(영문) 서울고등법원 2013.10.25.선고 2012누22616 판결

The following facts are not disputed between the parties, or can be acknowledged in full view of the purport of the entire pleadings in Gap evidence Nos. 1 and 2.

A. The Defendant is in charge of the registration of a stem cell line owner (the name of the Ministry of Health and Welfare was reorganized to the Ministry of Health and Welfare (the Ministry of Health and Welfare as the Ministry of Health and Welfare on March 19, 2010) by being delegated by the Ministry of Health and Welfare (the Ministry of Health and Welfare as the Ministry of Health and Welfare on March 19, 2010) pursuant to Article 47(1) of the former Bioethics Act, which was wholly amended by Act No. 11250 on February 1, 2012, which was enforced since February 2, 2013, and was in force since February 2, 2013, Article 19-2(1)3 of the Enforcement Decree of the Bioethics Act.

B. On May 29, 2010, the Plaintiff filed an application for registration of stem cell lines under Article 20-2 of the amended Bioethics Act (hereinafter referred to as the "application for registration of this case") with respect to the Defendant as a person in charge of research on April 29, 201, on the part of the Plaintiff (hereinafter referred to as the "the stem cell line of this case"). The Defendant rejected the application for registration of this case on September 6, 2010 for the following reasons (hereinafter referred to as the "reasons presented by the Defendant" and the Defendant's rejection of the disposition of this case is referred to as the "disposition of this case").

Reasons for rejection: Disqualified for registration due to ethical scientific issues

(1) Ethical problem: A scientific problem is revealed in a prior investigation (the report on the Investigation Committee of the Seoul National University and the report on the National Bioethics Committee) conducted in the course of ovum supply and demand used to establish a cell owner. ② According to the report of the Seoul Investigative Committee and the data known to the present date, the relevant cell owner is highly likely to have been generated by parthenogenesis 4), not by the somatic-cell nuclear transplantation. The research on part of parthenogenesis is not subject to registration, because it is not limited to the scope permitted by the current Bioethics Act 5

2. The plaintiff's assertion

A. Regarding ethical issues

The Plaintiff did not engage in any non-Ethical act as claimed by the Defendant in the course of supply and demand of ovum used for the instant stem cell line research. ② Even if the Plaintiff had committed non-Ethical act in the course of supply and demand of ovum, the stem cell line of this case was established before the enforcement date of the Bioethics Act (amended by Act No. 7150, Jan. 29, 2004; hereinafter referred to as the “Bioethics Act”), so Article 12-3 (2) 1 of the Enforcement Rule of the 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 Bioethics Act”) does not require the requirement of “the method of establishment and the procedure for consent stipulated in Article 12-3 (2) 1” to the extent permitted by the Bioethics Act. Therefore, the Defendant cannot refuse the registration of the stem cell line of this case for any ethical problem in the process of supply and demand of ovum.

B. Regarding scientific issues

① The stem cell line of this case is not a stem cell line with a somatic cell line with a somatic cell line, but a single-productive stem cell line with a somatic cell line. ② Even if the stem cell line owner is a single-productive stem cell line, the revised bioethics Act does not restrict the scope of stem cell line subject to registration by means of reproductive organ or embryo formation. Therefore, the Defendant may not refuse the registration of the stem cell line of this case on the ground that it is a single-productive embryonic stem cell line owner.

The defendant added at the trial that the stem cell line owner of this case did not meet the "vehicle identification" requirement under Article 12-3 (1) 2 of the Enforcement Rule of the Bioethics Act. The argument regarding the requirements for the "Replacement" cannot be added to the grounds for the disposition of this case because it is difficult to view that the grounds for the disposition of this case and the basic facts are identical, and even if the grounds for the disposition of this case are identical to those for the disposition of this case, the stem cell line owner of this case satisfies the requirements for "Replacement identification" under the Enforcement Rule of the Bioethics Act, so the defendant cannot reject the registration of the stem cell line of this case on the ground of the "Replacement Identification" requirement.

3. Relevant statutes;

It is as shown in the attached Form.

4. Progress in the enactment and amendment of bioethics Act;

In order to determine whether the defendant's disposition rejecting the application for registration of this case on the ground of ethical and scientific issues and the requirement of â€˜personal identification' is legitimate, it is necessary to examine the details of the enactment and amendment of the Bioethics Act, the purpose of introducing the stem cell line registration system and its contents, etc.

A. The enactment of Bioethics Act on January 29, 2004

1) Legislative intent and major contents of the Bioethics Act were enacted on January 29, 2004 and enforced on January 1, 2005. Article 1(1) of the Bioethics Act provides that “The purpose of this Act is to enhance the health and quality of life of citizens by ensuring bioethics and safety in biotechnology and ensuring human dignity and value, and by creating conditions in which bioscience and technology can be developed and used for the prevention and treatment of human diseases.” The Bioethics Act defines the terms used in the Act (Article 2), and establishes the National Bioethics Committee under the President to deliberate on matters concerning bioethics and safety (Article 6), prohibit her somatic-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell cloning-cell-celled-cell-cell-cell-cell-cell-cell-cell-cell-cell-cell-cell-making-making (Article 11 and Article 13), prohibit embryo production-making-research-research-making-research-making-making-making-making-making-making-making-specific.

2) Articles 18, 19, and 23 of the Bioethics Act provide that a person who intends to research embryos or somatic cell cloning embryos or who intends to produce or research somatic cell cloning embryos shall be equipped with facilities and human resources prescribed by the Ordinance of the Ministry of Health and Welfare and register with the Minister of Health and Welfare; where an embryo research institute registered intends to research embryos or somatic cell cloning embryos, it shall submit an embryo research plan in advance to the Minister of Health and Welfare in accordance with the Ordinance of the Ministry of Health and Welfare

Therefore, after the enactment bioethics law enters into force, the production and research of residual embryos (including not only the process of establishing stem cell lines through research of embryos, but also the research of the established stem cell lines) shall be subject to the regulation of the enacted bioethics law, and it shall be allowed only when it satisfies certain requirements, such as registration as an embryo research institute, submission of an embryo research plan, and approval.

B. Amendment of Bioethics Act on June 5, 2008

1) Major contents - The Bioethics Act introduced the stem cell line registration system by newly establishing Article 20-2 at the time of the amendment of the Bioethics Act, 6, 5, and 208. The revised Bioethics Act defines the term of stem cell line, Article 20-2(1) provides that a person who establishes or imports a stem cell line shall register the stem cell line with the Minister of Health and Welfare before providing or using the stem cell line, as prescribed by the Ordinance of the Ministry of Health and Welfare, and Article 20-3(1) of the same Act provides that the person who establishes or imports the stem cell line shall undergo deliberation by the Institutional Life Deliberation Committee (hereinafter referred to as the "Institution Committee"), as prescribed by Ordinance of the Ministry of Health and Welfare, in order to provide the stem cell line, and Article 20-4(1) of the same Act provides that the registered stem cell line can only be used for research purposes prescribed by each subparagraph.

In addition, Article 2 (2) of the Addenda to the amended Bioethics Act (hereinafter referred to as "the Addenda to the amended Bioethics Act") is a transitional measure for the registration of stem cell lines already established or imported before January 1, 2010, which is the enforcement date of the amended Bioethics Act, and the person who has already imported or imported stem cell lines before the enforcement date of the amended provisions of Articles 20-2 through 20-4 shall be deemed to have established or imported the stem cell lines in accordance with the amended provisions of Article 20-2. In this case, the application for registration shall be made until June 30, 2010.

(ii) the amendment purpose;

According to the pre-established Bioethics Act, as seen earlier, the stem cell line research conducted by receiving stem cell lines established through research on the production of embryos as well as research on the production of embryos shall be subject to the same level of regulation as that of research on the production of embryos (registration of embryo research institutes, submission of an embryo research plan, approval, etc.).

However, there is a need to strictly regulate bioethics issues, such as the consent of ovum providers, embryo reproduction, and embryo destruction, while there is a need to strictly regulate the research using the stem cell line, and there is a request to relax regulations on embryo production, etc. because the necessity of activation of research is larger than that of bioethics issues already established (see subparagraph 8 of this paragraph). Accordingly, the amended Bioethics Act transparently managed the process of using and providing stem cell lines to ensure the safety of stem cell line research by transparently managing the process of use and provision of stem cell lines, while establishing a stem cell line registration system to relax regulations on the stem cell line by separating the research using the already established stem cell line from the research establishing the stem cell line (see subparagraphs 7-1 and 8 of evidence 7).

Therefore, Article 17 of the Bioethics Act was applied to the existing research on embryonic stem cell lines, as well as the existing research on embryonic stem cell lines, and limited to the research on infertility treatment and rare or incurable disease treatment. In accordance with Article 20-4 of the Bioethics Act, the research on the general treatment of diseases, the characteristics of stem cells, and the division of stem cell lines were expanded into the basic research on embryo therapy. Furthermore, Articles 18 and 19 of the Bioethics Act are applied to the existing research on embryonic stem cell lines, and the embryo research plan was registered as an embryo research institute and submitted to the Minister of Health and Welfare for approval. However, in accordance with Article 20-4 of the Bioethics Act, the regulation was mitigated to obtain approval from the competent institutional committee and the head of the competent institution without approval on the registration and research plan of the embryo embryo

C. After the wholly amended Bioethics Act enters into force on February 1, 2012, the Bioethics Act was completely amended on February 1, 2012 to improve and supplement the problems arising from the operation of the system, and came into force on February 2, 2013. The current Bioethics Act also stipulates that research on part-cell cloning embryo is permissible within the same regulatory framework as that on research on part of somatic-cell cloning embryo (Articles 20, 30, and 31). The provisions on the registration, provision, and use of stem cell lines (Articles 33, 34, and 35) regarding stem cell lines (Articles 33, 35) separately stipulated in Section 4 of Article 3, and separately stipulated that the stem cell line is included in Section 3 of Article 2, and that the stem cell line is also included in the stem cell line (Article 2, subparagraph 10).

A. The plaintiff and the defendant's assertion

The plaintiff asserts that it is unlawful to return an application for registration of ovum supply and demand due to problems in the process of ovum supply and demand before the enactment of the Bioethics Act, and the defendant asserts that the failure to comply with the amended provisions of the Bioethics Act (Articles 13 (3), 15, and 15-3) in the process of ovum supply and demand constitutes an ethic act and that it is necessary for the public interest to refuse the registration of the stem cell in this case

B. Determination

In light of the details and purport of the enactment and amendment of the Bioethics Act, it is difficult to expect that the Plaintiff complied with the level of ethical standards stipulated in the Bioethics Act at the time of the establishment of the stem cell line. ② Ethical issues in the process of receipt of ovum can only be considered as the legislative issues that can be applied retroactively to the acts before the enactment of the Bioethics Act. ③ The purpose of the Bioethics Act was to allow the establishment of the Bioethics Act to obtain consent by any means with respect to the use of ovum, the number of ova that can be extracted from the donor, and whether the payment for the provision of ovum can be made to the donor. ③ If the amendment introduced the Bioethics Act on January 1, 2005, it is difficult to expect that the Plaintiff would be able to comply with the standards for registration of stem cell lines for the purpose of facilitating the research of stem cell lines already established in order to promote the development of stem cell lines, the amendment of the Bioethics Act is unlawful. ④ If the amendment of the Bioethics Act provides for the provision of the Bioethics Act on the supply of stem cells.

6. Whether the return of an application for registration is legitimate for scientific issues;

A. The plaintiff and the defendant's assertion

The plaintiff asserts that the stem cell line owner of this case, as argued by the defendant, is subject to registration pursuant to Paragraph 2 of the Addenda of this case even if the stem cell line owner of this case is a single-productive stem cell line, and the defendant asserts that the stem cell line of this case is not a stem cell line owner subject to registration under the amended Bioethics Act.

B. Determination

As seen earlier, unlike the provisions of the current Bioethics Act (Article 2 subparagraph 7 of the Bioethics Act), parthenogenesis (Article 2 subparagraph 9), and parthenogenesis stem cell line (Article 2 subparagraph 10 of the Bioethics), the revised life law does not provide for participatory embryos and parthenogenesis stem cell line, and Paragraph 2 of the Addenda of the instant case provides that the person who has already imported or imported the stem cell line before January 1, 2010 shall be deemed to have established or imported in accordance with the amended provisions of Article 20-2.

However, in full view of the following circumstances, the term "a stem cell line" under Paragraph 2 of the Addenda of this case means all the part of the cell line corresponding to "a cell line that can be continuously reproduced and that can be divided into diverse cells" under the productive conditions stipulated in subparagraph 10 of Article 2 of the amended Bioethics Act. Thus, the rejection of the application for registration of this case on the ground that it is not subject to the record by the defendant, etc. is illegal without the need to determine whether the stem cell line is the stem cell line of the part-born embryo.

① Article 2 of the Addenda to the instant case only provides that the subject matter is already established as a stem cell line before the enforcement date of the amended provision, and that it is not limited to "a stem cell line derived from artificial insemination embryos or somatic-cell cloning embryos" before the enforcement date of the amended provision, and Article 2.10 of the amended Bioethics Act only provides that "a cell line that can be continuously reproduced under the conditions that can be differentiated from stem cell line and can be divided into diverse cells", and that it is not possible to establish the stem cell line of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of an embryo of this case."

③ The purport of the amended Bioethics Act introducing the stem cell line registration system is to relax the regulation on research using the already established stem cell line by separating it from the research to establish the stem cell line, and the ethical problems, such as the collection, reproduction, and destruction of ovum, occur mainly in the research to establish the stem cell line, while the research field using the already established stem cell line is unlikely to cause such problems, so it is necessary to promote the research of the stem cell line and protect autonomy of the already established stem cell line, the supplementary provision of the instant case is deemed to have been established in accordance with the amended provisions of Article 20-2 regarding the stem cell line at the time of the implementation of the stem cell line registration system, and it is determined as a transitional measure to enable the registration of the stem cell line.

① A stem cell line registration application (attached Form 12-2) that a person who intends to register a stem cell line pursuant to Article 12-2 of the Enforcement Rule of the amended Bioethics Act shall submit to the Defendant (attached Form 12-2) is required to indicate only “the establishment and importation of a stem cell line” in the stem cell line division column, and there is no difficulty in stating the method of creation of stem cell line in the certificate of registration of stem cell line issued by the Defendant after the registration of the stem cell line (attached Form 12-5). On the other hand, the letter of approval of the embryo research plan submitted by an embryo research institute to the Minister of Health and Welfare in order to obtain approval for embryo research line (attached Form 8) pursuant to Article 8 of the Enforcement Rule of the amended Bioethics Act is subject to the embryo research plan or somatic cell line. In light of this, the amended Enforcement Rule of the Bioethics Act does not constitute the subject matter of examination of the defendant’s stem cell line in the stage of creation of stem cell line, etc.

7. Whether the rejection of an application for registration on the ground of the de-identification requirement is legitimate.

A. Whether the grounds for the disposition are added;

1) The plaintiff and the defendant's assertion

At the trial, the defendant asserts that the disposition of this case is legitimate since the stem cell line owner fails to meet the requirements for the replacement identification under Article 12-3 (1) 2 of the Enforcement Rule of the Bioethics Act. The plaintiff argues that the defendant's assertion on the requirements for the replacement identification constitutes a separate reason for disposition, and that the ground for disposition on the requirements for the replacement identification is not identical to the grounds for disposition of this case, so it cannot be added to the grounds for disposition.

2) Determination

In an appeal litigation seeking the revocation of an administrative disposition, a disposition agency may add or modify other reasons only to the extent that the original reason and basic factual relations are recognized to be identical, and the existence of basic factual relations in this context shall be determined based on whether the grounds for disposition are identical in a basic point of view with the relevant basic social factual relations, based on the specific facts before legally assessed the grounds for disposition. The existence of additional or modified grounds merely did not state such grounds at the time of initial disposition, and the relevant parties are aware of such facts, and cannot be deemed identical with the original grounds for disposition (see Supreme Court Decision 2003Du8395, Dec. 11, 2003).

Article 12-3 (1) 2 of the amended Enforcement Rule of the Bioethics provides that "the individual identification of stem cell lines, gene transmission, decentralization, etc. shall be verified scientifically," and Article 12-2 (1) 1 provides that a person who intends to register a stem cell line shall attach a description of the characteristics of stem cell line (attached Form 12-3) to the defendant in the application for registration of stem cell line, and the above description of the characteristics of stem cell line requires STR (hereinafter referred to as "genetic geographical analysis test") to be conducted by an inspection for judgment on the replacement.

In full view of the above provisions, the "individual identification" under the amended Enforcement Rule of the Bioethics refers to the distinction between the stem cell line subject to registration and another stem cell line that has already been registered or has not been registered, and the defendant's original reason for return is the concept of â€˜medical problem' (the fact that the stem cell line of this case was created by parthenogenesis, not the somatic-cell nuclear transplantation), which is the reproductive method of the stem cell line, which is distinct from the â€˜individual identification', so the defendant's argument about the requirements for â€˜individual identification' is a new reason for disposition.

In addition, as to whether the defendant can add the requirements of the "individual identification" that he did not present at the time of the disposition in this case as the grounds for disposition, the requirement of the "individual identification" added as the grounds for disposition in the original reason for disposition by the defendant and the "individual identification" added as the grounds for disposition in the trial is different from the evaluation of the genetic characteristics of the stem cell line in this case, and it does not change the facts that form the basis for the assessment. Thus, the addition of the grounds for disposition by the defendant constitutes a case where the identity of the disposition is maintained.

B. Whether the stem cell line owner of this case satisfies the requirements of "vehicle identification"

Comprehensively taking account of the overall purport of arguments in Gap evidence Nos. 2, 3, 7, and 17, Eul evidence Nos. 1, 3, and 11, the stem cell line owner of this case deposited with the Korean cell line Research Foundation established on December 29, 2003, which is an international certified institution, and ② the Seoul Research Commission, which was sufficient to investigate the plaintiff's suspicion related to the stem cell line of this case from December 2005 to January 2006, conducted a genetic text analysis on the stem cell line of this case, and compared the genetic text analysis data on the stem cell line of this case to identify the well body of the stem cell line of this case, but the same stem cell line was not found, ③ the research on the stem cell line of this case was conducted in comparison with the genetic text analysis data on the stem cell line of this case, ③ the research on the gene text analysis results submitted by the plaintiff to the defendant at the time of the application for registration of the registration of the stem cell line of this case, ④ the genetic text analysis results of this case No. 2.

In full view of the above facts, the stem cell line of this case can be distinguished from other stem cell lines by genetic geological analysis tests, and it is judged that it satisfies the requirements for replacement under Article 12-3 (1) 2 of the Enforcement Rule of the amended Bioethics Act. Therefore, it is illegal for the Defendant to return the application for registration of this case on the ground that it fails to meet the requirements for replacement.

8. Conclusion

Therefore, the plaintiff's claim is justified, and the conclusion of the judgment of the court of first instance is justified, and the defendant's appeal is dismissed and it is so decided as per Disposition.

Judges

Appointment of presiding judge judge;

Judges, forestry leaves

Judges Park Jong-ho

Note tin

(i) means the cell main body that can be continuously reproduced and differentiated into a variety of cells under productive conditions (on the face of);

Bioethics Act (No. 10).

2) The Plaintiff’s research team injects a human somatic cell into an ovum with its nucleus removed (nuclear transplant, NT (Nu Titter).

It is also called ‘D stem cell line' to be the first established stem cell line.

(iii) transplanting a human somatic cell nucleus to a human ovum with its nucleus removed (Article 2(6) of the current Bioethics Act);

Technologies that extract nucles from a somatic cell and then put them into an ovum for which nucles have already been removed, and shall be included in an ovum through static manipulation.

After removing the nucleus, the nucleus of a somatic cell using the bitomy shall be transplanted to the ovum, and the nucleus of an dives cell using the bitomy shall be the nucleus of the dives cell.

It shall induce the convergence of ovums. A cell cell group created by somatic-cell nuclear transplantation shall be called somatic-cell cloning (on the port).

Bioethics Act (No. 8 of Article 2)

(iv) means the division of cells without alteration (Article 2 subparagraph 7 of the current Bioethics Act) and sperm;

In that the division of cells is made, 'mhenogenesis' is also called 'cell group produced by parthenogenesis.

The stem cell line derived from the base is a stem cell line of parthenogenesis (Article 2.9 and 10 of the current Bioethics Act);

5) The current Bioethics Act referred to in the Defendant’s return disposition was in force at the time of the instant disposition.

means any of the following:

6) An embryo remaining after an embryo produced through artificial insemination is used for pregnancy (Article 2 of the Bioethics Act)

No. 3)

7) The STR test (St defat, short-term heat return test) is on the top of the end of the DNA chromosome, with a certain union salt on the top of the end of the DNA chroe.

An inspector who measure a section in which a short salt heat composed of them is repeated and applies to the judgement of identity of the chromosome.

It is also called the name of DNA Fringerp Anlysis (e.g., hydro-electronic geological analysis).

8) Therefore, whether the stem cell line subject to registration was created by the somatic-cell nuclear transplantation, and whether it was generated by parthenogenesis

If it is possible to distinguish it from other stem cell lines by genetic geographical analysis tests even if it is not known whether it is possible to distinguish it from other stem cell lines.

of this case, it can be deemed that the

9) The results of genetic geographical analysis conducted by the research team of the Baddern University are as follows: the results of the examination conducted by the research committee of the Seoul National University;

The difference was found in value (D75820), but the research team of the Badern University was investigated by the stem cell line owner subject to the investigation.

A research is conducted on the reproductive origin of stem cell lines recognized as the same as the stem cell line investigated by the Committee.

It is judged to be.

심급 사건

-서울행정법원 2012.6.28.선고 2010구합44221

서울고등법원 2013.10.25.선고 2012누22616

-대법원 2015.6.24.선고 2013두24433

참조조문

-생명윤리 및 안전에 관한 법률

-생명윤리 및 안전에 관한 법률 제1조

-생명윤리 및 안전에 관한 법률 제2조

-생명윤리 및 안전에 관한 법률 제2조 제2호

-생명윤리 및 안전에 관한 법률 제2조 제5호