의료기기분쟁과 분쟁조정제도— 독일의 법적 현황을 참고하여 —

Abstract

Recently, as medical device disputes such as human rights violations due to medical devices increase, the revision of the Korean 「Medical Devices Act」 is being reviewed. As the proportion of medical devices in medical practice today increases, resolving the problem of defects in medical devices and its disputes becomes an important issue. Accordingly, it is necessary to establish a legal system that can adequately protect patients and users from damage caused by defects in medical devices. The amendment to the Korean 「Medical Devices Act」 is evaluated to take into account this awareness. The amendment proposes two main things. The first is to oblige the manufacturers of medical devices to buy a liability insurance. The second is to establish a dispute mediation system for the medical device disputes. So, is this amendment valid? To review that question, this article uses the comparative law method. In particular, this article examines the legal system and situation of Germany, which has had a great influence on Korean legal systems, especially how it regulates dispute settlement of medical devices. Through those, this article has obtained the following implications. First, the German 「Medical Devices Act」 does not contain legal and institutional mechanisms that govern medical device disputes. Second, German legal systems do not have a medical dispute mediation law dedicated to medical disputes like ours. The ADR on medical disputes is established by the private sector. The ‘Schlichtungsstelle’ or ‘Gutachterkommssion’ are those. Third, ‘Freiwilligkeit’ and ‘Unverbindlichkeit’ are applied as basic principles to the ‘Schlichtungsstelle’ and ‘Gutachterkommssion’. Fourth, the ADR for medical device disputes can refer to the mediation system according to the German mediation law. The mediation under the German mediation law is also ruled by the principle of autonomy. Based on these implications, this article evaluates the amendment of the Korean 「Medical Devices Act」 as follows. First of all, the amendment which mandates buying a liability insurance can be evaluated positively. However, the establishment of an administrative dispute mediation system should meet questions. This is because the administrative dispute mediation system does not seem to fit the original purpose of the mediation system. In particular, it seems to be a problem to impart a strong legal binding power to agreements reached through a mediation. Of course, the article does not argue that the agreements should have no legal binding power. Instead, it seems appropriate for the author to recognize the legal binding power as executive power to improve the efficiency of the mediation system in agreements reached through a mediation. In addition, this article proposes the following measures for legal policy. This is a propose to add medical device disputes to the subject under the jurisdiction of the medical dispute mediation system currently in operation in Korea