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Italian parliament approves sweeping restrictions to use of research animals

The Italian parliament has voted in favour of introducing extreme restrictions on the use of animals in research — which some scientists say would halt important biomedical research in the country.

But some experts say that this may contravene European Union (EU) legislation — leaving the Italian government with the uncomfortable choice of either upsetting its democratically elected parliament or upsetting the European Commission.

The dilemma arose as the government began earlier this year to prepare legislation required to adopt into national law an EU directive covering the protection of animals for scientific purposes.

The directive, which was approved in 2010 after a long battle, strikes a delicate balance between animal welfare and the needs of biomedical research. It is considered to be among the strictest in the world.

Earlier last month the senate approved a series of amendments that further tighten the directive, and these were rubber-stamped yesterday by the Chamber of Deputies.

The amendments would, for example, forbid the use of nonhuman primates, dogs and cats in research, except in mandatory drug testing or when directly related to translational medicine. They would also forbid procedures that impose mild pain — such as injections — without anaesthesia.

The legislation further prohibits the use of animals in some research areas — such as xenotransplantation, in which cells and tissues are transplanted between species, and addiction. “It’s terrible,” says  Gaetano Di Chiara, a pharmacologist at the University of Cagliari, Sardinia. “Drug addiction is a major health issue, and it requires research with animals.”

But Roberto Caminiti, a physiologist at the University of Rome La Sapienza, who chairs the Committee on Animals in Research for the Federation of European Neuroscience Societies, points out that the second article of the EU directive explicitly bars EU member states from ‘gold-plating’ the directive by adding restrictions.

“If the government does actually implement these changes, we will call on the EU to open a procedure against Italy — that’s for sure,” Caminiti says.

The final legislation must be in place by the end of this year.

Comments

  1. Report this comment

    Sergio Stagnaro said:

    Caminiti’s conclusive statement ““If the government does actually implement these changes, we will call on the EU to open a procedure against Italy – that’s for sure” sounds as a double-edged sword. As a matter of facts, someone will open a procedure against the EU, that’s for sure, because the EU hides to the Europeans the existence of Inherited Real Risks of CVD, T2DM, and Cancer, bed-side recognized from birth with a stethoscope and removed promptly with the no expensive Quantum Therapy (References on request). That accounts for the reason CVD, T2DM, and Cancer are today’s growing epidemics.

    1. Report this comment

      Sergio Stagnaro said:

      After the condemnation of Berlusconi, 1 August, 2013, Italy is now a country with excellent morality and justice. Surely, the Italian magistrates will investigate, as soon as possible against unknown persons for the silence on CVD, T2DM, and Cancer Inherited Real Risks, bedside recognized since birth and removed by Quantum Therapy.

  2. Report this comment

    Stefan Treue said:

    It is a sad day for Italy because its politicians seem so detached from understanding the process of science that they believe that arbitrary and unjustified restrictions on gaining critical biomedical insights will not be a major blow to its scientific community in their quest for helping patients (and animals) deal with cancer, with AIDS, neurodegenerative diseases, drug abuse and other life-threatening ailments. It will also push research-based companies to leave Italy for places with a transparent, dependable and supportive climate for research or worse, make them move to countries where animal-based research is under-regulated. I am sure the very same politicians that passed these restrictions will happily enjoy the future medical advancements for themselves that will be achieved abroad.

    It is also a sad day for the EU, because the Italian Senate and Chamber of Deputies made a mockery of the EU’s efforts to harmonize animal research standards across the EU. What is the motivation now for countries in Europe that lack adequate animal research regulation to implement the EU directive exactly as it was passed if countries return to their old habits of defining their own standards?

    Last but not least it is a sad day for researchers as the Italian decision represents a failure of us and our professional societies to convince this particular set of politicians of the critical need to support responsible and essential scientific research.

    Stefan Treue,
    Professor of Biological Psychology and Cognitive Neuroscience,
    Goettingen University and German Primate Center

  3. Report this comment

    FRANCESCO CLEMENTI said:

    Thanks to Nature that is one of the few Journals that gave notice of this incredible story for biomedical research in Italy.
    Biomedical research in this country is facing a very difficult time due to found restriction and to the lack of position renewals . Only the few large and well organized laboratories will survive for some time.
    Our biomedical University are still able to form excellent young investigator that after the degree leave Italy for other more appealing foreign laboratories. Unfortunately no plans are foreseen for calling them back.
    This new act of the Parliament imposing un-rational vetoes to research is a further indication of the poor consideration that research has in our Country.

  4. Report this comment

    Nikos Logothetis said:

    It’s about time that universities, education ministries, institutions and funding organizations took their role seriously. The discussion about “the importance of animal experimentation” goes absolutely nowhere and it is not a “discussion” to begin with. Those remaining politically silent, while at the same time being fully aware of the critical importance of basic research and its impact on all aspects of the wellbeing of humans, should speak up before it’s too late. This is not an “Italian” story; tomorrow it will pop-out elsewhere..
    Nikos K. Logothetis
    MPI for Biological Cybernetics

  5. Report this comment

    Nikos Logothetis said:

    It’s about time that universities, education ministries, institutions and funding organizations took their role seriously. The discussion about “the importance of animal experimentation” goes absolutely nowhere and it is not a “discussion” to begin with. Those remaining politically silent, while at the same time being fully aware of the critical importance of basic research and its impact on all aspects of the wellbeing of humans, should speak up before it’s too late. This is not an “Italian” story; tomorrow it will pop-out elsewhere..
    Nikos K. Logothetis
    MPI for Biological Cybernetics

  6. Report this comment

    Paul Browne said:

    The approval by the Chamber of Deputies of the amendments to directive 2010/63/EU – referred to as Article 13 – was a very sad day for science in Italy (there have been far to many of these lately). While some of the provisions in Article 13 are quite innocuous, even rather pointless are they just restate what the directive already says in a slightly different form of words , several of the amendments have the potential to do enormous and lasting damage to biomedical research in Italy.

    A recent article on the Speaking of research website http://speakingofresearch.com/2013/07/03/senators-welcome-pro-test-italia/ highlights some of the problematic amendments in article 13, which were approved by the Italian Senate earlier in July and then by the Chamber of Deputies on Wednesday.

    The amendment dealing with xenotransplantation alone has the potential affect many areas of medical research – and even medical practice – as it does not define what is meant by “xenotransplantation”. Thus it may block vital cancer research that involves xenografts or tumorgrafts, the use of porcine heart valves in cardiac surgery (a common procedure that has saved many thousands of lives) as well as research to improve those valves, block bioengineering/tissue engineering research which uses any tissues from one species in another, and even stop significant numbers of stem cell research projects where stem cells from one species are transplanted into another (e.g. human cells in mice).

    These amendments must not be enforced, if they are they will do terrible damage to science in Italy.

    Fortunately there is hope!

    The law transposing the EU directive into Italian law was rushed through the Chamber of Deputies by the Italian government because it was facing large financial penalties due to the delay in implementing the Directive, so the government did a deal with the Deputies so that the text approved earlier by the Senate was approved without further amendment (any amendments would have been sent back to the Senate for approval again causing more delays). In doing this the Parliament approved the delegation to the government for the implementation of the Directive. So now the ball is in the government, which will have to write the legislative decrees, and the Government will have to do so in a manner consistent with the provisions of paragraph 2 of Article 13, which states that “In the application of the principles and criteria referred to in paragraph 1, the Government is obliged to respect the obligations arising from legislation or national pharmacopoeias, European or international”. As the article above mentions Directive 2010/63/EU specifically bars countries from imposing additional restrictions on animal research unless they were in force before 9 November 2010, which meant that the most worrisome amendments in Article 13 are actually in breech of Directive 2010/63/EU.

    As an article on the Pro-Test Italia website http://protestitalia.wordpress.com/2013/08/02/recepimento-direttiva-sulla-protezione-degli-animali-da-esperimento-facciamo-il-punto/ earlier today points out the Italian government, and specifically health Minister Beatrice Lorenzin, has accepted the advice or the parliamentary commission and several orders-of-the-day by deputies that the amendments in article 13 are highly problematic. The Government now has the opportunity to introduce safeguards that ensure that these amendments do not harm Italian science (and lead to the EU starting infringement procedures against Italy), and to prepare new amendments to correct the problems at the next reading in the Italian parliament.

    In short there is still everything to play for, and it has become apparent that the voices of science are beginning to be heard by Italian politicians. Now is the time for the Italian scientific community – and their colleagues hroughout Europe and beyond – to redouble their efforts and make sure that these amendments which threaten science in Italy are consigned to the dustbin of history where they belong!

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      Sergio Stagnaro said:

      If the experiments in animals are so important, because CVD, T2DM, and Cancer epidemics are growing on and they will continue, as generally admitted?

  7. Report this comment

    francois lachapelle said:

    Sad day for research in Italy, but especially sad day for democracy in Italy: the absurd vote of this regulation is a disgrace to the Italian political class.: by limiting the use of certain species for direct search of cures they deny the importance of basic research and the freedom of knowledge. These people show their incredible ignorance of the reality of research: they ignore that 49% of the cures effectively applied to the human or animals directly derives from fundamental research. They ignore that the greatest discoveries of modern biology are all derived from basic research. The implementation of such a law would lead to forego discoveries as important as the discovery of GFP in studying the biology of jellyfish or discovery of stem cells in the adult brain evidenced by studying canary bird songs. They don’t know or don’t understand the importance of a discovery as extraordinary as that of mirror neurons from research conducted on primates in Italy for understanding the neurobiological underpinnings of empathy. Such discoveries are the real glory of Italy but political class does not know that. Moreover by limiting animal research to the development of cures they would abandon all basic research on animal health and on the protection of the environment. Finally by voting a regulation that will be canceled by the European Commission (and they all know that) they do not just show their cowardice facing the most ignorant part of public opinion, but also their lack of respect for their country and the Italian People. When considering addiction as a sin, not a disease, or by forbidding xenotransplantation they return to the darkest days of the Inquisition forgetting that they themselves are primarily addicted to their reelection: Science without conscience is but the ruin of the soul, but without courage, political action is the ruin of honor.
    It is now time for the scientific community to raise and provide clear and objective information to the public on the relative place of research on animals and alternative methods: they both are essential and complementary, are developed by the same research teams and cannot be dissociated from each others. None of them can replace the other one, and both can only be issued from research not from ideology

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    mario colombo said:

    How to change the perception that animal research can be abolished in medical science? The question is for the Italian politicians who vote in favor and for all journalists and show-people who surfed the big emotional wave of banning vivisection to stop animal research as a whole?
    Would these people refuse any therapy that has been discovered and tested in animals to safe the life of their children or close relatives affected by disease requiring such therapies?
    Would they also abolish pest control and rat disinfestation?
    The voice of Scientists working in Italy is thousand times less influent than that of our colleagues working abroad whose scientific success are celebrated on Italian newspapers and television. I would ask them, please, to raise their voice and write in favor of animal research within the standards approved by the European Union.

    Mario P Colombo, PhD
    Deputy Director, Department of Experimental Oncology and Molecular Medicine
    Director of Molecular Immunology Unit
    Fondazione IRCCS Istituto Nazionale Tumori
    Via Amadeo, 42,
    20133 Milano, Italy

  9. Report this comment

    Kausik Datta said:

    Illustrious scientists have commented here voicing this important concern, beyond which I don’t have much to add. However, Paul Browne’s comment brought back to my mind an excellent 2010 post he wrote along with Dr. Allyson Bennett on the Basel Declaration, “a declaration that affirms commitment to responsible research and animal welfare and calls for increased effort to facilitate public understanding of the essential role that animal studies play in contributing to scientific and medical progress” (Full Disclosure: I am an individual signatory to the Basel Declaration).

    Particularly in relation to the Italian legislation’s intent to allow animal research for some, but not all, biomedical research, this line from the Declaration is especially important: “…Biomedical research in particular cannot be separated into ‘basic’ and ‘applied’ research; it is a continuum stretching from studies of fundamental physiological processes to an understanding of the principles of disease and the development of therapies.”

    Paul’s comment includes a note of hope. He writes, “… it has become apparent that the voices of science are beginning to be heard by Italian politicians.” I hope that is true – not only for Italy, but across the world, especially in the US, as well.

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    Cristina Lucchetti said:

    The Italian Universities would be able to produce excellent research if the Italian Government addressed more financial resources for it and it did not approve this restrictive law. If this law received a final approval, the most obscure phase
    of the last century for the Italian country will open, as for the educational and economical systems. The research would be conducted exclusively abroad.

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    doug leith said:

    The article assumes and accepts without evidence claims that humans have and will benefit from animal experiments. There is nice diencephalic to support these assumptions. From SirAlexander Fleming re penicillin; “How fortunate we didn’t have these animal tests in the 1940’s for penicillin would never have been granted a license and possibly the whole field of antibiotics might never have been realised” quoted by ProfDVParke to the present “92% of drugs fail clinical trial after passing all the safety tests in animals.” US FDA 2004; “Innovation or stagnation: challenge and opportunity on the critical path to new medical products”. Vivisectors use assumptions and fallacious argument to support their personal interests. The elimination of animal experimentation in Italy and globally would be a Godsend for human health. mrmcmed . org

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