German animal welfare act in breach with Directive 2010/63/EU.

The German Federal Administrative Court recently announced an order (finalized on January 20, 2014) on the neurobiological experiments on primate brains of Prof. Kreiter at the University of Bremen. With this order, a preceding court decision by the Higher Administrative Court of Bremen was established as final and absolute and the last glimmer of hope to end the suffering of the primates in Bremen was extinguished. The court decision had claimed the experiments to be ethically justified. The Federal Administrative Court upheld the court decision and issued the order on the grounds that due to the phrasing of both the former and the current German Animal Welfare Act, authorities had no entitlement to assess the ethical justification of an experiment, but were obliged to approve an application if all formalities were complied with. The impact the order will have on the authorization of animal experiments and testing in Germany caused an outrage in the animal welfare community.

Guidance on determining indispensability and balancing potential benefits of animal experiments with costs to the animals with specific consideration of EU directive 2010/63/EU.

Within the context of a workshop, a concept and practical guidance were developed that seek to balance potential benefits of animal experiments to humans, other animals, and the environment against the pain, suffering, and distress caused to the experimental animals. The aim was to achieve transparent decisions that can be communicated in a concise manner that is accessible to a layperson and is in accordance with German national law and EU Directive 2010/63/EU. The steps of the resulting decision process deal with the classification of procedures into the four severity levels, the consideration of humane endpoints, determination of the indispensability of the procedure on the basis of sound scientific argument, classification into applied or basic research, determination of the probability of success in the case of applied research, and the cost-benefit analysis, culminating in a decision on the approval or denial of the procedure.

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing.

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science.

[Revision of the EU Directive 86/609/EEC: results of the Internet consultations of the European Commission]. / Ueberarbeitung der EU-Richtlinie 86/609/EWG Ergebnisse der Internetbefragungen der Europaeischen Kommission.

In the context of the process of revising EU Directive 86/609/EEC on the protection of animals used in experiments, the European Commission conducted a public internet consultation for EU citizens in mid-2006. Simultaneously, the Commission requested opinions from experts on specific animal welfare issues. The results of both consultations were published in the internet in December 2006. An overwhelming majority of EU citizens answered that the protection of laboratory animals currently is poor and that efforts are needed to improve the level of welfare for these animals. Additionally, they request increased transparency and public participation in the determination when and how the use of animals in experiments is to be considered acceptable. They also asked for an increased promotion of the research for replacing animal experiments. Amongst other issues, the experts called for an extension of the scope of the Directive to also cover animals used in basic research and the establishment of a compulsory authorization procedure which should include a concrete ethical review process. The estimations put forward on the consequences of introducing a retrospective analysis of projects with animal experiments were controversial just as the opinions submitted regarding different options regarding a ban to using wild caught primates and their direct offspring. All in all, both the responses of the citizens and experts consultations are a promising basis to justify the need to improve the protection of animals used in experiments within the EU.

A survey concerning the work of ethics committees and licensing authorities for animal experiments in Germany.

In 2006, the German Animal Welfare Federation started its 3rd survey since the establishment of ethics committees for animal experiments according to the German Animal Welfare Act in Germany in 1987. As animal welfare has been included as a "state goal" in the German constitution in 2002, the present survey aimed at an analysis of specific changes within the licensing process. A series of other aspects of the work of ethics committees and licensing authorities was also examined. The survey was based on questionnaires that had been addressed to licensing authorities and members of ethics committees. One of the main results is that the importance of animal welfare within the licensing process, after inclusion of animal welfare into the German constitution, has not changed or changed only to a small extent. It also becomes clear that ethical parameters are still of minor importance when animal experiments are licensed. The findings underline the importance to reform the German authorization system for animal experiments. The pending revision of EU-Directive 86/609 is an opportunity which should not be missed in this context.

[EU-Cosmetics: timetables for the replacement of animal experiments]. / EU-Kosmetik: Zeitplaene fuer den Ersatz von Tierversuchen.

According to the 7(th) Amendment of the Cosmetics Directive the European Commission had to establish timetables for the phasing out of the various animal tests for the safety evaluation of ingredients used in cosmetics. However, the published timetables do not reflect the objectives of the 7(th) Amendment but contain longer deadlines for the ban on animal experiments of several endpoints. The European Commission also had to draw up a Directive for establishing an Annex IX that should list validated alternative methods which are not already listed in Annex V of the Dangerous Substances Directive. Although various alternative methods could have been listed in this Annex IX, the Commission published an empty table. From the point of view of the German Animal Welfare Federation amendments of the timetables and the Directive establishing Annex IX are urgently required. Additionally, the Commission has to provide optimal conditions for the replacement of alternative methods.

[About animal experiments for a face without wrinkles]. / Uber Tierversuche zum faltenfreien Gesicht.

Botulinum toxin, a nervous poison produced by bacteria, is increasingly being used - besides its medical application - as a beauty product for smoothing facial wrinkles. It is unknown in public that each batch of the toxin has to undergo a quality control before marketing. The test used is a LD50 test using mice that is very animal consuming and causes extreme suffering. Although several alternative methods exist, none of these are have yet been adopted by the European pharmacopoeia. Consumers in the EU do not accept animal experiments for cosmetic purposes. However, Botulinum toxin does not fall under the definition of a "cosmetic product" and therefore the bans on animal experiments laid down in the EU Cosmetic Directive do not apply. Therefore on a short term scale, only the voluntarily renouncement of the use of this toxin as an anti-wrinkling agent can prevent the suffering and death of animals for a beauty product.

EU sales ban on new cosmetics tested on animals: impact on alternative methods, WTO implications and animal welfare aspects.

In 1993, the European Union (EU) adopted Directive 93/35/EEC, calling for a sales ban on new cosmetic products containing ingredients tested on animals after 1 January, 1998, provided that alternative methods had been developed by then. In May 2000, for the second time, the European Commission postponed that ban. The Commission justified the repeated postponement of the sales ban by saying that no animal-free methods were available, although three in vitro methods were scientifically approved in 1997. With three years delay, these methods have been published and therefore "made available" in the EU. OECD acceptance is still awaited. Another reason for the postponement was the fear of possible World Trade Organisation (WTO) conflicts. However, according to WTO rules, the protection of public morality or animal health could justify a restriction of the free trade principle. From the animal welfare point of view, an unqualified EU sales ban, combined with an animal testing ban, would provide the incentive to further promote the development and acceptance of alternative methods and to prove that ethical standards are legitimate concerns under WTO rules.

[Monoclonal antibodies: in vivo- and in vitro-production in laboratory scale with consideration of the legal aspects of animal protection]

Monoclonal antibodies are valuable tools in medical and biological research which can be used for identifying, characterizing and purifying medically and biologically important substances. Due to their high specificity monoclonal antibodies are more and more used in the diagnosis and therapy of infectious diseases and tumor illnesses. Large amounts of antibodies are needed for use in these areas and this necessitates mass production (g - kg range). Many production systems and possibilities for optimizing mass production have been described. In contrast, at universities and other research institutions the production of monoclonal antibodies in laboratory scale (mg range) is still carried out mostly in the ascites mouse. This article described our own experiences and results with the in vitro production in mg range. Using the German animal protection law (22.8.1986) as an example the legal aspects of animal protection in the production of monoclonal antibodies are discussed. In addition the legal regulations in Switzerland and the Netherlands are presented.