摘要:Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a national and international public good instead of a private good and proposes that the government should oversee and fund the clinical trials to stimulate more innovative research and development with lower costs and better information.
关键词:Prescription Drugs; Clinical Trial; Patent; Public Policy; Public Disclosure; Marketing Exclusivity; Drug Company; Clinical Trial Data