KOSDAQ-listed company Nature Cell filed a disqualification request on grounds of fairness against the representative of a competing company who participated as a committee member in the review of the marketing authorization for the degenerative arthritis stem cell treatment 'Jointstem,' but it was later confirmed that the Ministry of Food and Drug Safety (MFDS) dismissed the request.
According to a comprehensive report by Asia Economy on the 14th, Nature Cell submitted a disqualification request to the MFDS last December against Professor B, a well-known private medical school professor who participated as a committee member in the Central Pharmaceutical Affairs Deliberation Committee reviewing the marketing authorization of Jointstem.
At the time, Nature Cell argued that Professor B also served as the representative of a competing company, which constituted a disqualification reason for committee members under the Enforcement Decree of the Pharmaceutical Affairs Act. Article 14-3, Clause 6 of the Enforcement Decree of the Pharmaceutical Affairs Act stipulates that "if the chairperson of the deliberation committee recognizes that there is a significant reason that impairs the fair deliberation and resolution of the committee, such as having a direct interest in the agenda, the member shall be disqualified from deliberation and resolution."
The MFDS did not accept Nature Cell’s request. The MFDS judged that the company represented by Professor B was not considered a competitor of Nature Cell, and therefore no direct interest was established, resulting in dismissal of the request. An MFDS official stated, "For a company to be considered a competitor of Nature Cell, it must be engaged in research and development of treatments similar to Jointstem, but the company represented by Professor B is not involved in that field as far as we know."
However, upon checking the corporate registration certificate, it was found that the company’s business purposes include ▲ research and development of cell therapy products ▲ development of stem cell therapies and therapeutic application materials ▲ pharmaceutical and medical research and development. The corporate registration certificate explicitly indicated that the company is a competitor of Nature Cell, which holds the domestic distribution rights for the stem cell therapy Jointstem.
Nature Cell shareholders suspect that Professor B, who has expressed negative opinions about the development of Jointstem multiple times in the past through the media, led the deliberation and resolution of the Pharmaceutical Affairs Deliberation Committee in the two sessions held in September last year and February this year, resulting in the rejection of the marketing authorization. They also view the MFDS’s appointment of Professor B as a committee member and his participation in the committee as a serious procedural defect, and filed a complaint with the prosecution on the 10th. The accused are Professor B and MFDS employee A, with charges including dereliction of duty and obstruction of business by deception.
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