In vitro tests are basically used for research or legislative purposes. hence, any effort to reduce, replace or refine the muber of animals used should address these two areas. Unfortunately, however, many people think that allocating sufficient money to research on in vitro tests will automatically result, at the end of the day, in in vitro tests that are useful in research and can be used to comply with regulatory requirements. The first assumption is more or less true, as witnessed by the fact that many in vitro tests are currently used in academia and industry for research purposes. The second, use for regulatory purposes, is unfortunately not true: only a very small number of tests has been approved by legislators to replace animal testing. The key word here is validation.
According to an internationally accepted definition, validation is the procedure by which the relevance and the reliability of a test method are assessed for a specific purpose. It can be said that validation is the link between research and regulation. This link ensures that an alternative method developed by academic or industrial scientists will be accepted by regulatory authorities for product approval or safety purposes.
In 1985, the Members States of the European Union recognised the need tdesign new animal-free tests based on animal and human cells and tissue in cultures to fulfil the needs from industry, regulatory authorities and the public on the use of animals in research. Accordingly, the European Council adopted a research programme which supported the development of in vitro tests (for pharmacotoxicological purposes). It was to be followed by many more research initiatives.
The Member States also recognized the importance of legislation. In 1986, the Council Directive 86/609/EEC regarding the protection of animals used for experimental and scientific purposes was adopted. In article 23 it stated:
The Commission and Member States should encourage research into the development and validation of alternative techniques which could provide the same level of information as that obtained in experiments using animals, but which involve fewer animals or which entail less painful procedures, and shall take such other steps as they consider appropriate to encourage research in this field. The Commission and Member States shall monitor trends in experimental methods".
As a direct response to articles 7 and 23 of the Animal Protection Directive, the European Centre for the Validation of Alternative Methods (ECVAM) was established in 1991. ECVAM was given the task to validate novel methods and to serve as an information centre. ECVAM monitors the research projects funded by the European Commission and maintains good working links with IVTIP.