The 3Rs Principle in Animal Experimentation: A Legal Review of the State of the Art in Europe and the Case in Italy.

Enrico Maestri

doi:10.3390/biotech10020009

Abstract

The aim of this paper is to describe the essential points of Italian and European legislation governing the use of animals in biomedical experimentation. A close look will be taken at the principles of the 3Rs, which represent the mainstay of the legal architecture based on which a correct interpretation may be drawn of the legislative documents on animal experimentation. Furthermore, this paper will address the ways in which Directive 2010/63/EU is implemented in Italian legislation on the welfare of laboratory animals. In addition to an assessment of legal issues (such as the scope of jurisdiction of supervisory authorities tasked with issuing authorizations), it will include a discussion of cases of inadequate and insufficient implementation of the requirements laid down by Directive 2010/63/EU. Both the consistency of the interpretation of national legislation with the Directive and the direct effectiveness of the Directive in national law, in which animal testing has been and still is the subject of heated debate between supporters and opponents, will be examined.

Highlights

The creation of an adequate legal framework for the conduct of experiments on animals requires careful and responsible consideration of various interests at stake.The conflicts among the obligation to maintain and improve human health, the valuable gains made possible by the freedom of science, the improvement of social welfare, the protection of the environment, and the deep concern about preventing animal pain and suffering cannot be resolved through general judgments
The right to life is universally recognized, and this is explicitly stated in international treaties such as the Universal Declaration of Human Rights (Article 3), the Charter of Fundamental Rights of the European Union (Article 2), the International Covenant on Civil and Political Rights (Article 6), and the Convention on the Rights of the Child (Article 6)
The binding principles regarding experiments on humans were laid down for the first time in history by the Nuremberg Code of 1947, which was the result of legal actions against physicians who were being tried in Nuremberg for the crimes against humanity perpetrated by the Nazi dictatorship

Summary

Introduction

The creation of an adequate legal framework for the conduct of experiments on animals requires careful and responsible consideration of various interests at stake. The relationship between research and ethics raises complex questions, many of which are related to the specificity of the scientific field in which they operate On this basis, experiments on animals are expressly provided for in legislation on pharmaceutical products and international guidelines applicable to pharmaceutical testing (OECD guidelines or European Pharmacopeia in the case of alternative methods of quality control for batches of vaccines). Animals have often been essential to research as a model organism, because experiments on animals provide important information about how drugs work and on the human toxicity of individual chemical products This has given rise to a dilemma between health and safety requirements on the one hand and the moral need to protect laboratory animals on the other [5]. An overview will be given of the main animal welfare guidelines, rules, and good experimental practices adopted in this field by scientific societies and bioethics committees that have attributed a pivotal role to the 3Rs method in the design of experiments that include animals

The Principle of the 3Rs and Law: A Legal Genealogy

The Principles of the 3Rs

An Example of Legal Challenges in a European Member State

Procedures cannot be authorized:

Conclusions