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The precautionary principle within European Union public health policy. The implementation of the principle under conditions of supranationality and citizenship.

The present study examines the precautionary principle within the parameters of public health policy in the European Union, regarding both its meaning, as it has been shaped by relevant EU institutions and their counterparts within the Member States, and its implementation in practice. In the initial section I concentrate on the methodological question of "scientific uncertainty" concerning the calculation of risk and possible damage. Calculation of risk in many cases justifies the adopting of preventive measures, but, as it is argued, the principle of precaution and its implementation cannot be wholly captured by a logic of calculation; such a principle does not only contain scientific uncertainty-as the preventive principle does-but it itself is generated as a principle by this scientific uncertainty, recognising the need for a society to act. Thus, the implementation of the precautionary principle is also a simultaneous search for justification of its status as a principle. This justification would result in the adoption of precautionary measures against risk although no proof of this principle has been produced based on the "cause-effect" model. The main part of the study is occupied with an examination of three cases from which the stance of the official bodies of the European Union towards the precautionary principle and its implementation emerges: the case of the "mad cows" disease, the case of production and commercialization of genetically modified foodstuffs. The study concludes with the assessment that the effective implementation of the precautionary principle on a European level depends on the emergence of a concerned Europe-wide citizenship and its acting as a mechanism to counteract the material and social conditions that pose risks for human health.

Animals↗

Impact of the European Union enlargement on health professionals and health care systems.

As the European family enlarges, the admission of new human resources in the health services will have an impact on the European market and health care system. Under the umbrella of the European Union (EU) equality, the educational quality barriers (e.g. PLAB test in UK, DIKATSA test in Greece) will be abolished. The overproduction of health professionals and their heterogeneous regional and per specialty distribution will lead to medical unemployment and demotion of the medical profession. Medical and political authorities and decision makers of the EU need to reform the European Health System, supervise, and assess the quality of medical education, harmonize the individual National Health System policies, and follow the World Health Organization (regional office for Europe) guidelines on health policy. An agreed, structured European Health Policy might moderate the vibrations of the forthcoming EU enlargement.

Curriculum↗

[Primary care in European Union countries: configurations and organizational reforms in the 1990s].

During the 1990s, proposals to contain health expenditures and demands raised by changes in the epidemiological profile led to organizational reforms in primary healthcare services in European Union countries, aimed at promoting the coordination of services provided by the various levels of care. Based on a literature review, document analysis, and interviews with key informants, the current study analyzes the institutional configurations for first-level healthcare and discusses the pre-coordination organizational reforms in the European Union countries. First-level outpatient care is provided in these countries through a wide variety of institutional configurations, observing the different financing mechanisms, range of healthcare professionals, range of clinical services provided, and the position occupied by physicians in primary care within the healthcare system. Reforms in the last decade were accompanied by a diversification in the outpatient care organizational models, with an expansion in the clinical, healthcare coordination management, and financing functions of primary care professionals, indicating a process in transition, with a redefinition of the roles played by general practitioners as the leaders of patient care.

European Union↗

[Attempt to exclude invasive cardiology services in Poland--rationing, national sovereignty and European Union law].

One of the guiding principles of health policy in many European countries is equitable access to health care services. One of the life saving procedures is percutaneous transluminal coronary angioplasty (PTCA) performed after coronary angiography. Introducing payment for these procedures would limit access for low-income patients. Fortunately, despite political debate, invasive cardiology develops well in Poland. It is important to notice that within the European Union Polish citizens would be able to receive this treatment in other member states and, according to a European Court of Justice ruling, the costs would have to be reimbursed by the National Health Fund. The wider implication is that the 10 new EU member states now have to realise that health care is no longer a matter of national sovereignty - a fact legislators and health care managers in the 15 member states of the pre-accession EU are still struggling with.

Angioplasty, Balloon, Coronary↗

The burden of mortality from smoking: comparing Sweden with other countries in the European Union.

We describe the mortality currently attributable to smoking in the European Union (EU), and the change that would result if all EU countries had the smoking prevalence of Sweden. Almost 500,000 smoking-attributable deaths occur annually among men in the EU; about 200,000 would be avoided at Swedish smoking rates. In contrast, only 1100 deaths would be avoided if EU women smoked at Swedish rates. The low smoking-related mortality among Swedish men probably is due to their use of snus (Swedish smokeless tobacco).

Adolescent↗

Science and norms in policies for sustainable development: assessing and managing risks of chemical substances and genetically modified organisms in the European Union.

Use of chemical substances and genetically modified organisms cause complex problems characterised by scientific uncertainty and controversies. Aiming at sustainable development, policies for assessment, and management of risks in the two areas are under development in the European Union. The article points out that both science and norms play a central role in risk assessment as well as risk management and suggests that the precautionary principle, the principle of public participation, and the polluter pays principle, all adopted in the European Union, offer a way to operationalise the concept of sustainable development. It is shown, however, that a number of steps ought to be taken to better implement the principles through different policy measures. In doing so, and by recognising the role of both science and norms, the decision-making on risks related to the use of chemicals or genetically modified organisms can be improved to better promote sustainable development.

Chemical Industry↗

The use of correlates of immunity in European Union licensing of influenza vaccines.

Influenza vaccines are licensed in the European Union (EU) by means of the mutual recognition procedure, which includes a "fast track" variation for rapid approval of new vaccine strains. This "fast track" procedure involves an annual clinical trial and assessment of immunogenicity according to serological criteria published by the EU Committee for Proprietary Medicinal Products (CPMP). A survey of vaccine clinical trials in the elderly over the past four years has demonstrated that inter-laboratory differences in serology results can affect compliance with CPMP licensing criteria. Thus even well established immune correlates of influenza vaccine efficacy can be problematic. For the next generation of vaccines, however, where mucosal or cell-mediated immunity may contribute towards vaccine efficacy, the serological correlates may be inadequate.

Drug Approval↗

Variation in antibiotic use in the European Union.

Data on antibiotic use are not publicly available in most European Union countries. We obtained data for non-hospital antibiotic sales for 1997 from the 15 member states and analysed these according to the Anatomic Therapeutic Chemical classification system, and expressed them as defined daily doses per 1000 people per day. Sales of antibiotics varied more than four-fold: France (36.5), Spain (32.4), Portugal (28.8), and Belgium (26.7) had the highest sales, whereas the Netherlands (8.9), Denmark (11.3), Sweden (13.5), and Germany (13.6) had the lowest. There was also profound variation in use of different classes of antibiotics. Detailed knowledge of antibiotic use is necessary to implement national strategies for optimum antibiotic use, and to address the threat posed by resistant microorganisms.

Anti-Bacterial Agents↗

[Genetically modified plants and food safety. State of the art and discussion in the European Union].

Placing genetically modified (GM) plants and derived products on the European Union's (EU) market has been regulated by a Community Directive since 1990. This directive was complemented by a regulation specific for genetically modified and other novel foods in 1997. Specific labelling requirements have been applicable for GM foods since 1998. The law requires a pre-market safety assessment for which criteria have been elaborated and continuously adapted in accordance with the state of the art by national and international bodies and organisations. Consequently, only genetically modified products that have been demonstrated to be as safe as their conventional counterparts can be commercialized. However, the poor acceptance of genetically modified foods has led to a de facto moratorium since 1998. It is based on the lack of a qualified majority of EU member states necessary for authorization to place genetically modified plants and derived foods on the market. New Community Regulations are intended to end this moratorium by providing a harmonized and transparent safety assessment, a centralised authorization procedure, extended labelling provisions and a traceability system for genetically modified organisms (GMO) and derived food and feed.

Consumer Product Safety↗

Changes in nursing education in the European Union.

PURPOSE: To provide an overview of changes in nursing education in the European Union (EU) within the framework of the Bologna Declaration, signed in 1999 by the European ministers of education, and to describe specific efforts and changes in Spain. ORGANIZING CONSTRUCTS: (a) the Bologna Declaration process, its recent reforms in all disciplines including nursing, and perspectives on future developments; (b) the Tuning Project, designed and carried out by a group of European universities to meet the challenges posed by the Bologna Declaration; and (c) efforts in a group of Spanish universities to promote higher education in nursing. FINDINGS AND CONCLUSIONS: These changes promote enhanced academic recognition, professionalism in nursing education, and graduates' competencies in practice in most European countries by specifying the undergraduate nursing degree as the minimal entrance level for practice and master's and doctoral programs for further career development.

Curriculum↗

Scientific basis and regulatory aspects for the toxicology of plant protection products in the European Union.

Authorization of plant protection products/agrochemicals/pesticides in the European Union is done on the basis of their toxicological properties. This paper reviews the current legislation for placing an agrochemical on the market (ie a new substance or a existing active substance), and the toxicology studies needed for inclusion of a substance in any of the annexes of the Council Directive of the European Economic Community 91/414/ EEC. Risk analysis and its steps is discussed. The "threshold toxicity" employed to allow risk characterisation of plant protection products is described, such as acceptable daily intake, acceptable operator exposure level, acute reference dose, and maximum admissible concentration in water.

Agriculture↗

Perceived need to alter eating habits among representative samples of adults from all member states of the European Union.

OBJECTIVE: To examine the perceived need to alter eating habits among nationally-representative samples from each member state of the European Union (EU). DESIGN: A cross-sectional study in which quota-controlled, nationally-representative samples of approximately 1000 adults from each country completed a face-to-face interview-assisted questionnaire. SETTING: The survey was conducted between October 1995 and February 1996 in the 15 member states of the European Union. SUBJECTS: 14,331 subjects (aged 15 y upwards) completed the questionnaire. Data were weighted by population size for each country and by sex, age and regional distribution within each member state. RESULTS: 71% of EU subjects agreed with the statement 'I do not need to make changes to the food I eat, as it is already healthy enough'. There was wide variation between the member states ranging from 47% in Finland to 87% in Italy indicating agreement. Overall there was little difference between the sexes except in Austria, Belgium, Germany, Greece and Ireland, but the proportions of subjects agreeing with the statement generally increased with advancing age and decreased with higher levels of education. The effects of demographics were not consistent across member states. A total of 49% of EU subjects agreed with the statement 'I usually do not think of the nutritional aspects of the food I eat'. Significantly more females than males disagreed with the statement in all countries except Portugal. In all member states there were widespread beliefs that people in general should decrease their consumption of savoury snacks and increase their consumption of fruit and vegetables. CONCLUSIONS: The results of this study demonstrate that dietary advice may not be perceived as personally relevant among EU subjects. In addition important target groups for the promotion of healthy eating have been identified for example, males or subjects with low levels of education. Because of the variation in attitudes a single pan-EU healthy eating programme is unlikely to be effective for all countries or for different demographic groups.

Adolescent↗

Trends in injury mortality among young people in the European Union: a report from the EURORISC working group.

PURPOSE: To examine the trends in injury mortality among young people aged 15-24 years residing in the 15 current member states of the European Union between 1984 and 1993. METHODS: As part of a European Commission-funded project entitled European Review of Injury Surveillance and Control (EURORISC), mortality data for all externally caused physical injuries (International Classification of Disease Codes E800-999) were obtained from the World Health Organization. Data were analyzed to generate age-specific injury mortality rates and proportional differences in rates over the study period. Linear regression was used to represent the linear component of the mortality profile. RESULTS: Almost a quarter of a million young people died as a result of sustaining an externally caused physical injury (either unintentional or intentional) in the study countries between 1984 and 1993. Injury accounted for two-thirds of all deaths in this age group. Over three-quarters (76%) of deaths were due to unintentional injury, a further 17% to self-inflicted injuries, and the remaining 7% to homicide and other violent causes. Motor vehicle traffic fatalities accounted for 84% of unintentional injury deaths. Although a decline in injury mortality was observed throughout Europe, rates of mortality owing to both unintentional injuries and suicide varied widely among study countries at both the beginning and end of the study period. CONCLUSIONS: Whereas injury mortality rates in young people in most European countries are lower than in other parts of the world (including the United States), injuries represent a major public health problem in the European Union. The death toll from motor vehicle traffic crashes is a particular cause for concern.

Accidents, Traffic↗

The biological evaluation of medical devices used in dentistry. The influence of the European Union on the preclinical screening of dental materials.

The advent of the European Union requires the biological evaluation of all medical devices used in dentistry prior to their general availability for clinical use. Biological evaluation is one component of the 'Essential Requirements' with which all devices need to conform. Such conformity will result in the issue of the CE mark. To facilitate this process, harmonised European standards are required. It is the policy of The European Committee for Standardisation (CEN) that, whenever possible, the relevant International standards will be adopted as European standards.

Animals↗

[Surveillance of communicable diseases in the European Union].

Important developments are taking place in the Public Health framework in the European Union (EU). A number of international surveillance networks have been developed between the countries of the EU. The European Commission has initiated horizontal and disease specific programmes in the field of infectious disease surveillance. These have stimulated European co-operation for prevention and control of infectious diseases. Much topical information can be found on several Internet pages. The challenge is to set up networks for all public health relevant infectious diseases.

Communicable Disease Control↗

A summary of boron surface water quality data throughout the European Union.

The distribution of boron in rivers across European Union countries is described. The data have been collected from national and international monitoring programmes. The data show a wide range of concentrations but only in a few instances do concentrations exceed environmental quality standards. Although there is a good body of data for the analysis presented here, it is clear that there is not a full coverage of environments and for some studies there is a clear bias towards sampling of the main rivers or specific rivers where there are environmental concerns. The variations in concentration link directly to pollutant sources although assessment of the details of the spatial variations is clouded by factors such as the location of monitoring points in relation to pollutant discharges, the variation in dilution potential of the various rivers and contrasting hydrological and geological environments. The data are presented to complement more detailed studies on particular river basins as a basis for the further development of regional environmental impact water quality modelling frameworks and within the newly developing field of typological settings.

Journal Article↗

[Harmonisation of personal injury compensation in the European Union. Application to medical liability case law].

Harmonisation of personal injury compensation in the European Union (EU) is crucial. Continuing on from the work begun by the European Federation of Medical Academies, a working party of the XVth Committee of the French National Academy of Medicine has sought to go beyond the restrictive framework of automobile accident compensation in order to address more universal concerns, regardless of the causes and effects of bodily injury. The specific situation of injuries resulting from medical acts was considered, both for its medicolegal complexity and its potential human consequences. After recalling relevant European legislation, the authors consider the different philosophies of medical liability and health care systems in Europe. Methodological convergence is required to achieve harmonisation of personal injury compensation regimes, and especially for the classification of different types of bodily injury, the role of social services, and the establishment of a reference for medical evaluation of injury with built-in compensation levels. The doctrines and concepts of all EU member states (civil law, common law, Nordic medical liability regimes, etc.) are discussed, together with means of facilitating their harmonisation.

Compensation and Redress↗

Is the Turkish health care system ready to be a part of the European Union?

Lately, Turkey is struggling to recover from the economic effects of the economic crisis so that the government officials are trying to impose budget cuts in health and education sectors. After the United States, the country's national defense expenditures are the highest among the NATO countries. Therefore, Turkey allocates only 3-4% of the gross domestic product for health care expenses. Overall, the health status in Turkey is the lowest among the European Union countries; infant mortality rate is about 45 per 1000 live births, which is the highest on the European continent, and per capita health care expenditure is $120. Although 75% of the people are covered by some type of public insurance, 25% of the Turkish people do not have any insurance coverage. The national system is funded by taxes (43%), out of pocket payments (32%), and social and private insurance premiums (25%). This study examines whether Turkey is ready to be a part of the European Union in terms of the health sector of its economy and health status of its people.

Birth Rate↗