@ARTICLE{26583261_55147011_2012, author = {Andrey Pashchenko and Viktoria Hreshkova}, keywords = {, waste, toxic waste, medical waste, waste destruction, clinical researchwaste management}, title = {Legal Regulation of Disposing Medical Drugs Intended for Clinical Trials}, journal = {}, year = {2012}, number = {1}, pages = {69-79}, url = {https://law-journal.hse.ru/en/2012--1/55147011.html}, publisher = {}, abstract = {Pashchenko Andrey - LLM candidate, Department of Financial Law, Law Faculty,National Research University Higher School of Economics, Candidate of Medical Sciences. Address: 20 Myasnitskaya Str., Moscow, 101000, Russian Federation. E-mail: apashchenko@hse.ru.Khreshkova Viktoria - Lecturer, Department of Financial Law, Law Faculty,National Research University Higher School of Economics. Address: 20 Myasnitskaya Str., Moscow, 101000, Russian Federation. E-mail: vkhreshkova@hse.ru.The article reveals the factors which can promote to developing a single approach to regulating the disposal of pharmaceutical drugs aimed for clinical trials. The research is based on the Federal law of 12 April, 2010 № 61-FZ On Circulation of Pharmaceutical Drugs and other RF laws, the Register of medical organizations, decrees of the government and the RF Health Ministry, National State Standard (GOST). The authors criticize the provision under which the RF legislation does not provide any direct information on the pharmaceutical drugs intended for clinical trials. There is no differentiation on the concepts wastes of production and consumption, wastes of healthcare facilities, medical wastes. The control over the disposal of drugs intended for clinical trials are performed by three institutes: Federal Service for the Supervision of Public Health and Social Development, Federal Service for Supervision of Natural Resource Usage, Federal Service for Supervision of Natural Resource Usage. The legislation provides them a discretionary power if disputable situations arise. Interpretation of laws and norms lets the authors conclude that inferior pharmaceutical drugs are wastes of production and consumption but their handling is not regulated by the Law on Wastes of Production and Consumption. Applying normative basis has met challenges. The authors conclude that terminology requires unification and the law on handling pharmaceutical drugs needs development.}, annote = {Pashchenko Andrey - LLM candidate, Department of Financial Law, Law Faculty,National Research University Higher School of Economics, Candidate of Medical Sciences. Address: 20 Myasnitskaya Str., Moscow, 101000, Russian Federation. E-mail: apashchenko@hse.ru.Khreshkova Viktoria - Lecturer, Department of Financial Law, Law Faculty,National Research University Higher School of Economics. Address: 20 Myasnitskaya Str., Moscow, 101000, Russian Federation. E-mail: vkhreshkova@hse.ru.The article reveals the factors which can promote to developing a single approach to regulating the disposal of pharmaceutical drugs aimed for clinical trials. The research is based on the Federal law of 12 April, 2010 № 61-FZ On Circulation of Pharmaceutical Drugs and other RF laws, the Register of medical organizations, decrees of the government and the RF Health Ministry, National State Standard (GOST). The authors criticize the provision under which the RF legislation does not provide any direct information on the pharmaceutical drugs intended for clinical trials. There is no differentiation on the concepts wastes of production and consumption, wastes of healthcare facilities, medical wastes. The control over the disposal of drugs intended for clinical trials are performed by three institutes: Federal Service for the Supervision of Public Health and Social Development, Federal Service for Supervision of Natural Resource Usage, Federal Service for Supervision of Natural Resource Usage. The legislation provides them a discretionary power if disputable situations arise. Interpretation of laws and norms lets the authors conclude that inferior pharmaceutical drugs are wastes of production and consumption but their handling is not regulated by the Law on Wastes of Production and Consumption. Applying normative basis has met challenges. The authors conclude that terminology requires unification and the law on handling pharmaceutical drugs needs development.} }