Supreme Court: "Sale" and "Dispensing" of Pharmaceuticals under the Pharmaceutical Affairs Act Are Different... Veterinarian Acquitted for Displaying Expired Injections

Since the 'sale' of pharmaceuticals and 'dispensing' or other 'medical acts' are distinct concepts under the Pharmaceutical Affairs Act, the Supreme Court ruled that a veterinarian who injected an animal with an expired veterinary injectable drug cannot be punished under provisions that penalize storing or displaying expired pharmaceuticals for the purpose of sale.

According to the legal community on the 1st, the Supreme Court's First Division (Presiding Justice Kim Seon-su) upheld the lower court's acquittal in the final appeal of veterinarian Kim, who was indicted for violating the Pharmaceutical Affairs Act.

Kim, who operates an animal hospital in Cheoin-gu, Yongin-si, was indicted for storing and displaying one 50ml bottle of the veterinary injectable drug 'Kingbellin,' which had expired more than five months earlier (expiration date April 22, 2021), in the hospital's dispensing area for the purpose of sale on October 12, 2021.

Prior to this, on October 6 of the same year, Kim had administered the injectable drug once to an animal for medical purposes and charged an injection fee of 6,000 won.

The prosecutor brought charges against Kim for violating the Pharmaceutical Affairs Act.

Article 85, Paragraph 9, Subparagraph 2 of the Pharmaceutical Affairs Act stipulates compliance requirements for those who sell veterinary pharmaceuticals, stating "matters prescribed by the Ministry of Agriculture, Food and Rural Affairs or the Ministry of Oceans and Fisheries for the safe use of veterinary pharmaceuticals, including prevention of misuse."

Furthermore, Article 22, Paragraph 1, Subparagraph 2 of the 'Regulations on Handling Veterinary Pharmaceuticals,' a decree of the Ministry of Agriculture, Food and Rural Affairs, prescribes as a compliance requirement for veterinary pharmaceutical manufacturers, etc., that "expired, deteriorated, or contaminated veterinary pharmaceuticals shall not be sold or stored or displayed for sale."

Violation of Article 85, Paragraph 9 of the Pharmaceutical Affairs Act is punishable under Article 95, Paragraph 1, Subparagraph 8 of the same Act by "imprisonment for not more than one year or a fine not exceeding 10 million won."

The first-instance court recognized Kim's act as falling under the prohibited conduct in the handling regulations and found him guilty but suspended the imposition of a 500,000 won fine.

This judgment considered that Kim was a first-time offender, that only one bottle of expired injectable drug was stored and displayed, and that there was only one instance of use of the injectable drug after expiration until the crackdown.

The suspension of sentence is a system where, when a sentence of imprisonment for not more than one year, detention, disqualification, or fine is to be imposed, the court may suspend the sentence if the defendant shows clear remorse, and if two years pass from the date of suspension, the case is deemed dismissed.

In the trial, Kim argued, "I only stored and displayed the injectable drug for 'medical purposes,' not for 'sale purposes.'"

However, the court rejected this, stating, "Article 85, Paragraph 4 of the Pharmaceutical Affairs Act stipulates that 'animal hospital operators under the Veterinarian Act may, notwithstanding Article 44, sell veterinary pharmaceuticals to animal breeders or purchase pharmaceuticals from pharmacy operators under the proviso of Article 50, Paragraph 2.' From a textual interpretation, it is reasonable to consider that 'when a veterinarian directly administers an injectable drug during the treatment of animals and charges a corresponding fee,' this also falls under 'selling veterinary pharmaceuticals to animal breeders.'"

Article 44 of the Pharmaceutical Affairs Act stipulates that only pharmacy operators (including pharmacists or oriental medicine pharmacists working at the pharmacy) may sell or acquire pharmaceuticals for sale.

In other words, since Article 85, Paragraph 4 of the Pharmaceutical Affairs Act provides an exception allowing animal hospital operators who are not pharmacists to purchase pharmaceuticals for sale, and lists 'sale purposes' and 'medical purposes' in parallel, the Act does not distinguish between veterinarians purchasing pharmaceuticals to sell to animal breeders and those purchasing pharmaceuticals for medical treatment such as injections.

Kim also claimed, "I did not intentionally keep expired injectable drugs; I simply failed to check that the injectable drug had expired."

However, the court judged, "Considering that the manufacturing date and expiration date are clearly marked on the packaging of the injectable drug, and that the injectable drug was stored for more than five months after expiration, it is reasonable to conclude that the defendant knew the injectable drug had expired but still stored and displayed it."

The prosecutor appealed the first-instance court's suspended sentence, arguing that the sentence was too lenient.

However, the second-instance court ruled that the first-instance court's guilty verdict was mistaken and acquitted Kim.

The court found that Kim's conduct did not constitute a crime before considering the prosecutor's claim of inappropriate sentencing.

The court stated, "Since the facts of the indictment are not proven, the original judgment recognizing guilt contains errors in fact-finding and legal interpretation, and thus is overturned ex officio," and acquitted Kim.

The second-instance court held that interpreting the injection act as a medical act by a veterinarian as falling under the 'sale' of pharmaceuticals regulated by the Pharmaceutical Affairs Act and the Regulations on Handling Veterinary Pharmaceuticals exceeds the permissible scope of textual interpretation, even considering the legislative intent and purpose of the Pharmaceutical Affairs Act and related laws.

The court cited several reasons for this judgment.

First, the court noted that the Pharmaceutical Affairs Act does not separately define the concept of 'sale' but only states in Article 2, Paragraph 1, which defines 'pharmacists,' that 'sale includes transfer,' implying that the concept of sale under the Act should be interpreted in its dictionary meaning as 'selling goods for a price.'

Meanwhile, Article 22 of the Pharmaceutical Affairs Act prohibits anyone other than pharmacists or oriental medicine pharmacists from 'dispensing' pharmaceuticals but recognizes exceptions where doctors may directly 'dispense' pharmaceuticals in the course of 'injection acts' or 'medical acts.'

The court pointed out, "The Pharmaceutical Affairs Act classifies cases where injections or administration of pharmaceuticals are performed by doctors as exceptions to the pharmacist dispensing principle, but there are no provisions regarding this in the 'sale' regulation. This indicates that the Act distinguishes between 'sale' and 'injection or medical acts.'

Finally, the court focused on the fact that Article 85, Paragraph 9 of the Pharmaceutical Affairs Act explicitly states, 'Persons who sell veterinary pharmaceuticals under this Act must comply with the following matters,' thereby explicitly specifying that the provision applies to 'animal hospital operators who sell veterinary pharmaceuticals.'

The court noted, "Even if a veterinarian only performs medical acts without engaging in the dictionary meaning of pharmaceutical sales, the medical act of injecting pharmaceuticals can naturally occur. If the regulation in question intended to regulate injection acts and related dispensing acts as pharmaceutical sales, there would be no need to specify 'animal hospital operators who sell veterinary pharmaceuticals'."

It concluded, "In other words, Article 85, Paragraph 9 of the Pharmaceutical Affairs Act and the relevant regulations separately consider cases where animal hospital operators only perform medical acts and cases where they also sell pharmaceuticals, and injection acts during medical treatment were not intended to be regulated from the outset." This interpretation distinguishes between veterinarians separately 'selling' veterinary pharmaceuticals and performing injection and other medical acts during treatment under the Pharmaceutical Affairs Act.

The prosecutor appealed again, but the Supreme Court's ruling was the same.

The court stated, "There is no error in the lower court's legal interpretation regarding the establishment of the offense of violating the Pharmaceutical Affairs Act," and dismissed the prosecutor's appeal.