[Desk's View] The 16-year shackle around K-toxin must be broken

The declassification of botulinum toxin as a National Core Technology is under discussion. This time, the atmosphere is noticeably different. It has been reported that the Biotechnology Expert Committee under the Ministry of Trade, Industry and Energy (MOTIE) has reached internal consensus in favor of declassification. All that remains now is a conclusion.

According to MOTIE and industry sources, the Biotechnology Committee, operating under the Industrial Technology Protection Committee, is currently reviewing whether to remove botulinum toxin product manufacturing technology and its strains from the National Core Technologies designation list. MOTIE states that this is part of a routine, periodic review process to reassess 79 national core technologies across sectors such as semiconductors, displays, and biotechnology.

However, the market does not view this as a mere routine review. This is because a regulatory controversy that has persisted for 16 years is shifting direction for the first time.

In fact, sources inside and outside the industry observe that the Biotechnology Committee has reached consensus primarily on the declassification view. Assessments also indicate that the atmosphere shifted noticeably after MOTIE recently replaced several long-tenured, consecutively reappointed committee members.

This change is significant. Previously, the controversy surrounding the national core technology designation for botulinum toxin focused on the issue of specific committee members serving long, consecutive terms. During last year's National Assembly audit, critics pointed out the expert committee's closed nature and its structural reliance on specific individuals. MOTIE's personnel overhaul aligns directly with this trend, implying that the newly appointed expert committee members for this year have converged on the opinion of lifting the designation. 

The core issue is simple. The current discussion is not about whether to unlock a single technology. It is about whether the outdated regulatory framework can be normalized.

Meanwhile, the domestic botulinum toxin industry has long argued that the National Core Technology designation constitutes excessive, duplicate regulation. Their view is that because management systems are already functioning under the Pharmaceutical Affairs Act, the Infectious Disease Control and Prevention Act, and the Foreign Trade Act, layering National Core Technology regulations on top has only inflated administrative burdens.

Critics have pointed out that South Korea is the only country to designate botulinum toxin as a National Core Technology, even though it is recognized globally as a generic manufacturing technology. Furthermore, the strains are publicly available on global genetic information networks, and a significant number of domestic companies utilize overseas strains. Despite this, additional reviews were repeatedly required in South Korea for every export, technical cooperation, and licensing process. Ultimately, it was a structure where administration outpaced industrial development.

The problem lies in the outcome. The global botulinum toxin market has reorganized around American and European companies. Even though domestic companies possess manufacturing competitiveness, they have found themselves tied down by various administrative procedures. Uncertainty has also repeatedly plagued overseas market expansion and technology transfer negotiations.

The National Core Technology system itself cannot be discredited. However, regulations must keep pace with reality. If the restrictive effects on industry outweigh the actual benefits of protection, the policy must be amended.

Above all, these discussions must not end in another round of dragging time. In the past, whenever the possibility of declassification was raised, postponing a conclusion was a recurring pattern. In the meantime, market uncertainty only intensified.

Now, the situation is different. A shift in the committee's internal current has been detected, and MOTIE has signaled a personnel overhaul. Now, only the final judgment remains.

If the shackles that have bound K-toxin for 16 years cannot be broken this time either, the market will inevitably ask once again. For whose benefit is the South Korean biotech industry being regulated?

The ball is now in the Industrial Technology Protection Committee's court. Conclusion awaits.