Professor Acquitted on Appeal After Self-Testing Anti-Cancer Drug in Development

Indicted for Violating the Pharmaceutical Affairs Act
Court: "Not for Personal Gain"

A university professor who had been convicted in the first trial for administering an anti-cancer drug he was developing to himself as part of a clinical trial has been acquitted on appeal.

On August 14, Yonhap News reported that the Ulsan District Court Criminal Appeals Division 3-3 (Presiding Judge Cho Sangmin) overturned the original verdict, which had suspended a fine for Professor A, a man in his 60s indicted on charges of violating the Pharmaceutical Affairs Act, and found him not guilty on appeal.

Professor A was accused of injecting himself with an anti-cancer therapeutic vaccine he was developing in January 2022 and collecting blood samples over two weeks to observe physical changes and adverse reactions, conducting this "self-experiment" without approval from the Ministry of Food and Drug Safety. He was initially fined 1 million won in a summary trial but contested the ruling and requested a formal trial.

From the first trial, Professor A consistently argued that self-experimentation does not constitute a clinical trial under the Pharmaceutical Affairs Act. However, the first trial court ruled that self-experimentation is included within clinical trials and is not among the types of clinical trials exempt from approval by the Ministry of Food and Drug Safety. As a result, the first trial court suspended the imposition of a fine for Professor A.

However, the appellate court reached a different conclusion. The appellate court determined that there were grounds for justification in Professor A's actions. While the court acknowledged that self-experimentation falls under the category of clinical trials regulated by the Pharmaceutical Affairs Act, it found Professor A not guilty, citing that his experiment was not for personal gain or to evade regulations, and that no harm to the public interest was caused.

The court explained, "The defendant's actions were not for personal benefit, and the experiment was conducted while hospitalized, with medical advice from a co-researcher. The only subject was himself, and there was no distribution of the virus or leakage of experimental information, so there was no harm to the public interest or any significant safety or ethical issues." The court further stated, "As a developer of anti-cancer drugs, it was necessary to confirm a safe dosage after animal testing and before administering it to actual cancer patients, and this was done following ethical review and expert consultation. Therefore, the act can be considered reasonably permissible by social standards, and it is difficult to regard it as sufficiently unlawful to warrant punishment."