Responsible Translation of Regenerative Medicine in Japan

Abstract

Background Issues:
Healthcare is essential for individuals and society, but faces challenges such as diseases, aging populations, financial burdens, and fair distribution of services. Regenerative medicine, which aims to replace or regenerate human cells, tissues, or organs, offers promising solutions but encounters difficulties in transitioning from research to clinical practice. This transition requires societal changes including political, regulatory, and public acceptance.

Regenerative Medicine in Japan:
Japan’s healthcare system is strained by an aging population and other health issues. To address this, Japan has implemented unique regulations over the past decade to promote regenerative medicine. These regulations allow hospitals to provide regenerative treatments without extensive scientific assessments and enable pharmaceutical companies to market products with conditional approval before full scientific validation. Although these measures aim to expedite access and industry growth, they also raise concerns about safety and standardization.

Research Question:
This research investigates how ethical considerations can be incorporated into the translation of regenerative medicine in Japan. Using an interdisciplinary approach, the study examines key processes and actors involved, ethical issues, and potential solutions through literature review, actor analysis, thematic analysis, conceptual synthesis, and an online questionnaire with supplementary interviews.

Results and Conclusion:
Key processes and influential actors in the translation of regenerative medicine in Japan were identified, including the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Education, Culture, Sports, Science and Technology (MEXT), large hospitals, and universities/national research institutions. Current and potential ethical issues were explored, with suggested approaches derived from literature and comparative analysis with other countries.

Recommendations include:

MHLW should clearly define terms like “unproven,” “innovative,” “research,” and “treatment.”
Hospitals should refine their practices and guidelines, collaborating with MHLW and MEXT.
MHLW and MEXT should gather feedback from practitioners to update ethical guidelines.
Doctors and researchers should contribute to policy-making and practical guideline reflections.
Public discussion should be encouraged to gain societal acceptance and contribute to policy formation.

The research proposes a framework for incorporating ethical considerations into regenerative medicine in Japan, offering insights for policy refinement and further research in emerging technologies both in Japan and globally.