After nearly three years of legal battles between Medytox Inc. and the Ministry of Food and Drug Safety over the indirect export of botulinum toxin or botox, a Korean court ruled in favor of Medytox on Thursday, giving a breather to six other botulinum toxin manufacturers facing ouster from the market due to similar reasons.

In October 2020, health authorities ordered Medytox to suspend manufacturing and sales of its botulinum toxin products, while initiating proceedings to revoke the product license after determining the products intended for export had been transferred to a local wholesaler without passing a mandatory lot release protocol.

But the Daejeon District Court ruled against the ministry, lifting the revocation order on five of Medytox’s products, including four Medytoxin (50U, 100U, 150U and 200U) and Coretox (100U).

Biological products such as botulinum toxin require a lot release protocol under the Pharmaceutical Affairs Act to verify manufacturing and quality control before being sold. However, a separate protocol is not required for products intended for export. The ministry claims that Medytox’s transfer constitutes sales in South Korea and therefore violate the law unless a lot release protocol is obtained since the intermediate wholesaler receives botulinum toxin products from Medytox and independently determines the price and sells them back to an overseas exporter.

In response, Medytox argues that the products were not distributed in full in Korea and its transfer is an indirect export that the domestic industry practices when sending botulinum toxin products to overseas markets like Southeast Asia. The company also claims that there is no reason to distribute the products intended for exports in Korea as they are usually more expensive than domestic products.

The court ruling is significant because it is the first of its kind, as seven Korean botulinum toxin companies are facing the same issue. Currently, seven of the 16 companies licensed to sell botulinum toxin in the country have received administrative penalties from the ministry due to their indirect export. In addition to Medytox, Hugel Inc., PharmaResearch Products Co., BMI Korea Co., BNC Korea Co., and Jetema Co. have received license revocations.

According to the industry, the annual production volume of botulinum toxin products facing the threat of being removed from the market for these reasons is estimated to be around 20 billion won ($15.3 million). This is a figure corresponding to two-thirds of South Korea’s total botulinum toxin production.

By Kim Ji-hye and Minu Kim

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