JIN Yulu*

 

Abstract: Whether the legitimate boundary of human genome editing is gene therapy or genetic enhancement is an issue of fierce debate. To safeguard basic human rights such as the right to autonomous development and personal dignity, and protection of the current human social ethics and moral outlook and natural evolution order, gene therapy should be permitted while genetic enhancement should be prohibited. After the boundary of the genome editing application category is clearly defined, the risk that social inequality may increase, the biosafety and damage risk and the privacy and personal information disclosure risk brought by human genome editing should be analyzed. Based on this, the legal approach to regulating genome editing should be to adopt an inclusive and prudent hierarchical supervision idea ensuring universal access to genome editing under the social permission theory. A human rights impact assessment system and an in-process framework for diversified risk evaluation and inclusive and prudent hierarchical supervision, determine a posterior attribution principle and dynamically standardize genome editing application order in a closed-loop way.

 

Key words: genome editing · ethics · morality · legitimate boundary · risk analysis · legal regulation

 

 

Genome editing technology is a technique of editing targeted genes to modify the gene expression and change the biological characteristics by enabling the knockout, knock-in and replacement of specific DNA fragments or a basic group method in a selected genome.¹ At present, genome editing technology is mainly developed and applied in basic research, animals, plants, microbial breeding and human medical science. In essence, humans have indirectly manipulated genes for over one thousand years. For example, plant breeding and animal domestication (from wolves to dogs) are all the process in which the genes of plants and animals have been changed.² Therefore, the genome editing technology applicable to new plant variety cultivation, animal disease treatment related to microorganisms, and basic research aiming to solve actual survival problems, such as food shortages, and facilitating the well-intentioned human reconstruction of the world that conforms to the morality of the human process of evolution is widely accepted. On January 10, 2022, the University of Maryland Medical Center successfully transplanted a genetically edited pig heart into a human body to cure a patient’s heart disease.³ This event aroused widespread concern over the application genome editing. 

 

As the CRISPR/Cas9 technology vitalizes genome editing technology,⁴ there is always a lot of debate over the genome editing technology regarded as “magic scissors” of human somatic cells that applies to the subject. The discussions of this paper will focus on the development pathway and legal regulation problems of contentious human genome editing technology. The human genome editing application has been classified into two categories: One category aims to treat and prevent diseases, i.e., gene therapy, and the other category aims to enhance genes for not-yet-being good traits, i.e., genetic enhancement. Genome editing can be used as gene therapy to solve existing problems. It can help mankind overcome the harassment and damage of viruses and solve some disease problems such as cancer in the interaction process between human and nature and the human evolution process. The genetic enhancement aiming to pursue not-yet-being traits by editing genomes can be theoretically used to improve human traits and functions, such as prolonging the human lifespan, enhancing human vision and improving human appearance. It can even be used to design perfect babies, create “new species” by using exogenous genes, etc.⁵ The technology advantage that can be used to break through biological boundaries is as attractive to people today as the “elixir of life” was to our ancestors. 

 

If genome editing technology is regarded as neutral and not related to values, it may possibly become either the Noah’s Ark or the nightmare of mankind. At present, there are three major viewpoints on genome editing: The first viewpoint completely opposes genome editing. It believes that neither gene therapy solving existing problems nor genetic enhancement used to pursue not-yet-being traits is applicable to human beings or can “match” any personalities of people.⁶ The second viewpoint completely approves genome editing. It believes that everybody has the right to limitless free autonomous improvement and both gene therapy and genetic enhancement should be permitted.⁷ The third viewpoint is a neutral optimistic viewpoint. It believes that science and technology development should increase social welfare and everybody has the right to pursue his own interests through technology.⁸ After all the ethics, moral principles, basic human rights such as the right to freedom of development and personal dignity,⁹ and social risks and other factors brought by genome editing are comprehensively considered, restricted support should be provided for genome editing.¹⁰

 

As for how genome editing should be developed and applied, Alexy’s so-called Law’s Claim to Correctness¹¹ requires the law to give a correct response and guidance to genome editing. This paper will first explore the just typological boundaries that genome editing application conforms to in the ethical and legal philosophy horizon, then analyze the legal and social risks that may be caused by genome editing application, and finally explore the legal approach to regulating genome editing based on clearly-defined typological boundaries of genome editing application. 

 

 

There are four plans for the application of two major genome editing categories in human society: Plan A: Both gene therapy and genetic enhancement are permitted. Plan B: Gene therapy is permitted while genetic enhancement is prohibited. Plan C: Genetic enhancement is permitted while gene therapy is prohibited. Plan D: Both gene therapy and genetic enhancement are prohibited. What is the legitimate boundary of genome editing application? What are the social and legal risks brought by genome editing application? To thoroughly research the legitimate categories and risks of genome editing application is the precondition for a legal position on and regulation of genome editing. 

 

 

 

(1) Genome editing conforms to the liberal idea of justice

 

The establishment of justice in the Republic of Plato, the dichotomy between distributive justice and corrective justice in the politics of Aristotle, the appearance of the social contract theory and the advent of the “veil of ignorance” are indicative of human society’s unremitting pursuit of fairness and justice and people’s boundless imagining of the social features expected from the viewpoint of fairness and justice. Genome editing has broken the ideal of fairness and justice in human civilization, and liberalist advocates have given a negative answer. 

 

The neo-liberalist eugenicists defined by Sander believed that to protect the personal ability to make unforced, free and autonomous choices and the personal right to unforced, free and autonomous selection is the fairness and justice that should be protected and maintained first of all.¹² Genome editing has, in essence, provided possible therapy options and self-improvement options for human beings. Gene therapy can better ensure both the right of a natural person to his or her body and the right of a natural person to his or her health. About 6,000 to 7,000 human genetic diseases have appeared in the human history. Genome editing can be used to treat many genetic diseases such as cancer, blood disease, loss of vision, acquired immunodeficiency syndrome, cystic fibrosis and Huntington’s disease and restore patients’ health.¹³ Because everybody may contract a disease, universal access to gene therapy can ensure everybody’s right to their body and everybody’s right to their health. Genetic enhancement can maximize the right of a person to free and autonomous selection. With the help of gene enhancement, people can prolong their lifespans and improve their quality of life. Genetic enhancement helps improve some human traits such as human vision, human stature, and human appearance. It can even be used to design a perfect baby. People can have the right to free and autonomous selection of their own traits and their descendants’ traits and their right to free and autonomous selection can be maximized. People should not be deprived of the individual right to free and autonomous selection of genome editing applications. Otherwise, it becomes an injustice against individual freedom.¹⁴

 

Meanwhile, Dworkin’s theory of “ethical individualism” has provided a legitimate basis for the application of genome editing technology. According to Dworkin’s ethical individualism, in the sense of morality, the individual rights to the realization of the potential energy of their life, improvement of their physical defects, the pursuit of their happiness, and interest maximization are both legitimate and unrestricted, and they conform to morality, fairness, and justice.¹⁵ Dworkin believed that “individual self-determination” should be the first principle of human social justice, and it provided a legitimate basis for all genome editing categories. Therefore, both personal treatment of his or her own diseases caused by the “unfair fortune” and personal genetic enhancement in pursuing higher not-yet-being traits should be permitted and protected. 

 

(2) Genome editing goes against free will and the fairness and justice in spontaneous order 

 

However, the idea of justice for the supremacy of freedom has not been agreed by some scholars. Habermas made a famous assertion: A person with edited genomes will not be the only author of his/her personal life history.¹⁶ Individual autonomy is more or less disturbed in the joint life “creating” process with the participation of other people. Therefore, genome editing will surely make individual autonomy fail to be completely implemented in the substantive meaning, and the individual will no longer be the only person responsible for his or her own life. The occasionality of life is the start of freedom and personal free will in the life and morality forms. Genome editing breaks the occasionality of “the Creator’s praises and rewards.” If the birth of a “person” is manipulated, it is impossible to define the free will and autonomous morality.¹⁷ Genome editing goes against the original purity of life. It disturbs the maintaining of the spontaneous order (non-designed order) posited by Hayek.¹⁸ According to this theory, personal natural birth in a non-designed order is the greatest fairness and justice everybody enjoys in the world. However, genome editing will obviously destroy the fairness of the occasionality in the birth of human beings. If some technology is used for social eugenics, human beings will be treated as the means for social progress in the desired direction of whoever employs the technology, no matter whether the technology application is forced by a government or selected by individuals, which goes against the basic human rights proposed by Kant based on morality.¹⁹ The European Parliament believes that cloned human beings in any form and human genetic modification technology violate both moral principles and the basic human right to personal dignity in compliance with the bottom line of personal dignity.²⁰

 

 

As we can see, except for the resistance to the old eugenics and fear of its results, the difference between the people who agree entirely with genome editing and the people who completely oppose genome editing comes from their different understandings of the origin of justice and their different criteria. Now, we may as well explore the justice of genome editing instead of the risks and drawbacks of eugenics. 

 

According to the idea of justice for personal dignity protection, the personal occasionality of birth is the origin of human equality in the state of nature. Therefore, equal human dignity which all human beings are endowed at birth is the first main idea. Human beings are treated as some means to optimize the society in genome editing, which greatly damages human dignity that has developed in the natural spontaneous order, affects the independent free will of contemporary people and the integral autonomous right of “future people”, and destroys the distributive justice. Therefore, genome editing should be prohibited. The people who agree with genome editing view genome editing from the angle of complete liberal justice. They believe that both the individual right to free selection and the personal right to autonomy are at the highest rank, and they should be maintained first of all. According to ethical individualism, to realize the potential energy of human life and maximize self-interest conforms to individual morality and justice. Gene therapy can be regarded as correcting the unfairness of personal life arranged by fate. At the same time, genetic enhancement can be viewed as the highest good in pursuit of happiness. Both gene therapy and genetic enhancement should be supported. Both the people who agree entirely with genome editing and the people who oppose genome editing stick to their views. The focuses of their dispute are: (1) whether the birth is a just starting point of justice and (2) whether personal dignity maintains morality and the justice of spontaneous order or pursues optimized results of interest and happiness improvement.

 

First, ethics, morality and justice view cannot be used to interpret the occasionality of birth very well. The fact and the philosophical problem are as difficult to answer and explain as the question “How did the universe come to be.” Therefore, because we cannot interpret and solve the essential problem about birth, we may well turn to the law and adjust the results brought by birth. Irregularity and the occasionality of natural birth randomly distribute human beings to different courses of life and different starting points. Examples are given here to show two different courses of life. For example, person A is born into a rich family and is physically sound and intelligent, while person B is born into a poor family, is born sick, and has average or low intelligence. Person A starts enjoying good health, high intelligence, and wealth as soon as he is born. He enjoys a high level of dignity and pursues self-fulfillment.²¹ Meanwhile, Person B is always accompanied by some diseases and pains that ordinary people never suffer, and he experiences difficulties throughout his entire life. The differing fortunes of Person A and Person B indicate that birth is not entirely equal and just. On the contrary, the difference in physical health, intelligence level, social class, wealth, etc. gained at birth is the most significant unfairness because the actual situation at birth cannot be changed. It causes people to live very differently. When some people are born sick and born in deplorable conditions, the distributive justice obviously does nothing to change the inequality. Justice and fairness should not let the unequal spontaneous order develop freely. Just as human communities and groups are formed to better resist risks, states are founded to ensure that every citizen will live happily and healthily. To redress inequalities at birth is what a state is formed to do. Therefore, as the technology used to redress social unfairness, gene therapy conforms to national-level justice and morality, and it should be supported. 

 

Second, except for utilitarianism and human rights view, the realization of personal dignity is a link that should be emphasized and carefully considered when “the life ethics triangle theory” is used to ensure complete implementation of genome editing.²² Genome editing can be used to free patients with diseases from suffering and make them live a dignified life like ordinary people, which maintains personal dignity. Based on equal personal dignity and free will, everyone should have the right to live a happy and decent life. Genome editing can be used to make human beings no longer suffer the pains and self-abasement brought by disabilities or diseases, and rid everyone of the unfair dignity brought by a disadvantaged natural birth, live a healthy and happy life and pursue the value of self-fulfillment. What genome editing can be used to do should be the best realization of personal dignity. It does not pursue the spontaneous unfair personality order brought at birth in the formal meaning regardless of some people’s suffering. Because people’s fates are unjust. To respect and protect every citizen’s basic personality and human rights (including the fundamental right to healthy life) requires social communities or states redress unfairness.²³

 

According to Sander’s “neo-liberal eugenics”, based on equality and liberalist thought, the human self-determination right to autonomous selection of their own values and purposes is the paramount equality and freedom.²⁴ The right should be regarded as one of the basic human rights and should be supported. John Muller has also proposed that everybody should be permitted to pursue his or her freedom of personality for self-development as long as the person does not interfere in others’ interests.²⁵ Therefore, if there are some diseases that are unfair to some people, no matter whether the diseases are acquired diseases such as viral diseases and cancer or congenital diseases, patients with the diseases should have the right to use genome editing therapy and the right to live a healthy and happy life based on maintenance of fairness, justice, the human right to free and autonomous selection, as well as personal dignity. Usually, countries with the Anglo-American Law System agree with the above-mentioned opinion, which is entirely different to the opinion of the European Union. In 2015, British House of Lords approved a bill that permitted the application of the “three-parent” technology in clinical tests to prevent a parent from passing genetic diseases such as mitochondrial diseases on to babies.²⁶ The British and American political philosophers generally agree to the application of the genome editing technology for the treatment of genetic conditions. 

 

Finally, we come to the fear and horror of the old eugenics issues and consider whether genetic improvement is legitimate. With the coercive force of a state, eugenics has been abused in the past on racial grounds,²⁷ so that the people who oppose genome editing regard the application of genome editing in human body as a tool for the improvement of a society via selective application and seek to prevent genetic discrimination from becoming racial discrimination. Their concern over genome editing makes sense. If genetic enhancement is permitted, it will be possible to design babies, prolong the human lifespan and enhance human intelligence, vision and appearance. Human gene diversity will disappear, and all human beings will become the same. If things continue this way for long, disappearance of genes will cause traits to disappear, and finally some human races and groups will perish. Meanwhile, genetic enhancement entails tremendous moral and ethical risks, including challenges of “manmade human beings” to “natural human beings.” In addition, the existence of “designer babies” will cause one kind of subjects (babies) to become tools of another kind of subjects (parents) for achieving self-value.²⁸ The right to freedom, the right of “future people” to autonomy and the right to selection of “future people” will be restricted and infringed by application of genetic enhancement. Personal dignity of some people will be restricted, and the people will be deprived of personal dignity. 

 

The widespread application of compulsory education and the internet, and the advent of medical cosmetological techniques have caused people to move towards the mainstream and gradually pursue the aesthetics. However, it is also possible that the complete liberalist value may accept autonomous enhancement of human traits such as human intelligence and appearance through genetic modification. The acceptable self-improvement should still be postnatal treatment and adjustment instead of birth modification and enhancement. The beauty of life lies in uncertainty and an infinite number of possibilities. Just as people do not admire well-designed lives and lifestyles, superbabies designed by people through genome editing have obviously been deprived of the beauty of life expectability. With the rapid development of technology, the development trend of future value is unpredictable. Based on current morality and ethics, maintaining of biological order, and conservation of the right of future people to autonomous selection and respect for personal dignity and free will, genetic enhancement such as designing babies and human trait optimization should be prohibited lest the mistakes of old eugenics will be repeated. The American Human Genome Editing Committee has explicitly agreed to genome editing therapy and opposed the application of genome editing in genetic enhancement in any form in its research report Human Genome Editing: Science, Ethics and Governance.²⁹

 

 

It can be known from the above analysis that Plan B for genome editing application adopted in human society, i.e., gene therapy permission and genetic enhancement prohibition, is the legitimate boundary of genome editing application that conforms to ethics, morality and justice. The balancing of complete openness and a complete prohibition of genome editing still has some social and legal risks to some extent. The common risks of genome editing application are as follows: the risk that it be used as a tool to produce new inequality categories in society; the moral and ethical risk caused by some genetic enhancement application due to the unclear boundary between gene therapy and genetic enhancement; the risk cost of some damage caused in some genome editing technology research and development process such as genetic mutation; the bio-safety risk in a genome editing application process such as a manmade disease risk brought by some off-target effect; the genetic and biological diversity reduction risk, such as the risk of causing genetic discrimination and eliminating biological diversity; the risk of disclosure of personal genetic information and privacy in the personal genetic sample collection, editing, storage and destruction processes of gene therapy, etc.³⁰ To put it bluntly, the typical risks of genome editing application are the risks of intensifying social inequality, biosafety damage and disclosure of personal genetic information and privacy. 

 

 

Equality originates from the fact that people equally acquire the interests needed in pursuit of a happy life.³¹ Genome editing can be used to redress the inequality caused by fate through treatment of genetic conditions and disease, which turns the technology and tool attribute of genome editing into genome editing “power.” When the “power” of genome editing is used to achieve substantial justice and is equally distributed to the people who need it, it can be used to maintain the fundamental rights of each citizen to be equally exempt from disease, maintain physical fitness and live a happy life in the real world. If the genome editing technology is regulated and controlled by the market, the scarce high-end technology or “power” will be inevitably transferred to social elites. The existing social inequalities in the opportunity and resource aspects will rapidly extend to inequalities of genome editing, influenced by the Matthew Effect. The social inequality will transform from the traditional inequality in wealth and opportunity to the inequality in genome editing power, etc. The former may be related to the difference in the social resources, wealth and social status that people enjoy, and people’s pursuit of higher needs on the precondition that their basic survival conditions are met. Once the latter appears, it is directly related to whether people can equally and fully enjoy personality equality and personal dignity of a happy life as human beings like any other people in the real world. The latter inequalities physically classify people into different categories in essence. Therefore, if the allocation of genome editing “power” is out of balance, severer inequalities will appear between the people with genome editing power and the people without it. The enlarged social inequalities are closely related to the fundamental human rights such as the right to survival. Except for the inequalities caused by whether genome editing can be equally applied, the inequalities of genome editing power include the inequalities of genome editing technology power, such as inequalities in the efficiency when genome editing is applied, inequalities in incomplete editing (mosaic phenomenon) caused by different instruments or techniques, inequalities in the accuracy of genome editing targets, inequalities in the off-target probability, etc.³²

 

 

The biosafety risks brought by genome editing can be classified into two aspects: The first aspect is the biosafety risks represented by man-made genetic diseases caused by the off-target effect of genome editing technology itself or genetic mutation. The second is the biosafety risks represented by the genetic changes in human reproduction and genetic order that may occur in an intergenerational genetic process.³³ The biosafety risks brought by genome editing are accompanied by the risks of potential damage to human body. 

 

To ensure the healthy and stable development of biological technology is one of the aims of China’s Biosafety Law and it is also one of the fundamental principles advocated by all countries of the world for genome editing regulation. For example, both the American Biosafety Committee and the National Health Research Institute have pointed out in their policies and guidelines that applications of genome editing technology must guarantee the safety and harmlessness of the technology.³⁴ The potential safety risk of genome editing technology itself is the off-target effect of genome editing technology, which is also called collateral damage. The potential safety risk of genome editing technology refers to the possible harm caused by off-target editing genes when genetic modification accidentally occurs in a non-expectant DNA area and the harm that cannot be seen by observing the receptor but may cause damage to offspring of the receptor,³⁵ including the transformation from normal cells to malignant cells caused by accidental off-target, man-made genetic diseases caused by genetic mutation and other biosafety risks.³⁶

 

Another biosafety risk of genome editing comes from mosaic embryos. Mosaic embryos may produce the biosafety risk of human genetic order being modified and unknown dangerous traits being designed. If the genes edited as planned constitute only a part of the embryos being cultivated and not all the embryos have been edited, mosaic embryos will be produced. The mosaic embryos are a mixture of edited DNAs and the original DNAs that have not been edited. When mosaic embryos are used to treat corresponding diseases, they may prove to be successful and the descendants of the individuals with some genetic diseases may have normal traits. In the growing process of the children who have been treated with gene therapy, however, cell division and cell differentiation are constantly carried out in the mosaic embryos and there may be some risks that some unknown genetic mutation may occur and some unknown diseases or traits be produced. Mutated mosaic embryos may be passed on to numerous descendants in the reproductive and genetic process of individuals who have been treated with gene therapy. Genome editing has the risk of disturbing the normal human reproductive order safety in the intergenerational genetic process.³⁷ At present, there are no accurate conclusions about the off-target rate of genome editing, the probability of mosaic embryos, or the biosafety risk occurrence probability in the genetic process, etc.³⁸

 

 

It is necessary to acquire the genetic information about patients and donors in the practical operation process of genome editing technology research and treatment. Genes are in fact DNA fragments with genetic information. All the personal genetic information about a patient can be extracted and acquired by using some technical means as long as the corresponding DNA fragments are acquired. UNESCO has defined personal genetic information (data) as information containing personal genetic characteristics acquired through nucleic acid tests or other scientific analysis means in the supplemental document of its Universal Declaration on the Human Genome and Human Rights.³⁹ Gene management and control institutions have abundant personal genetic information, including biological recognition information and personal genetic information about donators and patients. Once personal genetic information is disclosed, the disclosure will cause patients and donors who have provided genes to suffer irreparable privacy infringements or even lead to genetic discrimination against gene providers. Therefore, besides dealing with the risk of intensifying social inequality and the risk of biosafety and damage, all countries have always mentioned the regulation of risks of disclosing privacy and personal genetic information when they prepare laws to regulate genome editing.⁴⁰ To carry out genome editing, relevant institutions can acquire identifiable personal privacy information and identifiable gene samples.⁴¹ Improper usage, storage and disposal of gene specimens and anonymized gene samples whose identifications and codes have been removed contain risks of disclosing privacy and personal genetic information. 

 

 

In the horizon of ethics and legal philosophy, the neo-liberalist eugenics described by Sander and the improved viewpoint of Dworkin’s ethical individualism believe that a happy society should endow everybody with the right to pursue the maximization of self-interest and development. Mankind always enjoys achievements brought by constant development of technology, which has helped mankind enter one new era after another. The benefits brought by machines of the industrial society are obvious and the machines have liberated man from heavy physical work. Internet technology has greatly changed the physical world, brought a lot of convenience and facilitated the communication and sharing of knowledge and sharing. Therefore, the benefits of internet technology are supported and approved. Similarly, because genome editing can be used to treat human diseases and restore patients’ health, genome editing technology should also be supported. Viewed from the angle of human free will, Habermas believed that the impact of genome editing as the technology interfering with the life operation and planning of descendants should not be greater than that of the random free combination of human genes in the human evolution process. Conforming to ethics and morality and respect for natural biological laws, we should prohibit improvement and creation of not-yet-being traits and unknown genes, such as the design of new superbabies. 

 

The dispute over justice of genome editing application categories has been going on for a long time. Based on the corrected justice theory, human free will and fundamental human rights should be maintained. This paper agrees that genome editing should be used to treat the genetic diseases that are rare to the public, including the genetic diseases that can be passed on to descendants by a parent, to resist and redress the fates that cause unfairness and injustice to some people. This also helps people enjoy the benefits brought by technological innovation and helps people have the right to pursue a happy life. 

 

Therefore, according to the current technology development level, morality, and ethics, the law should allow genome editing to be used to treat existing human diseases and modify defective genes and prohibit genetic enhancement for not-yet-being gene or trait optimization such as designing “superhuman organisms,” which is both the technical outlet and the legitimate boundary of the genome editing application in the human body. The genome editing application plan with this justice still contains some risks such as the risks of new social inequality categories, biosafety, biological damage and disclosure of privacy and personal genetic information. To ensure that the genome editing application risks are under control, then we discuss the legal regulation approaches for typical risk categories of genome editing applications. 

 

 

After the legitimate boundary of genome editing is clarified, how to ensure the Pandora’s box of genome editing is opened to a controllable range and direct genome editing technology to do people good according to the risks brought by feasible genome editing technology application is the proper response of law to the application of genome editing technology. Based on the overall thinking about definite legal regulation of genome editing, the legal regulation approach of genome editing can be used to design a legal system matching the application of genome editing and carry out the prior, in-process and post-event comprehensive dynamic regulation. 

 

 

 

Just as governments ensure that every citizen can equally enjoy benefits brought by new technology, benefits brought by genome editing technology should be fairly distributed among the people who need it.⁴² Universal acquisition of genome editing should be ensured and genome editing should be prevented from intensifying social discrimination and inequality. All inventions (new technologies) have their potential social responsibilities.⁴³ Genome editing technology can be provided for every social member who needs it to treat his or her disease, which is what genome editing, with social responsibilities, should do under the social permission theory. The social permission theory originated in the mineral industry in the 1990s. it was originally designed to endow a community with some permission “power” so that the community could permit or refuse the operation of a program or project, and the enterprise of the project should assume some social responsibility if it acquired the permission.⁴⁴ This theoretical basis originated in corporate social responsibility.⁴⁵ Then, the social permission theory was gradually applied and developed in many industries, such as alternative energy industry, agriculture, banking industry, insurance industry and medical industry. Whenever some highly controversial projects or applications of technology are considered, the social permission theory is adopted as an infrangible principle by relevant government departments while they stipulate laws and policies.⁴⁶ Under the social permission theory, enterprises should make persistent promises to the society. They should promise that their behaviors will conform to morality and guarantee the welfare of all social members while they make contributions to the economic development. It is regarded as one of the three major core principles that new technology development should conform to the social permission theory in Universal Ethical Code for Scientists.⁴⁷ It is emphasized that technology should conform to social morality and ethics, as well as take the social responsibility of benefiting all members of society and improving social welfare after being permitted by society. 

 

When the law is used to regulate the ethical, moral and inequality risks accompanying genome editing, the social permission theory should be applied as the fundamental theory for the regulation. Under the scope of this theory, states should take some measures. For example, states should issue some laws and decrees so that genome editing technology bear the social responsibility of guaranteeing the rights of all social members to body and health and ensuring that genome editing can be universally acquired by the public and fairly distributed among all those who need it, instead of being controlled by a handful of elites. Such measures can resolve the social inequality risks brought by genome editing power. 

 

 

To reduce the potential ethical, moral and biosafety damage risks, the European Union and the United States have adopted different supervision ideas. The European Union has adopted a process-based supervision mode, emphasizing prior and in-process timely and effective supervision of the whole genome editing process. The US has adopted a product-based supervision mode, believing that the important thing is supervision of the genome editing results, and it mainly assesses final product risks and supervises biosafety and other risks.⁴⁸ The supervision ideas of European Union and the US are very different. The difference is mainly reflected in their deontology, consequentiality and ideas on inclusive and prudent supervision. The idea of the European Union mode emphasizes that genome editing applications should conform to the moral framework, all the risks of the whole genome editing implementation process should be supervised and they should be under a controllable range. However, the starting point of the regulation of the US mode is the result (product) compliance, and the US mode believes that genome editing should not be improperly interfered with, and the technology development should not be hindered as long as no negative results are produced. 

 

In consideration of diversity and complexity of the risks in genome editing technology, genome editing applications should be classified into different risk levels. A prudent or inclusive supervision idea should be adopted in the classification. In terms of the division of gene therapy and gene enhancement technology, biosafety risk management and other issues in genome editing, which are related to social ethics and the order and safety of the entire human evolution and reproduction, extremely prudent regulatory attitude should be adopted. Before any genome editing technology is applied, what genome editing technology is used for gene therapy and what genome editing technology is used for genetic improvement should be decided according to the relevant standards. Genome editing should be given close attention and be carefully supervised throughout its application to ensure that genome editing is operated and carried out legitimately and it conforms to ethics and morality and guarantees that dangerous genetically-edited cells or man-made genes produced due to off-target effect or genetic mutation will be timely destroyed and completely removed. At this moment, the openness and transparency of genome editing applications should be guaranteed and the public participation in applications should be ensured,⁴⁹ that is, the scope and standards of genome editing technology applications should be open to the public and genome editing operations should be timely and openly reported to relevant special supervision departments. As for the scientific research and technology development risks of gene therapy technology on the precondition that the gene therapy technology conforms to ethics and morality, such risks are the isomorphism development trials of individuals and community with a shared future for human beings⁵⁰. An inclusive regulatory strategy should be adopted for research and development of gene therapy technology. If gene therapy technology is regarded as neutral and not related to values, sufficient space should be offered for the development of gene therapy and the biosafety risk coefficients of products generated due to things like technical reasons should be evaluated. Therefore, the prudent and inclusive supervision idea emphasizes hierarchical supervision and regulation. 

 

 

After the potential risks of privacy and personal information infringement in genome editing are understood, the privacy and personal information protection should be strengthened in the whole genome editing process from genetic specimen acquisition and personal biological identification information extraction and application to personal genetic information and genetic biological samples, so as to ensure that the handling of genetic specimens and personal privacy information is open, transparent, confidential and secure in the genome editing process. First, things such as the acquisition and usage of genetic specimens, extraction and usage of personal biological information should be explicitly approved by the gene providers. Gene providers should have the right to know the usage of their genes, genome editing means and measures adopted, and all the categories and contents of the personal privacy information that relevant medical institutions or handling institutions are going to acquire. Second, the genetic information acquired through gene specimens should be kept confidential and stored well. The storage sites, storage time and confidential measures of the genetic biological specimens and personal genetic information should be open to the providers. Finally, after the genome editing is completed, how the remaining samples are disposed of and destroyed should be informed to the genetic specimen providers. The disposal and destruction should be safe, harmless, complete and non-traceable. Thus, the samples cannot be recycled by any other organizations, genetic specimen providers cannot be traced, and their privacy and personal information cannot be infringed. 

 

 

After the risks brought by genome editing are analyzed and the overall idea about legal regulation of genome editing risks is determined, the whole dynamic closed-loop process of genome editing, including the prior, in-process and posterior operations, can be analyzed. A law system related to genome editing should be established. The whole system includes the prior human rights impact assessment (HRIA) and the common carrier, the in-process diversified risk evaluation and hierarchical supervision system, as well as the posterior responsibility bearing system of genome editing damage. 

 

 

In order to ensure that genome editing can be universally acquired by social members under the social permission theory, both the human rights impact assessment and the common carrier should be introduced to regulate genome editing acquisition. In 1994, Gostin and Mann first introduced the human rights impact assessment (HRIA). Human rights impact assessment refers to assessing whether technology will have adverse effects on the human rights of citizens when the technology is put into use and the permission-based universal social responsibility.⁵¹ In the genome editing regulation, human rights impact assessment is established to assess whether genome editing application will cause social exclusion, that is, whether genome editing will guarantee the fundamental rights of all social members without discrimination. Genome editing can be placed into the market after it has undergone the HRIA test. A precondition for HRIA application is to recognize gene therapy as a fundamental human right. When people with chronic diseases such as hearing disorder, vision disorder and mental retardation believe that they deserve to live continuously and social reality has yet reduced their values, they have the basic right to use gene therapy to redress their unfair fates.⁵² Before each genome editing technology aiming to treat diseases starts to be used, it should undergo a test of the HRIA mechanism. First, an independent genome editing application standard commission should be established, and the commission should determine what condition and status genome editing is applicable to, and how to distinguish between gene therapy and genetic enhancement in the genome editing application, that is, a definite genome editing application standard should be established to decide whether some genome editing application belongs to gene therapy or genetic enhancement so that it conforms to the social ethics and morality and it is approved by society. Second, it should be ensured that every genome editing technology that has been put into use will guarantee the implementation of the fundamental human rights of all social members, such as the right to survival and the right to health without discrimination. To put it bluntly, HRIA aims to guarantee that all social members will enjoy their fundamental rights, such as the right to the body and the right to health, by acquiring genome editing without discrimination. 

 

After HRIA is introduced to ensure that people can enjoy the fundamental right to genome editing, a common carrier should be established for genome editing regulation to ensure that genome editing can be universally acquired. The concept of common carrier originated in countries with the Anglo-American law system. It is mainly applied in the public utility field, such as the public transportation field and the water, electricity, and gas fields. The core of a common carrier is service. A common carrier should provide services of the same quality for all social members without discrimination.⁵³ The common carrier introduced in the genome editing regulation should guarantee that genome editing is provided as some public medical service or by establishing a special fund and giving some financial support,⁵⁴ it is provided for all social members indiscriminately and without discrimination. The common carrier should ensure that all social members can universally acquire genome editing treatment. 

 

 

In order to reduce the biosafety risk of genome editing technology and the privacy and personal information disclosure risk, a framework for diversified risk evaluation and inclusive and prudent hierarchical supervision should be established. When the framework is established, the framework should not only match the biosafety risk prevention and control system specified in the Biosafety Law of the People’s Republic of China and give more detailed information than the biosafety law, but also unify the standards and supervision rules on genome editing specified in China’s existing laws and regulations, such as the Administrative Regulations on Human Genetic Resources of the People’s Republic of China and the Ethical Guidelines for Human Embryonic Stem Cell Research.⁵⁵

 

To be specific, in the diversified risk evaluation mechanism, different modes of diversified risk evaluation have been established according to various evaluation categories. The evaluation mainly includes the ethical and moral risk re-evaluation in the genome editing operation, the technology safety and biosafety risk evaluation and the risk evaluation of privacy and personal information disclosure. The risk evaluation mechanism dynamically carries out evaluation in real time according to diversified standards in the whole genome editing operation process. It ensures that all requirements of the ethics, morality, technology safety, biosafety, privacy and personal information protection are met in the whole genome editing operation process. It also makes corresponding adjustment or correction or stops the genome editing according to the degrees of excessive risks when it is found that some requirements are not yet met. The core of the prudent and inclusive hierarchical supervision framework is to classify different risk problems of genome editing into different levels and adopt different supervision strategies. As for conforming to morality and human cell editing biosafety problems, more prudent supervision should be emphasized, openness, transparency, and public participation should be required in the whole genome editing operation process, and they should be closely supervised. Suppose morality is conformed to solve gene therapy technology research and development problems, etc. In that case, a more inclusive supervision idea should be adopted, sufficient space should be offered for the technology development, and genome editing products should be emphasized more vigorously. 

 

If a supervision organization needs to be established under the framework of diversified risk evaluation and prudent and inclusive hierarchical supervision, a special commission should be set to carry out the supervision work, and the commission should be further divided into different departments, such as ethics department, technology department, and law department to evaluate various risk problems. For example, the American Society of Gene & Cell Therapy and Japan Gene Therapy Association are organizations that evaluate, test, and examine ethical and moral risks, technical risks, efficiency, safety, etc., in a unified way in a gene treatment process.⁵⁶ The Association for Responsible Research and Innovation in Genome Editing has been divided into two mutually-independent camps. Technical experts and scientists offer advice on biotechnology problems, while ethics experts, sociology experts and legal experts formulate criteria to solve social, ethical, moral and legal problems.⁵⁷ As for specific genome editing supervision in China, to establish a unified risk evaluation and supervision organization, different discipline talents at different levels should be recruited according to the diversified risks.⁵⁸ Three different commissions should be established to solve the ethical, moral, technical and biosafety problems and the privacy and personal information protection problem. 

 

 

The damage of genome editing technology application mainly includes diseases and health damage caused by off-target effect, health damage of descendants caused by gene therapy and infringement of the rights to personal privacy and personal information. The relief afterwards for damage caused by genome editing should be determined according to whether it is the damage caused by genome editing technology itself or the collateral damage caused in the genome editing operation process and the category of the damaged right. If the rights to body and health are damaged by genome editing technology, the principle of no-fault liability (gefährdungshaftung in German) should be adopted. In Germany, the fields that have adopted the gefährdungshaftung in a legal form mainly include aviation, railways, high-voltage power lines, nuclear energy and gene technology.⁵⁹ The introduction of no-fault liability or gefährdungshaftung aims to reasonably distribute “unfortunate damage” caused by some necessary but high-risk social behaviors, services or technology instead of cracking down on any unlawful act.⁶⁰ Gene therapy brings great social welfare to human society. The increase of the great welfare has made research, development, constant trials and application of genome editing technology approved under the social permission theory. However, genome editing technology contains tremendous risks while also offering huge benefits. To legally regulate “unfortunate damage” caused by the application of genome editing technology conforms to the basic idea and legal principle basis of gef?hrdungshaftung. Therefore, gefährdungshaftung, i.e., no-fault liability, should be adopted to deal with damage caused by genome editing itself. The collateral infringement of privacy and personal information that occurs in the operation process of genome editing is different from the damage caused by applications of genome editing technology itself. The collateral infringement of privacy and personal information is caused by improper collection, handling or storage of personal genetic information, or improper sample use of the gene sample institutions. In consideration of the absolute information handling and storage “power” of genetic information institutions, the tremendous damage to individuals after information disclosure, difficulty of obtaining evidence for improper operation or storage by individuals, etc., presumed fault liability should be adopted. 

 

 

The history of human evolution is a history of progresses in which human beings constantly invent and create new technologies, change the world and pursue the maximizing of their own interests. It is obvious that technology has promoted human civilization development and greatly increased the social welfare. The interactive boundary between technology and human beings has been constantly adjusted and re-determined under different moral and ethical ideas in different eras. How the future rapid development of technology will promote the development of human ethical and moral ideas and human values cannot be known. The response to and correct guidance of law to genome editing is to discuss the order adjustment of human society with the participation of genome editing based on the current technology background and values. 

 

According to the neo-liberalist eugenics described by Sander, Dworkin’s ethical individualism and the corrected justice theory, everybody has the right to self-interest maximization pursuit and unfair fate correction through gene therapy. In comprehensive consideration of free will and the autonomous ethical ideology of Habermas, Kant’s defense for the rights of future people to freedom and autonomy and personal dignity, Hayek’s idea on spontaneous order maintenance, etc., genetic enhancement should be prohibited. Out of conservation of the current human social ethics and morality, respect for the rights to freedom and autonomy and maintenance of human rights, this paper thinks that the current legitimate boundary of genome editing application is to permit gene therapy and prohibit genetic enhancement. 

 

After the legitimate boundary of genome editing is determined, as for legal regulation approach of genome editing, we should first learn that genome editing intensifies social inequality, leads to biosafety risks, damage risks and risks of privacy and personal information disclosure. Second, the basic idea of legal regulation of genome editing should be to ensure universal social access, carry out inclusive and prudent hierarchical supervision, and strengthen privacy and personal information protection. Finally, we should establish a prior human rights impact assessment and a common carrier, an in-process framework of diversified risk assessment and inclusive and prudent hierarchical supervision, as well as a posterior no-fault and fault presumption principle of attribution regarding genome editing. Thus a good order for the application of human genome editing can be ensured. 

 

(Translated by LIU Zhao)

 

* JIN Yulu ( 靳雨露 ), Doctoral Candidate of the Law School of Beijing Normal University. This paper is a phased achievement of both Research of the Theory of Legal Principles in the Modern Hermeneutic Horizon (Project Approval No. 21AFX003) of the National Social Science Fund of China and the 2021 Annual Special Scientific Research Fund for Academic Postgraduates (Project Approval No. 2021LAW005), Law School, Beijing Normal University. 

 

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