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.
10 luglio 2012
Fonte: Nicola Nosengo, Nature
The times are changing for European biologists who work with octopuses, squid and cuttlefish. A European Union (EU) regulation on animal experiments will soon make them familiar with the bureaucracy that is already the daily routine of those who experiment on monkeys and mice.
The EU directive on “the protection of animals used for scientific purposes”, which member states must incorporate into their national laws by January 2013, for the first time extends protections to cephalopods as well as vertebrate lab animals.
Under the rules, all scientific experiments that can cause pain, distress or lasting harm to animals will have to undergo ethical evaluation. Researchers will have to justify the use of animals by proving that no alternative method is practical, and will have to use all possible means to reduce suffering. Some research projects may also go through a retrospective assessment to verify whether their objectives have been achieved.
Cephalopod researchers discussed the regulation at the Euroceph meeting in Vico Equense, Italy on 7–11 April. “It’s going to be a big change for most people in the field, and will affect research on many levels,” says Paul Andrews, a biologist at St George’s University of London, who was one of the organizers of the meeting.
Although researchers agree that the welfare of animals is important, they worry that the new regulation will mean more paperwork, and that it may even make some experiments that would be allowed on vertebrates impossible in cephalopods.
Typical research on cuttlefish — which can change their skin colour at will — involves studying how their camouflage varies in response to flashing lights or changing backgrounds. Such a behavioural study would not in principle require authorization, but a strict interpretation of the directive could argue that strong light causes distress to the animal, thus putting the experiment under the scope of the new rules.
Participants at the Naples meeting criticized the ‘mammal-centric language’ of the directive. For example, the text of the regulation recommends that analgesics and local or total anaesthesia be used to reduce animals’ pain, when necessary. But researchers do not know much about how pain signals are transmitted in the nervous systems of cephalopods, and what effects anaesthetics would have on them. It is possible that such measures could actually cause more harm to the animal, or seriously interfere with the biological mechanisms being investigated.
“We will need new research in this area, so that our requests to regulators are based on evidence,” says Andrews.
The greatest concern for cephalopod researchers is an article in the directive that states that, “animals taken from the wild shall not be used in procedures”. Exceptions will have to be justified, and the capture of animals in the wild should be carried out by “competent persons using methods which do not cause the animals avoidable pain, suffering, distress or lasting harm”.
Unlike the rodents typically used in biomedical lab research, cephalopods are difficult to breed in captivity. Researchers usually get their octopuses and cuttlefish from local fishermen, whose concern for animal welfare generally falls short of the directive’s demands.
Currently, only Canada has such strict rules on cephalopod research. UK laws give special protection to octopuses, but not other cephalopods, whereas in the United States, research on invertebrates is not regulated at all.
Scientists say that it would be damaging to restrict research on cephalopods, because the animals have a unique physiology and cognitive ability, and are useful models in many fields. Presentations at Euroceph, for example, covered topics ranging from basic neuroscience to the biological basis of personality and consciousness, by way of robots and new materials inspired by cephalopods.
Susanna Louhimies, a policy officer at the European Commission’s directorate-general for the environment, says that the latest directive is necessary because existing EU animal-research legislation, which dates from 1986, does not reflect the latest experimental techniques, or take into account new evidence on how animals perceive pain and distress. She says that a changed ethical climate and increasing pressure from animal-rights activists were also factors.
“I do not believe any single line of research on cephalopods will have to stop,” says Louhimies. But she advises scientists to get organized and ensure that national legislators take the specifics of the field into account when implementing the rule. “And they should do it now,” she warns.
For the next three years, Euroceph’s organizing committee will work to help researchers develop guidelines for their national regulators. “Whether people like it or not, this is not going away,” says Andrews. For researchers, unlike the camouflaged cuttlefish, “hiding is not an option”.
12 aprile 2011
Fonte: Nicola Nosengo, Nature