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PubMed2005

More attention to public health in the European Union - implications for dentistry?

At present the European Union is developing its competence on health and new important issues will be taken on board in European health policy. Increasing mobility of people and integration of the applicant countries puts pressure on the current health care provision systems. A mandate for an open co-ordination process in public health is expected to be given by the European Council. The process will start by exchange of information and best practice models. The next step will be the presentation of common targets between member countries, followed by national action programmes and indicators. It is likely that a lot of emphasis will be put on access to health services, comparisons of costs of health care and benchmarking the costs of items of care. In the long run this will mean convergence of the health care systems. If oral health is to be considered an integral part of general health dental professionals need to be aware of and be able to influence the actions to be taken.

Benchmarking↗
PubMedDate not supplied

[Comparison of the safety of the medicinal product in the European Union and the United States, tolcapone (Tasmar) -- COMT inhibitor as the analyzed example].

The authors present regulatory procedures and pharmaco-vigilance systems obligatory in the European Union and the United States. The post-approval procedures in the European Union and the United States in case of serious drug reaction (urgent safety restriction) are discussed. Worldwide implementations of the post-approval safety procedure for the tolcapone case are analyzed. Some practical information concerning tolcapone and regulatory procedures obligatory in the European Union and the United States is included.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Availability of medicines in the European Union: results from the EURO-Medicines project.

OBJECTIVE: There is at present no comprehensive directory of medicines available in European countries. Such a directory would be valuable to policy analysts, clinicians, regulatory agencies, pharmaceutical companies and consumer groups. The aim of this project was to compile such a directory of all medicines marketed in each of the European Union member countries. METHODS: Lists of medicines for each country, compiled from several national sources, classified by Anatomical-Chemical-Therapeutic (ATC) code. Census date was late 1998. RESULTS: A comprehensive directory was created using data from 14 of the 15 European Union countries. Numbers of trade names and of active ingredients varied widely, from Germany with 18,554 and 1,973, respectively, to Denmark with 1,915 and 1,016, respectively. In individual therapeutic areas, there were variations in the numbers of active ingredients available: the least variation between countries was in antineoplastic medicines (ATC code L, maximum number available in any country 101, minimum 60) and wider variation in alimentary (ATC code A, maximum 256. minimum 103) or cardiovascular (ATC code C, maximum 269, minimum 112). Only 7% of all the active ingredients were available in all the countries studied. The Scandinavian countries had the greatest proportion of active ingredients (60%) available in all other countries. Each country had a number of active ingredients available only in that country Italy had the largest number of these. CONCLUSIONS: The directory illustrates the wide variations in the availability of medicines across the European Union. The range of drugs available in each country represents differences in regulatory and market policies, as well as cultural and historic differences. This directory lends itself to many further analyses.

Data Collection↗
PubMed2004

The legal protection of test subjects in clinical trials of medicinal products for human use in the European Union.

On the international as well as on the level of the European Union a legal framework has been developed on the protection of test subjects has been developed. In 2000, the Declaration of Helsinki, issued by the World Medical Association, was revised and the previous distinction between therapeutic and non-therapeutic trial situations has been eliminated. Non-therapeutic trials that only aim at the progress of scientific knowledge and do not benefit the patient are now admissible. This is not to the benefit of the position of the test subject and most certainly not when the test subject should be given special protection. The question arises what this recent revision means for the group of incompetent adult patients in clinical trials on medicinal products (hereinafter called drugs) in the European Union (EU). This group needs special protection. Also relevant are national and international legal frameworks and the protection offered by informed consent procedures and screening by ethics committees and member states' competent authorities.

Adult↗
PubMed2000

Epidemiology of hepatitis C virus infection in seven European Union countries: a critical analysis of the literature. HENCORE Group. (Hepatitis C European Network for Co-operative Research.

Hepatitis C is now recognized as the most common infection causing chronic liver disease in the European population. Our aim was to assess the prevalence of the antibody to hepatitis C virus (HCV), and the incidence of HCV seroconversion in the general population and the main risk groups, namely intravenous drug users, haemodialysis and transfused patients, in seven countries of the European Union, by carrying out a critical analysis of the literature. Data sources used were the Medline database and a manual search using the key words: hepatitis C, prevalence, incidence, transmission, risk factors and epidemiology. Articles published between January 1990 and March 1997 were reviewed. Articles were reviewed according to a critical analysis method regarding title, type of article, study design, period and population, tests, results and their consistency with data. The tests performed were mainly second- or third-generation serological tests. The average prevalence rate in blood donors was 1%, with a north-south gradient ranging from 0.04% to 2%. Prevalence varied from 20% to 30% in haemodialysis patients. The incidence in transfused patients was less than 1% after 1991. The prevalence in intravenous drug users was about 80%. Multicentre studies conducted in larger samples are needed to obtain more accurate and reliable results, in particular. However, the epidemiological studies available allowed us to assess the magnitude of HCV infection in Europe.

Europe↗
PubMed2003

[Third statistical report on the numbers of laboratory animals used in the European Union--tendencies, problems, decisions].

In 2003, the European Commission has published its third statistical report on the numbers of laboratory animals used in the European Union, in which the data of 1999 are analysed. For the first time, with the exception of Germany, the data presented were raised on the basis of a new registration scheme. The significance of these data is limited due to deficiencies of the tables used, restricted comparability with previously raised data, and lacking relevance to the current situation. Despite this imperfect basis, the European Commission concludes in its report that there has been a significant reduction in the number of laboratory animals used in the EU compared to the previous statistics. This statement must be regarded critically as several national statistics of the last years verify that the number of laboratory animals used has in fact increased. According to the comments of various national authorities included in the report, particularly genetic engineering is responsible for the increase in animal numbers.

Animal Welfare↗
PubMed1999

[European public health professionals express ten priorities for the European Union...to be followed].

Even if the European Union acquired explicit competencies in public health with the Maastricht and Amsterdam Treaties (articles 129 and 152), public health professionals still have not had their word in the definition of public health priorities. Yet it is they, whatever their mission, who must take into consideration the new constraints imposed by Community directives. The French Society for Public Health (FSPH) took the initiative of running a project, financed by the European Commission, aiming to shed light on some of the public health problems considered priority in the 15 member states, and to provide suggestions for facing them. The FSPH adopted a resolutely participative and pragmatic process. At each step (definition of priorities and compiling arguments), the intention of the SFPH was more to allow different, even diverging, points of view to be expressed, than to aim for a hypothetical representativeness. The undertaken themes are the social gradients in health, alcohol, illicit drugs, tobacco, surveillance of health issues, quality of care, older persons, mental health, the environment, nutrition and food security. This work marks the wish of the FSPH for international openness toward Europe. The FSPH hopes that this work becomes a platform for the development of a reinforced dialogue between public health professionals and European decision makers.

Attitude of Health Personnel↗
PubMed2003

General aspects on the assessment of functional foods in the European Union.

During the last 6 y, the European Union has undergone a profound qualitative change in the focus on food safety problems. In 1997, nine new scientific committees were created, including the Scientific Committee on Food (SCF) and the Scientific Steering Committee (SSC), and were put under the auspices of the Directorate General in charge of defending consumer interests and health. The process is foreseen to be completed by the incorporation in 2003 of all food safety activities of these committees into the European Food Safety Authority (EFSA). Among the immediate challenges in the near future are the scientific and technological developments and the regulatory measures for the so-called 'functional foods', which can positively affect the health and well-being of consumers. Functional foods are a recent phenomenon in Europe and are, as yet, not covered by any specific legislation. The two key aspects in the evaluation of functional foods are safety and efficacy. Whereas safety can be covered under different legislative umbrellas such as novel foods (NFs), foods for particular nutritional purposes, supplements, additives and others, the issue of evaluation of their efficacy is only at a very early stage since the criteria to establish the validity of 'health claims' has not been clearly addressed at a European level.

European Union↗
PubMed2005

Inequalities in the prevalence of smoking in the European Union: comparing education and income.

BACKGROUND: The aim of the study was to determine whether education or income was more strongly related to smoking in the European Union at large, and within the individual countries of the EU, at the end of the 1990s. METHODS: We related smoking prevalence to education and income level by analyzing cross-sectional data on a total of 48,694 men and 52,618 women aged 16 and over from 11 countries of the European Union in 1998. RESULTS: Both education and income were related to smoking within the European Union at large. After adjustment of the other socioeconomic indicator, education remained related to smoking in the EU at large, but income only remained so among men. Educational inequalities were larger than income-related inequalities among younger and middle-aged men and women. Educational inequalities were larger than income-related inequalities among men in all individual countries, and among women in Northern Europe. For women from Southern European countries, the magnitude of education- and income-related inequalities was similar. CONCLUSIONS: Education is a strong predictor of smoking in Europe. Interventions should aim to prevent addiction to smoking among the lower educated, by price policies, school-based programs, and smoking cessation support for young adults.

Adolescent↗
PubMed2003

Geriatric medicine in the European Union: future scenarios.

The differences in training and services in geriatric medicine between European Union member countries raise some questions: what is a geriatrician, what is geriatric medicine, what will be the future development of the specialty and how does it interact with other medical specialties? To find answers to these questions, a questionnaire was sent to a selected group of 122 geriatricians. The response rate was 60%. A description has been given of what is a geriatrician and what is geriatric medicine. Based on data from the literature and the answers of the respondents six future scenarios were designed. The six scenarios are: the 'healthy old people', the 'adapted specialties', the 'general practitioner + additional training', the 'co-ordinator geriatrician', the 'community geriatrician' and the 'hospital geriatrician'. The answers of the respondents gave doubts whether general practitioners are able to provide the full range of services for geriatric patients in the community. A small majority of the respondents opted for a division of the specialty into community geriatric medicine and hospital geriatric medicine. Such a division offers good opportunities to raise the quality of medical services and to reduce age-related treatment limitation. It is expected that some aspects of geriatric medicine will be included in the training of other specialties and some GPs will obtain additional training. The collected data can not be considered as a representation of the ideas of the European Union geriatricians. However, they may contribute to the discussion on the national and European level about the future of the specialty.

Aged↗
PubMed2004

Developing specialist healthcare for older people: a challenge for the European Union.

The state of health in the European Union is better than ever before. This is due to spectacular progress made over the second half of this century in terms of medical research, health services provision and living conditions. However, older people require more, and substantially different, health and care services than younger people. The central challenge of the policy makers is to ensure that future health care policies will provide an adequate and cost effective response to the changes brought about by demographic trends.

Aged↗
PubMedDate not supplied

The European Union: open to the practising physician?

The European Union (EU) has powers and responsibilities in the area of public health, while the organisation of healthcare facilities remains the concern of member states. However, a series of directives has, since the late 1970s, sought to ensure the right of individual practitioners to travel freely throughout the EU, both to obtain specialist training and to practise in all member states on the same basis as doctors working in the member states where they were first registered. More recently, there has been mutual recognition of completion of specialist training across the EU. A new directive concerning the mobility of medical practitioners across the EU is under discussion.

Career Mobility↗
PubMed2002

Attitudes toward biotechnology in the European Union.

Public attitudes toward biotechnology in the European Union have been characterized as negative using Eurobarometer data, but so far little attention has been paid to building a robust metric appropriate for emerging public opinion issues which combine high salience with very limited knowledge by the public. On the basis of the general literature about the formation and structure of attitudes and about public perceptions of science, this article presents a new metric and analysis: first, for estimating the level of awareness and knowledge of biotechnology in Europe; second, for assessing the stability and depth of these evaluative perceptions; and third, for exploring the roles of canonical socio-demographic variables, the knowledge variable and general attitudinal schemas for understanding the perceptions of both benefits and risks of biotech applications. The results show the importance of general value orientations or "worldviews" in shaping positive attitudes, and more of these general cognitive schemas should be measured in future research. The same multivariate model was unable to account for a significant percentage of the total variance in the perception of risks, suggesting that new measures are needed to tap this critical area in the acceptance of biotech in Europe.

Adult↗
PubMed2007

Assessment of the pharmaceutical market in Poland after accession to the European Union.

The Republic of Poland joined the European Union (EU) on 1 May 2004. The EU accession brought new opportunities to the Polish health care system and the pharmaceutical market. However, there are still barriers to overcome such as bureaucracy, lack of transparency in pricing and reimbursement, decision-making processes, the short period of data exclusivity, respect for intellectual property rights, favorisation of local companies and low health care investment. Additionally, drug costs outpace overall economic development, a trend which is universally valid for almost all EU countries and which forms one of the most serious factors in health care expenditure. A systematic cost-effective assessment, the so-called fourth hurdle (after quality, efficacy and safety), of prescription drugs seems a necessity in most EU countries. The Polish Ministry of Health has defined aims for the future health care system in the National Drug Policy 2004-2008, including health economical criteria and instruments. However, it is to be expected that for some time there will be more a reimbursement hurdle instead of a fourth hurdle in controlling drug expenditure. This review focuses on the Polish pharmaceutical market with special consideration of the history of the Polish health care system. It will highlight the present situation of the Polish health care system after EU accession and provide an outlook to its possible future.

Cost-Benefit Analysis↗
PubMed1997

European Union System for the Evaluation of Substances (EUSES). Principles and structure.

In the European Union, Directive 92/32/EC and EC Council Regulation (EC) 793/93 require the risk assessment of new and existing substances, respectively. Principles for this risk assessment have been laid down, supported by a detailed package of Technical Guidance Documents. Against this background the European Union System for the Evaluation of Substances (EUSES) has been developed. This software can be used to carry out tiered risk assessments of increasing complexity on the basis of increasing data requirements. The exposure assessment, effects assessment and risk characterisation are carried out for environmental populations as well as for human beings, including workers, consumers and man exposed through the environment. EUSES is the result of a co-ordinated effort of EU Member States, the European Commission and the European Chemical Industry.

Animals↗
PubMed2000

Childhood injuries in the European Union: can epidemiology contribute to their control?

UNLABELLED: An average of 6000 children (0-14-y-old) died every year from injuries in the European Union during the last decade. Although the trends are overall favorable, injuries continue to represent the leading cause of death in this age group. The aim of this paper is to present childhood-injury-related public health issues and consider possible remedies of contemporary epidemiologic methods as applied to injury epidemiology and prevention. It has been estimated that half of the lives lost to childhood injuries could have been saved if all European Union countries matched the accomplishments of the country with the lowest mortality rate in each injury category. There is no specific pattern of association between Gross Domestic Product and incidence of motor-vehicle accidents by category of road user, whereas fatality from motor-vehicle accidents seems to be inversely, strongly and significantly related to Gross Domestic Product. CONCLUSION: The ongoing development of large injury databases in the European Union is a prerequisite for understanding the complex interactions that lead to a childhood injury. Moreover, possible remedies for overcoming the genuine problems associated with the application of traditional epidemiologic methods to the investigation of the frequently transient in nature causes of injuries should be considered.

Accident Prevention↗