and organisation of meetings. The outsourcing of such administrativ