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PubMed1981

Directive of the European Communities relating to the quality of water for human consumption.

A draft directive relating to the quality of water for human consumption was submitted on 22 July 1975 to the Council of Ministers of the European Communities. The submission of this proposition was requested by the Council of Ministers in the Action Programme of the European Communities on the environment, approved by them on 22 November 1973. The objective is the protection of public health by establishing standards to be respected by the Member States. This directive was adopted by the Council of Ministers of the European Communities June 30, 1980. This report deals with technical aspects of this directive and gives some additional comments.

European Union↗
PubMed1997

[Development of the occupational carcinogen legislation in the European Community].

The aim of this study is to sum up the development of European Community legislation concerning occupational carcinogens. In terms of prevention, 4 periods were studied. From 1951 to 1972, only a few texts of law were promulgated. From 1972 to 1984, after the ratification of the convention 139 of the International Labour Office, more texts were promulgated. Then, from 1985 to 1992, the protection against occupational carcinogens increased for workers, especially after the specific european directive edicted in 1990. Since 1992, most of the countries in the European Union have included this directive in their legislation. In terms of compensation for occupational cancer, a recommendation of the European Commission stated in 1962 had already proposed a list of compensable diseases. Because of the diversity of compensation means, it is difficult for the European Community to impose a common status.

Carcinogens↗
PubMed1993

Legislation by the European Community on carcinogens.

A brief overview is given of the legislation in the European Community concerning the classification and labelling, marketing and use, occupational exposure, etc. of carcinogenic agents. This includes data on the regulation of 739 agents which have been evaluated for carcinogenicity by the International Agency for Research on Cancer and/or the European Community. These data have been collected in a computerized data base. Although no comprehensive evaluation of the legislation is attempted, it is suggested that a number of carcinogenic agents still need attention, and that the labelling requirements should be supplemented with more restrictive legislation.

Carcinogens↗
PubMed1997

Organ transplantation and European Community law: the case of non-residents.

OBJECTIVES: The role of the European Union in influencing health care policies in member states is of increasing importance. The Eurotransplant Foundation is an organization which provides donor organs to the most suitable transplant recipients. It covers a region of five countries (Austria, Belgium, Germany, Luxembourg, The Netherlands). As there is a severe shortage of donor organs within its region, registration of so-called non-resident patients on the waiting lists aggravates this shortage. Could European Community law, especially rules on competition, limit Eurotransplant's freedom to introduce a restrictive policy on non-residents? If so, could participating transplant centres or patients initiate legal action against Eurotransplant to stop the execution of such a policy? METHODS: Quantitative descriptive data on organ donation and use by the Eurotransplant Foundation during 1994 and 1995, by residents and non-residents. Analysis on basis of economic and legal framework. RESULTS: Solidarity between potential donors and potential recipients is organized in a different manner in an organization such as Eurotransplant as compared to a national organization under national law. National regulations may introduce a restrictive policy for the acceptance of non-resident patients. Eurotransplant--as a matter of its own policy--has to consider international solidarity. The scope of the non-resident issue is dealt with, and it is explained why it is considered to be a problem. On the basis of a discussion of the economic and the legal framework for a non-resident policy, an answer to the question is suggested. CONCLUSION: It might be possible for Eurotransplant to introduce a restrictive policy on the admission of non-residents without violating the European Community Treaty.

Emigration and Immigration↗
PubMed1993

On the options for the European cardiologist in the enlarging European Community.

In conclusion, European integration in 1992 will mean several things for the European cardiologist, the most important of which are the following: 1. The E.S.C. will and must be able to exert more influence than ever before on the legislative and executive processes in Brussels, now and in 1993, and therefore collectively in the partner countries. 2. Only then, like its American counterparts the A.C.C. and A.H.A., will the E.S.C. be able to join with the politicians to guide the all-important question of allotment of funds. Funds for patient care, teaching, research, advanced planning, for investments in hospitals and laboratories, are all part of our fight against heart disease. These can much better be applied for and allocated on a European scale than on a national basis. The mere avoidance of duplication and repetition may be the greatest benefit of integration. 3. Only by strengthening the E.S.C. with a "cadre" of experienced cardiologists we can deliver the expert manpower which this integrative process will require: "Let not our Society miss the opportunities which 1992 offers!" 4. As a final point, only when we, as a professional unit show that we can make choices, and desist from asking everything possible for every patient we see, will we be able to regain and retain the trust of the patient as well as the political representatives of our member nations. Let us capture this genie before it, too, escapes from the bottle (Braunwald, 1988). These points are symbolized in Figure 1.

Cardiology↗
PubMedDate not supplied

[The sixth Framework Programme of the European Community for research activities and role of the Italian Community].

The sixth Framework Programme of the European Community for research activities is founded on two new elements, which are essential for the realisation of the European Research Area. They are the Networks of Excellence and the Integrated Projects. The Italian Government has recently approved the new Guidelines for the scientific and technological policy. They are based on four Axes, which involve basic and applied research for a total funding of 14.175 million euro in three years. If this Programme is carried out, the Italian Research Community will further improve, both qualitatively and quantitatively, its scientific productivity. It should be pointed out that, in a recent review, the Institute for Scientific Information included Italy at 7th place in the international classification of medical research.

European Union↗
PubMed2006

Distribution and determinants of house dust mite allergens in Europe: the European Community Respiratory Health Survey II.

BACKGROUND: Several studies in European homes have described allergen levels from the house dust mite species Dermatophagoides pteronyssinus and to a lesser extent Dermatophagoides farinae, but geographic comparisons of exposure levels and risk factors have been hampered by a lack of standardized methods. OBJECTIVE: To study the distribution and determinants of the major house dust mite allergens Der p 1 and Der f 1 in 10 European countries using a common protocol. METHODS: During home visits with 3580 participants of the European Community Respiratory Health Survey II from 22 study centers, mattress dust was sampled and analyzed for Der p 1, Der f 1, and Der 2 allergen. Information on housing characteristics was obtained by both observations and interview. RESULTS: Der 1 and Der 2 allergens were detectable (>/=0.1 mug/g) in 68% and 53% of the samples, respectively. Large differences in allergen levels between study centers were observed, and geographic patterns for Der p 1 and Der f 1 were different. Low winter temperatures reduced Der p 1 rather than Der f 1. Important risk factors for high allergen levels included an older mattress, a lower floor level of the bedroom, limited ventilation of the bedroom, and dampness for Der p 1 but not for Der f 1. CONCLUSION: There are large qualitative and quantitative differences of house dust mite allergen levels in Europe, which can partly be explained by geographic and housing characteristics. CLINICAL IMPLICATIONS: Mite allergen exposure may be reduced by replacing the mattress regularly and increasing ventilation of the bedroom, particularly in winter.

Allergens↗
PubMed1998

References values for forced spirometry. Group of the European Community Respiratory Health Survey.

The European Coal and Steel Community (ECSC) prediction equations exemplify a significant effort carried out approximately 15 yrs ago to provide uniform standards for lung function testing, but this set of equations has not been properly validated as yet. The present study evaluates the ECSC reference values and four other sets of prediction equations, using spirometric data collected in 12,900 nonasthmatic subjects (43% lifetime nonsmokers and 36% active smokers) aged 20-44 yrs from the European Community Respiratory Health Survey (ECRHS). Standardized spirometric measurements were obtained using a common protocol in 34 centres in 14 countries. For each prediction equation, the prediction deviations (i.e. observed minus predicted value) for forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were examined for the whole study population and for each centre. For the age range included, the errors about the ECSC equations showed the most prominent underestimation of both predicted FVC (+355 and +360 mL on average in males and females, respectively) and predicted FEV1 (+211 and +200 mL, respectively) among the five studies examined. As expected, FVC and FEV1 in active smokers from the ECRHS were significantly lower than in lifetime nonsmokers (each p<0.01). We conclude that the present European recommendations on lung function reference values should be reconsidered, but further data for nonsymptomatic subjects above the age of 44 yrs are needed.

Adult↗
PubMed1992

Pharmaceutical regulation in the European Community: barriers to single market integration.

The European Community (EC) plans to create a single market for pharmaceutical medicines, but the drug industry is closely linked to cultural and societal values concerning health; to the national regulatory agencies responsible for the evaluation of safety, quality, and efficacy of new drugs; to multinational and domestic companies competing in national and international markets; and to varied interest groups of professionals and consumers organized along national and multinational lines. We review the history of the EC's policy proposals, examine reactions from all these interested parties, and assess the prospects for integration into a single market. The contentious debate that continues among the parties over national prerogatives, industrial interests, professional mandates, and consumer concerns clouds the prospects for a system of centralized drug registration that will be acceptable to all EC member states.

Community Participation↗
PubMed2001

Efficacy testing of cosmetic products. A proposal to the European Community by the Danish Environmental Protection Agency, Ministry of Environment and Energy.

BACKGROUND/AIMS: Regulations for cosmetic products primarily address safety of the products that may be used by large populations of healthy consumers. Requirements for documentation of efficacy claims are only fragmentary. This synopsis aims to review and conclude a set of standards that may be acceptable to the European Community, and the cosmetic industry, as a legal standard for efficacy documentation in Europe in the future. METHODS AND RESULTS: Ethical, formal, experimental, statistical and other aspects of efficacy testing are described, including validation, quality control and assurance. The importance of user relevant clinical end points, a controlled randomized trial design and evidence-based cosmetic product documentation, validation of methods, statistical power estimation and proper data handling, reporting and archiving is emphasized. The main principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) should be followed by the cosmetics industry in a spirit of good documentation standard and scientific soundness, but full GCP is not considered mandatory in the field of cosmetics. Documentation by validated bio-instrumental methods may be acceptable, but efficacy documentation based on information about raw materials, reference to literature and laboratory experiments are only acceptable in exceptional cases. CONCLUSIONS: Principles for efficacy substantiation of cosmetic products in Europe, as described in this synopsis, are officially proposed by the Danish Ministry of Environment and Energy to the European Community as a basis for an amendment to the Cosmetics Directive or otherwise implemented as a European Community regulation.

Clinical Trials as Topic↗
PubMed2002

[European Community Respiratory Health Survey: The main results so far with special reference to Iceland.].

INTRODUCTION: The European Community Respiratory Health Survey (ECRHS) was the first project embarked on extensive study of geographical difference between countries with regards to asthma and atopy incidence in a young adult population. The same methodology and definitions were used at all study sites. The purpose of this article is to review the published results of the ECRHS with a special emphasis on the findings from the Icelandic population, and compare these results with those from the participants from the other nations and study sites. METHODS: Compiled results from all study sites participating in the ECHRS hereto published were reviewed. The compiled data are derived from approximately 140.000 individuals aged 20-44 (birth-years 1946-71) from 22 nations and 48 study sites. The Icelandic population was chosen from the greater Reykjavik metropolitan area. Subjects responded to seven questions on respiratory symptoms, diagnosis of asthma and use of asthma medications. In the latter part of the investigation, 800 individuals were randomly selected from each study site. They were asked to respond to a detailed questionnaire. Subsequently spirometry, methacholine challange and skin prick testing to 11-12 common aeroallergens was performed. Additionally, allergen specific IgE and total IgE was measured. Somewhat fewer sites participated in this latter part: 17 nations and 37 study sites. RESULTS: The findings are presented from two angles: the compiled data from all study sites and the results from the Icelandic population; specifically comparing the Icelandic data with the participants from the other nations. The study showed a geographical difference in the incidence of asthma, bronchial hyper- responsiveness and other respiratory symptoms. In the first part of the study, an eight-fold difference in wheezing, six-fold difference in asthma, ten-fold difference in physician- diagnosed asthma and a four-fold difference in the prevalence of allergic rhinitis was found between the study sites. "English-speaking" nations had the highest prevalence of respiratory diseases and Iceland, Spain, Germany, Italy, Algeria and India had the lowest incidence. A three-fold difference in the prevalence of allergy and an eight-fold difference in bronchial responsiveness were found between study sites in the latter part of the study. The incidence of asthma was highest in the lower age groups. Atopy prevalence (defined as a positive specific IgE for at least one allergen) was highest in Australia. Other English speaking nations and Switzerland had prevalence over 40%. Iceland had the lowest prevalence of atopy (23.6%) and Greece, Norway and Italy all had a prevalence of atopy under 30%. Total IgE was highest in Greece, France, Ireland and Italy (>50kU/L), but was lowest in Iceland (13.2 kU/L). The article speculates on the possible effects of the environment on the prevalence of wheezing, bronchial reactivity and atopy in the different study sites. SUMMARY: RESULTS from the European Community Respiratory Health Survey demonstrate a substantial difference in the prevalence of asthma, bronchial responsiveness and atopy between study sites. The prevalence was highest in countries where English is the native language. Of all study sites, the prevalence was lowest in Iceland. In the articles, possible explanations for this discrepancy are reviewed.

English Abstract↗
PubMedDate not supplied

The European Community concerted action on ambulatory monitoring.

The diffusion of instruments for ambulatory monitoring is rapidly expanding and the related cost to the European Community is increasing, while their role and their effectiveness are still controversial. The Biomedical Engineering Group, belonging to the Committee for Medical Research of the European Community, has approved a project for the co-ordination of the research ('concerted action') in the field of ambulatory monitoring, to tackle the problem. The project, directed by a Project Management Group, following some meetings of experts being organized to identify high-priority goals, has been aimed at promoting common efforts in two specific fields: evaluation of the quality of ECG ambulatory monitoring analysers, by means of a standard reference, and assessment of the performance of non-invasive techniques for arterial blood pressure ambulatory monitoring. In its first six months (July-December 1985) the project has produced: (1) a preliminary agreement about ECG recording and an annotation scheme, to be definitely adopted, after a pilot experiment, by June 1986; (2) a protocol for hypertensive patient characterization and data collection, to be initiated by September 1986.

Blood Pressure Determination↗
PubMed1998

Mutual recognition of pharmaceutical good manufacturing practice inspection reports, medical device quality system audit reports, and certain medical device product evaluation reports between the United States and the European Community--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its regulations pursuant to an international agreement between the United States and the European Community (EC). The agreement is entitled "Agreement on Mutual Recognition Between the United States and the European Community (MRA). Under the terms of the agreement, the importing country authority may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by the exporting authority determined by the importing authority to have an equivalent regulatory system. Likewise, the importing country authority may normally endorse medical device quality system evaluation reports and certain medical device product evaluation reports by conformity assessment bodies (CAB's) determined by the importing country authority to have equivalent assessment procedures. FDA is taking this action to enhance its ability to ensure the safety and effectiveness of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The proposed rule which published in the Federal Register on April 10, 1998 (63 FR 17744), carried an incorrect docket number in its heading. This final rule carries the correct docket number.

Device Approval↗
PubMed2002

[European Community Respiratory Health Survey in Adults (ECRHS)].

The European Community Respiratory Health Survey (ECRHS) was the first study to assess the geographical variation in asthma, allergy, and allergic sensitization in adults using the same instruments and definitions. The database of the ECRHS includes information from approximately 140 000 individuals aged 20 - 44 years from 22 countries. The aim of this review is to summarize the results of the ECRHS and to present the specific contribution of the German centers in Hamburg and Erfurt. The prevalence ranged from 2.0 - 11.9 % for asthma, 9.5 - 40.9 % for allergic rhinitis, 4.0 - 32.0 % for wheeze, 3.4 - 27.9 % for bronchial hyperreactivity, and 16.2 - 44.5 % for allergic sensitisation against common aeroallergens. Although the prevalence of these atopic disorders were found to be consistently higher for the Hamburg center compared to the Erfurt center, strong regional differences in the prevalences were also found within several other European countries. Overall Europe, the lowest prevalences were seen in the Eastern and Middle European countries with the center Erfurt, followed by the Mediterranean region. The highest prevalences were reported for all English speaking centers. Strong geographic variation was reported for medication for asthma. Asthma seems to be undertreated in several countries. Environmental exposures and in particular indoor factors, and exposures at the workplace are playing a major role for asthma in adulthood. Furthermore, protective effects on atopy were found for exposures to pets (dogs) and a large number of siblings in early childhood. In conclusion, the ECRHS has shown that the prevalence of asthma varies widely. The fact that the geographical pattern is consistent with the distribution of atopy and bronchial responsiveness supports the conclusion that the geographical variations in the prevalence of asthma are true and likely due to environmental factors.

Adult↗
PubMed2004

The European Community strategy against antimicrobial resistance.

In 2001 the European Commission presented a 'Community strategy against Antimicrobial Resistance'. In previous years, the problem was addressed through an increasing number of isolated measures, but in this strategy the Commission outlined a comprehensive European Community approach across all sectors. The strategy consists of fifteen actions in four key areas: surveillance, prevention, research and product development, and international cooperation. An important part of this strategy is the 'Council Recommendation on the prudent use of antimicrobial agents in human medicine'. The Recommendation provides a detailed set of public health actions to contain antimicrobial resistance. This paper presents the eleven points of action of the strategy that are directly related to human medicine, and discusses related European Community activities. Under the new public health programme as well as under the research programme of the European Union, antimicrobial resistance is a key priority.

Drug Resistance, Microbial↗
PubMed1998

The European Community Humanitarian Office (ECHO): 1992-1999 and beyond.

The European Community Humanitarian Office (ECHO) was established in 1992 to co-ordinate and administer European Union (EU) humanitarian aid and by 1994 had grown to be the world's largest humanitarian aid donor. Since it was set up for an initial period of seven years, ECHO's performance and the question of its continuing existence will be reviewed next year; it seems unlikely to be abolished. In light of this, this paper starts with a description of how ECHO functions: its mandate, sources of finance and funding mechanisms. It looks then at some of the ongoing challenges that ECHO faces--its relations with Member States, its links to other Commission services and its attempts to establish a distinctive role within the humanitarian aid field. In terms of this last issue, the paper concludes that ECHO should focus instead on establishing itself as a credible donor agency.

Decision Making, Organizational↗
PubMed1998

[A review of the European community directives relating to materials and articles intended to come into contact with food products in the light of Polish legislation].

The integration of Poland with the European Community makes the harmonization of Polish legislation necessary. Among numerous Directives, which provisions should be introduced into domestic legislation before Poland enters the European Union, the Directives related to materials and articles intended to contact with food consist a large group. The review and analysis of 17 Directives that appeared up to the end of year 1997 have been done. The list of these Directives is shown in the Table I. The framework Directive 89/109/EEC on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs have been comprehensively discussed together with the specific Directives concerning the following matters: symbol which should accompany the materials and articles intendet to contact with food: Directive 80/590/EEC; plastics materials: Directive 90/128/EEC with later ammendments provided by the Directives: 90/128/EEC, 93/9/EEC, 95/3/EC and 96/11/EC; vinyl chloride monomer (acceptable limit and analytical method): Directives: 78/142/EEC, 80/766/EEC and 81/432/EEC, regenerated cellulose film-Directives: 93/10/ECC i 93/111/EEC; ceramic articles: Directive 84/500/EEC; testing migration of constituents of plastic materials-Directives: 85/572/EEC and 82/711/EEC with later ammendments: Directives: 93/8/EEC, 97/48/EC, The relevant Polish regulatory provisions concerning the matters related to materials and articles intendet to contact with foodstuffs have also been discussed. The need for harmonization of Polish regulations with the relevant legislation adopted by the Member States of the European Community was emphasized.

Humans↗
PubMedDate not supplied

The role of the Community Bureau of Reference in harmonizing compliance with the laws of the Commission of the European Communities.

While Community Directives provide the legal basis for the harmonization of national regulations (e.g. food quality, quality of plastics in contact with foodstuffs, etc.), their implementation sometimes requires measurements and analyses which are beyond the capabilities of many laboratories. The BCR Programme of the Commission of the European Communities has undertaken a series of actions in order to help with the implementation of Directive 90/128/EEC for plastics materials intended to come into contact with foodstuffs. The certification of the overall migration characteristics of a polyamide material in aqueous food simulants by total immersion is well advanced. This material will be available through the BCR Programme in 1993 and will allow the laboratories to check their correct application of the normalized method and will provide a basis for laboratory quality assurance. A project is in progress for the preparation of a reference material for the measurement of overall migration by total immersion in olive oil. The preparation of a bank of monomers in the positive list of the above Directive and a handbook of physical and spectroscopic data for these monomers has been supported. Projects are being prepared for supporting the development of methods for the analysis of more than thirty monomers with restrictions in the positive list of Directive 90/128/EEC.

European Union↗