가축질병의 진단과 치료를 위한 유전자기술의 활용에 관한 법적 쟁점

Legal Issues Regarding Utilization of Genetic Technology for Diagnosis and Treatment of Livestock Disease

Regulation of gene technology should be applied differently depending on contents of individual genetic technology, its scope of application, and effect. At this time, it is desirable to establish the legislations that specify the content, method, and degree of differentiated regulation according to the characteristics of genetic technology by delegated administrative legislation or the rules of the specialized agencies, taking into consideration the characteristics of each genetic technology applied to veterinary health. The European Parliament is now restructuring the regulation of veterinary medicine in 2015. March 18, 2015, European Parliament’s Environmental Health Food Safety Committee (Environment, Public Health and Food Safety (ENVI) committee) hold a meeting on the European Union Regional Animal Pharmaceutical market regulation to simplify and comprehensively readjust it for amendment to the agreement. The background of regulatory change is designed to separate the regulatory sysstem into dual system, human medicine and veterinary medicine. Until the European Union has maintained in parallel system the human medicine and the veterinary drug. But human medicines and veterinary medicine was recognized as a needed separated regulatory object. However, the European Parliament recognized the problem of law enforcement based on the type of guidelines and decisions adopted inside the European Commission s revised guidelines for medicines in 2009 for animals. In the decision it proposed to the European Commission, while strengthening the supervision of animal food veterinary medicine remaining in the system at the same time restructuring the norms so as not to discourage the availability of veterinary medicine. Efforts of these changes has been promoted for the past five years the drug regulatory system for animals in the future. Our country also needs to develop regulatory tools how to manage separately human medicine and veterinary medicine so as to promote public health protection, while ensuring the possibility of appropriate use of medicines and medical devices applied with genetic technology for animals.