10. The Bioethics and Biosafety Act Regarding Embryo Research

[22-1(B) KCCR 275, 2005Hun-Ma346, May 27, 2010]

In this case, early embryos and embryo creators filed a constitutional complaint, arguing that the related provisions of the Bioethics and Biosafety Act, which view embryos created for artificial fertility treatments as the cluster of cells, rather than as a human entity, and stipulate storage, disposal and research of the remaining embryos, violate their fundamental rights. Regarding the constitutional complaint by early human embryos, the Constitutional Court held that the matter is not justiciable as the early human embryos do not possess fundamental rights. Regarding the constitutional complaint by the complainants who created embryos for artificial fertility treatments, the Court held that Article 16 Sections 1 and 2 of the Bioethics and Biosafety Act, which stipulate the five-year storage period of embryos and their subsequent disposal, do not violate the Constitution. The Court dismissed the constitutional complaint filed by other complainants.

Background of the Case

Complainants A and B are early human embryos, which are fertilized eggs stored in frozen form. Complainants C and D are a married couple who created Complainants A and B for artificial fertility treatments for the purpose of pregnancy. Other complainants are legal scholar, ethicist, philosopher, doctors, etc.

The group of complainants filed this constitutional complaint on March 31, 2005, arguing that Article 16 Sections 1 and 2 of the Bioethics and Biosafety Act infringe on the complainants' fundamental rights and thus are unconstitutional, 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 use of remaining embryos for medical research; insufficiently regulate storage, 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.

Provisions at Issue

The provisions at issue in this case are 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 to 3 of the former Bioethics and Biosafety Act (before revised by Act No. 8852 on February 29, 2008). Among the provisions, major provisions at issue are as follows:

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.

②Embryo Producing Medical Institutions shall dispose of all embryos at the end of their storage period, except for those that are to be utilized for the purpose of research outlined in Article 17.

③Embryo 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;

2.To conduct research aimed at curing muscle dystrophy and other

rare or incurable diseases, as decreed by the President; or

3.To conduct other research approved by the Presidential Decree after being reviewed by the Review Committee.

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.

②The 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 Consenters. However, this requirement does not apply in cases where obtaining consent is impossible because the Consenters' whereabouts are unknown.

Summary of the Decision

1.Decision on the constitutional complaint by Complainants A and B (early human embryos)

A prenatal developing 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 regarding the origin of life and the normative necessity derived from constitutional interpretation based on such development.

Complainants A and B are 'embryos' (referring to Article 2 Section 2 of the Bioethics Act) as defined in the Bioethics Act. Specifically, they are early embryos that are fertilized eggs before emergence of embryological primitive streaks which appear after 14 days from fertilization.

Because early embryos are fertilized eggs, it would be possible to say that they took the first steps 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, unless they are implanted into a mother's womb or the embryological primitive streaks appear. Given the contemporary level of technological development, an embryo can be 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, setting aside the necessity for the State to protect the early human embryos. Therefore, the constitutional complaint filed by Complainants A and B, early human embryos, are non-justiciable as they do not possess fundamental rights.

2.Decision on the constitutional complaint by Complainants C and D (embryo creators)

Embryo creators like Complainants C and D 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 embryo is successfully implanted into the mother's womb and then born as a human being. They have the right to self-determination regarding management and disposal of the embryo. Although not explicitly stated in the Constitution, an 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 require evaluation in light of public welfare and socio-ethical values. In this regard, the embryo creator's right to self-determination toward the embryo, despite its nature as a right to personality, is a type of fundamental right that can be restricted when it clearly runs against the constitutional value in legal protection of embryos.

Article 16 Sections 1 and 2 of the Bioethics Act directly restrict the embryo creator's right to self-determination since the provisions set the embryo storage period as five years and allow disposal of all embryos after the storage period except for those that are to be utilized for research purposes.

Nevertheless, the Court finds that Article 16 Sections 1 and 2 of the Bioethics Act have legitimate legislative purposes and apply appropriate means to achieve the purposes, considering that remaining embryos seem to be inevitably produced as it is usual practice to produce multiple fertilized eggs to raise the possibility of pregnancy in the process of in vitro fertilization; and that it is highly necessary to decrease social costs caused by the increased number of remaining embryos and to prevent the remaining embryos from being used for improper research purposes, which may be caused by reckless management of embryo medical institutions.

Moreover, it seems hard to say that there clearly exists less restrictive means that achieves the legislative purposes; the five-year storage period is not clearly unreasonable in terms of providing some opportunity to use embryos to 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 creator's disadvantage caused by the restriction on their right to self determination. Thus, the Court finds that Article 16 Sections 1 and 2 the Bioethics Act are neither in violation of the principle of least restrictive means nor against the principle of balance between legal

interests.

Therefore, Article 16 Sections 1 and 2 of the Bioethics Act do not run afoul of the Constitution in violation of Complainants C and D's right to self-determination toward the embryos.

3. Decision on the constitutional complaint by other complainants

Regarding other complainants, consisting of legal scholar, ethicist, philosopher, 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 infringement on their fundamental rights and their self-relatedness cannot be recognized.