Avoiding ambiguity, enhancing transparency

Abstract

When new technologies with powerful social impacts are developed, the corresponding regulatory system follows as well. While the social and economic benefits from the technologies are important, it is the state’s duty to protect its citizens’ right to safety. In the health technology sector in South Korea, there is a regulatory system called new Health Technology Assessment (nHTA), but its status as a gatekeeper has been greatly damaged recently. This study analyzes the issues of ambiguity and transparency, which are directly related to the legitimacy of nHTA. Along with the absence of a clear legal definition of health technology, the conceptual ambiguity inherent in the word itself has caused the procedural ambiguity of nHTA. Moreover, the ambiguity gave rise to the boundary work surrounding the objects and procedures of evaluation between the National Evidence-based Healthcare Collaborating Agency (NECA) and the Korea Food and Drug Administration (KFDA), which has greatly reduced the regulatory functions of nHTA. In addition to the issue of ambiguity, nHTA is faced with the problem of transparency. The transparency of the system is obtained and enhanced in two primary ways. The first is through an ostensible public participation in decision-making process under the banner of Medical Service Act and the second through a harmonious agreement among internal experts who have a decision-making authority. This study focuses on the decision of nHTA system to strengthen its transparency by allowing the public participation in its decision-making process in order to secure its institutional legitimacy. This study has also examined whether unclear legal definitions have an effect on the legitimacy of regulatory institutions and programs.