The legal requirement for animal testing
Animal testing is influenced by both national and EU legislation. Although the Home Office officially claims that all new drugs are required by law to undergo animal experiments (5), on closer examination, this would appear not to be the case. For example, the UK Medicines Act 1968 and other UK regulations do not specifically require animal tests (6).
The only piece of legislation that specifically refers to animal testing (Annex I of Directive 2001/83/EC) states that toxicity tests 'shall be carried out on two species of mammals one of which must be a non-rodent'. However, this seemingly solid statement is tempered by article 7.2 of Directive 86/609/EEC, which states that an animal experiment must not be carried out if a non animal method could be used to provide the information in question (see Section on non-animal testing methods).
It must therefore be concluded that there are essentially no legal obstacles to the replacement of animals in toxicity testing.