Confirmation hearing preparation team says Han deleted full context to distort public inquiry as lobbying
The camp of Justice Minister nominee Kim Seung-won on Sunday pushed back against independent lawmaker Han Dong-hoon, who had released a recording as part of what he called the "Ministry of Food and Drug Safety lobbying allegations," saying Han had "clipped the recording to make a routine inquiry look like pressure for approval."
Kim's confirmation hearing preparation team issued an explanatory statement Sunday afternoon, urging Han to "stop the political attacks that distort a public-interest inquiry into illegal lobbying by deleting the full context."
According to the team, Kim contacted then-Ministry of Food and Drug Safety Commissioner Kim Kang-rip in October 2021 to ask him to check on the status of a clinical trial plan review for Genencell, a company developing a COVID-19 treatment.
During a phone call with an acquaintance surnamed Yang, Kim reportedly told him, "I'll ask the commissioner to look into it personally" and "I'll ask him to report back." The team said, "What the nominee requested was not 'approval' but 'a check and a report.'"
After speaking with the former commissioner, Kim reportedly told Yang, "He said he would confirm the status and report back to me, so just wait a little." The team said Kim also described the former commissioner's response as "He's giving me the standard line" and "Let's just wait and see."
The team also said the exchange Han released — in which Kim says the matter "is being held up at the division chief level" — was stripped of its surrounding context. At the time, Yang had told Kim that the review was being delayed because those responsible were avoiding accountability, saying he needed to know the reason even if it took longer. Kim responded, "OK, got it — this is also related to capital outflow." The team said this showed Kim was agreeing to look into the reason Yang had cited for the delay.
"This cannot be interpreted as meaning he pressured the division chief to secure approval," the team said, adding that Kim never directly contacted any Ministry of Food and Drug Safety official or division chief.
The former commissioner later told Kim that "the Genencell matter is currently proceeding with the company on supplementary materials and other steps, and I have passed word to the working-level staff to handle it carefully." The team said a relevant department following up on a complaint received by the head of an agency is standard administrative procedure, and that for the contact to constitute "successful lobbying," there would need to be evidence that the review order or criteria had changed or that special measures had been taken.
During the investigation, Ministry of Food and Drug Safety employees testified that they had received no separate instructions and filed no special reports, and the former commissioner and relevant staff were all cleared of charges, the team said.
The preparation team also released the timeline of the Ministry of Food and Drug Safety's review of Genencell's clinical trial plan. Genencell held a pre-meeting on Phase 2 and 3 clinical trials on June 23, 2021 — about four months before Kim's contact — and applied for clinical trial plan approval on Sept. 23 of that year. The ministry requested supplementary materials on Sept. 30, and Kim contacted the former commissioner on Oct. 12.
Genencell submitted its final supplementary materials on Oct. 18, went through an expert advisory meeting on Oct. 22, and received clinical trial plan approval on Oct. 26. The team said a formal review and supplementary procedure were already under way at the time of the nominee's contact, and that even after the contact, the company still had to submit final supplementary materials and go through an expert advisory meeting.
According to the team, Genencell's review period, calculated using the ministry's official standards, was 11 days — longer than the average of 8.8 days for other novel COVID-19 treatments. The team cited this as grounds to rebuff the claim that Kim's contact had expedited the review, saying the assertion was inconsistent with the objective review record.
The team also noted that Kim did not know the company's name or the relevant department at the time. In the recording, Kim asks Yang, "What's the name of that company?" and "Tell me the company name — send it, by text" and "Which department is the person in charge?" The team said this was "inconsistent with the claim that the nominee had coordinated with the company in advance to act as a lobbyist on its behalf."
The team also said the subject under discussion was approval of a clinical trial plan, not a new drug sales permit. In the recording, Kim says, "Phase 3 approval? Approval to run Phase 3 trials?" and "Shouldn't we get Phase 3 approval quickly and see the results either way?"
"The nominee was not demanding that the treatment be approved for sale — he was asking for a check on the review status so the results could be verified through clinical trials," the team said, adding that "nowhere in the recording is there any demand for unconditional approval, a relaxation of review standards, or the skipping of procedures."
yg@heraldcorp.com
