What’s happening in Italy in terms of biomedical research and use of animals in experimentation.
Preclinical biomedical research, that is all the research carried out before attending to the patient, is the cornerstone every hope to make progress in the diagnosis and in the cure of the diseases troubling mankind still today is based on. We refer to well-known disorders for which there are strong commitments nationwide in the fields of prevention, treatment, infections, cardiovascular or neurodegenerative diseases. However, we also and above all refer to several new diseases that are better acknowledged today but for which no indications on the causes and on possible treatments exist yet. In all these environments, the “controlled” use of animals for experimentation represents a condition that is “essential” to research. This was also the conclusion drawn by the European Committee which, after years of confrontation with animal-rights movements all over the world, reached an agreement on the final text of a law issued in December 2010 (2010/63/UE) on the “protection of animals used for experimental or other scientific purposes”, replacing the previous Directive 86/609. A very limiting law with regards to control on experimentation urging the use of methods that are alternative to those with animals and anyway giving indications so that the number of animals used would be reduced thus preventing them from suffering during their breeding period.
The use of animals in Europe is then regulated but not abolished.
Following its implementation, a heated debate started within the scientific community that had to face new attacks from the animal-rights movements often supported by political forces seeking easy mass consensus based on emotions and too often on misinformation. So whilst this directive was fully adopted to become a state law in the member states of the EU, in Italy an attempt to literally have it overturned is underway, through a clause approved by the Senate and subsequently by the Lower Chamber, the former clause 9-bis now clause13 (Criteria of delegation to the Government for the adoption of Directive 2010-63-EU of the European Parliament and Committee, dated 22 September 2010, on the protection of animals used for scientific purposes). Whilst originally the European Directive established the possibility to use animals for basic and biomedical research aiming to study diseases and their treatment, clause 13 introduces a series of bans which hit basic research for the cure of diseases (translational research) and the breeding of animals for experimentation.
The use of animals for the study on xenotransplants is then banned thus preventing in actual fact the implant of tumour cells in mice to study mechanisms and new tailored treatments. It will also prevent the implant of human stem cells in the animal which aims to study the regenerative and side effects of these cellular treatments before being used on humans. Think for a minute of the several lives saved thanks to the successful techniques used on pigs which have allowed the development of human heart valves.
Clause 13 forces the use of anaesthetic or analgesia whenever an animal may feel pain and prevents the re-use of animals previously subjected to experimental techniques. It is not therefore clear how it will be possible to develop new surgical techniques on the animal and then analyse the benefits to the functions of the organs, to the movement and to the behaviour.
The use of transgenic animals, which is revealing a lot about the mechanisms of genetic diseases, will be considerably limited. It will not be possible any longer to carry out studies where the development of the transgene (the sick gene inserted into the animal’s genome) involves a real worsening of the animal’s health as our test of the process of the disease is linked to the gene.
Drugs and abuse substances, a plague affecting today at least 2 million Italians, are also banned.
Doing research in Italy will be unthinkable if this law is put into effect definitively with such obligations. Our best researchers will have no choice but to go abroad to be able to continue studies that are acknowledged worldwide as absolutely innovative and promising. Scientists working at universities, research centres and associations are continuously liaising with the parliament appealing to the people and to the patients’ rights associations. On 19 September last year researchers from all over Italy gathered to protest outside the Italian Parliament to express their deep discontent regarding the new regulation. The press once again didn’t help research as newspapers barely reported it. The media unwillingly cover these stories and they do it taking the side of the animal-rights activists. It is known that emotions win and sell copies. So one day some newspapers defend the patients who cry out the need to have efficient treatments and another day they support energetically the animal-rights activists.
In such a social and political environment the ministerial authorities assigned to assess and approve all the studies on animals are acting extremely cautiously trying to limit as much as possible the use of animals and their suffering.
Aware of all these limitations, the researchers of the Giorgio Brunelli Foundation are working so that the studies on the regeneration of the central nervous system can continue on well-standardised animal models and along with in vitro alternative models as intended by the European Directive. The studies on animals will be carried out abroad waiting for a clear Italian stance on these issues, whereas at the University of Brescia studies on alternative models will be implemented setting up organotypic cultures of spinal cord and stem cells.
As researchers we are deeply concerned that these new bans contained in clause 13 might lead to exclude Italy from international funds, both the future ones and those already allocated, as well as from the collaboration with the rest of the world in basic and translational research on issues that are fundamental to man’s health.
