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CHINA LEGAL SCIENCE 2021年第2期|冷冻胚胎返还的处置规则与风险预防机制
日期:21-06-04 来源: 作者:zzs
DISPOSAL RULES AND PRECAUTIONARY MECHANISM OF FROZEN EMBRYO RETURN


Hao Tingting & Jiang Zhiyu

Since 2014, cases of requests for the return of frozen embryos have been occurring in various parts of the country, and disputes over the ownership and disposal of frozen embryos are new types of cases in judicial practice, the law has no clear provisions on the legal nature, ownership and disposal of frozen embryos and the opinions of different parties are different. Following the entry into force of China’s first judgment on the return of frozen embryos to elderly people who had lost their only child in 2014, and with economic and social development, the number of requests for the return of frozen embryos surged in 2019, with local courts taking care of individuals’ reproductive rights and social considerations, the unanimous decision ordered the hospital to return the frozen embryos that it had made and stored to individuals. Whether frozen embryos should be returned to individuals is currently a difficult legal issue in new types of cases, involving risks such as medical supervision, offspring safety and genetic safety, the judicial and administrative departments should establish the principle of ‘non-return as the principle and conditional return as the exception’ to properly handle the relationship between the protection of individual rights and the interests of the state and human security in the development of high-tech life science and technology, achieving a balance of values between development and security.

I. AN OVERVIEW OF DOMESTIC CASES INVOLVING FROZEN EMBRYOS

Since the first case of embryo return in China, the Wuxi Return Case in 2014, the disputes involving frozen embryos have entered the judicial procedure one after another. Data shows that as of November 21, 2020, China has publicly adjudicated 34 cases involving frozen embryos, and shows the following trends.

A. Disputes over Frozen Embryos Have Been on the Rise in the Past Two Years

From 2014 to 2018, there were only one or two sporadic cases each year. Since 2019, the number of cases has doubled to 14. It has continued to climb to 16 in 2020, accounting for 88.24 percent of the total disputes in the past two years. In terms of growth rate, compared with 2018, 2019 and 2020 increased six-fold, seven-fold respectively, showing a sustained growth trend. From the point of view of the places where the disputes took place, except in North China, Northeast China and Northwest China, all other areas have occurred, of which the Sichuan area, especially Chengdu area, has the most cases. Sichuan province has 14 cases and Chengdu has 13, frozen embryo cases account for nearly 40 percent of China’s population in areas where the proportion of the population does not exceed 2 percent. This has a lot to do with the fact that Chengdu is in the south-western part of China, where the economy is relatively developed and there are large general hospitals with high medical standards.

B. The Return of Frozen Embryos Is Currently the Main Claim

One of the parties requested that the hospital return the frozen embryos, and the other requested that the hospital continue to perform in vitro fertilization and embryo transfer. A total of 24 applications for the return of frozen embryos have been filed, involving both the germ cell which formed the frozen embryos and the relatives of the providers, the cases in which the relatives sued for return were essentially cases in which both providers had died. A total of nine cases have been brought against the background of the death of one of the spouses following the conclusion of a medical service contract with the hospital and prior to the successful implementation of the embryo transfer procedure, and another wanted the transfer to continue with a frozen embryo created by the couple’s germ cell, which the hospital would not do without the couple’s signature. Only one of the sample cases did not include a petition for confirmation of a retrial in which the production of frozen embryos after transfer violated the reproductive rights of a party. In addition, in judicial practice, there are disputes over custody of frozen embryo transfer after surrogacy, and disputes over infringement of frozen embryo after its loss without mutual consent, it does not rule out the possibility of new types of cases, such as paternity confirmation disputes, custody disputes or abandonment disputes, to enter the judicial process.

C. The Current Ruling Is Primarily in Favor of the Return of Frozen Embryos

There were 24 requests for the return of frozen embryos and only one decision denied the request for return. Only 4 of the cases in support of the claim for the return of embryos have entered the second instance procedure, except for the Wuxi Return Case, all of which are not appealed by the hospital. Of the nine cases in which the hospital was requested to continue the procedure of in vitro fertilization and embryo transfer, six valid decisions supported the parties’ claims and three rejected the parties’ claims, among them, in 2019, two grass-roots courts in Kunming, Yunnan, issued contrary rulings on cases with similar basic circumstances based on different considerations of interests, showing the absence of clear provisions in the law, and the objective reality of different judgments in the same case.

II. THE SOCIAL RISK CAUSED BY THE CURRENT VERDICT

In recent years, due to the influence of environment and life style, the incidence of infertility in China is more and more, and the incidence of infertility is between 12 percent and 15 percent. The development of high-tech life science has broken the objective limit of the human body, and human-assisted reproductive technology ‘in vitro fertilization and embryo transfer’ provides the possibility for sterile couples to have offspring and becomes an important means for the infertile population to solve the fertility problem; however, there are some legal problems such as the nature of frozen embryos, the determination of ownership and the guardianship of frozen embryos. Under the background that frozen embryo is not clearly defined in the Civil Code and surrogacy is not explicitly prohibited by law, the ownership of frozen embryo and the disputes arising from it, it is no longer a dispute of medical service contract or custody contract between a germ cell provider and a medical institution, but a major social issue concerning individual reproductive rights and the overall security of the human being, and the return of frozen embryos to individuals may pose multiple social risks.

A. Social Cognitive Bias

1. Forming a Social Reality in Which Frozen Embryos Are Actually Returned to Individuals. — While the decisions in favor of the return of frozen embryos have emphasized that the decisions are based on considerations of social reason and human concern, requiring the parties concerned to lawfully use the frozen embryos after obtaining them, and not violate public order and good customs or harm the legitimate rights and interests of others, but Huaxi the Second Hospital, the Chengdu Women and Children’s Center Hospital, the Jinjiang District Maternal and Child Health Hospital, and other assisted reproductive technology hospitals in Chengdu are constantly facing similar requests from the parties. Some of the hospitals directly returned. By the end of 2020, there were 18 cases in Jinjiang MCH hospital alone, 32 patients had removed frozen embryos by various means, and the average number of embryos removed per patient was 4. Some patients obtained frozen embryos and even performed a second assisted reproductive surgery, and continued egg production in the same hospital.

2. The Special Case Should Not Be Used as a Uniform Standard for the Rules of Adjudication in the Case of the Return of Frozen Embryos. — In the Wuxi Return Case, the subject of the request for return is the parents of the couple who entrusted the hospital with the assisted reproductive technology, due to the couple’s tragic death, four elderly people, two families face the pain of  the loss of only child, for the consideration of social emotion and human ethics, the court decided that the return of frozen embryos by the hospital was a judicial response to the special social phenomenon of the loss of only child, and did not harm the public welfare. In cases of unjustified requests for return and failure to guarantee follow-up supervision of frozen embryos, a new analysis and a new evaluation of the new situation should be conducted, and a special judgment based on special circumstances should not be used as a trial guide, and the request for return was indiscriminately upheld and the judgment ruled it could not open a gap in the administrative supervision of frozen embryos.

B. Weak Regulation

As a high-tech life technology developed in the past 30 years, the assisted reproductive technology has overcome the difficulty in technology implementation. According to the Health Administration Department, the underground black market can also achieve more mature frozen embryo synthesis technology. With the implementation of technology, the safety of embryo supervision, the safety of using and the safety of eugenics are the most important things in supervising and standardizing the development of high-tech life science and technology. The administration has put in place very strict regulations to guard against the misuse of the assisted reproductive technology and to protect the safety of the human gene pool. 

According to paragraph 3 of article 7 in the Measures for the Administration of the Clinical Application of Medical Technology, the human assisted reproductive technology involves major ethical issues and is a specially regulated medical technology directly prescribed by the Ministry of Health, which belongs to the third category of medical technology, as closely monitored as the medical techniques used in organ transplants. Since 2001, the National Health Administration has issued the Measures for the Management of Human Assisted Reproductive Technology, the Technical Norms for Human Assisted Reproduction, the Basic Standards and Technical Norms for Human Sperm Banks, and the Ethical Principles for Human Assisted Reproductive Technology and Human Sperm Banks. The implementation of the assisted reproductive technology has been vigorously regulated, making it clear that the application of the assisted reproductive technology shall be carried out in medical institutions for medical purposes and in conformity with the national family planning policy, ethical principles and relevant laws and regulations, and the National Health Commission and the Health Administration have the overall supervision and day-to-day supervision responsibilities.

1. The Assisted Reproductive Technology Has Been Vetted by the Executive Branch. — The assisted reproductive technology, as the third category of medical technology prescribed by the state, from the National Health Commission to the corresponding Municipal Health Administration Department, carries out strict supervision over the qualifications of the medical institutions that carry out the relevant technology through three systems. 

First, strictly examine and approve the certificate. The certification of the assisted reproductive technology and the human sperm bank is organized and verified every two years by the original approval authority. The number of beds in medical institutions, the setting up of departments, the personnel situation such as the qualifications of doctors, the equipment and the staffing of technical personnel, and other indicators should be strictly checked, and medical institutions that fail to pass the examination will have their licenses revoked, to stop the assisted reproductive technology immediately. The Mianyang Central Hospital in Sichuan province was ordered to stop carrying out assisted reproductive technology after failing to pass a qualification test for an index, and the frozen embryos were transferred to Chengdu Xi’nan Women’s Hospital under strict procedure supervision after being examined and coordinated by the Provincial Health Administration Department. Second, random checks. The health administration selects randomly selected tests and randomly selected examiners from qualified assisted reproductive facilities, including those that have been approved to carry out human assisted reproductive technology and establish human sperm banks, spot-check institutions for inspection, spot-check and investigation results in accordance with the provisions of the public, and the results of random spot-check is an important reference for the approval certificate verification results. Third, the organization’s self-examination. Institutions that carry out assisted reproductive technology check themselves periodically or irregularly against existing laws and regulations, and the operation of the self-checking mechanism is also an important part of random checks and verification of certificates of approval.

2. The Removal of Frozen Embryos from Medical Institutions Will Weaken the Regulatory Effect of the Executive Branch. — The assisted reproductive technology cannot yet control the survival rate and quality of frozen embryos after thawing. To ensure assisted reproduction, the number of frozen embryos formed is usually larger than the actual number of embryos transferred, and the medical establishment will follow the medical procedure. Frozen embryos that do not undergo the procedure are therefore under the effective supervision of medical institutions and administrative departments, which ensures that information on frozen embryos is accurate and their use is legitimate. After the initiation of assisted reproductive therapy, the hospital will carry out a one-year observation period for infertile couples, after which they can be artificially inseminated only after the physical indicators have been qualified, and before the embryo transfer and after the production of frozen embryos, the survival rate and quality of frozen embryos were tested by special indexes, and the frozen embryos could be used for embryo transfer. From the thawing stage, they will consult with eugenics experts, follow the pregnant women throughout the whole process, track the live birth rate of the embryo, and after the embryo is transferred to the mother, the medical staff will follow up and check regularly or irregularly, and count the indexes of the embryo growth, thus as far as possible to ensure the genetic quality of prenatal eugenics. The mission of the medical establishment is not to successfully implement the assisted reproductive technology, but to implement the assisted reproductive technology safely and controllably, through the healthy development of children through technology as a goal. If a frozen embryo is removed from care because it is returned to an individual, it will be removed from a range of administrative controls and tracing, breaking the assisted reproductive technology’s closed loop.

C. Offspring Security Risk

1. The Highest Value of Assisted Reproductive Technology Is the Safety of the Offspring. — For medical research and medical institutions, assisted reproductive technology is a medical means to treat infertility. The use of such means and techniques shall not harm the health and interests of individuals, families, and future generations, or the public good. The Ethical Principles of Human Assisted Reproductive Technology and Human Sperm Banks, issued by the National Health Commission in 2003, puts forward seven major ethical principles for assisted reproductive technology, one of the most important of which is the principle of protecting offspring, that is, children born through assisted reproductive technology have the same legal rights and obligations as those born through natural conception, and couples undergoing assisted reproductive technology treatment have ethical, moral and legal rights and obligations to technically born children, including those with birth defects. Assisted reproductive technology also stressed that medical personnel should stop using the technology if its implementation would cause serious physical, psychological and social harm to future generations. It can be seen that in order to deal with the relationship between reproductive freedom and reproductive responsibility, individual reproductive rights should make concessions for the safety of offspring when necessary.

2. Underground Surrogacy Market Threatens Safety of Offspring. — The assisted reproductive technology clearly prohibits all types of surrogacy in medical institutions and family planning services of the assisted reproductive technology. Although there is no explicit prohibition of surrogacy in the Population and Family Planning Law, the regulations of the National Health Commission define the illegal nature of surrogacy, and no medical institution in China with a human assisted reproductive technology can engage in surrogacy. In 2015, the National Health and Family Planning Commission and other 12 departments jointly launched a nationwide campaign to crack down on surrogacy, but because of the huge interests involved, it was unable to stop it. According to the information available to the health authorities, illegal surrogacy agencies have carried out procedures ranging from artificial insemination to the formation of frozen embryos and even the final transfer of embryos, which are operated by people without professional qualifications using unsafe medical devices, and illegal surrogacy agencies do not care if frozen embryos are normal or if babies born after transplantation are healthy and healthy, the executive branch and the medical establishment are unable to regulate their actions. The current tendency of the returning judges may be that the wrongdoers may request the return of frozen embryos from artificial insemination in a regular hospital to an individual and then use the returned embryos for illegal surrogacy; as a result, the hospital has instead provided the source convenience for the illegal surrogacy.

3. Health Risks of Offspring and Pregnant Mothers. — In the process of carrying out embryo transfer technology in medical institutions, hospitals should regularly track the rate of live embryos to ensure maternal and fetal health. In the process of embryo transfer, illegal surrogacy institutions lack security, ranging from the safety of surgery and doctors’ technology during the transfer process to the regular inspection and protection of the pregnant mother during pregnancy. Furthermore, we cannot realize the risk management and eugenics intervention of fetal development. From the point of view of offspring safety, physical health is only one of the contents of human healthy survival; living environment safety, physical health and mental health are the important contents of offspring safety. In the follow-up to the Wuxi Return Case, four elderly people sent frozen embryos returned by the hospital to Laos. The frozen embryos gave birth to a baby girl through a surrogate outside China. Although the bereavement of the four elderly has been temporarily alleviated by the continuation of the offspring, the absence of their parents will have a negative impact on the healthy growth and mental health of the children, the lack of attention to the safety of the living environment and the interests of mental health of the children is not consistent with the goal of the development of mankind.

D. National Security and Safety Risk of Human Gene Pool

1. Risk of Chinese Genetic Resources. — The Baby Lulu and Nana Case of Gene Editing in 2018 aroused the state’s great attention to gene resources, and the State Council promulgated the Regulations on the Management of Human Genetic Resources in July 2019, article 2 of the regulations specifies that embryos as tissues containing human genome, genes and other genetic materials belong to human genetic resources materials. After the frozen embryos were returned to individuals without the supervision of the National Health Commission, the Health Administration Department and Medical Institutions, all the supervision departments lost control over the flow of embryos. A significant number of frozen embryos will enter the illegal surrogacy industry through the underground black market, and illegal genetic experiments may even be carried out for specific human genetic experiments. Once foreign hostile forces make use of China’s rich genetic resources to develop genetic weapons against China and launch biological gene warfare against China, it will bring extremely serious consequences to the survival and reproduction of the Chinese nation, and it is not conducive to the realization of national security strategy and hinders the construction of national security system and capacity.

2. There Is a Risk of Subsequent Inbreeding. — The subsequent transfer of frozen embryos formed through assisted reproductive technology must involve kinship and parentage. At each stage of the procedure, hospitals with assisted reproductive technology must double check the genetic information of the embryo to see if it matches the genetic information of the couple in preparation for the transplant, at the same time, it is necessary for both spouses to sign the legal relationship, and some hospitals also need to check the original identity card and fingerprint or face recognition to ensure the accuracy of the transplant. But unsupervised frozen embryos will be difficult to trace and match genetic information from the embryo and the transplanted mother, even if there are no obvious diseases or defects in the post-transplant baby, if they are used by individuals or enter the illegal black market for surrogacy, however, because they are unable to identify their genetic origin, it is not possible to confirm at the time of registration that their biological parents can only be registered as the child of the birth mother, making it even more difficult to identify the parents of such infants once they have been abandoned. When such infants grow up to give birth and continue to do so, the risk of consanguinity increases because of the uncertainty of kinship, causing not only ethical problems but also the risk of giving birth to children with genetic diseases or birth defects, it is contrary to the value orientation of eugenics and good breeding and ensuring the safety of offspring.

3. The Safety of Human Genome. — Because frozen embryos require special preservation conditions, -196 °C liquid nitrogen environment is only one of the conditions, the individual is usually unable to guarantee the necessary conditions for frozen embryo preservation. During transfer, transportation and subsequent preservation, there is a high risk of damage to the embryo or changes in its genetic sequence, and the transfer of embryos with such genetic mutations or abnormalities and the successful birth of such embryos will greatly increase the risk of birth defects or diseases. It may even result in genetic disorder that modern medicine cannot detect, which can be passed on from generation to generation through reproductive activity, affecting the safety of offspring, thereby contaminating and destroying the entire human gene pool. At present, in the field of genetic safety education, China is basically in a blank, the popularization of relevant basic knowledge is equal to zero, and the public and even some of the executive branches lack the awareness of the value of genetic resources and the protection of genetic resources, and the lack of genetic knowledge in the basic education creates objective barriers to the timely detection of genetic safety risks. Although the serious consequences of the subsequent contamination or control of human genetic resources have not been found or cannot be predicted, the popularization and education of human genetic security are undoubted of top priority.

III. STUDY ON THE ATTRIBUTE AND ASCRIPTION OF FROZEN EMBRYO

There are many opinions about the nature of frozen embryo, but there is no consensus in theory and judicial practice. However, the potential risks and the number of disputes related to frozen embryo are increasing rapidly; there is an urgent need to clarify the attributes and entitlements of frozen embryos.

A. Mainstream Theory of Frozen Embryo Attribute and Its Evaluation

There are three main theories about the attribution of frozen embryos: the subject theory, the object theory and the compromise theory, which are used by Chinese scholars to study the attribution of frozen embryos.

1. Subjectivism. — The idea of the subject theory comes from the traditional civil law, and the concept of the embryo as a special natural person is the traditional content of the Roman legal system. Since it denies the ‘property of things’ of tissues separated from the human body, and maintains that tissues separated from the human body are ‘the limited category of human beings’. Thus as protecting the integrity of the human body, under certain conditions, it is considered that the violation of these separate tissues is also a violation of human body integrity. From the perspective of life law, scholars who advocate the theory of subject think that embryo is between person and thing but closer to person, and it is a special ‘personality’. ‘Since the ethical status of the human embryo is a kind of personality body between person and thing but closer to person, it cannot be treated as a thing in law. Since it is not a matter of law, the legal rules governing such matters as ownership, transfer, inheritance, and disposition cannot simply be applied to human embryos’. Due to the nature of the personality, it cannot be owned by anyone, so it cannot be disposed of like an object.

2. Object Theory. — The object theory holds that the embryo is a thing. According to this theory, objects are divided into general objects and generalized special objects according to whether they have special natural properties; the generalized special object is divided into bioethics object and narrow special object. Such a classification can still be accommodated by the existing system of the civil law of person-thing dichotomy, and at the same time, it can not only reflect the relationship between this type of right and general real right and personal right, but also in judicial practice, the concept of ethical physics facilitates the confirmation of the ownership of things such as frozen embryos.

Professor Yang Lixin is the representative of the objective view that frozen embryos with personality attributes of ethics belong to a special thing. Its basic viewpoint is: the human body has a special attribute, and the human body is the carrier of personality, so it cannot be regarded as an object, this is the material form of the subject opposite to object in the world of civil law, but when human tissue is separated from the human body, it should belong to the category of object, to establish ownership. Frozen embryos have no human form, but only the ‘potential to become human’, that is, they belong to people but are not people, belong to subjects rather than subjects. Therefore, it is not feasible in the theory of civil law to protect it in the form of personal right. Fully recognizing the possibility of frozen embryos developing into human beings and considering them as ethical objects, it not only emphasizes that frozen embryos should be given the fullest protection as the supreme legal object, at the same time, it is emphasized that the exercise of such ownership should be properly restricted by law.

3. Middle Ground. — Professor Xu Guodong is the representative of the compromise theory, who holds that organs and tissues separated from the human body, such as in vitro fertilization embryos, are neither subject nor object, but a compromise position between the subject theory and object theory. The embryo should be regarded as a special object according to the situation of China, and the legal provisions should be designed on the premise of respecting the potential possibility of life.

4. Comment on the Theory. — The subjective theory holds that organs and tissues separated from the human body are the subject and have personality attributes, which is for the purpose of protecting the personality attributes and ethical attributes of frozen embryos, however, this doctrine is in contradiction with the provisions on the subject rights of the fetus in the first Civil Code of China, article 16 of the Civil Code involves the protection of the interests of the fetus, such as inheritance and acceptance of gifts. The fetus is regarded as the subject with the capacity for civil rights, but if the fetus is dead at the time of birth, its capacity for civil rights does not exist from the beginning. The frozen embryo is subordinate to the human but not the human, and belongs to the subject rather than the subject, which advocates the subject protection of the frozen embryo. It is contrary to the theory of civil rights to advocate the creation of new rights to strengthen the protection of frozen embryos and potential adults. 

It is true that the law should consider the protection of the new object of the right, but the creation of the new right must meet the necessary conditions, that is, it is difficult to carry out any protection to the relevant object without the creation of the new right, the protection of rights is mainly the dichotomy of person and thing, which deliberately creates a third concept between the subject and object of civil legal relations. Regarding frozen embryo as a thing can realize the full protection of rights and defining frozen embryo as a thing does not deny its particularity, instead, it takes its unique personality attribute and ethical attribute as the distinguishing factor between it and the ordinary object, and based on this, carries on the standard, the degree is higher than the ordinary object’s right protection and the restriction. As a typical civil law system country, Germany is equally difficult to define the nature of subject or object of the frozen embryo in legislation and jurisprudence, but the thinking of judgment reflected in relevant cases is consistent with that of the object. The decision in the classic case of Post-mortem Artificial Neubrandenburg of 1991 judged embryos as ethical objects, it not only reflects the special protection of frozen embryos as potential human beings, but also conforms to the dichotomy of characters in Chinese civil law system, and at the same time responds to the concern of the society about the ownership of frozen embryos.

To sum up, the authors agree with the basic point of view of object theory. In support of the object of frozen embryos as an ethical reason, the authors believe that the biological and clinical research on human embryos should also be combined. The embryo is pre-embryonic until the second week (14 days) of development after the sperm and egg combine. It has no nerves or brain and is in a state of unconsciousness and insensibility. It can be used for stem cell research. After embryo evaluation on the third day after fertilization, embryos developed into viable blastocysts will be cryopreserved on the 5th to 6th days and need to be transplanted within 2 hours after thawing and returning to room temperature. Therefore, it is in line with the relevant medical and biological research to regard the frozen embryo which has no sensory nerve and cannot develop without the human body being implanted into the mother’s womb as a special protective thing.

B. A Case Study of Foreign Ownership of Frozen Embryos

In China, the theoretical research is still focused on the determination of the attributes of frozen embryos, and the attribution research is still at the initial stage. The research on the attribution of frozen embryos abroad has been carried out earlier and is more mature, which has aroused widespread concern in society as early as the last century. In the United States, for example, because most states have legal surrogacy, there are more disputes on the ownership or disposal of frozen embryos, and the United States mostly decides on the ownership according to the specific circumstances of the case, but does not determine the nature of frozen embryos, that is to say, in the United States, the attribution of frozen embryos does not affect the attribution of frozen embryos, at present, there are three models in the United States, namely, contract model, concurrent agreement model and benefit measurement model.

1. Contract Model. — The contract model was first established in the United States by the New York State Supreme Court with Kass V. Kass case established as a rule. The Kass couple, in their informed consent, agreed to use the embryos for scientific research when they ‘no longer wanted to become pregnant or were unable to make a decision regarding the disposal of those stored frozen embryos’, in their reasoning, the court held that the Kass couple had clearly and beforehand agreed on the disposal of the frozen embryos and that the disposal agreement should be respected and the embryos should be used for scientific research.

2. Simultaneous Agreement Model. — The pattern was first established by the Iowa Supreme Court with In Re Marriage of Witten. In this case, there was a disagreement between the husband and the wife over the disposal of the embryo, the wife wanted the embryo to be transferred and the husband did not, and the court expressly objected to the contractual model in its decision reasoning, holding that the agreement was valid in principle, but the agreement cannot be enforced as a violation of public policy ‘if either party objects to the treatment of frozen embryos or makes it clear that the agreement no longer reflects its current value or ideas’. In its ruling, the court emphasized that Iowa’s public policy ‘requires that we respect the right of every person to make family and reproductive decisions based on their current views and values.’ Taking into account that ‘such decisions are highly emotional and changeable’, the court, therefore, held that ‘judicial enforcement of the agreement between the spouses regarding their future family and reproductive choices is contrary to Iowa public policy’ and required the spouses to agree on a mode of disposal of frozen embryos.

3. Benefit Measurement Model. — The model of the balance of interests was established by the Tennessee Supreme Court in Davis v. Davis. In this case, the wife argued that the frozen embryos should be donated to others for embryo transfer, while the husband argued that the frozen embryos should be discarded, since there was no prior agreement on the disposal of the frozen embryos in this case, the Tennessee Supreme Court held that consideration should be given to ‘the situation of the spouses, the size of their interests, and the potential burden of different disposal methods on the spouses.’ That is, the freedom of each spouse to bear children, the right of the wife to bear children and the right of the husband not to bear children. The court upheld the husband’s claim, considering that the fear of becoming a father without his knowledge would be greater for the husband than the dismay of the wife at the failure of the transplant.

The judicial systems of Germany and the United States are obviously different from those of China, and the value orientations of legislation and system design are different. However, the extraterritorial judicial practice on the attribution of frozen embryos has reference significance for China to correctly identify the attribution of frozen embryos and establish the rules of attribution: first, as a country of written law, it is suggested that the attribution of frozen embryos be determined through legislation; second, the right and obligation of frozen embryos with human development should be more strict and special; third, the rights and interests of frozen embryos are complicated.

IV. SUGGESTIONS ON THE RULES FOR THE DISPOSAL OF CASES OF RETURN OF EMBRYOS

A. In the Face of New Situations and New Problems, We Should Strengthen Social Interaction and Response

High-tech life science is a general term for modern cutting-edge medical technology represented by Gene Technology, human organ transplantation technology, assisted reproductive technology, and life and public health technology. High-tech life science and technology with the characteristics of digitalization, integration of material and information, intellectualization and self-source will benefit the health of human life so that people’s health can go to a new starting point with improving people’s social value and quality of life as the fundamental purpose of development and application. However, the development of high-tech life science and technology, while promoting social progress and human well-being, has also brought new problems to the whole society and posed new challenges to the legal profession. In view of the proportion of the infertile population in China, the assisted reproductive technology which is a high-tech life science and technology, provides infertile couples with the opportunity to have children and plays an important role in social life. The legal profession should maintain its initiative and enhance its sensitivity in the face of the new situation of social development; we should strengthen the judicial response which is legal, scientific and social in nature.

1. A Comprehensive Understanding of the Evolution and Stages of the Dispute over Frozen Embryos. — Since the Wuxi Return Case in 2014, the number and types of disputes involving frozen embryos have been increasing, and with the development of the assisted reproductive technology. In addition to the custody, ownership and disposal of frozen embryos, in the different stages of embryo pre-production, embryo post-transfer and offspring-bearing, there will be various disputes, even those difficult to predict. The custody disputes after the frozen embryo transfer and surrogacy, and the tort disputes after the frozen embryo was lost without the consent of both parties, as well as the frozen embryo transfer and the birth of children’s kinship confirmation disputes, custody or abandonment disputes and other new types of disputes will gradually enter the public field of vision and judicial procedures.

2. Understanding the Importance and Seriousness of the Frozen Embryo Dispute. — As a product of high and new life science and technology, frozen embryos objectively have the potential to cause technical risk, interpersonal risk, social risk and human safety risk, and national legislatures, the executive branch, Public Security Bureau, medical institutions, and all sectors of society should jointly produce risk reports and alerts with a prudent and speculative attitude to the frozen embryo return disputes to make the value of scientific development, social and human values and the value of legal norms to deal with ideas, and adhere to the study of new problems and new situations, and timely and effective solutions.

3. A Correct Understanding of the Appropriateness of Handling Frozen Embryo Cases. — As a new dispute, the unconditional return of frozen embryo obviously does not conform to the current judicial reality and the judicial development path, but when making the judgment of non-return cases, we should clearly recognize the appropriateness of the relevant rules and the contribution to similar cases. In the case that Hangzhou Shangcheng District People’s Court rejected the return of frozen embryos in 2019, in accordance with the regulations of the People’s Republic of China on the management of human genetic resources, the court made it clear in its judgment that the embryos in question belonged to the material of human genetic resources due to their possession of human genetic tissue; at the same time, it made it clear that only if the relevant conditions were met, it was reported to the Administrative Department of Science and Technology under the State Council for approval before the materials of human genetic resources could be preserved, thus concluding that ‘the plaintiff does not have the right to keep the embryos, and does not support the plaintiff’s request that the defendant returns the frozen embryos’. The judgment of this case from the perspective of biological safety is worthy of being affirmed, but the judgment does not provide a practical way to judge this complex issue. First, its application to the regulations on the management of human genetic resources is beyond the scope of the legislative purpose. The judgment does not directly cite specific provisions, but the regulations and legislative notes on preservation clearly regulate the object ‘of providing a basic platform for scientific research’ and individuals do not fall into this category. Second, the judgment did not analyze and explain the rescission of the contract under the condition that the attribute of the frozen embryo is not clear.

B. To Establish the Disposal Principle of ‘Non-return as the Principle, Conditional Return as the Exception

From the point of view of legislation, the nature of frozen embryo is defined, and from the point of view of ethics and physics, the unified disposal principle of ‘non-return as the principle, conditional return as the exception’ is established.

1. The Basic Thought of Establishing the Principle of Non-return. — Under the current civil law system, frozen embryos can and should be regarded as things, but because embryos have the potential to develop into life, and they are special things with the characteristics of future life, they cannot be considered as personal property in the same way as ordinary objects which are traded or disposed of without restriction. The return of embryos is permitted only if necessary, without the consent in the principle of the individual’s request for return. Because embryos contain rich information about human genes and have close blood ties and emotional ties with germ cell providers, a total ban on return would not be consistent with the protection of individual rights and interests, nor with the humanistic values of the Chinese legal system, nor is it conducive to reconciling the contradictions between social ethics and public sentiment, and therefore requests for return should be supported in exceptional cases, while recognizing the ownership of frozen embryos by the germ cell and heirs, to impose appropriate and necessary legal restrictions on such ownership.

2. Set Conditional Return as an Exception. — In the establishment of special property right in China, there is a precedent of forbidding the exercise of special property right. Such as cultural relics can be owned by individuals but cannot be traded, guns and drugs also have the property of objects, but because of endangering social public security and public welfare, individuals cannot hold them. The Biosafety Law of the People’s Republic of China clearly stipulates that the state enjoys sovereignty over China’s human genetic and biological resources which are important resources related to national and national security. The embryo contains abundant information of human genes, and the determination of exceptional cases should take full account of many factors, such as individual reproductive rights, offspring safety, human genetic safety, social order stability and Chinese traditional culture. This ensures the necessary legal restrictions on the exercise of rights, ultimately achieving an overall balance of composite values. Therefore, it is necessary to establish a unified rule in the dispute of frozen embryo return through legislative or judicial interpretation, ‘non-return as the principle, conditional return as the exception’, and establish a mechanism of application qualification examination, and through the ‘example+bottoming clause’ set the ‘positive+negative’ list to unify the rules of embryo return disputes.

3. Set Specific Rules for Conditional Return. — Considering that it is difficult for individuals to secure the necessary medical conditions for the custody of frozen embryos, and from the point of view of preventing the flow of frozen embryos into the illegal surrogacy industry chain, the risk of misuse or contamination of genetic resources, the court shall reject the application for return without reasonable cause and bring it before a court. If it is necessary to return it, the conditions under which it can be returned shall be strictly set up and clearly enumerated. At the same time, since high-tech life science and technology and the whole society are in a state of constant development, it is also possible to set up a bottom-covering clause in order to make a proper response to the new situation, but it is necessary to strictly set up the main body of the interpretation of the bottom-covering clause and take the administrative examination as the pre-procedure of return attached conditions.

Since it is difficult for an individual to obtain the necessary medical conditions for the storage of frozen embryos, the prosecution shall be dismissed if the application for return is made without proper reasons; if it is necessary for return, strict and clear conditions for return shall be set up, and a bottom-up clause shall be set up. In the case of a couple eligible to request restitution, woman shall be under the age of 50 years old (inclusive) and may still become pregnant after the transfer of the embryo. In the case of a request for the return of frozen embryos on the grounds of the continued operation of a replacement medical institution after several unsuccessful transplants at the original medical institution, the following conditions shall be met at the same time. 

It may be returned: (1) the medical institution of the other party is a medical institution that has obtained the state’s qualification for admission to assisted reproductive technology; (2) the medical institution of the other party shall issue a written opinion to the couple or the original medical institution requesting permission to accept the frozen embryo; (3) to request that the conditions of both husband and wife meet the relevant provisions of the current national family planning, and to produce local health commission certification documents; (4) the medical institution of the other party and the staff of the former medical institution, the legal personnel, the husband and wife, the court or the notary office shall be present at the same time for the transfer of the embryo, and shall make a record of the transfer to confirm or certify the signature; (5) the couple is requested to clarify the matter and to make a written declaration that the transfer of the embryo may have an adverse effect on the embryo, due to factors such as the use of reagents and consumables in the freezing and thawing of the embryo by the medical institution of the other party, the former medical institution, etc. After thawing, the embryos may be degraded in quality or died. The applicant shall apply to the Health Commission Departments for examination and verification if it is necessary to return the embryo that does not conform to the provisions of the preceding paragraph. The Health Commission Departments shall organize an ethics committee and other relevant institutions to conduct an assessment and make a comprehensive review and approval after taking into full account such values as the protection of individual rights, the overall safety of human beings, the social-ethical order, and Chinese traditional culture.

4. Set a Negative List That Is Not to Be Returned. — Where an individual applies to a medical institution or to the court for the return of a frozen embryo for the purpose of obtaining physical possession of the frozen embryo, out of a strong personal feeling or a strong tendency towards profit, it may expand or enrich the scope of the above-mentioned return conditions or impose a bottom-up clause. In order to avoid the extended interpretation of the bottom-up clause, it is clear that no return will be given: (1) no support will be returned to other units or individuals; (2) the couple to which the frozen embryo belongs has divorced and one or both of them have died or one of them has lost his or her full civil capacity; (3) the age of the woman in the couple to which the frozen embryo belongs is over 50 years old (the age of the woman receiving the egg donation cycle shall not exceed 50 years old in accordance with the relevant regulations of the reproduction branch of the Chinese Medical Association); (4) the couple to which the embryo belongs can obtain offspring only through surrogacy (if the woman has had a hysterectomy or suffers from a serious physical disease). For these four types of circumstances, the parties to the court should not be supported.

C. The Establishment of a Scientific Review and Supervision Mechanism for Frozen Embryo Return

1. The Establishment of the Frozen Embryo Return Administrative Review Mechanism. — In the dispute settlement process, the currently direct entering into the civil proceedings is adjusted to pre-audit by the executive branch  first, and then enter the judicial process. The executive branch shall also follow the principle of ‘non-return as the principle, conditional return as the exception’ in reviewing the return application. If the applicant does not accept the result of the review, he or she may file an administrative action with the people’s court after reconsideration.

2. Establish a Mechanism to Verify the Eligibility of Requests for Return. — Frozen embryos are the product of assisted reproductive technology, as an important part of high-tech life science, ‘in vitro fertilization and embryo transfer’ set up a strict technical community, and in the process of technical implementation request return, they should also meet the specific application conditions. If the applicant is qualified, and if the provider is a germ cell, the relationship shall be between husband and wife who are legally married in China (same-sex couples are not eligible for application), forming frozen embryos during the marriage, upon the breakdown of the marriage, both the individual and the couple are disqualified from applying for restitution. In the case of a relative of the germ cell provider, in the event of the death of both the germ cell providers, it is only applied if the only child dies of an illness or an accident after sterilization in response to a family planning call, others have no right to claim restitution, and if a claim is made to the people’s court, the court shall dismiss the claim.

3. Set up the Performance Specification for the Transfer of Frozen Embryos. — Under the established rule of ‘non-return is the principle, the conditional return is the exception’, an individual requests the return from a medical institution, if the conditions for return are met, the medical institution can definitely return it after examination, and a return agreement shall be signed with the individual specifying the rights, obligations, risks and liabilities, and the validity of the agreement shall be ascertained through judicial confirmation; if the conditions for return are met and the medical institution still refuses to return, the return obligation of the medical institution may be clarified through litigation in the form of a court decision. In the execution of a return agreement or return judgement: (1) the necessary medical conditions shall be reviewed, i.e., the environment in which the embryo is transferred, the qualifications of the technical personnel involved in the transfer and the environment in which the transfer is accepted; (2) a letter of commitment shall be signed prior to the transfer, undertaking not to provide frozen embryos to organizations, individuals and institutions established or under their effective control abroad, and that their subsequent use does not violate ethical principles and does not endanger public health, national security and the public interest of society; (3) the transfer procedure shall be carried out in the presence of a judiciary or notary public and the health regulatory authority, and audio and video recordings shall be made throughout the procedure; (4) after the return of the embryo, the individual shall regularly report the subsequent flow of the frozen embryo to the health regulatory authority to ensure the proper and legal use of embryos.

D. Multi-sector Cooperation to Strengthen the Supervision and Protection of Genetic Resources

The fifth plenary session of the 19th CPC Central Committee has put forward new requirements for overall development and safety. The risks involved in the development of high-tech life science and technology belong to non-traditional safety. Therefore, the multi-sector joint governance should be carried out from the perspective of the high-tech life science and technology, social stability and human security development. Medical institutions should continue to carry out assisted reproductive technology in accordance with the law and regulations, strengthen the standardization of the contents of medical form contracts, and make explicit the rights and obligations concerning embryos in the terms of contracts; and the health administration departments should strengthen supervision and control to establish legal and standardized administrative examination procedures and increase the corresponding administrative punishment, and strengthen the follow-up supervision of the return of frozen embryos under special circumstances through random sampling, the state security and public security organs, and together with the relevant departments crack down on illegal surrogacy, cut off the industrial chain of illegal surrogacy and crack down on illegal genetic experiments; the departments of justice incorporate relevant legal risks into the content of legal education and publicity; women’s and children’s federations call on the community to pay attention to the development of children’s mental health, laying the foundation for the comprehensive establishment of a high-tech normative system for life.

At the same time, we should strengthen the criminal crackdown on illegal acts. Frozen embryos, as high-tech life products, are regulated at the same level as human organs. In order to crack down on illegal trade in human organs, in 2011, the Standing Committee of the National People’s Congress passed the Amendment to the Criminal Law of the People’s  Republic of China (VIII), which stipulated the crime of organizing the sale of human organs, and established the illegality of the sale of human organs. We have cracked down on the illegal and criminal activities in the sale and purchase of human organs, and achieved remarkable results. On this basis, in order to strengthen the maintenance of national security and bio-security and prevent bio-threats, the newly introduced Amendment to the Criminal Law (XI), which is in line with the Bio-security Law, has added three types of crimes, that is, illegal human gene editing, cloning embryo crime, serious harm to the security of national human genetic resources and illegal disposal of alien invasive species crime. Therefore, in regulating the use of frozen embryos as high-tech products containing human genetic information, the judiciary should adhere to the ‘civil+criminal’ combination, crack down on illegal crimes, and safeguard national security.

E. We Will Intensify Publicity for the Rule of Law and Popular Science Education

At present, there are many legal issues related to genetic safety and ownership of frozen embryos, as well as the relevant technical points of the assisted reproductive technology that are not known to the public. There are few science popularization activities of related basic knowledge, and the public lack not only the awareness of the value of genetic resources, but also the awareness of the protection of genetic resources. In accordance with General Secretary Xi Jinping’s requirement of ‘improving the rule of law literacy of the whole nation’ in his report of the 19th National Congress of the Communist Party of China and considering the trend of risks related to frozen embryos, it is necessary to strengthen the gene safety and the publicity and education of the rule of law and the popularization of scientific knowledge to promote the rule of law of the whole nation. It is suggested that the relevant departments, in the course of public service advertisements, propaganda films on the rule of law and medical services, adopt the methods of story display, case interpretation and special notification, explaining that frozen embryos, as human genetic information materials, must be regulated by the state to avoid security risks. At the same time, it is necessary to respect the highest legal protection status of the frozen embryo as an ‘ethical object’ and the potential of the frozen embryo to be an adult, emphasize on the relevant legal issues and scientific knowledge to make in-depth, easy-to-understand, simple and vivid explanation, strengthen the education of genetic resources, and enhance the general understanding of social public genetic security, national security and sense of responsibility. 

To sum up, under the current civil law system, frozen embryos can and should be regarded as ethical objects, belonging to the category of thing, but because embryos have the potential to develop into life, they cannot be regarded as ordinary as personal property and transactions or disposal, for the return of the individual request in principle is not agreed. The determination of exceptions should take full account of individual reproductive rights, offspring security, human genetic security, social order stability and Chinese traditional culture, so as to ensure the necessary legal restrictions on the exercise of rights in order to realize the overall balance of comprehensive value. We should establish the basic disposal principle of ‘non-return as the principle and conditional return as the exception’, and take it as the general principle when dealing with the disputes involving frozen embryos.

 

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