KLRI : KOREA LEGISLATION RESEARCH INSTITUTE

Ⅰ. Backgrounds and Purposes

▶ Globally, about 0.3% of infants born annually are pregnant using assisted reproductive technology (hereinafter referred to as 'ART'), and the use of ART is increasing due to a decrease in fertility.

▶ As is well known, natural pregnancy and childbirth are achieved by combining sperm and eggs through sexual intercourse between men and women. However, as in all fields, the development of science and medical technology is making it possible to use artificial technology, or ART, in these natural pregnancy and childbirth processes. However, since pregnancy and childbirth using ART result in the birth of a new human (child), it is natural to provoke various debates over existing perceptions and systems such as bioethics, safety, and family systems, and representative legal issues as follows:

○ First of all, how far will the scope of subjects (reasonable couples, same-sex couples, non-marriage, etc.) who can conceive and give birth using ART be set?;

○ Second, whether to allow surrogacy of childbirth; 

○ Third, what will be done with the paternity and other rights relationship between the commissioned couple participating in the pregnancy and childbirth process using ART, sperm and egg donors, surrogate mothers, and children born?;

○ Fourth, how to set the standards for the qualification requirements and consent procedures of the relevant parties;

○ Fifth, the issue of compensation for sperm and egg donors and surrogate mothers, including whether to allow commercial use of ART, etc. 

▶ These issues related to the use of ART have been widely discussed at the religious, ethical, and legal level, and many countries have long established and implemented laws and systems to solve these issues.

▶ Korea also has the Bioethics and Safety Act (hereinafter referred to as the "Bioethics Act") and the "Maternal and Child Health Act", and the Korean Society of Obstetrics and Gynecology Ethics Guidelines (Version 9.0, January 1, 2021).

▶ However, it seems that these domestic laws on assisted reproductive care do not properly regulate the various legal issues mentioned above. Representatively, it is a case that has become a major social controversy in recent years, and it is said that a unmarried woman received related medical services from abroad because she could not conceive and give birth through assisted reproductive medicine in Korea. In addition, the current relevant laws do not stipulate clear regulations on post-production and surrogate pregnancy, and do not clearly legislate paternity for children born through assisted reproductive care, leading to disputes over it.

▶ Therefore, this study analyzes major problems in the current domestic laws and regulations related to assisted reproductive medicine and provides basic data for future social discussions on the overall improvement of legal systems related to assisted reproductive care in Korea.

 

Ⅱ. Major Content 

▶ Status of domestic assisted reproductive medicine implementation

○ In vitro fertilization, which is most commonly used and represents assisted reproductive techniques (ART), has steadily increased over the past 10 years, and a total of more than 100,000 cases have been performed recently.

- In 2018, a total of 108,527 in vitro fertilization procedures were performed, of which 45,880 were sperm injections in the egg cytoplasm, and 28,410 were found to have used embryos that were preserved frozen.

▶ The main contents and problems of the domestic subsidiary reproductive medicine-related legislation.

○ First of all, the current Bioethics Act focuses on the discipline of human and human-derived research activities, and it is difficult to regard it as a professional law on assisted reproductive medicine.

○ Articles related to assisted reproductive care under the Maternal and Child Health Act may be entirely covered by the definition of the terms of assisted reproductive techniques in Article 2 (Definition) 12 of this Act and the specific types of assisted reproductive techniques in the enforcement rules enacted under this Act. The reason why this law defines the terminology of assisted reproductive techniques is to define assisted reproductive techniques as a law to support infertility procedures. Accordingly, it is difficult to say that the Mother and Child Health Act is also a professional assisted reproductive medical method.

○ The current domestic subsidiary reproductive care laws have some regulations on legal issues related to subsidiary reproductive care, but the legal system is confused by two laws with completely different legislative purposes. 

▶ Status of subsidized reproductive care implementation and legal systems in major countries.  

○ UK

- Britain is the country where Lewis Brown, the world's first tester, was born in 1979, so it has a fairly long history in the practice of assisted reproductive medicine, and assisted reproductive medicine is active to match its history.

- Over the past 30 years, approximately 595,000 people have undergone procedures with approximately 1.3 million IVF cycles and more than 260,000 donor sperm injections (DI) cycles, resulting in approximately390,000 babies.

- In terms of the legal system, the UK enacted the Human Fertilization and Embryology Act (hereinafter referred to as the 'HFE Act') in 1990 to professionally and integrally regulate assisted reproductive medicine, and revised the HFE Act once in 2008.

- The UK is one of the most active countries in assisted reproductive care, and the criteria for determining paternity for children born through assisted reproductive care are stipulated in laws and regulations to block the possibility of disputes. In addition, post-production and surrogate pregnancy are clearly stipulated in the law and allowed under certain conditions.

○ Canada

- According to CARTR Plus records, Canada's official statistics on assisted reproductive medicine, the total treatment record was 219,889 cases, with the cycle start date between January 1, 2013 and December 31, 2019.

- The number of births by year through ART is gradually increasing every year from about 5,800 in 2013 to 7,320 in 2018.

- In terms of the legal system, Canada has enacted and enforced the "Assisted Human Reproduction Act" in 2004 to professionally regulate assisted reproductive care, and has very detailed subordinate laws to resolve specific legal issues related to the implementation of assisted reproductive care.

- Canada legally recognizes various types of families, such as legalizing same-sex couples in a relatively early period, so conclusions and sexual orientation are not considered as in the UK, and post-production and surrogate pregnancy are allowed under certain conditions.

○ USA

- In the United States, more than 440 clinics have provided services to infertile patients since the birth of a pregnant child through assisted reproductive technology for the first time in 1981.

- In 2018, 306,197 assisted reproductive techniques were performed at 456 infertility clinics in the United States, and a total of 81,478 were born with 73,831 births.

- In terms of legal system, the United States, as a federal state like Canada, has enacted the "Uniform Parental Act" as a model law for the unified discipline of each state, and as of 2000, a total of 19 states are known to have adopted subsidized reproductive care laws based on this model law.

- As the title suggests, this model law mainly stipulates the paternity of children born as assisted reproductive medicine, and in particular, stipulates in great detail the criteria for determining paternity according to surrogate pregnancy. 

- As is well known, the United States is a country with very advanced assisted reproductive medicine, and it is found that it is more free to use assisted reproductive services than the United Kingdom and Canada, thereby taking the freest stance on each of the aforementioned legal issues.

○ Germany

- Germany can be evaluated as having relatively strict regulations compared to the three countries discussed earlier, but considering the number of procedures and other implementations, assisted reproductive care is also very active in Germany.

- For example, the actual number of procedures in Germany in 2019 was 107,373, which has gradually increased since 2015, with more than 100,000 procedures each year and more than 30,000 children born as assisted reproductive techniques.

- In terms of the legal system, Germany does not have professional and integrated assisted reproductive medicine laws such as Britain and Canada, and has a distributed legal system that regulates the needs of the embryo protection law enacted in 1990 and the static capital registration law enacted in 2017. 

- As the family system recognizes various types of families, such as legalizing same-sex marriage, it was found that the scope of those who use assisted reproductive care is relatively free, such as the UK and Canada, but prohibits post-production and surrogate pregnancy.

○ Japan

- As of 2016, the total number of assisted reproductive treatments in Japan was 447,790, with 54,110 births and 536,737 cumulative births.

- Although the subsidiary reproductive medicine law system is not properly equipped and relatively regulated, it can be evaluated that subsidiary reproductive medicine is being actively implemented.

- In terms of the legal system, Japan does not yet have a fully equipped subsidiary reproductive and medical legislation like Korea.

- It can be said that the Ministry of Health, Labor and Welfare has dealt with legal issues related to assisted reproductive care, but recently enacted the Act on Special Cases of the Civil Act on the Provision of reproductive care and Childhood Relations of Born Children in 2021.

- The main contents of this law are to enact laws related to assisted reproductive care in the future, and to enact some of the criteria for determining paternity for children born through assisted reproductive care as special laws in civil law.

- Legal issues related to assisted reproductive care dealt with in this study are strictly regulated similar to those of Korea or related legal regulations are insufficient.

- Accordingly, it was found that those who can use assisted reproductive care are limited to legal couples, and both post-production and surrogate pregnancy birth are prohibited.

▶ Suggestions for the improvement of laws related to the domestic subsidized reproductive medicine legislation.

○ First of all, it is necessary to establish a public debate mechanism that can be discussed long-term, systematically, and globally to improve the legal system related to assisted reproductive medicine, so that various stakeholders can reach an agreement on related issues one by one.

- Since various legal issues related to assisted reproductive care themselves are basically related to the collective perception of certain members of society, such as human life, ethics, and long-formed family systems, it is impossible to improve the legal system simply benchmarking foreign cases.

- In addition, as shown in the cases of the five countries examined in this study, there are similarities between countries, but the differences are quite large, making it difficult to judge which country's case is better. Therefore, from a long-term perspective, it is necessary to discover related issues through extensive and sufficient social discussions, derive directions for system improvement that the majority can agree on, and promote legal institutionalization. Based on the problems of the current domestic legislation analyzed in this study and the implications derived from foreign cases on the premise of the direction of system improvement as described above, I would like to suggest some ideas that can be referenced when discussing future directions for related legislation.

- In terms of the legal system, the current regulation system related to assisted reproductive care distributed by the Bioethics Act and the Maternal and Child Health Act is distracting and confused, so either the Bioethics Act or the Maternal and Child Health Act can review the enactment of independent laws.

- Since each legal system maintenance plan has its advantages and disadvantages, it seems difficult to say that some measures are far superior. Foreign legislation also adopts both the independent legal system and the decentralized legal system, so it can be said that it is a matter of choosing a legal system considering the specificity of individual countries.

- In the long run, it is necessary to separate provisions scattered in the current laws and consider one independent law, such as parental standards and surrogate birth, considering the ambiguity of provisions related to assisted reproductive care, lack of regulations on specific issues. 

- Next, regarding the improvement of legislation related to specific legal issues related to assisted reproductive care covered in this study, all of these issues should be institutionalized step by step through long-term discussions, such as social awareness of our family system and bioethics.

- In the process of system improvement, more active responses are needed by comprehensively considering the family form, changes in people's perception, development of medical science and technology, and trends in foreign legislation.

 

Ⅲ. Expected Effects

▶ It is expected that it can be provided as basic data when discussing the improvement of the legal system related to domestic assisted reproductive medicine.

▶ It is expected to contribute to enhancing interest in the legal system related to assisted reproductive medicine by related academia and experts in Korea and promoting related