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，本研究对日本制药行业进行了调查。首先，我们考察了价格管制在全民医保计划中的作用。本研究考察了价格变量与需求之间的关系。本研究的重点是“差价比”，它的定义是官方价格与批发价格之间的差额除以官方价格。这一比例在20世纪90年代末因官方降价而大幅下降。然而，存在仿制药竞争的旧产品的比例较高，这表明旧产品的销售者显著降低了批发价以抵御仿制药竞争。即使在20世纪90年代末，较高的价差率也可能增加对产品的需求，这表明即使在那个时期，价格竞争也是占上风的。其次，我们利用各种专利数据考察了制药技术的来源。这项研究…更多地关注地点、类型、技术、公司规模和机构类型。美国和欧洲的制药公司被发现已经建立了技术社会分工，范围包括小型生物技术公司、大学和公共研究机构。日本制药公司落后于美国和欧洲公司。第三，这项研究考察了当制药公司面临降价时，它们是否能够为不断增加的研发支出提供资金。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，本研究考察了制药企业的盈利能力。我们发现，当R&D支出继续以目前的速度增长时，制药公司将无法维持研发支出。这项研究的结论是，制药企业需要更加宽松的官方价格管制，在研发过程中注入巨额公共资金，或者干脆放弃目前依赖研发资金从产品现金流中获得资金的商业模式。较少

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