International clinical trials: Policy, legal and ethical implications

Abstract

The article discusses a number of challenges of the Russian legislation relevant to the pharmaceutical industry. It considers the problem of establishing national and international mechanisms for legal protection of clinical trial results. According to the legislation of the Russian Federation, such clinical trials as research and development studies are a kind of studies performed either under a civil contract or a public contract. Research results are presented in respective reports subject to state registration of medicines along with other documents. A research report that refers to intellectual property can be both a way to present research and development studies as well as their integral part and the proof of research. A patent research must ensure timely identification of protectable results of research and development and design and engineering studies so that its legal owner could register his/her intellectual property rights. It is reasonable to develop a mechanism for confirming customer's exclusive rights to use the results of research and development studies if they are made either under a civil contract or a public (municipal) contract