Italy may soon become the European country with the most restrictive legislation on animal experimentation, if a draft law due for discussion in the Senate tomorrow is approved in its current form.
The Italian government says that it considers the draft “a good balance point”, but scientists fear that the restrictions would hamper biomedical research and damage the country's pharmaceutical industry.
The changes stem from the adoption of the European directive 'On the protection of animals used for scientific purposes’, adopted in September 2010 after a long negotiation (see ‘Lab-animal battle reaches truce’). The directive imposes stricter limits and controls on animal experiments than those in place in most European countries, and all member states must incorporate it into national law before the end of this year. Nations that already had more-stringent regulations in place are allowed to carry those over into their updated legislation.
The draft being discussed in Italy contains several prohibitions that are not in the EU legislation, however, and that were not part of Italy’s regulations before the directive was adopted. It bans the breeding of primates, cats and dogs for laboratory use, and requires the government to impose “sufficiently cautious” norms for the authorized use of transgenic animals. It also bans experimentation on “anthropomorphic apes”, cats and dogs, unless the tests are mandatory for new drugs to be approved, or are aimed at “improving human health”. Finally, it prohibits all experiments without anaesthesia that cause pain to an animal. The draft was originally proposed by former minister for tourism Michela Brambilla, an animal-rights activist, and has already been approved by the Chamber of Deputies, the other half of Italy's bicameral parliament.
According to Roberto Caminiti, a physiologist at the University of Rome 'La Sapienza' and chairman of the Committee on Animals in Research for the Federation of European Neuroscience Societies, most of these rules would damage research without improving the welfare of animals. “The ban on breeding would result in animals being transported from other countries, where we have no control on how they are treated,” he says. He also believes that there is no reason to have special rules for transgenic animals, which the directive protects like any other animal. As for experiments without anaesthesia that cause pain, he notes that they are already tightly regulated, and are necessary in some cases — such as in research on painkilling drugs.
The section about “anthropomorphic apes” is even more problematic, says Caminiti. “Experiments on great apes are banned outright by the directive, but the Italian law would seem to reintroduce them, although with limits,” he says.
Ignazio Marino, a surgeon and a senator for the Democratic Party, says that the new law could lead to the closure of major centres for pharmacological research, and would make it very difficult for Italy's branch of the European Mouse Mutant Archive — a world-class facility near Rome for research on transgenic mice — to continue operating.
Caminiti says that if the law is approved in its current form, the scientific societies he represents will immediately bring a case to the European Commission on the basis that it contains stricter provisions than were in place before the directive. He adds that scientific leaders have been asking for meetings to discuss the legislation with the government’s health and research ministers, but have had no response.
Michela Kuan, a biologist and a member of the animal-rights group Lega Anti Vivisezione in Rome, hopes that the law will send a signal to other European countries. “The directive does not really ban anything, researchers can do all they want provided they get permission,” she says. “But people will never start working on alternative methods unless they are forced to do it”.
Marino has proposed dropping the draft law in favour of simply adopting the European directive. In the next few weeks, the Italian Senate's Committee for Policies of the European Union will discuss his proposal, as well as amendments suggested by other Senators, some of which would make the law even more restrictive. A final decision is expected at the end of July.
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