Korea urged to drop botulinum toxin from ‘core national technologies’ amid global market loss

A proposal has been raised to reconsider the designation of botulinum toxin production technology as a national core technology and to remove some designations to strengthen the international competitiveness of Korean pharmaceutical companies.

Government officials stated that they would review the removal of the designation after gathering opinions from industry and academia.

On Monday, Rep. Kang Seung-kyu of the People Power Party, Rep. Heo Jong-sik of the Democratic Party of Korea, and the Korean Association for Civic Education held a discussion titled “Improvement Measures for the National Core Technology Protection System to Strengthen K-Bio’s Global Competitiveness” at the National Assembly.

Professor Lee Seung-hyun of Konkuk University College of Medicine’s Department of Microbiology presented on the topic “Reviewing the Validity of the National Core Technology System: Focusing on the Case of Botulinum Toxin.”

The National Core Technology System is designed to protect technologies that could significantly impact national security, the economy, or public health if leaked overseas. It targets technologies with high scarcity and strategic value, with the goal of maintaining national competitiveness and securing national security.

To be designated, a technology must possess scarcity, meaning it is difficult to acquire; strategic importance, meaning it is directly linked to national competitiveness; and irreplaceability, meaning it is a monopoly technology with no substitutes. Once designated, government approval is required for exporting the technology, and prior review is mandatory for joint ventures, investments, or mergers and acquisitions (M&A). Violations are subject to criminal penalties and administrative sanctions.

Using these criteria, the government designated botulinum toxin production technology in 2010 and botulinum toxin strains in 2016 as national core technologies.

According to Professor Lee, the pharmaceutical industry argues that the designation of botulinum toxin-related technologies as national core technologies is causing significant industrial damage. For instance, by 2025, Korean companies are projected to hold less than 10 percent of the global botulinum toxin market, valued at approximately 25 trillion won ($17.8 billion).

The industry cites several issues: annual export delays amounting to 90–100 billion won due to export approval procedures that take an average of 74 days and sometimes exceed 12 months; reduced sales from delayed product shipments; and diminished trust from overseas buyers.

Reflecting these concerns, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association has formally requested the removal of botulinum toxin-related technologies from the National Core Technology list.

Professor Lee also stated that it is necessary to exclude “botulinum strains and general toxin preparation technology” from the designation, while retaining only “advanced core production processes.” He emphasized that administrative notice, regulatory impact assessment, and post-designation evaluation should be mandatory for all core technology designations.

Lee further stressed the need to maintain regulatory consistency with countries such as the United States and the European Union (EU), to clarify export support and regulatory guidelines. These measures, he said, should restore the system’s original intent and strengthen industrial competitiveness.

Lee Sang-soo, standing representative of the Korean Association for Civic Education, in a presentation titled “Balancing Industrial and Security Development through Comparative Analysis of Botulinum Toxin Product Regulations and Management Approaches in Advanced Countries,” disclosed the results of a survey conducted Sept. 12–24 targeting 18 Korean pharmaceutical companies producing and selling botulinum toxin.

The survey showed that 82.4 percent of respondents supported removal. The most common reason, cited by 32.6 percent, was that the cost of losing the opportunity to rapidly enter global markets outweighs the benefits of regulation.

Other reasons included: perception of excessive regulation by overseas partners, causing wasted time and resources in persuasion (30.2 percent); the fact that core processes and strains are already widespread and commonplace (27.9 percent); and the argument that special processes are better protected through individual patents (9.3 percent).

“While lifting the designation of botulinum toxin production technology as a national core technology should promote technology diffusion and bio-industry growth, selective regulations must remain to safeguard national security and true core technologies,” Lee said.

During the discussion, diverse views were presented.

“It is a fundamental contradiction that botulinum toxin is the only one among the 75 designated national core technologies that includes bacterial strains,” said Jeong Se-young, chair professor at Jeonbuk National University Hospital’s Institute of Biomedical Research. “Not only are 13 of 17 Korean botulinum toxin companies and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association demanding removal, but most academic experts also agree.”

Lee Jae-guk, vice chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, added, “Despite significant changes in the industrial environment since its designation, it remains listed as a national core technology, causing industry-wide difficulties in business activities.”

A decision to remove the designation is necessary, he said, for Korean companies that have already secured competitiveness in botulinum preparations to make a greater leap in the global market.

You Han-beom, co-representative of Transparency International Korea, remarked, “It is surprising that botulinum toxin production technology is one of only four biotechnology technologies designated as national core. The lack of sufficient consultation with the bio industry during designation and revision raises concerns over transparency and predictability.”

In response, the government said it would review whether to remove botulinum toxin from the list.

“The government plans to review the designation and potential removal of botulinum toxin production technology as a national core technology, balancing input from Botox manufacturers and relevant experts while adhering to procedures under the Industrial Technology Protection Act,” said Choi Kwang-jun, director of the Bio-Convergence Industry Division at the Ministry of Trade, Industry and Energy.