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.
본 논문은 신의료기술평가제도의 정당성과 직접적 연관이 있는 모호성과 투명성 쟁점을 사회과학적 관점을 통해 분석한다. 신의료기술평가제도의 절차적 모호성은 평가 대상과 과정을 둘러싼 유관기관들 사이의 ‘경계작업’을 유발시킨다. 이들 간의 모호한 경계는 명확한 법적 정의의 부재와 더불어 ‘의료기술’이라는 개념 자체에 내제된 모호성으로 인해 빚어진다. 신의료기술평가제도는 모호성 이외에도 투명성 문제를 안고 있다. 제도의 투명성은 크게 두 가지 경로를 통해 확보 및 강화되는데, 첫째로 법적 규정에 의거한 의사결정과정에서의 표면적 시민참여, 그리고 두 번째로 실제 의사결정 권한이 있는 내부 전문가들간의 원만한 합의 도출을 통해 이루어진다. 본 연구는 신의료기술평가제도가 존립의 정당성을 확보하기 위해 의사결정과정에서의 시민 참여를 통한 투명성 강화를 중요한 방법으로 택했다는 점에 초점을 두며, 불분명한 법적 정의가 제도 및 기관의 존립에 미치는 영향을 검토했다는 점에서 의의가 있다.
