Ethical considerations in animal experiments

SHIONOGI is consistently working on research and development of pharmaceutical products on the basis of its company policy of “SHIONOGI strives constantly to supply the best possible medicine to protect the health and well-being of the patients we serve.” Predicting the safety and efficacy of pharmaceutical products in humans is an extremely difficult challenge even with current science and technology, and SHIONOGI therefore considers this a research field in which the need for animal experiments is high. However, animal experiments are conducted only after their necessity has been carefully examined, with priority given to alternative methods where available, and are carried out only when no reasonable alternatives exist.

SHIONOGI has established its company regulations based on the “Basic Guidelines for the Conduct of Animal Experiments, etc. in the Implementing Agencies under the Jurisdiction of the Ministry of Health, Labour and Welfare,” and practices the internationally recognized principles of the 3Rs^※1 (Replacement, Reduction and Refinement), which form the basic philosophy of animal experiments. Specifically, SHIONOGI systematically promotes the use of alternative methods (Replacement), the reduction of the number of animals used (Reduction), and the alleviation of pain and distress experienced by animals (Refinement). SHIONOGI makes every effort to ensure appropriate care and scientific use of animals with respect and a sense of responsibility toward animals, taking into account their physiology, ecology, and natural behaviors. The SHIONOGI Institutional Animal Care and Use Committee (IACUC) reviews all animal study protocols ethically and scientifically, including assessment of the availability of alternative methods, the appropriateness of the planned number of animals, and considerations related to animal welfare, and confirms the results of approved studies, thereby ensuring the proper implementation of animal experiments based on the principles of the 3Rs. The committee also provides continuous education and training to all personnel engaged in animal experiments to further promote  awareness of the responsibilities and the 3Rs principles involved in conducting animal experiments and to minimize animal pain and distress through improvement of their practical skills. In addition, SHIONOGI conducts self-inspections and evaluations regarding the care of laboratory animals and the conduct of animal experiments on a regular basis to ensure compliance with relevant laws, guidelines, and internal regulations. Furthermore, SHIONOGI continuously maintains accreditation from AAALAC International^※2, an international third-party accreditation body for the ethical and humane care and use of laboratory animals.

These initiatives are implemented under the oversight of management as part of SHIONOGI’s policies and management framework related to animal experimentation.

※1　3Rs: The 3Rs—Replacement (the use of alternative methods), Reduction (the reduction of the number of animals used), and Refinement (the alleviation of pain and distress experienced by animals)—are internationally recognized principles for conducting animal experiments, proposed by Russell and Burch in the United Kingdom in 1959.

※2　Association for Assessment and Accreditation of Laboratory Animal Care International