The multiple roles of cord blood banks in Taiwan: competition and collaboration

Abstract

In Taiwan, as in many countries where national cord blood donation programs are not available, cord blood donation and banking services are provided by non-governmental sectors. This article discusses: (1) the various cord blood banking models to critically examine the public and private binary; and (2) the collaboration and networking between cord blood banks and other institutions as strategies in response to strict governance and fierce competition. This article, based on fieldwork in Taiwan, gives an overview of cord blood banking models in Taiwan and shows the interdependent relationship among different stakeholders in the generation of stem cell knowledge. The concept of “bionetworking” is drawn upon to analyze the networks that cord blood banks establish with various stakeholders. I argue that, through analyzing networks and activities that cord blood banks engaged in and their relation with science, our understandings of stem cell knowledge and therapies production can be deepened.

Keywords:

• cord blood bank
• hybrid model
• Taiwan

Introduction

Since the first successful cord blood transplantation was performed in 1988 (Gluckman et al. 1989), cord blood has been an important source for stem cell transplantation, in addition to bone marrow and peripheral blood. Cord blood is becoming promising in regenerative medicine (McGuckin and Forraz 2008; Kluth, Radke, and Kogler 2012). Cord blood clinical trials are going on all over the world, attempting to treat incurable conditions such as spinal cord injury (Saporta et al. 2004; Park et al. 2011), cerebral palsy (Chen and Clowry 2011), and diabetes (Bahk et al. 2010). In the past few years, cord blood- or cord-derived stem cell drugs have been approved in the USA, Korea, and Canada, as demonstrated by numerous new drugs such as Hemacord, Cartistem, and Prochymal (Bersenev 2012; Salter, Zhou, and Datta 2013).

The division of public and private cord blood banks is often treated as a dichotomy between altruism and self-interest (Waldby and Mitchell 2006; Dickenson 2013). Some medical and bioethical bodies, such as the American Academy of Pediatrics (2007), RCOG (2006), and the European Group on Ethics in Science and New Technologies (2004), have published statements supporting public cord blood banking as opposed to private cord blood banking for families that do not have a foreseeable risk, such as a family history in blood disease. But how do we define public and private cord blood banks? Do we classify a bank in reference to its funding organizations or by the way the cord blood is used? How do the hybrid banks challenge the public and private division, and create alternative networks and collaborations in stem cell sciences? Taiwan epitomizes diverse arrangements of cord blood banking, which lead to different forms of network and collaboration. This article gives an overview of cord blood industry in Taiwan and introduces various cord blood banking models to question how we define public and private cord blood banks. I then draw attention to the roles that cord blood banks in Taiwan play in local and global stem cell science through various cord blood banking models and partnerships with different stakeholders.

Bionetworking

The cord blood industry has developed various banking types which generate different forms of networks and collaborations. I use the notion of “bionetworking” that is termed by Sleeboom-Faulkner (2014) to analyze these collaboration in the cord blood industry. Bionetworking is defined as “a social entrepreneurial network activity involving biomedical research and healthcare organisations that thrive under conditions of health inequality” (Sleeboom-Faulkner and Patra 2011, 647). It emphasizes on capturing informal social and entrepreneurial liaison within the local, national, and global interconnectivity and dynamics of life sciences (Patra and Sleeboom-Faulkner 2013). This concept highlights the informal, in addition to the formal, networks to mobilize and exchange resources from different stakeholders such as scientists, entrepreneurs, regulators, and patients in biotechnology (Patra and Sleeboom-Faulkner 2013; Sleeboom-Faulkner 2014). This approach focuses on how different actors build up collaborations and networks and utilize existing gaps in knowledge, regulations, and socioeconomic levels across geographical spaces, regulatory regimens, and social institutions. Patra and Sleeboom-Faulkner (2009, 2013) use cases in India to show how therapies with little scientific evidence of support are made possible through networking. They argue that it is through these networks, liaising, and collaboration that bioscience is produced.

Cord blood banks exemplify the mixed nature of the biotechnology industry, which involves networks of divergent institutes and actors. The cord blood industry attracts various stakeholders with common or competing interests, such as government, science, business, medicine, patients, and donors. Bionetworking provides an analytical framework to examine activities and exchanges among biomaterials, research institutes, healthcare services, biotech enterprises, administrative authority, and so on. Actors in the bionetworks, however, do not necessarily target producing scientific knowledge, but on various interests, such reputation and business profit, that might promote, or hinder, knowledge production.

Taiwan epitomizes diverse arrangements of cord blood banking which lead to different forms of networks and collaborations. Using the theory of “bionetworking,” this article moves beyond the normative discussion of cord blood banks; instead, it discusses the multiple roles that cord blood banks play in the stem cell sciences through examining different banking models and the collaborations and networks these banking models build up in response to strict governance and the competitive market in Taiwan.

Method

This article is based on fieldwork between December 2012 and September 2013 in Taiwan. The data were collected through interviews, participant observations, and documentary analysis. Thirty-one semi-structured interviews were conducted with cord blood bankers (8), physicians (4), parents (12), scientists (2), scientific entrepreneurs (1), officials (2), and social scientists (2). I visited eight of the ten cord blood banks in Taiwan. The length of the interviews ranges between one and two hours. The data include transcriptions, field notes, and collected documents. The names used in this article are pseudonyms. In addition, I analyzed documents such as brochures, newspapers, government reports, regulations, websites, and TV programs to develop a deeper understanding of the context of cord blood banking in Taiwan. Finally, I visited four hospitals and two maternity workshops to understand how the information of cord blood banking is disseminated.

Cord blood banks in Taiwan

There are 10 cord blood banks in Taiwan, and all of them are operated by the non-governmental sector. Unlike counties such as the United Kingdom and the United States, the Taiwanese government did not initiate a national cord blood donation program. Cord blood donation services are offered by two foundations, and cord blood companies through their public and private hybrid model. (I will introduce this in a later section.) Table 1 lists the cord blood banks in Taiwan in operation during the period of my fieldwork. The cord blood industry in Taiwan is highly competitive because these cord blood banks have overlapping areas. Most of the headquarters of the cord blood banks are located in Taipei and New Taipei, except that of the Tzu Chi Cord Blood Bank, which is located in Hualien in the east coast. There are no geographic divisions between the cord blood banks.

Table 1. The cord blood banks in Taiwan and the stored cells.

Cord blood bank	Cell stored
Taiwan Blood Services Foundation	UCBhSC
Tzu Chi Foundation	UCBhSC
VIA Cord Blood Stem Foundation	UCBhSC, plasma & DNA
Stemcyte	UCBhSC, cord MSC
Alarvita^a	UCBhSC, cord MSC & immunocyte from peripheral blood
BabyBanks	UChBSC, PBSC, cord MSC, teeth MSC & adipose MSC
Taiwan Advance	UCBhSC, cord MSC
SinoCell	UCBhSC, cord MSC, amnion MSC
Healthbanks	UCBhSC, cord MSC, adipose MSC
Guang Li Biomedicine	UCBhSC, adipose MSC

UCBhSC, umbilical cord blood hematopoietic stem cell; MSC, mesenchymal stem cell; PBSC, peripheral blood stem cell.

^aAlarvita was acquired by Meribank in 2014.

Different types of stem cells are stored in these cord blood banks (Table 1). Public banks (Taiwan Blood Services and Tzu Chi Cord Blood Bank) in Taiwan store hematopoietic stem cells (hSCs) from umbilical cord blood only, while other banks store adult stem cells from various sources, ranging from cord blood, peripheral blood, umbilical cord, placenta, amnion, and adipose, to teeth. Other biomaterials, such as plasma and DNA, are also stored by the VIA Cord Blood Stem Foundation. Broadly speaking, these cord blood banks store hSCs and mesenchymal stem cells (MSCs) from newborns and adults.

Commercial advertising and recruitment are prohibited in public hospitals. It is against the law for a salesman to promote cord blood banking in hospitals. Pamphlets for cord blood banks can be displayed in private hospitals, but not in public hospitals. Mother’s workshops (mama jiaoshi) are essential for effective recruitment. Mother’s workshops were once offered by the government to enhanced women’s role in maintaining harmony at home and to promote developmental and educational programs, which was a national agenda to enhance population quality, instead of a way to take care of mothers’ interests and needs (Cheng and Hsiung 1994). Public hospitals offer mother’s workshops to educate pregnant women and couples about pregnancy, birth, breastfeeding, and mothercraft. Now, mother’s workshops are increasingly being offered by the maternity and baby industry. All cord blood banks, except public cord blood banks, organize mother’s workshops, which usually take place in the private hospitals and clinics, as well as in conference halls and local community centers. In addition to those lessons mentioned above, staff from cord blood banks give a talk about the knowledge regarding stem cell therapy and banking. At the end of the workshop, participants are offered gifts sponsored by the industry, through which their contact information is obtained. The information about cord blood banking is packaged with the maternity knowledge. In Taiwan, mother’s workshops are a very important opportunity for women and couples to find out about cord blood banking. In these mother’s workshop, product placement is practiced under the guise of knowledge delivery.

Cord blood and stem cell regulations in Taiwan

The Taiwanese government encourages the development of biotechnology, but strictly regulates stem cell therapy and research. Biotechnology has been a “star” sector that the Executive Yuan has been keen to foster (Wong 2011). In order to foster the biotech industry, the government sets up organizations and initiates action plans. This has led, for example, to the creation of the Institute for Biotechnology and Medicine Industry, the Research Centre for Biotechnology and Medical Policy, and the National Research Program for Biopharmaceuticals. In addition, in order to promote research and development (R&D) in the biotech industry, certificated “biotech and new pharmaceutical companies” enjoy tax concessions and deductions since the enactment of the Biotech and New Pharmaceutical Development Act in 2007. Due to the policy of support, cord blood banks such as Taiwan Advance have received permission from the Ministry of Economic Affairs to operate as “biotech and new pharmaceutical companies,” which are encouraged to invest in R&D of new drugs.

Cord blood banks in Taiwan are overseen by the Taiwan Food and Drug Administration (TFDA) and Ministry of Health and Welfare (MOHW). The TFDA examines cord blood bank facilities, process procedures, and whether firms adhere to the cord blood bank good tissue practice (GTP), and renews approval licenses on this basis every three years (Chou et al. 2011). The cord blood regulatory framework in Taiwan can be grouped into two categories: (1) regulations for the collection and banking of cord blood, and (2) regulations for the use of different types of stem cells from various sources, including cord blood. The current governance of cord blood banks gives guidelines to process management of cord blood storage, but restricts the use of stem cells in therapy, clinical trials, and industrialization. In terms of collection and banking, the MOHW has issued regulations for the collection process, storage requirements, and the contract for the conduct of cord blood banking. In 2002, the MOHW announced a regulation regarding cord blood collection and management which set the basic standard for cord blood collection. It was not until 2011 that the MOHW published a template of the contract for commercial cord blood banking. This template aimed to protect customers’ rights by regulating the advertisement, fee, storage facility, and the quality of cord blood for storage. For example, it regulates advertisement as part of the contract so that cord blood banks cannot advertise beyond what they can provide in the contract. In addition, it regulates that the storage of cord blood units (CBUs) needs to fulfill the minimum volume requirement of 40 ml and that there must be satisfactory tests result for disease markers. Nevertheless, parents can still choose whether they want to bank their cord blood if the volume is less than 40 ml.

The MOHW concerns more about the safety of any medical treatments, and, therefore, is strict about stem cell applications, especially the use of MSCs. The MOHW did approve umbilical cord blood transplantation as a regular treatment for 29 diseases (i.e. blood-related diseases, bone marrow failure, and genetic diseases) in 2005. Using stem cells to treat other diseases is permitted only through clinical trials in teaching hospitals with approval of the TFDA and an Institutional Review Board (IRB). To date, the MOHW has not approved any stem cell drugs in Taiwan and the clinical use of MSCs is available through clinical trials only. Cord blood bankers think that stem cell regulations in Taiwan are over-strict, conservative, and unclear. The excerpts below show some regulatory issues that cord blood bankers are concerned about. One cord blood banker thinks that the application of stem cell clinical trials is so strict that it is almost impossible to conduct any clinical trials. The other banker indicates that the problem of the current regulation lies in the lack of regulatory standards, so that significant space is left for the reviewers of the health authority to interpret the regulations in their own way, which is often very risk-evasive. The health authority is regarded as so conservative that the policy implementation is believed to be stricter than the regulation itself.

Banker 1:

The review is very strict, almost impossible, so patients keep waiting. Clinical trials in Taiwan, from my perspective, are over-conservative. Some patients want you to try because that is their only hope, but the authority [is strict]. The good side is that the health authority wants to protect the patients … If the health authority gave clear instructions, we would know what to do even if the regulation is strict. The problem is that the regulations are not clear, so we don’t know.

Banker 2:

The biggest blind spot of these regulations is that although the MOHW made many regulations, they don’t articulate regulatory standards.

The issue of regulatory standards that cord blood bankers face shows the difficulties and confusion that they confront. Cord blood banks in Taiwan are mostly small and medium-sized enterprises (Wong 2011). In this context, it is difficult for cord blood banks to provide services from bench to bedside. Therefore, cord blood banks make national and international collaborations with various institutions, such as hospitals, universities, and even cord blood banks in other countries, in response to the competitive cord blood industry. These collaborations are made possible through various banking models, which I will introduce below.

In addition to national regulations, these cord blood banks seek international accreditations. All of these banks obtain at least one of the following international accreditations: AABB (American Association of Blood Banks), FACT (Foundation for the Accreditation of Cellular Therapy), CAP (College of American Pathologists), ISO 17025, and ISO 9001. Four cord blood banks (Bionet, HealthBanks Cord Blood Center, StemCyte Taiwan, and Taiwan Advance) acquired AABB accreditations. One bank obtained all these accreditations, and advertises on its website that “the cord blood bank that obtained most accreditations is your top choice of quality.” Nevertheless, international accreditations not only improve the quality management of CBUs, but also serve as a symbol of prestige and international recognition to compete with other cord blood banks. As one cord blood banker mentioned, “We have the pressure when other companies get accreditations. Accreditation is definitely helpful for the quality but I think all accreditations are good for cord blood storage. It is not necessary to limit to certain accreditation.” Also, the same cord blood banker said that the AABB is too expensive to apply for. He said his company considers cost-effectiveness and advertising effectiveness, his company got the national license and do not think getting the AABB accreditation will bring them much more customers. In the cord blood market that lacks balanced and transparent information, accreditation is one of the very few visible criteria that customers can refer to when they consider cord blood banking. It can also be a reference for the oncologist when choosing CBUs for transplantation. Therefore, international accreditation is important to facilitate the business of storage as well as the use of CBUs as it serves as a symbol of quality.

Banking models and cell flow

Cord blood banks in Taiwan have developed different types of banking models. I categorize the cord blood banking models in Taiwan into five types: A. public banking, B. family banking, C. public and private hybrid banking, D. charitable family banking, and E. donatable family banking. The ownership and application of these models are shown in Table 2. Elsewhere, I provided a brief analysis of the cell use, finance, and quality of the “public and private hybrid banking” and “donatable family banking” (Chang 2014). Here, I focus on the analysis of scientific collaboration derived from various banking models. Cord blood banks in Taiwan usually adopt one or more of the models I outlined below. Babybanks, for example, provides services of public and private hybrid banking and donatable family banking.

Table 2. The types of cord blood banking in Taiwan.

Type	Storage program	Ownership of cells	Cell use
A	Public banking	Bank	Allogeneic transplant only
B	Family banking	Client	Transplant within family
C	Public and private hybrid banking	Bank/client	Autologous and allogeneic transplant, research, and clinical trials
D	Charitable family banking	Client	Transplant within family
E	Donatable family banking	Client	Autologous and allogeneic transplant

A. Public banking

There are two public cord blood banks in Taiwan, which are operated by foundations − the Taiwan Blood Services Foundation and the Tzu-Chi Foundation. The Taiwan Blood Services Foundation initiated the first public cord blood bank in Taiwan in 1998. It collected and stored 2142 CBUs from 1998 to 2004 (Taiwan Blood Services Foundation 2012). The other public cord blood bank, which is subordinated to the Tzu-Chi Stem Cell Center, collected CBUs from 2001 to 2008, and has accumulated approximately 12,000 CBUs. These two banks both stopped collecting cord blood donations when the quantity stored reached their planned capacity, but they still maintain and release the existing CBUs for transplantation. Informants from these two public banks stated that it is unnecessary to expand the cord blood bank. They estimated that the amount of CBUs stored in their banks, and the data in the bone marrow registry, are sufficient for patients in Taiwan to find a match. Another reason to stop collection is the limitation of funding and space (Hsieh and Cheng 2013).

The CBUs stored in these two banks are provided for allogeneic transplants. The CBUs are not used for research, as the informed consent of the cord blood donation limits its use to therapy. Therefore, these two banks generate networks with hospitals and international registries to release CBUs for allogeneic transplants. However, there are challenges concerning public cord blood banks in Taiwan. The utility rate¹ of CBUs for these two public banks is low (0.1% and 0.6% respectively). The Taiwan Blood Services Foundation is not a member of any international registry, so only two units have been used from this bank. Tzu Chi has so far released 113 CBUs nationally and overseas for transplants. In Taiwan, 95% of stem cell transplants use peripheral blood, while some use bone marrow and the remainder cord blood (Wu, Chiu, and Wang 2012). The use of cord blood involves issues of clinicians’ knowledge and skills, competition with other therapies, and cost. Among these issues, the release fee of donated CBUs is high and problematic in the context of Taiwan.

Unlike the UK and Japan, whose governments financially support public cord blood banks, and where the national health systems cover the fee of CBUs released from public cord blood banks, the National Health Insurance in Taiwan covers the medical cost of transplantation only but not the fee for the cord blood unit. The release fee for the cord blood is paid by the patients. The release fee of a cord blood unit from public cord blood banks in Taiwan is NT$300,000 (US$10,000) per unit.² This fee is three times the fee for using bone marrow or peripheral blood (US$3500). Therefore, patients might prefer to use peripheral blood or bone marrow to cord blood.

The high release fee from public cord blood banks, combined with the low utility rate and lack of national support, create a dilemma for parents in the choice between public and private cord blood banking, forcing parents to becoming “biological consumers” in the “political economy of hope” (Rose and Novas 2004). This also creates an opportunity for cord blood companies to promote and encourage parents to choose cord blood banking over donation. In the mother’s workshop I attended, cord blood companies criticized the high release fee from public cord blood bank and encouraged parents to choose fee-paying banking services. When parents compare the storage fee for private banking (US$1500–2500) in Taiwan and the release fee of cord blood from public cord blood banks (US$10,000), private banking might be the option for them. Although the price of the unit from public bank is calculated from the units used for transplantation only, and that of private banking is charged from every unit stored (Hsieh and Cheng 2013), the system in Taiwan calls into question the notion of public cord blood as common goods. “Biological citizenship” (Rose and Novas 2004) here shows that the duty of being a health gatekeeper is transferred from the nation to the individual. Parents are left uncertain as to whether they should pay less for private banking or if they should donate their cord blood but pay a higher release fee if cord blood is needed despite the likelihood of such use being very low. In this context, parents are vulnerable to banking options that cord blood companies offer.

B. Family banking

The family banking or private banking model allows parents pay a fee for storage of cord blood, and the use of the CBU is restricted to the family. The fee for family banking for 20 years in Taiwan ranges from US$1500 to US$2500. Similar to other countries, the utility rate of the family-banked CBUs is very low in Taiwan. In addition, the CBUs belong to the family so the units cannot be used for any other purposes, such as research. Bioethical bodies have published statements against this model on the ground that the likelihood of individuals needing a cord blood transplantation is very low and that such family-banked cord blood cannot be searched and used by other patients in need (Waldby 2006). This model limits the “therapeutic value” of cord blood but enhances the economic value of cord blood by marketing hope (Martin, Brown, and Turner 2008). Nevertheless, family banking can still collaborate with scientists and clinicians through providing sponsorship to scientific activities. Some cord blood banks add altruistic elements into the tradition family banking model, and turn it into charitable family banking and donatable family banking, which I will discuss later.

C. Public and private hybrid banking

“Public and private hybrid banking” is the model by which a cord blood bank runs both a cord blood donation program and a private banking program. The bank has ownership of the donated cord blood while the privately banked cord blood belongs to the clients. This banking model allows the donated CBUs to be used for different purposes, and the cord blood bank builds up extensive networks with various institutions and stakeholders. The donated cells can be used for therapy, basic research, animal studies, clinical trials, system monitoring, and quality control or be developed into a stem cell drug or product. Such banks collaborate with scientists in research institutes, hospitals, and universities to provide the cells for transplantation, clinical trials, and basic research.

Commercial cord blood banks have faced criticism for their intense advertisement strategies targeting parents. Their active promotion and collaboration with the transplantation centers, however, have promoted the use of cord blood transplants. For instance, Stemcyte Taiwan has facilitated more CBUs for allogeneic transplants (meaning the patient receives stem cells from another person) than public banks in Taiwan. Through public and private hybrid banking, Stemcyte Taiwan has facilitated more than 300 units for transplantation (Table 3), and Tzu Chi Cord blood Bank (the public bank) facilitated 105 units. Therefore, this model not only plays a crucial role in maintaining the donation program, but also supplies cord blood for allogeneic transplantation in Taiwan.

Table 3. The CBUs listed on BMDW and the units used for transplantation.

Name	Units list on BMDW^a	Units used for transplantation^b
Tzu Chi	12,632	105
Stemcyte	9460	327
Bionet	32,955	>70
Healthbanks	6424	Unknown

^aAccessed from the BMDW website on 11/09/2013.

^bData from websites and interviews in 2013.

The storage of the donated cord blood is expensive. According to an informant, only one out of four donated CBUs are successfully cryopreserved due to the high standards required. The discarded cord blood can be used for research. In this model, the cord blood donation program is financially supported by investments from the private sector, the income from the bank’s family banking, and the release fees of donated CBUs. Users are charged NT$210,000–600,000 (US$7000–20,000) per unit in Taiwan when released for transplantation, but the CBUs for clinical trials are free. The public and private hybrid model provides an alternative way to sustain cord blood donation programs, and actively collaborate with hospitals and universities for clinical trials and research. In this model, cord blood is attached to therapeutic value (through transplant and clinical trials), scientific value (through research), and economic value (through release fee).

D. Charitable family banking

The charitable family banking service, an innovative form of family banking, is provided by a Christian non-profit organization. This banking service charges parents a fee to store their child’s cord blood. The profit is used for charitable work, including free storage of cord blood for high-risk families and minority groups, stem cell R&D, and stem cell education. For this organization, cord blood banking is not profit making; instead, it is a means to do charitable work.

Its director and a biologist, Vincent (a pseudonym) advocates autologous transplants (use the person’s own stem cells), and believes that even though human leukocyte antigen (HLA) is matched (immunologically compatible) between the cord blood and the patient, the complications caused by allogeneic transplant remain a major problem. He thinks that allogeneic transplants should be used only in emergency. Autologous transplantation, if the situation allows, is safer for patients. There have been ongoing clinical trials using autologous transplants, such as acquired neurologic disorders (Sun et al. 2010), autism, pediatric stroke (Cord Blood Registry 2015), acquired hearing loss, and autologous T regulatory cell therapy in type I diabetes (Theil et al. 2015). Medical bodies such as the European Group on Ethics in Science and New Technologies (2004) state that autologous use of cord blood is inappropriate in the case of genetic diseases, but Vincent believes that when the technology is ready in the future, cell therapy could be combined with gene therapy to treat genetic diseases. Therefore, Vincent views self-storage as “smart” rather than “selfish.” He says,

It is my responsibility to help the next generation prepare wings for the wind of biotechnology. I don’t know when the wind will come, but I know the wind will definitely come. When the wind comes, they can fly with it.

The introduction of this cord blood bank resembles the future-oriented “regime of hope” (Martin, Brown, and Turner 2008), but the charity work it does is grounded in the “regime of truth.” Unlike the NHS cord blood bank in the UK, of which 40% of cord blood is collected from ethnic minorities (NHS Blood and Transplant 2010), it is difficult for minority groups in Taiwan, such as aboriginal peoples, to find a match from public banks. The HLA of the aboriginal peoples in Taiwan (2.5% of the population) is very different from the majority Han people and they inherit different genetic diseases. To bridge this gap, this charitable family banking model provides free storage to indigenous peoples and high-risk families. Every four families who choose to store cord blood through this model can help a minority family store their cord blood for free. As such, free banking service helps some high-risk families who are most likely to use cord blood to store it and establish a database for minority groups.

In terms of research and therapy, this bank also builds a longitudinal database to monitor children’s health. It follows children for 18 years and collects the blood and DNA samples of the children every three years to monitor any change in their genes and health. In addition, the data might also be used for further scientific research. In terms of clinical trials, Vincent thinks that the health authority in Taiwan is conservative and has thus not applied for any clinical trials in Taiwan. Instead, he collaborates with scientists in the United States and sends children with cerebral palsy to undergo clinical trials abroad.

Charitable family banking is a specific type of family banking model that challenges the presumption that family banking is always profit driven. As a non-profit organization that operates the cord blood bank, the profits are used for free storage for high-risk and minority groups. Through charitable work, this cord blood bank creates a unique network to bring fee-paying and free-storage families together and intends to break the boundaries between them. This banking service, along with the longitudinal follow-up, also builds collaboration between scientific research, cord blood banks and clients (children) for cord blood stem cell sciences. This charitable family banking model creates the therapeutic, scientific, and charitable values of the cord blood instead of its economic values.

E. Donatable family banking

Donatable family banking is a model by which CBUs are collected primarily for related use by relatives, but the HLA typing data are also put in a registry. Therefore, the CBUs are able to be searched and used for allogeneic transplants. In this model, parents sign a commercial contract and pay a fee of NT$85,000 (US$2700) for the storage of 20 years. Differently from the traditional family banking, these CBUs are HLA typed, and the HLA typing data are open for search. If a match is found, the bank will inform the parents, and they can decide whether they want to keep the cord blood unit, sell it, or donate it to the patient in need of an allogeneic transplant. Donatable family banking model overcomes the problem that family-banked samples cannot be searched and circulated. It is estimated that the inventory of private cord blood banks is at least triple that of the public banks (Ballen et al. 2008; Dickenson 2013). Through this model, the cord blood still has the potential to be used. This model maintains the economic value and therapeutic value of cord blood.

This model is welcomed by parents who recognize that the likelihood of using the banked CBU is very low and who can thus also receive monetary compensation when the CBU is matched and used by other people. These units are released upon request with a fee of US$7000 but it is unclear how much the parents receive. Nevertheless, an important consideration in donatable family banking model is the volume, quality, and accessibility of the units. CBUs in this model need not follow the high volume or total nucleated cell count (or TNC) set for public banks, nor do they have to complete a six-month follow-up as the CBU still belongs to the client, who agree to open the HLA typing data. Hence, the volume and quality of the CBUs can vary from one to another. Also, it needs another consent from the client, so accessibility is not guaranteed.

The Bone Marrow Donors Worldwide (BMDW) annual report showed that the CBUs available in Taiwan reached 64,014 units, a ratio of 27.5 units per 10,000 inhabitants, which is the highest ratio in the world, followed by Cyprus with a ratio of 16.9 in 2013 (BMDW 2014). The figure in Taiwan is comprised of the units from public donation programs and donatable family banking model, but the respective proportions are unclear. Ostensibly, the CBUs listed on the BMDW are all available for transplant but the data here show that the quality and accessibility are questionable due to different standards required for these banking models (Chang 2014).

After outlining these different banking models, I come back to the question that I asked at the beginning: how do we define public and private cord blood banks? The American Congress of Obstetrician and Gynecologists (ACOG 2008) differentiates public and private cord blood banks according to allogeneic or autologous use. The AABB defines public cord blood banks as those that collect, process, and store cord blood products for public use (AABB 2014). The NHS in the UK (2015) categorizes them according to funding organizations and the ways the cord blood is used. Hence, the NHS defines public cord blood banks as public- or government-funded facilities that collect altruistic cord blood donations, and private cord blood banks as privately owned facilities that store cord blood solely for family use. According to these organizations, funding bodies, transplant option, and the relationship between the donor and the patient are associated with the distinction between public and private cord blood banking. At a practical level, the international registry BMDW does not differentiate public and private cord blood banks but welcomes all “cord blood registries” that meet its standard to join this platform and share the HLA data. For the BMDW, which facilitates the allogeneic use of cord blood, a public and private division is superfluous. What matters is that a bank has the capacity to provide HLA typing data and exchange cord blood.

The complexity of cord blood banking models in Taiwan demonstrates that the public and private binary is superficial. Most of the cord blood banks in Taiwan contain mixed features of “public” and “private.” These banks adopt more than one banking model for various purposes. For example, setting up a cord blood donation program by a commercial cord blood bank can serve as a business plan to attract additional customers using moral values, but it also facilitates the use of cord blood in clinical trials and allogeneic transplantations.

The multiple roles of cord blood banks in Taiwan

I illustrated in previous sections that fierce competition among cord blood banks and strict governance from the Taiwanese government coexist in the Taiwan context. Using the concept of “bionetworking,” I now discuss how cord blood banks make use of CBUs to collaborate with other institutions through various cord blood banking models. These collaborative activities include (A) research and development, (B) collaboration and partnership, and (C) bridging research and application. The networks blur the sectoral boundaries and enable cord blood banks’ multiple roles as cell providers, researchers, facilitators, and sponsors in stem cell sciences. These collaborative activities illustrate the networks that cord blood banks maintain with other institutions, and the various roles that they play in the stem cell sciences. In addition to the cord blood storage services, cord blood banks are involved in networking and exchange activities. As “bionetworking” highlights that the networks are created for the cord blood industry to thrive, I demonstrate with the Taiwanese cases to show that some forms of networks have created an interdependent relationship between cord blood banks and stem cell therapy and science, particularly in the context of strict governance. The relationship between science and cord blood banks is essential for each other’s progress and survival in the case here.

A. Research and development

Cord blood banking services go hand in hand with stem cell research and clinical trials. In the highly competitive cord blood industry, cord blood banks in Taiwan are keen to conduct research both independently and collaboratively. Cord blood banks attract funding from the Ministry of Economic Affairs and the Ministry of Science and Technology, and publish their results in international journals. One research focus of cord blood banks lies in process improvement and standardization to provide stem cells that meet clinical standards. By processing and developing stem cells under good manufacturing conditions, the banks have been developing standardized stem cell products to be used in clinical trials and to be ready for production once government approval is granted. Additionally, cord blood banks patent their core techniques. Despite the existence of international standards, there is no consensus as to how to process and store stem cells. Therefore, cord blood banks process tissues differently, including which part of the umbilical cord being processed, the procedure, and the agent. These banks patent their techniques and procedures. A patent is not just a way to protect intellectual property, but, more importantly, it is a symbol which advertises to clients the professional and scientific ability of the cord blood bank.

Research collaboration among cord blood banks, hospitals, and universities is common in Taiwan for various reasons. First, the current regulation, the Application and Operational Guidelines for Somatic Cell Therapy Human Clinical Trials, requires that stem cell clinical trials be conducted in teaching hospitals with the TFDA’s permission. Therefore, collaborations between cord blood banks and hospitals are necessary for clinical trials. Cord blood banks in Taiwan have collaborated with hospitals and provided hSCs and MSCs for preclinical studies and clinical trials, such as those for spinal cord injury, thalassemia, cirrhosis, stroke, brain injuries, and type I diabetes.

The cell sources for research come from the discarded CBUs or those collected from voluntary donors. If the clinical trials are for autologous cord blood transplant, the sources can come from the models of family banking, charitable family banking, donatable family banking, and public and private hybrid banking. If clinical trials are for allogeneic transplant, however, only the public and private hybrid banking will be able to provide CBUs, for it is the cord blood bank that has the ownership of the donated units. In the case of public cord blood banks, although they also have ownership of the CBUs, their units can be used for transplant purposes only.

Second, collaboration with universities is also a partnership strategy, because it allows cord blood banks to outsource research to universities. In this way, universities can help cord blood banks to conduct basic research and animal research. For them, collaboration allows an efficient division of labor to maximize efficiency and minimize cost.

Banker 1:

The clinical trial is a form of industry–academic cooperation. We also collaborate with universities for preclinical trials and animal experiments because we don’t have an experimental animal room. We focus on the improvement of process and testing.

Nevertheless, the pitfall of research led by cord blood banks is that these studies are often market-oriented. The research director of one cord blood bank said that her company stopped its research and clinical trials on liver diseases because another cord blood bank was doing it. Usually, each cord blood bank would focus on one or two diseases to avoid overlap. Long-term research is difficult to maintain in the context of the pragmatic nature of this strategy.

B. Collaboration and partnership

Cord blood banks forge international alliances with cord blood banks in other countries in order to compete with other cord blood banks in Taiwan. It is in this context that the Asia Pacific Cord Blood Bank Consortium was formed in 2002 between a number of cord blood companies across several countries. Each year, its members gather in an annual convention to exchange experiences of each country. Through this closed network, members can understand the market and regulations in other countries, as well as building up collaboration and alliance. The donatable family banking model, for instance, was adopted by other countries through this consortium. In addition to annual meetings, the alliance brings substantial international partnership in terms of infrastructural development and technology transfer. Bionet (babybanks) in Taiwan collaborates with StemOne, the member in India, to build up a GTP laboratory, and to facilitate technology transfer of mesenchymal stem cell process and storage. This alliance network is beneficial for its members. International collaboration serves as a symbol of international standard and capacity which can enhance the image of the cord blood bank in Taiwan. On the other hand, through cross-national collaboration, cord blood banks have more opportunity to expand their business to other countries.

Another form of collaboration is sponsorship. Some cord blood banks sponsor scientific activities such as clinical trials and conferences. One cord blood bank I visited has sponsored clinical trials through providing funding as well as stem cells. Sponsorship of stem cells is possible only for public cord blood banks and public and private hybrid banks, as these models have the ownership of the cells. Public cord blood banks have difficulty sponsoring clinical trials and therapies because of limited resources. Tzu Chi cord blood bank, however, provided free CBUs for therapy between 2012 and 2014 to promote cord blood therapy.

In addition, some cord blood companies sponsored international academic conferences and symposia to facilitate knowledge exchange in the field of stem cell science. For the cord blood banks, these conferences have been a platform for education, communication, advertisement, and networking among various stakeholders, such as physicians, scholars, and the industry. The interdependent relationship between science and industry is crucial for the advancement of both parties.

C. Bridge research and application

Stem cell research is a convergence of knowledge, biotechnology, and business. Stem cell research encompasses a spectrum from basic laboratory research aimed at understanding of the biological function of life to the clinical application of knowledge that involves ethical and social debates about the science. However, scientists conducting basic research usually do not extend their research to clinical practice, while clinical practitioners usually do not conduct basic research or animal studies. There is a gap between them. Cord blood bankers believed they fill the gap. One cord blood banker I interviewed conceived the cord blood bank as a mediator that bridges different parts of the stem cell production chain, from basic research and animal studies to clinical trials. Through the research capacity these cord blood banks have, such as production procedures and patents in certain laboratory skills, they are able to translate research results into clinical practice through collaboration with different stakeholders.

Banker 2:

The collaborating scientist brings [the cord blood bank] good research results used for industrial applications.

This section has considered the interconnectedness and dynamics in life science, especially the informal liaison among different stakeholders with common and conflicting interests (Sleeboom-Faulkner and Patra 2011). Bionetworking aims to capture the multiple interests among various stakeholders, and how their networks relate to the science production. Individual work, either from cord blood banks or the universities, is not enough for science translation in Taiwan. Nevertheless, despite their divergent interests, the networks that cord blood banks create with various actors, and at both the national and global level, produce more opportunities for the cord blood industry to thrive under the strict governance in Taiwan. The key stakeholders, such as cord blood bankers, scientists, and clinicians, combine their resources to facilitate stem cell clinical trials, which can benefit both stem cell science and the cord blood industry. It also shows that the scientific work in stem cell sciences, including research and clinical trials, is supported by funds generated by the cord blood industry. Science is not solely produced by scientists; instead, it involves collaborations and negotiations between scientists and many stakeholders such as regulators, entrepreneurs, clinicians, and patients. The cord blood bank, as a stem cell provider for research and therapy, is a convergence of knowledge, biotechnology, and business in which collaboration and negotiation among scientists, clinicians, patients, donors, governors, and entrepreneurs happen. The networking among them blurs the sectoral boundaries and manifest the cord blood banks’ multiple roles and identities, including cell providers, researchers, facilitators, and sponsors.

Conclusion

This article uses examples from Taiwan to illustrate how hybrid cord blood banking models and networks blur sectoral boundaries. It demonstrates that cord blood banks are subject to standard-setting, regulatory bodies, healthcare systems, markets, science, patients, and so on. I argue that “public bank” is not a universal concept, but takes different forms in different countries. Public banks are not necessarily sponsored by governments, but can be set up by charities or companies for divergent purposes, including transplantation, research, good reputation, or even profit making.

It is ideal for a government to provide public cord blood banking services but, in practice, public cord blood banks are not the panacea in countries without strong governmental support. It requires enormous resources to maintain a public cord blood bank. McGuckin and Forraz (2008) suggest that it is unrealistic to expect governments to pay for public cord blood banking within a free healthcare system. They believe that both public and private cord blood banking should be promoted because it will enable an increase in the CBU inventory which will also limit the healthcare costs associated through the public–private partnership model. From a pragmatic perspective, I argue that it is crucial to analyze the cost, unit quality, and social implication of different banking models. The different cord blood banking models show that most of cord blood banks in Taiwan are neither altruistic public banks nor self-interested private banks. As opposed to these, cord blood banking models such as public and private hybrid banking, charitable family banking, and donatable family banking are located in the middle ground of the spectrum. Among them, charitable family banking models exemplifies that fee-paying banking services do not necessarily lead to self-interested profit making; instead, it can be used for altruistic work. The classification of public and private cord blood bank needs more careful considerations, such as the funding bodies.

These hybrid models add mixed values (scientific, therapeutic, economic, and charitable value) to cord blood, and facilitate various ways of networking and using cells. Hybrid models are becoming common around the world. In South Korea, for example, the government assigned some existing cord blood registries to operating the national cord blood donation program instead of building up new public cord blood banks (Roh et al. 2014). Also, similar public and private hybrid banking models are seen in the case of Eticur in Germany (O’Connor et al. 2012), National Marrow Donor Program (NMDP) network cord blood banks in the USA, and national licensed cord blood banks in China.

Healthcare systems play an important role in the accessibility of cord blood. In countries where health insurance does not cover the fee for CBUs, it is not unusual that the patient cannot afford the cord blood for transplantation from the public cord blood bank. For instance, a report shows that in China, almost two-thirds of children who require a hematopoietic stem cell transplant did not finish the treatment for financial concern (Chinese Red Cross Foundation 2013). Citizens in Taiwan encounter the challenge that CBUs are more expensive than other stem cell sources such as peripheral blood, and the fee is not covered by the National Health Insurance but paid by patients. In addition, I have shown in this article that cord blood banks that operate within the public and private hybrid model have facilitated more transplants than public cord blood banks in Taiwan. Therefore, although medical bodies in Europe, the USA, and the UK encourage public cord blood banking (European Group on Ethics in Science and New Technologies 2004; RCOG 2006; American Academy of Pediatrics 2007), other forms of cord blood banking model are shown in this article to illustrate alternative options in response to different cultures, healthcare systems, and governance.

In conclusion, I suggest that the operation and network of cord blood banks should be considered in its context. The concept of “bionetworking” highlights the multiple roles of cord blood banks in stem cell sciences. The cases in Taiwan show that cord blood banks have shifting roles in the stem cell sciences in order to facilitate the collaboration with divergent actors. Cord blood banks play the roles as researcher, sponsor, and moderators to get involved in research work, partnership, sponsorship, and bridging the gaps in the cord blood industry. The advance of cord blood therapies in Taiwan is closely linked to these activities. The examples illustrate that collaboration and partnership among various actors are used as strategies for science production in response to strict regulations. I move beyond a normative judgment of the different cord blood banks. Instead, I argue that it is through analyzing the networks and activities that these cord blood banks engage in, and their relation with science, that our understandings of the production of stem cell knowledge and therapies can be deepened.

Acknowledgements

I am grateful for the informants who participated in this study. I would like to thank the anonymized reviewers, Margaret Sleeboom-Faulkner, Rachel Douglas-Jones, and Stuart Blume for their kind comments on this work.

Disclosure statement

No potential conflict of interest was reported by the author.

Additional information

Funding

This work was supported by the Economic and Social Science Research Council (ESRC) [grant number ES/I018107/1] and European Research Council (ERC) [grant number 283219].

Notes

1. Utility rate here refers to the proportion of stored cord blood units that are used in therapies.

2. To promote the use of cord blood, Tzu-Chi Cord Blood Bank initiated a two-year free-for-use plan during 2012 and 2014.