‘Indirect Toxin Export’ Litigation, Medytox Hands?

[팍스넷뉴스 민승기 기자] While the debate about ‘indirect botulinum toxin export’ is spreading, attention is focused on the legal case against Medytox, which is the first to receive an administrative disposal from the health authorities. This is because the logic of the legal response of companies that have recently been subject to an administrative disposal is almost identical to Medytox’s claim, so it is anticipated that the outcome of the company’s legal case will be the point of reference.

According to related industry sources on the 8th, the hearing date for Medytox, which received the disposition of revoking the product license for the indirect export of botulinum toxin, will be held on the 24th of this month. Medytox previously filed a lawsuit to stay the execution when the Ministry of Food and Drug Safety issued a disposition to cancel the license in November 2020. A conclusion is expected as early as this year, as it has already held several pleas.

The reason why the industry is paying attention to the results of the Medytox lawsuit is that there are a number of companies pursuing administrative disposition cancellation lawsuits for the same reason. Not only Hugel, but also Zethema, BMI Korea, and BNC Korea, who have recently received administrative disposals, have announced that they will take strong measures in the future, saying that they are ‘unfair disposals’.

All of these companies only have botulinum toxin for export without a domestic product license. They had been exported abroad through domestic wholesalers and traders, but were open to disposal. This is because the health authorities have interpreted the export of botulinum toxin through domestic trade and wholesalers as ‘domestic sales’ rather than ‘indirect exports’.

The companies argue, “The botulinum toxin products subject to administrative disposition are all exported overseas after receiving export permits.” Moreover, it is emphasized that the botulinum toxin products have not been distributed at all in Korea, and that all of them have been exported overseas. This is the same as the claim Medytox made several times during the Food and Drug Administration’s litigation hearings and pleadings.

A bio industry official said, “If you look closely at the claims of companies that have been subject to administrative disposal for the indirect export of botulinum toxin, they are all almost identical to those of Medytox. It will not,” he said. .

Another industry official also said, “Medytox is in the process of being sued to have its license revoked for allegedly using an undiluted solution without a license.” He added, “Medytox was the first to have his license revoked, and it seemed he was in crisis, but now he is in a situation where he is holding a knife.”