Animal Experimentation Regulations in Japan and Recommended Legal Education
By Kenta Minamitani | April 18th, 2024
Introduction
Animal law, particularly animal experimentation law, constitutes an essential component of modern legal education, highlighting both ethical dilemmas and scientific imperatives. While the United States is steadily integrating this subject into its legal education curriculum, Japan has been slow to implement these reforms.
Japanese Regulations on Animal Experimentation
In Japan, regulations governing animal testing are not strictly defined by law. Instead, each animal testing facility is left to self-regulate and follow voluntary administrative guidelines.
The Law for the Protection and Management of Animals (the PMA) stipulates that animals should not be subjected to unnecessary pain and suffering. It requires using methods during animal experiments that minimize such distress and emphasizes the appropriate use of animals, such as reducing the number of animals used wherever possible. This provision explicitly articulates alignment with the 3Rs in animal testing: replacement, reduction, and refinement. Moreover, three Japanese ministries have issued basic guidelines for animal experimentation. These guidelines are almost identical in content, but the target institutions differ depending on the ministry that issued them. Specifically, the Ministry of Education, Culture, Sports, Science and Technology covers animal experiments at universities, the Ministry of Health, Labor and Welfare covers animal experiments at government facilities, pharmaceutical companies, and contract research organizations, and the Ministry of Agriculture, Forestry and Fisheries covers animal production facilities.
However, facilities that handle laboratory animals are not designated as animal facilities under the PMA. Therefore, these facilities are not subject to the reporting system. As a result, data on the number of facilities that handle laboratory animals and the number of animals held and used in experiments remain unknown to the government and the public. As a result, the appropriate conduct in animal experimentation in Japan relies primarily on self-regulation.
An example of self-regulation, the Science Council of Japan has formulated guidelines for research institutions to adopt in creating voluntary in-house programs for conducting scientifically appropriate animal experiments. These guidelines require the director of each research institution to assume responsibility for the animal experiments conducted within their facilities and establish an internal review committee to review the experiments from a scientific standpoint.
Current Approaches to Teaching Animal Law in Japanese Law Schools
The existence and challenges of the PMA and regulations have received limited attention in Japanese legal education. In Japan, although a core curriculum has been established as a common attainment goal for law school education, it only covers basic law and comprehensive practice subjects (constitutional law, administrative law, civil law, commercial law, civil procedure law, criminal law, criminal procedure law, civil practice, criminal practice, and legal ethics) and no official guidelines have been established for health-related law, including animal law. As a result, health law courses in Japanese law schools focus primarily on medical law, so it is rare to find a well-developed curriculum on health law, including one that covers animal law or public health law. In fact, few scholars specialize in animal law and public health law. On the other hand, in the United States, there are a variety of courses on health law, including FDA regulations, food law, public health law, and animal law. Some law schools offer a variety of animal law courses that include lectures, clinics, advocacy, and comparative law. Also unlike in Japan, lawyers in the United States publish academic papers containing detailed legal analyses regarding the status and treatment of laboratory animals.
The Preferred Law School Curriculum Regarding Animal Testing
In this section, I propose what kind of content should be incorporated in Japanese law schools when they offer a course on animal law. If law schools do not have scholars specializing in this area, it would be better to cooperate with graduate schools in other fields, such as medicine and public health
1.Basic Information and Regulations Regarding Animal Testing
First of all, the course should provide students with a basic knowledge of the regulatory framework for animal experimentation from both a national and international perspective. It will cover the main laws governing animal experimentation in Japan while also examining key foreign regulations such as the Animal Welfare Act in the United States and the European Union’s Directive 2010/63/EU on the protection of animals used for scientific purposes. Emphasis will be placed on understanding the practical application of these laws, their historical context, and their evolution over time.
2.Ethical Perspective and Sustainable Practices Regarding Animal Testing
Ethical considerations are central to the debate surrounding animal experimentation. Therefore, the curriculum should include opportunities to examine the arguments for and against animal experimentation and to explore concepts such as animal rights, speciesism, and the ethical implications of using animals to improve human and animal health. The module will also discuss sustainable practices in animal experimentation, focusing on how regulatory frameworks and ethical guidelines attempt to balance scientific progress with animal welfare. In addition, as an applied discussion, introducing students to the arguments for using new species such as cephalopods in animal experiments could be thought-provoking.
3.Impact of Animal Testing on Scientific Research
Students will develop an understanding of the role of animal experimentation in the advancement of scientific research, recognizing its contributions to advances in the medical and veterinary fields. This includes studying cases where animal experimentation has led to significant scientific breakthroughs, as well as cases where it has proven inadequate. The curriculum will examine the reliability of animal models in predicting human outcomes and the challenges faced in biomedical research.
4. The Need for Animal Testing and Alternatives
It is also crucial to address the continuing need for animal experimentation in certain areas of research while emphasizing the development of alternative methods. Such methods include in vitro techniques, computer modeling, and the use of lower organisms as alternatives to animal testing. The goal is to present a balanced view that recognizes the current need for animal experimentation in certain areas while encouraging the development and regulatory acceptance of alternative research methods. The module will also cover the latest developments, such as the current trend toward the abolition of animal experimentation in the United States and will provide a forum for reflection on the future of animal experimentation and potential improvements.
Conclusion
The disparity in animal law education between Japan and the United States underscores the need for adopting a global perspective in legal education, particularly in areas where ethical and scientific considerations intersect. Enhancing the understanding and application of animal law, guided by ethical imperatives and sustainable scientific practices, can not only significantly enrich legal education in Japan, but also improve the circumstances regarding animal testing generally.
Kenta Minamitani is a Japanese lawyer specializing in health and labor law. He holds a BA in Economics from the University of Tokyo, a JD from Keio Law School, an MPH from Harvard T.H. Chan School of Public Health, and is currently enrolled in the LLM program at Stanford Law School. He has published a number of books, articles and newsletters in the fields of health and labor law. He has been recognized as Best Lawyers: Ones to Watch in Japan™ (both the 2023 and 2024 editions).
Bibliography
Tatsuji Nomura. Japan, ILAR Journal, Volume 37, Issue 2, 1995, Pages 60–61, https://doi.org/10.1093/ilar.37.2.60
Bryan E Ogden, et al. Laboratory Animal Laws, Regulations, Guidelines and Standards in China Mainland, Japan, and Korea, ILAR Journal, Volume 57, Issue 3, 2016, Pages 301-311, https://doi.org/10.1093/ilar/ilw018
The Law Concerning the Protection and Management of Animals. Article 41.
Rihito Yoshida, No. 2 Relationship with Practice (2) Laboratory Animals - Animal Protection Law 2019 Amendment and Practical Issues, LIBRA. Volume 19. No. 11 (Nov. 2019).
Lewis & Clark Law School. https://law.lclark.edu/centers/animal_law_studies/curriculum/
Pamela D. Frasch, Gaps in US Animal Welfare Law for Laboratory Animals: Perspectives From an Animal Law Attorney, ILAR Journal, Volume 57, 2016, Pages 285-292.
JALAS. https://www.jalas.jp/english/en_about.html (Accessed on Nov. 17, 2023)
The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.
