Replacing Animal Tests to Improve Safety for Humans

Animal safety testing for new medicines is arguably the most difficult use of non-human animals (hereinafter referred to as animals) to challenge, for two reasons: first, it is required by governments (regulatory testing); second, pro­ tecting patients is a vital goal, and it seems intuitively obvious that animal tests must protect patients. Animal testing became institutionalized in the mid twentieth century (Parke, 1994) in response to early drug disasters, with the aim of preventing further tragedies. However, even the laudable aim of protecting patients cannot justify animal testing, unless it is the most effec­ tive means to ensure the safety of medicines. European Union (EU) law (Euro­ pean Parliament, 2010, Directive 2010/63/EU) states that animals must not be used if a non-animal method could achieve the same purpose. So, it is crucial to know how well animal tests predict the safety of medicines, and whether any other methods are equally or more predictive. In addition to the question of predictive value, other important issues must also be taken into consider­ ation, including the efficiency of different methods in terms of time and costs; and the ethical acceptability of using animals, if their use is deemed to be of irreplaceable value. The issue of whether animals should be used as human surrogates for safety testing is highly contentious; individual views range from no use of animals