|
COPYRIGHT 2005 Health Law Institute
In April, 2005, National Geographic Society and IBM launched a genetics research project which targets indigenous populations, the 'Genographic Project.' They aim to gather and analyze DNA samples from 100,000 indigenous peoples over a five-year period. Genographic Project researchers intend to use these samples to track the migratory pathways through which humans have populated the globe. (1) This project was officially launched just one month after news broke that another human genetics project, the International HapMapProject, had completed Phase I on schedule. (2) The HapMap Project researchers are studying genetic markers called 'haplotypes', (3) which can be used to map genetic inheritance over many generations. The HapMap researchers are looking for patterns of genetic variation, which they believe will illuminate how genetics contribute to disease. (4) Both the Genographic and HapMap Projects follow on and reflect aspects of an earlier research endeavor, the Human Genome Diversity Project [the "HGDP"], which also sought to collect genetic materials for population-based research. Like the Genographic Project, the HGDP focused on collecting tissue samples from indigenous populations. And, like the HapMap Project, the HGDP had a medical research component.
Presumably, the proponents of both the Genographic and HapMap projects know very well that the HGDP met with broad opposition, primarily from indige groups. (5) In the end, the HGDP was only marginally successful. (6) Although its proponents had hoped to collect tissue samples from 500 to 700 target indigenous populations, it only ended up with DNA samples from about 50 populations, many of which were 'donated' from pre-existing collections. (7)
The HGDP's limited outcome reflects the complex context in which the research was to take place. Genetic research involving indigenous populations provokes many legal, ethical and cultural issues. (8) Like any genetic research project, it incites questions about ownership of genetic samples including the information gleaned from those samples and, of course, about whether human genetic material is or ought to be patentable. As with the debate on the commercialization of indigenous peoples' 'traditional ecological knowledge,' genetic diversity sampling raises questions about access, consent, (9) exploitation and benefit sharing. (10)
Arguably, of these issues, two dominate the literature. The first is whether human genetic materials are or ought to be patentable, which is often argued against on the basis that such patents offend human dignity generally and are culturally offensive to many indigenous peoples. The second is whether researchers must obtain informed consent from representatives of indigenous groups as a whole before attempting to obtain consent for participation from individual members of that group. This paper is, in part, a call for researchers and those concerned with indigenous/non-indigenous research projects to reconsider whether and how these debates should continue. In particular, I argue that there is limited benefit in continuing to debate the patentability of human genetic material. I also argue that the debate on informed consent is not only about the complexity of ensuring culturally effective knowledge transfer, nor as a simple means of appeasing frustrations of local peoples, but also has to be understood as a manifestation of indigenous political and legal rights aspirations which researchers must consider and address. The through-line in this paper, therefore, is that by virtue of their research agendas, both commercial and scholarly scientists have become on-the-ground players in contests over indigenous people's claims of identity and rights.
The paper opens by identifying some of the reasons why scholarly and commercial researchers engage in population-based genetics research, and how commercial, medical and academic research interests often converge. In the second section, I turn to the now virtually defunct HGDP and consider how it was received by indigenous peoples and international organizations. I use the example of the HGDP to explore why genetics research with indigenous populations is so provocative. I then illustrate how the proponents of the Genographic and HapMap Projects have attempted to differentiate themselves from the HGDP. Having established a relatively full contextual map of these past and present research projects, and exampled key moral and ethical 'hotspots' arising from them. I turn to issues of law, especially in Canadian and U.S. contexts.
The third section analyses intersections between moral, legal and ethical problems. In particular, I show how the potential for exploitation is--or is perceived to be--inherent to population based genetic research with indigenous populations. (11) These problems are often reduced to discussions about whether morality demands that patenting law not extend to human genetic material. To do this I analyse how patenting law in Canada, the United States, and the European Union engage with matters of morality. With that, I conclude by raising the limited practical effects of making changes to patenting law such that it might somehow be more responsive to the ethical or cultural concerns of indigenous populations. I also question the practical effects of an outright prohibition on patenting human genetic materials. My premise here is simple: if the debate on patents resulted in a prohibition, the patent would merely be obtained further down the research, commodity, and development chain. If it were not available for a genetic marker, it would be sought on a cell line, if not on a cell line, then on a procedure, ad nauseum. Crucially, a prohibition is unlikely to materially affect the practice or terms under which genetic sampling occurs, or under which genetic samples are sold. Such a prohibition would risk creating a perception that the moral issues which are provoked by patenting, such as respect for cultural difference and human dignity, have been addressed. In fact, they simply would have been deferred or deflected.
Finally, I turn from patenting law to consider the law of informed consent, and its underlying principles. The law on informed consent is patchy at best, but is emerging rapidly especially in quasi-legal environments and in human rights discourse. The project of making 'consent' meaningful in the context of population-based research involves legal, cultural, and political challenges. Addressing these challenges requires addressing not only effective information transfer, but also engaging with the fact that for indigenous populations, questions of consent provoke issues regarding claimed rights of self-determination as well as tensions regarding cultural, legal and political definitions of group membership. Because these issues underlie consent, any suggestion that authorization is not required from an indigenous group representative is to suggest that the indigenous people are not a rights-bearing political entity. Although a researcher may not believe that an indigenous people has such a status, this presumption must not eclipse the fact that indigenous peoples are likely to claim and actively assert this status.
My position accepts the premise that population-based genetic research has the potential to affect human good, especially by further medical science. However, there are terms which must be present for such research to be legitimately undertaken and researchers, as well as their sponsors, must be alive to the political, moral and legal complexities which are engaged when seeking to work with indigenous peoples, especially in contemporary conditions where indigenous people have widely adopted strong stances on proprietary interests, cultural autonomy, self-determination, and other human rights. (12)
1. The Value of Genes
Population genetics is a discipline which considers "the characteristics of genes within a population as opposed to a description of the genes in a particular individual." (13) It is scientific research which is key for the advancement of knowledge on several fronts, (14) including human migratory pathways and the relationship between genetics and disease. (15) In some instances, genetic data is, in and of itself. quite lucrative, even before any medical products have been developed. For instance, cell lines and tissue cultures are estimated to have yielded $427.6 million U.S. to American genomics companies in 1996. (16) This figure can only have increased over the last decade. More recently, Incyte Pharmaceuticals reported $220 million U.S. in profits in 2001 for selling access to genes on which it held, or had applied for, patents. (17) Where a genetically 'isolated' population (18) is involved, the financial stakes can be surprising. A well-documented example involves a University of Toronto affiliate, the Samuel Lunenfeld Research Institute of Canada, who worked in conjunction with a California genomics company, Sequana Therapeutics. (19) Representatives of the Institute collected blood samples from the 300 inhabitants of the small island of Tristan da Cunha, who were of research interest because of their genetic closeness and high incidences of asthma. The islanders agreed to be sampled en masse, in return for which they would receive free pharmaceutical-based treatment if drugs were developed based on information gleaned through the sampling. (20)
In 1995, Sequana Therapeutics announced it could identify and so eventually patent genes which predisposed people to develop asthma. It then sold the licensing rights to develop a genetic diagnostic test to a German company, the Boehringer Institute, for 70 million dollars U.S. (21) Both Boerhringer and the Islanders have gambled that benefits will accrue to them: of note is the distinct disparity between the realized and potential benefits to Sequana and Boerhringer, and the potential benefits to the Islanders who will merely receive 'free' pharmaceuticals if a drug-based treatment is ever developed.
Despite these compelling profit figures which may attach to medical research, legal scholar Russel Barsh has concluded that much genetic diversity research with indigenous populations is actually directed to academic advancement. (22) Collections of genetic tissue from indigenous populations can indeed be a key source for professional advancement within the academy. A case in point is the 400 blood samples from members of Arizona's Havasupai Tribe, which are at the centre of a lawsuit against Arizona University, and which allegedly formed the basis for no less than 23 scholarly papers, articles and dissertations. (23) Similarly the 833 blood samples taken by Dr. Richard Ward in 1985 from the Nuu-chah-nulth of Vancouver Island served as the basis for some of his most important career research, leading eventually to his appointment as the Head of the Institute of Biological Anthropology at Oxford University (U.K.). (24)
It is, however, not uncommon for scholars to work with corporations. Mark Swindells, of Inparmatica Ltd., a pharmaceutical company, has commented that "the implementation of large-scale genetics and biology is unique in appealing to both commercial and academic spheres simultaneously." (25)
For example, Harvard researchers have established an agreement with Millenium Pharmaceuticals to explore links between genetics and respiratory disease. Researchers have gathered tissue samples from a specific population of the Anhui region of China. Referring to the high homogeneity of group members' DNA, the lead Harvard researcher reportedly told his colleagues that it was "more valuable than gold." (26) According to investigative journalists from the Washington Post, John Pomfret and Deborah Nelson:
Harvard ultimately reaped millions of dollars in federal grants and private investment for the university and the project's lead research because of its access to Anhui DNA. And Millennium was able to raise tens of millions of dollars from corporate investors. (27)
The imagined value of genetic information from such populations is so great as to sometimes result in cascades of investment and profit, long before any commercially viable results have emerged. On a much smaller scale, a casual perusal of genetic samples available from the U.S. based Coriell Cell Repositories, a division of Coriell Institute for Medical Research, indicates that cell cultures from various indigenous populations, including the Karitiana Indians of Brazil and a people described only as "Aboriginal Tribe from Taiwan (Ami)," can be purchased for as little as $85 U.S. a sample. (28) Once again, there is an academic connection as these samples originated from academic collectors, from "the Yale-Stanford collection."
The Genographic Project certainly embraces both academic and commercial spheres, although it does not appear to have an applied medical research component in its conception. At first glance, the Project resonates as a highly scholarly one: most of its regional heads hold academic posts, and its primary products will include creating a public database of anthropological genetic information, and publications on the evolution of key genetic markers and tracking human migration. (29) Its secondary products, though not strictly academic and with a commercial value, are certainly scholarly in character. They include "magazine articles, books, television documentaries, and exhibits." (30) IBM's corporate interest, as explained by IBM spokesman Jay Cadmus, is the expectation that it will "raise the company' s profile as a provider of technology to research institutions, both academic and governmental." They hope to become a major player in the market for life sciences research, which "is projected to grow into an $34 billion market by 2007." (31)
What of the HapMap Project? Like the Genographic Project, most of its proponents hold prominent academic posts, and it has not joined forces with pharmaceutical companies. Although the stated goal of the HapMap Project is to generate a medical research database that catalogues genetic variation, (32) proponents have said from the start that no commercial products will result directly from the HapMap Project. However, like the academic/corporate relationships described above, "in the short term, the main beneficiaries will ... [be] researchers, who will gain professional rewards, and companies, that will be able to develop drugs, diagnostic tests or other commercial products from research using the HapMap." (33)
And so the global commodification of genetic resources, as a source of profit and professional advancement, as a forum where market-based and academic research may be symbiotic, (34) has pushed indigenous peoples, with their allegedly homogeneous genetic lines, to centre stage. (35) The Genographic Project, presumably, will sooner or later be a part of this fray.
2. Lessons From the HGDP
The fact that the HGDP would be plagued with controversy and opposition from indigenous groups came as something of a surprise to its original proponents. Indeed, this group of population geneticists, led by star geneticist Dr. Lucas Cavalli-Sforza, (36) may have seen themselves as quite progressive, as they had already lead a critique of the Human Genome Project (the "HGP") for its Eurocentricity. They queried how one could map "the" human genome when the genes under examination were an amalgamation of genetic materials gathered from just 5 individuals who self-identified as African-American, Asian, Causasian and Hispanic. (37) As one observer stated: when the HGP is complete, "they'll tell us everything there is to know about one French farmer and a lady from Philadelphia." (38)
They proposed the HGDP as a systematic study of the whole range of human genetic diversity. (39) Those involved would compile a database of genetic samples from all over the world, and extract white blood cells to create self-replicating samples--so called "immortal cell lines." The cell lines would then be stored in a non-profit DNA database. The HGDP proponents had great expectations about the research this database could support. They expected it would answer questions about human evolution by revealing "the biological relationship among different human groups" and, anticipating applied research, "may be useful in understanding the causes of and determining the treatment of particular human diseases." (40) They posited the samples would give definitive evidence that there is no scientific support for racial distinctions. To maximize the research possibilities, researchers worldwide would also have access to this unified set of samples for their own research agendas. (41)
The proponents had a promising budget and time line, especially in comparison to the HGP, which was projected to span 15 years, and cost 3 billion U.S. The HGDP was only expected to take 5 years, and cost 25 million U.S. (42) An International Executive Committee, standing committees on ethics and infomatics, (43) and regional teams for Europe, India, S.W. Asia, the Americas, Africa and China were soon established.
It is now 2005. The HGP finished in 2000, ahead of schedule and under budget. (44) The HapMap finished Phase I and its sampling activities within 3 years, as planned, and Phase II is proceeding ahead of schedule. (45) The HGDP, however, met such opposition that it actualized on a rather limited scale. Where it did operate. it was primarily beneath the reach of the radar of public scrutiny--largely outside of public funding and public institutions, and involving no indigenous populations from within Canada and the United States. (46) Why such an outcome?
UNESCO offered clear insight on this matter. In a report drafted by its Bioethics Committee in 1996, (47) it noted that much of the opposition was in response to past experiences where northern parties--corporate and state--collected genetic material and traditional knowledge from indigenous and third world populations. and used these to develop and patent agricultural and pharmaceutical products with little, if any, benefits accruing to the original donors of the material or the knowledge.
UNESCO illustrated its position with reference to the International Board for Plant Genetic Resources, a 1970s project which resulted in a public domain resource of 125,000 plant germplasm specimens, 80% of which came from the South, much of which was identified by indigenous peoples. This database has been the source for the development of product hybrids worth billions of dollars to farmers and...
Read the full article for free courtesy of your local library.
|
Bookmark this article
Print this article
Link to this article
Email this article
Digg It!
Add to del.icio.us
RSS
