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At least 19 recordsLinked to original sources
PubMedDate not supplied

The role of ECVAM in promoting the regulatory acceptance of alternative methods in the European Union. European Centre for the Validation of Alternative Methods.

The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.

Animal Testing Alternatives↗
PubMed2005

Scope and patterns of tourist injuries in the European Union.

European Union (EU) countries are among the leading tourist destinations in the world. Despite growing consumer demands on the safety of travelling, injuries amongst tourists remain an essentially invisible problem. Unique national and regional data sources are the only means by which the important negative impact of injuries on the health of non-domestic tourists in the EU-15 is underlined. With an estimated number of 3800 tourists dying each year, injuries account for up to 30% of fatalities during vacation. This toll reflects an increased risk of mortality in tourists compared to the domestic population. Amendments to national and EU health and injury monitoring are suggested in order to enable authorities to examine personal risks to travellers in more detail.

Adolescent↗
PubMed1997

Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group.

OBJECTIVES: This survey was conducted to assess the attitudes of medical practitioners in the European Union regarding their national spontaneous reporting scheme, to identify reasons for under-reporting and to determine what steps might be effective in increasing reporting rates. National spontaneous reporting schemes rely on health care professionals reporting individual cases of suspected ADRs to a central or regional agency. National schemes, however, vary considerably and reporting rates and patterns differ between member states. Accumulating evidence suggests that doctors' attitudes to national ADR reporting schemes are significant determinants of reporting rates. METHODS: A self-administered questionnaire and letter of invitation was sent to a random sample of approximately 1% of medical practitioners in each of nine EU member states (Denmark, France, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden and the UK). One month later, a reminder letter and a second copy of the questionnaire was sent to the non-responders (except Denmark and Italy). RESULTS: Response rates, and the percentage of responders who stated that they had reported previously an ADR, varied substantially between countries. Issues that appeared to discourage reporting included lack of availability of report forms; the address or telephone number of the reporting agency; lack of information on how to report; and not having enough time to report. Issues which did not apparently discourage reporting included concern about patient confidentiality; fear of legal liability or appearing foolish; reluctance to admit that harm had been caused to a patient; and ambition to collect and publish a personal series of cases. CONCLUSIONS: The results of this survey demonstrate some of the advantages and disadvantages of transnational, multilingual studies of this type, but indicate that there is scope for the further development of such techniques and their use on a wider basis in the EU and elsewhere.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Legislative requirements for the identification and traceability of farm animals within the European Union.

European Community (EC) legislation requires identification and registration of bovine, ovine, caprine and porcine animals. For intra-Community trade, bovine animals must be accompanied by a passport and the required health certificate, and identified by a tag on each ear. The principles of active identification of bovine animals (by ear tags) and of ovine, caprine and porcine animals (by ear tags or tattoos) are harmonised within the EC. International passports are issued and recognised only for registered Equidae. The life-number was introduced as an instrument to allow uninterrupted identification of Equidae using passports. The principles of issuing and recording such numbers have been outlined by the affected industries, but require official approval. Active identification of Equidae using electronic devices is not regulated by EC legislation, but research in livestock is underway.

Animal Husbandry↗
PubMed2001

[Human cloning in the activities of the European Union].

The European Union has been concerned with human cloning since the late 80. It resulted from inclusion of biotechnology into the sphere of European integration. The attitude of the European Union in the domain of human cloning was shaped, in principle in the second part of the 90. As the Community law stands at present, the European Union is not able to regulate all aspects of the cloning of human beings. It has no general power to decide in that sphere, especially, as far as bioethic aspects are concerned. The cloning of human beings in the European Union is understood as a process aiming at producing new human being, genetically identical with another live or dead human being. Thus the notion of human cloning is reduced to reproductive cloning. Three instruments are at the disposal of the European Union in the domain of human cloning. The first is prohibition of reproductive cloning as a general principle of Community law. However, that principle is not the result of judicial activity of the European Court of Justice (as general principles normally are), but the logical consequence of views formally expressed by the European Parliament, the Council of the Europe as well as the Commission. The principle was finally included in the Charter of fundamental rights of the European Union. The second instrument is an imperative prohibition of patent granting to biotechnological inventions on human reproductive cloning. Last, but not least, the Union applies a prohibition of financing scientific research connected with human cloning from the budget of the European Communities within the V Framework Programme in the field of research and technological development.

Bioethics↗
PubMed1998

Childhood immunisation in the European Union. Confederation of European Specialists in Paediatrics (CESP).

Harmonisation of working conditions is one of the major aims of the European Union. The Confederation of European Specialists in Paediatrics has elaborated documents on the harmonisation of immunisations in 1987 and 1992. The new and completely updated version focuses on the variations of immunisation practices and schedules and gives criteria for minimal agreement of immunisation schedules among the member countries. Catch-up vaccinations and false contra-indications are especially stressed.

Adolescent↗
PubMed1997

[Is it possible (and desirable) to administer a standard for an effective health policy for the European Union?].

The European Union has a formal interest in public health under the Article 129 of the Maastricht Treaty. Hitherto, the main contribution of the European Union action in public health has been limited to research, health information and education concerning, in particular major diseases and drug dependence. Unfortunately the European architects did not clearly conceive a plan for the establishment of a common health policy despite the fact that the European health policies are fragmented and are often the indirect results of economic policies. Indeed, the domain of public health is essentially governed by the principle of national sovereignty, onto which the principle of subsidiarity has been grafted. Whereas Article 129 of the Maastricht Treaty applies especially to preventive health policies, the concomitant affirmation of the principle of subsidiarity in this field tends to suspend any establishment of a European health policy. In the same way, the lack of compulsory provisions relating to Community actions, expressed as recommendations, raises the question whether the European Union is willing to move to a European health policy.

Europe↗
PubMed2002

The practice of clinical chemistry in the European Union.

The European Communities Confederation of Clinical Chemistry has been actively engaged in raising the level of clinical chemistry in the European Union. Closer contacts between the national societies for clinical chemistry have resulted in more comparable programs for postgraduate training of clinical chemists, closer similarity of contents and practice of the profession in the different countries, and the official registration of professionals. This article reviews some of the characteristics of professional organisation, practice, and regulation in the fifteen European Union countries. Many similarities appear. In half of the countries microbiology, blood-banking and transfusion medicine fall within the domain of clinical chemistry. The minimum number of years for training (university and postgraduate) is eight, but in practice this will extend to 10 or more years. Official regulation of the profession by law exists in a minority of countries. Continuing education and re-registration have not been officially instituted yet in any country, but these issues will be the next steps forward. In those countries that prepare themselves for entering the European Union, training and practice of clinical chemistry are moving towards the common standards of the European Communities Confederation of Clinical Chemistry.

Chemistry, Clinical↗
PubMed2001

Integrative efforts in occupational safety and health in the European union.

The European Union has had a long tradition in developing a common European social policy from its beginning. A milestone to European social policy in the field of occupational safety and health was the Single European Act in 1986. With this Single European Act the improvement of the work environment became an explicit objective of the community. Since that starting point several legislative and nonlegislative actions have been taken to face the huge challenges of globalisation with a targeted social policy. The aim of this policy is to reconcile the interests of the employers in productive and competitive workplaces with the interests of the employees in healthy working conditions.

Employment↗
PubMed2005

An ethical framework for stem cell research in the European Union.

The European Union is a nightmare from the perspective of the ethics and regulation of science. A hitherto insoluble problem has been the task of drafting ethical principles which do not founder on the radically different attitudes taken to the question of the moral status of the human embryo. Following the conclusions reached in an international project, EUROSTEM, we suggest that this problem can be solved by concentration on the scope of principles and we emphasize that European research should be funded in a way that does not discriminate between individual states and researchers in the EU. Finally, we observe that the availability of any eventual embryonic stem cell therapies will pose a dilemma for those countries and those people that have declared stem cell research to be unacceptable.

Embryo Research↗
PubMed2003

Regulatory recognition of indirect genotoxicity mechanisms in the European Union.

The European Union (EU) system for the regulation of chemicals includes approval systems for pharmaceuticals, pesticides and biocides, requirements for hazard classification and for risk assessment of industrial chemicals. Regulators have traditionally used the commonly accepted categorisation of chemicals into genotoxic (DNA-reactive) or non-genotoxic agents in their decision-making processes, and have generally considered that there is no threshold level for the former group. The recognition that a number of genotoxic agents operate by indirect genotoxicity mechanisms such as induction of aneuploidy, oxidative stress, inhibition of DNA synthesis or cytotoxicity presents new problems for the regulator. The dose-response relationship for a number of such agents is generally accepted to show a threshold, however, the degree of acceptance of the threshold effect differs in different EU regulatory systems. The classification system for mutagens is based primarily on intrinsic hazard rather than risk, and the classification criteria do not allow for a less stringent classification for chemicals operating by a threshold mechanism. In contrast, regulatory approval systems for plant protection products and therapeutic agents are based on a risk assessment approach, in which a demonstrated threshold effect for a genotoxic agent is likely to be an important factor in reaching a decision concerning authorisation of the product.

Animals↗
PubMed2000

The single market for pharmaceuticals in the European Union in light of European Court of Justice rulings.

This article analyses the likely implications for the European pharmaceutical market of 2 European Court rulings (Kohll and Decker) and addresses whether these will contribute to the completion of the single European market. In doing so, the Kohll and Decker cases are discussed and the likely implications of these cases for key stakeholders (patients, providers, payers and the industry) are investigated. Of the 2 cases, the latter has direct application to pharmaceuticals as tradable goods. The article argues that the short term implications for the stakeholders, relating to the freedom of providing goods, may lead to a re-thinking of how pharmaceutical products are financed and provided in European Union (EU) countries in the long term. A key corollary of the Decker case is that it leads to greater transparency and awareness of pharmaceutical price differentials across the member states. As part of this transparency, consumers may benefit directly by gaining access to a product that may not be available in their country of residence, or may be available but at a higher cost. Consumers may also benefit indirectly through greater transparency and efficiency in the long term. Providers may wish to increase their procurement from cheaper sources of the same product and much will depend on their future procurement strategies. Manufacturers will in this case face an increase in parallel trade streams and may respond by not marketing or producing in 'low-price' countries. The rulings add a further supranational dimension to a national policy issue and may have far reaching implications for the EU pharmaceutical market and industry.

Drug Industry↗