The meaning of "evaluation under Article 53" under Article 56 (2) 1 of the former Medical Service Act and the scope of "new medical technology which has not undergone the evaluation under Article 53" prohibited by Article 56 (2) 1 of the former Medical Service Act.

Articles 53(1) and (2), 54, 56(2)1, and 89 of the former Medical Service Act (Amended by Act No. 9932, Jan. 18, 2010);

Defendant

Prosecutor

Law Firm Jeong, Attorneys Kim Jin-jin et al.

Ulsan District Court Decision 2011No261 decided June 24, 2011

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 shall be placed on “new medical technology that fails to undergo evaluation under Article 53”.

Article 53(1) of the Act provides that “The Minister of Health, Welfare and Family Affairs shall conduct an assessment of the safety, effectiveness, etc. of new medical technology (hereinafter “assessment of new medical technology”) under Article 54 of the Act, as prescribed by Presidential Decree, in order to protect national health and promote the development of medical technology” (hereinafter “Evaluation Committee”), and Article 53(2) of the Act provides that “The Minister of Health, Welfare and Family Affairs deems it necessary to assess the safety and effectiveness of new medical technology under Article 53(1) as the newly developed medical technology.” In light of the relationship between the above provisions and their language, Article 53(2) of the Act is not a provision that generally define new medical technology, but rather a provision that sets the requirements for prior examination or procedure for being subject to the assessment of new medical technology by the Evaluation Committee under Article 53(1) of the Act 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 of the language and text, namely, the “new health technology evaluation conducted by the Minister of Health and Welfare as deemed necessary to assess new health technology.” In other words, it is interpreted that the new health technology evaluation conducted by the Minister of Health and Welfare without going through deliberation by the Evaluation Committee, i.e., new health technology evaluation conducted by the Minister of Health and Welfare, although it is recognized that there is a need to assess new health technology, and the new health technology that was not subject to new health technology evaluation by the Evaluation Committee because it did not deny or judge whether it is necessary to assess new health technology, is prohibited as an “new health technology which was not subject to new health technology evaluation under Article 53”.

Medical technology refers to medical treatment, diagnosis, prescription, medication, or surgery on the basis of medical expertise, and other acts likely to cause harm to public health and hygiene if performed by a medical person (see Supreme Court Decision 2004Do3405, Oct. 28, 2004). As such, medical technology performed as medical practice should be based on experience and skill based on medical expertise. Accordingly, it is necessary to establish medical safety and effectiveness as long as it is a medical technology. Accordingly, medical practice is not subject to new safety and effectiveness assessment under Article 14 of the former Medical Service Act (Act No. 8366, Apr. 11, 2007). As such, medical practice is not subject to new safety and effectiveness assessment under Article 5 of the former Medical Service Act (amended by Act No. 8367, Oct. 27, 2006).

2. On the grounds stated in its reasoning, including the provision of Article 53(2) of the Act, the lower court deems that the new medical technology is subject to the assessment of new medical technology that the Minister of Health and Welfare recognizes as necessary to assess the safety and effectiveness of the new medical technology, and that the advertisement of the new medical technology for which the need is recognized by the Minister of Health, Welfare and Family Affairs is restricted, and that the advertisement is not limited for the new medical technology that did not determine

However, it is almost impossible for the Minister of Health, Welfare and Family Affairs to identify all new medical technologies and determine the necessity of evaluation of their safety and effectiveness in advance, and there is no clear provision recognizing duties in the former Medical Service Act, etc. Accordingly, according to the opinion of the court below, among new medical technologies for which the Minister of Health, Welfare and Family Affairs did not determine the necessity of evaluation thereof, the Minister may have health technologies suspected of safety and effectiveness and allow advertisement thereof without any evaluation of their safety and effectiveness. This goes against the language and text of Article 56 of the Act prohibiting advertisements that did not undergo new medical technology evaluation and the purport of the Act aiming at protecting and promoting the health of the people. Rather, a person wishing to undergo new medical technology evaluation may undergo new health technology evaluation under Article 53 of the former Regulations on the Evaluation of New Medical Technology (amended by Ordinance of the Ministry of Health, Welfare and Family Affairs No. 19, Mar. 19, 2010). Thus, in order to advertise new medical technology that did not undergo new health technology evaluation, the Minister of Health, Welfare and Family Affairs, despite its necessity is not permissible.

Therefore, the court below's finding the defendant not guilty on the ground that the Minister for Health, Welfare and Family Affairs recognized the necessity of the evaluation of new medical technology prohibited by Article 56 (2) 1 of the Act, but it is not unlawful as it erred by misapprehending the legal principles on advertisements of new medical technology prohibited by Article 56 (2) 1 of the Act. The prosecutor's grounds for appeal pointing this out are with merit.

3. Therefore, the lower judgment is reversed, and the case is remanded to the lower court for further proceedings consistent with this Opinion. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Shin Young-chul (Presiding Justice)