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is not required by the EU Directive. “The situation, however, is not easy as regulations controlling research have been under close reexamination since 2010, and the anti-vivisection lobbies see this as a perfect opportunity to step up their efforts against biomedical research. Sadly, high-impact actions by extremists have now spread to countries like Italy.” Italy “The situation here is extremely disconcerting,” confirms Silvio Garattini, director of the Milan-based Mario Negri Institute for Pharmacological Research, where some 750 people are involved in basic and clinical research on cancer, psychotropic drugs, or organ transplantation, which includes animal testing, mostly on mice and rats. The reason for his pessimism is that the Italian Parliament restricted the already tight regulations governing animal research by drafting legislation that goes above and beyond the framework of the EU Directive. “This is contrary to Article 2 of the Directive and the Commission has already warned the Italian government,” says Garattini. The Parliament has outlawed the breeding of cats, dogs, and monkeys for research purposes, put a moratorium on addiction-related studies, and forbidden the use of animals for xenotransplantation. “We cannot transplant human tumors in mice that are immunologically incompetent, for example. Yet this is essential for our research, since it allows us to study the behavior of tumors in a living organism.” Although FEATURE The new EU Directive applies strict rules on caging and housing of animals, such as NHPs (pictured here). Rise of the 3Rs Contemporary philosophers like Peter Singer,10 who continue to advocate more ethical treatment of animals, trace the first seeds of this great shift in paradigm to eighteenth century England and the founder of modern utilitarianism, Jeremy Bentham. No longer should animals be viewed as property, with no mind or reason: the ability to suffer should be the benchmark of how we treat other beings. Perhaps fitting that the UK would become the first country in the world to enact laws to protect animals—first cattle from improper treatment in 1822, and soon after, the first-ever piece of legislation on animal experimentation: the Cruelty to Animals Act of 1876. It ensured that “the proposed experiments are absolutely necessary for the due instruction of the persons to save or prolong human life.” Less than a century later, the 1959 seminal book The Principles of Humane Experimental Technique,11 would describe key guidelines that continue to structure animal testing legislation to this day, and across the world, hereafter referred to as the 3Rs: 1. REPLACE the use of animals with alternative techniques, or avoid the use of animals altogether. 2. REDUCE the number of animals used to a minimum, to obtain information from fewer animals or more information from the same number of animals. 3. REFINE the way experiments are carried out, to make sure animals suffer as little as possible. This includes better housing and improvements to procedures that minimize pain and suffering and/or improve animal welfare. Although most countries in Europe operated under these ethical guidelines, few of them (notable exceptions being the UK and Germany) had any enforceable legislation on animal testing until the first EU Directive in 1986 (86/609/EEC). … 21 SPRING 2015 N° 37 © CNRS


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