ABA Country Report for China 2003

- Zhai Xiaomei, Ph.D.

Associate Professor, Executive Chairperson; Department of Social Sciences and Humanities, Peking Union Medical College

Executive Director, Research Center for Bioethics

Chinese Academy of Medical Sciences & Peking Union Medical College

Vice-President for China, Asian Bioethics Association

Email: xmzhai@hotmail.com

Eubios Journal of Asian and International Bioethics 14 (2004), 5-10.

1. A Brief History of Bioethics in China

Although the morality of traditional medicine has long history of thousands of years, the bioethics began in modern China with a series of events during 1970s-1980s.

In December 1979 a Conference on Philosophy of Medicine was held in Guangzhou at which a major report was focused on ethical issues raised by advanced biomedical technologies, such as life-sustaining technology, assisted reproductive technology and organ transplantation technology etc. In 1980 the journal Medicine and Philosophy was started, and in its first issue there was an article on brain death and euthanasia. From 1986 the Ministry of Education of China initiated a training program on Medical Ethics/bioethics for training advanced teaching staff in medical schools in China. Many of them later became the backbone of bioethics in China. In 1987 the book Bioethics (Qiu Renzong, Shanghai People's Press) was published, the book was a very popular book in China, and 50,000 copies were sold out soon.

Among the most important events we have to mention two conferences in 1988 and two legal cases. In July 1988 the first National Conference on ELSI Issues in Euthanasia was held in Shanghai, the conference was concluded with a statement on the right of terminally ill to choice the way of dying, all except two participants agreed. The other was the National Conference on ELSI Issues in Human Reproduction (which was held in Yueyang, Hunan Province), this conference ended with a policy recommendation on the regulation on artificial insemination and sperm banks to the Ministry of Health and the State Commission on Family Planning. In 1986 and 1987 there were two legal cases respectively on euthanasia and artificial insemination by donor, which were publicized in the mass media and caused debate among professionals and the public. The case on euthanasia took place in Hanzhong City, Shaanxi Province. A patient's two daughters sued the doctor to the court for he had done active euthanasia to their dying mother upon the request of the patient's another daughter and son. The courts finally sentenced that according to China's Criminal Law the doctor was guilty, but in view of the crime being insignificant he could be treated as non-guilty. The other case was in Shanghai City where a wife whose husband was infertile gave birth to a baby boy with AID, but the husband's parents refused to accept the boy because the boy did not come from the husband's blood line.

Since then almost each year there was a national conference on bioethics in addition to local conferences. Every two years one national conference was organized by the Chinese Society for Medical Ethics and the other was done by the Committee on Philosophy of Medicine affiliated with the Chinese Society for Philosophy of Nature, Science and Technology. These national conferences covered almost all topics in bioethics. Academic exchanges between mainland, Hong Kong, Taiwan and Macao were getting more and more frequently. Apart from these, there were also bilateral or international conferences between China and other countries, such as Sino-Japan, Sino-US or Sino-German Conferences, and the Conference on Bioethics in East Asia (1995). Feminist approaches to bioethics were also promoted at the Symposium on Feminist Thought and Chinese Women (1994), in the Project of Reproductive Health and Ethics (1993-1999), in the project of Feminist Philosophy and Public Policy (1996-1999) and at the Symposium on Feminist Approaches to Bioethics (2002).

After the publicity of the cloned sheep Dolly, bioethics began to be institutionalized in the mainland and became a focus not only from academics but also from the government and legislature, from the public and mass media. The regulations or laws which have been promulgated since 1998 include: Ministry of Health (MOH): Interim Guidance on Ethical Review of Biomedical Research Involving Human Subject (1998); Ministry of Science and Technology (MOST) and MOH: Interim Measures for the Administration of Human Genetic Resources (1998); National People's Congress (NPA): Law on Practicing Doctors (1999); State Food and Drug Administration (SFDA): Drug Clinical Trial Guidelines (2000); MOH Regulations on Human Assisted Reproductive Technologies (2001); MOH Regulations on Compulsory Labeling on GMO (2002); MOH Ethical Principles of Human Assisted Reproductive Technologies (2003); MOH Guidelines on Human Assisted Reproductive Technologies (2003); MOST & MOH Ethical Guidance on Human Embryonic Stem Cell Research (2004). In drafting and discussing these guidelines or regulations bioethicists and other professionals have been involved and participated.

2. Human Genetics and Genomics: Ethical, Regulatory and Legal Issues

Chinese scientists participated in HGP and finished 1% of its work. They also participated in the HGDP the result of which showed that Chinese came from Africa. Now many centers are focusing on the relationships between genes and diseases, the main centers include Chinese National Human Genome Research Center (Northern) and Chinese National Human Genome Research Center (Southern), Chinese Academy of Science, Chinese Academy of Medical Sciences/Peking Union Medical College, Peking University, Fudan University, Shanghai Second Medical University, Central South University, etc. Chinese scientists also are participating in the International HapMap Project.

In 1994 a controversial law was promulgated by the Parliament (NPC): Law on Maternal and Infant Health Care. In Article 10 it is stipulated that if a couple is diagnosed with certain genetic disease of a serious nature which is considered to be inappropriate for child-bearing from a medical point of view after premarital medical examination, they may get married only after consenting to take long-term contraceptive measures of performance of ligation operations. This article is regarded as the discrimination on the basis of genome by critics. In August 1998 representatives of NPC/MOH accepted suggestions made by geneticists/bioethcists who proposed that informed consent/choice should be made a principle, which must be adhered in any place at any time, and promised that some articles of the law will be revised in some way at appropriate time.

At the 18th International Congress of Genetics (Beijing, 1998) participants reached the following consensus:

* Countries share many ethical principles based on the will to do good and not harm. These principles can be applied in many different ways.

* New genetic technology should be used to provide individuals with reliable information on which to base personal reproductive choices, not as a tool of coercive public policy.

* Informed choice should be the basis for all genetic counseling and advice on reproductive decisions.

* Genetic counseling should be for the benefit of the couple and their family: it has minimal effect on the incidence of deleterious alleles in the population.

* The term "eugenics" is used in so many different ways as to make it no longer suitable for use in scientific literature.

* In formulating policy on genetic aspects of health, international and interdisciplinary communication should be carried out at all levels.

* It is the responsibility of policy makers concerned with genetic aspects of human health to seek sound scientific advice.

* It is the responsibility of geneticists to educate physicians, decision-makers and the general public in genetics and its consequences to health.

In August 2003 the Government promulgated Regulations on Marriage Registry in which it is stipulated that marriage applicants only need to bring ID card and "registered permanent residence", premarital medical examination is voluntary, but not compulsory. However, marriage between homosexuals and cohabitation still not be protected by law.

On December 2, 2000 ELSI Committee, HGP China issued a four point statement:

* The research on human genome and its application should be focused on the treatment and prevention of diseases, but never on eugenics;

* In the research on human genome and its application, the principle of informed consent or informed choice should be adhered persistently;

* In the research on human genome and its application, the privacy of individual genome should be protected, and the discrimination on the basis of genome should be combated; and

* In the research on human genome and its application, efforts should be made to promote the equality between persons, harmony between ethnic groups, and peace between countries.

On June 10, 1998 "Interim Measures for the Administration of Human Genetic Resources" was promulgated by The Ministry of Science and Technology and The Ministry of Health and enforced, in which Article 13 (6) stipulates that "No approval for the application in which no evidence to confirm the informed consent being obtained from the donor of human genetic sample and her/his family member."

In November 2001 Ethics Committee, MOH submitted a proposal of Ethical Principles and Regulation on Human Embryonic Stem Cell Research to MOH, the major points include:

* Prohibit human reproductive cloning and permit human therapeutic/research cloning.

* Ethical principles include: Respect, Informed consent, Safety and Efficacy, Non-commercialization.

* Sources: first choice is to derive totipotent stem cells for research from aborted fetal primordial germ cells or the spared human embryo after the success of IVF. The use of nucleus transfer to create embryo to derive stem cells is permissive in special condition, but should be subject to strict regulation.

* Prohibit: Re-implanting the embryo for stem cell research into human or animal uterus; Mixing human and animal gametes or embryos to make chimeras; Using the embryo more than 14 days; Adding any external gene into embryo, or replacing the nucleus of the embryo with any other human or animal nucleus; Coercing or inducing donors to be pregnant and undergo abortion or manipulate the method and time of abortion; Selling and buying human gamete, embryo or fetal tissue. It also called for Ethical review, monitoring, inspection, and ethics training is required.

There has been much debate on ethical issues in human genome research, human cloning, stem cell research, gene therapy, xenotransplantation, GMO, gene patenting etc. A project on these issues under the directorship of Dr. Zhai Xiaomei was completed at the July of 2003. This project was sponsored Beijing Municipal Government. Some of the findings have been incorporated into the proposal of Ethical Principles and Regulation on Human Embryonic Stem Cell Research made by Ethics Committee, MOH. The next step is to draft an act on one or other specific issue such as GMO and submit it to Beijing Legislature.

In January 2004 Ethical Guidance on Human Embryonic Stem Cell was promulgated jointly by MOST & MOH, the major points of which include:

Article 1: In order for the human embryonic stem cell research in the field of biomedicine in China to comply with bioethical norms, to assure the international bioethical guidelines and Chinese regulations concerned being respected and observed, and to promote the healthy development of human embryonic stem cell research this guidance was developed.

Article 4: Any research for human reproductive cloning shall be prohibited.

Article 5: The human embryonic stem cell used for research can be derived only by: (1) spared gamete or blastula after IVF; (2) fetal cells after natural or voluntarily selective abortion; (3) blastula or monosexual split blastula by somatic cell nucleus transfer technique; and (4) germ cells voluntarily donated.

Article 6: The conduct of human embryonic stem cell research must comply with the following norms: (1) when a blastula is obtained by IVF, somatic cell nucleus transfer technique, monosexual reproduction technique or genetic modification, the culture period in vitro cannot be more than 14 days since fertilization or nucleus transfer; (2) the implantation of the human blastula which has been used for research into human or other animal's reproductive system is prohibited; (3) the hybrid between human germ cells and germ cells of other species is prohibited.

Article 7: Buying and selling human gamete, fertilized egg, embryo and fetal tissue are prohibited.

Article 8: The principle of informed consent and informed choice, the signing of informed consent form and protection of subject's privacy must be adhered in the conduct of human embryonic stem cell research.

Article 9: The institute which is engaged in human embryonic stem cell research should establish ethics committee the function of which is to conduct the scientific and ethical review, counseling and surveillance for human embryonic stem cell research.

3. Ethical Issues in Biomedical and Health Research in China

China is a country which has a long medical history with thousands of years but without the tradition of human experimentation. There are epistemological and ethical reasons to argue against human experimentation. However, Chinese are the main victims of anti-human and anti-humane human experimentation conducted by the Japanese Unit 731 Troops during the Japanese occupation, and they still bear the consequences of Japanese germ warfare. Since the policy of reform and openness scientists within and without mainland China found that China is rich with human, animal and plant genetic resources and pharmaceutical companies found that China would be one of the biggest markets in the world. So the research involving human subjects would be developed in China with an unimaginable pace and scope.

In 1998 MOH promulgated "Interim Guidance for Ethical Review of Biomedical Research Involving Human Subject" which emphasizes "this regulation is for safeguarding human dignity, protecting human life and health and observe basic ethical principles" and include chapters on informed consent, responsibilities of the investigators, rights of human subjects and IRBs.

On September 1, 1999 the State Food and Drug Administration (SFDA) promulgated "Drug Clinical Trial Guidelines" in which it is emphasized that: "All research involving human subjects must comply to ethical principles elaborated in Helsinki Declaration and in CIOMS' International Ethical Guidelines on Biomedical Research Involving Human Subjects, i.e. justice, respect, maximum benefits to human subjects, and avoidance of harms as far as possible" (Article 4) and "In the process of drug clinical trials the individual rights and interests of human subjects must be safeguarded, and the research must be scientific and reliable as well. Ethics Committee and informed consent are major measures to guarantee human subjects' rights and interests." (Article 8). At least 165 IRBs have been set up since 1999.

In the Law on Practicing Doctors, promulgated by National People's Congress and enforced on May 1, 1999 it is stipulated in the Chapter on "Legal Accountabilities" that if a doctor conducts experimental clinical treatment without the consent from the patient or her/his family member (Article 8) and discloses patient's privacy and cause serious consequences (Article 9), he/she has to bear the legal accountabilities.

Many IRBs did work very well, but many did not. Many members of IRBs/ECs and PIs are not ethically well trained, they don't know what is the function of IRBs/ECs and how to fulfill it. Some IRBs/ECs actually only did scientific review, not ethical review. There is no inspection to these 165 IRBs affiliated with SFDA, and the enforcement of regulations is very weak in MOH: some ECs only review the protocols in cooperation with foreign colleagues. So capacity-building for bioethics and research ethics is an urgent need in China. As a symbol with the publishing of the books An Introduction to Bioethics (2003) and Biomedical Research Ethics (2003), the training in bioethics and research ethics will be strengthened in coming years from 2004. The first training project is sponsored by CMB (Chinese Medical Board) and the training workshop will be held in February 2004. The Ministry of Education authorized PUMC Research Center for Bioethics to organize a workshop to train bioethics teaching staff for the course "Ethics in Biomedical and Health Research" in the middle schools in this summer. Following these training activities there will be other training projects include that under the sponsorship of NIH.

In complying with international ethical guidelines on biomedical and health research involving human participants the cultural characteristics emerged in China. As well as in clinical context in research context the elements of disclosure of information and comprehension of it were affected by the factors of scientific illiteracy and culturally different discourse. For example, how to disclose the information framed in scientific language to human participants who may only know the language of yin-yang and five agents and how to help them to understand the information disclosed. As for the element of consent, in the Chinese cultural context the individual is in a closer relationship with the family and community he/she belongs to than his/her western counterpart. So we have to consider how to deal with the relationship between individual's consent and family/community's permission when a research project will be conducted with human participants who are living with other members of her/his family/community?

4. Ethical and Policy Issues in HIV and SARS Ethical, policy and legal issues related to HIV prevention and treatment have been debated for a long time. In 1993 and 1996 Ethical Principles and Action Recommendations on STD/HIV and Action Recommendations on HIV and Prostitution have been submitted to the government and legislature respectively. In 2000 an action recommendations including an ethical framework for evaluation of action in HIV under the sponsorship by the Chinese Academy of Science was finished and sent the government, and the government accepted all recommendations except the suggestion of revising the law on prohibiting prostitution and drug use. In 2002 a report on law reform related to HIV was finished by a consultant team under the sponsorship of UNDP and sent to the government and legislature. The report addressed the issues such as: Why is it necessary to carry out law reform in the prevention and care of AIDS? What kind of laws do we need: Punitive or protective? Why are the conventional public health measures ineffective for AIDS? Why the prevention of AIDS should not be tied up with the solution of social problems? Is it necessary to re-evaluate the current policies on drug use and prostitution? Why it is impossible to escape the issue of human rights? Why NGOs are indispensable in prevention and treatment of HIV/AIDS? Do we have the political determination to carry out legal reform? The report contains the specified suggestions of how to revise the current laws related to HIV. Also the Chinese legislature has started to consider this law reform. (The English version of this report is available in the office of UNDP). Now in Suzhou City, Jiangsu Province, a regulation on HIV was promulgated in 2003 with the focus on combating discrimination against people living with HIV. In Shanghai City the current regulation on HIV would be revised soon.

The SARS epidemic in China in 2003 highlighted the weakness of public health system, the shortcomings of health care reform and the inadequacy of resources allocated to health care, and public health in particular. The health care needs of rural people including those who are working in urban areas became a focus of decision-makers', professionals' and public concern. Health information transparency and health literacy are also concerned.

5. Assisted Reproductive Technologies

The infertility rate in newly married couple is increasing for unknown reason in China. However, the Confucian value on having offspring still remains. What Mencius said still affects Chinese mind: "Among three sins which violate filial piety the largest is being without offspring." Infertility has been regarded as a punishment for the misbehavior done by infertile people's ancestors or in his/her previous life. So infertile people experience psychological and social pressure. The need or demand for the assistance from reproductive technologies is so great that ART became so popular and a money-making business. In the first National Conference on Reproductive Technologies participants worried about the social and ethical issues in artificial insemination and suggested MOH and the State Commission on Family Planning to regulate them. But the response was that these two ministries thought it was not the proper time to regulate them. In 1999 at the Fragrant Hill Science Conference on the 21st Dilemmas of Bioethics in Kunming City participants raised the regulation issue again. This time MOH accepted the suggestion and set up an expert team to draft the regulation.

On August 1, 2001 Regulation on Human Assisted Reproductive Technologies was promulgated by MOH and enforced. Article 22 prohibits: Selling or/and buying human gamete, zygote or embryo; Surrogate motherhood; or Unauthorized sex selection.

In July 2003 MOH promulgated Ethical Principles of Human Assisted Reproductive Technologies in which the following principles are specified: benefit to patient, informed consent, protecting children, social good, privacy and confidentiality and non-commercialization. At the same time MOH promulgated "Guidelines on Human Assisted Reproductive Technology" in which it is stipulated that practitioners must:

-- Must strictly observe the voluntary principle of informed consent or informed choice;

-- Must respect the patient's privacy;

-- Prohibit sex selection without medical indications;

-- Prohibit surrogate motherhood technology;

-- Prohibit the hybrid between human gamete and gamete from of other species; prohibit to implant gamete, zygote and embryo of other species into human body, and prohibit to implant human gamete, zygote or embryo into the body of other species;

-- Prohibit the coagulation between sperm and egg of close relatives;

-- Prohibit to transfer the gamete, zygote or embryo to other people or to do research without the patient informed and free consent;

-- Prohibit to do the study on human chimera embryo;

-- Prohibit human reproductive cloning.

6. Brain Death and Organ Transplantation

Human organ transplantation began in 1972 when Sun Yat-sen Medical College did the first kidney transplantation between family members, but the patient only survived more than one year. In 1981 the number of the cases have been underdone all over mainland China is kidney transplantation 800, liver 54, heard 3, lung 2. During the recent decade organ transplantation has been developed rapidly. In 2001 the number of kidney transplants reached to 5561, second only to USA. The advances of organ transplantation technology caused the social needs. The provision of organs has been far less than the demand. One reason is that Chinese have not accepted the concept of brain death yet, so China is only a major country in the world which brain death has not been legalized. The other reason is the influence of traditional cultural tradition which requires a person to keep his/her body intact before to cremation. According to rough estimate each year the number of patients who need to undergo organ transplantation reach to 100 or 150 millions, however, only 130 thousands undergo the operation.

In 1996 108 members of the National Political Consultation Conference (NPCC, China's Senate) presented an act on the legislation on corpse organ donation in Beijing, Tianjin and Shanghai cities. Since then almost every year there were members of NPC or NPCC provided the similar act. On December 15, 2000 Shanghai Municipal People's Congress promulgated "Regulation on Corpse Organ Donation" which was enforced on March 1, 2001. On August 22, 2003 Shenzhen Municipal People's Congress promulgated Regulation on Human Organ Donation and Transplantation in the Special Economic Zone of Shenzhen. Human Province's Regulation on Human Organ Donation and Transplantation will be promulgated in 2004. In recent years MOH initiated to develop the Regulation on the Determination of Brain Death, Criteria for Determining Brain Death, and draft the Regulation on Human Organ Transplantation. All these regulations emphasize the principle of voluntary consent and non-commercialization, organ selling and buying are prohibited.

In the case of the demand far much more than the provision the controversial practice of using organ of prisoners who were sentenced to capital punishment after the execution has done in mainland China. Some bioethicists (e.g. Qiu Renzong) has argued that this practice relying on organ of prisoners who were sentenced to capital punishment after the execution is ethically unjustifiable. And this practice will be ended with changing the way of execution (shooting replaced by injecting drug).

Chinese bioethicists have regrettably seen that some persons abroad have deliberately fabricated so-called facts and attacked China on the issue of organ transplantation. For example, an American University published an article on illegal organ trade of prisoners with capital punishment in China. In 1998 Carl Becker attacked China with distorted facts at a section of International Congress on Bioethics in Tokyo and his claims were refuted by Chinese scholars. However, in Bioethics vol. 13, no. 3/4, 1999 Carl Becker's article titled "Money Talks, Money Kills? - The Economics of Transplantation in Japan and China" was published. In this article the author attacked China to increase the number of the prisoners with capital punishment for the purpose to use their organ in transplantation and to make money. Carl Becker has never been in China and groundlessly related the number of the prisoners with capital punishment with the use of their organ after execution. Bioethics is a journal of International Association of Bioethics and the elementary requirement to publish an article should be evidence-based and reliable, and the article with prejudices should be carefully reviewed. As we knew that the article had been sent to Professor Gerhold Becker, Hong Kong Baptist University to review and Professor Gerhold Becker rejected this article as problematic. However, the editor of Bioethics persisted to publish it regardless of the article review procedure. We don't know why? What is the intention in the editor's mind?

7. Euthanasia

Euthanasia is the first bioethical issue that Chinese are interested in. There were a number of legal cases about euthanasia, however, the conception of euthanasia in the public as well as in professionals is confused. For example, Hitler's "euthanasia" is not euthanasia, passive euthanasia is not euthanasia too. Questionnaires showed that about 80% in the public favor euthanasia, while 20% against. In medical professionals there is conflicting attitudes towards euthanasia. However, the majority of ethicists favor euthanasia. But according to the interpretation of the Criminal Law euthanasia should be regarded as a kind of murder because of two elements: the actor has the intention to kill someone and someone's death is caused by the action. Nevertheless, even though euthanasia is treated as murder, but the sentence is always only three years prison for the offender, but in the case of murder the offender is usually sentenced to life prison if not to capital punishment. This shows that there is difference between euthanasia and murder.

Secondly there is some problem in the arguments for euthanasia. In Chinese literature there are some articles in which the argument for euthanasia is for relieving the burden from family or society, but more bioethicists argue that the justification for euthanasia is the beneficence to the terminally ill and for the respect for her/his autonomy or self-determination.

The third issue is whether euthanasia should be legalized. Almost in each session of NPC there are acts to request euthanasia legalized. But some bioethicists argued that it is not the time now to legalize euthanasia in Mainland China. In view of that the fiduciary relationship between physician and patient is getting worsen and the turn to market is eroding the sense of filial piety in the public, the legalization of euthanasia would lead to many unexpected negative consequences. What we need, they argued, is non-criminalization of euthanasia, that is to set a series of strict conditions, which is to be met if euthanasia is not treated as murder, while the interpretation of euthanasia as murder will be no change.

In 2003 a book titled as Dying with Dignity (Zhai Xiaomei) was published in Beijing. The book considered all ethical questions and discussed all arguments relating to euthanasia raised in Mainland China.

8. Recent Developments

In addition to those mentioned above, further developments that should be mentioned include setting up of Centers for Bioethics in universities or medical schools such as in Chinese Academy of Medical Sciences/Peking Union Medical College (PUMC), Huazhong University of Science and Technology / Tongji School of Medicine, and Wuhan University. Some representative books on bioethics were published in 2003, such as An Introduction to Bioethics (Qiu Renzong and Zhai Xiaomei, PUMC Press), Biomedical Research Ethics (Chen Yuanfang and Qiu Renzong, PUMC Press), Bioethics (Xu Zongliang, Shanghai People's Press) and Bioethics (Shen Mingxian, Higher Education Press).

Most recently was a cooperative conference under ABA, the Beijing International Conference on Bioethics. Organized by the Research Center for Bioethics, Chinese Academy of Medical Sciences/Peking Union Medical College (CAMS/PUMC), Philosophy Summer School in China: China, Britain, Australia; and the Committee on Bioethics, Beijing Society for Bio-engineering, the Beijing International Conference on Bioethics which had been postponed because of the SARS epidemic was rescheduled and held on January 5-7, 2004. There were about 120 bioethicists who participated in the conference, apart from those coming from mainland, Hong Kong, Taiwan and Macao, there were also those coming from Korea, Japan, the Philippines, Australia, New Zealand, South Africa, Britain, the Netherlands and USA, among them many are world famous bioethicists. Main topics of the conference are Ethics in Biomedical and Health Research, HIV/AIDS and Ethics, and Ethics and Genomics/Biotechnology. There were four panel discussions: Informed Consent in the Context of Non-Western Cultures, Ethical Lessons from Japanese 731 Troops, Ethical and Policy Issues in HIV Prevention and Treatment, and Social Responsibility of Geneticists/Scientists.

Furthermore, Chinese bioethicists are also considering hosting the 2006 IAB Congress.

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