ZHANG Xiaoxiao*

 

Abstract: Human germline genome editing has inherent risks in the use of the technologies, as well as unknown genetic and social risks. The application of such technologies by the present generations will adversely affect human dignity, right to life and health, right to biological information integrity, genetic autonomy and other specific rights of future generations. Legal protection should be provided for the rights of future generations affected by human germline genome editing, which is supported by the theories of intergenerational equity, the intergenerational social contract and an intergenerational community with a shared future for human beings. In spite of the continuously improved regulation of germline genome editing in China, the attention paid to the rights of future generations remains insufficient. Learning from international legislation, in combination with the current research and applications of germline genome editing, China can strengthen the protection of the rights of future generations in the context of human germline gene editing from three aspects: clarifying the principles and contents regarding the rights protection of future generations, strengthening the oversight of germline genome editing, and promoting the implementation of laws and regulations such as the Biosecurity Law.

 

Keywords: genome editing · rights of future generations · legal protection

 

Because it is possible to cure human diseases and prevent the next generation from serious genetic diseases, genome editing is of high scientific and economic value as well as social influence. With the gradual improvement of the accuracy of genome editing and the reduction of cost, the threshold for related research is greatly reduced. It is more convenient for institutions and researchers to conduct relevant experiments. As a result, the birth of genome editing babies has become a reality. In 2018, Professor He Jiankui of the Southern University of Science and Technology announced the birth of two genetically modified twin babies. He modified the babies’ CCR5 gene, claiming that genome editing can protect them from the inheritance and infection of AIDS. However, giving birth to babies after germline genome editing seriously violates the ethical principles of the “14-day period” of human embryo research and the “prohibition of implanting experimental embryos into the human reproductive system” as well as the prohibitive norms of law.

 

The incident not only exposes the ethical predicament and institutional shortcomings of controlling emerging technologies such as germline genome editing, but also shows the absence of a protection mechanism for the rights of future generations.

 

 

Logically, whether there are different “generations” or not and whether future generations enjoy rights or not is the starting point for discussing the protection of the rights of future generations. There has always been debate on the two questions in academia. Some scholars believe that although future generations are not present, they enjoy corresponding rights and the present generation has the obligation to protect and realize the rights of future generations; some other scholars believe that mankind is a collective concept that should not be divided into the present generation and future generations, so the rights of future generations are like flowers in a mirror and the moon’s reflection in water.

 

 

“Future Generations” do not exist at the same time as the present generation. In other words, they are “generations which do not overlap our own”¹ or “persons living in the future who will not be born until the last person now alive has died.”² Based on this, some scholars directly deny the concept of “future generations,” thinking that “future generations are not present but only a fictional subject.”³

 

The existence of “generations” should be affirmed before the discussion on the existence of “future generations.” In biology, the term “generation” refers to the replacement and continuation of mankind. In sociology, it refers to the connection of mankind in such fields as family, politics, and so on. However, opinions vary in the study of “generation” in jurisprudence and the root cause lies in the distinction between mankind as an aggregation and mankind as a species. The concept of aggregation reflects a total of things with emphasis laid on the group as a whole; while the concept of species reflects a group of things with some common characteristics and the emphasis is laid on individual members.

 

One scholar has argued that “the present generation and future generations should be considered as different development stages of mankind as a whole, so the two concepts should be considered as the same subject rather than two independent subject with conflicts of interest”⁴ and “the fundamental problem of the intergenerational theory lies in the fictional construction of multiple subjects of mankind, namely the so-called mankind of past generations, mankind of the present generation, and mankind of future generations.”⁵ He believes that “the foundation of the intergenerational theory is consideration of mankind as an aggregation...When they refer to past generations, the present generation, and future generations, and consider them as one of the two parties or multiple parties in arguing fairness and signing contracts, mankind is actually considered as a species rather than an aggregation... in fact, mankind is the only aggregation.”⁶ This fundamentally denies the division of human “generations” and treats future generations as a theoretical fiction. Some scholars refute this view and have proposed that “the logical process itself is a non-logical wrong argumentation which presupposes that the mankind is an aggregation for the demonstration from logical concept discrimination to falsification theory.” “Although the diachronic extension of ‘mankind’ and ‘human society’ constitutes an intricate and successive whole, the holistic view should not impact on the legal division of generations.”⁷

 

Mankind is the realistic unity of species, aggregation and individuals. The triple attributes show unity. The aggregation is constituted by individuals while the species is composed of aggregations. Therefore, the individual attribute inevitably demonstrates the aggregation attribute, which inevitably shows the species attribute.⁸ However, in specific situations, the emphasis on these three attributes of mankind is different.⁹ Whether mankind is an aggregation concept or a species concept can only be deduced in a specific context and connotation. The above-mentioned distinction of concepts of mankind is based on the external perspective of resources and environment, yet the influence of germline genome editing on mankind affects the internal genetic information of mankind, which should be discriminated from the internal perspective. Human genes are continuous from generation to generation and cannot be separated, so future generations should not only cover future and distant future generations who are not present, but also the immediate future generations who overlap, cross and live together with us.¹⁰ From the perspective of human germline genome editing, future generations include not only the descendants of “individuals” who have been operated on, but also the “aggregation” of their descendants and the entire descendants of mankind affected by the “gene pool.” Considering the case of He Jiankui, the human germline genome editing has actually hurt Lulu and Nana, the genome editing babies who exist as “individuals” and belong to the future generation living with us in the same era. Meanwhile, genome editing will further affect the aggregation of “genome edited people” represented by Lulu and Nana and have a substantial impact on future generations of the aggregation. Finally, through the continuation of genes, the human germline genome editing will inevitably affect the “mankind” that is not present as a whole.

 

 

Although future generations are not present yet, it does not mean that the rights of future generations are illusory. A series of problems, such as environmental degradation and genetic change, have inevitably endangered the survival and development of mankind and affected the interests of future generations. Therefore, scholars in many fields have made theoretical discussions on the rights of future generations. Meanwhile, the rights of future generations are stipulated in many international conventions and domestic laws of various countries to protect their interests.

 

Recognizing that the rapid development of scientific research and the application of technology will bring problems to future generations, some scholars have taken the lead in theoretical research on the rights of future generations. Joel Feinberg has clearly put forward that future generations enjoy rights in his article The Rights of Animals and Future Generations, believing that contemporary people have the obligation to avoid passing on an exhausted and garbage-filled world to future generations.¹¹ Professor Edith Brown Weiss has published several papers to elaborate on the rights of future generations from such aspects as intergenerational trust, intergenerational equity, and so on. Professor Partridge Ernest, an environmental ethicist, has conducted a lot of research on intergenerational justice and the rights of future generations and explored such issues as the contradiction of regenerated population, the absence of claims of future generations, and the uncertainty of the number of future generations.¹² Professor Shrader-Frechette, an American philosopher, has proposed that future generations enjoy moral rights and proved the rights of future generations with intergenerational social contracts;¹³ Professor Wright R G, a constitutional scientist, demonstrated the theory of the rights of future generations through the theory of intergenerational human community.¹⁴

 

Subsequently, the theory on the rights of future generations was gradually introduced into China. Related exploration is mainly in the field of environmental law. Some scholars believe that future generations enjoy legal rights. For example, Professor Cai Shouqiu has discussed the environmental rights of future generations from such aspects as the theoretical basis, the contents of rights, and so on, holding that it is the unity of the interests of contemporary people and future generations and the environmental rights of future generations can be guaranteed through the agency system.¹⁵Some other scholars summarized the contents of the rights of future generations. For example, Professor Liu Xuebin held that the rights of future generations include the right to enjoy the achievements of modern political civilization, the right to enjoy material wealth and development, the right to preserve spiritual wealth, the right to enjoy physical health and genetic perfection, the right to receive education and use scientific and cultural achievements, and procedural rights.¹⁶ From the perspective of human genome editing, Professor Qian Jilei summarized the characteristics of the rights of future generations as follows: the subjects of the rights of future generations are future generations as the counterparts of the present generation, which do not exist at present and include all subsequent generations; the object of the rights of future generations points to “preventing and avoiding unknown risks that may be brought to them” and the present generation should try the best to ensure the safety of genetic information and guard against risks, which include not only biological genetic risks but also social ethical risks; future generations will realize their rights through the passive way of “enjoying” and they should also bear obligations to their descendants.¹⁷

 

After the 1970s, the theories of the rights of future generations have gradually been included in legal norms. International organizations and countries began to protect the rights of future generations through legislation. The aim “to safeguard and promote the interests of the present and future generations” and a series of principles to safeguard the rights of future generations are proposed in the Universal Declaration on Bioethics and Human Rights. A more representative example is the Declaration on the Responsibilities of the Present Generations Towards Future Generations adopted by UNESCO. The Declaration recalls that the responsibilities of the present generations towards future generations have already been referred to in various instruments such as the Convention for the Protection of the World Cultural and Natural Heritage, the Rio Declaration on Environment and Development, and so on. It also emphasizes that “the present generations have the responsibility of ensuring that the needs and interests of present and future generations are fully safeguarded,” “the nature and form of human life must not be undermined in any way whatsoever,” and each generation inheriting the Earth temporarily should “ensure that scientific and technological progress in all fields does not harm life on Earth.” The laws of many countries also have relevant provisions on the rights of future generations, most of which are reflected in environmental laws. For example, it is stipulated in Article 101 (b) of the National Environmental Policy Act of the United States that the state as the environmental trustee of the present generation should fulfill its responsibilities for future generations. According to article 1 of the Russian Federal Law on Environmental Protection, the purpose of legislation on the environment is to strengthen the balance of interests between present and future generations. According to article 1 of the Hungarian Law on the Protection of Human Environment, the purpose of the law is to protect the health of mankind and to continuously improve the living conditions of the present and future generations. It can be seen that the rights of future generations are not only gradually recognized at the theoretical level, but also included in legal norms.

 

 

John T. Hardy questioned whether mankind is the master or slave of new technologies and whether technology promoted or restricted the development of the choice and freedom of mankind.¹⁸ Although genome editing technology has helped mankind increase grain production and cure diseases, there are also technical risks, genetic risks and social risks. Genes make people of all generations closely linked. Germline genome editing can help the present generation satisfy the desire to give birth or improve the descendants, yet it would endanger future generations as inheritors of genes, bring unknown and far-reaching risks to them, and harm their personal dignity and basic rights.

 

 

Many human rights treaties, including the Universal Declaration of Human Rights, emphasize that human dignity is the foundation of other values. According to the Universal Declaration on the Human Genome and Human Rights, the rapid development of life sciences and some of the applications would affect human dignity and the rights of individuals, the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity.¹⁹ The most fundamental and sacred human dignity is the dignity of life, which is the dignity enjoyed by mankind on the basis of life. The genes constitute the human body and make it possible for all humans to enjoy dignity. Human dignity is valuable for its sanctity, subjectivity, and integrity. The improper application of germline genome editing would harm the dignity of future generations. To be specific: First, it would destroy the sanctity (or naturalness) of human life. Before the invention of gene technology, human life was considered sacred and equal as the work of God or a natural arrangement. However, genome editing technology allows scientists to take the scalpel from God and turn humans into objects that can be studied and tested. The subjective will of humans could be injected into genes of natural evolution. Second, it could destroy the subjectivity of humans and “materialize” or “instrumentalize” them. Immanuel Kant once put forward that human is an end rather than a means.²⁰ If the human is regarded as a tool, it will completely violate human dignity. The genome editing technology itself is neutral, but without restrictions, people can transform future generations according to their own ideas and future generations will become tools enslaved by technology. The illegal germline genome editing experiment is an act to “materialize” humans, which makes the manufactured babies become “products” screened and synthesized by manufacturers. Third, it would destroy the uniqueness and integrity of mankind. Genes are like data programming. Each human body is a unique program composed of 23 pairs of chromosomes, which are randomly passed on to the next generation. Individual genetic differences and genetic uncertainty of sexes constitute the uniqueness of individuals, which constitutes the integrity of mankind.²¹ It is the unique personality of each person that constructs the building of human life. The disintegration of individual uniqueness would cause the disintegration of human integrity and thus infringe on human dignity. Genome editing changes individuals at the gene level, which weakens uniqueness and challenges integrity.

 

From the perspective of protecting human dignity, protecting the rights of future generations is one of the methods to protect the sanctity, subjectivity and integrity of human dignity. Strictly restricting the present generation from using genome editing technology to manipulate the genes of future generations is to protect the dignity of future generations. It is the proper exercise of the reproductive right for parents to give birth to children without a certain serious genetic disease gene through technical means, which reflects the benefit of genome editing for mankind. However, germline genome editing is different from other assisted reproduction technologies. Since the babies are edited in embryo, the forms of their future life are manipulated, which derogates the sacred dignity of life. The process of editing embryos reflects the will of others, so embryos become the means or tools for others to achieve a certain purpose. As a consequence, future generations are designed according to the will of the present generation and the dignity of subjects is inherently derogated.²² Therefore, protecting the rights of future generations in the field of genome editing is very important for safeguarding human dignity.

 

 

It is slightly narrow to summarize the content of the rights of future generations as the “security interests to free from danger”, which needs to be further clarified. From the perspective of human germline genome editing, the most relevant rights of future generations are the rights to life and health, gene inheritance, and disposal, which should include the right to life and health, the right to the integrity of biological information and the autonomy to gene, as well as the right to healthy and stable survival and development based on these rights.

 

The right to life and health, as the most basic right and the highest personal interest, is enjoyed by both the present generation and future generations, especially when germline genome editing gives the present generation the ability to change the genetic and vital characteristics of future generations. Throughout the development of mankind, the intergenerational transmission of previous generations, the present generation, and future generations reflects the unidirectional transmission of genes, which means that future generations will acquire much more depreciated values than those of previous generations and that the results of actions taken by the present generation are irreversible. At present, mankind knows little about the mechanism of gene operation and there are more blind spots in genome editing based on this. Common technical problems such as the miss-target effect and mosaic phenomenon in genome editing have not been solved, so the safety and reliability are seriously insufficient. For example, two research teams from Sweden and the United States found that successfully edited cells are likely to become potential cancer cells.²³ Therefore, the rash use of human germline genome editing to genetically modify future generations would not only fail to achieve therapeutic results, but also be counterproductive and irreversibly degrade the right to life and health of future generations.

 

Future generations have the right to inherit complete biological information, namely, the right to obtain the natural inheritance of genes. Future generations are not only the inheritors of environmental resources, but also the natural inheritors of gene information, which is directly influenced by the genome editing of the present generation. Human genes are formed in the long historical evolution. They are the ultimate unit of natural selection and the most basic unit of human existence. Genome editing consciously breaks the laws of nature and artificially intervenes in gene screening, repair and adjustment. These behaviors will directly affect the internal structure of the human body and cause the slightest but most fundamental changes in the human body. As the most profound transformation of human genes, germline genome editing shakes the core of human life, which affects not only one person but all future generations. The current gene change seems trivial, but it could trigger the butterfly effect and lead to great changes in the genes of future generations. The edited gene is irreversible. If the “wrong gene” is produced and brought into the gene pool, it would change the whole picture and break the integrity and stability of the gene. The change and confusion of the existing gene sequences would also have a profound impact on the integrity of the genetic information of future generations. Just as in the external environment, “the present generation has the obligation to avoid passing on an exhausted and garbage-filled world to future generations,” the present generation also has the obligation to avoid passing on an incomplete and unrecognizable genetic system to future generations in the internal genetics.

 

Future generations enjoy the right of personality to decide independently on genes, namely, the right to choose and decide independently on the micro level of genes. On the positive side, people can decide what kind of disposal and state their genetic materials or information will receive and be in according to their own wishes. On the negative side, they can exclude others from interfering with their genes and others shouldn’t interfere without permission, so they are not controlled or utilized by others. In the age of gene medicine, the exercise of autonomy is influenced by many complex factors rooted in the social system and decisions on some issues can only be made by stakeholders for common interests or their own purposes.²⁴ In most cases, the present generation will apply genome editing by virtue of their own preferences and equate their own needs with those of future generations, making future generations unable to decide and control the initial state of inherited genes and at a disadvantage in gene autonomy. The present generation can control their life potential with the help of genetic technology. For example, they can judge the situation of the embryo through genetic diagnosis. Generally, the effect is limited to the babies they give birth to. However, when the present generation applies genome editing to germline for reproduction, no matter it is for the purpose of giving birth by parents, for the purpose of scientific exploration by professional researchers, or for the purpose of improving the quality of life of the mankind by governments or social organizations, the behavior imposes the will of the present generation on future generations and damages their genetic autonomy. In addition, the results of human germline genome editing are irreversible, so the adverse consequences can only be passively borne by future generations.

 

 

From the perspectives of intergenerational equity theory, intergenerational social contract theory and the theory on an intergenerational community with a shared future for human beings, scholars have discussed the methods to protect the rights of future generations and solve intergenerational conflicts under the circumstances of deteriorating external environment and increasing shortage of resources. These legal-philosophical thoughts also provide important theoretical support for the rights of future generations to be free from the influence of genome editing as well as solutions for conflicts in the rights of different generations.

 

 

The intergenerational equity theory focuses on how to reasonably allocate resources between the present generation and future generations. According to the currently recognized definition, intergenerational equity refers to the guarantee of both the need of the present generation and the opportunity for future generations to satisfy their interests and needs in the continuation of human generations.²⁵ Professor Edith Brown Weiss first used the concepts of “intergenerational equity” and “planetary trust” in the article The Planetary Trust: Conservation and Intergenerational Equity. According to the article, all generations should enjoy equal rights and interests in the development and utilization of natural resources.²⁶ She put forward a complete intergenerational equity theory, holding that the subjects of rights should be extended to future generations and the rights of future generations should not be limited to moral protection, but also be transformed into legal rights and obligations and be brought under protection.²⁷ Future generations should not only enjoy the basic rights to a good environment and nature, cultural diversity as well as the substantive rights of equal access to and use of these resources, but also enjoy procedural rights like public participation.²⁸ The current generation should abide by the principles of “protecting choice” “protecting quality” and “protecting access,” and pass on the good conditions the same as that of the time they accepted it to future generations,which is the obligation of each generation to future generations.²⁹ Since then, scholars have explored the theory of intergenerational equity in multiple dimensions. T. R. Page put forward the theory of intergenerational equity on the basis of social choice and distributive equity. Pierce believed that intergenerational equity can be achieved when the welfare of the present generation can be increased without reducing the benefits of future generations.

 

Realizing intergenerational equity at the genetic level is one of the important aspects of protecting the rights of future generations. The present generation should not only consider the development opportunities and rights of future generations in terms of environment and resources, but also consider the opportunities and rights of future generations in terms of genetic inheritance and development. Generations are inherited. When the present generation gets the material and spiritual conditions for existence and development from their ancestors, they have the obligation to pass these conditions on to the next generation. Such continuous generation transmission becomes the link to maintain human survival and development.³⁰ If the present generation exhausts or destroys the heritage of the ancestors, it would lead to the derogation of the rights and interests of future generations, which is against the principle of intergenerational equity. On this basis, ethicist Brenda Almond put forward the principles for the present generation to protect the rights and interests of future generations: the first is to protect the freedom of choice of future generations, namely, to protect existing resources and avoid irreversible changes to existing resources; the second is to maximize the freedom of choice in the future, namely, to give priority to the most basic living conditions of human beings.³¹ Of course, the above principles apply to human genes, which are human genetic resources shared by past generations, the present generation and future generations. The reason for the enjoyment of the right to life and health and complete genetic information of the present generation is the protection of the ancestors in intergenerational inheritance. The present generation should also fulfill the prudent obligations in the process of transmitting genes downward. Facing the opportunities and crises brought by genome editing, we should fulfill the duties of “gene trustee,” pass on genes with no worse conditions than what we accepted, protect the genetic rights and interests of future generations from being derogated, and safeguard the welfare and health of future generations. Therefore, when human genome editing technology is not perfect, the present generation should not use the technology to make irreversible changes to the genes of future generations at will.

 

 

Professor Shrader-Frechette actively advocated the rights of future generations. In her article Future Generations and the Social Contract, she used the social contract theory to explore the rights of future generations. According to her exploration, the present generation and future generations are in a substantial social contract, so if we recognize the rights of future people, we will get a greater degree of happiness and self-realization in return. On this basis, the present generation should recognize the rights of future generations. Although it is true that the present generation does not know all the needs of future generations, we can at least stipulate for future generations the right not to be harmed by the actions of the present generation, assuming that there are rights of future generations. In other words, although we really don’t know (clearly) what people in the future will do, we still have good reasons for not doing what we shouldn’t do. Finally, the recognition of the rights of future generations is based on the idea that both the present generation and future generations are equal subjects of the social contract and that the right here is primarily a negative one. It is impossible for the present generation to sacrifice their own interests for the rights of future generations. Therefore, recognizing the rights of future generations does not diminish the extent of the needs of present-day people (especially the poor and disenfranchised) and still ensures social stability.³² She used the hypothesis of “original position” and “veil of ignorance” of John Rawls to demonstrate that the social contract can also be reached through human rationality, self-interest, justice and other elements, thus deducing the contract theory that future generations enjoy rights and the present generation has obligations to future generations. In other words, when it is difficult for us to confirm which generation we are in, how many generations we have experienced and how many generations there will be in the future, we should assume that all generations have the same rights. Future generations, like us, have the right to inherit complete genetic information and enjoy good health. Germline genome editing of the present people is based on their own understanding of good health and their intention to avoid diseases. However, when it is difficult to know the needs of future generations, the present generation should try their best to avoid harming the interests of future generations through genome editing and restrain relevant behavior.

 

She held that intergenerational reciprocity is not synchronic and equivalent like an ordinary contract, but a “chain-style” reciprocity of “A → B → C → D …”, spanning a long range of time. This also fits into the chain of gene transmission, in which the intact genes of previous generations are inherited by us and then passed on to future generations. Human genome editing has become an uncertain factor. Inserting, deleting or modifying any gene would prevent the gene from inheritance at a certain moment. Shrader-Frechette suggested that paternity can be used as a model for understanding the rights of the present generation and future generations, because some forms of contract can be formed not because a prearranged mutually beneficial agreement has been reached, but only because one of the parties to the contract has actively chosen to accept the obligation.³³ Future generations can’t have a dialogue with the present generation, or be asked about their wishes and needs for genes, or give some rewards and benefits to the present generation, so they can’t reach a contract based on reciprocity. However, when the present generation can determine the genetic status of future generations through genome editing, they have the most basic obligation to protect their rights from being harmed by the technology, just as parents naturally have the obligation to take care of their children, thus reaching an intergenerational contract.

 

 

Professor Wright, a constitutional scientist, demonstrated the theory of the rights of future generations through the theory of an intergenerational community with a shared future for human beings in the article The Interests of Posterity in the Constitutional Scheme. He discussed the relationship between generations from the perspective of the evolution of the human community itself and the development of human civilization. The core point of view is that continuous reproduction and evolution are the obligations of any generation for mankind as a whole. Generations are in a reciprocal relationship with each other and assume obligations and rights for each other. The present generation obtains the material and spiritual conditions for existence and development from the ancestors, and then maintains or increases its value through its own efforts, which should be passed on to the next generation. This is the process of maintaining and progressing the civilization of the whole mankind.³⁴ He also advocated the adoption of the “equal protection” clause of the US Constitution for protecting the rights of future generations to enjoy the rights of the present generation equally. Their rights can be defended through litigation.

 

From the perspective of a community with a shared future for human beings, protecting the interests of future generations can safeguard the interests of mankind as a whole and ensure the sustainable development of mankind. What connects mankind is not only economic, social and cultural life, but also an indispensable element, “human” itself. The species of human thrive by intergenerational transmission from generation to generation. From a macro point of view, human civilization has continued to this day by continuously inheriting material and spiritual conditions from generation to generation. After inheriting from the ancestors, the present generation can maintain or increase the value through their efforts and continue to pass on to the next generation, and then go on and on. From a micro point of view, the gene of each generation is an important link between the preceding and the following, so the stable existence of genes ensures the reproduction of mankind. It is through the shared human genes that the human community can be closely linked together. A community with a shared future for human beings is not only a concept of spatial dimension but also a concept of time dimension. Through genetic inheritance and reproduction, generations of mankind form a community of common destiny on the vertical timeline. The disaster caused by genetic problems makes it difficult for anyone to be immune to it. Mankind should transcend not only the gap between race, culture, region and emotion, but also the gap between past, present and future generations. The present generation should realize that the realization of the interests of future generations is the realization of the overall interests of a community with a shared future for human beings. The idea of “sharing weal and woe” should be extended to future generations who are not present.

 

Genome editing technology itself is neutral and the present generation should consider providing a good genetic environment for future generations when using it. This is in line with the thought of Xi Jinping, general secretary of the Communist Party of China (CPC) Central Committee that “we should not seek short-term gain at the expense of future generations” for ecological protection.³⁵ It is the same as genome editing, we should not allow the action at the expense of future generations to bring adverse effects on them. According to the thought of a community with a shared future for human beings, “we should not only think about our own generation, but also take responsibility for future ones.”³⁶ It is also true in intergenerational gene transmission. It is reasonable for us to use genome editing in somatic cell therapy for the benefit of the present generation. However, when it is used in germline that has a great influence on future generations, the present generation should take a very cautious and restrained attitude, consider future generations as a member of the community of intergenerational destiny, and be responsible for future generations.

 

 

Biotechnology such as germline genome editing poses a real threat to the rights of future generations. International laws and legislation in many countries restrict genome editing to protect the rights of future generations. The regulation of germline genome editing in China has also been continuously improved, yet on the whole, the attention to the rights of future generations is relatively low. China can learn from international legislation and judicial practice and improve the legal system for protecting the rights of future generations in human germline genome editing, on the basis of the current research and application of germline genome editing, to lay the foundation for a better and healthy life for future generations.

 

 

There is no special legislation on genome editing in China. Relevant regulations are reflected in laws and regulations related to biotechnology and human genetic resources. The basic position of law in China on genome editing is that the basic research and medical treatment application of somatic cell genome editing are allowed, but the research on germline genome editing is strictly limited while the clinical application is prohibited. After the “genome editing babies” incident, China accelerated the formulation of relevant laws and regulations and gradually improved and implemented the whole chain supervision mechanism to promote the development of genome editing along the correct path. However, while the technology is standardized, we should also pay attention to future generations affected by germline genome editing and effectively protect the rights of the group.

 

 

In 1993, the State Science and Technology Commission issued the Measures for the Safety Management of Genetic Engineering. As a milestone in the legislation on genetic technology in China, it is formulated around the supervision and management of genetic engineering including genome editing. In 2001 and 2003, the former Ministry of Health successively issued three documents related to human assisted reproduction technology, including the Measures for the Administration of Human Assisted Reproduction Technology, the Ethical Principles for Implementing Human Assisted Reproduction Technology and the Standards for Human Assisted Reproduction Technology. The research and clinical application of germline genome editing are standardized indirectly and assisted reproduction technologies like genome editing for reproduction purposes or violating ethics are strictly regulated. In 2003, the Ministry of Science and Technology and the former Ministry of Health jointly issued the Ethical Guidance for Human Embryonic Stem Cell Research. It is worth noting that it stipulates the “14-day principle” and requires that embryos used for research shall not be implanted into the reproduction system of humans or any other animals, nor shall human germ cells be combined with germ cells of other species.

 

For more than a decade after 2003, almost no law or regulation related to genome editing was formulated. It was not until 2015 that the National Health and Family Planning Commission and China Food and Drug Administration jointly formulated the Administrative Measures for Clinical Research of Stem Cells (Trial) and the Guiding Principles for Quality Control of Stem Cell Preparations and Preclinical Research (Trial). In October 2016, the National Health and Family Planning Commission issued the Measures for Ethical Review of Biomedical Research Involving Humans, which stipulates the functions and powers of the Ethics Committee to review and supervise biomedical research involving humans, including gene research on the human embryo. In 2017, the Ministry of Science and Technology issued the Measures for the Safety Management of Biotechnology Research and Development, which is applicable to biotechnology research and development activities such as genome editing with major risks, greater risks and general risks, and stipulates that the competent department of science and technology under the State Council shall provide safety guidance.

 

After the “genome editing babies” incident, relevant laws and regulations were further improved. The Civil Code of the People’s Republic of China sets a special provision on genome editing and clarifies the civil law norms that should be followed in genome editing activities.³⁷ The Amendment (XI) of the Criminal Law of the People’s Republic of China added the crime of illegally implanting genetically edited or cloned embryo³⁸ and intensified the crackdown on illegally engaging in genome editing experiments. On April 15, 2021, the Biosafety Law came into effect. It provides detailed regulations on the safety of biotechnology research, development and application, and strengthened the safety of human genetic resources. In December 2021, the Law on Science and Technology Progress was revised and adopted. It not only provides a legal guarantee for the development of science and technology, but also sets corresponding regulatory measures and legal responsibilities.

 

To effectively protect public health, national security and social public interests, the State Council promulgated the Regulations on the Administration of Human Genetic Resources, which strengthened the supervision of science and technology like genome editing that utilize human genetic resources in China. In March 2022, the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Strengthening Ethical Governance of Science and Technology. The principles of promoting the well-being of mankind, respecting the right to life, adhering to fairness and justice, reasonably controlling risks, and maintaining openness and transparency are proposed. Meanwhile, it is required to improve the governance system of science and technology ethics, strengthen the system guarantee for science and technology ethics, enhance the review and supervision of science and technology ethics, and deepen education and publicity of science and technology ethics. The Central Committee for Comprehensively Deepening Reform reviewed and approved the Plan for the Establishment of the National Science and Technology Ethics Committee, aiming to strengthen overall planning,standardization, guidance and coordination, and promote the construction of a comprehensive, standardized and coordinated science and technology ethics governance system with clear value guidance.

 

In addition, the Ministry of Science and Technology drafted the Regulations on Safety Management of Biotechnology Research and Development, aiming to establish and perfect the safety management system of biotechnology research and development, strengthen risk control and disposal, improve services, enhance supervision, and clarify legal responsibilities and punishment measures. The National Health Commission drafted the Regulations on the Administration of Clinical Application of New Biomedical Technologies to regulate the research, transformation and application of biotechnology in the clinical stage and establish the corresponding administrative examination and approval system. It stipulates the main contents of academic review and ethical review, emphasizes the main responsibility of institutions, increases penalties for violations, and links up with the management of drugs and medical devices. Based on the summary of the implementation of the Measures for Ethical Review of Biomedical Research Involving Humans, the National Health Commission drafted the Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, to provide detailed requirements for the construction of ethical review committees and ethical review mechanisms, emphasize the respect for the right to informed consent of the subjects, and define the supervision and management responsibilities of related departments.

 

 

The relevant legislation in China has gone through a process from stagnation to development and from fragmentation to systematic arrangement, but most of these institutional norms focus on the control of genome editing, the protection of the safety and rights of the present generation while neglecting the protection of the future generations and their rights. Although attention has been paid to the rights of future generations in some sectoral laws, for example, the Civil Code stipulates the inheritance right of fetuses,³⁹ the risks brought by germline genome editing remind us that future generations should not be limited to closely adjacent future generations, their rights should not be limited to property inheritance rights, and the protection of the rights of future generations should not rely only on the individual article.

 

For genome editing, the protection of the rights of future generations in China is mostly reflected in the prudent attitude towards germline genome editing. However, these are technological regulations and the tendency to protect future generations without direct provisions for future generations and their rights or specific measures for the protection of their rights. In contrast, laws outside China provide more careful and strict regulations on the rights related to genome editing. For example, genes are included in the protection of “the right to body” as “components of the human body” in the first part of the French Civil Code on Civil Rights. Specifically, it includes the rights to genetic autonomy, privacy and freedom from discrimination, prohibits “eugenics practice” and “any modification of human genetic characteristics for the purpose of changing future generations,” and stipulates the inspection and identification procedures of human genetic characteristics.⁴⁰ Incorporating the emerging rights related to genes into the legal system is conducive to better safeguarding rights. Foreign experience can provide a very important reference for perfecting the legal system in China.

 

 

 

To protect the rights of future generations in relation to germline genome editing, it is necessary for China to establish universal principles to protect the rights of future generations, clarify the rights enjoyed by future generations and the obligations of the present generation, and specify the contents of the rights of future generations.

 

First, the universal principle of safeguarding the rights of future generations should be clarified. Taking into account the responsibility of the present generation towards future generations, the Universal Declaration on Bioethics and Human Rights sets forth the purpose of protecting and promoting the rights of the present generation and future generations, and the universal principles including full respect for human dignity, human rights and fundamental freedoms and due attention to the impact of life sciences on future generations, including their genetic inheritance. It is also stipulated in Principle III of the Framework Convention on Climate Change that the right to development should be fulfilled to meet the development and environmental needs of the present generation and future generations in a fair and equitable manner. China can learn from the pattern to establish the principle of safeguarding the rights of future generations in legislation and set the tone for formulating and implementing specific protection measures. The principle should emphasize the influence of germline genome editing behavior on future generations, consider the sustainable development of future generations, and fully respect the dignity and related rights of future generations.

 

Second, it should be stipulated that future generations enjoy rights and the present generation has obligations to future generations in its germline genome editing behaviors. The United Nations pointed out in the Declaration of the United Nations Conference on the Human Environment that mankind has the responsibility to ensure and improve the environment of the present generation and future generations. In the report Our Common Future, the World Commission on Environment and Development proposed that our development should satisfy the needs of the present generation without endangering the ability of future generations to fulfill their needs.⁴¹ China should also stipulate that future generations have the right not to be affected by the genome editing behavior of the present generation and that the present generation should prudently fulfill their obligations in the process of genome editing to avoid harming the genes of future generations and infringing on their basic rights.

 

Third, the specific content of the rights of future generations should be clarified. The Declaration on the Rights of Future Generations put forward by the World Alliance of Reformed Churches and the Natural Rights and the Rights of Future Generations put forward by the United Church of Australia list in detail the specific rights enjoyed by future generations, including the basic right to life and genetic rights.⁴² In the context of germline genome editing, the rights of future generations need to be further specified. As mentioned earlier, future generations should enjoy the rights of life and health, the right to the integrity of biological information and genetic autonomy. These rights should be established one by one in the process of civil and administrative legislation and gradually implemented in research and practice.

 

 

First, we should strictly regulate the research of germline genome editing and prohibit illegal clinical trials of germline genome editing. Germline genome editing has its own technical defects, genetic risks and social risks, which potentially endanger the genetic safety of future generations, so it should be strictly prohibited in principle.

 

Second, we should strengthen the effective cooperation among various departments, standardize the examination and approval procedures for human genome editing, and strengthen supervision in administrative supervision. In the United Kingdom, human genome editing is divided into somatic cell genome editing and germline genome editing, which are supervised by the Medicines and Healthcare Products Regulatory Agency (MHRA) and Human Fertilization and Embryology Authority (HFEA) respectively. In China, the Ministry of Science and Technology, the National Health Commission, and the National Medical Products Administration have supervisory authority over germline genome editing. It is stipulated in the Regulations on Safety Management of Biotechnology Research and Development (Draft) that the Ministry of Science and Technology is responsible for the basic research management of biotechnology. It is stipulated in the Regulations on the Administration of Clinical Application of New Biomedical Technologies (Draft) that the National Health Commission is responsible for the supervision and management of the clinical research and transformation application of biotechnology. Meanwhile, the regulations are connected to the Drug Control Law of the People’s Republic of China and the Regulations on the Supervision and Administration of Medical Devices. The National Medical Products Administration is responsible for the management when the expected results of biotechnology clinical research are drugs or medical devices. It covers all key links from basic research to clinical application, and then to achievement transformation. After the adoption of the two Regulations, it is necessary to implement the whole chain supervision system as soon as possible and establish a coordination and cooperation mechanism among the different departments concerned.

 

Finally, the ethical review of germline genome editing research should be strengthened. China has not yet constructed a scientific ethical review system through legislation, nor has it set up an efficient ethical review committee. Because germline genome editing has not been subject to strict ethical review, the “genome editing babies” incident happened. The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans (Draft) will close this loophole. Only by establishing an effective ethical review system for germline genome editing, carrying out scientific evaluation and review, and applying effective supervision and management, can germline genome editing truly benefit all generations of mankind.

 

 

The Biosafety Law, which came into effect on April 15, 2021, regulates biotechnology including germline genome editing technology. It also protects human genetic resources such as genes shared by the present generation and future generations, which is conducive to protecting the rights of future generations and promoting the sustainable development of mankind.

 

One of the purposes of the Biosafety Law is to promote the healthy development of biotechnology. The law is applicable to the activities of biotechnology research, development and application. Of course, germline genome editing technology is regulated by the law. For these biotechnologies, the state strengthens safety management and classifies them into three categories: high risk, medium risk and low risk. It is stipulated in the law that the clinical research of new biomedical technologies should be ethically reviewed in the medical institution with corresponding conditions by qualified health professionals. Meanwhile, relevant departments should track and evaluate biotechnology application activities. This further strengthens the supervision mechanism covering every stage of the whole process for biotechnologies such as germline genome editing. It is conducive to curbing the arbitrary application of germline genome editing, like the “genome editing babies” incident.

 

Human genes belong to human genetic resources. The Biosafety Law further constructs the institutional system for the protection of human genetic resources on the basis of the Regulations on the Management of Human Genetic Resources. From the “collection, preservation, utilization and external provision” of human genetic resources, it covers the investigation system, declaration and registration system, ethical review system, administrative examination and approval system, report and register system, rights and interests sharing system, etc., and constructs a strict protection network of human genetic resources.⁴³ Strict protection of the application of human genetic information is also conducive to protecting the genetic rights of future generations 

 

The Biosafety Law is a big step forward in the journey of protecting the rights of future generations. On this basis, it is necessary to speed up the improvement and implementation of relevant legal systems to further protect the rights of future generations. Other weak points in the legal system, such as the relief of infringement damage caused by germline genome editing to future generations, also need to be responded to in theory and practice to address the weaknesses one by one. There is a long way to go to establish a complete legal system of genome editing, but we still need to vigorously promote the process of legalization in the field of human genome editing to escort the development of gene technology in China.

 

(Translated by HU Liang)

 

* ZHANG Xiaoxiao ( 张晓肖 ), PhD student of Wuhan University School of Law and Researcher of the Institute of Human Rights at Wuhan University (A National Human Rights Education and Training Base).

 

1. D. C. Hubin, “Justice and Future Generations,” 6 Philosophy & Public Affairs 1 (1976): 70.

 

2. Solum, Lawrence B, “To Our Children’s Children’s Children: The Problems of Intergenerational Ethics,” 35 Loyola of Los Angeles Law Review 171 (2001): 163.

 

3. Wei Bo, “Witnessing Intergenerational Equity through the Inheritance of Existential Significance,” Jiangxi Social Sciences 11 (2006): 16.

 

4. Liu Weixian, Critique of the Theory on the Rights of Future Generations (Beijing: Law Press · China, 2012), 190.

 

5. Xu Xiangmin and Liu Weixian, “Fictional Intergenerational Equity — Refuting ‘the Theory of Intergenerational Equity’ from the Analysis of the Concept of Mankind”, Law Review 2 (2012): 79.

 

6. Ibid.

 

7. Guo Wu and Guo Shaoqing, “Realistic Intergenerational Equity — Reconsideration of ‘the Theory of Intergenerational Equity’ for the Environmental Law,” Law Review 4 (2012): 73.

 

8. Yi Xiaoming, “Triple Attributes and Dual Attributes of Mankind,” Academics 6 (2005): 194-195.

 

9. Yi Xiaoming and Cao Xiaoxian, “On Universal Values — from the Perspective of the Unity of the Triple Attributes of Mankind as Species, Aggregations and Individuals,” Morality and Civilization 6 (2011): 49.

 

10. Qian Jilei, “On Intergenerational Rights as Emerging Rights — Starting from Human Genome Editing Events,” Political Science and Law 5 (2019): 85.

 

11. Joel Feinberg, “The Rights of Animals and Future Generation,” accessed October 19, 2021,http://www.animal-rights-library.com/texts-m/feinberg01.pdf.

 

12. Partridge Ernest, “Future generations”, “On the Rights of Future Generations,” “Posterity and the ‘Strains of Commitment’,” accessed October 19, 2021, http://gadfly.igc.org/index.htm.

 

13. Kristin Shrader-Frechette, Future Generations and the Social Contract, P. Aarne Vesilind & Alastair S. Gunn, Engineering, Ethics and the Environment, translated by Wu Xiaodong and Weng Duanze (Beijing: Tsinghua University Press, 2002), 199-209.

 

14. R. G. Wright, “The Interests of Posterity in the Constitutional Scheme,” University of Cincinnati Law Review 59 (1990). Quoted from Liu Weixian, Critique of the Theory on the Rights of Future Generations (Beijing: Law Press · China, 2012), 34.

 

15. Cai Shouqiu, Theory of Adjustment: Reflection and Supplement to Mainstream Jurisprudence (Beijing: Higher Education Press, 2003), 515-538.

 

16. Liu Xuebin, “On Legal Protection of the Rights of Future Generations,” Journal of Guizhou Normal University (Social Science) 5 (2008): 18.

 

17. Qian Jilei, “On Intergenerational Rights as Emerging Rights — Starting from Human Genome Editing Events,” Political Science and Law 5 (2019): 92.

 

18. John T. Hardy, Science, Technology, and the Environment, translated by Tang Jianwen (Shanghai: Popular Science Press, 1984), 58.

 

19. It is stipulated in Article 1 of the Universal Declaration on the Human Genome and Human Rights that “the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.”

 

20. Immanuel Kant, Fundamental Principles of the Metaphysics of Moral, translated by Miao Litian (Shanghai: Shanghai People’s Publishing House, 1986), 46.

 

21. Yi Xianfei, “Ethical Issues and Resolutions in Gene Editing of Human Germ-cells”, Wuhan University Journal (Philosophy & Social Science) 4 (2019): 41.

 

22. Liu Yafei et al., “Challenge of ‘Gene-edited Baby’ on Human Dignity,” Medicine and Philosophy 11 (2019): 31.

 

23. Ren Yunxiao et al., “Research advance and application in the gene therapy of gene editing technologies,” Hereditas (Beijing) 1 (2019): 25.

 

24. Wang Kang, Private Law Norms of the Right to Gene (Beijing: China Legal Publishing House, 2014), 223.

 

25. Edited by Lv Zhongmei, Transcendence and Conservation — Innovation of Environmental Law from the Perspective of Sustainable Development (Beijing: Law Press · China, 2003), 101.

 

26. Edith Brown Weiss, “The Planetary Trust: Conservation and Intergenerational Equity,” 11 Ecology Law Quarterly 4 (1984): 495-581.

 

27. Edith Brown Weiss, “Intergenerational Fairness and Rights of Future Generations,” International Justice Review 3 (2002).

 

28. Edith Brown Weiss, In Fairness to Future Generations: International Law, Common Patrimony and Intergenerational Equity, translated by Wang Jin et al. (Beijing: Law Press · China, 2000), 109.

 

29. Ibid., 41-42.

 

30. Liu Xuebin, “On Basis of Philosophy of Law of Rights of Future Generations,” Inner Mongolia Social Sciences (Chinese Edition) 1 (2007): 36.

 

31. Brenda Almond, Exploring Ethics: A Traveller’s Tale, translated by Liu Yuli and Yang Zongyuan (Beijing: China Social Science Press, 2002), 244.

 

32. Kristin Shrader-Frechette, Future Generations and the Social Contract, P. Aarne Vesilind & Alastair S. Gunn, Engineering, Ethics and the Environment, translated by Wu Xiaodong and Weng Duanze (Beijing: Tsinghua University Press, 2002), 201-207.

 

33. Ibid., 204.

 

34. R. G. Wright, “The Interests of Posterity in the Constitutional Scheme”.

 

35. Publicity Department of the CPC Central Committee, Outline for Studying Xi Jinping Thought on Socialism with Chinese Characteristics in the New Era (Beijing: Xue Xi Chu Ban She, People’s Publishing House, 2019), 192.

 

36. Xi Jinping, “Towards a Community with a Shared Future for Human Beings”, People’s Daily, January 20, 2017.

 

37. According article 1009 of the Civil Code of the People’s Republic of China, “a medical and scientific research activity related to human genes, embryos, or the like, shall be done in accordance with the relevant provisions of laws, administrative regulations, and the regulations of the State, and shall not endanger human health, offend ethics and morals, or harm public interests.”

 

38. According to Amendment (XI) of the Criminal Law of the People’s Republic of China, “Whoever implants any genetically edited or cloned human embryo into the body of a human being or animal or implants any genetically edited or cloned animal embryo into the body of a human being shall, if the circumstances are serious, be sentenced to imprisonment of not more than three years or limited incarceration and a fine; or if the circumstances are especially serious, be sentenced to imprisonment of not less than three years nor more than seven years and a fine.”

 

39. According to article 16 of the Civil Code of the People’s Republic of China, “A fetus is deemed as having the capacity for enjoying civil- law rights in estate succession, acceptance of gift, and other situations where protection of a fetus’ interests is involved. However, a stillborn fetus does not have such capacity ab initio.”

 

40. The French Civil Code, translated by Luo Jiezhen (Beijing: Peking University Press, 2010), 2-5.

 

41. World Commission on Environment and Development, Our Common Future, translated by Wang Zhijia et al. (Changchun: Jilin People’s Publishing House, 1997), 52.

 

42. The rights of future generations are listed in the Declaration on the Rights of Future Generations in detail: future generations have the right to life; future generations have the right to avoid the manipulation of their human genetic inheritance, that is, not to be artificially altered... future generations have the right to allow them as a whole to live in substantial conditions of life in human dignity, and in particular, they have the right not to be forced to accept substantial changes deliberately produced by previous generations which will limit their individual or collective right to autonomy in cultural, economic, political or social fields.

 

43. Xu Ming, “Implementing the Biosafety Law to Protect Human Genetic Resources”, Chinese Social Sciences Today, May 19, 2021.