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(영문) 대법원 2015.06.24 2013두24433
줄기세포주등록반려처분취소
Text

The appeal is dismissed.

The costs of appeal are assessed against the defendant.

Reasons

The grounds of appeal are examined (to the extent of supplement in case of supplemental appellate briefs not timely filed).

1. As to the grounds of appeal that cannot be registered due to lack of ethical requirements, (1) on May 29, 2010, the Plaintiff filed an application for registration of the instant stem cell line with the Defendant under Article 20-2 of the Bioethics and Safety Act (wholly amended by Act No. 11250, Feb. 1, 2012; hereinafter “Revised Bioethics Act”).

(2) The amended Bioethics introduced a stem cell line registration system to relax regulations on research using the stem cell lines already established in order to separate the research to establish the stem cell line from the research to establish the stem cell line.

According to Article 20-2(1) of the Revised Bioethics Act and Article 12-3 of the Enforcement Rule of the Revised Bioethics Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 180, Feb. 1, 2013; hereinafter “Enforcement Rule of the Revised Bioethics Act”), the stem cell line owner established before January 1, 2005 only meets the requirement of “the identification of the stem cell line owner’s identity, genetic transmission, decentralization, etc. should have been verified scientifically,” under Article 12-3(1)2 of the 2 of the Revised Bioethics Act, if the stem cell line owner satisfies the requirement of “the method of establishment and consent procedure should not be within the scope permitted by the Act” as stipulated under Article 12-3(1)1 of the Revised Bioethics Act.

Article 13(3) of the Bioethics and Safety Act (amended by Act No. 7150, Jan. 29, 2004; hereinafter “Bioethics Act”) prohibits the provision of, or the use of, ovum under consideration for money, etc. and soliciting or arranging the act thereof. Article 15 of the Bioethics Act provides for the procedure and method of consent to, an authorized medical institution producing embryos when it extracts ovum. The aforementioned provisions begin with January 1, 2005.

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