K-Toxin Exports Near $500 Million: Will the Shackles Be Removed? Delisting as a National Core Technology Picks Up Pace

Biotechnology expert committee says legal safeguards are needed

Trade Ministry backs amendment to the Industrial Technology Protection Act

A preliminary step toward removing the National Core Technology designation

Exports expected to energize the domestic toxin market

Discussions on removing botulinum toxin, which is used to reduce wrinkles, from the list of National Core Technologies are gaining momentum. After concerns mounted that the regulation was hindering domestic companies' exports and weakening their competitiveness, authorities have begun taking preliminary steps toward lifting it.

Botox-related image. The Asia Business Daily DB.

According to industry sources on October 20, a biotechnology subcommittee under the Industrial Technology Protection Committee recently said, during a review of whether to remove botulinum toxin from the list of National Core Technologies, that legal safeguards were needed to ensure penalties remain in place for past technology leaks. The concern is that if botulinum toxin is removed from the list, the legal basis for punishing leaks that occurred while it was designated could be weakened.

The Ministry of Trade, Industry and Energy is also reported to have conveyed its verbal support for an amendment to the Act on the Prevention of Divulgence and Protection of Industrial Technology, sponsored by Democratic Party of Korea lawmaker Park Heeseung, and is monitoring its progress. The bill would allow authorities to hold people accountable for illegal leaks that occurred while a technology was designated, even if the designation is later lifted. The move is seen as a plan to first close the gap in penalties through a legal amendment and then proceed with removing botulinum toxin from the list of National Core Technologies.

The botulinum toxin production process was designated a National Core Technology in 2010, and the bacterial strain was designated in 2016. As a result, domestic companies have had to obtain government approval for overseas technology exports involving the toxin, the establishment of local production facilities or joint ventures, and efforts to attract investment. Industry estimates suggest that the approval process alone takes an average of four to six months, and sometimes more than a year, resulting in annual losses of KRW 90 billion to KRW 100 billion due to canceled overseas contracts and delays in entering markets.

Some in the industry say there is little benefit to protecting the technology, as toxin cultivation and purification techniques have already been commercialized overseas. They argue that there is no substantial technological gap between countries warranting the designation of the botulinum toxin manufacturing process as a National Core Technology, given that the technology has been known since the 1960s. Choi Gyu-jin, an attorney at DR & AJU who specializes in regulatory affairs in the biotech and healthcare sectors, emphasized, "More than 2,000 botulinum strains are registered in GenBank alone," adding that "the toxin's competitiveness depends more on good manufacturing practice (GMP), regulatory approval capabilities and branding than on the strains or manufacturing technology."

If the designation is lifted, the domestic toxin market is expected to gain momentum. South Korea's botulinum toxin exports surged 88% in three years, from $223.21 million in 2022 to $420.2 million last year. They also rose 47% year over year to $275.26 million in the first half of this year. Industry sources expect overseas expansion to accelerate as companies broaden their approach beyond exporting finished products to include establishing local joint-venture plants and licensing out technology.

An industry official said, "I understand that authorities also recognize the difficulties companies face and that there is growing consensus on the need to change the system." The official added, "Once the parliamentary audit concludes, the amendment will be discussed in earnest and, if passed by the National Assembly, the removal of botulinum toxin from the list of National Core Technologies will proceed in stages."

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