Balancing Innovation & Protection: IP in the EU's Health Data Space vs. Japan's Framework
Seminar with Takeshi S. Komatani, Ph.D., LL.M.
The secondary use of health data—whether for clinical trials, real-world evidence, or genomics—holds enormous potential to accelerate innovation. Yet, it also raises critical challenges around data protection, privacy, and intellectual property. This seminar explores two contrasting governance models: the European Health Data Space (EHDS) and Japan’s current legal framework under the Act on the Protection of Personal Information (APPI) and the Unfair Competition Prevention Act (UCPA).
The EHDS represents a proactive “by-design” approach, featuring secure processing environments and output vetting to minimize risks while enabling cross-border data use. By contrast, Japan’s system takes a reactive “rights and remedies” approach, relying heavily on contractual agreements and ex-post enforcement, which places a substantial burden on data holders.
Through a comparative analysis, the seminar will highlight strengths and weaknesses of each system, and propose several models for Japan including new models such as those combining contractual flexibility with stronger governance and secure infrastructure.
Bio
Takeshi S. Komatani, Ph.D., LL.M., is a litigation-certified Japanese patent attorney and an acclaimed IP strategist, specialising in the pharmaceutical and life sciences sectors. His expertise, deeply rooted in his early career as a pharmaceutical researcher at F. Hoffmann-La Roche AG in Basel, Switzerland, lies in crafting and executing comprehensive IP strategies that bridge cutting-edge science with sophisticated legal practice, driving innovation from academic research to global commercialisation.
Takeshi is also deeply engaged in academia, contributing to the education and development of future leaders in IP and life sciences. He serves as a Visiting Professor at Kobe University's Graduate School of Science, Technology and Innovation (since 2021) and Doshisha University's Graduate School of Medical Sciences (since 2023). He also lectures regularly at esteemed institutions such as Keio University Law School (IP law practice in life sciences), the University of Tokyo (IP studies in pharmaceutical medicine), and Osaka University, where he contributes to the EU-certified PharmaTrain program. His interdisciplinary approach is grounded in dual doctoral training—a Ph.D. in Pharmaceutical Sciences from the University of Tokyo and a second Ph.D. in Law from Keio University (already defended), complemented by an LL.M. in Global Legal Practice with IP Certificate therefrom. His most recent Ph.D. dissertation was directed to IP protection of pharmaceutical research data, which was featured in the most recent annual conference of Japan Association of Industrial Property Law held in June, 2025.
Internationally, Takeshi holds key leadership positions within the International Association for the Protection of Intellectual Property (AIPPI), serving as Head of the Genetic Resources Subcommittee, Vice Chair of the TRIPS Standing Committee, and Senior Director of AIPPI-Japan.