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Ursula G Sauer

Publications and source records attributed to Ursula G Sauer.

11 recordsLinked to original sources
PubMed2006

[The use of transgenic animals in biomedical research in Germany. Part 2: Ethical evaluation of the use of transgenic animals in biomedical research and perspectives for the changeover in research to research animal-free methods].

As a rule, transgenic animals are being used in in vivo experiments to examine gene functions, their regulation or the contribution of genetic alterations to the development of diseases. Many transgenic animals already are affected in their wellbeing due to the genetic modification alone regardless of the procedures performed with them. Moreover, it is to be questioned whether the experimental use of transgenic animals led to results that were of such outstanding scientific relevance that they legitimated the suffering of the animals. In order to point to possible approaches to avoiding the use of transgenic animals in the areas of research identified, subsequent investigations aimed at collecting information on non-animal test methods that might be applied in pursuing the aforesaid questions. In particular, these were non-animal test methods that make use of genetic techniques. Amongst these are in vitro cell culture methods with genetically modified cells, such as the so called Transfected Cell Array, as well as in vitro test methods, in which specifically targeted genes can be turned on or off selectively for example by the so-called RNA interference technique or by antisense oligonucleotide genes. Since such technologies can also be applied to cell cultures with human cells, investigations with these methods enable direct information on the function of human genes. Even though a one to one replacement of animal experiments with transgenic animals by non-animal test methods is considered unlikely, from the point of view of animal welfare the broad spectrum of already available non animal test methods with which to study the function of genes and genetically caused pathophysiological reactions proves that waiving of animal tests with transgenic animals is possible without impeding biomedical research. Even if it cannot be totally excluded that some very specific questions linked to the respective animal experiment might not be pursued for the time being, nevertheless research that would be restricted to modern and ethically acceptable in vitro test methods would certainly conceive its very own questions to pursue and solve the problems currently faced by biomedical research. It is against this background that it is to be welcomed that the German Federal Government currently actively promotes the further development of genetechnological non-animal test methods. In order to ensure that these funding measures will make an effective contribution to reducing animal experiments, as spelled out by the government itself, the conversion of genetechnological research, just like biomedical research as a whole, to non-animal testing methods should be supported by concrete political actions. From the point of view of the German Animal Welfare Federation the following issues are to be requested: (1)In order to enable a fast and comprehensive advancement of promising genetechnological non-animal test methods, it should be ensured that public funding is provided with an adequate budget and over a sufficiently long period of time. (2)The legislator should initiate broad discussions on the question if society would be willing to dispense with certain pieces of knowledge if they would necessarily have to be gained at the expense of a certain degree of animal suffering. As the case may be, in the German Animal Welfare Act it should be laid down that certain procedures should not be considered acceptable as such. (3)As long as animal experiments with transgenic animals continue to be performed, concrete legal measures should be laid down in the German Animal Welfare Act to ensure that the distress of the animals (taking into account all factors relevant for transgenic animals) and the expected benefit of the research project are determined objectively so that the outcome of the ethical evaluation process becomes comprehensible. (4)The legislator should provide the authorities responsible for the licensing of research projects with concrete instructions in order to ensure that all aspects relevant for the welfare of the animals are fully taken into account when evaluating the ethical acceptability and scientific indispensability of projects and that special attention is given to research projects with transgenic animals. (5)The German Decree on the Reporting of Laboratory Animals should be amended to ensure that all individual transgenic animals are included in the official statistical reports regardless of whether they end up being used in scientific procedures or not. From the point of view of animal welfare it is possible to redesign biomedical research to do without transgenic animals without impeding necessary scientific progress. The survey in hand sought to make a contribution to providing a scientifically sound background for initiating these discussions.

Animal Testing Alternatives↗
PubMed2006

[The role of animal testing advisory committees in biomedical research in Germany].

In accordance with the German Animal Welfare Act, animal experiments in fundamental biomedical research may only be performed after licensing by the responsible authority. This license may only be granted if the experiments are considered indispensable and if the distress of the animals seems ethically acceptable in relation to the purpose of the study. Since 1987 advisory committees have been established to support the authorities in the evaluation of these provisions. Animal welfare organisations had expected case-by-case evaluations of the in-dispensability of research proposals and of the distress of the animals and the scientific benefit of the experiments to take place in these committees, so that such projects that would not meet the criteria of ethical acceptability could be prevented. However, already the lack of parity in the advisory committees alone, in which as a rule four scientists counterpart two representatives from animal welfare organisations, often-times prevents a balanced discussion of these provisions from taking place. Additionally, due to the freedom of science granted in the German Constitution without reservations, until 2002 also the licensing authorities were merely permitted to perform a formal examination of the applications. In the mean time, by including animal welfare as a national objective in the Constitution, the preconditions were made to enable an examination of the contents. From the point of view of animal welfare it therefore is to be requested that now also the advisory committees are ascribed more importance in the course of the licensing procedure and to establish the legal framework for this, if necessary by a revision of the Animal Welfare Act.

Advisory Committees↗
PubMed2005

Animal vs. non-animal tests for the monitoring of marine biotoxins in the EU.

Since bivalve molluscs can contain algae biotoxins that can cause gastroenterological or even lethal neurological diseases in humans, a public health control system on marine biotoxins has been implemented in EU Directive 91/492. Currently, the reference method laid down for this purpose is the so-called "mouse bioassay" with death of the animals as an endpoint. To date, this extremely distressful animal test has not been standardised or validated, and there is scientific evidence that it is neither relevant nor reliable. Therefore different EU Member States have been striving to replace the mouse bioassay or to reduce the animal numbers and the distress for the animals. In the United Kingdom, the test is being performed with two instead of three mice, the animals are anaesthetised before injection of the mollusc extract and remain in narcosis until their death. In Germany the mouse bioassay has not been performed for many years; without restriction of consumer health safety, marine biotoxins are detected with chemical analytical test methods. The application of alternative test methods is legally required according to EU Directive 86/609 on the Protection of Laboratory Animals. Apparently there is a conflict between two equal valid EU Directives, which has to be overcome.

Animal Experimentation↗
PubMed2005

Fourth EU report on the statistics on the number of animals used for scientific purposes in 2002 -- trends, problems, conclusions.

In the beginning of the year 2005, the European Commission published the fourth statistical report on the number of laboratory animals used in the EU Member States in the year 2002. A total of 10,731,020 experimental animals was reported, the majority of which were mice, rats and fish. In comparison to 1999, the year of the previous data collection, this is an increase by over 900,000 animals, which is mainly attributed to an increased use in fish. As in the previous years, France, the United Kingdom and Germany were the Member States that reported the highest numbers of laboratory animals. 4.5 million animals were used for the development, production and quality control of products for human medicine, dentistry and veterinary medicine and 1 million animals in toxicological and safety evaluations. 3.7 million animals were used in fundamental studies, and therefore are not covered by the scope of Council Directive 86/609/EEC on the protection of laboratory animals. This regulatory gap leaving more than a third of the laboratory animals used in the European Union without protection by EU legislation is unacceptable and should be closed during a revision of the Directive. All national authorities submitted some kind of explanatory notes alongside their national tables. In the article, an extensive summary and discussion of the contents of these notes is presented. Germany, Austria, Finland report on providing financial support for the development of alternative methods. The numbers put forward in the fourth EU statistical show that such support is desperately needed.

Animal Testing Alternatives↗
PubMed2005

[The use of transgenic animals in biomedical research in Germany. Part 1: Status Report 2001-2003].

While the German Federal Government has set itself the goal to make an active contribution to reducing animal experiments, the use of transgenic animals in biomedical research continuously increases every year. It is against this background that the study at hand aimed at providing an overview over the goals and the contents of research projects performed in Germany, in the course of which transgenic animals were produced or used in experimental procedures. Specifically, it was envisaged to spell out those specific areas of research, for which transgenic animals mainly were being used. Subsequently it was evaluated whether the research goals revealed might also be pursued with non animal test methods. In a literature survey, a total of 577 scientific publications relevant for the purposes of the study were collected. This material enables conclusions on those scientific areas, in which transgenic animals are used, applying to fundamental research, but not on their use in routine procedures in applied research or for the maintenance of transgenic breeds, since such purposes do not tend to be the subject of publications in scientific journals. According to the topics covered by the publications, main areas of biomedical research with transgenic animals can be found in the fields of neurobiology, immunology, cardiology, embryology and oncology. However their use can be discerned in all other areas of fundamental biomedical research as well. In accordance with the official German laboratory animal statistics, the vast majority of transgenic animals used were mice, followed by rats and pigs. Additionally, singular research projects with fish, rabbits and chicken were recorded. (In the official German laboratory animals statistics, very small numbers of transgenic hamsters, sheep and amphibians were also recorded in the past years.) A high percentage of the rats were used in cardiovascular research, whereas transgenic pigs as a rule were produced and bred as organ donors in xenotransplantation research. The majority of research projects either dealt with the experimental use of already established transgenic animal lines, or they described that transgenic animals specifically were produced for the purpose of the respective research project. Mostly, transgenesis was initiated by inserting the foreign gene into the germ cell genome. In some research projects, it was reported that the transgenic material was inserted into normally bred animals some time after parturition.

Animal Welfare↗
PubMed2004

Avoidance of animal experiments in the new EU Chemicals Regulation - opportunities and problems from the point of view of animal welfare.

On 29 October 2003, the European Commission forwarded the "Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants" to the European Parliament and the Council for adoption under the so-called co-decision procedure. From the point of view of animal welfare it is to be welcomed that it is envisaged better to protect humans and the environment from unknown risks through chemical substances. However, in order to ensure that this goal can be met, extensive amendments to the proposed draft are requested: Instead of continuing to perform animal tests, relevant and reliable non-animal testing strategies should be implemented. Before considering testing, all existing data must be made available, shared and evaluated. This request should be enforced in the new Regulation through an adequate mandatory system. Data requirements must be tailored to the specific substance, to ensure that only such information is collected that is necessary for its safe handling by workers and consumers. Missing data should be determined with non-animal test methods. Finally, the European Union and its Member States are called to provide adequate funding for alternative method research without delay and to call for tenders on those information-gaps that currently prevent the implementation of an entirely non-animal testing strategy, so that such new methods will be available in time for application under the REACH system.

Animal Experimentation↗
PubMed2004

Third EU report on the statistics on animals used for experimental and other scientific purposes: trends, problems, conclusions.

A brief overview is given of the data published in the third report on the number of animals used for scientific purposes in the European Union (EU), in 1999. In comparison to the second EU statistical report, the meaningfulness of the data has been greatly improved, since 14 EU Member States have now used the "EU tables". Even though the total number of animals officially reported in the EU for 1999 (9.81 million animals) is lower than the number reported for 1996 in the second report (11.65 million animals), an increase in animal numbers was observed in several Member States. Repeatedly, the use of transgenic animals was considered to be the cause for this. Most national authorities provided some comments on the data they submitted. However, the quality of these accompanying notes varies considerably, with the comments provided by The Netherlands, Finland, Sweden, Austria, Denmark and the United Kingdom containing the most-detailed remarks on their data.

Animal Experimentation↗
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↗