Main Issues
(a) The concept of manufacturing and preparing medicines;
(b) The case holding that the preparation of medicines does not fall under the manufacture of medicines as preliminary acts by which the chief of medicine of a general hospital prepares in advance any antibiotic substance preparation to use for the future treatment of patients with doctors of the above hospital by means of advance promise and advance response with them;
Summary of Judgment
(a) For the purpose of Article 26 (1) of the Pharmaceutical Affairs Act, the term “manufacture of medicines” means an act of producing medicines or unclaimed medicines listed in the Korean Pharmacopoeia according to a certain work, which are approved by the Minister of Health and Welfare, in order to meet the general demand, and the preparation of medicines as provided for in Article 21 (1) of the same Act means an act of preparing medicines for the purpose of treating or preventing specific diseases of a specific person in accordance with a specific usage method by mixing two or more medicines or dividing one kind of medicines into a certain quantity according to a specific prescription;
B. The case holding that, in order to promote proper administration of efficacy of medicines prepared by minimizing an error in their names on the ingredients of medicines with extreme quantity used in the preparation process of a general hospital, and to respond to a prescription clearly anticipated in the future for the convenience, speedy and cost saving of the medicines, the preparation of antibiotic substances to be prepared in advance by prior promise with doctors and prior response to the preparation of medicines to be used in the future for the treatment of the future patients of the above hospital, if the prescription was issued by the doctor for the target patient, the act of making the above antibiotic substances does not constitute the manufacture of medicines because the act of preparing the above antibiotic substances is not the calculation of medicines to meet the general demand widely, and even if not on the premise of the treatment or prevention of the specific disease of the present patient, it is nothing more than the preparation of medicines in advance by prior response to the situation and needs of the hospital, which constitutes preparation of medicines or preparation of medicines, which can not be included in the scope of medicines.
[Reference Provisions]
Articles 26 (1) and 21 (1) of the Pharmaceutical Affairs Act
Reference Cases
A. Supreme Court Decision 81Do2596 delivered on March 9, 1982 (Gong1982,448) 83Do1715 delivered on May 27, 1986 (Gong1986,830), Supreme Court Decision 91Do2348 delivered on December 10, 1991 (Gong192,554) (Gong1974, 7843)
Escopics
Defendant 1 and one other
upper and high-ranking persons
Prosecutor
Defense Counsel
Attorney Jeong-tae (for the defendants)
Judgment of the lower court
Seoul Criminal Court Decision 91No1319 delivered on July 19, 1991
Text
The appeal is dismissed.
Reasons
We examine the grounds of appeal.
For the purpose of Article 26 (1) of the Pharmaceutical Affairs Act, the term "manufacture of medicines" means an act of calculating the medicines that are listed in the Korean Pharmacopoeia or not listed in a certain work to respond to the general acceptance, and approved by the Minister of Health and Welfare (see, e.g., Supreme Court Decision 83Do1715, May 27, 1986); and the term "preparation of medicines" in Article 21 (1) of the same Act means preparing medicines to be used for the purpose of treating or preventing specific diseases of a specific person in accordance with the specific directions by mixing two or more medicines according to a specific prescription or dividing one medicine into a certain quantity according to a specific prescription (see, e.g., Supreme Court Decision 91Do2348, Dec. 10, 191).
According to the reasoning of the judgment below, the court of first instance determined that the act of this case by Defendant 1 was deemed as the preliminary act of preparing medicines and it does not constitute the manufacture of medicines. However, according to the judgment of the court of first instance maintained by the court of first instance, since the defendant's doctors made necessary volume according to the prescription, it cannot be deemed as the preparation of medicines, and it constitutes the category of preparation of medicines only for the same reason as the preliminary act of preparing medicines, since the court of first instance judged that the act of this case belongs to the category of preparation of medicines as the preliminary act of preparing medicines for the same reason as the instruction of the court of first instance, the court of first instance stated that all of the preparations of this case were deemed as the preliminary act of preparing medicines of this case.
However, Defendant 1’s statement at the court of first instance is right and wrong in response to the timely evidence of the court below. Although 24 pharmacists work in the Department of Gyeonghee University and its affiliated hospital, the number of treatment facilities of the medicine department remains 3,016 per day, even if 1989, average 5.3 medicines are prepared, which require large number of human resources and time, and it is difficult for the patients to take medicine as above, so it constitutes an act of preparing medicines in the future by minimizing error in the volume of medicines used for the preparation process, and thus, it constitutes an act of preparing medicines in accordance with the above provision of the first instance court’s provision of the medicine at the time of preparation of the medicine at the time of preparation of the first instance court’s first instance court’s judgment. It is also necessary for the above provision of the medicine at the time of preparation of the medicine at the time of preparation of the first instance court’s first instance judgment, and it is also necessary for the above provision of the medicine at the time of preparation of the medicine at the time of preparation of the above general treatment guidelines.
Therefore, the appeal is dismissed. It is so decided as per Disposition by the assent of all participating Justices on the bench.
Justices Kim Yong-ju (Presiding Justice)