Sato Keigo, Kodama Kota, Sengoku Shintaro
Department of Innovation Science, School of Environment and Society, Institute of Science Tokyo, 3-3-6 Shibaura, Minato-ku, Tokyo 108-0023, Japan.
School of Pharmacy and Pharmaceutical Sciences, Hoshi University, 2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.
Foods. 2024 Oct 18;13(20):3302. doi: 10.3390/foods13203302.
This study addresses the critical need for innovation in the healthcare sector, particularly in Japan's functional food industry, amid rising chronic diseases and healthcare costs. It explores the complex relationship between regulatory design and corporate behaviour, focusing on how companies' compliance strategies influence their research and development (R&D) investments. A mixed-method approach was used, analysing data from 15 major dietary supplement companies and 74 products under Japan's Foods with Function Claims (FFCs) regulation. The study reveals a correlation between companies' engagement in the FFCs system and their preference for conducting in-house clinical trials, indicative of higher R&D investments ( = 0.66, = 0.007), and that between the latter variable and average product sales, which is a measure of returns on regulatory compliance ( = 0.66, = 0.008). Companies actively complying with FFCs regulations tend to conduct R&D and accumulate knowledge in-house, to innovate and differentiate their products, gaining competitive advantages. The study also highlights the role of a company's size, market presence, and industry origins in shaping regulatory strategies, with firms from other industries using FFCs regulations to explore new business opportunities. The research underscores the importance of flexible regulatory frameworks that encourage R&D investment, leading to innovation and competitive advantages in the healthcare sector.
随着慢性病和医疗成本的不断上升，本研究满足了医疗保健领域，尤其是日本功能性食品行业对创新的迫切需求。它探讨了监管设计与企业行为之间的复杂关系，重点关注公司的合规策略如何影响其研发投资。研究采用了混合方法，分析了日本具有功能声称食品（FFCs）法规下15家主要膳食补充剂公司和74种产品的数据。该研究揭示了公司参与FFCs系统与其进行内部临床试验的偏好之间的相关性，这表明研发投资更高（r = 0.66，p = 0.007），以及后一个变量与平均产品销售额之间的相关性，平均产品销售额是监管合规回报的一个衡量指标（r = 0.66，p = 0.008）。积极遵守FFCs法规的公司倾向于在内部进行研发和积累知识，以创新和差异化其产品，从而获得竞争优势。该研究还强调了公司规模、市场地位和行业出身在塑造监管策略中的作用，其他行业的公司利用FFCs法规来探索新的商业机会。该研究强调了灵活监管框架的重要性，这种框架鼓励研发投资，从而在医疗保健领域带来创新和竞争优势。
