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text: COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 04. 06. 1997 COM(97) 266 final 97/0153 (COD) COMMUNICATION FROM THE COMMISSION concerning a programme of Community action on pollution-related diseases in the context of the framework for action in the field of public health Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action 1999-2003 on pollution-related diseases in the context of the framework for action in the field of public health (presented by the Commission) -1 - COMMUNICATION FROM THE COMMISSION concerning a programme of Community action on pollution-related diseases in the context of the framework for action in the field of public health -2- TABLE OF CONTENTS I. INTRODUCTION II. POLLUTION-RELATED DISEASES IN THE EUROPEAN COMMUNITY III. THE PREVENTION OF POLLUTION-RELATED DISEASES page 3 4 9 IV. OVERVIEW OF PUBLIC HEALTH ACTIONS IN THE MEMBER STATES AND INTERNATIONALLY CONCERNING POLLUTION-RELATED DISEASES 10 V. OVERVIEW OF COMMUNITY ACTIONS RELEVANT TO POLLUTION-RELATED DISEASES 11 VI. APPROACH TO COMMUNITY PUBLIC HEALTH ACTION ON POLLUTION- RELATED DISEASES. 13 VII. COMMUNITY ACTION PROGRAMME ON POLLUTION-RELATED DISEASES. 15 VIII. CONSULTATION ASSESSMENT AND REPORTS 18 I. INTRODUCTION 1. 2. 3. The protection of health has been made a priority under Articles 3(o) and 129 of the Treaty establishing the European Community. The Community's role is to contribute towards ensuring a high level of human health protection, directing actions towards the prevention of diseases, in particular by encouraging cooperation between Member States and, if necessary, lending support to their action, by promoting coordination of ' their policies and programmes, and by fostering cooperation with third countries and the international organisations competent in the sphere of public health. In its communication of 24 November 1993 on the framework for action in the field of public health (COM (93) 559 final), the Commission defined a framework for future action at Community level in order to attain these objectives. In accordance with the criteria laid down in the Commission communication pollution-related diseases have been identified as a priority for Community action in the field of public health. Pollution-related diseases are those diseases which are caused, provoked or aggravated by environmental pollution. In the context of environmental programmes, pollution has been defined as an effect on the environment linked to human activities that disturbs the absorption and regeneration of the ecosystem. But in relation to public health a more limited definition is that pollution is an environmental imbalance or disturbance, man- made or naturally occurring, which can have an adverse effect on human health. These pollutants may be biological, chemical or physical in nature and may be present in air, water, soil or food. H. POLLUTION-RELATED DISEASES IN THE EUROPEAN COMMUNITY 4. 5. 6. 7. Environmental pollution has created problems for health throughout the course of human history. But the increase of urbanisation and industrialisation and the rapid growth of population have led both to greater numbers and concentrations of pollutants and a greater number of people exposed to them. As knowledge has grown about the impact of pollution on health, so steps have been taken to control pollution and improve hygiene and living and working conditions, for example by supplying clean water and installing sewage systems in towns. Indeed the improvements in the state of health of Member States' populations over the last 200 years owe more to such measures than to advances in medical care and treatment. Today in the European Community many of the diseases linked to poor environment and hygiene that were previously rampant, notably infectious diseases arising from polluted water, such as cholera and typhoid fever, have been greatly reduced, and in many cases virtually eliminated. Although a number of infectious diseases do remain as significant threats to health, their place as the major 'health scourges' in the Member States has been to a large extent filled by diseases which are caused by an interaction between environment, genetics and life style, such as respiratory diseases and certain forms of cancer. Long-term exposure to relatively low levels of pollution and acute exposure to high concentrations may play a part in such interactions, and different pollutants may interact with each other. Although pollutants contribute to the causation, provocation or aggravation of these diseases, and are also associated with effects on health which might lead to subsequent disease, the extent of their impact in any particular case will depend on a range of factors, such as genotype, age, occupation and lifestyle of the people concerned. It is clear, however, that even where the contribution of a pollutant to the causatioa or aggravation of any specific disease is relatively small, the impact of the pollutant on public health may be considerable if that disease is responsible for significant morbidity and mortality. Pollution contributes to many of the major causes of morbidity and mortality in the European Community, including respiratory problems, allergies, cancers, cardio vascular diseases and infectious diseases, neurological disorders and immunological impairment. RESPIRATORY DISEASES 8. Over the last decades there has been a rise in the prevalence of a number of serious respiratory diseases in the Community, such as asthma. Asthma 9. Bronchial asthma is a disease of the respiratory tract characterised by unusually high sensitivity of the airways to a wide range of stimuli including inhaled irritants and allergens. Asthma, may be either episodic or chronic, and in some cases may be fatal. 10. During the past few decades, there has apparently been a considerable increase in the prevalence of asthma in the European Community and in some other developed countries. This has created public concern about the disease and the possible causative 11. 12. factors involved. In the European Community the increase in death rate due to asthma was 27% between 1974-78 and 1980-84. In Finland the number of people with asthma more than doubled between 1964 and 1987. By 1994 3% of its population had been diagnosed as asthmatics. Similarly, in the Netherlands adult cases of asthma doubled between 1972 and 1991. In the UK a parallel increase has been seen. In 1994 asthma was estimated to affect 4% of adults sufficiently severely to require medical supervision. The trends among children are of especial concern. There has been a doubling of prevalence in young children during the 1970s and 1980s. Also in the UK, figures for 1994 indicate that 4-6% of children had asthma requiring medical supervision. It is estimated that twice as many have had a diagnosis of asthma. In Denmark between 1987 and 1994 the prevalence of asthma has increased from 3 to 5%. It has been suggested that part of this reported increase in asthma may be the result of changes and improvements in diagnostic criteria and techniques. However, recent studies, which take into account these changes, point strongly to the conclusion that there has been a real and continuing rise in cases of asthma. Many factors have been put forward to explain this increase. There has been much interest in outdoor air pollution as a possible major cause. Although levels of some pollutants have decreased greatly, the relative importance of emissions from traffic has increased at the same time as increases in asthma prevalence in several Member States. However, the importance of the outdoor environment appears to be less significant than indoor air quality and lifestyle. There is a possibility, however, that there may be a link between some types of air pollution and the marked increase in the prevalence of early onset asthma which generally occurs in atopic individuals i. e. those who readily form IgE antibodies to commonly encountered allergens. Changes in the indoor environment, caused by changes in building construction, such as the increased use of central heating systems and insulation, (resulting in a warm, damp indoor climate which favours the growth of house-dust mites and fungus) and in people's lifestyles leading them to spend more time indoors, are deemed to be of particular importance in this respect. Smoking, particularly maternal smoking, and diet are among other factors which may play a part. 13. Because of the large numbers of people within the European Community who are now affected by asthma, factors which exacerbate the disease are potentially important in public health terms. There is clear evidence of effects of outdoor air pollution on existing asthmatics. Several large-scale epidemiological studies analysing changes in daily concentrations of air pollutants have indicated that increases in concentration are associated with substantial increases in hospital admissions for asthma increased visits to paediatricians and emergency departments for asthma, and increased use of medication by asthmatics. Chronic Obstructive Pulmonary Disease 14. Chronic Obstructive Pulmonary Disease (COPD), notably bronchitis and emphysema, is a significant cause of mortality and morbidity in the European Community. In France, for example, it has been estimated that 2. 5 million people are suffering from chronic bronchitis, one third of them with chronic airway obstruction. Prevalence of COPD increases with age, and is currently higher for men than for women. Prevalence is also higher among smokers (and more women are now smoking), among those with low social status, and those who have worked in occupations where there are high concentrations of airborne particles. In Finland, the prevalence in the elderly in 1994 was estimated at 12. 5% for men but was less for women at 3%. With respect to mortality, COPD represents a major cause of death in developed countries. In some countries, the mortality rate has increased, for example in France the mortality rate rose -6- between 1980 and 1991 from 26. 7 per 100,000 to 29 per 100,000 for men and from 12. 3 to 17. 0 for women. 15. It is, however, difficult to determine with precision the prevalence of COPD in the general population, because the diagnosis of the disease is usually made only on hospital patients using a variety of tests, including pulmonary function. It is also difficult to compare prevalences between countries as different definitions are used and data are not always available. 16. With regard to causal factors for COPD, as with asthma, among known risk factors, some are genetic and others are related to behaviour. Smoking certainly plays a key role. Air pollution is known to play a part in worsening these conditions. The first results of the Community's European APHEA project (Air Pollution and Health: a European Approach) indicate that an increase in daily concentrations of some pollutants has a detectable effect on both hospital admissions for COPD in European cities and on COPD mortality. But further work is needed to determine the causative agents, and the relationships, temporal as well as spatial, between exposure levels to air pollutants and short and long term effects. ALLERGIES 17. 18. 19. 20. Over the last 20 years, there has been a substantial increase in illness perceived as allergies throughout Europe, particularly in urban areas. Since 1970 the prevalence of allergic rhinitis in both adults and children has doubled in a number of Community states, such as the UK and Sweden. Current prevalence rates in the Community vary from 2 to 10%. The response to foreign antigens is governed by the immune system and is influenced by a variety of factors including genetic predisposition, dietary habits, lifestyle and exposure to environmental allergens. It appears that although genetic factors play a very important role, environmental pollutants are key factors in influencing the specific allergens to which ? person will develop hypersensitivity. Among these, biological agents such as pollen, animal dander and house-dust mites are of significance. Pollen allergy is the most common form of allergic disease. 150 years ago when hay fever was first described, it was a rare condition, but in recent years it has been increasing rapidly, particularly in urban areas. Since the turn of the century, a correlation between the level of pollen and the extent of allergic symptoms, such as conjunctivitis and rhinitis, has been widely recognised. But since the level of pollen in the atmosphere has not increased, the observed rise in allergies cannot be due to this factor alone. The influence of air pollutants is a factor that has to be taken into account as they may worsen the problem in three ways. First they may increase the development of pollen allergy through a direct influence on the pollen grains to make them more allergenic. Second, there is evidence that people react more strongly to allergenic substances if they have already been exposed to certain outdoor air pollutants, such as particulates. Finally, exposure to pollutants in the urban atmosphere, such as suspended particulate matter and tobacco smoke, can cause a general increase in airway reactivity for example by assisting the pollen grains' penetration into the human body. 21. Indoor air pollution is also a factor to be considered. The main allergens in the indoor environment are the droppings of house-dust mites, fungal spores and animal dander. House-dust mites, which live predominantly in and on mattresses and bedding and in floor dust, can provoke allergic reactions and aggravate existing respiratory allergic symptoms. The prevalence of sensitivity to these mites has been estimated to be almost 30% in certain countries. As mentioned earlier insulation and poor ventilation may enhance the growth of house-dust mites and fungi. OTHER DISEASES 22. A number of other diseases are associated with pollution, including both cardiovascular diseases and cancer, which are already covered by Community public health programmes. 23. Cardiovascular diseases are the biggest cause of mortality in the Community. WHO has estimated that 1-2% of cardiovascular mortality (in people with pre-existing disease) in Europe may be attributable to small increases in fine particulate air pollution, and 3% or more in the most polluted areas. An association has been found between the level of fine particles (less than 10 mm or less than 2. 5 mm) polluting the air on a given day and the level of mortality in people with pre-existing cardiovascular or respiratory diseases. The physiological mechanisms involved are not yet clear, but it is thought that the particulates may impair pulmonary function and produce acute inflammatory reactions. 24. There is evidence that other pollutants, such as environmental tobacco smoke (ETS) and carbon monoxide may also aggravate cardiovascular disease. 25. Cancer is second only to cardiovascular diseases as being the most important cause of overall death in the European Community. Chemical carcinogenesis, that is the causation of cancer by chemicals, has long been recognized in the occupational setting. The carcinogenic chemicals have for the most part, been the subject of legislation, both at national and at European Community level, in order to reduce levels of exposure. The presence of even low levels of carcinogens, both naturally occurring and man made, in the environment has raised concern about their possible effects on the general population. There are a number of factors that need to be given due consideration in the aetiology in this disease, including the long latency period. Studies of th^ geographical distribution of cancers give some leads as to the possible influence of environmental factors in their causation. However, it is considered that three quarters of cancer cases are linked to lifestyle, and tobacco alone is responsible for a third of cancer mortality. Although the major causal factor for lung cancer is smoking, non- smokers also develop this disease. Estimates vary, but it has been suggested that some 9 - 13% of cases in Europe have been associated with exposure to environmental tobacco smoke (ETS) i. e. passive smoking in the indoor environment. 26. A lot of attention by the general public has been given to the increase in the use of electrical power in domestic and occupational environments, and in telecommunication and broadcasting devices which have resulted in increased levels of exposure to electromagnetic fields (EMF) and radiation. This has given rise to public concern about the possible consequences for health, notably whether living near electrical power lines can cause childhood leukaemia or brain cancer. However, there is no clear evidence of an increased risk of cancer from EMF. A recent Commission report (Non- ionising radiation: sources, exposures and health effects - ÇEC/V/1/LUX/35/95) found that existing epidemiological data are inconclusive and that biological studies have not so far demonstrated a plausible biological mechanism for EMF carcinogenesis. 27. Communicable diseases prevalence is in many cases related to environmental pollution. Contamination of drinking water and foods by microbiological agents can for instance lead to hepatitis A, typhoid fever, cholera and shigellosis, and tuberculosis is related to poor living conditions. Thus the improvements made in public hygiene and housing - proper waste disposal, sanitation, food processing and storage, and so on, combined with vaccination and other medical interventions, have greatly reduced the threat from many of these diseases in the European Community. However, the incidence of illness related to food contamination in particular with salmonella, Campylobacter and listeria has increased in certain countries and is a cause for concern. 28. Auditory and non-auditory adverse health effects caused by noise is an issue of growing importance. Available European data indicate that noise levels in the urban environment are steadily increasing. Important sources of background noise in urban areas are road traffic, railways, aircraft, industry and construction work. On the other hand changes in lifestyle such as the increasing use of personal stereo systems and the exposure to high sound levels (e. g. in discotheques) have been associated with impaired hearing. Besides hearing impairment, auditory health effects include possible impairment of language acquisition and cognitive development in children. The non-auditory health effects include stress, anxiety and sleep disturbance. m. THE PREVENTION OF POLLUTION-RELATED DISEASES 29. 30. 31. 32. The prevention of pollution-related diseases has three elements. ^First, reducing the amount of pollutants by taking action at their source; second, acting to limit the amount of people's exposure to them; and third, mitigating the effects on individuals who are exposed to them. Much work has already been done both in Member States and at Community-level on the first two elements in controlling levels of pollution in the fields of air, water, food, waste and radiation protection; in researching into health effects and in limiting exposure to pollutants in occupational and domestic settings. It is not feasible or cost effective to decrease the levels of all pollutants, or limit people's exposure to them, to the extent that they have no potential remaining to cause adverse effects on health. In the case of naturally occurring potentially harmful agents in the environment, such as UV light, pollen and some naturally occurring toxins, control of exposure is most likely to be achieved by changes in individual behaviour. However, the possibilities of synergism between air pollutants and pollen might make it possible to lessen the impact of pollen by controlling levels of ambient air pollution. Furthermore, controls on the levels of pollutants adequate for the protection of the general population may be insufficient to prevent adverse effects on the health of certain vulnerable individuals or groups in the population, such as children and the elderly. For these reasons it is necessary to complement the measures aimed at controlling emissions of and exposure to pollutants by public health actions relating directly to the general public. These actions have as their goal the prevention of the development of diseases by limiting the exposure of individuals and mitigating the related health effects. An example of such an action is the Directive on Ambient Air Quality: Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management (OJ No. L 296 21. 11. 96, p. 55-63). The Directive provides for limit values to protect human health, but also enables thresholds to be defined at which Member States would inform or warn the public of poor air quality. A prerequisite for undertaking such preventive actions effectively is having appropriate information about the problems to be tackled. At the European Community level, current data do not provide a clear picture of the relationship between environmental pollution and disease, particularly as regards quantitative exposure-effect relationships. Although data on environmental pollution have been collected for a long period at Community level and in the Member States, these data are primarily about levels and kinds of pollution. Data on the effects of pollutants on health in the Member States, particularly the acute effects do exist. But in many instances the precise causal relationships involved have not yet been established. The difficulties involved in doing so include problems in making accurate assessments of exposure, particularly long-term exposure, in establishing links between levels of exposure to pollutants of individuals or populations and longer term effects on health and the long latency periods between exposure to a pollutant and the development of clinical symptoms, together with the presence of confounding factors. Moreover, relatively little data exist for the Community as a whole, and this is an issue that needs to be addressed. -10- IV. OVERVIEW OF PUBLIC HEALTH ACTIONS IN THE MEMBER STATES AND INTERNATIONALLY CONCERNING POLLUTION-RELATED DISEASES Member States 33. 34. The growing importance of pollution-related diseases across the European Community, and the increase in public concern, has led a number of Member States to initiate preventive activities, particularly in relation to asthma and other respiratory diseases and to allergies. For example, in Denmark, the Ministry of Health produced an "Action Plan for a Strengthened Prevention of Asthma and Allergy" in 1993, and the following year the French Ministry of Health and. the Comité Français d'Education pour la Santé launched a four-year programme aimed at raising the awareness of the public and health professionals about these diseases. Specifically on asthma, Finland has established a ten-year programme which includes a range of measures aiming to increase information, improve early diagnosis, strengthen guided self-care and decrease atmospheric irritants which provoke asthma, such as tobacco smoke. With regard to allergies, in 1995 Sweden carried out a nationwide campaign 'Allergy year 95' which featured among other things a travelling exhibition, the "allergy train' designed to spread information about the practical effects of allergies on people's lives, promoted training of key groups, such as teachers and parents and provided support for local projects. International Action 35. At the international level, the WHO organised a Second European Conference on Environment and Health with financial support from the Commission. A report on environmental health in the European Region entitled "Concern for Europe's Tomorrow" was prepared for the Conference. which was held in Helsinki in June 1994 and included representatives of 47 of the WHO/EURO Member States. The representatives endorsed the Environmental Health Action Plan for Europe, a strategy to prevent and control environmental health hazards, and adopted a Declaration on Action for Environment and Health in Europe. Under this the participating countries committed their respective health and environment departments to developing jointly national environmental health action plans by the end of 1997. Italy and the United Kingdom are two of the six countries participating in a Pilot Project to develop their action plans by 1996 and to share their experiences with other countries. 36. The Conference also established a European Environment and Health Committee to support the development of National Environmental Health Action Plans and to assist in the coordination and evaluation of the implementation of Environmental Health Action Plan for Europe. The Commission is represented on this committee so helping to ensure that these activities complement rather than overlap Community action. -11- V. OVERVIEW OF COMMUNITY ACTIONS RELEVANT TO POLLUTION- RELATED DISEASES Environment Policy 37. Many measures to control pollution and exposure levels are being taken in the framework of the Fifth Community Action Programme for the Environment "Towards Sustainability" (OJ No. C 138, 17. 5. 93). Among its priorities are "the improvement of public health and safety" and the integration of environmental concerns into all aspects of Community policy and decision making. This programme builds upon the large volume of existing Community legislation on air, water and soil pollution, chemicals, waste disposal and protection from radioactivity. 38. A Framework Air Quality Directive has recently been adopted (Council Directive 96/62/EC on ambient air quality assessment and management (OJ L 296 21. 11. 96, p. 55-63). Within the context of this Framework Directive, the Commission is developing or revising legislation on ambient air quality standards for the major atmospheric pollutants taking into account the impact on human health and the environment. Pertinent proposals will also include provisions for the dissemination of information to the public. 39. New initiatives are being taken in several areas, such as controlling emissions from motor vehicles, revising existing directives on bathing and drinking water quality, providing public information about the effects of radiation on health and drawing up a strategy to reduce the risks from chemical products. On the other hand, work under the directive on the classification and labelling of both new and existing dangerous chemical substances (OJ L 133, 30. 5. 88), and under the directive on the classification and labelling of dangerous chemical preparations (OJ L 187, 16. 7. 88, p. 14) is on going. These directives contain the criteria that need to be fulfilled for chemicals to be classified on the basis of their e. g. dermal toxicity and by the inhalation route, skin sensitization, skin and eye irritation. Such criteria can be updated on the basis of the latest scientific evidence. 40. 41. The European Environment Agency was established to provide policy makers at European and national level with environmental information that is objective, reliable and comparable. The Agency, working closely with national authorities and the Commission, is compiling information on air and water pollution, with details of the pollution sources that will be a useful input to the field of pollution-related diseases. It is collaborating with the WHO and has produced a first report on Environment and Health. The Agency plans to undertake further studies in this area. Commission services and the European Environment Agency have recently compiled extensive information concerning both current and future air quality. In addition, initiatives to reduce anthropogenic emissions of atmospheric pollutants are already in place or being developed via a number of Community initiatives e. g. the Auto Oil Programme and the resulting legislation on vehicle emissions (OJ No. L 100, 19. 4. 94, p. 42), the Directive on Integrated Pollution Prevention and Control (OJ No. C 87, 25. 3. 96, p. 8), and the Directive on the control of Emission from Non-road Mobile Machinery (OJ No. C 328, 7. 12. 95, p. l). Actions In Other Policy Areas -12- 42. 43. Relevant Community activities are also being undertaken within other policy areas. Within the foods policy framework, three directives were adopted by the Council in 1995 on maximum residue levels for a number of active substances in pesticides. In health and safety at work there is an extensive body of up-to-date legislation to protect the worker, including directives on the physical, chemical and biological agents at work. Activities are on-going, including work on occupational exposure limits for chemical substances (including broadening the existing directive on occupational exposure to carcinogens), and in developing the Safety Action for Europe (SAFE) programme which aims at improving safety, hygiene and health at work, particularly in small and medium-sized enterprises. Finally, within In 1995 the Commission also presented a Green Paper for a European Union Energy Policy ( COM (94) 659 final 11. 1. 1995) which inter alia covers public health issues and makes proposals for the support of new clean technologies to reduce emission of pollutants. the framework of the Community Research and Technological Development Programme, relevant research projects are being carried out in the programmes on Environment and Climate, Agriculture and Fisheries, and Biomedicine and Health. In the Community's Fourth Framework Programme for research and technological development (Decision 94/1110/EC of 26. 04. 1994, OJ L126, 18. 05. 94, p. l, as amended by Decision 96/616/EC of 25. 03. 1996, OJ L86, 04. 04. 96, p. 69), namely the Biomedicine and Health Programme, the research under the area of "Chronic diseases, Ageing and Age-related diseases" is conducted on including environmental aspects, and treatment and management of aetiology, respiratory problems including asthma. Research objectives under the research area of "Occupational and Environmental Health" cover identification of important risk factors and their control also related to respiratory problems and allergies of public and occupational health importance. Council 44. In its Resolution of 11 November 1991 (OJ C304 23. 11. 91, p. 6) the Council and the Ministers for Health, meeting within the Council, invited the Commission, in close cooperation with the competent authorities of the Member States to take stock of the knowledge and experience available in the Member States, the Community and the international organizations regarding environment. the relationship between health and European Parliament 45. In its Resolution A4-0311/95 (OJ C 032 05. 02. 96, p. 15-24) on the Medium-Term Social Action Programme 1995-1997 the Parliament asked the Commission to present, under the proper procedures, the action programme foreseen in the Commission's framework communication on public health for pollution-related diseases as well as the other two programmes foreseen, on rare diseases and on accidents and injuries. Economic and Social Committee 46. In recent years the Committee has delivered a number of Opinions relating to environmental pollution and to health. In its wide-ranging Opinion of 6 July 1994 on the Commission's framework communication on public health it urged the Commission to adopt a broad approach to the subject and emphasised the importance of the environment for health promotion. -13- VI. APPROACH TO COMMUNITY PUBLIC HEALTH ACTION ON POLLUTION-RELATED DISEASES 47. 48. Future Community public health action on pollution-related diseases must take account of the existing large body of work in particular that undertaken under Articles 129 and 130r of the E. C. treaty. In accordance with Article 129 of the Treaty the Community shall contribute towards ensuring a high level of human health protection by encouraging cooperation between Member States, lending support to their actions and promoting, in close contact with them, coordination of their policies and programmes, and fostering cooperation with third countries and international organisations competent in the sphere of public health. According to the principle of subsidiarity, the Community shall take action in this field only if and in so far as, by reason of its scale or effects the proposed action can be better achieved by the Community, compared to action at national level. In addition action by the Community must be proportional to the objectives to be achieved, selected on the basis of prior appraisal and expected to yield added value. 49. With the limited resources available it would be impractical for a Community public health programme to address all the numerous pollution-related diseases. Moreover, to try to do so would both reduce the effectiveness of such a programme by making the actions too diffuse and also increase the risk of straying into areas covered by other Community programmes. 50. In order to select which pollution-related diseases should be priorities for this programme a number of selection criteria have to be considered, based on the methodology for setting priorities described in Commission communication COM (93) 559 on the framework for action in the field of public health. These are that public health actions relating to the disease are not being undertaken as part of other Community programmes; there is evidence that current levels of exposure to pollutants represent a health risk and furthermore there is considerable population exposure; the disease produces a substantial burden of morbidity and/or mortality in the Community and/or there is evidence of its prevalence increasing significantly; and actions by the Community add value compared to the activities of the Member States. 51. 52. In the light of these criteria this programme will place the central focus on diseases related to air pollution, primarily respiratory diseases and allergies. Currently in the European Community, the highest exposure levels of the population to pollutants are to atmospheric pollutants. Moreover, despite a reduction in the concentration of some air pollutants, recent evidence shows that there are still important effects associated with pollution at concentrations now present in the European Community. These effects may be associated with short term changes in concentrations of pollution and there is emerging evidence of effects from long-term exposure. The resulting morbidity and mortality are giving rise to public concern. Second, preventive actions on several of the other categories of pollution-related disease are already being taken within the framework of the Community's public health strategy. Actions in relation to cancer fall within the scope of the Europe against cancer programme; prevention of cardio-vascular diseases is covered in the programme on health promotion; and actions on communicable diseases are being undertaken under the programme on AIDS and certain other communicable diseases. -14- 53. 54. 55. As regards diseases related to noise, effective prevention has to be focused on actions to reduce emissions and exposure levels. Community-wide requirements regarding occupational exposure to noise have been laid down in directive 86/188/EEC (OJ L 137 24. 05. 86, p. 28) and proposals for amending provisions have been put forward by the Commission. There are several Community initiatives addressing the various issues and aspects of air pollution e. g. THERMIE II (COM (94 ) 654 final), CO^ from cars strategy paper (COM(95) 689 final), and the Green paper on Fair and Efficient Pricing in Transport policy - options for internalizing the external cost of transport in the EU (COM(95) 691 final) Respiratory diseases and allergies, on the other hand, are not within the ambit of other public health programmes. They also offer significant opportunities for action to be taken by the Community which can complement both the existing Community work on control of pollution in the environment and the activities of the Member States. Action on these diseases will therefore constitute the core of a programme on pollution-related diseases which is the object of a proposal by the Commission pursuant to Article 129, for a decision by the European Parliament and the Council. -15- VH. COMMUNITY ACTION PROGRAMME ON POLLUTION-RELATED DISEASES 56. In order to make the best possible contribution to efforts directed at pollution-related diseases, the proposed Community action programme contains a mix of horizontal, and disease-specific actions focusing on respiratory diseases and allergies. Several horizontal actions aiming at the improvement and sharing of information and experience on risk perception and risk management of pollution-related diseases are proposed which will help underpin the actions directed at specific pollution-related diseases. There is a need to ensure complementarity between the information collected by this programme and other Community programmes or activities which are relevant to this area of public health. 1. Improvement of Information on pollution-related diseases at Community Level 57. Data on pollution-related diseases exist but at present are insufficient and inadequate at Community level for use, in particular, in decision-making or for the provision of information to the public about risks to health. In large part this is because the data are not detailed enough or suitable for the purpose of understanding causation, thresholds for effects and exposure-response relationships or synergisms; also data are often not comparable. In connection with respiratory diseases, in particular, there are considerable variations in diagnostic criteria and classification of the different diseases. 58. What is needed is to work towards critically reviewing the data and then to improve their comparability. This will involve for instance seeking agreement on diagnostic criteria and surveillance methods and establishing comparable indicators. This latter task must be undertaken in tandem with the proposed Community programme on health monitoring (COM(95)449 of 16. 10. 1995). It will require strengthening cooperation between those involved in the collection and analysis of the data concerning pollution-related diseases and improving the existing mechanisms for exchanging data between the Member States. It will be necessary to check that pollution data are available to support health effect analysis. Long-term data abou. pollution should be sought in addition to data about short-term peaks. 59. The objective of Community action is to contribute towards a better understanding of the role of pollutants in the causation and aggravation of diseases in the European Community and of the basis and effectiveness of preventive actions. 60. The actions to be taken to achieve this objective could include: Establishing priorities for the identification of those diseases in which specific pollutants are thought to play a role; comparing their prevalence and/or incidence and their relation to data on environmental factors in the different parts of the European Community; examining the data quality and identifying where data are lacking; analysing and reviewing data currently available on the toxicology of these pollutants, and identifying gaps in knowledge; comparing these data, including methods of collections, definitions and criteria used, as well as the way in which the information is used in analyses, in determining the actions taken and in informing the public. Contributing to improve the comparability of data used in preventive actions by the support of exchanges of information on pollution-related diseases and their prevention, including cost-benefit analysis of the effectiveness of actions. -16- 2. Risk Perception and Risk Management with respect to pollution-related diseases 61. 62. 63. 64. The public perception of the risks to health from pollution, especially their magnitude and their ranking in terms of importance from the health point of view, often differ considerably from an expert assessment, and this can lead to unnecessary public concern and pressure for disproportionate actions to be taken. Experience shows that there are several reasons for this. First, people are better informed and made much more aware of risks by information provided through the media. Second, the expectation that there should be zero risk to health is an ideal that is rarely achieved, if ever, in practice. Third, there is frequently a lack of understanding of how pollution-related risks are assessed and the principles adopted for their management and of the scope of some of the terminology, such as "negligible", "tolerable" or "acceptable" levels of risk, as used in national and Community prevention and control measures. Fourth, misunderstandings can arise because of a lack of information about the proportion of the risk to health attributable to pollutants compared with other factors, such as lifestyle, and because of the ways in which the media sometimes present the information. The tendency of the public to underrate the contribution of smoking, including environmental tobacco smoke, compared with that of ambient air pollutants to the causation of respiratory and cardiovascular diseases illustrates this point. The public concern about possible risks from Electromagnetic Fields (EMF) provides another example of the disparity between experts and public opinion. Fifth, in general the public perceives risk differently than what is suggested by scientific evidence. This might mean that factors that lead to certain lesser risks are given much greater importance compared to others. This is in part due to the acceptance of risk as a result of the degree of personal control that can be exercised over the sources of risks. 65. In this light the objective of Community actions is: to increase the level of knowledge and understanding about pollution-related health risks, their perception, assessment and management. 66. The actions to be taken to achieve this objective could include: Supporting actions aimed at achieving better public understanding of risks, their assessment and management; promoting work on the public perceptions of pollution-related risks to health throughout the Community. Promoting actions and exchanges of information on the methods of increasing the level of knowledge of the general public and opinion-formers about the assessment of pollution-related risks to health. 3. Respiratory diseases and allergies 67. The increase in the prevalence of respiratory diseases and allergies in recent decades has created increasing burdens on society in general, added pressure on health services, and led to considerable public concern. •17- 68. The objective of Community actions in this area is to support activities aimed at reducing the prevalence and/or incidence of these diseases. 69. The actions to be taken to achieve this objective could include Contributing to the provision of information to the general public and to specific groups, on these diseases and the agents that play a role in them; supporting the development of ways to reinforce and link information campaigns; contributing to the efforts of self-help or support groups active in the field of respiratory diseases and allergies. Contributing to the comparison of various education and training initiatives used to combat these diseases, with a view to promoting best practice; reviewing the effectiveness of the preventive measures undertaken, including cost/benefit analyses. Vm. CONSULTATION, ASSESSMENT AND REPORTS -18- Consultation 70. The actions of this programme will be implemented in close collaboration with the Member States, particularly in so far as regards coordination of their policies and programmes. To facilitate this, the Commission proposes the creation of an Advisory Committee of representatives of the Member States. Appropriate links will also be maintained with the European Environment Agency, the WHO, other relevant international organisations and third countries in accordance with the requirements of the programme's actions. Evaluation reports 71. Assessment of the programme will be provided in two reports: an evaluation report during the third year of this programme to the Council, the European Parliament, the Economic and Social Committee, and the Committee of the Regions. The purpose of this report is to ensure that the Community institutions and, through them, all the parties concerned, are kept fully informed on the progress of actions undertaken in the context of this programme. a final report on the implementation of the programme, which will include an evaluation of the actions undertaken, will be submitted to the above mentioned institutions by the Commission after the completion of the programme. General information activities 72. The Commission will ensure that reports on the activities undertaken are made available to concerned parties and the general public. A <3 Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action 1999-2003 on pollution-related diseases in the context of the framework for action in the field of public health la EXPLANATORY MEMORANDUM 1. 2. 3. 4. 5. 6. 7. In its Communication (COM(93) 559 final) of 24 November 1993 on the framework for action in the field of public health, the Commission outlined the principles and strategy to be followed in undertaking Community activities directed towards the attainment of the objectives on health protection laid down in Articles 3(o) and 129 of the Treaty establishing the European Community. The role of the Community is identified as underpinning the efforts of the Member States in the public health field, assisting in the formulation and implementation of objectives and strategies, and contributing to the provision of health protection across the Community, setting as the target the best results already obtained in a given area anywhere in the Community. In accordance with Article 129, the Commission presents proposals for the adoption by the European Parliament and the Council of incentive measures intended to contribute towards ensuring a high-level of human health protection. The aforementioned Commission's communication sets out criteria on which to determine priority areas for Community action programmes. In accordance with these criteria, pollution-related diseases were identified as such a priority area. The present Commission proposal, based on Article 129 and already announced in the Commission programme of work for 1996, comes under the principle of shared competence between the Community and the Member States, and seeks to improve information on and prevention of pollution-related diseases especially respiratory diseases and allergies, and increase the level of knowledge and understanding about risk • perception, and risk assessment and management with respect to these, in order to contribute towards ensuring a high-level of protection against pollution-related diseases. Community action in this field does not come under the exclusive competence of the Community and is geared towards the prevention of pollution-related diseases. According to the principle of subsidiarity, Community action shall be undertaken only if and in so far as, by reason of its scale or effects, it may be better achieved at Community level. Pollution-related diseases are those diseases which are caused, provoked or aggravated by environmental pollution. These diseases, particularly those linked to air pollution, both indoor and outdoor, constitute an important and growing part of morbidity and mortality in the European Community, and they are the object of considerable public concern. The prevention of pollution-related disease pre-supposes knowledge of relationships between pollutants and diseases, and has three subsequent elements. First, reducing the emission of pollutants by taking action at their source; second, acting to limit concentrations of pollutants and exposure to them; and third, mitigating the effects on individuals who are exposed to them. Much work has already been done both in Member States and at Community-level in controlling levels of pollution in air, water, soil, food and waste, in researching into its effects and in limiting exposure to pollutants. The proposed 5-year action programme seeks to complement this work by actions addressed to the public, health professionals, and the authorities, which aim to enhance people's ability to reduce exposure and mitigate the effects of pollution on their health. With the limited resources available it would be impractical for a Community public health programme to address all the numerous pollution-related diseases. This programme will therefore place its central focus on diseases related to indoor and outdoor air pollution, primarily respiratory diseases, and on allergies. In the context of this programme indoor air relates to non-occupational environments, where less is known at Community level about the nature and extent of exposures. Currently the highest exposure levels of the Community population to pollutants are to atmospheric pollutants, and this exposure is creating a significant risk to health; The prevalence of pollution-related diseases is continuing to rise with accompanying public concern. Finally, these diseases offer significant opportunities for action to be taken by the Community which can complement both its existing work on control of pollution in the environment and the activities of the Member States. To underpin these actions, it is also proposed to undertake, in close cooperation with the Member States, actions in two general fields. The first is aimed at improving information on pollution-related diseases at Community level. This is currently inadequate, particularly because Member States' data are often not comparable. Action to improve this situation is proposed to be undertaken, complementary to that proposed under the future health monitoring programme (amended proposal COM(96) 222 final). The second set of actions is aimed at addressing the problems that arise from people's perception of the risks to health from pollutants and how these risks are assessed and managed, as well as from the lack of adequate information on such perceptions. In selecting objectives and defining actions to be included in the programme, account has been taken of the situation currently existing in the Member States and at Community level in the field covered by the programme. The programme aims at bringing about an accelerated and effective sharing of information and experience, Community wide understanding of key issues and questions on tackling pollution- related diseases, and increased cooperation of Member States so as to avoid unnecessary duplication of work and speed up the adoption of best solution to problems common to all the Member States concerning such diseases. These problems have been the object of resolutions by the Council and the Ministers for Health of the Member States meeting within the Council on 11. 11 1991 (OJ No C 304, 23. 11. 91, p. 6) as well as by the European Parliament A4-0311/95 (OJ No C 032 05. 02. 96, p. 15-24) calling for Commission proposals in the area. The implementation of the programme will yield added value in a number of ways: a) It will bring together the Member States in a common effort to critically review and improve methods for collecting and using information on pollution-related diseases and its content, extent and quality; It will improve the collective capacity of the Member States to analyze public perceptions of pollution-related risks and better explain how they are assessed and managed, especially when contributors to pollution in a given Member State have their origin or source in other Member States; It will accelerate and deepen the process of addressing the increased prevalence and concern over respiratory diseases and allergies by promoting focused cooperation between the Member States in this area. b) c) This programme is undertaken on the basis of a European Parliament and Council decision pursuant to Article 129. It does not require the harmonisation of national provisions in the field covered. An evaluation of the actions implemented under this programme will be provided in two reports that will be transmitted to the Council, the European Parliament, the Economic and Social Committee, and the Committee of the Regions: during the third year of the programme, an evaluation report; 8. 9. 10. 11. 12. 13. 2. z - a final report on the implementation of the programme. These reports will incorporate information on Community financing in the various fields of action as well as the results of evaluations. 23 Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DECISION adopting a programme of Community action 1999 - 2003 on pollution-related diseases in the context of the framework for action in the field of public health THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION Having regard to the Treaty establishing the European Community, and in particular Article 129 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the procedure referred to in Article 189b of the Treaty, 1. Whereas pollution-related diseases are growing in importance throughout the European Community and raising public concern; 2. Whereas, in accordance with point (o) of Article 3 of the Treaty, Community action shall include a contribution to the attainment of a high level of health protection; 3. Whereas Article 129 expressly provides for Community competence in this field, by encouraging cooperation between the Member States and, if necessary, lending support t„ their action; promoting coordination of their policies and programmes, and fostering cooperation with third countries and international organisations competent in the sphere of public health; whereas Community action should be directed towards the prevention of diseases, and the promotion of health education and information; 4. Whereas Article 13Or of the Treaty states that Community policy on the environment shall contribute to protecting public health; 5. Whereas the prevention of pollution-related diseases has to include not only measures aimed at the sources and concentrations of pollutants and on limiting exposure, but also public health actions directed at the public to enable individuals to reduce exposure and mitigate adverse effects on health and whereas data on health effects and on exposure should be collected in parallel with data on concentrations of air pollutants; 6. Whereas in its Resolution of 11 November 19911 the Council and the Ministers for Health of the Member States, meeting within the Council, invited the Commission, in close cooperation with the competent authorities of the Member States, to take stock of the knowledge and experience available in the Member States, the Commumty and international organizations regarding the relationship between health and the environment; 1 OJN°C304 23. 11. 91, p. 5 2V 7. Whereas pollution-related diseases have been identified as a priority area for Community action within the framework for action in the field of public health2; 8. Whereas in its Resolution (A4-0311/95) on the Medium-Term Social Action Programme 1995-19973 the Parliament asked the Commission to present, under the proper procedures, the action programme on pollution-related diseases foreseen in the Commission's framework communication on public health; 9. Whereas, in accordance with the principle of subsidiarity, action on matters not under the exclusive competence of the Community, such as action on pollution-related diseases, must be undertaken by the Community only if and in so far as, by reason of its scale or effects, it may be better achieved at Community level; 10. Whereas the proposed measures in the present programme will yield a Community-added value by bringing together activities already undertaken in relative isolation at national level and by complementing one another with significant results for the Community as a whole, by contributing to the strenghtening of solidarity and cohesion in the Community and by leading, where the need is recognised, to the establishment of best practice norms and standards. 11. Whereas cooperation with the international organisations competent in the field of public health and with third countries should be fostered; 12. Whereas, by providing support for acquiring better knowledge and understanding of, and wider dissemination of information about, pollution-related diseases, their association with pollutants and their prevention, ensuring improved comparability of information on these subjects and by developing actions complementary to existing Community programmes and actions, while avoiding unnecessary duplication, the programme will contribute to the achievement of the Community objectives set out in Article 129; 13. Whereas a "modus vivendi" between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994; 14. Whereas this decision lays down, a financial framework constituting the principal point of reference, within the meaning of point 1 of the Declaration of the European Parliament, the Council and the Commission of 6 March 1995, for the budgetary authority during the annual budgetary procedure; 15. Whereas the Community's financial perspective is valid up until 1999 and will have to be revised for the period beyond that date; 16. Whereas the financial framework for the last four years of the programme (2000-2003) shall be determined after the establishment of the future financial perspectives; 17. Whereas, in order to increase the value and impact of the programme, a continuous assessment of the actions undertaken should be carried out, with particular regard to their effectiveness and the achievement of the objectives set and, with a view where appropriate, to making the necessary adjustments; 2 COM (93) 559 final 3 OJ N° C 032 05. 02. 96, p. 15-24 2-S 18. Whereas this programme should be of five-year duration in order to allow sufficient time for actions to be implemented to achieve the objectives set; HAVE DECIDED AS FOLLOWS Article 1 Establishment of the programme 1. A programme of Community action against diseases which are caused, provoked or aggravated by environmental pollution, hereinafter referred to as "this programme", is hereby adopted for the period 1 January 1999 to 31 December 2003 in the context of the framework for action in the field of public health. 2. The aim of this programme is to contribute towards ensuring a high level of health protection against pollution-related diseases by improving knowledge and understanding about health risks associated with them and how to address them, in particular with regard to asthma and other respiratory diseases, and to allergies. 3. The actions to be implemented under this programme and their specific objectives are set out in the Annex under the headings: 1. Actions on improvement of information on pollution-related diseases 2. Risk perception and risk management with respect to pollution-related diseases 3. Respiratory diseases and allergies Article 2 Implementation 1. The Commission shall ensure implementation, in close cooperation with the Member States, of the actions set out in the Annex. 2. The Commission shall cooperate with institutions and organisations active in the field of pollution-related diseases. Article 3 Budget 1. The financial framework for the implementation of the programme for the year 1999 shall be ECU 1. 3 Million, in keeping with current financial perspectives. The financial framework for the final four years of the programme (2000-2003) shall be determined in detail after the establishment of the future financial perspectives. 2. The annual appropriations shall be established by the Budgetary Authority in accordance with the financial perspectives. Article 4 Consistency and complementarity The Commission shall ensure that there is consistency and complementarity between the Community actions to be implemented under this programme and those implemented under other relevant Community programmes and actions. Article 5 Committee 1. In implementing this action plan, the Commission shall be assisted by an advisory committee, hereinafter referred to as "the Committee", consisting of representatives of the Member States and chaired by the Commission representative. 2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken concerning, in particular: (a) (b) the criteria, and procedures for selecting and financing projects under this programme; the evaluation procedure. The Committee shall deliver its opinion on the draft, within a time limit which the chairperson may lay down according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee on the manner in which its opinion has been taken into account. 3. The representative of the Commission shall keep the Committee regularly informed about Commission proposals or Community initiatives and the implementation of programmes in other policy areas which are relevant to the achievement of the objectives of this programme. Article 6 International cooperation 1. In the course of implementing this programme, cooperation with third countries and with international organisations competent in the field of public health shall be fostered. 2. This programme shall be open to participation by the associated countries of Central Europe (CEC), in accordance with the conditions laid down in the Association Agreements or Additional Protocols related thereto concerning participation in Community programmes. This programme shall be open to participation by Cyprus and Malta on the basis of additional appropriations in accordance with the same rules as those applied to the EFTA countries, in accordance with procedures to be agreed with those countries. Article 7 Monitoring and evaluation 1. In the implementation of this Decision the Commission shall take the necessary measures to ensure the monitoring and continuous evaluation of the programme, taking account of the general and specific objectives referred to in Article 1 and in the Annex. 2. In the third year of operation of this programme, the Commission shall present to the European Parliament and the Council an evaluation report. 3. The Commission shall submit to the European Parliament and the Council a final report on completion of this programme. 4. The Commission shall incorporate into these two reports information on Community financing in the various fields of action and on complementarity with the other actions referred to in Article 4, as well as the results of the evaluations. The reports shall also be submitted to the Economic and Social Committee and the Committee of the Regions. Done at Brussels, For the European Parliament The President For the Council The President ANNEX SPECIFIC OBJECTIVES AND ACTIONS L ACTIONS ON IMPROVEMENT OF INFORMATION ON POLLUTION- RELATED DISEASES Objective: to contribute towards a better understanding of the role of pollutants in the causation and aggravation of diseases in the European Community and of the basis and effectiveness of preventive actions. 1. 2. H. Establishing priorities for the identification of those diseases in which specific pollutants are thought to play a role; comparing their prevalence and/or incidence and their relation to data on environmental factors in the different parts of the European Community; examining the data quality and identifying where data are lacking; analysing and reviewing data currently available on the toxicology of these pollutants, and identifying gaps in knowledge; comparing these data, including methods of collections, definitions and criteria used, as well as the way in which the information is used in analyses, in determining the actions taken and in informing the public. Contributing to improve the comparability of data used in preventive actions by the support of exchanges of information on pollution-related diseases and their prevention, including cost-benefit analysis of the effectiveness of actions. RISK PERCEPTION AND RISK MANAGEMENT WITH RESPECT TO POLLUTION-RELATED DISEASES Objective: to increase the level of knowledge and understanding about pollution-related health risks and their perception, assessment and management. 3. 4. Supporting actions aimed at achieving better public understanding of risks, their assessment and management; promoting work on the public perceptions of pollution- related risks to health throughout the Community. Promoting actions and exchanges of information on the methods of increasing the level of knowledge of the general public and opinion-formers about the assessment of pollution-related risks to health. ffl. RESPIRATORY DISEASES AND ALLERGIES Objective: to support activities aimed at preventing and reducing the numbers of these diseases. 5. 6. Contributing to the provision of information to the general public and to specific groups, on these diseases and the agents that play a role in them; supporting the development of ways to reinforce and link information campaigns; contributing to the efforts of self-help or support groups active in the field of respiratory diseases and allergies. Contributing to the comparison of various education and training initiatives used to combat these diseases, with a view to promoting best practice; reviewing the effectiveness of the preventive measures undertaken, including cost/benefit analyses. 2 -3 FINANCIAL STATEMENT 1. TITLE OF OPERATION Proposal for a European Parliament and Council Decision adopting a programme of Community action 1999-2003 on pollution-related diseases in the context of the framework for action in the field of public health 2. BUDGET HEADING INVOLVED B3- 3. LEGAL BASIS Article 3(o) and Article 129 of the Treaty establishing the European Community. 4. DESCRIPTION OF OPERATION 4. 1 General objective To contribute to achieving the objectives laid down by the Treaty: - under Article 3 (o), the Community is required to make a contribution to the attainment of a high level of health protection; - Article 129 requires the Community to contribute towards ensuring a high-level of human health protection, in particular by encouraging cooperation between the to. their action, promoting Member States, and coordination of their policies and programmes, and fostering cooperation with third countries and the competent international organisations in the sphere of public health. Community action is directed towards the prevention of diseases, in particular major health scourges, by promoting research into their causes and their transmission, as well as health information and education. lending support if necessary The general objective of the action programme is to contribute towards ensuring a high level of health protection against pollution-related diseases by improving knowledge and understanding about pollution-related health risks and how to address them, in particular with regard to asthma and other respiratory diseases, and allergies. The method for achieving this objective consists of undertaking actions which: contribute towards a better understanding of the role of pollutants in the causation and aggravation of diseases in the European Community and of the basis and effectiveness of preventive actions; increase the level of knowledge and understanding about pollution-related health risks, their perception, assessment and management; support activities aimed at preventing and reducing the numbers of these diseases. 3 >^ 4. 2 Period covered and arrangements for renewal or extension 5 years: 01. 01. 1999 to 31. 12. 2003 Report on implementation to be transmitted to the Council and European Parliament during the third year of operation of the programme. Report to the Council and European Parliament after completion of the programme together with the results of evaluations. 5. CLASSIFICATION OF EXPENDITURE OR REVENUE Non-compulsory expenditure Differentiated appropriations 6. TYPE OF EXPENDITURE OR REVENUE Subsidy for joint financing with other sources in the public and/or private sector (not exceeding a certain percentage of the total cost of the proposed projects). The level of funding granted depends on the scope of the measure to be financed and on the extent to which the action programme is reflected in the various activities planned. Such funding will not exceed 70% of the total budget earmarked for the proposed projects except in the case of networks and work ordered and of direct use to the Commission, where the subsidy may amount to 100%. 7. FINANCIAL IMPACT 7. 1 Method of calculating the total cost of operation (definition of unit cost) The method of calculation is the result of experience acquired in previous activities related to public health. This encompasses the various types of Community action listed in Table 4 of the Commission Communication (93) 559 final of 24 November 1994, and represents extensive experience in financing cooperative efforts with Member States as well as Non Governmental Organisations as regards collection, analysis and dissemination of information, setting up networks, the establishment of mechanisms and procedures of consultation and cooperation for setting common objectives and for policy coordination and for the formulation and development of strategies at Community level. The specific cost estimates are based on the assumption that half of the activities to be undertaken under this programme will require 100 percent funding while the other half will require 50 percent funding and that the activities to be undertaken will involve most or all of the Member States. An amount of ECU 1. 3 Million is deemed necessary for the implementation of these activities for the first year of the programme, 1999. The budget framework for the subsequent four years of operation shall be established by taking into account the Community's future financial perspectives. The annual allocations will be decided in accordance with the normal budgetary procedures. 7. 1. 1 Improvement of information on pollution-related diseases Reviews on the data currently available on pollution-related diseases shall be undertaken. The cost estimate for this is 100. 000 ECU for the first year. In addition, networks have to be set up in order to work on the information gained by these reviews. For the setting up of networks in this context the minimum amount of 200. 000 ECU is deemed necessary. 7. 1. 2 Improvement of risk perception and risk management Dissemination of information targeted at the public and specific groups such as journalists has been scheduled at an average cost of 200. 000 ECU. In parallel actions to better understand public perception of pollution-related health risks shall be launched. For this a budget of 100. 000 ECU is forseen. 7. 1. 3 Prevention of respiratory diseases and allergies Support for networks to promote information on the prevention of respiratory diseases and allergies in order to link information campaigns will require an estimated cost of 300. 000 ECU in the first year of operation of the programme. This activity shall take into account the information gained from a comparision of various education and training initiatives undertaken in order to promote best practice. 300. 000 ECU are planned to be spent on this. 7. 2 Itemized breakdown of cost (in ECU million) OBJECTIVE ACTION AREA YEARS 1999 2000 2001 2002 2003 TOTAL Indicative programming 0. 3 0. 3 Improvement of information on pollution- related diseases Establishing priorities for the identification of those diseases in which specific pollutants are thought to play a role; comparing *heir prevalence and/or incidence and their relation to data on environmental factors in the different parts of the European Community; examining the data quality and identifying where data are lacking; analysing and reviewing data currently available on the toxicology of these pollutants, and identifying gaps in knowledge; comparing these data, including methods of collection, definitions and criteria used, as well as the way in which the information is used in analyses, in determining the actions taken and in informing the public. Contributing to improving the comparability of data used in preventive actions by the support of exchanges of information on pollution-related diseases and their prevention, including cost- benefit analyses of the effectiveness of actions. 0. 1 Oo 0. 1 OBJECTIVE ACTION AREA YEARS 1999 2000 2001 2002 2003 TOTAL Risk perception and risk management Respiratory diseases and allergies Supporting actions aimed at achieving better public understanding of risks, their assessment and management; promoting work on the public perceptions of pollution-related risks to health throughout the Community. Promoting actions and exchanges of information on the methods of increasing the level of knowledge of the general public and opinion- formers about the assessment of pollution-related risks to health. Contributing to the provision of information to the general public and to specific groups, on these diseases and the agents that play a role in them; supporting the development of ways to reinforce and link information campaigns; contributing to the efforts of self-help or support groups active in the field of respiratory diseases and allergies. Contributing to the comparison of various education and training initiatives used to combat these diseases, with a view to promoting best practice; reviewing the effectiveness of the preventive measures undertaken, including cos^enefit analyses. 0. 2 0. 1 0. 3 0. 3 0. 2 0. 1 0. 3 0. 3 t/J 00 T O T AL 1. 3 pm pm pm pm 1. 3 3M 7. 3 Indicative schedule of appropriations (in ECU million) 2000 2001 2002 2003 TOTAL 0. 78 0. 52 1999 1. 3 0. 78 0. 52 Commitment appropriations Payment appropriations 1999 2000 2001 2002 2003 Subsequent years TOTAL 1. 3 pm pm pm pm 1. 3 FRAUD PREVENTION MEASURES; RESULTS OF MEASURES TAKEN The grant application forms will require information on the identity and nature of potential beneficiaries so that their reliability can be assessed in advance. Fraud prevention measures (checks, intermediate reports, final report) are included in the agreements or contracts between the Commission and beneficiaries. The Commission will check reports and ensure that work has been properly carried out before intermediate and final payments are made. In addition, spot checks are carried out by the Commission to verify how funds have been used. Checks have already been carried out in other public health budget lines in relation to the financial years 1991 to 1995 and have shown their effectiveness. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS 9. 1 Specific and quantifiable objectives The Community measures aim at contributing towards ensuring a high level of health protection against pollution-related diseases by improving knowledge and understanding about pollution-related health risks and how to address them, in particular with regard to asthma and other respiratory diseases, and allergies. The indicators showing whether or not objectives are achieved will include measures of the following kinds. These will be redefined further in collaboration with the new Community programme on health monitoring whose tasks include the development 3T of indicators for Community public health policies. The method for achieving this objective consists of undertaking actions which : encourage and assist the creation of networks that contribute towards a better understanding of the role of pollutants in the causation and aggravation of diseases in the European Commumty; and of the basis and effectiveness of preventive actions (membership, production of e. g. information bulletins, conferences, www-discussion groups etc. ); disseminate information about pollution-related health risks, their perception, assessment and management; improve information and data on pollution-related diseases at Community level and the prevalence and/or incidence rates of these diseases foster consultation and cooperation between Member States (description of cases of such consultation etc. ) and help public health bodies assisted in making better use of other Community policies in their efforts aiming at the prevention of pollution-related diseases. Target Population 1. 2. 3. Competent health authorities of the Member States, at national, regional and local level and competent international organisations in the sphere of public health; Health professionals, health epidemiological services, health and medical associations, academic institutions etc; NGO's and other bodies interested in health matters, and the public in general. 9. 2 Grounds for the operation In initiating action under Article 129, the Community has to address itself to preventing diseases and protecting health. The Commission's communication on the framework for action in the field for public health (COM(93) 559 final of 23. 11. 93) sets out criteria on which to determine priority areas for Community programmes. In accordance with these criteria, the 1993 "framework" communication evaluated the different options for addressing diseases, in particular major scourges and their underlying causes, by various types of Commumty actions and retained on the basis of criteria listed in that communication, eight priority areas of which the prevention of pollution-related diseases was one. In its Resolution of 11 November 1991 the Council and the Ministers for Health of the Member States, meeting within the Council, invited the Commission, in close cooperation with the competent authorities of the Member States, to take stock of the knowledge and experience available in the Member States, the Community and international organizations regarding the relationship between health and the environment. In its Resolution A4-0311/95 on the Medium-Term Social Action Programme 1995- 1997 the Parliament asked the Commission to present, under the proper procedures, the action programme on pollution-related diseases foreseen in the Commission's framework communication. The programme aims at bringing about an accelerated and effective sharing of information and experience, Community wide understanding of key issues and questions on tackling pollution-related diseases, and increased cooperation of Member States so as to avoid unnecessary duplication of work and speed up the adoption of best solution to problems common to Member States concerning such diseases. This input envisaged for the Community and the Commission by Article 129 provides a clear common framework of rules. This would be substantially more effective than leaving such questions to inter-governmental co-operation without a Community contribution. As regards the intervention methods and the allocation of funds, the following will apply: specific application of the principle of subsidiarity when identifying measures to be undertaken and co-financed; identification and selection of projects for co-financing in the fields of pollution-related diseases the concept of added Community value, which will continue to be realised in particular through the coordination of national measures, the dissemination of information and experiences, the establishment of priorities, the development of networking as appropriate, selection of European projects and the motivation and mobilisation of all involved. Two methods will be employed to implement the programme. One is to support projects carried out in Member States and at the Community level. The selection of priority projects is based largely on general and intermediate objectives, and implementation of the measures themselves depends on the quality and effectiveness of projects submitted to the competent department during the course of the year. The other is to undertake specific activities necessary to achieve the objectives of the programme, which will be fully financed by the programme. The selection criteria for projects are as follows: Compatibility with the objectives and conformity with at least one of the established objectives; Examination of the "added Community value" of the projects (transnational participation, development of a model applicable in other Member States, information usable in other Member States, etc. ); Presumed effectiveness and profitability; Clarity and justification of requirements; Relevance of selected methodology; Organizational competence and experience; Suitability of budget for objectives; Support for projects from national partners; Objective assessment; Opinion of the advisory committee involved. The budget proposed for this programme, of 1. 3 MECU for the first year of this programme, matches that proposed at the same time for the Community action programmes on rare diseases and injury prevention. This reflects the equal priority attached to these fields for action determined by the Commission Communication on the framework for action in the field of public health (1993), an evaluation which remains valid today. The amount proposed represents the bare minimum required to start the programme. 9. 3 Monitoring and evaluation of the operation 9. 3. 1 Monitoring of the operation Monitoring at the Community level is to be carried out by the Commission, which will submit a report half-way through the implementation of the programme, and a final report after its completion to the Council, the European Parliament, the Economic and Social Committee, and the Committee -of the Regions, drawing from national reports as well as evaluations of the actions under the programme and of individual projects. 9. 3. 2 Evaluation Evaluation will be by means of: An evaluation of the main measures and of subsidised projects involving, where necessary, the participation of independent experts; An evaluation report during the third year, An overall report on the quality and effectiveness of projects implemented under the action plan, to be submitted by the Commission to the other Community institutions after completion of the programme. Performance indicators selected for this evaluation: Evaluation of projects by Commission officials and/or those cooperating with them; Analysis of intermediate reports on measures scheduled and financed, allowing a shifting of emphasis where possible; Impact studies by external bodies Relevance of the methodology used by organizers; Suitability of the budget for the objectives; Skills and experience of bodies; Dissemination of results; Evaluation procedures and intervals: Drawing up of intermediate and final reports on the various measures undertaken in the field; Development of a "standard" evaluation form for the measure, to be forwarded by the beneficiaries with their final reports, and checking of these documents by officials either at the Commission or in the field. 3* 10. ADMINISTRATIVE EXPENDITURE (PART A OF THE BUDGET) Actual mobilisation of the necessary administrative resources will be conditioned by the Commission's annual decision on the allocation of resources, having regard in particular to additional staff and funds provided by the budgetary authority. 10. 1 Impact on the number of employees Types of employees Staff carrying out action Source of employees Duration permanent employees temporary employees from within DG or service supplementary staff Officials or temporary agents A B C Other resources Total 1 1 1 3 0 0 0 0 1 1 1 3 10. 2 Financial impact of supplementary staff No supplementary staff are envisaged 0 0 0 0 10. 3 Increase in other running costs arising from the action Budget line Meetings A2510 ° Amounts 104,250 ecus Method of calculation ? meetingsi of ad^sory cornmittee/year, 1 representative/Member State = 2 meetings/year x 15 reprs x 695 ecus/reprs x 5 years = 104,250 ecus The resources necessary to cover the expenditure below for the 5-year period will be obtained by re-deployment of existing financial resources and the use of supplementary resources will not be required. a) Personnel Expenses (Title Al, A2 and A5) 3 x 100,000 ecus x 5 years = 1,500,000 ecus b) Operational Expenses Expenses for meetings (A-250) 2 meetings/year x ID experts x 825 ecus/expert x 5 years = 123,750 ecus Expenses for travel (A-130) 24 missions/year Brussels-Luxembourg x 200 ecus/mission x 5 years = 24 000 30 missions/year to Member States x l000 ecus/mission x 5 years = 150,000 < ecus ecus c) Total: 1,797,750 ecus 23 ISSN 0254-1475 COM(97) 266 final DOCUMENTS EN 04 05 14 13 Catalogue number : CB-CO-97-253-EN-C ISBN 92-78-20670-9 Office for Official Publications of the European Communities L-2985 Luxembourg