경계영역 보건의료제품의 안전관리에 관한 행정법적 쟁점

Abstract

The COVID-19 infectious disease health crisis, which has recently spread worldwide, has provided an opportunity to increase the number of products which using advanced convergence-technologies in the health and medical field. As of the increasing demand for various products for diagnosis, prevention, as well as treatment of diseases, there are some cases that cannot be managed by classifying them into specific regulatory types currently set. Accordingly, in order to prepare an appropriate management system, a theoretical review of the law is required to prepare a plan to reasonably manage emerging new-atypical cases. In particular, various types of health care products applying advanced technology or convergence technology are being released as the technology that utilizes drugs, medical devices, and health care products changes and develops.
 To address these issues, administrative authorities regulating the health and medical product sector sometimes prepare ‘borderline guidance’ so as to ensure consistency in law enforcement. This article examines how to classify and approach products that across the boundary areas, such as food/pharmaceuticals, health functional foods/pharmaceuticals, pharmaceuticals/ medical devices, quasi-drugs/hygiene products, and health products/industrial products, and how to establish classification standards.
 Borderline health and medical products have the characteristics of invasiveness in the human body and irreversibility of effects due to the inherent characteristics of the product. For this reason, the management system for boundary health products should consider the following: It is assumed that convergent helath products which sold in the consumer goods market might have information asymmetry between producers and consumers when new technologies are applied, and measures are sought to protect consumers. The legal system governing convergence health products may have similarities with the legal system in the field of product safety law. However, it is necessary to consider the specificity of the health care field. In addition, a management system applicable to each regulatory area of the boundary product was developed by the dual management system that of the health-medical product market centered on the regulation of consumer information and that of the specific medical service delivering system where used health care products as a medium of medical service. It is desirable to establish product classification criteria based on sound legal theory so as to guarantee institutional consistency and predictability.