[2026 Parliamentary Audit] Over 2,600 Clinical Trial Documents Withheld from National Assembly Downloaded via ChatGPT

Rep. Lee Sohee: "You refused to submit the documents, yet allowed outside access"
MFDS Minister Oh Yookyung: "We became aware of it yesterday and blocked access early this morning"

It has emerged that thousands of clinical trial results documents that the Ministry of Food and Drug Safety (MFDS) had not submitted to the National Assembly, citing trade secrets, could be accessed through ChatGPT, a generative artificial intelligence (AI) service. The documents included confidential corporate information and even the mobile phone numbers of officials in charge, prompting criticism that the MFDS had inadequate security controls.

When People Power Party lawmaker Lee So-hee revealed these facts at the MFDS’s parliamentary audit before the National Assembly’s Health and Welfare Committee on October 13, MFDS Minister Oh Yu-kyung said, “We became aware of the data leak yesterday (October 12) and blocked access early this morning. I apologize for our shortcomings.”

Lee said, “When our office checked, not a single document was available on the results page of the Drug Safety Korea website, but we were able to download 2,672 clinical trial results documents through ChatGPT. This was possible not through hacking but through ChatGPT, which anyone can use, and no login or password was required.”

Lee added, “The MFDS locked the door on the National Assembly, citing trade secrets, yet stood by while people outside the agency took files. If the information could be made public, why didn’t you show it to the public? If it shouldn’t have been made public, why didn’t you block access?”

Lee’s office said it had alerted the MFDS to the issue through a request for materials on October 11, but had received no response or contact by the day of the questioning. Meanwhile, the MFDS reportedly contacted a journalist several times while discussing the related news coverage, saying the information should not be reported and asking whether the journalist would publish a story and how the materials had been accessed.

When Lee asked whether the materials obtained by her office could be made public during the audit, MFDS Minister Oh replied, “I think you should destroy them.”

Lee criticized the ministry, saying, “You contacted the journalist but not the lawmaker’s office that obtained the materials. Is this a security response, or an attempt to muzzle the press?”

The issue of submitting materials related to the approval of Genencell’s clinical trial for a COVID-19 treatment also came under scrutiny. The lawmaker’s office said that although the MFDS had restricted the submission of related materials, citing the need to consider trade secrets and the public interest, it had not actually prepared any documents assessing whether disclosure would serve the public interest.

Article 88 of the Pharmaceutical Affairs Act generally prohibits disclosure of materials related to medicines, but allows disclosure when necessary in the public interest. However, 95 of the 96 related documents have been kept confidential, and the MFDS has not applied the article’s “public interest disclosure” provision in any case since 2016.

When Lee asked whether the MFDS had a document assessing whether disclosure of the Genencell materials would serve the public interest, Minister Oh replied, “There is no such document.” Lee said, “We want to find out how the MFDS reviewed the false documents and what it relied on when granting approval, in connection with the Genencell founder’s four-year prison sentence on appeal. The MFDS says there was no problem, but won’t provide the materials needed to verify that claim.”

Lee also told Minister Oh, “You should be someone responsible for public safety, not a shield for the administration,” and demanded that the MFDS submit the documents reviewing and approving disclosure of the Genencell materials in the public interest, as well as the review documents with trade secrets redacted.

This content was produced with the assistance of AI translation services.