A message from ​ the Chairperson

Twenty years of Regenerative Medicine and Our Connection

Ken-ichiro Hata, Chairperson of the Forum for Innovative Regenerative Medicine
Ken-ichiro Hata, Chairperson of the Forum for Innovative Regenerative Medicine

It was the Millennium Project planned by the Obuchi Cabinet in 1999 when the term “Saisei-Iryo”, or Regenerative medicine in English, made an appearance in Japan. Twenty years have passed since then. During that time, nine products were marketed as regenerative medicine products. Seven of these are cell-based, and two are gene therapy. In 2001, the Japanese Society for Regenerative Medicine, the largest academic association in the field of regenerative medicine in Japan, was established. The number of members now exceeds 6000 after approximately 20 years of the history. FIRM started in 2011, and 256 companies currently participate in the program. Do you think 20 years is a long or short time? Do you think these results over two decades are many or few? I think that you may have different impressions for each of them.
Japan’s related regulatory reforms in 2014 were also very important for regenerative medicine. The category “Regenerative Medicine products” was defined, and it was an opportunity to think about the characteristic content different from conventional pharmaceuticals and medical devices. Regenerative medicine requires diverse and complex modalities. In particular, those transplanted for tissue regeneration have the characteristics of both a “product” provided by companies and of a “medical procedure” provided by medical institutions. In order to develop regenerative medicine, in addition to how to develop these rationally, we must build a method to evaluate them appropriately, and then look for better ways to use them after use. “Regenerative Medicine Safety Assurance Act” and “Conditional and Time-Limited Approval” now receive a variety of opinions from overseas. However, this regenerative medicine contains many realistic contents from the perspective of a “product” and a “medical procedure.” Currently, we are in the process of firmly appealing to the Japanese system of regenerative medicine. We believe the Japanese system has much to offer the model of regenerative medicine, so while we are taking into account the different viewpoints of international cooperation, we believe in the system and hope that regulation of regenerative medicine can become a major subject not only in Japan, but around the world a well.
In this way, the biggest achievements over the last two decades may be all the contents we have discussed under the new category of regenerative medicine so far; Where to disclose as a cooperative area and where to compete. Even this cannot be considered in existing frameworks, as regenerative medicine is falsely similar to the conventional drugs and medical devices. What should an appropriate business model look like? All members of FIRM worked to conceive an unknown area of regenerative medicine after various discussions, literally without pay, together with the government and academia. We are convinced that this experience is essential for the future development of regenerative medicine in Japan.

We are currently being deprived of the connection among people by the threat of new coronavirus (COVID-19). The Earth, which has become smaller under globalization, also has the potential to change significantly through the prolongation of this influence. Needless to say, new and unique industries and cultures will also emerge. However, in order to develop the complex field of regenerative medicine, industry-academia-government collaboration, collaboration between companies, and cooperation between goods and technologies will not be born without a connection. I look forward to the return of our daily lives, where we can overcome this disaster and have discussions together in the future.

Ken-ichiro Hata, Chairperson of the Forum for Innovative Regenerative Medicine