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CHINA LEGAL SCIENCE 2019年第6期 | 我国人类基因组编辑研究和应用的法律规制
日期:20-03-28 来源:CHINA LEGAL SCIENCE 2019年第6期 作者:zzs

THE PERFECTION OF LEGAL REGULATION OF HUMAN GENOME EDITING RESEARCH AND APPLICATION IN CHINA


Xiao Peng


TABLE OF CONTENTS


I. INTRODUCTION

II. ANALYSIS ON THE BENEFITS AND RISKS OF HUMAN GENOME EDITING RESEARCH      AND APPLICATION

A. Benefits Involved in Human Genome Editing Research and Application

B. Risks and Problems of Human Genome Editing Research and Application

III. LEGISLATION STATUS AND DEFICIENCIES OF HUMAN GENOME EDITING                      RESEARCH AND APPLICATION IN CHINA

A. The Status of Legislation

B. Deficiencies in Legislation

IV. INTERPRETATIONS OF MAJOR FOREIGN LEGAL TEXTS OF HUMAN GENOME                EDITING RESEARCH AND APPLICATION

A. Major Legal Texts that Regulate Human Trials, Human Rights Protection and                Human Genome Editing

B. Positions on Germline Genome Editing Mirrored by the Legislation of Countries             around the World

V. IMPROVEMENT OF CHINA’S LEGAL REGULATION ON HUMAN GENOME EDITING          RESEARCH AND APPLICATION

A. Clarifying the Guiding Thought, Basis, Principles and Models of Legislation

B. Formulating the Human Genome Editing Safety Law and Improving the Regulatory      System and Mechanism

C. Establishing and Improving Relevant Systems

VI. CONCLUSION


In terms of applied research and clinical practice, human genome editing can be generally divided into somatic genome editing and germline genome editing, in addition to basic research. Genome editing is performed in somatic cells for prevention or treatment of illnesses or disabilities, which is of great benefit to humans and poses relatively small risks. Genome editing is performed in germline cells for prevention or treatment of illnesses or disabilities and genetic enhancement, which is expected to produce great benefits, but may bring about technological, ethical, legal and even social risks and problems. One good example is that the world’s first genetically modified baby twins have aroused considerable controversy around the globe. There are quite a few deficiencies in the legal regulation of human genome editing research and application in China, therefore China needs to clarify the guiding thought, basis and principles of legislation by referring to relevant foreign legislation and considering China’s practicalities, formulate the Human Genome Editing Safety Law, establish and improve the regulatory mechanism as well as pertinent systems, and strengthen legal regulation.
 
I. INTRODUCTION
 
Human Genome Editing, also referred to as human gene editing, is the technologies that enable scientists to edit DNA, leading to changes in physical traits, like eye color, and disease risk, etc. By utilizing these human genome editing technologies, it is possible to locate and cut DNA at a specific spot and then add, remove, or alter genetic materials at particular spots in the genome, so as to treat diseases or fix genetic defects, etc. Currently, CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9), a site-specific genome editing technology, is becoming increasingly popular as a result of its simplicity, quickness and affordability, etc. Human genome editing consists of three main parts: basic research, including basic scientific experiments involving genome editing of somatic cells and germline cells; somatic cell genome editing, mainly used for the treatment or prevention of diseases or disabilities; germline genome editing, used for the prevention or treatment of diseases or disabilities and genetic enhancement.

As a breakthrough technology, human genome editing generates health benefits, but at the same time it gives rise to technological, ethical, legal and even social risks and problems. This is exactly why the two gene-edited babies not only engendered great controversy around the world, but also brought human genome editing to the public’s attention. This article aims to explore how China can improve its legal regulation of human genome editing research and application by investigating the gene-edited baby controversy.
 
II. ANALYSIS ON THE BENEFITS AND RISKS OF HUMAN GENOME EDITING RESEARCH AND APPLICATION
 
A. Benefits Involved in Human Genome Editing Research and Application
 
Compared with the traditional approach which selects appropriate treatment based on the general biological characteristics of humans, genome editing technologies personalize treatment based on patients’ genomes to provide targeted therapy so that better curative effect can be achieved. There is a successful case of somatic gene therapy. After decades of gene therapy research and clinical experiments, it is widely acknowledged that if it has been proven safe and effective to cure one’s disease by editing his or her somatic cells, then this treatment should be encouraged. Genome editing helps to treat incurable diseases such as AIDS and cancer, and can eradicate diseases on a large scale to improve people’s health and prolong one’s life expectancy, which is equivalent to great health benefits to humans. Therefore, the 13th Five-Year Bioindustry Development Plan stipulates that China needs to accelerate the development of precision medicine.

Through the germline gene editing, it is possible to prevent or treat the offspring’s diseases, which are genetic diseases from their family or other gene-related diseases. In the future, provided mature technologies, germline genome editing, similar to the operation that the two gene-edited babies received, will be able to prevent or treat disabilities before babies are born, on the premise of observing laws and regulations. Genetic enhancement refers to the procedure of providing people with superhuman traits or capabilities by virtue of germline genome editing. There might be two purposes: one is medical, like selecting longevity genomes from the genome pool and inserting them into someone’s genomes to extend his or her life; the other is non-medical, such as changing one’s skin colors, increasing his or her height and improving his or her running speed. Hence, parents can capitalize on genome editing technologies to choose genomes with traits or capabilities they like to design their children. This technology is thus called ‘the scalpel of God’. 

Human genome editing research and application are loaded with deep social and legal values: one is to satisfy the value pursuit of human beings to relieve suffering and enjoy life; the other is to satisfy the value pursuit of human beings to expand their independent choice of life and enhance the physical and mental foundation of a better life.
 
B. Risks and Problems of Human Genome Editing Research and Application
 
Compared with benefits, what technological, ethical and legal risks and problems human genome editing, especially germline genome editing, could give rise to, receives more attention from people.

1. Technology Security Risks. — Human genome editing technologies are still immature, and the risks are uncertain. Genome editing in somatic cells can only modify patients’ immune cells and not affect their germline cells, which means that only patients themselves rather than their descendants will be affected if the editing is not successful. This can be deemed as the firewall of genome editing technologies. Nonetheless, it is not the case with germline genome editing because it is aimed at changing genomes, suggesting that it will not only influence patients’ children, but also those children’s offspring thanks to the modified genomes in their bodies, and finally affect the mankind by altering the genome pool of humans. There are also risks in operations. For instance, the genome to be deleted might possess functions that have not been identified yet. Even if one genome is currently believed to be the trigger of a disease, it might be found to be able to prevent an illness in the future. After it is deleted, gene-edited babies might suffer from unexpected physical and mental problems, etc. In addition, there is a high risk of off-target mutations. Off-target editing means that genomes that should not have been edited haven been edited wrongly and therefore genomes off the target are modified, which easily causes damage to irrelevant genomes in human bodies that used to be normal and leads to serious risks of genetic diseases that are hard to precisely diagnose. For example, if one of the gene-edited twins has not been successfully edited, she will still be subject to the same risks as her sister is. Moreover, it is hard to detect off-target genetic modifications in the embryo stage, but everything will be too late after the babies are born. They will grow up, get married and have their children. Because their germline DNA will be passed down to all future generations, any harmful changes in the genome will be as well, including changes caused by off-target gene editing. Before these security problems are tackled, any action of performing genome editing in germline cells or creating genome-edited humans will be extremely irresponsible. In April 2015, Huang Junjiu and his colleagues from Sun Yat-sen University made an attempt to perform genome editing on human embryos, which is believed to be the world’s first publicly reported genome editing event. Though it did not go any further than nonviable human zygotes, it still provoked widespread discussion around the world. The case of genome-edited twins was even more controversial. 

2. Legal Interest of Survival and Dignity of Humans. — There might be conflicts between the business interests of stakeholders and the health of research subjects in the process of editing subjects’ somatic cells. If business interests take precedence over the health and even the legal interest of survival of subjects, there is bound to be disastrous consequences, which can be illustrated by the first case of death from experimental gene therapy in the US that could be directly attributed to a conflict of interests. In the meantime, the objects involved in germline genome editing are human embryos or germ cells that have the potential of developing into humans, which brings inevitable ethical issues. The legal status of human embryos, as is stated in the law of the Oklahoma State of US, is that embryos enjoy the same legal status as newborn babies, based on which it can be concluded that violating embryos equals the violation of human rights. Nevertheless, when the legal status of embryos is not clear, ethical and legal problems easily occur. For example, when researchers edit genomes of human embryos, they need to cut embryos and destroy the remaining embryos. Can that be deemed as disrespect to human dignity and a violation of the legal interest of survival? The most crucial thing is that the dignity and legal interests of gene-edited babies must be fully considered. In the gene-edited baby controversy, people were more concerned about the twins’ future instead of technical problems. Some people advocated that they should be confined, and some believed that they should not get married and bear children.

3. Informed Consent and the Intergenerational Proxy Consent of Elder Generations Rather than Their Offspring. — Informed consent is a basic principle of human trials around the world. It is a process where researchers inform research subjects about the experiment, obtain their consent and ask them to sign informed consent forms. In somatic genome editing, the major problem is whether subjects are completely autonomous, fully informed, and fully expresses their willingness. If not, then there is an ethical issue. According to relevant regulations in China, there is still the question of who is the subject of informed consent. For instance, the Guiding Principles on Human Gene Therapy Research and Preparation Quality Control Technology stipulates that the treatment shall only begin once the patient and his or her family have a full comprehension and sign on the informed consent form. This results in problems such as who is the subject, the patient or the family? Whose opinion should be listened to if there is disagreement between the patient and his or her family? Furthermore, when it comes to germline genome editing, it is germline cells, pre-embryos or babies that will receive genetic intervention. In the case of gene-edited twins, they cannot but let their parents exercise the right of informed consent when they are either embryos or babies, out of which arise several questions: do parents have the right to consent on behalf of them? If they are entitled to the right, then how should the right be defined, and should the right be limited? How to prevent parents from depriving their children of self-identity before they are born for the sake of their own interests by exercising the right? Fundamentally, the problem is how to cope with ethical and legal issues so as to safeguard children or future generations’ rights and interests. 

4. Genetic Enhancement and Social Issues Such as Social Inequality. — The use of genetic enhancement technology leads to some problems other than the abovementioned intergenerational proxy consent issues. If subjects’ traits or abilities are enhanced, they will be genetically superior to average humans. The genetic enhancement will be costly once it is commercialized and will be the privilege of the rich. The hasty application of this technology may contribute to the random selection of life by human, intergenerational chaos, genetic determinism, genetic discrimination, irreversible polarization of society between rich and poor, and serious social inequality, etc. It can be concluded that illegal research into and antihuman application of genome editing technologies will encroach on human dignity and life, which should be inviolable and sacred, and further break the life cycle and order of humans.
 
III. LEGISLATION STATUS AND DEFICIENCIES OF HUMAN GENOME EDITING RESEARCH AND APPLICATION IN CHINA
 
A. The Status of Legislation
 
In addition to articles 20 and 33 of the Constitution of the People’s Republic of China which respectively stipulate that the State ‘commends and rewards achievements in scientific research as well as technological discoveries and inventions’ and that ‘the State respects and preserves human rights’, and provisions of laws such as the General Provisions of the Civil Law of the People’s Republic of China, Law of the People’s Republic of China on Scientific and Technological Progress and Law of the People’s Republic of China on Promoting the Transformation of Scientific and Technological Achievements, there are no specially formulated laws and administrative regulations on human genome editing research and application, but only a few departmental rules.

1. Rules concerning Basic Research into and Preclinical Study of Human Genome Editing. — Measures for the Administration of Genome Engineering Safety, Interim Measures for the Administration of Human Genetic Resources, Administrative Measures for Assisted Human Reproductive Technology, Technical Standard for Assisted Human Reproduction, Basic Standards and Technical Specifications for Human Sperm Bank, Ethical Principles of Assisted Human Reproductive Technology and Human Sperm Bank, and Ethical Guiding Principles on Human Embryonic Stem Cell Research, etc.

2. Rules concerning the Clinical Research into and Application of Human Genome Editing. — Key Points in Quality Control in Human Somatic Cell Therapy and Gene Therapy Clinical Research, Guiding Principles on Human Gene Therapy Research and Preparation Quality Control Technology, Measures for the Ethical Review of Biomedical Research Involving Humans, Administrative Measures for the Safety of the Biotechnology Research and Development, etc. On February 26, 2019, three months away from the gene-edited baby controversy, the National Health Commission of the People’s Republic of China issued an announcement about Seeking Public Comments on the Administrative Regulations for the Clinical Practice of New Biomedical Technologies (Draft for Comment), which lasted for one month.

The abovementioned rules demonstrate China’s stance on human genome editing research and application. First, genome editing is limited to research and only for medical purposes. For example, article 6 of the Ethical Guiding Principles on Human Embryonic Stem Cell Research stipulates that it is allowed to perform genome editing and modification on human embryos, but all research activities shall comply with the 14-day norm. Second, research into and clinical practice of gametes and embryos that are in breach of ethics are forbidden. Third, it is forbidden to conduct any research on human reproductive cloning, and buy and sell human gametes, zygotes, embryos or fetal tissues; it is forbidden to fuse gametes of humans and another species, transplant gametes, zygotes and embryos of another species into human bodies, transplant human gametes, zygotes and embryos into another species; it is especially forbidden to genetically modify human gametes, zygotes and embryos for reproductive purposes, carry out research involving human chimera embryos, and clone humans. 

These rules have also established relevant principles and systems. Research on human embryonic stem cells should follow principles of informed consent and informed choice, etc. to protect the privacy of subjects. The use of assisted human reproductive technology and human sperm bank should comply with principles of beneficence, informed consent, offspring protection, public interest, confidentiality, non-commercialization and ethical supervision. Ethical reviews of biomedical research involving humans should conform to laws and regulations, respect subjects’ autonomy, and abide by principles of beneficence, non-maleficence and justice. Biomedical researchers whose work involves humans should observe principles of informed consent, risk control, free of charge, privacy protection and equitable compensation. Systems include ethical review, informed consent, supervision and management, and liability. To guarantee the safety of biotechnology research and development, a three-level management system has been adopted, the levels of which are determined based on the amount of risks involved in genome editing research activities.
 
B. Deficiencies in Legislation
 
In general, China has not formulated a well-defined, comprehensive and systemic legal system for human genome editing research and application. 

1. There Is No Comprehensive and Special Legislation and Rules Are Not Well-defined. — The rules mentioned above lack clear legislative purposes, principles and philosophy, did not delineate the connotative and denotative meanings of basic concepts such as basic research, somatic genome editing, germline genome editing, treatment or prevention of diseases or disabilities, and genetic enhancement, did not stipulate classifications and steps pursuant to technical specifications and ethics regarding basic research, preclinical study, clinical experiments or research, implementation research and clinical practice, and did not dictate genetic rights and rigid liability, to name just a few. For example, although the Administrative Measures for Assisted Human Reproductive Technology, which directly regulate germline genome editing, forbids performing genetic changes on human gametes, zygotes and embryos for reproductive purposes, it did not state clearly whether research on genome editing in human embryos and germline cells is allowed.

2. The Existing Legislation Is Low in the Hierarchy of Laws and Therefore Lacks Authority. — The aforementioned rules, no matter if they were formulated by the former Ministry of Health, the National Health Commission, or the Ministry of Science and Technology, all rank the lowest level in the hierarchy of laws in China. When they are applied, a few problems would occur. First, whether they can serve as the evidence in adjudication. According to relevant laws in China, rules cannot be regarded as the evidence in adjudication because they are soft laws rather than laws in a complete sense. They are generally administrative measures for technologies or ethical guiding principles, whose binding force is weaker than that of traditional law. As was pointed out in the report of China-UK Research Ethics Committee, ‘China’s regulatory approach to biomedical research consists of laws, regulations and guidelines, of which ministerial guidelines play the most important role’ and can be considered to constitute ‘soft law’. Second, when departmental rules conflict with local regulations, the former will be at a disadvantage. According to the Law on Legislation of the People’s Republic of China, departmental rules are low in status when they are applied. To summarize, there is a shortage of authority in the regulation of human genome editing research and application with departmental rules.

3. The Legislation Is Decentralized and Therefore Not Systemic. — The abovementioned rules were mainly formulated by the former Ministry of Health, the National Health Commission, or the Ministry of Science and Technology, among which there is a lack of communication. Normative documents did not probe into the relationship among technologies, ethics and social risks and institutionalize them. There is also a shortage of systematicity within rules. For example, the Measures for the Ethical Review for Biomedical Research Involving Human Subjects did not specify the rights and obligations of all parties involved in the biomedical research and application involving people, emergency response plans, compensation and liability, etc. The Administrative Measures for the Safety of the Biotechnology Research and Development did not institutionalize the rights and obligations in all fields and at all stages pertinent to the biomedical research.

4. The Rules Are Largely Abstract and Therefore Not Operable. — For instance, articles 5 and 6 of the Measures for the Ethical Review of Biomedical Research Involving Humans stipulate the establishment and duties of medical ethics committees of the Health and Family Planning Commission at national and provincial levels; Articles 7 to 16 specify the establishment, components, term and duties, etc. of ethics committees of healthcare institutions that work on biomedical research involving humans. However, medical ethics committees are advisory organizations that do not conduct ethical reviews; healthcare institutions are responsible for ethical reviews and establish ethics committees; ethics committees specialize in ethical reviews. The three parties’ relationships are not clear and hence it is not operable. In fact, driven by the interests of organizations, ethics committees are inclined to be much less strict about ethical reviews and even conduct no reviews.

IV. INTERPRETATIONS OF MAJOR FOREIGN LEGAL TEXTS OF HUMAN GENOME EDITING RESEARCH AND APPLICATION

 
Since the end of the Second World War, some international and regional organizations and countries enacted a series of legal documents to protect human rights and human dignity.
 
A. Major Legal Texts that Regulate Human Trials, Human Rights Protection and Human Genome Editing
 
The Nuremberg Code (formulated by the International Military Tribunal in 1947), as the first code that scientifically regulates human trials in human history, systematically set forth basic principles such as the principle of autonomy, the principle of beneficence, the principle of nonmaleficence and the principle of safety. It provided a blueprint and legal basis for regulating human trials.

The Universal Declaration of Human Rights (UDHR) (passed by the UN General Assembly on December 10, 1948), as the first document about human rights in human history and one of the UN’s basic laws, set forth the three aspects of modern human rights (civil rights and political rights, social, economic and cultural rights, the right to development and environment), announced that everyone is entitled to 29 rights, and emphasized the necessity of human rights protection.

Although the Nuremberg Code and UDHR have different emphasis, they both emphasize the respect for persons and the supremacy of human rights, ensure the safety and health of humans, and object to slavery, deprival of basic human rights and inhumane treatment. From the perspective of consequent legislation, the Nuremberg Code serves as the legal basis while UDHR provides guiding principles.

The Declaration of Helsinki in 1964 proclaims that ‘it is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.’ Other principles include voluntary and informed consent, validity and caution, ethical review and precautionary principle, etc. This declaration has been deemed as the guiding principles for doctors and medical researchers to give priority to the protection of human subjects’ rights and the basis on which countries stipulate laws and regulations since it was adopted. For example, the Belmont Report issued by the US in 1978, stipulates basic ethical principles underlying biomedical and behavioral research involving human subjects. The first principle is respect for persons, i.e. informed consent, which consists of three elements: information, comprehension and autonomy. The second principle is beneficence, which is composed of two general rules complementary to each other: (i) do not harm and (ii) maximize possible benefits and minimize possible harms. Risk/benefit assessment is also required. The third principle is justice. It is required that the procedures and results of the selection of subjects are both just.

The International Covenant on Civil and Political Rights (ICCPR) (enacted by the UN General Assembly on December 16, 1966) is the concretization of UDHR in the field of civil and political rights. Article 7 of ICCPR stipulates that ‘no one shall be subjected without his free consent to medical or scientific experimentation’ and establishes informed consent as a basic human right of human subjects.

International legal texts that specially regulate human genome editing technologies and ethics came into being in around 2000. For example, article 11 of the Vienna Declaration and Program of Action, adopted by the World Conference on Human Rights in 1993, notes that ‘certain advances, notably in the biomedical and life sciences as well as in information technology, may have potentially adverse consequences for the integrity, dignity and human rights of the individual, and calls for international cooperation to ensure that human rights and dignity are fully respected in this area of universal concern’. In the same year, the International Ethical Guidelines for Biomedical Research Involving Human Subjects (a revised version was published in 2000) prepared by the Council for International Organizations of Medical Sciences and the World Health Organization puts special emphasis on ethical justification and scientific validity of biomedical research involving humans, informed consent and special protection of vulnerable persons, etc. Moreover, the United Nations Educational, Scientific and Cultural Organization respectively issued the Universal Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data and the Universal Declaration on Bioethics and Human Rights in 1997, 2003 and 2005. The Human Genome Organization (HUGO) issued the Statement on the Principled Conduct of Genetics Research in March 1996 while HUGO’s Ethics Committee respectively published the Statement on DNA Sampling: Control and Access, the Statement on Benefit-Sharing and the Statement on Human Genomic Database in November 1987, April 2000, and December 2000. The Universal Declaration on the Human Genome and Human Rights stresses in its preface that human genome ‘research should fully respect human dignity, freedom and human rights, as well as the prohibition of all forms of discrimination based on genetic characteristics’. It reiterates in article 11 that ‘practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted’. It also further stipulates the right of informed consent of subjects. In terms of regional organizations, the European Council passed the Convention on Human Rights and Biomedicine in 1997, stating that ‘the creation of human embryos for research purposes is prohibited’.

Furthermore, during the first International Summit on Human Gene Editing held from December 1 to December 3, 2015 in Washington, DC, the Chinese Academy of Sciences, the Royal Society, the US National Academy of Sciences (NAS) and the US National Academy of Medicine (NAM) reached a consensus: genome modification and editing for reproductive purposes are forbidden, and announced that any clinical practice of germline genome editing is irresponsible, which represents the bottom line of the clinical practice of germline editing. After this summit, the NAS and the NAM immediately convened the Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations, which is made up of 22 academics, and published a research report on February 15, 2017, specially proposing ten norms concerning germline genome editing. These ten standards were reiterated by the committee during the Second International Summit on Human Genome Editing held at the University of Hong Kong on November 27, 2018, and were restated as ten principles that must be observed when clinical trials are performed on hereditary genomes under the rigorous supervision framework.
 
B. Positions on Germline Genome Editing Mirrored by the Legislation of Countries around the World
 
In a research published in 2014, Motoko Araki and Tetsuya Ishii from Hokkaido University analyzed policies on human germline gene modification for reproduction excluding reproductive cloning in 39 countries and divided these countries’ stances on germline genome editing into three types: forbidden, restrictive and ambiguous. As a result, 29 countries (such as Australia) were found to ban human germline genome modification, among which only China, India, Ireland, and Japan forbid it based on guidelines that are less enforceable than laws, and are subject to amendment, and the remaining 25 countries have legally binding bans. Nine countries (such as Argentina) are ambiguous about the legal status of genome modification. The US is the only country that chooses the restrictive stance and is an exception because it imposes very strict rules rather than a complete ban on genome editing. At least for now, human germline genome modification is stalled by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

The policies of one or more countries of these three types will be analyzed as below. Take countries that totally ban genome editing for example. Australia stipulates that ‘a person commits an offence if (a) the person intentionally creates or develops a human embryo by a process of the fertilisation of a human egg by a human sperm outside the body of a woman; and (b) the human embryo contains genetic material provided by more than 2 persons’ in the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. The Austrian Reproductive Medicine Act in 2004 forbids any intervention concerning human germline cells. The Bioethics Law of France in 2009 states its prohibition of genetic manipulations that may affect the descendants and prohibition of research on embryos. The Embryo Protection Act of Germany in 1990 prohibits artificial alteration of the genetic information of human germ cells and prohibits the use of human germ cells with altered genetic information to create embryos. The law prohibits artificial alteration of the genetic information of human germ cells and prohibits the use of human germ cells that have artificially altered genetic information to create embryos. The Ethical Guidelines for Biomedical Research on Human Subjects of India in 2006 prohibits germline therapy, genetic enhancement and eugenic genetic engineering.

As for countries that adopt an ambiguous attitude, Peru forbids people from utilizing human oocytes for non-reproductive purposes in its General Health Law (Act No. 26842) in 1997, but the legal status of human germline genome editing is not clear. In 2013, South Africa’s revised National Health Act prohibits reproductive cloning of human beings, but it is not clear whether it allows other types of germline genome editing.

The US, which adopts a restrictive stance, does not ban germline genome editing for the time being, but a temporary moratorium has been imposed on germline genome editing under the FDA vigilance and the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules in 2013. The Recombinant DNA Advisory Committee (RAC) of NIH does not accept any application for clinical experiments that would modify germline genomes, but it may consent when the safety of germline genome editing is enhanced.

Nonetheless, this type of classification is not rigid. For example, although Israel bans germline genome editing, permission might be obtained pursuant to relevant laws and if the adversary committee champions it.
 
V. IMPROVEMENT OF CHINA’S LEGAL REGULATION ON HUMAN GENOME EDITING RESEARCH AND APPLICATION
 
Having analyzed the problems in legal regulation of human genome editing research and application in China, a few suggestions have been made by drawing on the experience of foreign countries and focusing on the national conditions of China.
 
A. Clarifying the Guiding Thought, Basis, Principles and Models of Legislation
 
1. The Guiding Thought of Legislation. — At the 19th National Congress of the Communist Party of China, Xi Jinping, General Secretary of the Central Committee of the Communist Party of China, pointed out that the ‘commitment to our people-centered philosophy of development’ is vital to the Thought on Socialism with Chinese Characteristics for a New Era. Therefore, China must continue to be committed to the people-centered philosophy of development. The Party and the country put special emphasis on the legal regulation of new technologies, including human genome editing technologies. On January 21, 2019, General Secretary Xi Jinping emphasized that China should expedite the process of building a security alarming and monitoring system for science and technology, as well as the legislation on fields such as artificial intelligence, gene editing, medical diagnosis, autonomous driving, drones, service robots, etc. in a seminar aimed to educate leading cadres at provincial and ministerial levels on how to defend the bottom line and prevent and defuse major risks. On February 25, 2019, the Central Committee for the Comprehensive Rule of Law stressed at its second meeting that we should consider the legislation on intellectual property protection, biosafety, reform of the rural land system, the building of an ecological civilization and so on in a coordinated way, and enact, revise, repeal, and interpret laws as necessary. These have all shed light on how to accelerate the legislation on human genome editing. Moreover, the National People’s Congress has planned to legislate for biosafety in 2019, which will lay a solid foundation for legislation on human genome editing.

Human genome editing, especially germline genome editing, concerns not only the interests of modern Chinese and even their descendants, but also those of the community with a shared future for humanity. We should strive to race ahead in human genome editing research and application, and at the same time ensure Chinese people and humans’ health and safety. In the process of human genome editing legislation, we should avoid the misuse and abuse of genome editing technologies but encourage scientific and technological innovation, and balance the interests and risks to maximize the benefits and minimize the risks. To achieve this, we need to both regulate genome-editing with laws and adopt an open-minded attitude. On the one hand, we should strengthen supervision. Before genome-editing technologies become mature, and security, ethical and social problems are tackled; clinical trials and the application of germline genome editing should be forbidden. The clinical practice of somatic gene therapy shall not be allowed unless preclinical studies have been conducted, it belongs to clinical research or trials, it is proven to be safe and effective, and it has been approved. On the other hand, we should keep an open mind. Any exploration that is conducive to human health, including germline genome editing, should be given permission to advance scientific and technological innovation and social progress. To put it differently, we should undertake research into new technologies bravely but apply them cautiously on the basis of ensuring safety. However, driven by fame and profits (as is in the case of the genome editing twins), some researchers may violate relevant regulations, to which phenomenon we should pay attention. Last but not least, in the legislative process, we should fully respect the will of the people, fully promote democracy, acquire an in-depth understanding of genome editing technologies, and follow the objective law of scientific and technological development. To summarize, we must adhere to the philosophy of people-centered development and apply it to the enactment, enforcement, observation and supervision of laws when perfecting the legal regulation of human genome editing research and application as well as the discourse system.

2. The Basis of Legislation. — China should base laws and regulations on human genome editing on principles stipulated in the Constitution, such as ‘the state respects and guarantees human rights’ and the state ‘encourages scientific research results and technological inventions’, and also match and coordinate them with the General Provisions of the Civil Law of the People’s Republic of China, Law of the People’s Republic of China on Scientific and Technological Progress, and Law of the People’s Republic of China on Promoting the Transformation of Scientific and Technological Achievements, etc. Moreover, as a member of a community with a shared future for humanity and the International Law Community, China should also base its legislation on pertinent international treaties and relevant laws of regional organizations or countries or refer to them.

3. The Principles of Legislation. — Based on the Constitution and relevant laws, regulations and rules of the People’s Republic of China, as well as the legislation of other countries, nine legislative principles are summarized as follows.

First, the promotion of well-being. People involved, mainly research subjects must be provided with welfare, and harm must be prevented (including principle of beneficence and do no harm). Accordingly, the application of human genome editing, such as the prevention or treatment of diseases or disabilities, must help to promote the health and well-being of individuals and even nations and the mankind. Highly uncertain risks should be minimized at the early stage of practice. Potential benefits and risks should be reasonably balanced.

Second, respect for human rights and informed consent. The respect for human rights means that people should at least be treated as humans, instead of as animals, machines, objects, collections of their organs and objects without subjects. The respect for human rights is reflected in four aspects. We should admit that everyone has equal ethical value regardless of his or her genetic quality; we should respect and protect individual decisions; we should prevent the abuse of eugenics in different forms; we should commit ourselves to eliminating diseases and disabilities. In the field of human genome editing, the respect for human rights mainly finds an expression in informed consent, which consists of substantive and procedural aspects. Firstly, subjects’ autonomy about whether they will participate in the research and clinical trials and right of withdrawing unconditionally from the research at any stage must be respected and guaranteed. Secondly, subjects must be informed about the research, comprehend it and voluntarily consent to it. It is forbidden to deceive, induce or threaten subjects to consent to participate in the research or clinical trials.

Third, justice. The principle refers primarily to distributive justice, which requires the equitable distribution of both the burdens and the benefits of every subject or patient. It has three levels of meanings: both the burdens and the benefits should be distributed equitably and appropriately; the payment should be proportionate to the work; the established procedures should apply to everyone.

Fourth, responsible science. This principle emphasizes that the highest domestic and international standards and professional norms must be met, from laboratories to sickbeds. There are four specific requirements: the experimental design and analysis must be of high quality; the review and evaluation of protocols and results must be strict; the whole process must be highly transparent; the error correction mechanism must be rigorous.

Fifth, transparency and privacy protection. The privacy of subjects or patients should be protected while transparency is maximized. Information other than privacy or legally confidential documents should be accessed openly and shared so as to inform stakeholders in time. Ensuring that the public continuously participate in relevant decision-making processes and understand relevant technologies.

Sixth, precautionary principle. The principle requires continuous assessment of social interests and risks involved in human genome editing projects that still pose quite a few uncertain risks to safeguard the safety of subjects or patients and even the mankind.

Seventh, cautious development and strict regulation. At present, human genome editing implies both benefits and risks. Therefore, genome editing technologies must be developed with caution rather than be given full permission. Clear and strict regulations must be set down and reliable regulatory mechanisms must be established to prevent the misuse or abuse of genome editing technologies, guarantee the smooth development of relevant research or application for the benefit of subjects or patients, nations and even humans.

Eighth, law-based accountability. The major reason why the existing rules in China are deemed as soft laws by foreign academics is that they did not specify clear, serious and rigid legal responsibilities. Therefore, we must improve the accountability system, ensure that laws are observed and strictly enforced and that anyone who violates the law is held to account, and impose civil, administrative and even criminal penalties on offenders (such as the ‘manufacturer’ of genetically edited babies) depending on the nature and circumstances of his or her unlawful act.

Ninth, international exchanges and cooperation. Human genome editing, especially germline genome editing, concerns the interests of the community with a shared future for humanity. Therefore, we must strengthen international exchanges and cooperation and be committed to exploring a coordinated approach to research and governance on the basis of respecting different cultures. We must respect policies and laws of different countries; coordinate regulatory standards and procedures as much as possible; collaborate and share data with the scientific community and regulatory bodies of a variety of countries. 
 
B. Formulating the Human Genome Editing Safety Law and Improving the Regulatory System and Mechanism
 
1. Position on Genome Editing and Legislative Model. — There are mainly three types of legislation towards human genome editing, namely forbidden, restrictive and ambiguous. China’s legislation is classified as forbidden. However, it is argued by the author that China should adopt an ambiguous attitude. China should not only specify the scope of application of human genome editing technologies, but also encourage legal and orderly research and application so as to advance its development. When it comes to the legislative model, China should draw on the experience of South Korea by employing the model of centralized legislation and special legislation and granting relevant laws according to the hierarchy of laws.

2. The Title of the Law and the Purpose of Legislation. — To highlight the importance of the regulatory object of legislation on the safety supervision of human genome editing, the law must be titled precisely so that legal relationships can be accurately regulated and therefore develop in a sound system. Based on the practice of naming the law on seeds, the Seed Law of the People’s Republic of China, it is advocated by the author that human genome editing should be specially legislated for and that it should be named the Human Genome Editing Safety Law. Its purpose should be to treat or prevent diseases or disabilities, improve people’s health and life quality, promote human well-being, and bolster and guarantee the sound and orderly development of human genome editing technologies. China should adjust and regulate the technology, ethics, social issues and safety supervision systems related to human genetic editing, and then establish a special and systemic legal system that keeps technological, ethical and social risks under effective control, coordinates the rights and obligations of all parties, and guarantees and promotes scientific and technological innovations.

3. The Regulatory System and Mechanism. — It is advised that the State Council should set up the Committee on Human Genome Editing Safety under the centralized and unified leadership of the National Security Council of the CPC Central Committee. To put it specifically, Committees on Human Genetic Editing Safety should be set up in the State Council and the People’s Governments at or above county level, which are composed of experts specializing in medicine, life sciences, ethics, law and sociology, etc., staff of departments concerned, and public representatives. These committees are responsible for the formulation of policies and bills, decision-making consultation, organization, supervision, and so on.

There should be three sub-committees. First, the academic/technical review sub-committee, which is in charge of assessing and monitoring the legality, validity, feasibility, safety and related technical risks of research or practice programs. Second, the ethics review sub-committee, which is in charge of assessing and monitoring the validity and ethical rationality of research or practice programs, and whether informed consent is obtained legally in terms of content and procedure, specially evaluating safety and effectiveness based on risk/benefit assessment. Third, the public consultation sub-committee, which is made up of self-regulatory organizations in distinct industries, representatives from the press and the public. It makes full use of existing platforms to inform people about projects and respond to their questions and doubts before and after practice projects of human genome editing are reviewed and approved, and when they are put into practice. In addition, it encourages public discussion to ensure sustained public participation and the smooth implementation of projects.

It should also be noted that while the State Council and health commissions of the People’s Governments at or above county level are in charge of work pertaining to the safety supervision of human genome editing, administrative departments such as the Ministry of Science and Technology should take concerted action. Healthcare institutions also need to establish academic/technical review committees and ethics review committees to take charge of work such as the initial review of academic, technical and ethical issues. China must draw on the lessons of the gene-edited baby controversy, and respectively grant the right of approval of human genome editing research and application to the provincial People’s Governments and the National Health Commission of the State Council based on the type and risk level of genome editing.

After the enactment of Human Genome Editing Safety Law, the State Council shall issue the Measures for the Implementation of Human Genome Editing Safety Law in accordance with this law. Administrative departments such as the National Health Commission and the Ministry of Science and Technology shall formulate or improve relevant departmental rules in accordance with laws and administrative regulations.
 
C. Establishing and Improving Relevant Systems
 
1. Establishing the Legal Status of Human Embryos. — The gene-edited baby controversy implies that the legal status of embryos is vital to human genome editing research and application. Currently, there are three views about the legal status of human embryos, namely ‘embryo as legal subject’, ‘embryo as legal object’ and ‘embryo as the intermediate’, the last of which the author agrees with. The human embryo is in the intermediate form between human and object, has the potential of developing into life, and possesses a higher moral status than non-living things, therefore it should be specially respected and protected. In China, no laws stipulate the legal status of embryos. It is recommended that we refer to the aforementioned provisions of Oklahoma on the legal status of embryos, and consult article 16 of the General Provisions of the Civil Law, which states that ‘where a fetus is involved in inheritance, acceptance of gifts or any other protection of his or her interests, the fetus shall be deemed as having the capacity for civil rights.’ On that basis, we can delineate that the legal status of embryos is lower than that of babies and higher than that of objects in legislation. In this way, it is conducive to solving practical problems such as informed consent. Furthermore, we can not only prevent genome editing from being stalled under the influence of the ‘embryo as legal subject’ theory, but also avoiding regarding embryos as objects, i.e. experimental tools, due to the influence of the ‘embryo as legal object’ theory, which will desecrate human dignity greatly.

2. Establishing the Risk Analysis System and the Alarming and Monitoring System. — Risk analysis consists of risk/benefit assessment, risk management and risk communication. First, a comprehensive assessment of the safety, effectiveness and all kinds of risks or benefits of human genome editing research and application should be conducted. Laboratory research, animal research, clinical trials or research, implementation research, and clinical practice should all be assessed based on the step-by-step approach. Each step must be based on the conclusions drawn and data collected in the previous step, and the work will not proceed unless it meets the risk/benefit ratio requirement after a rigorous evaluation. Second, targeting risks or potential hazards confirmed by the risk/benefit assessment, appropriate security management measures should be taken to eliminate security hazards, or minimize the risks. Risk management is divided into normal management and crisis management. Crisis management usually adopts the rapid alert system. If any evidence shows approved human genome editing projects are likely to bring serious risks to human health or the genetic ecology, the most powerful measures should be taken (such as suspending or even prohibiting such activities). The rapid alert system should be accessible to domestic and international organizations. Last but not least, risk communication requires that the regulatory department and operating agencies communicate the assessment results and risk management plans of projects that are suggested to be approved, the opinions of the department and agencies, risks that occur after projects start, emergency response plans, and results to the public to maintain continued public participation and maximum transparency. The alarming and monitoring system can be built in parallel with the risk analysis system.

3. Establishing the Academic/Technical Review System and Improving the Ethical Review System. — China should set up academic/technical review committees and ethics review committees in healthcare institutions and Committees on the Safety of Human Genome Editing of People’s Governments at or above the county level to conduct academic/technical assessments and ethical reviews of the necessity, legality, validity, safety, effectiveness and ethical rationality of researches or projects. The results will lay a foundation for the examination of the People’s Governments at a provincial level or the National Health Commission of the State Council. The establishment or improvement of these two review systems can not only prevent the misuse of genome editing technologies, but also identify and address problems in a timely manner.

4. Establishing the Approval System for Human Genome Editing Research and Application. — According to article 12 of the Administrative License Law of the People’s Republic of China, an administrative license may be granted to human genome editing research and application projects pursuant to the law. Currently, basic research and the research into or application of somatic genome editing, as well as research projects on prevention or treatment of diseases by germline genome editing, can be reviewed for approval. But the clinical practice of prevention or treatment of diseases by germline genome editing and the research and application of genetic enhancement are excluded. For research projects that can be reviewed for approval, if anyone applies for the approval of the project, they shall be examined by either the provincial People’s Governments (medium and low level of risks) or the National Health Commission of the State Council (high level of risks) based to the level of risks involved. Any project that concerns the application of genome editing technologies shall be subject to the examination of the National Health Commission. The review is based on the conclusions of the academic/technical review and ethical review. Upon examination, if the application meets legal requirements and standards, the National Health Commission shall issue an administrative license in written form. Having obtained a permit, the applicant can carry out the research or trial.

5. Improving the Accountability System. — The main subjects involved in human genome editing research and application mainly include healthcare institutions, the staff in charge, medical personnel and institutions or individuals illegally engaging in related research and practice without obtaining the practice licenses of medical institution. Pertinent legal liability embraces civil, administrative and criminal liability. In terms of civil offenses, China can legislate to specify civil penalties in accordance with the General Provisions of the Civil Law and the Regulations on the Handling of Medical Accidents. According to article 179 of the General Provisions of the Civil Law, for an actor who ought to bear civil liability, civil liability shall be assumed in the most suitable manner, such as cessation of infringement, elimination of danger and compensation for loss, etc. Administrative penalties incorporate fining healthcare institutions, revoking practice licenses of healthcare institutions; dismissing medical personnel, revoking practicing licenses, a life-long ban on the engagement in clinical research on human genome editing technologies, confiscating illegal income and imposing fines, etc. Institutions and individuals that engage in genome editing research and application without practice licenses in particular, will have their equipment and legal income confiscated and be fined 10 to 20 times that of the illegal income. With regard to criminal liability, articles 333 to 336 of the Criminal Law respectively stipulate the criminal penalties to be imposed if anyone illegally arranges for another person to sell blood; anyone unlawfully collects or supplies blood or makes or supplies blood products; any medical worker who, grossly neglecting his duty, causes death or severe harm to the health of the person seeking medical service; anyone, without obtaining the qualification for practicing medicine, unlawfully practices medicine. However, none of these provisions could cover the criminal offense of performing human genome editing illegally. Accordingly, it is suggested that a new article be added and inserted between articles 334 and 335 which stipulates the offence of unlawful human genome editing. As for criminal liability, relevant extraterritorial laws can be consulted. For example, according to the nature and circumstances of the crime, South Korea imposed imprisonment with prison labor of less than 10 years, 5 years, 3 years, 2 years or 1 year. Moreover, those who are sentenced to less than 2 years or 1 year in prison will also be fined no more than 30 million or 20 million won respectively. In Canada, illegal editing of the human genomes could mean a maximum of 10 years in prison under the Assisted Human Reproduction Act in 2004. Under the Prohibition of Human Cloning for Reproduction Act of Australia in 2002, a person who alters the genome of an embryonic cell could face up to 10 years in prison.

6. The System for International Exchanges and Cooperation. — In the process of researching, applying and developing human genome editing technologies, China must abide by relevant international treaties that China concluded and bolster exchanges and cooperation with other countries. This allows China to keep abreast of the latest developments in this area and take precautions to prevent and control risks by drawing on the experience and lessons of other countries, thereby promoting technological development and the well-being of mankind. Additionally, by participating in the formulation and amendment of international treaties and rules, China will have a greater say in the system for human genome editing research and application.
 
VI. CONCLUSION
 
The two genetically modified babies, whose appearance sparked heated controversy in 2018, shed light on the fact that the research into and application of human genome editing technologies are double-edged swords. These technologies are conducive to human health, but pose a multitude of technological, ethical, legal and even social risks and problems. China should neither develop human genome editing technologies without regulation and restriction, nor lag behind in this field owing to failure to seize opportunities. It should regulate the development of human genome editing technologies strictly to ensure that they develop in a sound and orderly way, thus truly bringing benefit to the mankind. Based on the realities of regulation in China, there is a lack of special, well-defined, coordinated and operable laws with strong binding force, and the relevant regulatory systems and mechanisms are not centralized, systemic, rigorous and strict, which can be encapsulated in one phrase: the imperfection of legal regulation. Therefore, China should take its own national conditions into consideration, draw on foreign countries’ experience of legislation and legal regulation, determine the guiding thought, basis and principles for legislation, and formulate the Human Genome Editing Safety Law. In the meantime, China should establish and improve pertinent systems and the regulatory systems and mechanisms.


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