The State of the Law Regarding Assisted Reproductive Technology

2021/02/18

As of December 4, 2020, the "Act on Special Provisions of the Civil Code Concerning the Provision of Assisted Reproductive Technology and Parent-Child Relationships of Children Born Therefrom (hereinafter referred to as the 'Assisted Reproductive Technology Act')" was enacted. To begin with, under Japanese laws and regulations, the term "assisted reproductive technology" itself was used only once (the only instance!) until the enactment of this law, in Article 7, Item 11(a) of the "Ordinance for Enforcement of the Act on the Safety of Regenerative Medicine, etc." in connection with "surplus embryos (fertilized embryos that have lost their use for infertility treatment purposes in the process of assisted reproductive technology)" as materials for regenerative medicine. However, that did not directly define the content of assisted reproductive technology. In that sense, the Assisted Reproductive Technology Act has for the first time (finally?) provided a definition for "assisted reproductive technology as a legal term."

Evaluation of this newly born "Assisted Reproductive Technology Act" has not yet been settled. Previously, with the significant progress of assisted reproductive technology, judicial precedents had accumulated regarding family relationships that had become complex in a biological sense. This law focuses on the judicial decisions surrounding these issues and attempts to codify them in a way that maintains consistency with current general legal interpretations. In this sense, it is groundbreaking. However, it represents only a portion of the legal issues in assisted reproductive technology. Regarding points of contention where opinions are sharply divided, reaching a conclusion through this law has been postponed. There is strong criticism regarding this reserved stance.

For example, Article 3, Paragraph 2 of this law requires "necessary and appropriate explanations" when performing assisted reproductive technology, and Article 7 requires the government to "establish necessary consultation systems." On the other hand, the specific form of such procedural guarantees remains unclear. Furthermore, regarding issues such as so-called "surrogacy/surrogate birth" and the "right to know one's origins," Article 3 of the Supplementary Provisions of this law states that deliberations will continue for approximately two years, and necessary legislative measures will be taken based on the results. However, it is extremely difficult to predict whether the conflict of opinions over these difficult problems can be resolved within a two-year period. Legal discussions regarding medical care are difficult to find compromise on because they are closely related to people's ways of life and values (for example, the review of the Organ Transplant Act three years after its enforcement, as stipulated in Article 2 of its Supplementary Provisions, only actually materialized ten years later). The (in a sense, strategic) policy adopted during the enactment process of this "Assisted Reproductive Technology Act" also gives the impression of "starting small and growing big." Whether this law truly grows significantly may depend on how we, the citizens, nurture it from now on.

Furthermore, while the enactment of this Assisted Reproductive Technology Act is a limited measure regarding the domestic (local/domestic) discussion situation, the potential of assisted reproductive technology itself has an even greater scope. That is, such medical care, when combined with related technologies like genome editing, could affect the blueprint of the entire species of "humanity (humans)." In particular, genome editing is a field of high global interest, with its new method (CRISPR-Cas9) being the subject of the 2020 Nobel Prize in Chemistry. In other words, assisted reproductive technology also requires international (global/international) regulation.

However, regarding its specific form, complete consensus has not been reached even internationally. For example, in Japan, under administrative guidelines called the "Ethical Guidelines for Research Using Genetic Information Modification Technology, etc. on Human Fertilized Embryos," genome editing targeting human fertilized embryos is permitted only in the field of basic research that contributes to the improvement of assisted reproductive technology. Furthermore, while these guidelines prohibit the transfer of genome-edited fertilized embryos into a human or animal uterus as a line that researchers must not cross, there are no penal provisions for those who do so. To begin with, if genome editing is used in the clinical setting of assisted reproductive technology in a way that does not constitute basic research, these guidelines themselves do not apply. While the effectiveness of such regulations is questioned, in other foreign countries, there are nations that legally prohibit all genome editing involving human fertilized embryos under criminal sanctions (the Embryo Protection Act in Germany is an example of the strictest legal regulation).

When discussing the nature of such regulations, the problem of "dysfunction of democracy"—where legal discussions cannot keep up with the rapid development of the field of assisted reproductive technology—is often pointed out. There is also an argument that "science (including medical sciences) is objective and not suited to democratic control." In such cases, the law is spoken of as if it were a shackle. However, through democratic deliberation, the (abstract) risks that medicine or medical care can bring are also shared. As a result, medical professionals can be partially exempted from liability. There is no need for medical professionals to take on all the responsibility associated with assisted reproductive technology.