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New Cannibal Markets

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Jean-Daniel Rainhorn
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Samira El Boudamoussi

Part 5. The Human-Product-Banking Industry

Who Are the Owners?

Commercialization and Biobanking

Bernice S. Elger

Texte intégral

1Biobanks are repositories of biological samples with accompanying linked data (Shaw et al. 2014). For instance, the Organisation for Economic Co-operation and Development (OECD) defines biobanks as “structured resources that can be used for the purpose of genetic research and which include: (i) human biological materials and/or information generated from the analysis of the same; and (ii) extensive associated information” (OECD 2009). Globalization has produced new opportunities and challenges concerning biobank activities. On the one hand, globalization helps to strive towards international biobanks, which are particularly important when it comes to investigating rare diseases because samples have to come from different countries and geographical regions to permit a sufficiently large collection (Artene et al. 2013). On the other hand, globalization is a regulatory challenge (Knoppers et al. 2012) because it carries the risk that not all interests of biobank participants are respected. There is a risk that powerful commercial entities dominate the “biobank business” (Steinsbekk et al. 2013; Reymond et al. 2002). The fear is that they construct biobanks in poor countries or use minorities to develop new medication that will mainly be used by citizens from rich countries and majority groups. This could be interpreted as a commodification of the body of the most vulnerable to the benefit of health needs of the “better-off.” Several studies have shown that African Americans have concerns about participation in biobanks. Focus group research involving 27 leaders in the black African immigrant community showed that the memories of “colonial mistreatment and exploitation by Western researchers in their home countries in sub-Saharan Africa” are prominent obstacles when the leaders consider participation in biobank research (Buseh et al. 2013a; Buseh et al. 2013b). The consequence seems at present to be that racial or ethnic minorities are underrepresented in current biobanking programs (Hagiwara et al. 2014).

2Given the risk and fears concerning exploitation, it is no surprise that bioethical debates related to biobanks include concerns about ownership (Porteri et al. 2014; Nisbet and Fahy 2013). Lack of clarity concerning ownership rules has been described as one of the three “major roadblocks” that have hindered the success of previous biobank consortiums (Gaffney et al. 2012). In this chapter we will focus on issues related to research biobanks of the type that have been examined in a recent survey (Zika et al. 2011; Zika et al. 2010) and examine how ownership is handled at present, how existing guidelines recommend it should be handled, and what recent lawsuits and publications have contributed to the ethical debate.

Ownership of research biobanks: recent practice

3A survey carried out a few years ago (Zika et al. 2011; Zika et al. 2010) examined biobanks throughout Europe, as well as in some non-European regions (United States, Canada, Asia). The biobanks were identified through the Public Population Project in Genomics (P3G). The aim of the survey was to provide an overview of existing research biobanks in the above-mentioned four geographical regions. Of the 145 identified active biobanks, a total of 126 replies were received.

4Among these research biobanks only a small minority (3%) reported private ownership. Most biobanks are owned by either universities (39%), national or regional agencies (39%), or non-profit foundations (19%) (Zika et al. 2010). In contrast to the ownership, the type of research in which the biobanks are involved reflects a more mixed approach, where public biobanks may be used for public as well as private commercial research. About one third of the biobanks (36%) reported “public research only,” 24% public and clinical research, 7% public, private and clinical research, 10% clinical research only, and 23% either “other combinations” of research or “other reasons only” (Zika et al. 2010).

Ownership: a complex concept

5From a conceptual point of view, one can make two broad distinctions concerning “things” and “persons.” Property rights, in general, concern “things”—i.e., ownership refers to “things” such as for example a table, a lamp, or pieces of land that can be bought and sold (Waldron 2004). In contrast, human persons have autonomy rights and cannot be treated like things—i.e., human persons cannot be bought or sold. Other “entities” exist that seem to fall somehow between the two extremes. Animals are one example, many of which cannot be treated simply like “things” in most domestic animal laws (Switzerland 2005). Other examples include the ocean, which is considered a public good (Jones 2008), and human biological samples, which will be discussed in more detail below. Samples are detached from the human body, and therefore under certain conditions treated as owned “things” (theft of hair, etc.). At the same time samples are not purely “things” because they contain genetic material. This genetic material is related to the person and therefore subject to autonomy rights. Following Honoré (1961) property is often described as a “bundle of rights” in order to “capture the complexity of the rights associated with the concept of ownership” (Boggio 2008). The ownership question concerning human biological samples has been debated in court in the famous Moore case in California (Moore v. Regents of the University of California 1990; cert. denied 1991). Mr. Moore’s tissue had been used to create cell lines without his consent. The court did not recognize Mr. Moore’s property claim, but established the “principle of obtaining an informed consent to research uses of samples and genetic information—and, in particular, the requirement that researchers reveal their proprietary or commercial interests...[s]uch a requirement exists irrespective of the ‘property’ or ‘person’ characterization and allows a research participant to exercise a right of control” (Knoppers and Abdul-Rahman 2008).

Ownership of research biobanks: guidelines employ various approaches

6The controversy about ownership of samples that are stored in biobanks is reflected by the various approaches used in the various existing guidelines concerning biobanks.

7One extreme position is that the so-called tissue “sources” (or donors) own their samples: “Who owns the DNA in a bank? Banked DNA is the property of the depositor unless otherwise stipulated. Therefore, the word ‘donor’, which implies a gift, is inappropriate” (ASHG 1988). The opposite extreme position states that the agencies that fund a biobank own the samples: “Ownership of the samples and data held in UK Biobank will remain with the funding bodies” (UK Biobank 2007). The document explains further that ownership “conveys certain rights such as the right to take legal action against unauthorized use or abuse of the database or samples, and the right to sell or destroy the samples.” Interestingly, UK Biobank seems to feel a need to reassure sample donors that their samples will not be treated in the same way as “things,” as it continues: UK Biobank “does not intend to exercise all of these rights… it will not sell samples” (UK Biobank 2007).

8Between these two extremes lie a number of intermediate positions. The Convention on Human-Rights and Biomedicine stipulates that financial gain from the human body and its parts is prohibited (Council of Europe 1997). The Medical Research Council in the UK describes a gift relationship that can be characterized as a form of ownership with restrictions (MRC 2001). A more recently proposed concept is that the biobank should function as a steward or custodian for the samples and form a “charitable trust” (Winickoff and Winickoff 2003). An intermediate position is that DNA is a unique entity “sui generis” as such that lies somewhat between property rights and personal rights and should therefore not be treated as a commodity that can be owned or otherwise exploited as a private, proprietary, or commercial good (Pullman and Latus 2003). The French Comité cconsultatif national d’éthique (CCNE) holds that a biobank should act as a custodian as samples are a “common good,” e.g., like the ocean (CCNE 2003). Finally, often various positions are mixed, as for example with the UK Biobank, which in spite of claiming formal ownership for the funding agencies, adheres also to the idea of stewardship: “UK Biobank does not intend to exercise all [ownership] rights… Rather, UK Biobank will serve as the steward of the resource, maintaining and building it for the public good” (UK Biobank 2007).

9The Human Genome Organisation (HUGO) uses the concept of “common heritage” for genetic material (HUGO 1995; HUGO 1999). This concept stems from international law and implies non-appropriation, common management, equitable sharing of benefits, peaceful use, protection, and preservation for future generations.

10The College of American Pathologists states that samples are part of the patient’s health record (Grizzle et al. 1999), while the European Society of Human Genetics keeps alternatives open and defines ownership as “up to agreements” (ESHG 2003).

Ownership of research biobanks: recent cases

11Apart from the Moore case (see above), a few more recent cases illustrate that, on the one hand, legal ownership rights of tissue donors concerning “their” samples remain rather limited, but on the other hand, in spite of those limitations, public perception seems to be that biobankers have an ethical obligation to treat samples with respect and to grant their donors some control rights. The case Washington University v. Catalona (2006) concerns a prostate cancer surgeon and researcher, W. Catalona. During his employment by Washington University he collected more than 3,500 samples with the consent of his patients. His patients supported him and requested from Washington University that their samples be transferred to Catalona’s new employment site. Based on the original consent, the court refused to grant sample donors the right to control transfer (Charo 2006).

12In another case, Havasupai Tribe of Havasupai Reservation v. Arizona Bd. of Regents (2008), Arizona State University (ASU) agreed “to pay $700,000 to 41 members of the Havasupai Indian tribe to settle legal claims that university researchers improperly used tribe members’ blood samples in genetic research” (Mello and Wolf 2010). The Havasupai claimed that samples from a diabetes study had been used without adequate consent for other uses to which they objected, namely “a study evaluating the genetic basis of schizophrenia, which could stigmatize the tribe; one examining inbreeding, which raised stigmatization issues and concern related to a cultural belief that inbreeding brings harm to one’s family; and evolutionary-genetics studies suggesting that contrary to the tribe’s origin story, its ancestors migrated across the Bering Sea” (Mello and Wolf 2010). The fact that the university preferred a settlement in spite of the fact that previous similar legal claims of sample donors were unsuccessful shows that more is at stake than legal views. The university’s reaction could be understood as a form of recognition of moral duties towards sample donors that must be respected in order to maintain present and future donors’ trust in medical research. As Mello and Wolf (2010) state, “[c]ase law is fairly clear that biospecimen donors do not retain property interests in samples collected and used in accordance with properly obtained informed consent.” The case focuses rather on consent issues and shows that “what constitutes adequate informed consent is unsettled. Federal regulations require informed consent when identifiable biospecimens are collected for research purposes, but such regulations provide little guidance on how to obtain informed consent for future, unspecified uses” (Mello and Wolf 2010).

13A recent debate has started as to whether instead of using consent as a form of control over tissue based on autonomy rights of donors, one should refer to the concept of a “trade-secret model” (Mitchell et al. 2011). The authors claim that their concept provides a new way to promote autonomy of donors. They uphold that “[d]onating genetic samples for medical research is like selling a confidential commodity of potentially lucrative value, warranting individual licensing arrangements to secure acceptable benefit outcomes” (Weil and Compton 2011).

14“The conventional legal definition of a trade secret is any knowledge or information that is not generally available or readily ascertainable, confers an economic advantage on its proprietor over those who do not know it, and is the subject of reasonable efforts to maintain secrecy… Trade-secret owners often allow others to exploit their secrets under contracts or licenses that create a relationship between licensor and licensee. The licensor retains ownership of the trade secret but permits specific uses as long as the licensee complies with the conditions specified in the license” (Mitchell et al. 2011). Mitchell et al. explain that informed consent practice as well as commercial trade-secret licenses address four conditions: compensation, limits on access and use, measures for maintaining secrecy, and provisions for allocating rights in case of future technological improvements. They claim that the concept of trade secret allows for a more flexible approach to these four conditions.

Conclusion

15Ownership is a complex concept and any control rights over biological samples of various stakeholders should be described in detail, keeping in mind that ownership is best described as a “bundle of rights.” A pragmatic approach should not only take into account legal rights but also ethical obligations perceived by sample donors and fears about commodification of the human body, neocolonialism, and lack of respect for the dignity of human body parts. In order to maintain trust and to prevent exploitation of vulnerable populations for the benefit of the “better-off” and to cause or profit from social inequalities, biobanks should employ clear governance agreements that use comprehensible consent to define the use of samples, their anonymization and transfer, commercialization (patents, benefit sharing), destruction, etc. This form of “ownership” has been described as a “conditional gift” (Knoppers 1996) and implies that different control rights need to be distinguished, that these control rights are defined in bilateral contracts (e.g., material transfer agreements) and that consent is obtained from donors after thorough information. It is preferable to consider biobanks as custodians of samples and not owners because property rights concerning bodily material and DNA are controversial and—in Europe—clearly limited (Council of Europe 1997). Written rules of a repository should specify the special obligations and rights of the parties involved, and patients need to be informed about the details of control they maintain over their samples. It is widely acknowledged that traditional ownership concepts do not fit when it comes to human biological samples and that legal concepts are often too “country-based.” The bundle of “things” one is allowed to do with samples and data has to be defined in detail for each biobank using ethical reflection and maintaining trust and transparency. A wise choice is to think ahead and to be “compatible with the future.” This implies not to rely only on what one is “allowed to do,” i.e., to respect (minimal) legal requirements, but to decide based on broader values that have gained importance in today’s societies and that become more and more a common ground for many countries. Last, but not least, compliance with these ethical requirements will influence the reputation of biobank research and the willingness of future donors to participate in biobanks.

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Auteur

Studied medicine and theology in Germany, France, Switzerland, and the US and obtained a specialty degree in internal medicine. She is the head of the Institute for Biomedical Ethics, University of Basel, and of the Unit for Health Law, Ethics and Humanitarian Medicine, Center for Legal Medicine, University of Geneva, Switzerland, and obtained several awards for her work, including the Bizot Award for her work on biobanks (2005) and the Swiss Research Award in Primary Care (2010).

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