Hugel Breathes a Sigh of Relief... Appeal Against Suspension of 'Botulax' Manufacturing and Sales Dismissed

Manufacturing and Sales Suspension Decision by MFDS Amid 'Illegal Export' Controversy

Hugel Strongly Opposes Citing 'Legal Differences'
Continues Production and Sales Following Supreme Court Dismissal
Approval Cancellation Status Still Undecided

MFDS: "Action Based on Current Laws"

Hugel's botulinum preparation 'Botulax Injection' (Photo by Hugel)

[Asia Economy Reporter Lee Chun-hee] Hugel, which received a suspension order on the manufacture and sale of the botulinum toxin preparation 'Botulax' for exporting it overseas without national shipment approval, has breathed a sigh of relief after receiving a stay of execution decision from the Supreme Court.

According to the industry on the 6th, on the 5th, the Supreme Court dismissed the appeal filed by the Seoul Food and Drug Safety Administration against the Seoul High Court's decision on the 'stay of execution for the provisional manufacturing and sales suspension order of Botulax injection.' Accordingly, the suspension order on the manufacture and sale of Botulax injection will be suspended until the 30th day from the date of the judgment in the main lawsuit filed by Hugel against the Seoul Food and Drug Safety Administration. As a result, Hugel will be able to continue manufacturing and selling Botulax. However, the Supreme Court's decision on the Seoul Food and Drug Safety Administration's re-appeal regarding the cancellation of the product approval has not yet been made.

Earlier in December last year, the Ministry of Food and Drug Safety detected through the Central Investigation Unit for Serious Violations that Hugel and PharmaResearch Bio, two companies, sold six botulinum toxin products domestically without obtaining national shipment approval, and initiated administrative measures such as cancellation of product approval, suspension of manufacture and sales, and recall and disposal procedures for the relevant products.

The Ministry of Food and Drug Safety cited the fact that for biological products requiring special attention for health and hygiene, shipment approval must be obtained for each manufacturing batch after the Minister of Food and Drug Safety reviews manufacturing and quality control data and conducts testing and inspection before domestic sales to ensure safety and efficacy. It also stated that export-only drugs, which are permitted to be manufactured only for export based on the manufacturer's submission of the importer's specifications and are prohibited from domestic sales, were the reason for the measures.

Son Ji-hoon, CEO of Hugel, is speaking at an online press conference held last February. (Photo by Hugel)

However, Hugel strongly opposed the cancellation of product approval, arguing that the products in question were export-only drugs produced and sold as 'export products' that are directly exported overseas through domestic trading companies and are not subject to national shipment approval. They claimed that the Ministry of Food and Drug Safety suddenly raised issues with distribution practices that had not been problematic until now.

As a result, Hugel's application was accepted by the Seoul Administrative Court last year, and the Seoul Food and Drug Safety Administration appealed to the Seoul High Court. After the Seoul High Court dismissed the appeal, the Seoul Food and Drug Safety Administration filed a re-appeal, but the Supreme Court first dismissed the part related to the suspension of manufacture and sales.

Regarding this, Son Ji-hoon, CEO of Hugel, said at the stage of the High Court's dismissal of the appeal, "I think the controversy is almost settled," and added, "If indirect exports are considered domestic sales, many companies would inevitably violate the Pharmaceutical Affairs Act, so this is an issue that should be viewed carefully."

A Hugel official said, "The Supreme Court's judgment proves that the Ministry of Food and Drug Safety's disposition was merely a legal interpretation difference regarding indirect exports under the Pharmaceutical Affairs Act and has nothing to do with the quality of the Botulax product manufactured and produced by Hugel," adding, "Botulax is a verified quality product that has never had safety or efficacy issues in over 1,500 national shipment approval processes over the past 10 years."

Kim Kang-lip, Commissioner of the Ministry of Food and Drug Safety, is speaking at a press briefing held at the MFDS in Osong, Chungbuk, last November. (Photo by Ministry of Food and Drug Safety)

The Ministry of Food and Drug Safety reaffirmed its position to continue the related lawsuit. A ministry official said, "The main lawsuit is still in the first trial," and emphasized, "Indirect exports through entities such as trading companies that act as export agents are already permitted under the Pharmaceutical Affairs Act, and there are exemption regulations for national shipment approval for export-only products."

Earlier, Kim Kang-lip, Minister of Food and Drug Safety, also commented on the controversy, saying, "Multiple companies claim it was an action unaware of reality due to it being a practice, but if necessary, the court will make a judgment on this," and stated that the measures are understood as "actions in accordance with current laws and regulations."

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