Pharma industry makes a request to MOTIE and MOEF

To remove the national core technology designation for the botulinum toxin strain

Economic Regulatory Innovation TF plans to review the request and closely discuss the issue with MOTIE

Toxin preparations, lack originality and progressive superiority...should allow free trade

Terrorism through chemical weaponry of botulinum toxin is virtually impossible...industry eyes on whether authorities will cancel national core technology designation

Public opinion has been rising for the government to revoke the designation of botulinum toxin as a national core technology.

 

The rise of this public opinion brings more meaning as the request was made by Korea Pharmaceutical and Bio-Pharma Manufacturers Association, which represents the industry.

 

Breaking away from lesser movements that had been made by individual companies or internally within the Ministry of Trade, Industry, and Energy, KPBMA has taken entitative and requested the above for industry development and the future.

 

According to industry sources, KPBMA sent an opinion statement last week requesting the MOTIE to revoke the national core technology designation it had set for the manufacturing technology of botulinum toxin strain and products.

 

In addition, within this week, the association plans to deliver an improvement proposal to the Ministry of Economy and Finance’s Economic Regulatory Innovation TF that requests the revocation of the designation of the national core technology on toxins.

 

KPBMA submitted the petition to MOEF to revoke the toxin national core technology destination request to MOEF because the ministry had organized an 'Economic Regulation Innovation TF' to foster and support the industry, which team listens to the voices of the field, and reflects them in actual policy and institutional improvement.

 

The TF consists of 13 private members and 12 government members and is jointly led by the Deputy Prime Minister of Economy and Finance and a private expert.

 

An industry official said, “Since a written opinion has already been submitted to MOEF, the agenda will be discussed at MOEF’s TF meeting.

 

After setting the direction, official discussions will be made between the two ministries on the withdrawal of the national core technology designation to toxins.” The designation, maintenance, and cancellation of toxin as a national core technology is regarded a sensitive issue for which considerable debate has taken place even within MOEF.

 

The MOTIE Minister can designate or drop the designation of a certain technology after deliberation with the Industrial Technology Protection Committee (which consists of less than 25 members including the chair) under Article 9 ① and ③ of relevant laws.

 

However, the agenda is busy being discussed due to the strong difference in opinion among the 25 committee members, which is why the committee is having trouble setting the specific direction of modifications, and the technology is far from originality and lacks progressive superiority.

 

The representative key core technology designations in Korea include the following technologies: ▲Semiconductor (DDI design technology for OLED to operate driving display panels); ▲Electricity and electronics (design, process, manufacturing, and evaluation technology of ultra-high-performance electrodes or solid electrolyte-based lithium secondary batteries); ▲Display (AMOLED panel design, process, manufacturing, and operating technology).

 

The technologies above are widely accepted as advanced technologies, however, the prevailing opinion is that toxins do not require advanced technology as the toxin strains are more discovered and purchased than developed.

 

As the safety of these toxins can be ensured with the existing management and supervision of the health authorities, the industry has been voicing that it is time for the government to actively prepare a blueprint (revocation of national core technology) on toxins to increase domestic demand and exports.

 

In the absence of general knowledge and information, concerns about the threat of terrorism due to the chemical weaponization of toxins could be raised, but it is a consistent opinion in academia that it is virtually impossible to weaponize the toxins in general pharmaceutical/bio-pharmaceutical research institutes or the private sector.

 

In this regard, another industry official said, "The national core technology designations are made to strengthen the competitiveness of domestic companies by preventing and protecting illegal leakage of industry technology and to contribute to national security and national economic development.

 

However, such toxins are already being approved, manufactured, and sold in a consigned CDMO format among domestic biopharmaceutical companies after they sign joint sales contracts.

 

Therefore, its value as a national core technology is lessening in value.” Meanwhile, KPBMA is taking active steps to revitalize the industry through cooperative governance, therefore, the specific direction on whether to maintain and revoke toxins as national core technology may be determined as early as this year.