Legislation requiring submission of botulinum strains

Welfare Committee Legislative Subcommittee decides to continue the review of the bill to strengthen the regulation of pathogens of bioterrorism infectious diseases

A bill that makes it mandatory to submit genetic information of bioterrorism infectious diseases such as botulinum toxin to domestic quarantine authorities and cancels the possession permit if not submitted did not pass the Health and Welfare Committee of the National Assembly held on the 22nd.

 

If the bill is passed, it may lead to excessive regulation of trade secrets and property values of pharmaceutical companies with botulinum toxin strains, and retroactive application of the submission obligation to pharmaceutical companies prior to the enforcement of the law may be intrusive or cause trust protection problems.

 

This is the result of reflecting the opinion of the expert member's office of the Welfare Committee that a policy judgment on legislation is necessary.

 

The members of the subcommittee on the bill sympathized with the expert's point out that corporate trade secrets and property values could be excessively regulated while acknowledging the necessity of the bill.

 

The bill has emerged as a controversial bill in the pharmaceutical industry as it contains a retrospective application clause that imposes the obligation to submit genetic information such as strains and base sequences to licensees and pharmaceutical companies that have obtained domestic marketing permission and have botulinum toxin before implementation after passing the National Assembly.

 

Pharmaceutical companies with botulinum toxin have mixed opinions about the passage of the bill, but the opposing pharmaceutical companies are in the position that the legislation, such as the source of the strain and the submission of the base sequence, is ineffective given that the botulinum toxin strain is a natural substance.

 

It is pointed out that Medytox and Daewoong Pharmaceutical are in a dispute over whether to steal botulinum strains in Korea, so if the bill is passed, disputes between pharmaceutical companies may escalate.

 

The amendment to the Infectious Disease Prevention and Management Act, proposed by Choi Jong-yoon, a member of the Democratic Party, requires those who possess a total of eight types of bioterrorism infectious disease pathogens, including botulinum bacillus, to submit the pathogens to the Director of the Korea Centers for Disease Control and Prevention within 30 days from the date of possession.

 

It also contains a provision allowing the director of the Korea Centers for Disease Control and Prevention to cancel the permit to possess the pathogen of an infectious disease of bioterrorism, even though it must be submitted within 60 days from the date of request for resubmission.

 

The Director of the Korea Centers for Disease Control and Prevention checked whether the submitted bioterror infectious disease pathogens and the bioterror infectious disease pathogens approved for possession matched and made it possible to build a database.

 

The purpose is to strengthen the safety management system for bioterror infectious disease pathogens.

 

While acknowledging the necessity of the bill, the expert pointed out that it is necessary to judge whether there is room for excessive regulation on companies and research activities if the state management of pathogens, which are corporate trade secrets and property values, is strengthened.

 

In particular, it was considered that it was necessary to review whether there is room for less invasive means to be applied and whether there is a possibility of specifying a legitimate reason for the content that allows the cancellation of the possession permit rather than an administrative fine as a sanction in the case of non-submission of pathogens of biological infectious diseases.

 

Regarding the clause imposing the obligation to submit bioterror infectious disease pathogens of previous holders, the expert committee's office believed that there should be a policy judgment on whether the database establishment would pose an additional burden or protection of trust in the related industry.

 

“The bioterrorism database, in which the state analyzes and builds genetic information for the submitted pathogens, is planned to be used for the purpose of preparing for and responding to bioterrorism, which requires strict security management", the director stated.

 

As the legislative subcommittees decided to continue the review, the bill requiring the submission of botulinum strains was a chance for future legislative review.