A university professor who conducted clinical trials on an anti-cancer drug he was developing without government approval was acquitted in the appeals court. He was convicted in the first trial.
On the 14th, the Ulsan District Court Criminal Appeals Division 3-3 (Director General Jo Sang-min) announced that it overturned the original ruling and acquitted the professor in his 60s, Mr. A, who was indicted for violating the Pharmaceutical Affairs Act.
Previously, Professor A was subjected to a summary indictment and fined for 'self-experimentation' by administering the anti-cancer vaccine he was developing to himself and observing physical changes and adverse reactions without approval from the Ministry of Food and Drug Safety.
In response, Professor A filed for a formal trial, but the first-instance court acknowledged his guilt while suspending the sentence. Professor A argued that 'self-experimentation' does not fall under clinical trials according to the Pharmaceutical Affairs Act.
The appeals court determined that there were grounds for exoneration regarding Professor A's actions, overturning the first-instance ruling and acquitting him. The court cited that the purpose of Professor A's self-experimentation was not for personal gain or to evade regulations and that it did not cause public harm.
In the ruling, the court stated, 'The defendant's actions were not for personal gain, and he conducted the experiment while hospitalized and receiving medical advice from a co-researcher,' adding, 'The experiment targeted only himself, and there was no circulation of the virus or leak of experimental information, thus there were no public safety or significant ethical issues.'
The court continued, 'As a developer of an anti-cancer drug, it was necessary to confirm a safe dosage before administering it to actual cancer patients after animal testing, and ethical review and expert consultation were conducted,' stating, 'It is difficult to view his actions as having illegality significant enough to warrant punishment, as they are actions that could be considered acceptable by societal norms.'