[“REPLACEMENT METHODS TO ANIMAL TESTING” AS THE INCENTIVE TOPIC OF THE GERMAN MINISTRY OF EDUCATION AND RESEARCH. SELECTED RESULTS ON BIOLOGICAL DRUGS].

Since 1980, BMBF, in co-operation with the appointed project representative BEO (Biology, Energy, Environment), supports research projects with the central goal of the reduction of animal testing. Beginning with the announcement about promoting “Projects in Replacement Methods to Animal Testing” in 1984, a separate incentive topic of research was fostered within the framework of the biotechnological program of the German Federal Government. It is being updated continuously by current reports. The BMBF incentive topic represents the largest and longest running support activity in the field world-wide. During a time-span of 20 years, about 14 million German Marks (approx. 7 millions per annum) were provided, supporting about 230 projects. To date, all applications judged favourably in regard to contributing to potential and substantial savings could also be funded.

The incentive topic is being realised in accordance with the 3R principle, following Russel and Burch. Primary attention is given to tests with high levels of stress or involving large numbers of animals. At present, special attention is given to the development and validation of alternatives to animal testing which are required by law. Emphasis is also put on joint projects by testing and regulation authorities together with industrial users in order to broaden the application of these methods and to aid in accelerating the amendment of respective legal regulations.

The BMBF continues to adhere to the objectives of the emphasised support and will furnish funding at the present level in the future. Also, together with representatives of testing- and regulating authorities, of industry, science, respective federal authorities and animal protection, the BMBF has developed a new concept to expand funded activities in the future to include animal testing in basic research in a target-fashioned structure. This will be published shortly through a new public announcement.

As a complement to the present application procedure (“bottom-up-principle”), new research approaches are being prepared within a limited scope regarding particularly relevant topics (i.e. transgenic animal models) as a “top-down-principle” by means of workshops and accompanying studies. Additionally, reports are appearing concerning the results of selected projects supported by the emphasised support of the BMBF for “Biologica”, particularly regarding the realisation of results in the practical reduction of animal testing. The BMBF is supporting a total of 27 projects with respect to “Biologica”. Central to the majority of these projects (21) is the test of vaccines, and there in particular, the potency test of particular vaccines. Using four examples, it is being demonstrated that the practical translation of the results of projects always requires the co-operation of the respective partners, and that the complete application of suitable replacement methods usually becomes possible only after the conclusion of a phase of development and testing of several years.