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从人类胚胎基因编辑浅析我国医学伦理相关法律法规

关祥宇 关祥宇 来源:医药魔方
2018-12-02
基因编辑
原文

2018年11月26日,一对名为露露和娜娜和基因编辑婴儿的降生不但引爆了生物医学界,也引起了公众的广泛关注,负责这项科研工作的科学家贺建奎也顿时站在了舆论的风口浪尖上。相比于在科学层面对实验所用CRISPR-Cas9技术及CCR5基因编辑本身的安全性和必要性提出的质疑,人们更加担忧的是“定制婴儿”在伦理层面造成的恶劣影响。一方面,“试验品”这个无情的标签将伴随这两个可怜的孩子终生,令人唏嘘不已;另一方面,一旦“定制婴儿”一发而不可收,人类社会将失去最起码的公平,甚至在未来“人类”这一物种也将被重新定义,后果不堪设想。

 

一般而言,伦理道德是一种比法律规定标准更高的社会规范。在某些情况下,鉴于问题的严重性和法律的可操作性,通过法律来约束人的行为使其符合道德伦理就显得合理且必要。如伦理道德要求我们尊老爱幼,法律也规定了抚养、赡养等义务,促使人们遵循尊老爱幼的伦理准则。

 

基因编辑技术作为能够改变生物遗传特征的技术,无疑是一把锋利的双刃剑。特别是在用于人类基因编辑时,其在技术之外牵涉复杂的道德、伦理、哲学问题,因此掌握该技术的各国科学家对相关研究的开展持非常谨慎的态度。我国究竟有哪些涉及医学伦理的法律规定有助于防止这把双刃剑造成无法挽回的损害,贺建奎事件中又暴露了法律的哪些问题,在本文中笔者将从伦理和法律的角度对这一热点问题进行探讨。

 

1. 基本的伦理准则


“临床试验”是以人为对象开展的医学试验,较之动物试验等其他试验必然涉及更复杂的伦理问题。国际上公认的临床试验伦理准则可以追溯到最早于1964年发布的《世界医学大会赫尔辛基宣言》,该宣言提出临床试验受试者的利益高于科学,也高于社会利益;在此基础上,该宣言要求临床研究必须在潜在风险和益处之间作出权衡,一旦发现风险大于益处则应停止临床试验,此外研究者必须在受试者充分知情的情况下取得其同意。随着时代的发展,该宣言又在后续的修订中增加了有关“临床实践中未经证明的干预措施”的内容,要求即使应用这种干预措施,也应建立在对其安全性和有效性进行评估设计的基础之上。

 

《赫尔辛基宣言》仅为指导性的纲领文件,其本身并不具备法律上的约束力,因此上述伦理准则需要体现在各国的具体法律法规之中,方能得到落实。例如,我国《药品管理法》、《药品注册管理办法》、《药品临床试验质量管理规范》等法律法规中就对药品研发中的临床试验所涉及的伦理委员会审查、知情同意原则以及对受试者的保护等内容作出了规定。

 

2. 相关法律法规与试验合法性探讨


CRISPR-Cas9基因编辑技术是一种新兴的生物学技术,经常被称作“基因剪刀”,与其说是一种用药过程,不如说是一种生物学的操作过程,因此并不适用前述与药品相关的法律法规。

 

具体到贺建奎事件中对于人类胚胎的基因编辑操作,目前我国与此相关的法律法规主要包括:

《人胚胎干细胞研究伦理指导原则》,以下简称“《干细胞伦理原则》”,2003年12月生效,

《干细胞临床研究管理办法(试行)》,以下简称“《干细胞试行办法》”,2015年7月生效,

《涉及人的生物医学研究伦理审查办法》,以下简称“《伦理审查办法》”,2016年12月生效,

《医疗技术临床应用管理办法》,以下简称“《应用管理办法》”,2018年11月生效。

 

值得注意的是,这些法规的发布机关分别是国家卫健委(原卫生部、卫计委)、原国家科技部、原食药监总局等国务院部委,从效力位阶上属于部门规章一级。也就是说,在位阶较高的法律(由全国人大及其常委会发布)和行政法规(由国务院发布)中,笔者尚未找出能够与此类临床试验直接相关的规范性文件。这导致现行相关法规的整体性不强,也没有得到足够的重视。

 

那么,基于上述法规来看,贺建奎的研究行为以及研究机构的相应行为是否合法呢?

 

对于研究行为本身,《干细胞伦理原则》第六条规定:“利用体外受精、体细胞核移植、单性复制技术或遗传修饰获得的囊胚,其体外培养期限自受精或核移植开始不得超过14天;不得将前款中获得的已用于研究的人囊胚植入人或任何其它动物的生殖系统”。贺建奎的试验正是将体外培养的基因编辑胚胎植入了母体的生殖系统才得以孕育两个婴儿,显然违反了前述规定。

 

对于研究机构的资格,《干细胞试行办法》第七条明确规定干细胞临床研究机构应为三级甲等医院。之所以作这样的规定,是因为包括基因编辑在内的干细胞试验不但会产生伦理争议,而且对科研能力、技术水平、质量控制、风险控制的要求也远远高于一般的临床试验,因此对试验机构也理应设置更高的门槛。然而,据笔者所了解,承担此次临床试验的深圳和美妇儿医院(以下简称“和美医院”)并不是一家三甲医院,因此同样不符合规定。

 

对于在研究机构中把守伦理审查大关的伦理委员会,由《伦理审查办法》和《干细胞试行办法》的规定可知,干细胞临床试验的伦理委员会应不少于七人,由生物医学领域和社会科学领域(伦理学、法学、社会学等)的专业人员及非本机构的社会人士组成。由于掌握的信息有限,笔者尚不能判断和美医院伦理委员会的七位成员是否满足上述要求,但网传委员会成员之一的黄华锋先生为该医院的口腔科医生,完全不属于干细胞临床治疗领域,这一令人啼笑皆非的安排似乎也与前述要求背道而驰。当然,至于伦理委员会是否在伦理审查中尽到了法律法规(例如《伦理审查办法》第二十条)赋予的职责,目前已有很多讨论,笔者不再予以过多置评。

 

此外,《干细胞试行办法》第十七条规定,干细胞临床研究应当符合《药物临床试验质量管理规范》(即“GCP”)的要求,而GCP第三十五条明确要求研究机构必须获得国家药监部门的批准方可进行临床试验。然而,从孩子11月26日出生可以推断,此项临床试验至迟于2018年初就已实际开始了,但中国临床试验注册中心网站显示该试验的注册时间为2018年11月8日,状态为“补注册”。也就是说,不能排除在临床试验开始时并未进行注册、更未获得批准的可能性。假设事实的确如此,那么这一临床试验的合法性更加存疑。

 

值得注意的是,今年11月甫生效的《应用管理办法》第九条规定了“禁止类技术”,并要求制定发布禁止类技术的目录。禁止类技术包括临床应用安全性、有效性不确切的技术、存在重大伦理问题的技术和未经临床研究论证的新技术,禁止被应用于临床中。笔者认为,此次事件中使用的针对人类胚胎的基因编辑技术满足上述所有条件,完全有理由被认定为“禁止类技术”。然而,由于贺建奎开展试验的时间早于该管理办法生效的时间,根据法不溯及既往的原则,不能依据此条款判断试验的合法性。

 

3. 研究者和试验机构需要承担的法律责任


根据上文所列的法律法规,此次临床试验确实有违法之嫌。那么违法者会付出怎样的代价呢?

 

首先,在上述法律法规中,关于对研究者的惩处措施的条款,笔者只在《伦理审查办法》中找到如下规定:

 

第四十七条:项目研究者违反本办法规定,有下列情形之一的,由县级以上地方卫生计生行政部门责令限期整改,并可根据情节轻重给予通报批评、警告;对主要负责人和其他责任人员,依法给予处分:

(一)研究项目或者研究方案未获得伦理委员会审查批准擅自开展项目研究工作的;

(二)研究过程中发生严重不良反应或者严重不良事件未及时报告伦理委员会的;

(三)违反知情同意相关规定开展项目研究的;

(四)其他违反本办法规定的情形。

 

然而,上述条款规定的情节主要涉及研究开展过程中的程序性事务,而并不涉及对研究课题内容的判断。换言之,一旦在程序上获得了伦理委员会的批准,并且尽到了及时汇报和知情同意的义务,研究者不会因为不合伦理的研究内容本身(例如将经过基因编辑的胚胎植入母体)而受到依据该条款的惩处(关于网传贺建奎未以正当手段取得受试者知情同意的说法,由于尚未定论,笔者暂不就此作出评述)。

 

关于对研究机构的惩处措施,《伦理审查办法》第四十六条规定如下:

 

第四十六条:医疗卫生机构及其伦理委员会违反本办法规定,有下列情形之一的,由县级以上地方卫生计生行政部门责令限期整改,并可根据情节轻重给予通报批评、警告;对机构主要负责人和其他责任人员,依法给予处分:

(一)伦理委员会组成、委员资质不符合要求的;

(二)未建立伦理审查工作制度或者操作规程的;

(三)未按照伦理审查原则和相关规章制度进行审查的;

(四)泄露研究项目方案、受试者个人信息以及委员审查意见的;

(五)未按照规定进行备案的;

(六)其他违反本办法规定的情形。

 

在此次事件中,作为研究机构的和美医院,除了伦理委员会的成员资质可能会出现上述第(一)项的情形之外,笔者基于目前所了解到的信息也很难再找出其他足以对其实施惩处的理由。此外,该条款规定对研究机构的惩处仅限于责令限期整改、通报批评和警告,这样的处罚力度是否能够产生足够的震慑作用尚有待讨论。

 

好在正如前文所提及的,本月刚刚生效的《应用管理办法》也让笔者看到了相关立法的发展,其中第四十三条规定,对于开展禁止类技术临床应用的、或不符合医疗技术临床应用管理规范要求擅自开展相关医疗技术的医疗机构,由县级以上地方卫生行政部门依据《医疗机构管理条例》第四十七条的规定进行处理(即,严重者可能吊销其执业许可证);情节严重的,还应当对医疗机构主要负责人和其他直接责任人员依法给予处分。这一规定显然增强了处罚力度,可以在一定程度上防止未来出现同样的事件。

 

对于违法者应承担的民事乃至刑事责任,现行法规也都没有具体细化。例如,《伦理审查办法》第四十九条仅笼统地规定:给他人人身、财产造成损害的,应当依法承担民事责任;构成犯罪的,依法追究刑事责任。然而这里所说的“依法”,具体应当依据何法呢?笔者认为,即使基因编辑胚胎的临床试验带来的全新法律问题能够适用现有法律法规中的某些条款,违法者付出的代价相较于其所带来的不良后果而言可能也十分有限。例如,《侵权责任法》第五十四条规定:“患者在诊疗活动中受到损害,医疗机构及其医务人员有过错的,由医疗机构承担赔偿责任”。也就是说,医疗损害赔偿的民事责任是以患者在诊疗活动中受到损害为前提的。然而,假设两个孩子及其父母幸运地没有出现因基因编辑操作引起的后遗症,或是在技术上难以对受到的损害进行举证,贺建奎与和美医院是否就能够免除侵权责任呢?即使侵权责任成立,这样的民事赔偿与其行为对医学伦理的践踏程度、对社会造成的不良影响或许也并不匹配。

 

从前面的分析来看,现行法律法规对于此类违法临床试验的惩处力度总体偏弱,且对于违法责任的承担方式也没有合理的细化,尚有待进一步的完善。

 

4. 结语


从上文中可以看出,我国在涉及重大伦理问题的医学临床试验方面的法律法规力度有限。诚然,对于成文法体系而言,针对新兴事物制定法律法规难免存在滞后性。包括生物技术在内的新技术发展日新月异,如何通过法律法规引导技术的应用方向,规范技术的应用方式,使新技术能够造福于人,而不是产生难以预见的不良后果,的确是立法者可以考虑的课题。

 

笔者从新近实施的法律法规中看到了演变和进步,在此基础上笔者认为可以考虑以下几点:一、可以考虑在法律和行政法规位阶上的立法工作,二、可以考虑通过出台禁止类技术目录的方式明确禁止某项争议性技术的临床应用,三、对于归责及违法惩处等具体内容也可以进一步细化,使其更具可操作性。

 

天下之大,我们无力要求所有人都受伦理道德的约束,敬畏自然、敬畏生命,但我们可以期待在不久的将来,投机者们至少还有法律可以敬畏。


机器翻译

On November 26, 2018, the birth of a pair of babies named Lulu and Nana and gene editing not only detonated the biomedical community, but also aroused widespread public concern. He Jiankui, the scientist in charge of this scientific research work, suddenly stood on the cusp of public opinion.Compared with the question of the safety and necessity of the CRISPR-Cas9 technology used in the experiment and the CCR5 gene editing itself at the scientific level, people are more concerned about the adverse effects of the "custom baby" at the ethical level.On the one hand, the relentless label of the "experiment" will be accompanied by the two poor children for life, which is embarrassing; on the other hand, once the "custom baby" is out of reach, human society will lose its minimum fairness, and even in the future, the "human" species will be redefined and the consequences will be disastrous.

Generally speaking, ethics is a higher social norm than the standard prescribed by law.In some cases, in view of the seriousness of the problem and the operability of the law, it is reasonable and necessary to restrict human behavior by law to make it ethical and ethical.If ethics and morality require that we respect the elderly and love children, the law also stipulates obligations such as upbringing and maintenance, and urges people to follow the ethical principles of respecting the elderly and children.

Gene editing technology as a technology that can change the genetic characteristics of organisms is undoubtedly a sharp double-edged sword.In particular, when it is used for human gene editing, it involves complex ethical, ethical, and philosophical issues outside the technology. Therefore, scientists from various countries who master the technology are very cautious about the development of related research.What are the legal provisions concerning medical ethics in our country that help prevent this double-edged sword from causing irreparable damage, and what problems of the law are exposed in the He Jiankui incident? In this paper, the author will discuss this hot issue from the perspective of ethics and law.

1.Basic ethical guidelines

"Clinical trials" are medical trials conducted on human subjects and inevitably involve more complex ethical issues than other trials such as animal experiments.Internationally accepted ethical guidelines for clinical trials can be traced back to the Declaration of Helsinki of the World Medical Assembly, first published in 1964, which states that the interests of subjects in clinical trials are higher than those of science and also higher than those of society; on this basis, the declaration requires that clinical research must make a trade-off between potential risks and benefits, and that clinical trials should be stopped once it is found that the risks outweigh the benefits, and that investigators must obtain their consent with the full knowledge of the subjects.With the development of the times, the declaration has added to subsequent revisions the content of "unproven interventions in clinical practice", requiring that even if such interventions are applied, they should be based on the evaluation and design of their safety and efficacy.

The Declaration of Helsinki is only a guiding platform document, and it is not legally binding in itself. Therefore, the above ethical guidelines need to be reflected in the specific laws and regulations of various countries before they can be implemented.For example, China's "Drug Administration Law," "Drug Registration Regulations," "Pharmaceutical Clinical Trial Quality Management Standards," and other laws and regulations on the review of the ethics committee involved in clinical trials in drug development, the principle of informed consent, and the protection of subjects, etc., made provisions.

2.Related laws and regulations and the legality of the test

CRISPR-Cas9 gene editing technology is an emerging biological technology, often referred to as "gene scissors". It is not so much a process of drug use as a biological process of operation. Therefore, the aforementioned laws and regulations related to drugs are not applicable.

Specific to the genetic editing operation of human embryos in the He Jiankui incident, the current laws and regulations related to this in China mainly include:

Ethical Guiding Principles for Research on Human Embryonic Stem Cells, hereinafter referred to as "Ethical Principles for Stem Cells", effective in December 2003,

Administrative Measures for Clinical Research of Stem Cells (Trial), hereinafter referred to as "Trial Measures for Stem Cells", effective in July 2015,

Measures for Ethical Review of Biomedical Research Involving Persons, hereinafter referred to as "Measures for Ethical Review", effective in December 2016,

Measures for the Administration of Clinical Application of Medical Technology, hereinafter referred to as "Measures for the Administration of Applications", effective in November 2018.

It is worth noting that the issuing agencies of these regulations are the State Health Commission (formerly the Ministry of Health, the Health and Development Planning Commission), the former Ministry of Science and Technology, the former Food and Drug Administration and other State Council ministries and commissions, which belong to the departmental regulation level from the validity level.In other words, in the higher-ranking laws (issued by the NPC and its Standing Committee) and administrative regulations (issued by the State Council), the author has not yet identified normative documents that can be directly related to such clinical trials.As a result, the integrity of the current relevant regulations is not strong and has not received sufficient attention.

So, based on the above regulations, is the research behavior of He Jiankui and the corresponding behavior of the research institution legal?

For the conduct of research itself, Article 6 of the Principles of Stem Cell Ethics states: "Blastocysts obtained by in vitro fertilization, somatic cell nuclear transfer, unisexual replication techniques or genetic modification shall not have an in vitro culture period of more than 14 days from fertilization or nuclear transfer; human blastocysts obtained in the preceding paragraph that have been used for research shall not be implanted into the reproductive system of humans or any other animal."He Jiankui's experiment was to implant genetically modified embryos in vitro into the maternal reproductive system to give birth to two babies, apparently in violation of the aforementioned regulations.

For the qualification of research institutions, Article 7 of the "Stem Cell Trial Measures" clearly stipulates that stem cell clinical research institutions should be tertiary A hospitals.The reason why such regulations are made is because stem cell tests, including gene editing, not only generate ethical controversy, but also require far higher scientific research capacity, technical level, quality control, and risk control than general clinical trials. Therefore, higher thresholds should also be set for experimental institutions.However, according to the author's understanding, the Shenzhen Hemei Women and Children Hospital (hereinafter referred to as "Hemei Hospital") that undertakes this clinical trial is not a top-three hospital, so it also does not meet the requirements.

For the ethics committees that are in charge of ethical review in research institutes, it can be seen from the provisions of the "Ethical Review Measures" and "Stem Cell Trial Measures" that the ethics committee for stem cell clinical trials should be No less than seven people are composed of professionals in the fields of biomedicine and social sciences (ethics, law, sociology, etc.) and non-institutional society.Due to the limited information available, the author cannot judge whether the seven members of the Ethics Committee of Hemei Hospital meet the above requirements. However, Mr. Huang Huafeng, one of the members of the Network Communication Committee, is a dentist of the hospital and does not belong to the field of stem cell clinical treatment at all. This ridiculous arrangement also seems to run counter to the aforementioned requirements.Of course, as to whether the ethical committee has fulfilled the duties assigned by laws and regulations (such as Article 20 of the "Ethical Review Measures") in the ethical review, there have been many discussions and the author will not comment too much.

In addition, Article 17 of the "Stem Cell Trial Measures" stipulates that stem cell clinical research should meet the requirements of the "Quality Control Practice for Drug Clinical Trials" (ie, "GCP"), while Article 35 of the GCP clearly requires that research institutions must obtain the approval of the State Drug Administration before conducting clinical trials.However, it can be inferred from the birth of the child on November 26 that this clinical trial has actually started by the beginning of 2018, but the website of the China Clinical Trial Registry shows that the registration time of the trial is November 8, 2018, and the status is "supplementary registration".In other words, it cannot be ruled out that there is no registration or approval at the beginning of the clinical trial.Assuming that this is the case, the legitimacy of this clinical trial is even more questionable.

It is worth noting that Article 9 of the Measures for the Administration of Applications, which came into force in November this year, stipulates "prohibited technologies" and requires the development of a catalogue of prohibited technologies.Prohibited technologies include technologies that are clinically safe and ineffective, technologies that have major ethical issues, and new technologies that have not been demonstrated by clinical research. They are prohibited from being used in clinical practice.The author believes that the gene editing technology for human embryos used in this incident satisfies all of the above conditions and is fully justified as a "prohibited technology".However, since He Jiankui conducted the experiment earlier than the time when the management measures came into force, the legality of the experiment cannot be judged based on this clause according to the principle that the law does not trace back to the past.

3.The legal responsibility of the investigator and the testing institution

According to the laws and regulations listed above, this clinical trial is indeed suspected of being illegal.So what would the offender pay?

First of all, in the above laws and regulations, regarding the provisions of the punishment measures for researchers, the author only finds the following provisions in the "Ethical Review Measures":

Article 47: If a project researcher violates the provisions of these Measures and has any of the following circumstances, the local health and family planning administrative department at or above the county level shall order it to make rectification within a time limit, and may circulate a notice of criticism and warnings according to the seriousness of the circumstances; for the main responsible person and other responsible persons,Disciplinary actions shall be given according to law:

(1) The research project or research program has not been approved by the ethics committee to carry out the project research work without authorization;

(2) Serious adverse reactions or serious adverse events occurred during the research process have not been reported to the ethics committee in a timely manner;

(3) Conducting project research in violation of the relevant provisions of informed consent;

(4) Other violations of these Measures.

However, the episodes specified in the above articles mainly involve procedural matters in the research process, and do not involve judgments on the content of the research topic.In other words, once the approval of the ethics committee is obtained in the procedure and the obligation of timely reporting and informed consent is fulfilled, the researcher will not be punished according to this clause for unethical research content itself (for example, implanting genetically edited embryos into the mother). (Regarding the statement that He Jiankui did not obtain the subject's informed consent by proper means, the author will not comment on this because it has not yet been determined).

With regard to the punishment measures for research institutions, Article 46 of the Measures for Ethical Review provides as follows:

Article 46: Where a medical and health institution or its ethics committee violates the provisions of these Measures and has any of the following circumstances, the local health and family planning administrative department at or above the county level shall order it to make rectification within a prescribed time limit, and may circulate a notice of criticism and warnings according to the seriousness of the circumstances;Disciplinary actions shall be given according to law:

(1) The composition of the ethics committee and the qualifications of the committee members do not meet the requirements;

(2) The work system or operating procedures for ethical review have not been established;

(3) The review has not been conducted in accordance with the principles of ethical review and the relevant rules and regulations;

(4) The disclosure of the research project plan, personal information of the subjects, and the review opinions of the committee members;

(5) The filing has not been conducted as required;

(6) Other violations of the provisions of these Measures.

In this incident, as a research institute of Hemei Hospital, in addition to the ethical committee's membership may appear in the above (1) cases, the author based on the information currently known It is difficult to find other reasons for punishing it.In addition, the article stipulates that the punishment of research institutions is limited to ordering rectification within a time limit, circulating a notice of criticism, and warning. Whether such punishment can produce sufficient deterrence remains to be discussed.

Fortunately, as mentioned earlier, the "Measures for the Administration of Applications" that came into force just this month also allowed the author to see the development of relevant legislation, of which Article 43 stipulates that for medical institutions that carry out the clinical application of prohibited technologies or do not meet the requirements of the medical technology clinical application management regulations and carry out relevant medical technologies without authorization, local health administrative departments at or above the county level shall handle them in accordance with Article 47 of the "Regulations on the Administration of Medical Institutions". (That is, if the circumstances are serious, the person in charge of the medical institution and other directly responsible personnel shall be punished according to law.This provision obviously strengthens the punishment and can prevent the same events in the future to some extent.

For the civil and even criminal responsibilities that the offender should bear, the current regulations are not specifically detailed.For example, Article 49 of the "Measures for Ethical Review" only stipulates in general that if damage is caused to the person or property of another person, civil liability shall be borne according to law; if a crime is constituted, criminal liability shall be investigated according to law.However, the "law" mentioned here should be based on what method?The author believes that even if the completely new legal issues brought about by clinical trials of genetically modified embryos can apply certain provisions of existing laws and regulations, the cost paid by offenders may be very limited compared to the adverse consequences they bring.For example, Article 54 of the Tort Liability Law stipulates: "If a patient is harmed in the course of diagnosis and treatment, and the medical institution and its medical personnel are at fault, the medical institution shall bear the liability for compensation."In other words, the civil liability for medical damages is based on the premise that the patient is harmed in the diagnosis and treatment activities.However, assuming that the two children and their parents are fortunate enough not to have sequelae caused by genetic editing operations, or that it is technically difficult to prove the damage suffered, can He Jiankui and Hemei Hospital be exempted from tort liability?Even if the tort liability is established, such civil compensation may not match the degree of trampling on medical ethics and the adverse effects on society.

Judging from the previous analysis, the current laws and regulations have generally weak penalties for such illegal clinical trials, and there is no reasonable refinement of the way in which illegal liability is assumed. It needs further improvement.

4.Conclusion

It can be seen from the above that China has limited laws and regulations regarding medical clinical trials involving major ethical issues.Admittedly, for the statutory system, there is inevitably a lag in the formulation of laws and regulations for emerging things.The development of new technologies, including biotechnology, is changing with each passing day. How to guide the application direction of technologies through laws and regulations and standardize the application methods of technologies so that new technologies can benefit people rather than produce unpredictable adverse consequences is indeed a topic that legislators can consider.

The author has seen the evolution and progress from the newly implemented laws and regulations. On this basis, the author believes that the following points can be considered: First, the legislative work on the level of laws and administrative regulations can be considered. Second, it can be considered to explicitly prohibit the clinical application of a controversial technology through the introduction of a list of prohibited technologies. Third, the specific content of attribution and illegal punishment can also be further refined to make it more operable.

The world is so big that we cannot demand that all people be bound by ethics, fear nature, and fear life, but we can expect that in the near future, speculators will at least have laws to fear.

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