[1] The case holding that an act of advertising a medical device that obtained permission for manufacturing as an item for relaxation of transit constitutes an exaggerated advertisement prohibited by Article 23 (2) 1 of the Medical Devices Act, as if the medical device had special efficacy and effect on a pre-affiliated disease

[2] Whether Article 23(3)5 of the Enforcement Rule of the Medical Devices Act prohibiting “advertisement using a user’s audit or experience room, regardless of the authenticity of the content, exceeds the delegation scope of the mother’s law, or goes against the principle of excessive prohibition (negative)

[1] Articles 23(2)1 and 44 of the Medical Devices Act / [2] Articles 23(2)3 and 44(1) of the Medical Devices Act; Article 29(1)5 of the Enforcement Rule of the Medical Devices Act

Defendant

Defendant

Attorney Park Dong-dong

Seoul Central District Court Decision 2006No1878 Decided October 31, 2006

The appeal is dismissed.

We examine the grounds of appeal.

1. Regarding ground of appeal No. 1

Article 23(2) of the Medical Devices Act prohibits “a false or exaggerated advertisement on the name, manufacturing method, performance, efficacy, effect, or principle of such name, efficacy, or effect of a medical device” under subparagraph 1 of the same Article, and provides a penal provision thereon under Article 44. The aforementioned provision is intended to regulate false or exaggerated advertisements on the efficacy, etc. of a medical device to the extent that it does not infringe the consumer’s right to know or right to choose, as the advertisement on the medical device is completely permitted without any restriction, there is a risk that consumers’ accurate judgment may be affected due to reckless false or exaggerated advertisements if it is permitted without restriction on the advertisement on the medical device.

In full view of the relevant employment evidence, the lower court: (a) stated that the instant medical device was manufactured as “personal hot heater” item, which is the second grade medical device for the purpose of relaxing the “sniffic transit”; (b) in the case of the second grade medical device, the use of the medical device is not permitted as a matter of principle; (c) advertised the Defendant to use the instant medical device by inserting it into the port of a human body into the workplace, and directly inserting the workplace into the front line; (d) further, the Defendant advertised the instant medical device in daily newspapers, etc. with the phrase “J2V” and “IV’s self-defiction fiction fiction fiction ficende ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen ficen fics; and (c) compared the Defendant’s legitimate use and effect of the instant medical device.

The court below did not err in the misapprehension of the rules of evidence or the misapprehension of the legal principle as to an exaggerated advertisement of medical devices.

2. Regarding ground of appeal No. 2

Since it is practically impossible to provide for all laws and regulations related to criminal punishment without exception due to the complex diversification of social phenomenon, the limit of professional and technical ability of the National Assembly and the limit of professional and technological ability to adapt to time, it is not only impossible in fact to provide for all laws and regulations related to criminal punishment by law within a formal meaning without exception, and it is not appropriate to do so, in particular, if there are unavoidable circumstances in which it is urgently required or it is impossible to provide in advance with a prior law, the delegation legislation is allowed under the premise that the act subject to punishment is clearly defined in terms of the constituent elements, and in terms of punishment, the kind, limit and width of punishment are clearly defined, and such delegation legislation is not contrary to the principle of no punishment without law (see Constitutional Court Order 94HunMa213 delivered on February 29, 196)

Article 23(2) of the Medical Devices Act provides that "no person shall place any advertisement falling under any of the following subparagraphs in connection with the advertisement of a medical device." Article 23(2)3 of the same Act provides that "an advertisement with respect to the performance, efficacy, and effect of a medical device shall be one of advertisements prohibited from using secret articles, photographs, designs, or other visual methods". Article 23(3) of the same Act provides that "necessary matters concerning the entries of a medical device and the scope of advertisements under the provisions of paragraphs (1) and (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare" and delegates the scope of advertisements specifically prohibited by the Enforcement Rule. Article 29(1)3 of the Enforcement Rule of the same Act provides that "in advertising efficacy or performance, any person shall not display or suggest the result of use by comparing it before and after the use, or an advertisement that indicates or suggests the result of use by a threat of adaptation," and Article 29(1)3 of the same Act prohibits any person who violates Article 4(2)3) of the Medical Devices Act.

The court below held that the delegation of the specific scope of the medical device to the Enforcement Rule of the Medical Devices Act was due to the fact that it is practically impossible to provide for the contents related to criminal punishment in the form of law without any omission, and also, the Enforcement Rule of the Medical Devices Act, which was enacted upon delegation of the mother law, stipulates the "in-service posting" as one of the "other in-cry advertisement" and its content does not seem to have been a new constituent element beyond the delegation scope of the mother law. In light of the contents and purport of the relevant provisions, the court below's above determination is just.

On the other hand, Article 23(2)3 of the Medical Devices Act does not regulate only false advertisements by means of cryptive means, and thus, Article 29(1)5 of the Enforcement Rule of the Medical Devices Act prohibits “advertisement using a user’s audit room or experience room” regardless of whether the content is true, it cannot be deemed as a new prohibited act beyond the scope of delegation.

In addition, the court below is just in holding that even if the contents of the experience center are true or false, it cannot be viewed as violating the excessive prohibition principle, considering the fact that it is necessary to prohibit advertisements that are not secured objectivity regardless of whether the contents of the experience center are true or false, and thus, even if the contents of the experience center are prohibited from all advertisement using it, it cannot be viewed as violating the excessive prohibition principle.

The court below did not err in the misapprehension of legal principles as to the limitation of delegated legislation or the principle of excessive prohibition under the Constitution, as alleged in the grounds of appeal.

3. Conclusion

Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices on the bench.

Justices Shin Hyun-chul (Presiding Justice)