[1] The limits of delegated legislation and the criteria for determining the scope of delegation

[2] Whether the proviso of Article 21(7) of the Pharmaceutical Affairs Act violates the principle of prohibition of comprehensive delegation of legislation under Article 75 of the Constitution (negative)

[3] The meaning of "preparation of drugs" under Article 21 (7) of the Pharmaceutical Affairs Act concerning herb drugs prepared by herb pharmacists

[1] A delegation order can be granted when there exists an individual delegation that specifically sets the scope in the law or upper level order. Here, the specific scope of delegation differs depending on the type and character of the subject matter to be regulated, and thus, uniform standards cannot be set. However, since at least the basic matters of the contents and scope to be stipulated in the delegation order are specifically stipulated in the pertinent law or upper level order, anyone who can at least be able to predict the outline of the contents to be stipulated in the delegation order from the pertinent law or upper level order, but in this case, the existence of predictability shall not be determined with only one of the pertinent delegation provisions, but shall be determined systematically and systematically by the overall structure and purpose of the pertinent delegation provision, the form and content of the pertinent delegation provision, and the relevant laws and regulations, and further, it is required to examine each specific

[2] In full view of the provisions of Article 21(1), (4), and (7) of the Pharmaceutical Affairs Act, a pharmacist is prohibited from preparing medicines, in principle, for the implementation of a pharmaceutical medicine business; while a pharmacist or herb pharmacist is prohibited from preparing medicines according to a prescription issued by a doctor or dentist; and a herb pharmacist is allowed to prepare medicines according to a prescription issued by a herb doctor. However, exceptionally, the Minister of Health and Welfare determines the types of oriental medicine locations where a herb pharmacist is allowed to prepare medicines without a herb doctor’s prescription and methods of preparing medicines to the extent that the substance of the pharmaceutical business is not undermined. In light of the overall system of the Pharmaceutical Affairs Act, the above provision’s legislative purpose, form, and content is clearly clear. In light of the above circumstances, the Minister of Health and Welfare is not only possible to predict the types of oriental medicine locations to be determined by the Minister of Health and Welfare, and the selection of oriental medicine pharmacists is complicated and technically required to have high level of professional and technological ability to perform administrative legislation, and thus, it cannot be viewed that a herb pharmacist violates the proviso of Article 217(7) of the Pharmaceutical Affairs Act.

[3] Article 21(7) of the Pharmaceutical Affairs Act provides that when a herb pharmacist prepares herb drugs, he/she shall do so according to the prescription of a herb doctor. The term "preparation of medicines" refers to preparing medicines for the purpose of treating or preventing a specific disease of a specific person in accordance with a specific usage by mixing two or more medicines or sharing one medicine in certain quantity according to a specific prescription (Article 2(15) of the Pharmaceutical Affairs Act). It is generally included in the concept of preparation of medicines as above.

[1] Articles 75 and 95 of the Constitution / [2] Article 21 (7) of the Pharmaceutical Affairs Act, Article 75 of the Constitution / [3] Articles 2 (15) and 21 (7) of the Pharmaceutical Affairs Act

[1] Supreme Court Decision 2001Du5651 Decided August 23, 2002 (Gong2002Ha, 2221) Supreme Court Decision 2003Du10701 Decided January 29, 2004 (Gong2004Sang, 398), Supreme Court Decision 2003Du7606 Decided July 22, 2004 (Gong2004Ha, 1530), Supreme Court Decision 2004Da3040 Decided March 25, 2005 (Gong2005Sang, 664)

Plaintiff (Attorney Shin Chang-chul et al., Counsel for the plaintiff-appellant)

Ilsan Market

Gwangju High Court Decision 2004Nu1154 decided Jan. 27, 2005

The appeal is dismissed. The costs of appeal are assessed against the plaintiff.

We examine the grounds of appeal.

1. As to the assertion of violation of Article 75 of the Constitution under the proviso of Article 21 (7) of the Pharmaceutical Affairs Act

An order of delegation can be issued when an individual delegation that specifically sets a scope in the Act or upper level order is possible. Here, the specific scope of delegation varies depending on the type and character of the subject matter to be regulated, and thus, uniform standards cannot be set. However, at least, since the basic matters of the contents and scope to be stipulated in the delegation order are specifically stipulated in the relevant Act or upper level order, anyone can predict the outline of the contents to be stipulated in the delegation order from the relevant Act or upper level order. In this case, the predictability of the delegation provision should not be determined with only one of the pertinent delegation provisions, but the overall structure and purpose of the relevant delegation provision, the relevant delegation provision form and content of the relevant delegation provision, and relevant Acts and subordinate statutes must be systematically integrated, and further, the specific individual review should be conducted according to the nature of each regulation (see, e.g., Supreme Court Decisions 2001Du5651, Aug. 23, 2002; 2003Du7606, Jul. 22, 2004; 304).

In the instant case, comprehensively considering the provisions of Article 21(1), (4), and (7) of the Pharmaceutical Affairs Act, a pharmacist is prohibited from preparing medicines, in principle, for the implementation of pharmaceutical medicine business; while a pharmacist or herb pharmacist is prohibited from preparing medicines according to a prescription issued by a doctor or herb doctor; and a herb pharmacist is prohibited from preparing medicines according to a prescription issued by a herb doctor or herb doctor; Provided, That exceptionally, the Minister of Health and Welfare determines the types of oriental medicine locations where a herb pharmacist is able to prepare herb drugs without a herb doctor’s prescription and methods of preparing herb drugs to the extent that such determination does not harm the essence of the pharmaceutical industry, and is clearly in light of the overall system of the Pharmaceutical Affairs Act, the legislative purpose, form, and content of the above provision. In light of the above circumstances, the Minister of Health and Welfare is not only possible to predict the types of oriental medicine locations to be determined by the Minister of Health and Welfare, and the selection of oriental medicine pharmacists is complicated and technically required to require high level of professional and technical ability, and thus, it cannot be viewed that a herb pharmacist violates the proviso of Article 217(7) of the Pharmaceutical Affairs Act.

Therefore, the ground of appeal pointing this out is without merit.

2. As to the assertion of violation of the principle of proportionality of the provision on the category and preparation method of herb drugs (Notice of the Ministry of Health and Welfare No. 1995-15)

In light of the legislative purport of the proviso of Article 21(7) of the Pharmaceutical Affairs Act, it is clear that all the herb drugs listed in the already accepted herb medicine book may not be defined as the type of herb drugs and the method of preparing medicines that a herb pharmacist may prepare without the prescription of a herb doctor. According to the records, the types and method of preparing herb drugs listed in the above Ministry of Health and Welfare’s notice includes the prescription and method of preparing medicines for the overall specialized department of oriental medicine, and the majority of oriental medical doctors are performing the preparation and treatment of oriental medicine medicine within the original theory of prescription stipulated in the above Ministry of Health and Welfare’s notice. Thus, the above notice of the Ministry of Health and Welfare cannot be deemed to excessively restrict the scope of direct preparation without the prescription of a herb doctor, and thus, it cannot be said that the grounds for appeal on this point also contravenes the principle of proportionality under the Constitution.

3. Article 21(7) of the Pharmaceutical Affairs Act provides that when a herb pharmacist prepares herb drugs, he/she shall do so according to the prescription of a herb doctor. The term "preparation of medicines" refers to preparing medicines for the purpose of treating or preventing a specific disease of a specific person in accordance with a specific usage by mixing two or more medicines or sharing one medicine into a certain quantity according to a specific prescription (Article 2(15) of the Pharmaceutical Affairs Act). It is generally deemed that the preparation of medicines for a specific disease of a specific person by mixing the herb drugs according to a prescription by another person is included in the concept of preparation of medicines as above.

Therefore, the court below is just in holding that the act of making sugar after mixing two or more medicinal drugs according to the order received by the plaintiff from five persons, including the non-party, etc., was an act of making sugar under Article 21 (7) of the Pharmaceutical Affairs Act, and there is no error in the misapprehension of legal principles as to the concept of preparation under Article 21 (7) of the Pharmaceutical Affairs Act.

4. Conclusion

Therefore, the appeal is dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices.

Justices Park Jae-sik (Presiding Justice)