Abstract
China has no special legislation on biobanks, and it regulates these banks by several different laws and regulations. In the past 15 years, China's biobanks have collected a large number of biological samples. The law gives many institutions the right to store and use biological samples; however, due to the absence of government regulation, lack of ethical norms, and unclear legal provisions, the risks related to biosafety are rising. In terms of informed consent, China's current legislation clearly defines the scope and standard of “informed consent,” but the corresponding boundaries are still vague, and there are loopholes in practical operation. In terms of privacy and confidentiality, Chinese laws do not specify the ownership of genetic information. In the event of genetic risk, Chinese doctors often tell the family members of patients about genetic information. In terms of cross-border supervision of biological samples, the Chinese government not only regulates the entry of biological samples, but also controls the exit of biological samples. In recent years, the corresponding law enforcement and punishment efforts have increased. In terms of trust, China's biobanks often rely on hospitals. Against the background of tense doctor-patient relationships, biological sample donors do not trust hospitals, which is unfortunate because biological sample donors often donate out of their trust in doctors. In terms of benefit sharing, China's legal system still lacks clear provisions, and there are disputes about the mode and subject of benefit sharing. In China's future legislative revision(s), the above aspects should be improved, the ethical traditions of China's “patriarchal system” should be considered, and a biobanking system in line with China's national conditions should be formulated.
I. Background
B
In 2016, after the Obama administration put forward “Precision Medicine” in the State of the Union Address, China also launched its own precision medicine program 4 aimed at building a large-scale health cohort and a major disease–specific cohort with a natural population of more than a million people; establishing a biomedical big data sharing platform and developing an experimental and analytical technology system to study biomarkers, targets, and preparations on a large scale; building a demonstration, application, and popularization system for the clinical program of precision medicine for typical diseases of Chinese population; and pushing a number of precision therapeutic drugs and molecular detection technology products into the national medical insurance list. 5
At the legal and policy level, the Chinese government put forward the Outline of Healthy China 2030 Program aimed at forming a diverse social co-governance pattern in which the government coordinates society, industries, and individuals. 6 In 2019, the Chinese government formulated the Regulations on the Management of Human Genetic Resources (CRMHG), and put forward that the state should strengthen the preservation of human genetic resources and speed up the standardization of the basic platform for the preservation of human genetic resources and the construction of human genetic resource big data, so as to provide support for the development of related research and development activities. 7 On October 17, 2020, the Biosafety Law of the People's Republic of China (CBL) was promulgated (effective on April 15, 2021), which defined the important position of biosecurity and improved various specific risk prevention and response systems. Among them, the provisions related to biobanking are stipulated in Chapter 1, “General Provisions,” and Chapter 6, “Human Genetic Resources and Biological Resources Security,” which clearly stipulate the principles of state sovereignty and ethics, the approval and exception of activities related to human genetic resources, and the restrictions on the use of human genetic resources by overseas individuals and organizations. The promulgation of the CBL will help fill the legal loopholes in China's biobanking system and regulate the development of corresponding research activities. However, it is the superior law in China's biological field, which aims to systematically sort out and regulate the main risks in the field of biosecurity and improve the basic system. 8
Therefore, as a basic framework norm, the CBL is relatively broad in terms of specific system design, and it needs to be refined and implemented in the future by issuing special legal norms. Generally speaking, these regulations (see Table 1) provide legal protection for the development of biological bank, but there is no special biological bank law in China. Biological banks in China are still in a new stage, are immature, and have many problems.
Main Events of China's Biobanks
II. The Current Situation and Problems
Based on the qualitative research method of literature, this article reviews the relevant legislation, regulations, guidelines, and standard operating procedures of China biobanks, browses the websites of the Ministry of Science and Technology of China and the National Health Commission, and interviews researchers and ethical scholars in the field.
The research on the ethical and legal issues related to biobanks has achieved initial results, which mainly focus on three aspects: first, how to balance the relationship between privacy and development; second, how to balance the individual's informed consent and group informed consent; and third, how to adjust the contradiction between the national security and sharing. Specifically, this article mainly considers “informed consent,” “privacy and confidentiality,” “cross-border supervision,” “trust,” and “benefit sharing.”
The problem of informed consent in the process of collection, storage, and utilization of biobanks mainly revolves around the application of informed consent. Ma Yuhua et al. 9 concluded that doctors play a dominant role in the process of informed consent and that the traditional informed consent model should be applied in China after analyzing 1972 questionnaires. Min Liu and Qingli Hu 10 compared classic informed consent, layered consent, and one-time general (or blanket) consent, and concluded that one-time general (or blanket) consent is the most suitable way for the development of China's biobanks based on the actual situation of China. Wu Chunyan, Jiao Hongtao, and Fan Jiande 11 believed that although the concept of informed consent was formulated in the Interim Measures for the Management of Human Genetic Resources, it should be further deepened in view of the legislative level of administrative regulations; in terms of informed consent mode, individual consent mode should be adopted instead of family informed consent or group informed consent. Huang Xu, Wang Xiuqin, and Zhao Jun 12 thought that the traditional informed consent mode wasn't operational in practice after studying the relevant ethical guidelines of biobanks; the life of a law is its execution. Peng Zhen et al. 13 found that there were problems in the authenticity and integrity of sample provider screening and informed consent signature after reviewing the drug clinical trial data of specific agencies.
As for privacy and confidentiality in the process of collection, storage, and utilization of biobanks, there are three kinds of attitudes towards the privacy protection for biological samples among Chinese local researchers: First, to try to protect the privacy of biological samples though the enforcement of privacy rights; second, to protect the privacy of biological samples as a general personality right; third, to take the privacy of biological samples as “personal information” and try to protect it through the right of personal information. Jiang Meishi and Kuang Yan 14 considered that, as a special right of personality, genetic privacy includes body privacy, property privacy, information privacy, and independent decision; in the absence of laws and slow legislation on genetic privacy protection in China, the basic ethical principles of genetic privacy protection should be established at first. Tian Ye and Liu Xia 15 thought that biological samples aren't suitable for privacy mode in China; in China, privacy rights emphasize the right to exclude others' knowledge of matters in the individual field and don't include the connotation of excluding the individual from knowing his or her own relevant information. Zhang Jianwen 16 believed that, in the era of biobanks, personal information law, as the basic framework of personal information protection, should give special treatment to highly sensitive personal biological sample information under the scope of personal information law.
There is a challenge in the cross-border supervision of biobanks in the process of cross-border transport. With the rapid development of the biological industry, more and more biological samples need to flow across borders. However, due to a lack of laws, weak implementation, and other reasons, the supervision of the Chinese government is relatively loose. Li Xiaobo, Huang Jicheng, and Chen Xiaodong 17 commented on the present situation of export control of biological samples in China, and believed that the control of biological samples in China is relatively loose even though it should be strictly controlled—but the examination and approval procedures should be simplified. Fu Liyuan et al. 18 analyzed the entry system of biological samples in the United States, and concluded that the Chinese government needs to do the following four things: First, import and export biomedicine enterprises must undertake the obligation of good faith management; second, the import and export biomedical enterprises must be the first responsible person for biosecurity management; third, the study and introduction of mature international laws and technologies is necessary to improve the authority and operability of domestic laws and regulations on entry and exit special goods; and fourth, the entry control work of biological samples must pay attention to the necessary investment in basic research. Liu Wenyu 19 believed that the rapid growth of the entry of biological samples in Beijing is in conflict with the efficiency of government supervision, which requires the introduction of credit management to make up for the deficiency of the linear working mode in approval and inspection.
Trust must exist between the sample providers and the collectors in biobanks. Ding Wenbin et al. 20 concluded, based on a questionnaire survey of patients' attitudes towards the donation of biological samples, that the intention to donate biological samples in China is relatively low, and that the education level and the degree of trust in medical institutions are the main factors affecting donation. Jiang Cong 21 conducted a questionnaire survey of people with non-medical backgrounds and found that the Chinese public lacked understanding of biobanks and that people with non-medical backgrounds lacked trust in biobanks. Keymanthri Moodley 22 believed that biobanks involve multiple interest subjects, and that building trust is a prerequisite for stakeholders' access to biobanks; also, that legal mechanisms can help to build such trust.
There is a benefit-sharing problem for biobanks. Tang Mi 23 issued questionnaires to 20 biological sample banks in Shanghai and interviewed 12 key people, then concluded that each bank has a strong desire to share; however, there are no laws and ethical rules on gene sharing at present. Therefore, in order to avoid risk, no actual sharing has taken place. Zhou Yifeng et al. 24 analyzed the construction of different biobanks in different parts of China and found that in the early stage of construction, the information collection, operation, and management of biobanks are seriously heterogeneous and there is no basis for sharing. Li Qian, Jin Liping, and Zhou Xuexun 25 conducted a questionnaire survey on 63 major biological sample banks in China and found that 88.6 percent (1,084/1,223) of the samples were only used in the sample banks or their affiliated institutions and not shared with the outside institutes. Zhang Qiuju and Jiang Hui 26 considered that biobanks are independent of each other, their construction standards aren't uniform, the concept of “intensification” is lacking, and the degree of sharing between different biobanks is low.
Reviewing the existing research, we can find there are certain studies on the following five elements in the construction process of biobanks: “informed consent,” “privacy and confidentiality,” “cross-border supervision,” “trust,” and “benefit sharing.” However, at present, none of these studies has presented the legal and ethical problems existing in the construction process of biobanks in China through an overall perspective. Therefore, this study will have certain theoretical and practical value.
III. Analysis and Discussion
A. Informed consent
The first paragraph of Article 9 of the CRMHG establishes an ethical principle for the research of human genetic resources and explicitly includes “informed consent” in the second paragraph.
27
In terms of legislative purposes, informed consent is placed under the ethical principle, which indicates that obtaining informed consent is an important part of the ethical review of human genetic resources, consistent with the international trend of regarding informed consent as an important medical ethical principle.
28
In Article 55 of the CBL promulgated in 2020, “ethical principles” are clarified and emphasized again.
29
Informed consent is the core of the ethical construction of biobanks. Its structure includes “right to know” and “right to consent.” Its purpose is to protect the “autonomy” of patients and research participants. Through informed consent, researchers can bring participants into the decision-making process of scientific activities. As the concept of “autonomous right” is increasingly agreed upon, as UNESCO wrote in its International Declaration on Human Genetic Data,
Prior to the acquisition of participatory autonomy and express consent, clear and appropriate information must be provided, including how genetic information is used and stored; if necessary, the relevant risks and consequences should be pointed out, and participants should be informed of their right to quit at any time without any reason. The acquisition, use, and storage of genetic information or human tissues, whether obtained by public or private institutions in invasive or non-invasive forms, shall be subject to prior express and voluntary consent.
30
CRMHG made clear in the construction process the scope and standards of informed consent, which must be timely requested when collecting human genetic resources: the human genetic resources provider shall be notified in advance of the purpose of collection, use, possible effect on health, personal privacy protection measures, and that participation is voluntary and that subjects unconditionally quit at any time. The process should proceed only with the written consent of the human genetic resource provider. When informing the provider of human genetic resources of the information provided in the preceding paragraph, the information must be comprehensive, complete, true, and accurate, and must not conceal, mislead, or deceive. 31
China still lacks the protection for the right to know. At present, there are mainly two ways to collect samples related to biobanks. One is to collect samples according to certain research purposes. For example, before testing a clinical trial of a biological drug for chest cancer, the informed consent notice will ask the sample provider whether he or she is willing to hand over the remaining biological samples to relevant institutions for follow-up research and will inform about specific contents. In cohort studies, the corresponding consultation is more common. Research institutions will collect and save biological samples and establish follow-up mechanisms. This type of informed consent is more standardized and meets the provisions of Article 12 of the CRMHG. On the other hand, another method of sample collection has no clear research purpose or plan in advance. For example, clinicians save remaining biological samples for possible future research. 32 In practice, this type of informed consent often lacks norms. There is no uniform standard for whether ethical review is required for the inclusion of the remaining biological samples in the sample bank, and whether the informed consent signed by the donor is needed.
Although China has set up the expectation of informed consent, there are still loopholes in the law. The right of consent can be further divided into the sample provider's expressive ability, intention, and consent decision. The expressive or communicative ability of the sample provider is the premise of exercising the right of consent, which requires that the subject of behavior is adult and has the ability to comprehend what they are being asked and to express their consent thereto. When these requirements cannot be satisfied, the agent will exercise the informed consent right on behalf of the sample provider, which leads to an exception to informed consent.
According to the patients' vulnerability and the state of emergency, Article 55 33 and 56 34 of China's Tort Liability Law (CTL) separately confirm that a close relative may exercise the right to informed consent on behalf of the sample provider. There are three situations in which the close relative functioning as agent exercises informed consent on behalf of the sample provider: First, the sample provider is a person without civil capacity or a person with limited capacity. Because the sample provider lacks capacity, the relevant provisions of the guardianship system in the Civil Law are directly applicable and the close relative has the right to exercise the informed consent right on behalf of the sample provider. Second, the sample provider is the vulnerable sample provider. The so-called vulnerable sample provider refers to the sample provider who has full civil capacity and no disturbance of consciousness but entrusts others to exercise the right of informed consent. 35 The definition of the vulnerable sample provider isn't a legal concept, but rather the concept that some information is “not suitable to be introduced to the sample provider” in Article 55 of Tort Liability Law, which is intended to protect the sample provider. 36 However, in practice, it's up to the medical personnel to determine whether the sample provider is vulnerable. In other words, if the medical personnel think it is not appropriate to tell the truth to the sample provider, they will directly tell the sample provider's close relative, depriving the sample provider of the right to the informed consent. Third, the sample provider has full behavioral capacity, but in case the patient has a temporary confusion of consciousness, the medical staff is required to tell the sample provider's close relative. If the close relative doesn't allow medical personnel to treat, medical personnel have no right to conduct the treatment.
In the gene-editing baby event, the informed consent provided by the researchers stated that the project team has the following right: “the project team or the medical institution shall reserve the umbilical cord blood for later use after the birth of the babies” and “a series of routine examinations shall be conducted by the project team or the cooperative medical institution after the birth of the babies.” 37 However, do all the above-mentioned three situations apply to the unborn baby? Chinese law doesn't regard an unborn baby as a natural person. Chinese law takes “independent breathing” for the concept of a natural person, 38 but an unborn baby can't breathe independently. Thus, the unborn baby doesn't fall under the circumstances stipulated in Articles 55 and 56 of the CTL. Since there is no legal condition, the sample provider's close relative can't exercise the informed consent right on behalf of the sample provider. It can be found from the gene-editing baby event that the “informed consent” system in the development of biobanks is still not perfect and contains limited exceptions.
B. Privacy and confidentiality
During the construction process of biobanks, the most criticized problem is how to ensure the privacy of the sample provider. The privacy right is the most sacred, but also the most difficult, right in contemporary life. In concept, privacy is the basis of personal personality formation, which is necessary to maintain human dignity; however, in practice, suspicions exist everywhere.
The genetic privacy right is the information source provider's dominant right to the genetic information, which is the basic thinking of the personal information protection law. 39 However, while this genetic information is taken from a person's body tissue, does it only belong to that person? There are two problems. First, the person doesn't produce the genetic information because of his or her own behavior—the information is inherited, and the person(s) who create(s) the genetic information is his or her parents. Second, the persons affected by the disclosure of the genetic information are not only this person, but also all his or her close relatives who will be potentially affected (except a spouse). So, a question exists whether these close relatives can—or should be able to—claim their privacy right and prevent a person from voluntarily providing his or her own genetic information to others. China currently has no special laws to regulate the above problems.
When constructing a genetic privacy right in China, we must take seriously the difference between genetic information and other information. Beside the power connection between family members, there is “health predictability.” There has been a great deal of empirical evidence linking genes to certain diseases, and there are two peculiarities of genetic information. In practice, there is the following paradox: suppose that a patient is found and diagnosed with genetic diseases when receiving medical treatment; the pathogenic gene may also exist in his or her close relatives, so there is a question of whether the attending doctor needs to notify the patient's close relatives, and whether doing so amounts to a violation of the patient's genetic privacy. The doctor's obligation is to save people: if the doctor doesn't inform the patient's close relative, the doctor may be violating this professional and ethical obligation. The question arises: does the doctor have a duty of care to the patient's close relatives? According to the privacy right protection principle, the doctor should first obtain the patient's consent if he wants to inform the patient's close relatives of the genetic risk; but if the patient doesn't agree to allow the doctor to do so, what then?
In practice, Chinese doctors pay more attention to the duty of care than to the obligation of confidentiality. The reasons are as follows: first, reviewing the essence of the genetic information, we will find that genetic information isn't a product or information created by the patient himself, but rather is inherited from ancestors, so China doesn't regard it (genetic information shared with close relatives) as a personal secret. At the same time, under China's historical tradition, the patient has an obligation to inform his or her close relatives (though this a moral obligation rooted in Chinese culture, not a legal obligation). However, it would be more objective and useful for a doctor to disclose such relevant genetic information because the link between genetic information and disease is a fairly complex scientific issue, beyond most laypeople's ability to convey accurately. Therefore, the actual practice is to let the doctor tell the patient's close relatives.
C. Cross-border supervision
Human genetic resources are an important national resource and are related to national security. With the gradual development of the precise medical strategy and the continuous development of the biobank construction, different countries are paying more and more attention to the genetic resources. In 1998, the Human Genetic Resources Management Office of China developed the Interim Measures for the Management of Human Genetic Resources, 40 with the purpose of putting an end to any type of trade in human genetic resources and international cooperation violating the principle of equity. 41 Genetic resources themselves have both a physical attribute and an information attribute. At the present stage, the supervision of genetic resources shouldn't only manage the entry of biological samples, but also the exit of biological sample data (see Table 2). In response to the new trend of cross-border regulation, Ministry of Science and Technology of the People's Republic of China (CMST) has issued a series of regulatory measures and regulations in recent years. Since 2018, China's law enforcement has been significantly strengthened. Judging from the published data, the Ministry of Science and Technology announced only one penalty decision in the two years from 2015 to 2017, 42 but three penalty decisions were announced in 2018, 43 indicating that the penalty has been strengthened. At the same time, CMST and the General Administration of Customs jointly issued the Notification on the Implementation of the Internet Verification of the Export Certificate and Exit Certificate of Human Genetic Resources Materials, requiring all units to check themselves. The results showed that there were still six companies, such as BGI (the Beijing Genomics Institute), Huashan Affiliated Hospital of Fudan University, Suzhou Wuxi AppTec, AstraZeneca, Amoydx, and Q'Solutions, still transporting the remaining samples of approved projects abroad “in the name of cooperation.”
List of Laws and Regulations on Cross-Border Supervision of Biological Samples from 2015 to 2019
The reasons why the cross-border regulation is weak are diverse, and the ambiguity of the law itself is one of the factors to be taken into account. The Human Genetic Resources Management Office is a department that examines and approves the exit of genetic resources in China, with the responsibility of protecting genetic resources. There are three key genetic resources protected by the Human Genetic Resources Management Office: First, the genetic genealogy of China; second, the human genetic resources in specific areas; third, the species and quantity of human genetic resources collection activities prescribed by CMST. 44 There is no difference in understanding between genetic genealogy and human genetic resources in specific areas. However, the specified types and quantity of human genetic resources collection activities are controversial. The category specified by CMST refers to the rare disease, special physical or physiological population with significant difference, and the specified number refers to the cumulative number of more than 500 cases. 45 In other words, when a certain genetic resource reaches more than 500 in total, it belongs to the category of resources under special protection in China. In addition, for the cumulative number of less than 500 cases, but also in line with the first three situations, it still belongs to the category of key protection. However, due to the vague and small number of the first three cases, it is difficult to identify them in practice, and there are some uncertainties.
In the newly promulgated CBL, the cross-border transmission and research of human and biological genetic resources in China are clearly limited. According to Article 56, “overseas organizations, individuals, and the institutions they set up or actually control shall not collect and preserve Chinese human genetic resources within the territory of China and shall not provide Chinese human genetic resources to overseas countries.” In addition, the transportation, mailing, and carrying out of China of human genetic resources materials must be approved by the Science and Technology Department of the State Council. 46 If the information of Chinese human genetic resources is provided or opened for use to overseas organizations, individuals, and the institutions established or actually controlled by them, it shall be reported in advance to the Science and Technology Department of the State Council, and the information backup shall be submitted. 47 In international research, scientific research cooperation using China's biological resources should be approved in accordance with the law, and Chinese units and their researchers should be guaranteed to participate in the research substantially and share relevant rights and interests in accordance with the law. 48 It can be seen that the shortcomings of China's cross-border supervision of biological resources have been recognized and are being improved through legislation.
D. Trust
Public participation is an important factor affecting the construction of biobanks. Li Rui et al. 49 believed that public participation is positively correlated with trust. Most of the biobanks in China are constructed based on medical institutions, and the reputation of biobanks and medical institutions are closely related to each other. 50 In recent years, the doctor-patient relationship has become more and more tense. The unreasonable aspects of the medical system, the uneven distribution of medical resources, and one-sided media reports have caused a situation where the public distrusts the medical institutions and the sample provider distrusts the biobanks. Zhang Yue, Chen Xiaoyun, and You Shengfu 51 found that personal trust in doctors became an important reason for public participation through a questionnaire survey among sample providers. Ding Wenbin et al. 52 investigated 648 sample providers and found that the willingness of sample providers to donate biological samples was low, which was mainly caused by the unclear ownership of biological samples.
Whether the ownership of biological samples should be owned by biobanks or individuals is still controversial in Chinese academic circles. Biological samples have an information attribute and also a physical property attribute, 53 and the corresponding results can be obtained from both the information attribute and the physical property attribute. Therefore, the authors think that the ownership of information attribute and physical property attribute should be discussed separately.
There are two statements about the physical property attribute of the biological sample. One is to assume that the biological sample belongs to the substance, and the biological sample provider enjoys its ownership. Yang Lixin and Cao Yanchun 54 believed that organs or tissues separated from the human body aren't part of the human body and should be equivalent to “objects.” In judicial practice, judges tend to identify biological samples as “objects.” 55 Another position is that biological samples are objects, but the biological sample library can acquire the ownership of the biological samples after the samples are abandoned by sample providers—in other words, biological samples are objects abandoned by patients and belong to discards, and therefore medical institutions acquire the ownership of the abandoned objects because of the patients' abandonment. However, the identification of biological samples as discards only takes into account the property attribute of biological samples and doesn't take into account their information attribute. The information itself can't be abandoned, so the abandonment theory isn't reasonable.
The core of the biological samples is the information attribute rather than the physical property attribute. In other words, the key biological information carried by biological samples is the genetic information (data) rather than morphological information in the histopathology. 56 The biological sample provider is the right holder of the genetic information, and the medical institutions have the right to possess, use, and benefit within the scope authorized by the patient. The violation of informed consent and other ethical norms is a violation of the rights of the biological sample provider. Therefore, we believe that the biological sample provider has the property right and information right for biological samples.
E. Benefit sharing
The intellectual property benefit-sharing mechanism involved in the biobanks is the most controversial part in the biological circle, jurisprudential circle, and ethical circle at home and abroad. 57 The new operation mode of the biobanks has a new logical way to the intellectual property, and it is embedded in the medical ethics. 58 When biobanks use biotechnology to discover new innovations, they need to balance the legitimate interests of the sample provider and the group. When it comes to genetic study, the biobanks will enjoy the dividend of the study in the form of genetic patents, medical patents, and so on. We think that researchers who share scientific research results should be rewarded with related benefits, but vulnerable groups should be protected. Moreover, genetic samples of patients with a certain disease (e.g., carriers of a virus) are often more valuable than those of ordinary people. At the same time, researchers are in a dominant position in many aspects, such as technology and capital, while patients are eager to get rid of the disease through medical research and development. Theory of Justice, by Rawls, mentions that social and economic inequality should be arranged in the best way to the worst party. 59 According to the statistics of the National Human Genetic Resources Sharing Service Platform, it found that only 28.5 percent of the sample providers were healthy or had a good body, 33.35 percent had chronic diseases, and 30.33 percent were tumor patients. 60
Genetic patent holders charge a high fee for testing genes, such as the “genetic tumor” test provided by the Beijing Genomics Institute. Feng Xiaoqing 61 believed that intellectual property rights exist to protect the rights of intellectual property creators. Zhang Geng and Xin Junfeng 62 thought that, in order to protect vulnerable groups, the biological sample providers should be protected to a certain extent and a benefit-sharing mechanism should be established.
At present, China has not yet established a benefit-sharing system, the main reason being that the subject and mode of benefit sharing are not clear. In terms of the objects of benefit sharing, the 1996 Statement on Benefit Sharing by the Ethics Committee of the International Human Genome Organization advocates that all human beings should share in and obtain the benefits of gene research, not only the specific population providing gene samples. The Taiwan region of China has promulgated the Measures for Commercial Use of Human Biological Database (2010), which divides the object of benefit sharing into two situations. When the contribution of benefit can be defined, it is recognized as “giving back to the specific group,” and when it is indeterminate, it is regarded as “giving back to the population group.” In Chinese mainland, some scholars claim that the role of human genetic resources providers is similar to that of service inventions, and provide the researchers with essential and decisive material conditions. Therefore, the providers of human genetic resources should also be able to share benefits and enjoy patent rights. 63 However, because there is no employment relationship between the providers of human genetic resources and the researchers, and the providers often do not participate in the research work substantively, there are some obstacles for the corresponding resource providers to become the intellectual property rights holders.
In terms of benefit-sharing methods, the methods suggested in the Statement include providing medical and health services needed by the community, in which event all participating researchers should at least receive information and thanks about genetic research results, and profit-making units should provide a certain percentage (for example, 1%–3%) of annual net profit and medical and health infrastructure construction and/or humanitarian assistance. 64 According to the Guidelines for Human Biobank and Genetic Research Database (2009) issued by the Organization for Economic Cooperation and Development (OECD), the benefits of using the database resources for research should be widely shared by means of information sharing, licensing, or technology transfer. China's Interim Measures for the Management of Human Genetic Resources (2008) only focuses on the ownership and subdivision of intellectual property rights between Chinese and foreign cooperation units in international cooperation projects, and lacks provisions on the interests of researchers, providers of human genetic resources, and other stakeholders. In Article 21 of the Regulations on the Management of Human Genetic Resources (Draft for review) (2016), 65 “benefit sharing,” as one of the principles to be followed in international cooperative research activities involving human genetic resources, was clearly defined. However, the corresponding provisions in the Regulations on the Management of Human Genetic Resources promulgated in 2019 have been deleted, causing widespread debate.
The acquisition and benefit sharing of human genetic resources are closely related to the intellectual property system. Both systems are based on the protection and utilization of human genetic data and information, which together constitute the protection chain of human genetic resources. A reasonable benefit-sharing mechanism for human genetic resources is considered to be the best way to solve the conflict of interests among human genetic resource providers, biobanks, and research developers, which is conducive to the realization of legal return on investment and conforms to the principles of equality, justice, and reciprocity for individuals, families, and groups of human genetic resources providers. 66 The reasonable design and operation of a benefit-sharing mechanism will not cause substantial conflict and damage to the current intellectual property system. Combining the acquisition and development of intellectual property rights with the appropriate benefit-sharing mechanism to jointly stimulate innovation can provide a longer-lasting impetus for the research on human genetic resources. Therefore, we should affirm the value of a benefit-sharing mechanism, and actively explore and establish corresponding sharing mechanism in China's future legislative revision.
IV. Conclusion
In China, biobanks have great potential for development. From the research point of view, Chinese scholars seldom study the storage, secondary utilization, and sharing of biobanks. From the practical point of view, in order to avoid the recurrence of the “Gene Baby” incident, it is necessary and urgent to formulate relevant laws and regulations. These regulations should not only be departmental regulations or administrative regulations but should be raised to the legal level. The CBL, as the framework legal norms in China's biosafety field, still needs to be further detailed by issuing special laws and regulations. When formulating laws and regulations, we should consider the ethical tradition of China's “patriarchy” as well as the changes in privacy and informed consent under the new situation. On the whole, there are still some problems in the legal regulation related to the biobanks, such as “lack of a complete system,” “empty legislative contents,” “unclear powers and responsibilities of the authorities in charge of the implementation of the detailed rules,” and “lack of supervision and punishment measures after the events.”
The control of biological samples in China is still relatively lax; however, it is becoming tighter and tighter. Genetic biological samples have physical property attributes and information attributes, and one of the main reasons that affects trust between parties is that the sample providers worry about their own information being disclosed. The doctor-patient relationship has been strained for a long time and has entered a vicious circle. Most biological sample banks are built in hospitals (or medical institutions associated with hospitals), and unfortunately patients don't trust medical institutions and doubt whether medical institutions will properly manage biological samples. All of these affect trust. In reality, more sample providers provide biological samples because of their trust in doctors rather than in medical institutions. It is a great pity that the benefit-sharing system isn't included in the revised regulations of the CMHGR. The greatest reason for this is that biological sample providers can't become the subject of genetic patent through the behavior of providing samples, but they should be given a certain extent of protection and a benefit-sharing mechanism should be established.
In the construction process of biobanks, many issues need to be solved urgently. The development of biobanks will benefit from the formulation of effective laws and ethical norms, which need to coordinate the interests of all parties. At the same time, it should take into account the social system with Chinese characteristics and the traditional Chinese family view. More importantly, it is necessary to strengthen the implementation of laws and regulations; in order to ensure the orderly and healthy development of biobanks, we shouldn't only legislate but implement the corresponding laws and regulations.