의료법위반
The judgment of the court below is reversed, and the case is remanded to the Ulsan District Court Panel Division.
The grounds of appeal are examined.
1. Article 56(2)1 of the former Medical Service Act (amended by Act No. 932, Jan. 18, 2010; hereinafter “Act”) provides that no advertisement of “new medical technology which has failed to undergo the evaluation under Article 53” shall be placed.
Article 53(1) of the Act provides that “The Minister of Health, Welfare and Family Affairs shall conduct an evaluation of the safety, effectiveness, etc. of new medical technology (hereinafter referred to as “evaluation of new medical technology”) after deliberation by the Committee for Evaluation of New Medical Technology under Article 54 of the Act (hereinafter referred to as the “Evaluation Committee”) as prescribed by Presidential Decree in order to protect national health and promote the development of medical technology.” Article 53(2) of the Act provides that “The new medical technology under paragraph (1) is newly developed and deemed necessary to evaluate the safety and effectiveness of new medical technology.”
In light of the relationship between the above provisions and the language and text thereof, Article 53(2) of the Act is not a provision that generally define new medical technology, but it seems that the requirements or prior examination procedure for becoming an object of assessment of new medical technology by the Evaluation Committee under Article 53(1) of the Act is set as a new medical technology.
Therefore, the "evaluation under Article 53" under Article 56 (2) 1 of the Act refers to the evaluation under Article 53 as it is, namely, the "evaluation of new medical technology which is newly developed" after deliberation by the Evaluation Committee, by the Minister of Health and Welfare as deemed necessary for the evaluation of new medical technology by the Minister of Health and Welfare. In other words, the new medical technology which is newly developed without the evaluation of new medical technology is recognized as necessary by the Evaluation Committee, but its safety and effectiveness has not been recognized by the Evaluation Committee.