September 2022
Dr. Chung-Teh Lee, Teresa Huang, Hannah Kuo, and Sally Yang
1. Introduction
The recent significant advancements in regenerative therapy has brought new hope to patients with various incurable diseases, and the thriving regenerative therapy technology and regenerative medicinal products[1] have also boosted the need for cells, genetic samples, and their derivative biological data for research use by research institutions, biotech companies, and healthcare institutions in the biotech industry chain. However, the difficulty in obtaining specimens and their derivative biological data for research use under the current laws, regulations, and practices indirectly increases the cost for and difficulty in research and development. Furthermore, because regenerative therapies are expensive, even when new regenerative treatment methods are introduced, many patients still cannot afford the therapy and receive the treatment after they and their families have been burdened by the long-term illness.
Hence, regarding the obtaining of human cells, genetic samples, or their derivative biological data for the research and development of regenerative therapy, in recognition of the patient’s right to determine the disposition of his/her body tissues and their biological data, it is worth discussing whether or not patients of specific diseases (e.g., critical or rare illnesses) are allowed to license the use of or donate their cells, genetic samples, or their derivative biological data on a benefit-sharing basis to lower their economic burden, as well as to facilitate the use of such cells and genetic samples having research value to help develop regenerative therapy technology.
2. Major legal bases governing the collection and use of human cells, genetic samples, and their derivative data
In early times, the Notice for the Collection and Use of Human Specimens for Research Use and Human Research Ethics Policy Guidelines promulgated by the competent authorities were the major legal bases for obtaining and using human cells, genetic samples, and the relevant data for the research and development of biomedicine. Following the addition of (1) the human trial-related regulations to the Medical Care Act in 2009; (2) the legislation and passage of the Human Biobank Management Act in 2010 to govern the establishment, use, and management of the human biobank; (3) the establishment of the Human Subjects Research Act in 2011 for the control over the “research involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information”; and (4) Article 6 of the Personal Data Protection Act (2016) to regulate the collection, processing, and use of sensitive personal data including medical records, healthcare, genetics, and health checkups, the legal basis governing personal cells, genetic samples, and their derivative data have been elevated to the level of an act.
In terms of the subjects governed by the aforementioned acts, the Human Biobank Management Act regulates “human biobank”, i.e. a database established “for the biomedical research (i.e., medical research in relation to basic biological characteristics, such as genes) to store the participant’s specimens, natural person’s information, and other related data and information based on human population or specific groups without delinking”. The Human Subjects Research Act governs “human subject research”, i.e. the act of engaging in “research involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information”. The Personal Data Protection Act governs “personal data”, i.e. a natural person’s name, date of birth, ID Card number, passport number, features, fingerprints, marital status, family information, education background, occupation, medical records, healthcare data, genetic data, data concerning a person’s sex life, records of health checkups, criminal records, contact information, financial conditions, data concerning a person’s social activities and any other information that may be used to directly or indirectly identify a natural person”. Since the above three acts respectively regulate the “research” of human subjects, the “human biobank” required for human subject research, and the sensitive personal data, such as “data” of medical records, healthcare information, genetic information, and health checkup information required for the research, the process of conducting regenerative medicinal research would fall within the scope of these acts.
3. Whether benefit sharing is allowed for the provision of human cells, genetic samples, and their derivative data under the current laws and regulations
(1) Current legal requirements
Previously, the Notice for the Collection and Use of Human Specimens for Research Use and Human Research Ethics Policy Guidelines governed the benefits derived from research by requiring notice to the provider/participant and entry of a written agreement, specifying that “when rights and interests, such as commercial benefits, may derive from the collection and use of specimens, the user of specimens shall inform the provider of specimens and a written agreement shall be concluded”, “the participants shall be informed of and a written agreement shall be concluded for potential commercial benefits derived from the human subject research”. Further, unlike the Assisted Reproduction Act and Human Organ Transplant Act, the Human Subject Research Act does not explicitly require the free donation or provision of specimens. According to the interpretation of such a legislative model, it seems that benefit sharing for the provision of human cells, genetic samples, and their derivative data for human subject research has not been completely banned by the current Human Subject Research Act.
Furthermore, with reference to Article 21, Paragraph 1 of Human Biobank Management Act: “Any benefits derived from the commercial use and received by an Operator and Biobank shall be given back to the human population groups or specific population groups to which the respective participants belong”. Based on the authorization, the competent authorities have further established the Regulations Governing the Benefit Sharing for the Commercial Use of Human Biobank (“Benefit Sharing Regulations”) to govern the benefit sharing scheme for the commercial use of the Human Biobank. According to Article 5 of the Benefit Sharing Regulations: “Benefits derived from the commercial use of the Human Biobank shall be shared according to the following methods: (1) the operator and user of the biobank shall define the amount or ratio of benefit sharing in a contract in advance for the predictable royalty income; and (2) the biobank operator shall define fixed-amount charges according to the nature and quantity applied for use for difficult-to-predict potential commercial benefits. When the biobank operator is the user as defined previously, the ratio of benefit sharing or fixed-amount charges shall be defined by its institutional review board (“IRB”).” According to Article 6 of the Benefit Sharing Regulations: “The recipients of the benefits from the commercial use charged by the biobank operator are as follows: (1) the specific group which is a major contributor to the production of benefits; and (2) the population when the connection with any specific group contributing to benefit production is hard to define. When sharing for the aforesaid recipients, the benefit sharing or fixed-amount charges in the preceding article shall not be lower than 50% of the amount actually charged and shall be disclosed to the public.”
Additionally, the Benefit Sharing Regulations also stipulate that the obligation for the user to declare the status of future commercial use shall be included in the contract between the Biobank and the user, and the IRB of the biobank shall supervise the regulation, use and management of the commercial benefits of the biobank. Moreover, the biobank operator shall, on an annual basis, disclose information regarding the benefits received from its commercial use of the biobank, and the biobank shall also explain the principles and provide participants with written information regarding the benefit sharing for the commercial use during the recruitment stage.
Based on the above, under the current laws and regulations, only 50% of the benefits from commercial use will be given back to specific groups or populations in human subject research using the specimens and data of the human biobank, the current laws and regulations do not require that biobank operators to share benefits with the individuals providing specimens. It seems that the direct benefit sharing for individuals of the potential commercial benefits, rights, or interests derived from human subject research is left to be determined in individual contracts, and neither the obligation for allocation of nor the right to request for such benefit sharing is mandatory.
(2) Current status of operation of the benefit sharing mechanism of commercial benefits from human biobanks and human subject research
Under the current regulatory framework, in consideration of the research ethics, to avoid the allegation of inducement with interest of participants in the research projects, projects with large databases will not provide direct monetary rewards to their participants. For example, the Taiwan Biobank of the Academia Sinica has stated that its participants will not receive economic benefits or rewards of any kind, and participants shall make no claim for any property interest for the specimens and their derived data provided. The outcomes (e.g., intellectual property rights) with commercial value directly or indirectly derived from the specimens and the relevant data or information provided by participants shall be awarded to the unit conducting the research and development, and participants shall make no claim of any rights over such outcomes. Instead of sharing benefits with individuals providing specimens, the Taiwan Biobank will provide the population or specific group to which the participants belong with the related commercial benefits produced or derived from the use of the biobank according to the Taiwan Biobank Directions for Benefit Sharing with the Benefit Derived from Commercial Use. Additionally, the Taiwan Biobank will never voluntarily provide the examination data or research outcomes of the specimens provided by participants, except at the request by the participants for an examination report. The Taiwan Biobank will only inform the general public of the research results obtained from the use of the biobank’s specimens and data over the institution website, news, or the press.[2]
In conclusion, as the right to claim for benefit sharing of the providers of personal cells, genetic specimens, and their derived data is not stipulated in the current laws and regulations, the common practice is: research and development or healthcare institutions request individuals or patients for free provision of personal cells, genetic specimens, or their derived data based on public interests, while the research outcomes, including intellectual property rights and the gains from the commercialization of medications developed, obtained from the use of such specimens or data, are awarded to the research and development units, biotech companies, hospitals, or pharmaceuticals. As a result, besides the inability to share in the benefits from the subsequent research outcomes and the development of medical technologies and medications, the individuals or patients providing their own specimens must pay high costs for therapies using the new technologies or medications developed instead. Consequently, it seems that under such a practice participants making contributions to the regenerative industry will not be able to effectively and adequately share in the overall profits and outcomes. Hence, it seems that there is a need to improve or relax the current commercial benefit sharing mechanism.
4. Recommendation and reflection
In general, the assessment of “access” to medical therapy usually include the affordability and availability of therapies. In terms of accessibility to regenerative medical resources, although the availability of part of the cell and genetic therapy is covered in the current laws and regulations and the three acts regarding regenerative therapy that are currently under discussion among administrative sectors, the affordability of regenerative medical therapy is not emphasized. As regenerative medical therapies are expensive, if patients may receive the commercial benefits gained by research institutions or biotech companies developing such therapies for providing their own cells and genes for research, besides benefiting the research of therapies for the relevant illnesses, this mechanism can help patients to lower the economic burden from the therapy.
Hence, this paper recommends the provision of substantial benefits and assistance for specific participants through and by adjusting the current mechanism for sharing commercial benefits. For example, institutions engaging in human subject research and human biobanks should be requested to provide participants with information regarding the research outcomes of the relevant illnesses, the opportunity to receive these treatments in priority, the direct payment from the commercial benefits or subsidy for the therapy expenses. Through the progressive development of a reasonable framework for allocating the benefit, rights, and interests of the biomedicine industry, the benefits gained from the successful commercialization in the industry can be directed to the upstream research institutions and directly provided to the individuals for providing specimens and data required for the research in order to further facilitate the research and development of the biomedicine industry.
However, while adjusting the current mechanism for sharing commercial benefits, it is necessary to pay attention to the ethical and other legal issues. From the viewpoint of upstream research and development institutions, will harming the body and health of individuals as a result of provision of specimens for money or other benefits without the need for examination or therapy constitute a violation of research ethics and medical ethics? If providing participants with a specific proportion of the substantial benefits, as higher commercial benefits are usually found in downstream industries, a carefully designed mechanisms would be necessary to ensure the credible assessment of the final commercial benefits, the benefit sharing for all participants providing biological data in the complete industry chain, and the protection of their privacy. Additionally, the possibility of coordinating the provision of specimens and data and facilitating sharing commercial benefits through a neutral agent in the benefit sharing system; the qualifications, authority, and restrictions of this agent; and the assessment of the level of contribution of individual providers of biological data and the overall equality of benefit sharing to each individual will all be inevitable issues.
Through the consultation and discussion of legislation relating to regenerative therapy in Taiwan, besides ensuring healthcare standard and safety and facilitating the development of the regenerative therapy industry, this paper also hopes to appropriately consider the affordability of the therapies from the viewpoint of current or potential patients in order to develop a legal system that can better fulfill the interests and needs of the complete regenerative therapy industry chain and participants and thereby facilitate the thriving development of Taiwan’s regenerative therapy technology and industry.
(The authors’ opinions do not represent the position of this law firm.)
[1] With reference to the recent consultation and discussion of the three drafted acts on regenerative medical treatment, no consensus has been reached regarding making independent legislation or a special law under the Pharmaceutical Affairs Act to govern regenerative medicinal products. Please refer to the consultation meeting on the Draft of the Act for the Management of Regenerative Medicinal Products dated 2022.4.18 at https://www.fda.gov.tw/TC/siteContent.aspx?sid=12095.
[2] Please refer to (1) Taiwan Biobank Participation Consent at https://www.twbiobank.org.tw/docs/%E7%A4%BE%E5%8D%80_%E5%8F%83%E8%88%87%E5%90%8C%E6%84%8F%E6%9B%B8_20210111_compressed.pdf and (2) Taiwan Biobank FAQ at https://www.twbiobank.org.tw/attendance_qa.php (last viewed on June 12, 2022).