Medytox Wins Big in First Trial Over Indirect Toxin Exports... Companies Filing Similar Lawsuits 'Cheer'

The court ruled in favor of Medytox in the administrative lawsuit between Medytox and the Ministry of Food and Drug Safety (MFDS) regarding the indirect export process of Botulinum Toxin (BTX) products. Since domestic BTX companies are engaged in similar legal disputes with the MFDS for comparable reasons, this ruling is expected to influence their ongoing lawsuits as well.

Medytox's botulinum toxin (BTX) preparation 'Medytoxyn Injection'.
[Photo by Medytox]

The Administrative Division 2 of the Daejeon District Court (Chief Judge Choi Byung-jun) on the afternoon of the 6th accepted Medytox's claim in the lawsuit filed against the head of the Daejeon MFDS office, which sought to cancel the manufacturing and sales suspension order. Additionally, the court also accepted Medytox's request to cancel the MFDS's revocation of the product approval for some of Medytox's BTX products.

Previously, in October 2020, the MFDS revoked the product approvals and ordered the recall and destruction of some of Medytox's BTX products, including 'Medytoxine (50, 100, 150, 200 units)' and 'Coretox,' citing reasons such as failure to obtain national batch release approval or violation of labeling regulations. In response, Medytox filed for a suspension of enforcement of the MFDS's disposition and simultaneously filed an administrative lawsuit seeking cancellation of the disposition. Subsequently, the suspension of enforcement requested by Medytox was accepted, allowing products like Medytoxine to be distributed normally.

This lawsuit originated from differing interpretations of the indirect export process of BTX products. Medytox has been exporting BTX products in the form of indirect exports. First, BTX products are supplied to domestic trading companies or wholesalers, who then export them overseas. In this process, Medytox transferred BTX products to trading companies without obtaining national batch release approval, but the MFDS judged this as domestic sales.

Under the Pharmaceutical Affairs Act, biopharmaceuticals distributed domestically must obtain national batch release approval from the MFDS to check for deterioration or contamination. National batch release approval is granted per manufacturing batch after the MFDS reviews manufacturing and quality control data and conducts testing. In contrast, export-only pharmaceuticals do not require national batch release approval but cannot be distributed domestically. Based on this, the MFDS revoked Medytox's product approvals, asserting that Medytox violated the Pharmaceutical Affairs Act by selling export-only pharmaceuticals domestically.

Having effectively won the case, Medytox expressed its intention to strive for the normal export of its products. A Medytox representative stated, "With this ruling lifting the cancellation of approval for related products, we will focus on enhancing our brand image and achieving normalization as soon as possible," adding, "We will establish a system that meets global standards to ensure such issues do not arise again."

On the other hand, an MFDS official said, "We have not yet received the judgment document and are waiting," and added, "We will analyze the judgment and determine our future response."

Since many BTX companies are engaged in lawsuits with the MFDS for similar reasons, this outcome is expected to influence their cases as well. After Medytox, the MFDS revoked product approvals for BTX products of five domestic companies exporting BTX: Hugel, PharmaResearch, Jetema, Korea BMI, and Korea BNC, citing the same reasons. Except for Hugel, these companies also received orders to suspend all manufacturing operations for six months. Among domestic BTX manufacturers, most except Daewoong Pharmaceutical have received similar dispositions. These companies also filed for suspension of enforcement injunctions and administrative lawsuits against the MFDS's dispositions. As the court similarly accepted the injunctions, their products are currently being distributed normally.

On the 4th, the MFDS revoked the product approval for Hugel's BTX product 'Liztox Injection 100 units' and ordered a six-month suspension of all manufacturing operations, citing domestic sales without national batch release approval. Hugel Bio Pharma immediately protested, stating, "Assuming this disposition is illegal and unjust, we will actively take all necessary legal measures, including filing objections," and is expected to follow a similar path as the previous companies.

The industry unanimously welcomed this ruling. A BTX industry official said, "Since Medytox, the first plaintiff against the MFDS, achieved a favorable result, it is expected to positively influence the outcomes of lawsuits by other companies awaiting judgment." Another official added, "This ruling undermines the logic the MFDS used as grounds for administrative dispositions," and said, "We view the ruling positively and will take necessary measures accordingly."

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