IP makes biocolonialism possible, but these critiques also fail to question the exclusionary premise of IP

Eva, phD candidate at the University of Sussex. “Intellectual Property and the Genetic Dispositif of Life: The Changing Role of Intellectual Property Law in Governing Participation and Knowledge in the Bioeconomy.” Submitted for the Degree of Doctor of Philosophy University of Sussex, May 2015. Pp 157-161. LJS

Processes of exclusion need to be understood as a separate strategic power exercise of the IP system, as shown in the previous chapter. This chapter argues that the IP system exercises power not only by bestowing exclusive rights on the IP holder, but also by operating in relative isolation on the international level. The continuing international division between IP on information derived from human genetic materials and the places of source of this material highlights IP’s exclusionary role in its starkest terms. On the basis of this realisation, the chapter then explores strategies challenging IP’s institutional isolation on the international level within an emerging frame of reference centred on life, which requires new legitimations from the previously entirely separate IP system. These responses are better understood as instances of governing. This thesis’ analytical perspective on IP as an emerging tactics of governing highlights how IP’s exclusivity is beginning to be contested in debates about IP and health, and IP and human rights, held within pro-IP international organisations such as the WTO and WIPO. The IP system continues to fulfil its economic role, however, this now needs to accommodate demands made on the basis of life and health, leading to a process of accommodation in which IP begins to act as a tactics of governing between life and the market. 1.1. Deriving exclusive rights from international bioprospecting and biobanking projects The relation between IP and genetic conceptions of life on the international level has been marked by several highly controversial instances of “bioprospecting” (Robinson 2010, 11) in developing countries followed by registration of gene patents on the gathered ‘materials’ in industrialised countries. Most notable amongst these was the Human Genome Diversity Project (HGDP)82, which collected a diverse range of genetic samples from different distinct peoples across the world, and gave rise to allegations of racism and ‘biocolonialism’. Indigenous peoples referred to it as the “Vampire Project” and strongly criticised the range of chosen donor populations and the patents derived from the samples later on (see Thacker 2005a, 134). An unrelated patent application on a leukaemia-resistant human T-cell line derived from a Papua New Guinean, filed by the US Department of Health and Human Services and the National Institutes of Health in 1993 (Oriola 2007, 6; Thacker 2005a, 134) was also heavily criticised for the cursory way in which it dealt with the original donor. These issues were addressed in the later Human Genome Project (HGP) in a dedicated ‘ELSI’ (Ethical, Legal and Social Implications) programme, entirely funded as part of the larger project itself. This programme focused in particular on the question of informed consent. IP is usually not included in such formal considerations of bioethics beyond the question of informed consent. The HGP proved less controversial due to the ELSI programme and the project’s less racially charged connotations, however, further controversies arose when an Australian pharmaceutical company named Autogen attempted to create a biobank containing blood samples and DNA of Tonga’s people in 2000 – also seeking to capitalise on this community’s relative isolation and distinctiveness. The project was dropped in the face of vociferous criticism from Tonga’s population, which complained that the informed consent procedures disregarded Tonga’s particular social structure and the importance of the family unit within it. Consent could thus not be obtained from the individual alone, but needed to take into account the views from the extended family group (Nwabueze 2007, 167). However, Autogen’s project addressed previous criticisms made of ‘bioprospecting’ programmes by promising to share the proceeds of any commercial products derived from the research, establishing laboratories on Tonga and assigning property rights over individual genetic samples to Tonga’s government – effectively nationalising this property (Ibid.). A similar approach to property was taken by deCode’s Icelandic Population Biobank. However, in the Icelandic case “informed consent was claimed on behalf of the people of Iceland through an act of parliament” (Senituli and Boyes 2002, 4; see also Fortun 2008). This model differs from other biobanks, which adopted a much more protectionist position towards the material and background information, as for example was the case in Sweden (Nilsson and Rose 1999, 894). Part of the Icelandic plan was to establish a Health Sector Database (HSD) in the Act on a Health Sector Database (No. 139/1998), passed by the Icelandic parliament on 17.12.1998, “which would link its clinical and research data to both the Icelandic health care system records and the genealogies” (H. Rose 2003, 78).83 The Icelandic government created a tissue bank “to complement the HSD” in the Act on Biobanks No. 110/2000 (Nwabueze 2007, 156). This tissue bank and the HSD operated on the basis of licenses, so that the property in the materials collected remained with the government of Iceland. However, the blanket presumption of consent encountered strong criticism, and “six years later that statute was overturned as unconstitutional, and subsequent national biobanks such as those in Australia, Estonia and the United Kingdom have required explicit consent at the time of donation” (Dickenson 2007, 126). Interestingly, the transfer of IP was not directly discussed in ethical debates, even in these very contentious examples of biobanks and bioprospecting projects. Bioethics debates usually revolve around the issue of informed consent to counter allegations of ‘biocolonialism’ perpetrated by companies based in industrial countries, and are slowly also including problems of IP in informed consent structure (Dickenson 2004). The assumption of IP rights by the Icelandic government did not give rise to a debate similar to that of its presumed consent – and still does not, as the details of the transfer of rights in the recently established structures of UK Biobank show. Where it comes to intellectual property, the consent form of UK Biobank clearly states: “I […] relinquish all rights to these samples which I am donating to UK Biobank” (UK Biobank 2011). There is an option for withdrawal from the programme promising “UK Biobank would destroy your samples (although it may not be possible to trace all distributed sample remnants)” (UK Biobank 2010). Thus the transfer of property rights is permanent, even though the samples themselves may be destroyed at a later date. UK Biobank then grants licenses to private corporations and scientists for the use of the genetic information (UK Biobank 2007, 13). Exclusive rights are derived from individually donated samples in all these examples of bioprospecting and biobanking projects – held either directly by a private company or in some cases by the respective national government. These rights are not directly contested in bioethics debates – but they are nonetheless criticised strongly by the Biopiracy and New Enclosure literature. In response, demands for Access and Benefit Sharing (ABS) aim to ensure a more direct connection between the donation of the materials and the eventual profits made from the intellectual property and commercialised products derived from this donation – albeit only in the area of plant genetic material. ABS agreements such as the Nagoya Protocol have been debated extensively for example under the CBD, suggesting amongst others a requirement for the disclosure of the provenance of the sample used for a particular patent application – but have not been included into the list of minimum provisions for patentability under TRIPS. The IP system thus remains doubly exclusionary – assigning exclusive monopoly rights to private entities and at the same time excluding any reference to the origin of samples used for the genetic ‘invention’ in question. This detachedness is mirrored in the division of debates between pro-IP international organisations such as WTO and WIPO, and pro-ABS organisations such as the CBD. This separation between sites of debate also masks a division of interests between industrial, IP-producing countries and developing countries, which are often the location of provenance of samples used in the production of IP. As the next section will show, this division of debates perpetuates the exclusive status of IP, as ABS agreements fail to make inroads on the TRIPS system. While the relation between the Nagoya Protocol and TRIPS is still under discussion, the exclusivity of the IP system remains especially effective in the area of IPRs on information derived from human genetic materials, where no similar ABS agreement has been negotiated.