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Vaccines constitute an essential tool for animal health management. In addition to applying traditional vaccine development strategies to new or changing pathogens, the use of innovative approaches in this area is increasing. Recombinant vaccines often have superior safety and efficacy profiles, due to their specific attenuation and the ability to serologically distinguish vaccinated from infected animals. The more detailed understanding of the immune system has also enabled the development of immune-based therapeutics, ranging from immunological castration to tumor therapy, and cell-based therapies for the treatment of cartilage or tendon injuries are increasingly used. In many of these cases, veterinary medicine applications provide important insights for future use in human patients. The associated regulatory challenges lie on the one hand in the integration of the innovative approaches in the existing national and EU legislative framework, and on the other hand in the development of appropriate criteria to evaluate their safety and efficacy. The promotion of innovative products has to be balanced with the safety of the target population as well as contact species and, in the case of food-producing animals, food safety. From the regulatory perspective, simplified licensing procedures represent an attractive alternative on the national level.

The Animal Health Act that replaces the Animal Disease Act, which is currently in force, creates a regulatory framework in order to not only, as has been the case so far, control animal diseases that had already broken out, but in order to already prevent in advance possible outbreaks of animal diseases by means of preventive measures. The instruments to this effect are described here. At European level, too, the idea of prevention is set to play a greater role in the future, with the draft EU legal instrument on animal health, that has to date only been discussed at Commission level, also contributing to a simplification and easier implementation by the persons subject to law by harmonising the currently fragmented Community law. It remains to be seen when the deliberations in the Council and European Parliament will begin.

In 2002 the current legal concept for animal protection "Ethischer Tierschutz" (ethics based animal protection) was declared a national objective in the Federal Republic of Germany. One of the aims laid down in the bill is to assure an ethical minimum (ethisches Mindestmass). An updating of and 7 Section 3 and and 17 No. 2b of the German Animal Welfare Act in compliance with the constitution and EU legislation could abolish the legal exception (regarding animal experiments) to the ban on inflicting "longer periods or repeated actions of severe pain or suffering". In this way an overall limit for causing severe harm to animals in any type of use, which is strongly demanded on the part of ethics, would be established, and this would equal an ethical minimum.

BSE was established for the first time in 1986 as a separate disease complex. Since 1989 measures to protect human and animal health have been adopted at Community level and under German law. The article describes the most important provisions governing the prevention, control and eradication of TSE. It addresses in detail the ban on feeding, active monitoring of BSE, active monitoring of small ruminants, measures taken after the detection of BSE, the removal and destruction of specified risk material and briefly addresses trade bans and restrictions.

The eradication of bovine tuberculosis and brucellosis of domestic stock in Germany through the combined efforts of veterinary medicine, the agricultural section and the state was an historic achievement. Since the two diseases are zoonoses, their successful control can also be seen as a valuable contribution to public health. Both these zoonoses are classic animal diseases presenting themselves as clinical entities complete with gross pathological lesions. In contrast, today we are confronted with pathogens causing zoonoses characterised by latent, i.e. clinically inapparent herd infections that do not result in visible tissue changes. Nevertheless, through contaminated foodstuffs, these pathogens contribute to food-borne infections leading to the outbreak of genuine zoonoses in humans. It has been estimated that there could be as many as two million cases of food-borne infections annually in Germany. Among them are salmonellosis, campylobacteriosis, yersiniosis, infections with verotoxin producing E. coli, listeriosis and toxoplasmosis. While the national animal disease legislation only foresees the control of notifiable diseases, the basis for zoonoses control is laid down in the EU Zoonosis-Directive, which is presently awaiting its transposition into national law and into practice. In order, for instance, to combat the most important Salmonella infections of humans, Integrated Quality Systems (IQS) have been formulated as a means of implementing the proven HACCP concept in animal production units and ensuring animal health from the point of view of consumer protection. The aim of all measures must be to free infected herds of pathogens, to investigate and eliminate all sources with a potential for further pathogen introductions, to maintain pathogen-free herds--with a reduced pathogen challenge in mid-term time periods--, as well as to develop diagnostics capable of identifying pathogen carriers before slaughter. For the disinfection of stock, it is important to have epidemiological data collecting systems and information systems that allow complete diagnostic tracing from herd to slaughterhouse and vice versa. All sides, including research and surveillance, as well as producers are called upon to actively share in protecting the health of consumers as far as it is threatened by latent infections in domestic stock.