Tag: Italy

Italian Biomedical Scientists Petition EC Officials and Italian Politicians Protesting Extreme Restrictions on Animal Research

I have written earlier about the peril that Italian Biomedical research finds itself in, due to extreme, immoderate and unreasonable restrictions on animal experimentation that the Italian Parliament approved recently. Via a missive from the Basel Declaration society (Disclaimer: I am an individual signatory to and supporter of the Basel Declaration), I learnt this morning about a PETITION (in Italian, and in English) that several prominent Italian Biomedical Scientists have launched, directed at European Commission officials and copied to several relevant ministers in Italy.

I am including here the text of the English version of the petition. Please read, support and share it. The place to put your name, email, and optionally, location and degree, is to the right side of the petition text (see the petition page link above). The field-names are unfortunately written in Italian even in the English page, but they are not difficult to understand. Upon signing the petition, you’d receive an email with a validation link which you must remember to click in order for your signature to be registered.

Please stand with these scientists for the sake of not only saving Italian scientific research, but also maintaining the integrity and continuity of biological research as a whole throughout the world.

Dr. Janez Potočnik

European Commissioner for the Environment
Directorate General for the Environment
European Commission
B-1049 Bruxelles
(janez.potocnik@ec.europa.eu)

Cc:

Dr. Susanna Louhimies
Policy Officer- Use of animals for scientific purposes
Directorate General for the Environment
Unit 3
European Commission
B- 1049 Bruxelles
(susanna.louhimies@ec.europa.eu)

Ccc:

Minister of Health of Italy
On. Beatrice Lorenzini
(segreteria.ministro@sanita.it)

Minister of EU Affairs of Italy
On. Enzo Moavero Milanesi
(seg.ministromoavero@governo.it)

Minister of the University and Scientific Research of Italy
On. Maria Chiara Carrozza
(segreteria.particolare.ministro@istruzione.it)


Subject: Implementation in Italy of EU Directive 63-2010 on the protection of animals used for scientific research in Italy. Art. 13, Law n. 96/2013.

Dear Dr. Potočnik:

We are writing to share our concerns on the criteria approved by the Italian Parliament concerning the implementation of the European Directive 2010/63 on the protection of laboratory animals in Italy.

As a scientific community we have approved and supported the decision to generate an harmonized approach shared by the whole Community.  The European discussion has lasted almost a decade and has led to a well-balanced compromise between the demands of animal welfare and the interests of research.

This well balanced compromise has been challenged by the Italian Parliament with
severe risks for the future of biomedical research in the country.

We ask you to help re-balance the discussion by warning the Italian Government that the Parliament has approved decisions is in violation of art. 2 of Directive EU 63-2010. If transformed into a legislative decree by the Government,  those decisions  will make the Italian law much more severe and restrictive than the EU Directive.

Specifically we ask you to convince the Italian Government to implement in Italy the EU Directive 63-2010 as the UE Parliament and Commission have licensed it. This will require the rejection of the Art. 13 of the national law of implementation of the EU Directives for 2013 (Legge di delegazione europea 2013, n. 96, published in the Gazzetta Ufficiale, Serie generale n. 194, 20/08/2013, into force since 04/09/2013).

The different paragraphs of art. 13 of the above mentioned law contains a severe limitation to the use of cats, dogs and non-human primates for basic research, limitations in the re-use of animals of any nature previously employed in procedures classified as of “moderate” severity, prohibition of research on non-anaesthetized animals, limitation in the use of genetically modified animals, a ban of animal experiments on xenotransplantation and drug addiction, a ban of animal breeding centers in the national territory.

We trust that the strict control and ethical review mechanisms proposed by the EU Directive are the most effective mechanisms to prevent unnecessary and unjustified pain and suffering for animals. The Italian scientific community is very supportive of this strict review process but opposes any total bans, as fully inappropriate to regulate the complexity of biomedical research, and liable to damage it severely without adding significant benefits to animal welfare.

In the interest of biomedical research in Italy, we ask you to follow our recommendations and help us obtain a new and well balanced Italian animal welfare legislation, in line with the European directive.

Yours sincerely,

Fabio BenfenatiProfessor of Physiology, University of Genova

Giovanni BerlucchiProfessor Emeritus of Physiology, University of Verona 

Roberto CaminitiProfessor of Physiology, University of Rome SAPIENZA, Chair, Committee of Animals in Research (CARE), Federation of the European Neuroscience Societies (FENS)

Enrico CherubiniProfessor of Physiology, SISSA, Trieste, President of the Italian Society of Neuroscience (SINS)

Francesco ClementiProfessor Emeritus of Pharmacology, University of Milan, and National Council of Research, Milan

Gaetano Di ChiaraProfessor of Pharmacology, University of Cagliari

Silvio GarattiniDirector, Institute for Pharmacological Research Mario Negri, Milan

Jacopo MeldolesiProfessor Emeritus of Pharmacology, University Vita-Salute San Raffaele, Milan, past President of the Italian Federation of Life Sciences

Giacomo RizzolattiProfessor Emeritus of Physiology, University of Parma

Carlo ReggianiProfessor of Physiology, University of Padua, President of the Italian Physiological Society

Piergiorgio StrataProfessor Emeritus of Physiology, University of Turin

Italian Biomedical Research in Peril

Those of you who are familiar with my views on animal experimentation (e.g. see here and here) probably know and understand that in order for biomedical science to progress for the benefit of humans and animals, it is important to engage in reasonable animal experimentation. I emphasize the word ‘reasonable’, because the welfare and humane treatment of research animals remains one amongst the most important tenets guiding animal experimentation. These tenets also behoove us biomedical researchers to actively seek non-animal, alternative study methods wherever possible, and employ rigorous analytical tools to minimize the number of animals to be used.

At the same time, however, I also emphasize that animal experimentation remains a very important and crucial experimental tool. Let’s take an example that I came across in today’s Nature Medicine alert. SARS (Severe Acquired Respiratory Syndrome), a form of viral pneumonia, affects a variety of small mammals, a fortuitous fact which the scientists have utilized for over a decade to study the ways and means to stop this deadly coronavirus pathogen. However, the etiological agent of the so-called MERS (Middle East Respiratory Syndrome), another coronavirus (CoV) that is wreaking havoc in Saudi Arabia, doesn’t seem to be able to infect the usual subjects, small lab animals (such as rodents) – reports Elizabeth Devitt (DOI: 10.1038/nm0813-952) in Nature Medicine News. This has seriously hampered the search for a treatment or preventive vaccine. Teams of scientists have, of necessity, moved to a non-human primate model, Rhesus Macaques, in which the MERS-CoV does cause a form of disease that is less severe than one seen in humans. In this model, possible vaccine candidates, as well as two antiviral drugs, are to be tested.

All this is why I found a piece of news in a recent Nature News Blog highly alarming and disappointing. Reported Alison Abbott, Italian parliament approves sweeping restrictions to use of research animals.

As Allison explained, Italy, as a member of the European Union, was required to legislate the protection of animals used in scientific research, following a 2010 EU directive that was seen as striking “a delicate balance between animal welfare and the needs of biomedical research” but was also amongst the strictest of such regulations around the world. However, the Italian Senate introduced last month a series of amendments in favour of placing extreme restrictions on animal research:

  • Forbidding the use of non-human primates, dogs and cats – except to test drugs or perform translational research,
  • Mandating anesthesia use even in mildly and transiently painful procedures, such as injections, and
  • Prohibiting animal use in some specific research areas, such as xenotransplantation (transplantation of cells and tissues between species, an important research area associated with transplant medicine), and addiction.

Not surprisingly, the scientific establishment of Italy is crying foul, voicing the concern that these measures would seriously hinder important biomedical research in Italy. It is not difficult at all to see why they should feel this way. Allison’s blog post is followed (at the last reading) by an illuminating discussion by five illustrious commenters, some noted biomedical researchers amongst them: neuroscientist Prof. Stefan Treue (Director of the German Primate Center, and Professor of Cognitive Neuroscience and Biological Psychology, University of Göttingen), Constitutional scholar Prof. Francesco Clementi (Professor of Political Science, University of Perugia), neuroscientist Prof. Nikos Logothetis (Director, “Physiology of Cognitive Processes” Department, Max Planck Institute for Biological Cybernetics, Tübingen), neuroscientist Prof. François Lachapelle (Research director, National Animal Welfare Office, INSERM) and Science blogger Dr. Paul Browne of the Speaking of Research blog. I encourage everyone to head over to Allison’s blog and read these comments.

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 after Allison’s post includes a note of hope. He wrote, “… 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.