Price Regulation, Intellectual Property Rights, and Business Model of Life Science

为了评价日本的生命科学研究政策，本研究以日本制药业为研究对象。首先，我们考察了价格调控在国家健康保险计划中的作用。本研究考察了价格变量与需求之间的关系。本文研究的重点是“价差比”，即官方价格与批发价格之差除以官方价格。由于官方降价，这一比率在20世纪90年代末急剧下降。而存在仿制药竞争的老产品所占的比例更高，说明老产品的销售者为抵御仿制药竞争而大幅降低了批发价格。即使在90年代后期，较高的价差比率也会增加对产品的需求，这一事实表明，即使在那个时期，价格竞争也很普遍。其次，我们通过使用各种专利数据来检查制药技术的来源。这项研究更多地关注于区位、类型、技术、企业规模和制度类型。据调查，美国和欧洲的制药企业已经建立了由小型生物技术企业、大学、公共研究所组成的技术社会分工。日本制药公司落后于美国和欧洲制药公司。第三，本研究考察了制药企业在面临降价时是否能够为不断增加的研发支出提供资金。本文通过对未来医药产品、需求、研发支出和研发项目失败率的假设，考察了制药企业的盈利能力。研究发现，如果制药企业的研发支出继续以目前的速度增长，企业将无法维持研发支出的增长。本文的研究结论是，制药企业需要更宽松的官方价格监管，向研发过程中注入大量公共资金，或者干脆放弃目前依靠产品现金流获得研发资金的商业模式。少

To evaluate Japanese life science research policy, this study investigates Japanese pharmaceutical industry. First, we investigate the role of price regulation for the purpose of national health insurance plan. This study examines the relationship between price variables and demand. This study focuses on the "price difference ratio" defined as the difference between the official price and the wholesale price divided by the official price. The ratio has declined sharply in the late 1990s in response to the official price reduction. Old products with generic competition, however, are found to have higher ratio, which fact indicates that seller of old products significantly reduces the wholesale prices to fend off generic competition. The higher price difference ratio could increase demand for products even in the late 1990s, which fact shows price competition prevailed even in that period.Second, we examine the sources of pharmaceutical technology by using various patent data. This study … More focuses on location, type, of technology, scale of firms, type of institutions. The U.S. and European pharmaceutical firms are found to have established technological social division of labor ranging small biotechnology firms, universities, and public research institutes. Japanese pharmaceutical firms are behind the U.S. and European firms.Third, this study examines whether pharmaceutical firms can finance ever increasing R&D expenditure when they face price reduction. By making assumption on future pharmaceutical products, demand, R&D expenditure, and failure rates of R&D projects, this study examines profitability of a pharmaceutical firm. We find that pharmaceutical firms will not be able to sustain R&D expenditure when it continues to increase with current rate. This study concludes that pharmaceutical firms need more lenient official price regulation, infusion of huge public fund into R&D process, or simply abandon current business model relying on R&D finance from cash flow from products. Less