Regenerative medicine and related technologies are advancing rapidly and attracting significant attention in the medical and beauty industries. The evolution of regenerative medicine has dramatically improved medical technology, and its benefits are now spreading to the beauty field. (AGELESS Navigator)Shiho HashimotoMr. and former Vice Minister of Health, Labour and WelfareJunko MiharaWe asked a member of parliament to speak about the current state and future prospects of regenerative medicine in Japan.
Advances in regenerative medicine and ensuring safety
Shiho Hashimoto This time, he was serving as the Vice Minister of Health, Labour and Welfare.Junko MiharaWe would like to invite a member of the House of Councillors to speak about regenerative medicine from an administrative perspective. Recently, Japan's regenerative medicine technology has achieved significant results, such as Professor Yamanaka's research on iPS cells. First, we would like to hear your opinion on how this research should be supported and regulated.
Junko Mihara The Act on Ensuring the Safety of Regenerative Medicine, etc., enacted in 2014, regulates the provision of regenerative medicine and ensures its safety. This law has promoted research and advanced the practical application of the technology. The government, in cooperation with private research institutions and medical institutions, provides various support measures to promote clinical research while ensuring safety.
International evaluation of regenerative medicine technologies
Shiho Hashimoto It seems that Japanese regenerative medicine technology is highly regarded overseas.
Junko Mihara That's right. Regenerative medicine is one of Japan's technologies that the world can be proud of. Japan's efforts are highly regarded internationally, and further development is expected in the future.
Shiho Hashimoto What are your outlook on the future direction of regenerative medicine technology in Japan?
Junko Mihara Regenerative medicine technology in Japan is expected to continue to evolve. The government will continue to collaborate with private research institutions and bio-ventures to promote efficient clinical research while ensuring safety. We will support research and development through AMED research grants and promote the appropriate application of the Regenerative Medicine Act. Regenerative medicine technology is a crucial field that will open up the future of medicine in Japan, and cooperation between the government and the private sector is essential to ensure its safety and effectiveness.
New medical technologies and legal regulations
Shiho Hashimoto In regenerative medicine, new technologies such as stem cell supernatant and exosomes are attracting attention, but how are they regulated under current laws?
Junko Mihara Stem cell supernatants and exosomes are treated as cell fragments and are therefore not subject to the regulations of the Regenerative Medicine Act. Furthermore, no pharmaceuticals utilizing these technologies have received regulatory approval. However, if they are dispensed in-house at the discretion of a physician, they fall outside the scope of the Pharmaceutical Affairs Act and are not regulated under current law.
Shiho Hashimoto However, these technologies are being sold to medical institutions under brand names. What is the legal interpretation of this situation?
Junko Mihara The wholesale distribution to medical institutions is likely conducted for research purposes. These products are provided for the purpose of being mixed with saline solution and other substances within the hospital to be compounded.
Shiho Hashimoto : So, there are no regulations on providing it as research material, right? In that case, how is safety ensured?
Junko Mihara When a drug is actually administered to humans, ensuring safety during the manufacturing process is crucial. Manufacturers must produce the drug in facilities that meet standards to prevent contamination by viruses and bacteria, and conduct contamination and infection tests on each batch. However, in the case of research purposes, the drug may be shipped even if it does not meet certain testing standards. When a physician administers this drug to a patient, they must carefully assess its safety and provide the patient with a thorough explanation.
The current state and regulations of exosomes in the beauty industry
Shiho Hashimoto Recently, exosomes have been advertised as having cosmetic benefits, and unlicensed intravenous therapy is being offered at cosmetic clinics and other establishments. What are your thoughts on this?
Junko Mihara While exosomes are not covered by the Act on Ensuring the Safety of Regenerative Medicine, the Medical Care Act prohibits medical institutions from providing patients with false or exaggerated information. False or exaggerated advertising by medical institutions is legally prohibited. Therefore, the Ministry of Health, Labour and Welfare monitors inappropriate websites, informs medical institutions of the regulations and encourages voluntary review, and provides information to prefectures and gives necessary guidance.
Shiho Hashimoto I recently attended a trade show for cosmetics, health foods, and beauty devices, and exosomes were being heavily promoted. What are your thoughts on this?
Junko Mihara Advertising for cosmetics, health foods, beauty devices, etc., is subject to necessary monitoring and guidance under the Pharmaceuticals and Medical Devices Act. Based on a comprehensive assessment of product labeling and advertising content, products that claim medicinal efficacy are prohibited from sale. To prevent these treatments from being inappropriately performed in clinics, etc., it may be necessary to develop scientific guidelines regarding the administration of exosomes, etc.
Legal framework and future prospects for regenerative medicine
In this discussion on the field of regenerative medicine, we discussed the effects, challenges, and future directions of the implementation of the Regenerative Medicine Act. The implementation of the Regenerative Medicine Act has led to a dramatic advancement in research and practice of regenerative medicine in Japan, attracting global attention. The government has indicated its intention to encourage collaboration with private research institutions and bio-ventures, and to provide support to efficiently advance clinical research while ensuring safety.
On the other hand, it became clear that the application of current laws is limited for new medical technologies such as exosomes and stem cell supernatants, which are not covered by the Regenerative Medicine Act. It was pointed out that in some forms, such as in-hospital dispensing by physicians, the regulations do not apply, leaving challenges in evaluating and managing their safety and effectiveness.
The use and sale of exosomes in the beauty industry also suggests the need for advertising regulations similar to those for pharmaceuticals and medical devices. Exaggerated or false claims about the efficacy of products are prohibited, and compliance with these regulations is required. Furthermore, the development of scientific guidelines and strengthened monitoring and guidance are considered important means of promoting the appropriate use of new medical technologies, including regenerative medicine.
Regenerative medicine technology will continue to evolve and will become a crucial field that will shape the future of Japanese medicine. We can expect an expansion of the scope of application of the Regenerative Medicine Act, the development of legal regulations for new medical technologies, and strengthened monitoring and guidance to ensure safety. As regenerative medicine technology advances, cooperation between the government, medical institutions, and researchers will become increasingly important as we strive to create an environment where safe and effective treatments can be provided.
With the advancement of regenerative medicine technology, new possibilities are opening up in the medical and beauty industries.Shiho HashimotoMr.Junko MiharaThrough the parliamentary discussions, I gained a deeper understanding of the current state and future prospects of regenerative medicine. To ensure the safety and effectiveness of regenerative medicine technology while aiming for further development, continued support and cooperation from all sectors are essential.
Junko Mihara
Born September 13, 1964, in Itabashi Ward, Tokyo. Dropped out of Meiji University Nakano High School. Former actress. First elected to the House of Councillors in July 2010 in the national proportional representation district. Chairperson of the House of Councillors Special Committee on Government Development Assistance and the Okinawa and Northern Territories Issue, Chairperson of the Special Committee on Consumer Affairs, Chairperson of the Health, Labour and Welfare Committee, Director of the Budget Committee, Director of the Health, Labour and Welfare Committee, Director of the Environment Committee, Director of the Special Committee on Abductions by North Korea, Vice Minister of Health, Labour and Welfare, Special Advisor to the Minister of the Cabinet Office, Director of the Liberal Democratic Party Women's Bureau, Chairman of the Liberal Democratic Party Kanagawa Prefecture House of Councillors Electoral District 4 Branch, Standing Advisor to the Liberal Democratic Party Kanagawa Prefecture Federation, Chairman of the Liberal Democratic Party Parliamentary League for the Promotion of Marriage and Bridal Activities, Secretary-General and Secretary-General of the Liberal Democratic Party Parliamentary League for Animal Welfare, Secretary-General of the Liberal Democratic Party Parliamentary League for Motorcycles, Chairperson of the Liberal Democratic Party PT on Motorcycle Issues, Secretary-General of the Liberal Democratic Party Parliamentary League for the Promotion of Motorsports, Secretary-General of the Liberal Democratic Party Parliamentary League for Thinking about the Future of People with Intellectual Disabilities, Elected to the House of Councillors Kanagawa Electoral District in July 2016 and July 2022
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Shiho Hashimoto
Born in Fukuoka Prefecture in 1967. Due to her small stature, lack of athletic ability, and frail constitution, she began track and field in the fourth grade of elementary school under the strict guidance of her father. During her school years, she belonged to the track and field club, and while in junior high school, high school, and university, she competed in national championships as a prefectural and Kyushu representative in ekiden (long-distance relay races). After graduating from the Faculty of Physical Education at Fukuoka University, she joined FBS Fukuoka Broadcasting. She worked in the news department as a reporter and announcer. During her four years and one month of employment, she met Guadalcanal Taka of Takeshi's Army, and they got married just four months after their first meeting, following only three dates. Currently, she is active as a talent in a wide range of fields including television, radio, and magazines, and also delivers the latest health and beauty-related information as an AGELESS navigator.
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