Embryo research

Embryo research (배아연구/胚芽硏究) was once conducted very actively in Korea, but the so-called "Hwang Woo-Suk scandal" threw a wet blanket the highly advanced human embryo and stem shell research staged by Korean bio-scientists. The Bioethics and Biosafety Act (생명윤리 및 안전에 관한 법률) (enacted in 2004, enforced in January 1, 2005, and amended from time to time) has stepped up its regulatory monitoring system since its enactment. In the United States, the Committee on Pediatric Research and Committee on Bioethics entrusted by the American Academy of Pediatrics issued a statement on the "Human Embryo Research". It reaffirmed in 2001 that, under certain conditions, research using human embryos and pluripotent stem cells is of sufficient scientific importance that the National Institutes of Health should fund it.

Key words
human embryo, stem cell, bioethics, Professor Hwang Woo-Suk, constitutional complaint

Bioethical issues involved
In the course of the embryo research, the following questions are raised from time to time:
 * Whether early human embryos possess fundamental rights
 * Regarding the constitutional complaint filed by complainants who are engaged in research work on embryos, whether there is a possibility of infringing on the complainants' fundamental rights and whether their self-relatedness can be recognized
 * Fundamental rights of embryo creators in relation to management and disposal of embryos and necessity of restriction on the rights
 * Whether Article 16 Sections 1 and 2 of the Bioethics and Biosafety Act, which allow disposal of remaining embryos after five years, restrict the embryo creators' right to self-determination regarding the embryos

Facts
(1) Complainant embryo 1 (hereinafter, Complainant 1) and complainant embryo 2 (hereinafter, Complainant 2) are remaining human embryos which were generated through in vitro fertilization with the sperms taken from Nam X Min (hereinafter, Complainant 3) and the oocyte taken from Kim X Mee (hereinafter, Complainant 4) at a branch hospital of XX Medical Foundation located in Choryang 3-dong, Dong-gu, Busan Metropolitan City in December 9, 2004, but not implanted into Complainant 4's uterus and stored at the aforementioned medical foundation.

(2) Complainants 3 and 4 are married couple who provided his sperms and her oocyte for the purpose of pregnancy by which Complainants 1 and 2 were generated through artificial fertility treatments.

(3) Complainant Chang X Soo is an obstrician/gynecologist; complainant Kang X Sung is an obstrician/gynecologist and a professor; complainant Koo X Mo and complainant Jin X Hoon are professors of Ethics; complainant Kim X Young is a college student; complainant Kim X Soo is a law professor; complainant Park X Eun is a physician; complainant Lim X Sik is a philosopher; and complainant Hwang X Sung is a clinical pathologist (hereinafter, Complainants 5 through 13).

(4) The complainants filed this constitutional complaint on March 31, 2005, arguing that the Article 16 Sections 1 and 2 of the Bioethics and Biosafety Act infringe on the complainants' fundamental rights because the provisions, while permitting the creation of embryos for the purpose of pregnancy, view embryos created for artificial fertility treatments as the cluster of cells, rather than as a human entity, thereby allowing the remaining embryos to be possibly utilized for medical research; insufficiently regulate the storage period, disposal and research of the remaining embryos; and allow research and disposal of somatic cell cloned embryos that are created through somatic cell nucleus transfer, without limiting the number of embryos to be created or specifying the condition, standard and method of artificial fertilization.

Constitutional Court Decision
The Constitutional Court held in its Decision 2005Hun-Ma346.:

1. A developing prenatal life can be regarded as possessing fundamental rights, when constitutional protection for the life is highly required and the case meets a certain standard. However, the questions regarding when its possession of fundamental rights should be recognized and what kind of fundamental rights the life may possess should be answered considering the development of natural science and technology, including biological knowledge on the origin of life and the normative necessity derived from the constitutional interpretation based on such development.

Because early embryos are fertilized eggs, it would be possible to say that they already took the first step in the life formation process. However, at the contemporary level of scientific knowledge, it is hard to affirm the continuity of the entity from embryos to an independent human being, unless they are implanted into a mother's womb or the embryological primitive streaks appear. Given the contemporary level of technological development, an embryo is expected to develop into a human entity only after being implanted into a woman's womb. Moreover, there seems no social recognition that such early human embryos are regarded or should be treated as a human entity. Considering all the facts above, the Court finds that early human embryos created for artificial fertility treatments do not possess fundamental rights under the Constitution. Therefore, the constitutional complaint filed by Complainants 1 and 2, early human embryos, are non-justiciable as they do not possess fundamental rights.

2. Regarding the complainants, consisting of legal scholar, ethicist, philosophers, doctors, etc., although they may experience inconvenience due to the provisions at issue in this case, such disadvantage is merely indirect and factual one, and the possibility of infringing on their fundamental rights and self relatedness cannot be recognized.

3. Embryo creators are those who provide parts of their bodies which contain their own genetic information and are expected to have the status as biological parents if the embryos are successfully implanted into the mother's womb and born afterward. They have the right to self-determination regarding management and disposal of the embryo. Although not explicitly stated in the Constitution, the embryo creator's right to self-determination toward the embryo should be considered as a constitutional right derived from the general right to personality under Article 10 of the Constitution.

Restriction on the right, however, is highly necessary, considering the facts that the peculiar status of an embryo, as a developing life, requires active protection by the State, and that the management and disposal of embryos necessarily requires evaluation in light of public welfare and socio-ethical values. In this regard, the embryo creator's right to self-determination toward the embryos, despite its nature as a right to personality, is a type of fundamental rights that can be restricted when it clearly runs against the constitutional value in legal protection of embryos.

4. That the provisions at issue in this case prescribe five years of embryo storage period and require disposal of all embryos after the storage period is legitimate in terms of the legislative purposes and also appropriate as a means to achieve the legislative purposes. Moreover, it seems hard to say that there clearly exists less restrictive means; the five-year storage period is not clearly unreasonable in terms of providing some opportunity to use embryos for those who want to have children. The public interests to decrease social costs arising from the increased number of remaining embryos and to prevent the possibility of improper research do not seem to be dwarfed by the embryo creators' disadvantage caused by the restriction on their right to self-determination. Therefore, the Court finds that the provisions at issue in this case are neither in violation of the principle of least restrictive means nor against the principle of balance between legal interests.

See the detailed reasoning at the Constitutional Court Website. The subject matter of review in this case is whether Article 13 Section 1, Article 16 Sections 1 to 3, Article 17 Items 1 and 2, Article 20 Section 4, Article 22, Addenda Sections 2 and 3 of the Bioethics and Biosafety Act (hereinafter, the 'Bioethics Act') and Article 16 Section 4, Article 17 Item 3, Article 20 Sections 1 through 3 of the former Bioethics and Biosafety Act (before being revised by Act No. 8852 on February 29, 2008; hereinafter, the 'former Bioethics Act') are unconstitutional, in violation of the fundamental rights of the complainants. The provisions at issue are as follows, and the related provisions are provided in Appendix: Bioethics and Biosafety Act (enacted as Act No. 7150 on January 29, 2004)

Article 13 (Producing Embryos)
 * (1) No one shall produce embryos other than for the purpose of pregnancy.

Article 16 (Storage and Disposal of Embryos)
 * (1) The storage period of embryos shall be 5 years. A storage period less than 5 years may be designated by the Consenters.
 * (2) Embryo Producing Medical Institutions shall dispose of all embryos at the end of their period of storage, except for those that are to be utilized for the purpose of research outlined in Article 17.
 * (3) Embryo Producing Medical Institutions shall record and keep record of details concerning the disposal of embryos.

Article 17 (Research on Remaining Embryos)
 * Remaining embryos that have passed the storage period outlined in Article 16 may be utilized for the following purposes, but only until the embryological primitive streaks appear in their developmental process. However, in order to utilize a remaining embryo that has been stored for less than 5 years, a new consent, for this new purpose, is required from the Consenters.
 * 1.To conduct research aimed at developing contraception and infertility treatments; or
 * 2.To conduct research aimed at curing muscle dystrophy and other rare or incurable diseases, as decreed by the President.

Article 20 (Supply and Maintenance of Remaining Embryos)
 * (4) The requirements under Article 16 Sections 2 through 4 shall apply to Embryo Research Institutions where they receive remaining embryos in accordance with Section 1 but do not use them for research. In such cases, "Embryo Producing Medical Institution" is regarded as an "Embryo Research Institution."

Article 22 (The Act of Somatic Cell Nucleus Transfer)
 * (1) No one shall conduct somatic cell nucleus transfer other than for the purpose of conducting research aimed at curing rare or currently incurable diseases, as described in Article 17 Item 2.
 * (2) The permissible type, subject, and scope of research on somatic cell nucleus transfer pursuant to the purpose stated in Section 1 of this Article shall be decided by the Presidential Decree after it has been reviewed by the Review Committee.

Addenda
 * (2) (Interim Measures on Remaining Embryo Research) To the extent that the embryological primitive streaks have not emerged, remaining embryos may be utilized for the purposes specified in Article 17, provided that:
 * 1.The remaining embryos were produced before this Act takes effect;
 * 2.A period of five years has passed since the remaining embryos were created; or
 * 3.Consent is obtained from the Consenter. However, this requirement does not apply in cases where obtaining consent is impossible because the Consenters' whereabouts are unknown.
 * (3) (Interim Measures on Somatic Cell Cloned Embryos Research) Anyone who is engaged in research on somatic cell cloned embryos for the purposes mentioned in Article 17 Item 2 at the time this Act takes effect may continue his or her research, with the approval of the Minister of Health and Welfare, on either of the following conditions:
 * 1.The researcher has been continuously engaged in research on somatic cell cloned embryos for at least 3 years; or
 * 2.The researcher has published at least one research paper on somatic cell cloned embryos in a related academic periodical.

Former Bioethics and Biosafety Act (before being revised by Act No. 8852 on February 29, 2008)

Article 16 (Storage Period for Embryos and its Disposal)
 * (4) The regulations on procedure and means of embryo disposal, and recording and record keeping of disposed embryos are to be provided by the Ministry of Health and Welfare Decree as necessary.

Article 17 (Research on Remaining Embryos)
 * Remaining embryos that have passed the storage period outlined in Article 16 may be utilized for the following purposes, but only until the embryological primitive streaks appear in their developmental process. However, in order to utilize a remaining embryo that has been stored for less than 5 years, a new consent, for this new purpose, is required from the Consenters:
 * 3.To conduct other research approved by the Presidential Decree after being reviewed by the Review Committee.

Article 20 (Supplying and Maintaining Remaining Embryos)
 * (1) When an Embryo Producing Medical Institution supplies a remaining embryo to an Embryo Research Institution for research approved under Article 19 Section 1, it shall do so for free. However, the Embryo Producing Medical Institution may, in accordance with the Ministry of Health and Welfare Decree, request that the Embryo Research Institution provide reimbursement for the expenses of storing and providing the remaining embryo.
 * (2) The supply procedures, the calculation of expenses, and any other details concerning the remaining embryos mentioned in ① shall be decided by the Ministry of Health and Welfare Decree.
 * (3) The Embryo Producing Medical Institution and Embryo Research Institution shall report all details concerning the storage and supply of remaining embryos to the Minister of Health and Welfare in accordance with the Ministry of Health and Welfare Decree.

The complainants also requested a review of constitutionality of Articles 18, 19 and 23 of the former Bioethics and Biosafety Act (revised by Act No. 7150 on January 29, 2004 before revised by Act No. 8852 on February 29, 2008). But these provisions have no relevance to the complainants as they simply stipulate procedures for registration of an embryo research institution and approval of embryo research protocol. Moreover, the complainants do not specifically argue unconstitutionality of the provisions, and there seems to be no need for the Constitutional Court to clarify these parts. Therefore, there provisions should not be reviewed. Bioethics and Biosafety Act (revised by Act No. 9932 on March 19, 2010)

Article 2 (Definitions)
 * The following definitions apply in this Act:
 * 2."Embryo" refers to a fertilized egg (or segmented cell) from the moment of fertilization to the point of time at which all organs of the given organism have developed embryologically.
 * 3."Remaining embryo" refers to an embryo that is created through in vitro fertilization procedures but is not implanted in the womb of any woman.
 * 4."Somatic cell nucleus transfer" refers to the transfer of a human somatic cell nucleus to a human or animal oocyte from which the nucleus has been removed. 
 * 5."Somatic cell cloned embryo" refers to an embryo formed by the act of somatic cell nucleus transfer.

Article 13 (Producing Embryos)
 * (2) In producing embryos for the purpose of pregnancy, no one shall perform any of the following acts:
 * 1.Fertilizing an oocyte, when the oocyte and/or sperm have been specially selected for the purpose of producing offspring of a particular gender;
 * 2.Fertilizing an oocyte, when the oocyte and/or sperm are those of a deceased person; or
 * 3.Fertilizing an oocyte, when the oocyte and/or sperm are those of a minor. However, an exception applies when married under-aged parents wish to conceive a child.

Article 15 (Consent to the Production of Embryos)
 * (1) When a medical institution that is designated as an embryo producing medical institution under Article 14 (hereinafter 'Embryo Producing Medical Institution') collects sperms or oocytes in order to produce an embryo, they shall obtain written consent from both the sperm and oocyte donors, as well as the artificial insemination patient and her spouse (hereafter called the 'Consenters').
 * (2) In the written consent described in Section 1, the following shall be included:
 * 1. The details of the purpose of producing an embryo;
 * 2. The details of the period of depositing embryos and their maintenance;
 * 3. The details of the disposal of embryos;
 * 4. Indication of whether or not consent is given to utilize the remaining embryos for purposes other than pregnancy; and
 * 5. Information on the procedures for the withdrawal of consent, the protection of consenters' rights and information, and other necessary information set by the Ministry of Health and Welfare Decree. 
 * (3) Embryo Producing Medical Institutions shall explain in detail the contents of Section 2 before obtaining a written consent under the provisions of Section 1
 * (4) Any other details or procedures required for the written consent outlined in Section 1, such as the consent form and record keeping, will be decided by the Ministry of Health and Welfare Decree .

Article 18 (Embryo Research Institutions)
 * Any one who wishes to do research on remaining embryos according to Article 17 should meet the facility and personnel requirements set by the Ministry of Health and Welfare Decree and be registered with the Ministry as an Embryo Research Institution. .

Article 19 (Approval of Embryo Research Protocol)
 * (1) When an embryo research institution that is registered with the Ministry of Health and Welfare under Article 18 (hereinafter "Embryo Research Institution") wishes to do research on embryos under Article 17, it shall submit an Embryo Research Protocol for the approval of the Minister of Health and Welfare. The same requirement applies even in the event significant changes are made to the Presidential Decree .
 * (2) The Embryo Research Protocol mentioned in Section 1 shall include documents showing the review results of that Embryo Research Institution's Board. 
 * (3) When an Embryo Research Institution submits a research protocol that is funded by a central government agency, the Minister of Health and Welfare shall discuss the matter with the head of that agency before granting approval. 
 * (4) The approval criteria, processes, documents, and any other relevant details shall be decided by the Order of the Ministry of Health and Welfare .

Article 23 (Production and Research of Somatic Cell Cloned Embryos)
 * (1) Any one wishing to produce or research somatic cell cloned embryos shall register with the Ministry of Health and Welfare, only after satisfying the Ministry's requirements concerning facilities and personnel.
 * (2) Articles 19 through 21 shall apply also to research on somatic cell cloned embryos. In such case, "remaining embryo" is regarded as "somatic cell cloned embryo."

Conclusion
Therefore, the constitutional complaint of Complainants 3 and 4 regarding Article 16 Sections 1 and 2 of the Bioethics Act should be denied because they are meritless. The complaint of Complainants 1 and 2 and Complainants 5 through 13, as well as the complaint of Complainants 3 and 4 regarding Article 13 Section 1, Article 16 Section 3, Article 17 Items 1 and 2, Article 20 Section 4, Article 22, and Addenda Articles 2 and 3 of the Bioethics Act, and Article 16 Section 4, Article 17 Item 3 and Article 20 Sections 1 through 3 of the former Bioethics Act should be dismissed as they are non-justiciable. We hereby decide as set forth in the holding with a unanimous decision.

Justices Lee Kang-kook (Presiding Justice), Lee Kong-hyun, Cho Dae-hyen, Kim Hee-ok, Kim Jong-dae, Min Hyeong-ki, Lee Dong-heub, Mok Young-joon, Song Doo-hwan