Seoul Radiation Services Co., Ltd. (Bae LLC, Attorneys Cho Nam-tae et al., Counsel for the defendant-appellant)

Director of the Korea Centers for Disease Control and Prevention (Government Legal Service, Attorneys Maximum Iron et al., Counsel for defendant-appellant

August 18, 2016

1. On November 30, 2015, the Defendant’s revocation of the registration of measuring agency against the Plaintiff shall be revoked.

2. The costs of the lawsuit are assessed against the defendant.

The same shall apply to the order.

1. Details and details of the disposition;

A. From October 31, 1995 to July 21, 2014, pursuant to Article 6 of the Rules on the Safety Control of Radiation Generating Devices for Diagnosis (hereinafter “Safety Control Rules”), the Plaintiff has been designated or registered as an institution measuring the exposed dose of radiation for radiation-related workers (hereinafter “measurement institution”).

B. From April 17, 2014 to April 18, 2014, the Plaintiff filed an application for re-registration with the Defendant, and received on-site inspections from the Defendant pursuant to Article 7 of the Radiation Safety Control Regulations for Diagnosis (hereinafter “instant Safety Control Regulations”), etc., and received the determination of suitability as a result thereof, and re-registered as a measuring agency on July 21, 2014 (term of validity: from July 22, 2014 to July 21, 2018).

C. Around November 11, 2014, the Defendant received a civil petition with the purport that “the Plaintiff is in an inappropriate conduct of measurement” through a citizen newspaper. Accordingly, the Defendant: (a) conduct an on-site investigation against the Plaintiff from November 18, 2014 to November 19, 2014; (b) conduct an additional investigation from November 20, 2014 to December 3, 2014; (c) conduct an additional investigation from January 2, 2015 to February 11, 2015; and (d) determined that the same fact as the attached Table 1 is recognized.

D. On November 30, 2015, the Defendant revoked the Plaintiff’s registration of a measuring agency based on Article 6(5)1 and 2 of the Safety Control Regulations, and Article 17(1) [Attachment 5] of the Safety Control Regulations (the date of revocation of registration: October 1, 2016) (hereinafter “instant disposition”).

[Reasons for Recognition] The facts without dispute, Gap 1-3 evidence (including virtual number), Eul 1-3, 9, 11 evidence, and the purport of the whole pleadings

2. Summary of the plaintiff's assertion

The instant disposition is unlawful since it was conducted by the Safety Control Rules (Ordinance of the Ministry of Health and Welfare) and the Safety Control Regulations without any legal basis.

Some of the grounds for the instant disposition (violation of registered matters and the method of examination) are not recognized, and the instant disposition based on the remaining grounds for the disposition is illegal as it deviates from and abused discretion.

3. Relevant statutes;

Attached Form 2 shall be as listed in attached Table 2.

4. Determination: Validity of Article 6 (5) of the Safety Control Regulations.

First of all, we examine whether the Defendant’s provision of Article 6(5) of the Safety Management Rules, which was based on the instant disposition, was in accordance with the delegation of this mother law and the scope of delegation of the mother law.

(a) The head of each Ministry may issue a Ministerial Ordinance concerning the matters delegated to him/her by Acts (Article 95 of the Constitution of the Republic of Korea).

In a case where a subordinate statute delegates a certain matter to a subordinate statute, when determining the scope of delegation of the parent law or whether the subordinate statute complies with the limits of delegation, the following should be comprehensively taken into account: (a) whether the subordinate statute is an essential matter to be governed by the principle of parliamentary reservation; (b) whether the legislative purpose and content of the pertinent provision; (c) the structure of the relevant provision; and (d) the relationship with other provisions; and (e) whether the delegation provision itself has exceeded the bounds of literal meaning even though the delegation provision expressly provides for the limitation of delegation by using terms that can accurately understand the meaning thereof; (d) whether the subordinate statute falls within the scope of prediction of the delegated content from the mother law itself; and (e) whether the subordinate statute can be evaluated as a new legislation beyond the stage of concreteizing the delegation by expanding or reducing the scope beyond the meaning of the terms used in the delegation provision (see, e.g., Supreme Court en banc Decision 2012Du23808, Aug. 20, 2015).

B. Article 37 of the Medical Service Act and Article 6 of the Safety Control Rule at issue in the instant case are as follows (Article 17(1) [Attachment 5] of the Safety Control Regulations as delegated by the foregoing.

(6) A person who intends to install and operate a radiation generator for diagnosis shall file a report with the head of the competent Si/Gun/Gu, as prescribed by Ordinance of the Ministry of Health and Welfare, and install and operate a medical institution that intends to install and operate the radiation generator for diagnosis in compliance with the safety control standards prescribed by Ordinance of the Ministry of Health and Welfare.

C. In light of the following circumstances, Article 6(5) of the Safety Control Rules is either prescribed without delegation of the provisions of the mother’s law or is deemed null and void because it goes beyond the delegated scope. Thus, Article 17(1) of the Safety Control Regulations delegated by the said provision is also deemed null and void. Thus, the instant disposition cancelled against the Plaintiff is unlawful as it was based on Article 6(5) of the invalid Safety Control Rules and Article 17(1) of the Safety Control Regulations.

1) According to Article 6(1) and (5) of the Safety Control Rules, a person who intends to inspect radiation-emitting devices for diagnosis and radiation-defense facilities, and to measure radiation dose of radiation-related workers shall register with the Defendant as a inspection and measurement agency. A person who is subject to revocation of registration or suspension of business by the Defendant is unable to perform his/her duties unless the registration is re-registered or the suspension period expires. As such, the registration system of inspection and measurement agency under Article 6(1) and (5) of the Safety Control Rules is related to the freedom of occupation, which is fundamental rights of citizens, and thus, is deemed to fall under essential matters to be prescribed by law. Accordingly, the Act adopting such system must directly stipulate basic matters concerning the registration and sanctions of inspection and measurement agency.

However, Article 37(3) of the Medical Service Act only provides that “the scope, reporting, inspection, installation, and measurement standards, etc. of radiation generators for diagnosis shall be prescribed by Ordinance of the Ministry of Health and Welfare,” and does not provide any provision regarding the registration system of the inspection and measurement institution. In such a case, if it is interpreted that “the scope, reporting, inspection, installation, and measurement standards, etc. of radiation generators for diagnosis” is included in the establishment of the registration system of the inspection and measurement institution, the legal provision that delegates essential matters to be prescribed by the Act is either contrary to the principle of statutory reservation or against the principle of prohibition of comprehensive delegation, thereby resulting in a violation of the unconstitutionality of the Act. Therefore, the registration system of the inspection and measurement institution under Article 37(3) of the Medical Service Act is not directly

2) Furthermore, Article 37(1) of the Medical Service Act explicitly states that the subject of installation and operation of radiation generators for diagnosis is a medical institution. Article 37(2) of the same Act imposes a duty on the founder or manager of a medical institution who has installed radiation generator for diagnosis to appoint a person in charge of safety control, regular inspection and measurement, and control of exposure to radiation for radiation-related workers. As such, the content delegated to the Ordinance of the Ministry of Health and Welfare under Article 3(3) is merely about the installation of radiation generators for diagnosis, the procedure and method of inspection and measurement, which are the subject of diagnosis, and further, it does not purport to delegate the registration of

Inasmuch as comprehensively taking account of the language, structure, and purport of Article 37(3) of the Medical Service Act, and relationship with other provisions, it is difficult to view that the registration system of inspection and measurement institutions is included in the scope delegated by Article 37(3) of the Medical Service Act. Otherwise, it is difficult to find any provision delegated by the Safety Control Regulations to prescribe matters concerning the registration and sanctions of inspection and measurement institutions.

3) In addition, it cannot be deemed inappropriate to define the registration system of an inspection and measurement institution as a legislative technical difficulty in regulating the system by law, or as it is a detailed, technical, and variable matter.

4) Meanwhile, the Veterinarians separately from Article 17-3, which is a provision on the installation and operation of “radiation for Diagnosis of Animals,” provides that “The Minister of Agriculture, Food and Rural Affairs may designate an institution meeting specific requirements prescribed by Ordinance of the Ministry of Agriculture, Food and Rural Affairs, such as the installation of equipment for inspection, as an inspection institution or measurement institution for diagnosis of animals” (Paragraph 1). The Minister of Agriculture, Food and Rural Affairs may revoke the designation or order the suspension of business for a specified period not exceeding six months (Article 6(5) of the Safety Control Regulations, where an inspection and measurement institution under paragraph (1) has been designated by fraud or other improper means (Article 6(5) of the same Act, and where it falls under any of subparagraphs 1 through 3, he/she shall revoke the designation (Paragraph 2). The procedure for designation of an inspection and measurement institution under paragraph (1) and matters necessary for the revocation of designation and the suspension of business under paragraph (2) shall be prescribed by Ordinance of the Ministry of Agriculture, Food and Rural Affairs (Article 3).”

4. Conclusion

The plaintiff's claim is justified and accepted.

[Attachment 1] Violation: omitted

[Attachment 2] Relevant Statutes: omitted

Judges Hong Jin-ho (Presiding Judge)

(1) On June 27, 2011, the safety control rules were amended by Ordinance of the Ministry of Health and Welfare No. 64, and were converted from the previous designated system to the registration system.

2) Paragraph 1, which provides for the registration of an inspection and measurement institution, is declared null and void, not only the legal confusion and instability caused by such declaration but also the legal gap and confusion until a new norm replacing it is enacted. Therefore, the fifth harbor declaration shall be made null and void in order to avoid such harm.

3) In its original context, Article 6(2) of the former Rules on the Safety Control of Radiation Generating Devices for Diagnosis of Animals (amended by Ordinance of the Ministry of Agriculture, Food and Rural Affairs No. 140, Apr. 22, 2015) and Article 6(5) of the Safety Control Rules of this case provide for the revocation of designation, suspension of business, etc. of inspection and measurement institutions. However, considering the fact that it is difficult to find the basis for the authorization thereof under the Veterinarians and that the revocation of designation, etc. is inappropriate to delegate subordinate statutes in view of the nature of the content thereof, Article 17-5 of the Veterinarians Act, amended by Act No. 13028, Jan. 20, 2015, directly provides for the designation, sanctions,