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IT-ARVO acts on animals in research regulations

This is part of a series of articles that highlight members and activities of ARVO’s 13 International Chapter Affiliates (ICAs).

Philipo Drago, MD, PhD, FARVOThe Italy Association for Research in Vision and Ophthalmology (IT-ARVO) officer Fillipo Drago, MD, PhD, FARVO, weighs in on the increased restrictions on the use of animals in research and how the research community in Italy has responded to these tighter regulations.

ARVONews: Would you describe the new rules restricting animal research? Why were the new rules implemented?

Drago: The Italian parliament has voted in favor of introducing extreme restrictions to the directive 2010/63/UE on the use of animals in research — which would halt important biomedical research in the country. 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. However, the Italian parliament approved a series of amendments that further tighten this directive.

Article 13, in fact, tends to change the spirit and substance of the E.U. Directive. For example, consider the following:

  1. The amendments, forbid the use of nonhuman primates, dogs and cats in research, except in mandatory drug testing or when directly related to translational medicine. This amendment seriously undermines both basic and biomedical research. Indeed, all clinical therapies in use derive from basic research.

  2. They also forbid procedures that impose mild pain — such as injections — without anesthesia. This rule prevents research on pain and stroke. Furthermore, it also greatly limits toxicological studies.

  3. 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. The xenotransplantation is critical to develop innovative therapies designed for serious pathologies, organ transplants, development of customized therapies for cancer and development of advanced and safe heart valves. Drug addiction is a major health issue, and it requires research with animals.

The animal lobbyists wanted to hold back in vivo research, and they succeeded in the two areas where ignorance and mystification could have an effect. In the case of substance abuse, lobbyist played the card of drug addiction being more a social problem than a healthcare or medical one, stating that pharmacological therapies are not effective, which scientists find to be false and intellectually dishonest.

ARVONews: What specific steps has the research community taken in response to the new rules? What message is the research community trying to deliver to policymakers and the public?

Drago: The research community started a battle against the animalist lobbyist and several Italian politicians As a result, Italian researchers obtained a temporary regulation (article 42) that suspends the ban on the use of animals for research on substance abuse and xenotransplants until Dec. 31, 2019. After that date, the ban will be subject to the Zooprophylactic Institutes of Lombardy and Emilia-Romagna Regions, which will consider if alternative methods to in vivo studies are available. Furthermore, by using meetings, conferences, lessons and symposiums, researchers focused on “the importance of proper information on the use of animals for scientific purposes.” In particular, our main message is that many human therapy has been discovered and tested in animals and that it should be impossible to refuse animal research in the biomedical sciences. Of course, it is important to use the principle of reduction, refinement and replacement. JJ

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