The costs of appeal are assessed against the Defendant.

1. As to the grounds of appeal that cannot be registered due to lack of ethical requirements (1) regarding the stem cell line of this case established around April 2003, the Plaintiff introduced the stem cell line registration system in order to relieve the regulation on the stem cell line by separating it from the research that has already been established in order to establish the stem cell line, under Article 20-2 of the Bioethics and Safety Act (wholly amended by Act No. 11250, Feb. 1, 2012; hereinafter referred to as the "Revised Bioethics Act").

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 referred to as the "Enforcement Rule of the Revised Bioethics Act"), if only the requirements of "the identification of the stem cell line, gene transmission, and decentralization, etc. should have been verified scientifically," which were established before January 1, 2005, the stem cell line owner satisfies the requirement of "the identification of the stem cell line, gene transmission, and decentralization, etc. should not meet the requirements of "the method of establishment and consent under Article 12-3(1)1 of the Revised Bioethics Act" and Article 12-3 of the Revised Bioethics Enforcement Rule of the Revised Bioethics Act, it shall not meet the requirements permitted by the law.

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, an ovum on condition of return, such as money, from providing, inducing, or arranging such act. Article 15 of the Bioethics Act provides for the procedure and method of consent to be complied with when an embryo production medical institution extracts an ovum. The above provisions were enforced only from January 1, 2005. Accordingly, the above provisions that the Plaintiff had never existed at the time of establishing the cell owner of this case cannot serve as a reasonable ground for rejecting the Plaintiff’s application for registration of this case.

Considering the contents and legislative intent of the amended Bioethics Act and the provisions of Articles 13(3) and 15 of the Bioethics Act as well as the timing of enforcement of the provisions, it is reasonable to interpret that, in the case of stem cell lines already established before January 1, 2005, the ethical suitability of the process of acquiring ovum and collecting ovum for the purpose of establishment does not fall under the requirements for registration.

(3) Examining the record in accordance with the above legal principles, it is justifiable for the lower court to have determined that the Defendant could not refuse the registration of the stem cell line of this case established around April 2003 on the ground of the ethical problem of the process of supply and demand of ovum. In so doing, the lower court did not err by misapprehending the legal doctrine on the registration standards of stem cell lines under the amended Bioethics Act.

2. As to the grounds of appeal that it is not subject to registration of a single-reproductive stem cell line, Article 20-2, which is a provision on the registration of stem cell lines, shall apply mutatis mutandis to research on somatic cell lines under Section 2 of Chapter III ( artificial insemination embryos), and it is true that there is no specific provision regarding single-reproductive embryo or its stem cell line for the purpose of preventing it from being registered, unlike the current Act amended by Act No. 11250, Feb. 1, 2012 (2) that it is possible to provide it to the defendant, and that the person who has already established the new stem cell line for the purpose of preventing it from being registered under Article 20-2, which is not subject to registration of the new stem cell line for the purpose of preventing it from being registered. However, the person who has already established the new stem cell line for the purpose of preventing it from being registered under Article 20-2, which is not subject to registration of the new stem cell line for the purpose of preventing it from being registered under Article 20-2.

Even if it is derived from the reproductive technology, it is reasonable to regard it as subject to registration.

(3) Examining the records in accordance with the above legal principles, the court below's decision constitutes registration of the stem cell line of part-time reproductive embryos established before the implementation of the stem cell line registration system on the grounds as stated in its reasoning.

Considering that the Defendant’s rejection of the instant application for registration on the grounds that the instant application for registration is not subject to registration, it is justifiable to determine that the instant stem cell line is illegal regardless of whether the instant stem cell line is a single-reproductive stem cell line. In so doing, there is no error of misapprehending the legal principles on the registration of stem cell lines

3. Examining the record of the grounds of appeal that cannot be registered due to the failure to meet the replacement identification requirements, the lower court, on the grounds indicated in its reasoning, deemed that the stem cell line of this case can be distinguished from other stem cell lines through the analysis and examination of gene fingerprints, and thus, did not meet the “vehicle Identification” requirement under Article 12-3(1)2 of the Enforcement Rule of the amended Bioethics Act.

The rejection of the application for registration of this case on the ground that it was unlawful is justified. In so doing, there were no errors by failing to exhaust all necessary deliberations or by misapprehending the legal principles on the requirements for registration of stem cell lines under the amended Bioethics Act.

4. Conclusion

Therefore, the appeal is dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices.

Justices Kim Jae-tae

Justices Jo Hee-de

Justices Park Sang-ok