The Ministry of Health and Welfare revoked Kolon Life Science’s innovative drug company certification for mislabeling and falsely reporting ingredients in Invossa, called the world's first cell and gene therapy for osteoarthritis, on Friday. The company received the certification in December last year.
The ministry grants the innovative drug company certification to companies that have an excellent capability to develop new drugs and expand to overseas markets. Benefits include additional points when applying for government-sponsored R&D projects or deducting corporate tax for expenses related to R&D or employees.
However, if a company received its certification under false or otherwise fraudulent ways or did not meet the criteria for accreditation, the Minister of Health and Welfare may cancel the certification through a hearing process.
“The government held a “Certification Evaluation Committee” and decided to revoke the qualification after reaffirming that Kolon Life Science had lost its development achievements due to the sales approval revocation of Invossa,” the ministry said.
The ministry plans to hold a public hearing regarding its decision. If Kolon Life Science’s plead is not accepted during the hearing, the ministry will finalize its decision to revoke the certification.
At the same time, the health and welfare ministry has begun the process of retrieving government R&D grants and canceling presidential citations that the company received. Kolon Life Science received about 8.2 billion won ($7 million) for three years after being selected for the government's global high-tech biopharmaceutical technology development project in 2015.
Of the total, the government will retrieve 2.5 billion won first and determine the remainder following the ongoing investigations by prosecutors.
After a public re-verification process, the ministry also concluded the presidential citation, awarded to Kim Soo-jung, Kolon Life Science’s research director, in December 2018 for the development of Invossa, is subject to cancellation and request the related ministry to revoke it.