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PubMedDate not supplied

[Availability of services for the aged in Germany and the European inland market].

Due to the Contract of Maastricht, the members of the European Community are obliged to an open-market system with free competition. Essential for the system is the freedom of movement for goods, persons, services, and capital. The consequences of the realization of the contract for institutionalized help for the elderly are tested. Objects of the investigation are the "four basic freedoms", as well as the positions of the institutions for the elderly in the market. Changes are to be expected for the free trade in pharmaceuticals, medicine technology, goods for production and consumption, and capital. The structure of personnel, of junior staff, and of the clients of the institutions for the elderly will be affected. The open-door policy for commercial activities promotes the establishment of profitable nursing care, senior homes, etc. Nevertheless, the institutions for the elderly in the Federal Republic of Germany and in all other member states of the European Community are, because of their special situation, only in limited areas open to free competition. Conclusions are drawn from the expected changes for owners, management, and staff of the institutions for the elderly, as well as for their representatives in social and economic policy.

Aged↗
PubMed1992

[Control of foodstuffs in international turnover. I. Documents of the European economic community].

Council Directive (89/397/EEC) is presented which harmonize official control of foodstuffs. The main principles are given, obligatory for the Member States, concerning control of foodstuffs, food additives and materials intended to come into contact with foodstuffs performed by home authorities. The proposal of supplementary Directive is discussed, dealing with problems of qualification and competence of laboratory personnel, introduction of quality assurance systems in the laboratories and the system of information exchange of foodstuffs within the Common Market.

European Union↗
PubMed1991

Regulation and abuse liability testing of medicines in Europe beyond 1992.

The procedures for approving medicines have been progressively harmonized within the European Community. The authorization of medicinal products beyond 1992 will be based on a more centralized procedure, with important safeguards to ensure that there is no dilution of strict standards of quality, safety, and efficacy. Although some efforts have been attempted to coordinate the procedures for approving medicines with Japan and the United States, some important problems still remain. An example of this lack of coordination is the lack of agreement about applying abuse liability testing to psychotropic drugs. In the United States, abuse liability data are routinely used for scheduling and labeling new drugs under the supervision of the Food and Drug Administration (FDA). This agency has codified the requirements for clinical studies of potential abuse of psychotropic drugs and requires pharmaceutical sponsors to submit specific data. However, requirements within the European Community in this matter are minimal. Clinical trials on subjective effects, drug discrimination or drug preference are not requested. This situation demands more scientific interchange between officials and scientists from the FDA and their counterparts from Europe. The Committee for Proprietary Medicinal Products (CPMP) must play a major role in this coordination and interchange.

Drug Evaluation↗
PubMedDate not supplied

[Temporal and spatial variations of coliforms and Escherichia coli in fluvial recreational waters (Salado River, Santa Fe, Argentina). Relationship with the quality standards].

There are no standards accepted by all the countries to fix top concentrations of microbiological indicators in recreational waters. Even now there is still a considerable discussion either in USA as in Europe. The universal application of a bacteriological quality criterion is hard due to several environmental factors that affect the relation between the indicator, the exposition and the health risks. Our purpose was to present a case study as an example of the influence of the climatic conditions in the application of the most known standards (Environmental Protection Agency of USA, Council of European Communities, World Organization of Health, and others from Canada, South Africa and Hong Kong). The pluvial rainfall increased the number of E. coli, thermotolerant coliforms (C Te), and total coliforms (CT) 6-10 fold, in comparison to the number registered during the steady-state conditions of the system. However, not all the standards included that factor. In Summer, hourly, daily and weekly variations were proved, therefore the standards that suggest fortnightly sampling frequencies would not be convenient in that system. Although the main source of variation was time, spatial variability was also detected. The percentage of E. coli among the C Te was very variable, but the average resulted low (26%) compared to the levels in temperate regions of other countries (> 90%). According to the directives proposed by the Commission of European Communities, the parameter has been changed (C Te for E. coli), but the standard has remained (2000/100 ml). Thus, the directive would be more permissive.

Argentina↗
PubMed2001

[Primary Sjögren's syndrome: clinical and immunological characteristics of 114 patients].

BACKGROUND: To analyze the clinical and immunological characteristics of a series of 114 patients with primary Sjögren's syndrome (PSS), and to evaluate the different diagnostic criteria and the association to lymphoproliferative disorders. PATIENTS AND METHOD: We included 114 patients (108 female and 6 male) with a diagnosis of PSS. All patients fulfilled the 1993 European Community criteria for the diagnosis of PSS and 76 patients fulfilled the San Diego Criteria. RESULTS: Mean age was 51 years with a mean follow-up of 7.3 years. The commonest clinical manifestation at onset (70%) was xerostomia/xerophtalmia (sicca syndrome). Extra glandular involvement was articular in 42% of cases, neurologic (35%), respiratory (21%) and hepatic (13%). Eleven patients (9%) developed vasculitis, and three (2%) developed a lympho-proliferative disorder. No statistically significant differences regarding symptoms at onset, frequency of glandular or extra glandular manifestations and severity of disease were observed between the two diagnostic criteria groups. HCV infection was associated with vasculitis (p < 0.001; OR: 20.6; CI 95%, 3.2-129) and lymphoproliferative disorders (p < 0.001). CONCLUSIONS: The clinical evolution of PSS does not vary when using different diagnostic criteria (San Diego and European Community criteria). A subset of patients with vasculitis and lymphoproliferative diseases is found to have an associated HCV infection.

Adolescent↗
PubMed1992

[Use of extracorporeal circulation oxygenators (CEC) in the European Economic Community (EEC)].

This study analyses the growth of CPB in the EEC. The study situates its position in the world taking into account several indexes such as the Gross National Product and its growth the life expectancy and other technical or economic factors. Only a broad analysis could be performed for Europe to the irregular development of CPB. A more detailed analysis was performed for France thanks to a greater number of data. In this type of study the most important problem is to estimate the relevance and consistency of the data provided either by companies or by other organizations because they can change very quickly.

Cardiopulmonary Bypass↗
PubMed1990

Population dynamics of bulk milk somatic cell counts.

The population dynamics for bulk milk SCC in 27,000 Dutch dairy farms was studied over 6 yr; SCC declined markedly in 1984 and 1985. This coincided with the introduction of the quota system in the European Community. The CV of SCC was .36, ranging from .15 to .89. Month of year had a significant effect on SCC with the highest SCC in October and the lowest in April. The dynamics of the annual SCC were modeled with a state transition model. Farmers managing herds with a fairly low SCC (less than 450,000) had a reasonable chance to remain in these states. Herds with a higher annual SCC were much more variable. The model simulated, the potential reactions of the farmers to the decrease of the SCC limit from 750,000 to 500,000 starting January 1, 1989. The simulations showed a further decrease in mean annual SCC, although the number of farms in the category with a very low SCC (less than 150,000) is not likely to increase. In all simulations an increased number of farmers will receive a penalty due to the more strict regulations of the European Community.

Animals↗
PubMedDate not supplied

[Orphan drugs and orphan diseases].

OBJECTIVES: To define the concepts of orphan drugs and diseases, the current situation of clinical investigation of them, the attitude of the pharmaceutical industry and aspects of health legislation, especially in the European Community. DEVELOPMENT: We review the history of orphan drugs, the name used for those drugs, apparatus, biological agents and dietetic preparations used to treat diseases so rare as to affect 650 1,000 persons per million inhabitants. Approximately 5,000 of such disease have been identified. Of these, 80% are genetic disorders which are very common in neuropaediatrics, since 50% appear in childhood. Half of these disorders affect the nervous system but in general there are no relative preventive and/or therapeutic methods. In view of the expense involved, the pharmaceutical industry is loath to develop products which are only used in rare diseases. Society cannot tolerate the fact that these patients do not have access to medical progress. For this reason organizations of affected persons (especially the National Organization for Rare Diseases) put pressure on the USA authorities leading to the Orphan Drug Act of 1983 which was subsequently copied by other countries. Since January 2000 there is a similar Regulation in the European Community. Orphan diseases need to be diagnosed early by specialists who have had patients referred to them by general practitioners. However, initial recognition of the disorder is often delayed and late diagnosis occurs in 45% of these rare diseases which make up 10% of human illnesses. Currently over 150 orphan drugs are being used for over seven million patients. CONCLUSION: The struggle to treat rare diseases must continue, since its true importance is shown when suffered personally.

Drug Therapy↗
PubMed1993

Extracorporeal circulation in European Economic Community (ECC in EEC): 1979-1989.

This study determines the evolution of ECC in EEC. After recollecting the great stages of ECC since its routinely use in open heart surgery, the study situates its position in the entire world taking into account several indexes like the Gross National Product (GNP) and its evolution, the life expectancy and some other factors either technical or economical. Only a coarse analysis could be done for Europe due to an unsteady evolution. A more detailed analysis has been achieved for France thanks to a greater number of data. In such a study the major difficulty is to estimate the relevance and consistency of data which can change very quickly and are provided either by companies or by other organization.

Economics↗
PubMedDate not supplied

Tobacco smoke exposure and serum cotinine in a random sample of adults living in Verona, Italy.

In this study, the authors attempted to validate answers to smoking-habit questions contained in the European Community Respiratory Health Survey questionnaire. The respondents were invited to visit the chest clinic at Verona, Italy, and their serum cotinine levels were measured. The authors invited each of 504 subjects to complete a respiratory interview and to give a blood sample for a radioimmunoassay serum cotinine measurement. A total of 375 subjects responded, of whom 129 were smokers (34.4%), 79 were exsmokers (21.1%), and 167 (44.5%) had never smoked. Exposure to environmental tobacco smoke was reported by 216 subjects (57.6% [mean exposure = 3.8 hr/day (+/- 3.4 hr/day standard deviation)]). In smokers, serum cotinine levels were directly related to the number of cigarettes smoked/day. The authors excluded from analysis nonsmokers who had serum cotinine levels that were > or = 14 ng/ml, and the resulting mean values were 1.7 ng/ml (+/- 2.1 ng/ml standard deviation) in nonsmokers unexposed to environmental tobacco smoke and 2.6 ng/ml (+/- 2.6 ng/ml standard deviation) (p < .002) in nonsmokers exposed to environmental tobacco smoke. There was a relationship between serum cotinine levels and hours of exposure to environmental tobacco smoke (R2 = .136, p < .05). Serum cotinine, which is an objective and accepted measure of tobacco exposure, confirmed the validity of the European Community Respiratory Health Survey questionnaire with respect to smoking habits and environmental tobacco smoke exposure.

Adult↗
PubMed1993

[Control strategies against salmonella infections in poultry raising at the European Economic Community level--translation of the so-called Economic Community Zoonoses Guideline].

Since at the end of the eighties there were reports on an increased occurrence in Great Britain of salmonella enteritidis infections in human beings which were predominantly caused by raw egg dishes, the Commission of the EEC also started activities designed as a protection against such an obvious new dimension of salmonella infections. Mainly prompted by British activities, the Commission of the EEC elaborated a proposal for a Zoonosis Directive of the EEC. This proposal was intended to provide for the recording of data on specific zoonoses and their pathogenic agents--i.e. a monitoring--as well as for the measures to be introduced at Community level or in the member states. The Directive was adopted in the Council of Ministers of Agriculture on 17 December 1992 (Directive 92/117/EEC), it is to be translated by a poultry salmonella regulation of the Federal Ministry of Food, Agriculture and Forestry. It will provide for controls by the farm manager, for official controls as well as for official measures including f.i. a quarantine of the poultry stock and a killing of the fowl. Beginning in 1995, there will probably be reports on EEC measures in the feeding stuffs sector (microbiological controls) as well as on national hygiene measures in the fields of egg marketing, raw egg consumption in canteens and voluntary control in laying hen farms--in anticipation of an EEC regulation on these stocks.

Animals↗
PubMed1992

[Cooperation of veterinarians in legislation in the area of environmental hygiene (Germany and the European Economic Community)].

After a brief exposition of the tasks about the protection against chemical, physical, and biological environmental risks, a demonstration will be given according to deliberations of our law system about the possibilities for veterinarians to cooperate in the legislative branches. A detailed examination on former activities in the fields of pollution and the food-chain are to serve as a model for the future legislative process in Germany with the intention to strive for a harmonization of the in parts independently developed legislative branches. The external harmonization, a long-term objective, is to be found in the form of an uniform environmental law. Veterinarians take a great interest to work in advance for this uniform law in the way they bring new perspectives by cooperating in the fields of environmental hygiene and toxicology for the protection of the environmental media, of species and the food-chain. In conclusion one finds a brief documentation about the impact of the adaptation of law and the process on the EC-level.

Environmental Health↗
PubMed1991

[Perspectives on veterinary infectious disease control in the European Economic Community].

The internal market of EC from 1993 is a provocation for the veterinary services of the member states to prevent dangers by animal infectious diseases and zoonoses in a big territory without borders. The systems for the control of animal infectious diseases, transport and trade have to be adapted and the veterinary services, especially on the local basis, will have more responsibility, they will be in action more as in the past and more intensive too. Primary aim is to reach a high uniform animal health level in the whole community. This requires more burden, strong and consequent measures as till now in the concerned region or member state. The control of infectious diseases in EC will stay on three big column --uniform measures for protection against animal infectious diseases, --common system for the control within the EC, --common control system on outside borders of EC for import from third countries. The already accepted and applied principle of regionalization will get essential importance. EC will participate in financing the control of animal infectious diseases particularly of very dangerous diseases, but also in certain control- and surveillance-programs. The veterinary controls on the internal borders in EC up to now will be replaced by controls at the place of origin and the place of destination. Imports from third countries will be controlled on outside-borders of EC.(ABSTRACT TRUNCATED AT 250 WORDS)

Animal Diseases↗
PubMed1991

[Comparative studies of fresh and seawater for the determination of total coliform and fecal coliform bacteria according to the European Economic Community guideline 76/160 (bathing water) by the use of the most-probable-number method with BRILA-MUG broth and differentiation according to the drinking water ordinance].

During the summer season of 1989 about 222 samples of bathing water (Northsea, Baltic Sea and inland waters) were investigated, i.e. 2 times 1998 dilution tubes (1501 positive) were tested. Results with BRILA-MUG and lactose-bouillon were compared and additional 97 samples were tested with one respectively three colonies by confirmative tests. -- The BRILA-MUG one-tube-test (gas, fluorescence and indol) has as expected larger numbers of total coliforms (GC) and faecal coliforms (FC) in comparison with corresponding numbers for E. coli and coliform bacteria according to German law for drinking water (TrinkwV). -- BRILA-MUG and lactose-bouillon with the same identification mode according to "TrinkwV" has corresponding results concerning E. coli and coliform bacteria. -- Following the identification mode according to "TrinkwV" the total coliforms (GC/gas in BRILA-MUG) depending on the origin proved 60-80% as coliform bacteria. Additional API-tests showed that the other bacteria are coliform bacteria too or bacteria which can be considered as indicators for water pollution. -- Faecal coliforms (FC/fluorescence and indol-positive) depending on the origin proved 70-90% as E. coli, if following the identification mode according to "TrinkwV". Using 3 instead of 1 colony per positive dilution tube for identification the positive results increased approximately by 9%. 15% of negative results with the identification mode according to "TrinkwV" proved as E. coli-positive with identification according to API-system, i.e. the corresponding rate of E. coli-positive tubes will therefore be higher than shown above. The BRILA-MUG one-tube-test in connection with the MPN-method can be used successfully to determine the number of total and faecal coliforms according to the EEC-directive for bathing waters. The test needs only a minimum of material and also a minimum of laboratory staff. Differences between this test and other more extensive tests with several biochemical identification steps are negligible. The work load for bathing water tests would not be justified in this case.

Bathing Beaches↗
PubMed2005

A pilot ontological model of public health indicators.

UNLABELLED: There are various public health databases in the world aiming to provide data to compare health conditions in different countries. Their data sets are more or less overlapping but data from different databases and different countries are hard to compare due to different definitions and interpretations. Our aim was to create a core ontological model that is able to represent public health indicators. We assumed, that by such representation comparability and quality of data could be improved. METHOD: Three sets of indicators were taken, and a core ontology was built from information objects describing their top level entities. The Protégé ontology editor with RDF backend was used for building the ontology. The used indicator sets were the indicators of the Health for All Database of the World Health Organisation (HFA), the OECD Health Data, and the set of indicators proposed by the European Community Health Indicators (ECHI) European project. Then 19 indicators selected from HFA was represented using the core ontology. Strength and weaknesses of the descriptive capability of the model was studied. RESULT: The drafted core model seems to be useful in representing many of the public health indicators. In some cases it really helps improve comparability. However, some of the semantic details cannot be sufficiently expressed by the used ontology representation language. There is a need of merging other domain ontologies to represent indicators related to other domains, such as economy, social and environmental sciences.

Databases, Factual↗