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It is this concept which excites advocates of genetic engineering. By reducing life to bits of genetic compounds, scientists can introduce, delete or enhance a particular trait in an organism. With ever increasing fervour, the biotechnology industry seeks to uncover the mysteries of creation, promising wonders for the future as they do so. With each new advance, however, the biotechnology revolution raises urgent moral, ethical and philosophical questions. Recently, the issues have intensified with the explosion of knowledge about human genes and the accompanying growth of human-based biotechnology.
A new dimension was added to the debate with the conception of the Human Genome Diversity Project (HGDP). With its focus on isolated populations, it has outraged indigenous peoples around the world. This paper seeks to explore the variety of concerns which fuel their vehement opposition to such a project. The first section explains the concept of population genetics research generally, in order to put the discussion of the HGDP proposal in context. It also discusses the aims and philosophies of the Project, and outlines its progress to date. The next section introduces a number of indigenous peoples' concerns specific to the HGDP. It becomes obvious that indigenous peoples also see the HGDP as being at the vortex of a number of wider issues. In particular, these concern the integrity of the human gene, issues of informed consent, and the much debated 'patenting of life-forms controversy'.
The discussion of whether or not 'life-forms' should be patented begins by outlining a number of recent attempts to patent human genetic material. It then canvasses cultural arguments concerning the commodification of life, and explores the rationale behind the patent system. It also examines the concerns of some members of indigenous communities that they will not receive any financial benefits from patents.
It is clear that there are a number of conflicting interests involved, not just as between indigenous peoples and the scientific community, but also as between and against different sectors of the biotechnology industry, first-world governments and multi-national corporations. The final section discusses potential options for the future, but at the same time acknowledges the huge influence that strong economic powers have over the debate.
Population genetics[2] is a well-established discipline. It is concerned with "studying genetic variation in defined populations, including relevant aspects of population structure and geographic variability of DNA sequences and their frequencies."[3] This type of research began with world-wide surveys designed to ascertain frequencies of single gene diseases. It was then extended to studies of allele frequencies of blood groups, HLA proteins and enzymes.[4]
As the term implies, population genetics "deals with the characteristics of genes within a population as opposed to the description of the genes in a particular individual."[5] According to the UNESCO[6] Subcommittee on Bioethics and Population Genetics, there are currently three main trends evident in population genetics research. These are known as genetic epidemiology, genetic screening, and spatial and temporal variation.[7] Genetic epidemiology focuses on the observation of genetic forces acting in human evolution. Genetic screening utilises the results of population genetic studies to implement mass screening programmes for particular disease genes. The most recent trend involves advances in molecular biology which have enabled geneticists to work out the spatial and temporal variation of gene frequencies. It is this last category which provided the main impetus for the HGDP.
Luigi Luca Cavalli-Sforza,[8] a population geneticist from Stanford University, explained the history of the HGDP in his 1994 address to a special meeting of UNESCO.[9] The HGDP formally began in 1991. It resulted from Cavalli-Sforza's interaction with a number of other leading geneticists,[10] including Sir Walter Bodimer who, at the time, was Chairperson of the International Human Genome Organisation (HUGO). In his capacity as Chairperson, Sir Walter named a committee to foster the development of the Project.
The HGDP is still largely in its planning stages[11] and is currently seeking funding. Cavalli-Sforza describes it as "an international anthropology project that seeks to study the genetic richness of the entire human species."[12] Indeed, he continues on to say that it is "as global as humanity itself."[13]
In January 1994, in an effort to promote global involvement and coordination, the Council of HUGO approved HUGO's continuing oversight of the development of the HGDP.[14] The 1994 HUGO Summary Document discussed the scientific aims of the Project.[15] Primarily, it would "investigate the variation occurring in the human genome by studying samples collected from populations that are representative of all the world's peoples."[16] In doing this, the genetic information contained in blood, skin and hair samples would be preserved indefinitely, either by developing cell lines[17] or by isolating and storing DNA segments using polymerase chain reaction (PCR) technology.[18] This would ultimately create a resource which would enable scientists to study the samples for many years into the future, ostensibly for the benefit of all humanity.
The Project's North American Committee explains[19] that the type of information to be gathered has the potential to clarify the history of specific populations and of the human species as a whole. In particular, it could illuminate current understandings of the major human migrations. Further, the Project may generate knowledge of potential health importance, including increased knowledge about the factors that lead to disease and eventually information about ways to treat or prevent specific diseases. The Project intends to collect and make freely available the results of any analysis and research through a database.[20]
In order to achieve such aims, the HGDP has identified certain categories of populations which it would be useful to sample. These are listed in the HUGO Summary Document as including: "Populations that can answer specific questions concerning the processes that have had a major impact on the genetic composition of contemporary "ethnic groups", language groups and cultures"; "populations that are anthropologically unique"; "populations that constitute linguistic isolates"; "populations that might be especially informative in identifying the genetic etiology of important disease"; and "populations that are in danger of losing their identity as genetic units".[21]
Organisers and supporters of the HGDP are concerned that some of these categories are being threatened by the fact that the human species is moving towards increasingly intensive amalgamation. This "leads to an interest in sampling those of the 'native' or 'aboriginal' populations in each region"[22] and scientists are anxious to do just that. They believe that this objective would be facilitated by the type of large-scale sampling envisaged by the HGDP.
In addition, the Project also has the potential to coordinate other population genetic studies which are "currently proceeding in a haphazard and largely invisible way"[23] and to make sure that this kind of research is done with the highest scientific and ethical standards. To this end, the North American Regional Committee of the HGDP has drafted a "Proposed Model Ethical Protocol for Collecting DNA Samples."[24] In support of this effort, Dr Darryl Macer[25] believes that the Model Ethical Protocol is a fairly advanced attempt to canvass the issues.[26] Indigenous peoples, on the other hand, do not seem the slightest bit impressed. Aware of their importance to the Project, they are increasingly sceptical that participation in the initiative would be in their best interests.
Once indigenous organisations became aware of the proposed HGDP, the reaction of intense condemnation was immediate. Probably the HGDP's first mistake was in failing to include representatives of indigenous peoples in early formative meetings, despite the fact that the Project carried such huge implications for them. Chief Leon Shenandoah[27] neatly summed up the character of this exclusion in a letter to Johnathon Friedlaender of the National Science Foundation. In denouncing the HGDP, Chief Shenandoah states: "That the Human Genome Diversity Project has progressed to the fifth meeting without discussion or consent of the indigenous nations and peoples it affects, we find unconscionable."[28]
It was not as if this situation occurred through lack of trying on the part of indigenous peoples. The Conference Report of the "First International Conference on DNA Sampling: Human Genetic Research - Legal and Policy Aspects"[29] highlights this and provides a perfect example of the controversial nature of the HGDP. It notes that "a group of native Canadians demanded the right to address the meeting but were not given an opportunity to speak.. ..The political and ethical dimensions of this project are clearly substantial."[30]
In the light of such exclusion, it is not surprising that many prominent indigenous organisations produced declarations[31] asking for the HGDP to be halted "until its moral, ethical, socio-economic, physical and political implications have been thoroughly discussed, understood and approved by indigenous peoples."[32] Predictably, given the track record of western society's interaction with indigenous peoples, this request was denied. Indigenous peoples, however, continue to express their opposition to the Project at every opportunity. According to Aroha Mead,[33] this has meant that organisers of the HGDP are now "retreating to a pathetic position of claiming to be victims of other peoples' ignorance."[34] Indeed, in discussing the status of the HGDP, Professor Greely[35] notes that he does not know of any publications from indigenous peoples' organisations supporting the Project. He believes that one of the reasons for this is due to "a set of misunderstandings about the Project."[36] Indigenous peoples find this type of attitude to be incredibly condescending. They are convinced of the validity of their concerns and believe that the burden of proof that the Project will benefit them rests with the HGDP.
The concerns directed at the HGDP exist on two levels. The first relates to criticisms specific to the HGDP and the type of research that it aims to conduct. The Project also raises a number of wider issues for indigenous peoples, however, which relate to the field of genetic research as a whole.
Much of the commentary aimed at the Project centres around five main themes. These concern: the history of colonisation; indigenous peoples' understandings of the origins of humanity; the belief that the money to be put into the HGDP could be better spent; issues of access to and use of data; and the somewhat related fear that misuse of information gathered by the HGDP could lead to biological warfare.
embedded in the minds of indigenous peoples are memories of a reign of European colonial domination. While indigenous peoples may represent important scientific resources for the HGDP, "many are also communities who have been colonised or enslaved, pushed off their lands and forced onto reservations, virtually wiped out by diseases introduced into their communities by Europeans...and generally marginalised within the global economy."[37] This exploitation and oppression of indigenous peoples around the world is still continuing today, with many still fighting tooth and nail to protect the lands and the resources that are left to them. It is hardly surprising then that the activities of the HGDP are seen as just another form of neo- colonialism. The Cordillera People's Alliance describes the Project as "a more sophisticated form of collecting and preserving Indigenous Peoples like those collections of yet unreturned mummies taken from their burial caves in violation of Indigenous Peoples' rights".[38]
Although aware that such ideas resonate strongly within indigenous communities, Professor Greely nonetheless argues that research conducted under the auspices of the HGDP will not exploit the populations involved.[39] He points out that since it was founded, "the HGDP has vowed that it would respect the rights of participating populations and make every effort to make sure others respected those rights."[40] While indigenous peoples' organisations generally accept that the organisers of the Project are genuine in stipulating this, the harsh reality is that they have heard similar promises before which have turned out to be empty. Good intentions are difficult to police.
We shall not cease from exploring And the end of all our exploring Will be to arrive where we started And know the place for the first time.[41]
The HGDP states that as a cultural resource the potential of the Project is enormous. It believes that the results of its research will allow the reconstruction of migration and settlement patterns and lead to a much greater understanding of the world's populations and their precursors.[42] As ArohaMead explains, however, "many consider further research into our origins and migration patterns based on genetic mapping as...unwarranted tampering with whakapapa processes which have already settled these questions to our satisfaction."[43]
It is clear that within most indigenous epistemologies, such questions are dealt with in an environmentally and culturally specific way. To rephrase a comment made by Ray Apodaca of the National Congress of American Indians, these communities know where they've come from, know who they are, and believe they know where they're going.[44]
It is also obvious that the cosmologies of indigenous peoples are not congruent with popular Western theories.[45] Thus it would seem that traditional communities see the primary motivating questions and assumptions posed by the HGDP as largely foreign and even insulting. Most scientists, on the other hand, feel that the pursuit of further knowledge expressed as scientific fact can only be good.[46] No matter how rational this argument may seem to western society, given that many indigenous groups view the primary motivating questions and assumptions posed by the HGDP as largely foreign, "a benefit designed with little regard to the perspectives of traditional communities may find difficulty gaining acceptance from targeted beneficiaries/donors."[47]
The HGDP is estimated to cost between $23-35 million to be spent over five years and will allow sampling from 10 000-15 000 human specimens. "At an average total cost of (US) $2300 per sample, the project will spend more money gathering the blood of indigenous peoples than the per capita GNP of any of the world's poorest 110 countries."[49] Indigenous peoples' organisations believe that this money could be better spent providing much needed basic social services to communities whose survival and human rights are threatened. This criticism is neatly summed up by Ruth Liloqula who states: "The project has very little interest in helping indigenous people to survive, or in addressing the social, the economical, the political, and the exploitation issues that endanger these indigenous groups of people."[50] Indigenous peoples allege that the fundraising efforts of the HGDP further limit the chances of those seeking funding for more crucial projects.
In defence of the Project, Kenneth Weiss argues that the HGDP is in no way a substitute for efforts to protect and enhance human populations everywhere. It is simply a scientific project, but even so it is one which he believes could help by raising awareness, and by modifying the harshness with which people can think of each other.[51]
The HGDP's North American Committee acknowledges that "almost any expenditure of funds would relieve more human misery if used for direct assistance",[52] but contends that the Project's hopes for funding of $5 million per year would not go far to solving the world's problems. They argue that if the funds were not spent on the HGDP, it is likely that they would be spent on another scientific project, and quite possibly one which is not as interested in emphasising "the importance both of human diversity and of the extraordinarily close relationship of the human family."[53]
Dr George Annas disagrees. He argues that, taking human rights seriously and for the very reason that indigenous peoples are part of the human family, it would be a much more important gift to humanity to try to ensure their cultural survival than perhaps whatever scientific advances may result from the taking of their DNA.[54] There is every reason why a project with this type of goal could successfully compete with the HGDP for funding.
The results of research projects conducted amongst indigenous peoples have often been used to their disadvantage. There is the potential for this to happen again under the HGDP due to its 'open access' policy, where the samples collected "will be available to all qualified researchers"[55] and the results of any analyses "will be widely available through computerised databases."[56]
As Posey and Dutfield explain, the concern is that some of the information will be used either to deny human rights or to justify human rights violations already taking place.[57] One possible example of this is the idea that some governments might try to grasp at any piece of genetic information concerning migration and settlement patterns as 'evidence' to deny traditional communities their land rights.[58] On the other hand, genetic information could enhance indigenous peoples' abilities to establish traditional resource claims. Which outcome is more likely would depend on who controls the use of the information.
Although the HGDP believes that it can put in place workable mechanisms to control access, the problem is that once genetic materials are stored in gene banks such mechanisms would be difficult, if not impossible, to enforce. For this reason, many indigenous peoples' feel that "there are too many unknowns for anyone to feel confident about the future use of materials and information."[59]
Given that access to and use of genetic materials and information generated by the HGDP would be difficult to control, the possibility of genocide by biological warfare is a concern that indigenous peoples continually raise. This is a fear that is not easy to quieten, especially since historical accounts exist of similar techniques playing a role in the domination of a number of indigenous communities.[60]
Organisers of the HGDP continually assert that "genocidal use of genetics is not possible with any currently known technology."[61] They explain that the idea stems from an outdated belief in 'racial essence', a concept based on the notion that there is a particular gene that defines each population group. Although some groups do have gene variants that are exclusive to them, organisers emphasise that not all members of these groups carry such a variant. They therefore believe that "if a government wanted to wage biological warfare on an ethnic group, it would be a lot cheaper, simpler and more effective to drop dead animals down wells."[62]
Such reassurances have had little affect on opponents, however, who continue to insist that HGDP research data and techniques could make it easier for those so inclined to design new biological weapons against specific populations. There is certainly some evidence which would seem to justify their concerns. The USA, for example, has built a large 'maximum containment facility' for the testing of biological weapons, even though this is outlawed by the 1972 Biological Weapons Convention.[63] Although the research is claimed to be defensive, there is no real distinction from offensive development.
Even if genetic-based targeting of specific populations seems far-fetched given 'currently known technology', at a time when many of the scientific impossibilities of the past are becoming reality indigenous peoples are likely to continue to refuse to be appeased by reassurances which can not be guaranteed.
In addition to criticisms aimed specifically at the HGDP, the Project has also become the focal point for indigenous peoples' concerns about the field of genetics as a whole. The first major issue which the Project raises relates to indigenous peoples' ideas about the integrity of the human gene. Much of the opposition to the HGDP cannot be fully understood without first considering this perspective. This leads on to a discussion of the controversy surrounding the patenting of 'life-forms' as it relates to human beings. Indigenous peoples' concerns in this area were underscored recently by the making of a number of applications to patent human genetic material. These attempts also stirred up the debate on procedural questions of informed consent.
For many geneticists, "DNA is a twist of biochemicals in the bottom of a test tube with no more moral or social significance than any other laboratory reagent."[64] It is a forceful difference of opinion on just this point that is at the heart of indigenous peoples' opposition to the HGDP.[65] It raises the fundamental question of whether genetic research is appropriate at all.
The need to even ask this question appears to present a foreign concept to many geneticists, not the least of whom are advocates of the type of research proposed by the HGDP. Rather than face the incomprehensible, these scientists instead imagine that opposition on this basis results from a lack of understanding of scientific aspirations and the nature of the HGDP. The problem, however, penetrates much deeper than that. It involves "a clash of philosophy and cultural insight concerning our understanding of the origins of humanity, the responsibility of individuals and the safety of the community in terms of past, present, and future generations."[66]
Western science has frequently sought to explain the whole by reducing life to its component parts, and then treating each as a separate entity. This world-view is known as "genetic reductionism". A feature of this approach, and indeed of much of western culture, is the tightly held belief that it can be objective[67] - that it can "exist outside of a cultural framework and is divorced from political and economic considerations."[68] One of the worst and most extreme manifestations of this idea can be seen in a comment made by Joseph Straus of the German-based Max Planck Institute. Discussing the "Future of Intellectual Property Protection for Biotechnology in the US, EC and Japan"[69] at a symposium at the University of Washington Law School in October 1993, he warned the participants against "ethics and other irrational considerations."
For indigenous peoples, attempts to try and divorce genetics from ethical, cultural and political realities are viewed simply as a means for scientists to pursue their own ends. While there is no question of the potential in genetic science to enhance life, it is also capable of using modern technology to desacralise, dominate and manipulate it. This process works to undermine the integrity of traditional communities since they share a holistic view of ife which stands in juxtaposition to the western world-view.[70] Many indigenous peoples regard the human gene as genealogy. In other words, "a physical gene is imbued with a life spirit handed down from the ancestors, contributed to by each successive generation, and passed on to future generations."[71] As such, it contains a life force that continues to exist 'ex situ' and so cannot be separated or isolated as "an entity devoid of life."[72] This same perspective is also carried over to issues of replication and manipulation. Further, for similar reasons, the scientific practice of synthetically reproducing a gene from an original and then distinguishing between the two would not withstand cultural scrutiny.[73] The reality is that a copy exists only because of an original.
Indigenous peoples' views about the integrity of human genes are also applicable to all other life.[74] They believe that all of nature descended from their ancestors, and so all must be held in the same high regard. Such profound respect for their ancestors stems from an understanding that is central to indigenous cultures and which is crucial to their very survival: that their most sacred role is in the preserving of the dignity of their ancestors. It is for this reason that many object so vehemently to the HGDP. As part of the larger genetic industry, it represents all that is profane - to borrow from Dr Reinhold Salgo, "dignity and a mechanistic view of life are mutually exclusive."[75]
In the industrialised world, "giant strides in biotechnology have left society behind to deal with the consequences."[76] The field of genetics is now incredibly fashionable among scientists and the itch to be first to manage it successfully is becoming stronger. The advances in biotechnology have also increasingly caught the eye of multi-national corporations who are ever on the lookout for new commercial opportunities. With the recent merging of some of the giant companies, it now seems that "a handful of transnationals with a less than acceptable curriculum in caring for Nature"[77] dominate this sector. Such a development has led to even more consternation among indigenous peoples as regards the proposed HGDP.
Although the HGDP portrays itself as a noble, uncommercial activity, there are many who feel that the Project cannot act outside of political and economic realities. With the spread of privatisation, it is becoming ever more difficult to secure funds for long-term research. Research involving human genetic materials may well begin with the best of intentions but there is no guarantee that research planned now will not become commercial
in the future. In admitting that samples it collects might generate commercial products,[78] the Project does nothing to alleviate such fears.[79] Rather, indigenous peoples' concerns have intensified due to a number of recent attempts by the US government to patent genetic material derived from members of indigenous communities.
Indigenous peoples' opposition to these patents is occurring on two levels. On the one hand, based on their beliefs regarding the integrity of life-forms, many object to the whole idea of commodifying life which to them these patents represent. Those in favour of the patent system retaliate by stressing the reasons why they see patents as being indispensable. At this level, arguments for and against the patenting of life-forms have become polarised into a debate about ethics and economics.
The second level of opposition relates to largely practical concerns. Patenting is opposed on the ground that those from whom genetic material is taken are not likely to receive any financial benefits from it.
Patent laws grant a limited property right to the patent holder. They allow the patent holder to benefit financially from the patented item by prohibiting others from profiting from its sale for limited periods of time.[80]
Recent attempts to patent the genetic material of members of indigenous populations is the latest evolution of the notion of applying patents to animate matter. It is generally conceded that this trend has been gathering momentum since the 1980 decision of Diamond v Chakrabarty,[81] where the US Supreme Court held that the creation of an oil-eating microbe was patentable. The next significant development came in 1988 when the US Patent and Trademark Office (PTO) recognised that genetically altered life-forms are protectable and granted the 'Harvard-onco mouse' patent.[82] This patent concerned a line of laboratory mice bred to have a genetic disposition towards developing cancer.
Then came Moore v Regents of the University of California,[83] a 1990 California Supreme Court decision that has been of singular importance in defining questions of property rights in the human body. The case resulted from a lawsuit filed in 1984 by John Moore against his doctor, the Regents of the University of California, and certain pharmaceutical companies.
Moore's story began in 1976 when he was treated at the UCLA Medical Centre for an extremely rare form of cancer, hairy cell leukemia, and his spleen was removed. Despite explicitly excluding the option on a consent form that permitted his tissue being used to develop a cell line, section from the removed spleen were sent to a research laboratory. The doctor who performed the operation and his technician then proceeded to use the samples to develop a cell line, which they named the 'Mo' cell line. They then succeeded in patenting the cell line and assigned the patent to the regents of the University of California. The cell line was predicted to have a long-term market value of $3 billion.
After a drawn out battle through the court system, the California Supreme Court finally ruled in 1990 that John Moore's doctor had breached his 'fiduciary duty' to Moore by not disclosing a research and financial interest in Moore's cells. What is significant, however, is that the Court went on to state that Moore did not have a 'property right' in the tissues removed from his body. This conclusion was based partly on public policy considerations. The Court reasoned that to rule otherwise would "...hinder research by restricting access to the necessary raw materials",[84] thereby interfering with the critical role that such research plays in medical science.
It is this decision which most directly prompted the run of applications for patents which have so outraged indigenous peoples everywhere. The first to be discovered, in August 1993, was a US Government application for US and world patents on the cell line of a 26 year old Guaymi Indian woman from Panama. The claim was lodged by US Secretary of Commerce, Ron Brown, for the Human T-Lymphotropic Virus Type 2, drawn from the 'immortalised'[85] DNA of the Guaymi woman.[86]
The Guaymi National Congress and the World Council of Indigenous Peoples were quick to protest the patent claim. They then took their concerns to the intergovernmental meeting on the Biological Diversity Convention in October 1993. Jean Christie, of the Rural Advancement Foundation international (RAFI), notes that "news of the Guaymi patent claim was met with incredulity and outrage by government and non- governmental representatives alike."[87] Later in October, the European Greens introduced an emergency resolution into the European Parliament opposing the world and US patent claims and calling for a common European position against human patenting.[88] Under mounting pressure, the US Government withdrew the Guaymi patent claim in early November 1993.[89]
The next watershed came in March 1995, with the US PTO ushering in "a new and outrageous era in intellectual property by issuing a patent to the US National Institutes of Health (NIH) for an unmodified human cell line drawn from an indigenous person from Papua New Guinea."[90] This was the first time that a patent had ever been granted for cells from an indigenous person and it resulted in global outrage from indigenous communities world- wide.
The patent was the end result of tests conducted amongst the Hagahai people of Papua New Guinea which established that the blood of many Hagahai carried a human T-cell leukemia virus, although they were not afflicted with the disease. It seems that a decision to patent a cell line from one of the Hagahai 'donors' was influenced by the fact that this discovery was "likely to have important application to testing populations everywhere in the world, and the potential exists for its use in vaccine development."[91]
Despite opposition to the patent, in early 1996 the US Department of Health and Human Services tried to enforce the patent world-wide. In an interview for the NZ Herald in February 1996, Aroha Mead said that this development meant that indigenous and non-governmental organisations would try to take the issue as far as the World Court.[92]
Finally on 10 December 1996, (which, coincidentally, is Human Rights Day), the NIH "disclaimed" the Hagahai patent[93] after pressure from indigenous peoples, non-governmental organisations and foreign governments. By this time, however, the patenting attempt had left behind "a trail of trauma and mistrust."[94] In describing the patent, Alejandro Argumedo said, "there has been no greater affront to fundamental human rights by western intellectual property systems than the Hagahai patent."[95]
The concerns raised by these incidents are heightened by the HGDP. While it was not involved in any of the patenting attempts,[96] the danger exists that the samples collected through the Project will one day find themselves the subjects of patent applications. According to Andrew Kimbrell, what the pattern of events has shown is "that if government will do it, we certainly know that companies will do it",[97] and while the HGDP continues to emphasise that its objectives are non-commercial there is no guarantee that the rules will not change in the future.
Indigenous peoples' arguments about the integrity of life[99] are applied most forcefully in the context of discussions about patenting. For indigenous societies, the patenting of life-forms is unacceptable because it transforms life into a commodity that can be owned and used for trade purposes.[100]
Those in favour of patenting human genetic material try to combat this idea by arguing that it is inaccurate to describe such patents as patents on 'life'.
The complexities surrounding this issue are aptly illustrated by a debate that occurred between Professor Greely of the HGDP and Edmond Hammond of RAFI in 1995 via the Internet. From opposite sides of the fence, but with neither being directly in the indigenous peoples' camp, these two argued about the status of the Hagahai patent. Greely argued that the patent "was not, of course, on 'a person'", rather the patent was on a cell line infected with a variant of the HTLV-1 virus, viral preparations made from the cell line, and various bioassays for detecting infection with this virus using the cell line.[101] Hammond strongly disagreed with this statement. He responded that the NIH had patented a cell line which contained all of the Hagahai man's DNA and chromosomes, so in a "very real and broad sense" the Hagahai man had been patented.[102]
Others also argue about this distinction. Poste, Roberts and Gentry,[103] for example, make the point that opponents of these kinds of patents "sometimes come close to confusing genes with life. Genes are essential to life, but a gene is not the same as life."[104] Kent also argues that DNA, isolated and purified, is not alive.[105]
When the patent concerns an indigenous person, however, this type of 'objective' analysis may be of very little importance. What is crucial is the world-view of indigenous peoples themselves. As Aroha Mead explains, "on the issue of patenting, we reject the use of this legal instrument to assert ownership over any life-form", whether human, plant or animal "in their smallest microbial form."[106] On this understanding of 'life', indigenous peoples condemn patents as being the primary means to legally enforce the practice of reducing life to nothing more than an industrial commodity. Although the willingness to regard human genetic material as property and exploit it as such is not dependent on obtaining patent rights, patents greatly reinforce this habit.
Further, in the eyes of indigenous peoples, the HGDP compounds the problems by making samples and data widely available. In doing so it potentially opens the doorway for further commercialisaton within the biotechnology industry. This concern has been plainly expressed in the 1995 "Treaty for a Lifeforms Patent-Free Pacific".[107] Article 3 of the Protocol concerning human genetic research states: "Indigenous peoples of the Pacific do not support the objectives of the Human Genome Diversity Project or any other project which seeks to ...commercialise the genetic materials of the indigenous peoples of the Pacific."
Another criticism of the intrusion of financial interests into this sphere is expressed by Ruth Liloqula of the Solomon Islands.[108] She believes that the issue of patenting human genetic material could have huge implications on some indigenous communities seeking medical help that they need. She explains that it took a very long time for her people to accept going into hospital and giving samples for the purpose of diagnosing illness. If they thought that these "would be used for other reasons they would be unwilling to give the samples and would stay away from hospitals even when they became very sick."[109]
In addition, there is also concern that the patent system will result in divisiveness amongst indigenous communities if one group should take out a patent on a product that is shared by more than one community. Relatedly, traditional communities may end up spending scarce resources in trying to protect any such newly won intellectual property rights.
When presented with traditional populations who so vociferously oppose patents, technological societies that are motivated by profits are unsure how to react. One response is to trivialise that which they do not fully comprehend. A variation on this approach is to insist that indigenous peoples adopt the western way of doing things now that their isolation is at an end. This group does not seem to find it ethically troubling to require indigenous peoples to participate in a foreign intellectual property regime, even though that regime contains concepts which do not exist in indigenous cultures. Another common response to the conflict is to ignore it all together. This alternative is most commonly illustrated by the belief that the patent system is not the appropriate place to consider ethical and moral issues.[110]
This last faction instead provides numerous economic reasons why the patent system is imperative for the growth of the biotechnology industry. This, however, is not an unconditional assumption. There are groups who proclaim the virtues of genetic engineering, but who nonetheless are not in favour of patenting human genetic material. This dispute highlights the fact that the issues involved go deeper than just an indigenous peoples versus 'first-world' confrontation. There is also competition as between groups within industrialised society, albeit based on fundamentally different values.
The most often argued justification for maintaining the patent system is that, as an instrument of economic policy, it provides an incentive for the development of new technology. In other words, "patents encourage inventors to engage in inventive activity because of the potential rewards reaped from exclusive control of the result."[111]
This argument is backed up by biotechnology industry analysts' claims that without patent protection much of the research currently available would not exist. This idea is constantly pushed by large pharmaceutical companies. Dr Poste, the architect of SmithKline Beecham's aggressive
expansion into genetics, points out that it costs between $NZ 350 million and $NZ 450 million to develop a new drug.[112] In an interview for the Christchurch Press early in 1997, he states that without intellectual property protection he can not see companies "coming forward with new drug development unless they feel there is a protectable asset."[113] To put it bluntly, the cry is "no patents, no cure."[114]
Patenting opponents, on the other hand, are not particularly impressed with these lines of argument. As Matthew Erramouspe explains, although rewards are one of the central premises of the patent system, "reward theorists have had surprisingly little success in explaining case outcomes by reference to their theory."[115] Contrary to the model's intimation, some significant inventions as well as some inventions having high development costs go unrewarded, while less important and less costly inventions receive generous patent protection.[116]
In addition, it is far from obvious that in the absence of patent protection some types of research would not be undertaken. For one thing, "there have been many societies in which economic or technological development has occurred without anything in the nature of intellectual property rights."[117] Even within industrial society as is stands today, there are other incentives available to prompt the basic research and clinical studies necessary to create new technologies and products. These incentives are inherent in the self-image of the scientific community, and in the strong unwritten rules of professional conduct which constrain the scientists who investigate and develop new biotechnologies.[118] Professional norms dictate "that a scientist will be forthright in reporting experimental results, will freely share those results with other scientists, and will acknowledge valid experimental results without regard to the researcher's status."[119] In this environment, successful research is valued for the peer recognition and community acknowledgment that it entails.
With the increase in priority of pecuniary gain as a motivating factor in the pursuit of knowledge, it is evident that the direction that research is to take has significantly altered. Some argue that the return to traditional incentives as a means of prompting scientists to undertake new kinds of research may have the added advantage of ensuring that such research is carried out within acceptable societal parameters.[120]
Another argument that opponents put forward is that patents confer a virtual monopoly on their holders. As such, they are likely to generate the type of inefficiencies generally associated with monopolies. Although a patent is only granted for a limited period, in an industry which develops so rapidly 20 years is a considerable length of time.
In arguing the monopoly point, those who object to the use of patents stress that there is much evidence to suggest that patents maintain the consumer prices for medicinal products at high levels for the duration of the patent.[121] Restricted supplies ensure that much-needed cures are only made available to those who can afford them and are therefore out of reach for many of those in immediate need. This belies the claim of many pharmaceutical companies that a large part of their support for patents lies in the ability of the patent system to benefit humankind by stimulating the development of crucial drugs. This philanthropic justification is further undermined by the fact that there is a clear disincentive in the industry to create cures which have limited commercial applications. There are "already many safe and efficacious drugs that languish without a manufacturer willing to make and sell them, because the demand is thought insignificant."[122] Further, if research is largely conducted at the whim of the pharmaceutical corporations, this may produce a galaxy of potential money making products for them, but put little emphasis on the development of preventative medicine. It is doubtful that this scenario would be to the ultimate benefit of humanity.
There is also concern that the monopolistic situation advanced by patenting can result in much inefficiency. Where excessive financial rewards are expected from the results of research in a particular area, inventors will often compete with each other to win the patent. Such competitions can lead to the duplication of inventive activity, both before a patent is acquired, and at the post-patent stage when an invention may spark a race to develop improvements.[123] Competitions of this nature may also "divert resources into the inventive sphere even though society would be better served were those resources used elsewhere."[124]
Of course, as is common in patenting debates, there is at least one writer who puts forward exactly the same points in favour of the present system. Looney contends that "in the absence of patent protection, genome researchers would pursue ideas independently, resulting in inefficient, duplicative research and misdirected, wasteful funding."[125] As argued previously, however, by replacing pecuniary interests with traditional incentives, scientists will be more likely to collaborate in an open and honest way. This should avoid the problem of any two research activities being conducted in the same way and allow for funding opportunities to be maximised.
Those who oppose the use of patenting in the biotechnology sector have also asserted that patents exploit taxpayer-funded research.[126] Much of the development of biotechnology has been supported by taxpayer dollars. Corporations can make use of existing research in the field and ultimately make profits on their patented products by charging high prices. In this way, citizens are being asked to pay twice for medicines and other products.
There is an additional concern that by favouring inventions entailing high development costs the patent system disadvantages small firms with limited capital. Small biotech companies may invest much time and money to find a gene with valuable utility only to be overtaken at the last moment by larger companies carrying substantial economic backing. A similar assertion is made as regards developing nations. Lack of resources for genetic research in these countries may result in them being deprived of the opportunity to obtain patents on research developments. Patenting becomes suspect when it concentrates the benefits of genome research in a few rich governments and corporations.
Many academics involved in gene research are also worried about patenting trends. In particular, they believe that the increasing commercialisation[127] of research promotes secrecy and thereby hinders the exchange of information between academic researchers.[128] In the words of Julie Sheppard, "openness is the oxygen of biomedical research but the secrecy required for a successful patent application slows publication and the sharing of important results."[129] Many inventors may invest heavily in keeping their inventions secret for long periods of time because a patent application may be defeated if the subject matter of the patent has been made available to the public. In the academic world, researchers might delay publication of scientific findings in a peer-reviewed journal until after they had applied for a patent. If the sharing of information is delayed in this way, international collaboration may become stifled and result in an academic struggle for priority.[130] Finally, secrecy may manifest itself in the deferring
of ideas. Some investors may not wish to expose particular concepts if they think that doing so would give an advantage to competitors who are better placed to exploit those ideas.[131] Although secrecy measures may protect the inventors innovative effort, their social costs may counteract this benefit.
Patenting proponents are quick to refute criticisms based on secrecy. Firstly, it is often pointed out that many research grants carry provisions which require public reporting of research within a given time period. In addition, safeguards are built into the patent system to guard against the inhibition of research due to secrecy. The most important of these are the publication requirements:[132] a patent cannot be validly granted unless the inventor gives a clear and complete description of the invention. The most forcefully argued counter to criticisms in this area, however, is that biotechnology research will continue whether the results of that research are patentable or not, but without patents companies would be forced to rely on secrecy to protect their products.[133] Patenting advocates maintain that, in comparison to patents, the trade secret route is less effective in protecting new ideas and much less conducive to information sharing.
Patents and trade secrets have long been considered the two alternative avenues for protecting valuable inventions and ideas.[134] Trade secret protection though, is more limited than patent protection. It is effective only so long as it remains a secret, and it only protects against intentional infringements.[135] Moreover, trade secrets can be expensive and difficult both to establish and maintain. They may also magnify rather than diminish the dangers associated with restricting the flow of knowledge that is basic to the scientific community.
Despite these counter-arguments, some economists maintain that "the exclusionary aspect of the patent incentive actually generates greater societal cost than any benefit it provides."[136] Again, it may be that in the absence of patents the professional norms of the scientific community, which promote knowledge sharing, would constrain scientists from engaging in trade secrecy. It is possible that patents have only achieved the status that they currently enjoy "as much because they are backed by great economic might as because of their appeal to our common sense or their innate conceptual force."[137] An analysis of their so-called 'indispensability' may require society to re-evaluate and re-prioritise the values that it considers important.
The difficulty with this proposition, however, is inherent in the very fact that monetary-powers support the patent system. Probably the most undeniable force in the repertoire of patenting proponents is the idea that
patents are necessary for any country that wishes to exploit the biotechnology industry. The reality is that it is this view which dominates big business, the media, and first-world governments. These groups are willing to pay any price to be internationally competitive, regardless of the price that others pay when they lose control of their knowledge.
For some indigenous peoples, criticisms of the growing trend towards the patenting of human genetic material are not confined to the threshold debate of whether life-forms should or should not be patented. On a completely different level, patenting is also opposed on the ground that people from whom genetic material is taken are not likely to receive any financial benefit from it. This strand of thinking is incompatible with the belief that it is culturally inappropriate to treat life as just another commodity.[138] Indeed, some indigenous peoples claim that "the very process of providing a financial reward...could threaten the cultural traditions of indigenous groups."[139] In adding to the dialogue, Knoppers[140] comments: "It would be ironic if through this approach to royalties we end up contributing to the process of commodification of individuals."[141]
Despite such scepticism, what this alternative approach does do is highlight the fact that there is not any one consolidated viewpoint amongst indigenous peoples as concerns the debate. Rather, it is quite valid for there to be a variety of perspectives within traditional communities, and indeed quite appropriate given the complicated array of issues involved in the patenting controversy.[142]
For those wary about the altruism of the HGDP,[143] an agreement entitling them to a part of any profits may be seen as an acceptable middle ground. This option may also allay the fears of groups who feel that the global map of genome diversity will be incomplete without data from their regions, but who are concerned that the results of collaboration might prove one-sided.[144] Such an approach also accords with the concept of distributive justice,[145] and the rules of US government-funded research which demand that special protections be applied to vulnerable populations.[146]
Although this proposal looks good on paper, it carries a number of difficulties along with it. There are myriad of questions begging for answers.
How do indigenous peoples themselves define benefits? Who should have a claim to some of the commercial value of a discovery - the affected group, the group members who participated in the research, or the individual from whose body the cell line was developed? Through what mechanisms can individuals and organisations working with indigenous populations provide such benefits? What quantity of compensation is both fair and realistic? How can such compensation be distributed fairly?
The North American Regional Committee of the HGDP in its "Proposed Model Ethical Protocol"[147] acknowledges the many hurdles that need to be negotiated in this area. It does, however, outline one way to protect the financial interests of the sampled populations. Anyone seeking to take samples or data from the HGDP's repositories or database would have to agree to be bound by contract to a set of terms and conditions imposed on samples by the populations that provided them.
Contractual agreements have the advantage of being flexible, however there are a number of problems with this approach. Reliance on contract could make effective enforcement difficult if the initial researcher passed the samples on to someone else who was not contractually bound. Further, many indigenous groups fear that "the emphasis on bilateral agreements between North and South may undermine future negotiations to establish stronger multilateral approaches for supporting conservation and use of biological diversity."[148] There is also the suspicion with which many traditional societies view written agreements, given bitter past experiences.[149]
By far the greatest complication though, is the huge inequality of bargaining power that presently exists between indigenous peoples and the economic backers of the biotechnology industry.[150] This obstacle may be incredibly difficult to surmount, and it is becoming ever more so with the global implementation of international trade agreements such as the GATTTRIPS,[151] which was designed to 'establish an internationally uniform and universally applicable intellectual property standard'. While proponents of the Agreement claim that such a standard has a universal value, McNeill argues that what the agreement in fact facilitates "is the internationalisation of an historically and culturally specific model of knowledge ownership".[152]
The development of the TRIPS Agreement was controlled largely by transnational corporations and politicians.[153] Many national governments
effectively excluded indigenous peoples from any debate, thereby effectively overriding indigenous peoples' right to self determination, and in this way emphasising where their main priorities lie. This raises questions as to the extent of government participation in the HGDP. Mead writes: "Greely confirmed that the HGDP will be seeking funds from States. How will this affect the status, integrity and self-determination of indigenous peoples?...What mechanisms are in place to ensure that States do not use the HGDP to substantiate biases and objectives of governments to undermine indigenous self-determination?"[154] In reality, where the relevant state government is not sympathetic to indigenous peoples' concerns, it may be infeasible to enforce indigenous peoples' rights.
For those governments who are sympathetic to the cause of indigenous peoples, the signing of the TRIPS Agreement makes the giving of any support practically impossible due to the Agreement's harsh sanctions and provision for cross-retaliation in the event that any country does not conform with its aims to remove world trade barriers.
The last major issue for indigenous peoples that is raised by the HGDP is that of 'informed consent'. This largely procedural consideration ties in a number of concerns already discussed and involves discussion of how these can be accommodated by genome diversity researchers.
Informed consent is a somewhat amorphous concept. Definitions vary depending on the context in which the term is evoked. One definition which the HGDP supports,[155] is that proposed by the Council for International Organisations of Medical Science (CIOMS). The CIOMS states that "consent is informed when it is given by a person who understands the purpose and nature of the study, what participation in the study requires the person to do and to risk, and what benefits are intended to result from the study."[156]
For indigenous peoples, the application of this principle to population genetics research is essential. This is because informed consent is a crucial element in recognising and respecting their right to self-determination. The Mataatua Declaration[157] recognises that: "Indigenous Peoples are capable of managing their traditional knowledge themselves, but are willing to offer it to all humanity provided their fundamental rights to define and control this knowledge are protected by the international community."
Indigenous peoples world-wide have been particularly preoccupied with issues of informed consent since the recent attempts to patent human genetic material.[158] Certainly no consent was obtained from Moore as to the research conducted on his cells and the subsequent patent application. In speaking of the Guaymi patent, an unidentified Guaymi man said: "I know nothing of any permission. They didn't consult us at all. We don't want them to keep coming to our country to take our blood."[159] It is difficult to make 'no'
any more emphatic than that. As for the Hagahai patent fiasco, how do you get consent from a tribe that has only recently had contact with the outside world and that has no conception of modern medicine?
The HGDP recognises the importance of confronting these issues. It is not enough to adopt the attitude of some scientists[160] that this type of research is for the greater good eventually and so must take priority over all else. In the words of Macer, "our ethics must be more than a rationalisation for things that we are bound to do because of interventions science has now made possible."[161]
The HGDP's "Proposed Model Ethical Protocol" attempts to tackle a number of aspects which bear on the question of informed consent.[162] Since the nature of the HGDP's proposed research objectives focuses on populations, not individuals, the HGDP believes that both the populations and the individuals must give their free consent to participate. The Project recognises that many of the populations that might participate in the HGDP have faced discrimination, oppression, and even genocide. To do other than obtain the informed consent of each group would be "another form of attack on the autonomy of the population."[163]
Before such consent can be sought, however, it is necessary to determine what the relevant 'population' is, who are the most culturally appropriate persons with whom to communicate, and what are the population's 'culturally appropriate governing authorities'. These points will often be extremely difficult to establish.[164] In order to define a population, for instance, and identify its culturally relevant authorities, researchers will require a deep understanding of the culture of the area and extended discussions with members. Professor Greely acknowledges that in some situations, the problems may be so severe that no group decision is possible.[165] Even if a population can be defined, there may be sharp division within the population about which authorities can speak for it. As Aroha Mead points out, "who within a community can possibly give their consent for research or activity that implicates everyone?"[166] There are again troubling issues about how far national governments will be involved in the consent process, and how far indigenous peoples' rights will be protected if the relevant state government is not sympathetic to indigenous peoples' concerns.[167] Finally, it has been suggested that the most difficult group consent question is who can give group consent for the genome project itself - a question that no one has been able to answer.[168]
The next logical issue that needs to be addressed concerns what information should be provided and how. The CIOMS defines the scope of informed consent as "any and all information that a reasonable person would consider material to making a decision about whether to consent."[169] The "Proposed Model Ethical Protocol" suggests that this should include, "information about the purpose and nature of the study, the nature and risks of the individual's participation, the benefits that are expected from the study and procedural aspects of his or her participation."[170] It will also be critical to inform potential participants about future uses to which samples and data may be put.[171] In addition, the idea of informed consent should include an appropriate form of feedback of the results of the study to the sampled populations.[172]
There are problems evident at this stage of the process also. It will be necessary for information about the Project to be explained in the local language. It may be difficult to translate unusual and foreign concepts in a way that does not impede a true understanding of the implications of the HGDP. As well, it has been argued that the state of being informed may take years to achieve.[173] Not everyone will be interested in the Project, and of those that are, not everyone will be motivated enough to seek the information needed for an informed choice.
Concerns have also been raised about what constitutes consent: "If 20 people say yes but 23 people say no, which group will prevail?"[174] Other questions need to be asked about what form the consent should take. Further, what mechanisms are in place to ensure that consent procedures do not threaten the unity of indigenous communities? How much control will indigenous peoples have over decisions about the storage of, access to, use of, and patenting of their genetic materials? Lastly, but most importantly, will the right of indigenous peoples NOT to sell or commoditise their bodily tissues, and NOT to participate in the HGDP, be respected?
Questions abound and definitive answers are few. It is clear that the HGDP is a long way from being accepted by indigenous peoples. There are also others who support indigenous peoples' assertions that there are too many unknowns for anyone to feel confident about participating in the Project. In 1995, UNESCO turned down the HGDP's proposal for UNESCO to become 'international patrons' of the Project, stating that there were far too many unanswered questions and opposition from indigenous peoples could not be ignored.[175]
Then in 1996, at the request of the National Science Foundation and the National Institutes of Health, the National Research Council established the Committee on Human Genome Diversity. The Committee's charge was to evaluate the consensus proposal to establish the HGDP. According to the executive summary,[176] "as the committee's fact-finding progressed,
it became apparent that the precise nature of the proposed HGDP was elusive; different participants in the formulation of the 'consensus' document had quite different perceptions of the intent of the project, and even of its organisational structure."[177]
Although the committee was persuaded that a global assessment of the extent of human genetic variability has substantial scientific merit, it also acknowledged that such a global effort would pose numerous ethical, legal and human-rights challenges, as well as technical and organisational difficulties. It recommended a less technically ambitious project than some of its planners had envisaged.
Scientific publications have interpreted this report in different ways. In 'Nature' magazine, a critique on the committee's report commented that it was another setback for advocates of the HGDP.[178] By contrast, the equivalent article in 'Science' was entitled, "NRC OK's Long-Delayed Survey of Human Genome Diversity". It commented that "both proponents of the HGDP and potential backers welcomed the report's conclusion."[179] Indeed, this is the view which Dr Jean Doble favours.[180] She verifies that the planners of the HGDP are keen to carry on with the Project[181] - and this, of course, means that indigenous peoples' organisations will continue to oppose it.
Given the complexities of the debate surrounding the HGDP, finding appropriate options for the future is not an easy task. In general though, considerations can broadly be separated into two categories — those concerning the Project itself, and those bearing on the patenting controversy.
It must be recognised at the outset that whether or not the HGDP proceeds, population genetics research will continue. It is not within the mandate of any international body to call for a moratorium on this type of research.[182] The HGDP has stated that it considers a partnership model between the Project and indigenous peoples as being appropriate for its operation, and it may be in indigenous populations' best interests to take advantage of this option. Given that the HGDP has had so much media coverage, indigenous peoples can probably be assured that it will strive to operate as ethically as possible. Greater dangers may be posed by less visible genetic research initiatives, and the partnership idea may be a valid way to prevent the burgeoning trade in human genetic material from taking place in a policy vacuum, and to ensure that research methodologies conform as closely as possible to traditional perspectives regarding the integrity of life.
Although, to date, the HGDP has been unable to coherently and comprehensively address many of indigenous peoples' concerns, its willingness to implement group consent procedures can be capitalised on. More importantly, it recognises "that the goals and aspirations of scientific projects may not always coincide with the goals and aspirations of particular cultures."[183] If practitioners of science and indigenous peoples both contribute to the creation of a code of ethics, this may lead to the implementation of similar codes in other research activities which involve populations.
For this proposal to work, the first requirement is that the body entrusted with the responsibility of overseeing such research should include legitimate and substantial representation of indigenous populations.[184] Such representation should be selected by indigenous communities themselves. Secondly, although the HGDP has committed itself to protecting indigenous peoples' intellectual property rights, the mechanisms for doing so need to be specified. Sanctions will also need to be envisaged to ensure that researchers are made more accountable and actual practices are made more transparent.[185] In addition, "standardised reporting requirements on a regular basis and publication of such reports",[186] and ongoing ethical and scientific review and monitoring are essential. Finally, other fundamental aspects of such a scheme include, "communication, education, benefits, and feedback strategies at the population level."[187]
The rights of indigenous peoples to define their intellectual property, and control its use, can only be enhanced by such a collaborative effort, if that effort is conducted properly. The attempt may even contribute to the breaking of "the rigid boundaries of Western philosophical thought" and help lead to "rich, cross-cultural realms that embrace other ways of knowing."[188]
The second major area of concern involves issues of patenting human genetic material. For indigenous peoples, the issues here are even more difficult, because unlike the organisers of the HGDP, patenting proponents are not the slightest bit interested in compromise. Although many knowledgeable scientists, policymakers and laypersons alike have joined indigenous peoples in saying that the patenting of the human gene can never be ethically acceptable, the reality is that the groups most able to influence the patenting system are the ones with the most money. In particular, some very powerful US based transnational corporations (TNCs) have succeeded in presenting the biotechnology industry as "the next shining hope for America's economic development."[189] Together with other high tech industries, they have "succeeded in making some substantial alterations in public consciousness, laws, and programs"[190] which directly benefit
their own interests. The push to include intellectual property rights in international trade negotiations, such as GATT:TRIPS, is one such example.[191]
Although to progress in the current economically-driven environment will be an uphill battle, there is much to be said for the resilience of the indigenous movement. It has already been successful in challenging the legitimacy of individual patents and particular patent laws. It has also "made the power of the bio-industrial complex visible, eroding the neutrality and anonymity which masks its power and forcing it to justify its decisions..."[192] In this way, indigenous peoples can create the conditions necessary for the renegotiation of the rules governing biotechnology and genetic diversity, and prevent further undermining of their right to sovereignty.
Recent initiatives include a campaign that RAFI is preparing, to take the issue of life patenting to the International Court of Justice in the Hague, Netherlands.[193] This will require one or several sovereign states to be persuaded to request an advisory opinion from the Court. In the words of RAFI, "at the very least, a campaign to take the issue of life patenting to the International Court of Justice is a means of mobilising public opinion and engendering a public debate at the highest and most visible judicial level."[194]
In addition to this action, indigenous peoples' organisations are acutely aware of the importance of monitoring all relevant international agreements and negotiations. The solution to the conflict will only be found at the political level. Whether it is found "will depend on the vibrancy, visibility, and agency"[195] of indigenous populations. For this reason, it will be vital for indigenous peoples to continue sharing their knowledge, perspectives and experiences with all who will listen. Indigenous peoples from many nations and regions, along with interested non-governmental organisations, must make the choice to network together. Even though the battle may seem overwhelming and the outcome uncertain, ultimately inaction is a decision.
[*] This paper was awarded the Canterbury Law Review Prize for the best undergraduate Honours Paper completed in 1998.
[1] Yoxen, The Gene Business: Who Should Control Biotechnology? (NY: Harper & Row, 1984), p 2
[2] This term may apply to any population of living organisms, but it is being used in this context to apply only to humans.
[3] Chee Heng Leng et al., 'Bioethics and Human Population Genetics Research', <http:// www.unesco.org/ibc/uk/actes/s3/chap3.html>
[4] UNESCO International Bioethics Committee, Bioethics and Human Population Genetics Research: Report of the Subcommittee on Bioethics and Population Genetics, Final version, 15 November 1995. This report has not been endorsed by UNESCO, and represents the views of the subcommittee members.
[5] Ibid 1.1 It is this distinction which explains the difference between the often confused Human Genome Project (HGP) and the Human Genome Diversity Project (HGDP).
[6] The United Nations Economic, Scientific and Cultural Organisation.
[7] Op cit n 4, at 1.2.
[8] Luigi Luca Cavalli-Sforza is a population geneticist from Stanford University. He has been involved in the study of human evolution since 1951. Writing of his beginnings, he explained his belief that "if enough data on a number of different genes are gathered, we may eventually be able to reconstruct the history of the entire human species." - quoted in Goodheart, 'Mapping the Past' Civilisation , Mar/Apr 1996, 40.
[9] Cavalli-Sforza, "The Human Genome Diversity Project - An Address to a Special Meeting of UNESCO", Paris, 12 September 1994, unpublished.
[10] For example, Allan Wilson, professor of biochemistry at the University of California; Mary-Claire King, professor of genetics at Berkeley; and Kenneth Kidd from Yale University.
[11] On this point, Pat Roy Mooney states in a letter to Professor Greely: "On reading your 25 October letter to SAIIC yesterday I learn that the European arm of the HGDP may have begun some work in Europe....We are aware that people and institutions have been collecting human cell lines independently of the Project....I am concerned that those involved in these collections may also be associated with the Project, if and when it does get underway." - quoted in Guillermo, 'Human Genome Diversity Project' <http:// bioc09.uthscsa.edu/natnet/archive/nl/9311/0026.html>
[12] Op cit n 9.
[13] Ibid.
[14] Op cit n 4, at 1.2.3.2.
[15] HUGO, 'The HGD Project - Summary Document', compiled on behalf of the HGD Committee of HUGO, <http://www-leland.stanford.edu/group/morrinst/Alghero.html>
[16] Ibid at 1.
[17] "Cell lines are genetically identical cultured cells that continue to divide as long as they are maintained under the appropriate culture conditions. This characteristic of 'immortality' makes cell lines invaluable for addressing specific scientific questions or problems.. " - quoted in Bhat, "The National Institutes of Health and the Papua New Guinea Cell Line" Cultural Survival Quarterly, Summer 1996, 29.
[18] Dutfield and Posey, Beyond Intellectual Property - Toward Traditional Resource Rights for Indigenous Peoples and Local Communities (1996), p 162. PCR is a technology that enables scientists to renew DNA from collected samples indefinitely in the laboratory without using recombinant DNA technology.
[19] North American HGDP Committee, "Answers to Frequently Asked Questions About the Human Genome Diversity Project" , <http://www-leland.stanford.edu/group/morrinst/
HGDP-FAQ.html>
[20] Greely, "Re: DNA Probe Angers the 'Endangered'", <http://bioc09.uthscsa.edu/natnet/archive/nl/9307/0046.html>
[21] Op cit n 15, at 12.
[22] Ibid at 6.
[23] Cavalli-Sforza and Greely, "Human Genome Diversity Project - Organisers' Response", 8 July 1993, <http://bioc09.uthscsa.edu/natnet/archive/nl/9307/0046.html>
[24] HGDP's North American Regional Committee, "Proposed Model Ethical Protocol For Collecting DNA Samples" (1997 version) 33 Hous L Rev 1431. (The Protocol has not yet been adopted).
[25] Dr Macer is one of New Zealand's leading bioethicists. At present, he is a foreign professor at the Institute of Biological Sciences, University of Tsukuba, Japan, and continues to research the ethical, legal and social implications of the use of new genetic technology.
[26] Macer, personal communication to author.
[27] Chief Shenandoah is on the Onondoga Council of Chiefs and affiliates to the Tadodaho people.
[28] Shenandoah, "Human Genome Diversity Project", 21 December 1993, <http:// bioc09.uthscsa.edu/natnet/archive/nl/9312/0122.html>
[29] Skene and Chalmers, "First International Conference on DNA Sampling: Human Genetic Research - Legal and Policy Aspects", Journal of Law and Medicine, vol 4, February 1997, 229.
[30] Ibid ' at 233.
[31] These include: Karioca Declaration, Brazil, June, 1992; Mataatua Declaration, June 1993; The UN Working Group on Indigenous Populations, Tenth Session, July 1993; World Council of Indigenous Peoples; Maori Congress Indigenous Peoples Roundtable, June 1994; Geneva IPR Workshop, August 1994; Latin and South American Consultation of Indigenous Peoples' Knowledge, September 1994; Declaration of Indigenous Peoples of the Western Hemisphere, February 1995; Asian Consultation on the Protection and Conservation of Indigenous Peoples' Knowledge, February 1995; Indigenous Leaders' Meeting about the HGDP, February 1995; National Congress of American Indians, Resolution No NV 93-118; Consultation on Indigenous Peoples Knowledge and Intellectual Property Rights, April 1995; Pacific Consultation on the Protection and Conservation of Indigenous Peoples' Knowledge, May 1995; Blue Mountain Declaration, June 1995; Ukupseni Declaration, November 1997.
[32] Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous People, Whakatane, June 1993, article 3.5
[33] Aroha Te Pareake Mead is of the Ngati Awa and Ngati Porou tribes. She is Director of the International Association of the Mataatua Declaration of Cultural and Intellectual Property of Indigenous People (IAMD), Foreign Policy Convenor and Deputy Convenor of the Maori Congress in Aoearoa, New Zealand, and a member of the Indigenous Peoples' Biodiversity Network.
[34] Mead, "Genealogy, Sacredness, and the Commodities Market" Cultural Survival Quarterly, Summer 1996, 46 at 49.
[35] Professor Greely is the Chairperson of the North American Regional Committee of the proposed HGDP.
[36] Greely, "Status of the HGD Project", 2 February 1994, <http://bioc09.uthscsa.edu/natnet/ archive/nl/9402/0020.html>
[37] Cunningham and Scharper, "The Human Genome Project Patenting Indigenous People", <http://venezuela.mit.edu/listas/atarraya-anteriores/9602/atarraya960223/0087.html>
[38] Philippine Solidarity Group, "PSG supports indigenous peoples", <http://bioc09.uthscsa.edu/ natnet/archive/nl/9312/0089.html>
[39] Greely, "Genes, Patents, and Indigenous Peoples: Biomedical Research and Indigenous Peoples' Rights" Cultural Survival Quarterly, Summer 1996, 55.
[40] Ibid.
[41] Little Gidding - T. S. Eliot, cited in Jordan, "Re Papua New Guinea Patents, the Human Genome Diversity Project..." 29 October 1995, <http://bioc09.uthscsa.edu/natnet/archive/ nl/9511/0282.html>
[42] Op cit n 15.
[43] Mead, "Tangata Whenua Issues: The Convention on Biological Diversity: Are Human Genes Biological Resources?" New Zealand Environmental Law Reporter, July 1995, 127 at 129.
[44] "The Gene Hunters", a video produced by Luke Holland
[45] Harry, "The Human Genome Diversity Project and its Implications for Indigenous Peoples" Information About Intellectual Property Rights, No 6, January 1995.
[46] There are, however, some within the scientific community who qualify this idea with the belief that some ways of gaining such knowledge are better than others. Dr Jack Heinemann, for instance, argues that the methodologies of projects like the HGDP may be examples of a 'tunnel-vision' approach to knowledge where only one explanation is accepted as 'truth', and that this may restrict the development of alternative studies with differing methodologies. He also feels that traditional genetics has the advantage of accepting fewer biases. (Heinemann, personal communication to author).
[47] Grounds, "The Yuchi Community and the Human Genome Diversity Project: Historic and Contemporary Ironies" Cultural Survival Quarterly, Summer 1996, 64 at 65.
[48] Tadodaho Chief Leon Shenandoah , op cit n 28.
[49] RAFI, "Patents, Indigenous Peoples, and Human Genetic Diversity" RAFI Communique, May 1993, <http://www.rafi.ca/communique/fltxt/19932.html>
[50] Quoted in RAFI, "Diverse Group Joins in Washington to Oppose U.S. Government Funding for the HGDP" Press Release, 11 September 1996, <http://www.rafi.ca/pr/release04.html> .
[51] Weiss, "Biological Diversity is Inherent in Humanity" Cultural Survival Quarterly, Summer 1996, 26 at 28.
[52] Op cit n 19.
[53] Ibid.
[54] Op cit n 44.
[55] Op cit n 24 at 1434.
[56] Ibid.
[57] Op cit n 18 at 170.
[58] Ibid.
[59] Mead, in a letter to Dr Macer, in Trujillo, "Re: Papua New Guinea Patents" 29 October 1995, <http://bioc09.uthscsa.edu/natnet/archive/nl/9510/0350.html>
[60] Such as the germ warfare conducted by the US Army in the 19th Century against Native American peoples in which the Army intentionally gave Native Americans blankets laden with chicken pox.
[61] Op cit n 15.
[62] Op cit n 20.
[63] Macer, Shaping genes: ethics, law and science (Christchurch, NZ: Eubios Ethics Institute, 1990), p 35. RAFI also points to an article by US technology writer Ed Regis which was published in the technophillic Wired magazine. It reported on a discussion at a US Army conference about military biotechnology possibilities. One such possibility concerned a genetically engineered super-pathogen that is so selective in its behaviour that it is capable of targeting specific individuals. (Regis, "Bio War" Wired, November 1996 at 146, 153 - quoted in RAFI, "The Human Tissue Trade" RAFI Communique, Jan/Feb 1997, <http:/ /www.rafi.ca/communique/fltxt/19971.html>
[64] Wilkie, "Laying Claim to the Building Blocks of Life" The Press, Saturday, 25 January 1997 - Weekend, 5.
[65] See also indigenous peoples' opposition to patenting on the grounds that it commodifies life. Discussed below under the heading "Should 'Life-Forms' be Patentable".
[66] Op cit n 4, at 3.1.4.
[67] On this point, McNeill argues that: "A great deal of research is carried out by, or sponsored by, large international drug companies. The potential profit from research activities obviously places additional pressure on researchers. It is therefore naive to view the scientific activity as purely objective and disinterested, operating simply for the good of others and sharing the same goals, attitudes and values as others in society." (McNeill, The Ethics and Politics of Human Experimentation (Cambridge: Cambridge University Press, 1993), p167.
[68] Op cit n 34 at 48.
[69] Quote included by Professor Philip L. Bereano of the University of Washington in: "Some Environmental and Ethical Considerations of Genetically Engineered Plants and Foods", <http://weber.u.washington.edu/~radin/phil.htm>
[70] It is also at odds with a number of religious world-views. See for example Bruce, "Patenting human genes - a Christian view" Bull Med Eth, January 1997, at 18.
[71] Op cit n 34 at 47.
[72] Working Party of the Ethics Committee of the HRC of New Zealand, The Clinical and Research Use of Human Genetic Material: Guidelines for Ethical, Cultural and Scientific Assessment, December 1995, p 16.
[73] Ibid.
[74] Op cit n 34 at 47.
[75] Salgo, "Patenting the human genome" Bulletin Medical Ethics, January 1997, 15 at 16.
[76] Riley, "Patenting Dr Venter's Genetic Findings: Is the National Institutes of Health Creating Hurdles or Clearing the Path for Biotechnology's Voyage into the Twenty-First Century?" 1993, 10 Journal of Contemporary Health Law and Policy 309 at 309.
[77] Indigenous Peoples' Biodiversity Network, "Patenting Life" 10 December 1995, <http:www.eco.utexas.edu/faculty/cleaver/wk5patent.html>
[78] Greely, "Mapping the Territory - Global genome project searches for cures, not controversy" Utne Media and Technology, <http://www.utne.com/lens/mt/ 15mtgenesmapping.html>
[79] Just one of many examples of the commercial viability of human genetic material concerns samples extracted from the inhabitants of Kosrae, an island in the Federated States of Micronesia in the South Pacific where obesity has a high incidence. The scientists who collected the samples are from the Rockefeller Institute in New York. They "hope to identify the obesity gene in humans in order to understand how the amount of fat stored in the body is regulated. Rockefeller University has been offered $20 million by Amgen, a California-based pharmaceutical company, for licensing rights to the obesity gene and has been promised additional payments of up to $90 million." (Cunningham and Scharper, "The Human Genome Project Patenting Indigenous People", op cit n 37).
[80] Typically 20 years.
[81] 477 US 303 (1980).
[82] 36 Pat Trademark & Copyright J (BNA) No. 888, at 271 (1988); US Patent No 4,736,866.
[83] 793 P 2 d 479, 271 Cal Rptr 146 (1990).
[84] Ibid.
[85] For an explanation of 'immortalised', op cit n 17.
[86] RAFI, "Patent Claim on Guaymi Indian Cell Line", Press Release, 25 October 1993, <http://www.rz.uni-frankfurt.de/~ecstein/gen/env/79>
[87] Ibid.
[88] RAFI, "The Patenting of Human Genetic Material" RAFI Communique Jan/Feb 1994, <http://www.rafi.ca/communique/fltxt/19941.html>
[89] Later, the Solomon Islands Government, (in collaboration with other groups opposed to the patenting of cells from indigenous people), suppressed another patent claim. This time for the human T-cell line of a 40 year old woman from Marovo Lagoon in Western Province and a 58 year old man from Guadacanal Province, both of the Solomon Islands. See ibid.
[90] RAFI, "New Questions About Management and Exchange of Human Tissues at NIH Indigenous Person's Cells Patented" RAFI Communique, March/April 1996, p 1.
[91] From the NIH's Employee Invention Report, 16 April 1990 - quoted ibid at 3
[92] New Zealand Herald, "Fight on over patent on human cells", 14 February 1996.
[93] RAFI, "1996 Biopiracy Update" RAFI Communique December 1996, p 4.
[94] Comment by Mead, quoted in RAFI, "US Government Dumps the Hagahai Patent", Press Release 3 December 1996, <http://www.rafi.ca/pr/release05.html>
[95] RAFI, op cit n 93.
[96] It is often erroneously reported that the HGDP was involved in the Hagahai patent claim. See for example McNally and Wheale, who state: "Patents on the genes of indigenous peoples collected under the Human Genome Diversity Project have been applied for. In 1995, for example, the US Department of Health and Human Services was granted a patent on a Human T-Lymphotropic Virus Type 1 (HTLV-1) derived from the Hagahai people of Papua New Guinea." (McNally and Wheale, 'Biopatenting and Biodiversity:
[97] Comparative Advantages in the New Global Order" The Ecologist Vol. 26, No 5, Sept/Oct 1996, 222 at 225).
[98] Op cit n 44.
[99] As well as this broad debate, there must also be a technical inquiry as to whether 'inventions' in the area of human genetic research meet the defined patenting standards within each jurisdiction. This aspect of the discussion is outside the scope of this paper, but see for example: Looney, "Should Genes be Patented? The Gene Patenting Controversy: Legal, Ethical, and Policy Foundations of an International Agreement" 1994, 26 Law and Policy in International Business 231; Burk, "Patenting Transgenic Human Embryos: A Nonuse Cost Perspective" 1993, 30 Hous L Rev 1597; Roberts, "The Prospects of Success of the National Institute of Health's Human Genome Application" [1994] 1 EIPR 30.
[100] Discussed above under "Wider Implications of the HGDP".
[101] Some humanitarian and religious groups hold similar views.
[101] Greely, "Papua New Guinea Patents, the Human Genome Diversity Project, and RAFI" 20 October 1995, <http://bioc09.uthscsa.edu/natnet/archive/nl/9510/0225.html>
[102] Hammond, "Re: Papua New Guinea Patents, the Human Genome Diversity Project, and RAFI" 22 October 1995, <http://bioc09.uthscsa.edu/natnet/archive/nl/9510/0241.html>
[103] George Poste is chairperson of Research and Development, David Roberts is director and senior vice president of Intellectual Property, and Simon Gentry is manager of External Scientific Affairs at SmithKline Beecham.
[104] Poste, Roberts and Gentry, "Patents, ethics and improving healthcare" Bull Med Eth, January 1997, 29 at 30.
[105] Kent, "Ethical aspects of the legal protection of biotechnological inventions and the principle of non-ownership of the human body" Bull Med Eth, January 1997, 32 at 32.
[106] Op cit n 59.
[107] This Treaty is symbolic. It expresses the dismay and anger of the Parties regarding biological prospecting and human genetic research. The establishment of this Treaty and its Protocols was mandated at a meeting on "Indigenous Peoples and Intellectual Property Rights" held in Fiji in April 1995.
[108] Liloqula, "Value of Life: Saving Genes versus Saving Indigenous Peoples" Cultural Survival Quarterly, Summer 1996, 42.
[109] Ibid.
[110] See, for example, paragraph 7.99 in the Report of the Australia House of Representatives Standing Committee on Industry, Science and Technology, Genetic Manipulation: The Threat or the Glory? (Canberra, 1992).
[111] Burk, 'Patenting Transgenic Human Embryos: A Nonuse Cost Perspective' 1993, 30
Hous L Rev 1597, at 1620.
[112] Op cit n 64.
[113] Ibid.
[114] Op cit n 104.
[115] Erramouspe, "Staking Patent Claims on the Human Blueprint: Rewards and Rent - Dissipating Races" 1996, 43 UCLA L Rev 961 at 975.
[116] Ibid. Erramouspe gives the example that 'the process of anesthetizing patients with ether, even though one of the "great discoveries" of the times, was denied patent protection, whereas the process of rendering animal fats into candles and soap received patent protection so broad as to encompass improvements.'
[117] McKeough and Stewart, Intellectual Property in Australia (1997), p 18.
[118] Op cit n 111 at 1666.
[119] Ibid.
[120] Ibid.
[121] Brody gives TPA, which is used for dissolving blood clots after heart attacks, as one example - Brody, Biomedical Technology and Human Rights (1993), p 135. Rodriguez and Gonzales also cite the example of AIDS treatments to evidence this point. (Rodriguez and Gonzales, "The Human Genome Project Has Inhumane Implications", <http:// www.latinolink.com/opinion/opinion97/0703ospe.htm>
[122] Op cit n 1, at 89. See also n 117 at 18, where McKeogh and Stewart also make this point: "This problem of socially beneficial ideas not being developed arises in its most acute form where private producers are
[123] deterred altogether from moving to exploit an idea because the potential market for it is so unprofitable. The classic example is that of 'orphan drugs', medicines which have enormous potential to treat or cure diseases, but which do not reach the public because they will benefit so few people that it is in no producer's interest to pay the substantial development costs involved."
[124] Op cit n 115, at 976.
[125] Ibid.
[126] Looney, "Should Genes be Patented? The Gene Patenting Controversy: Legal, Ethical, and Policy Foundations of an International Agreement" 1994, 26 Law and Policy in International Business 231 at 243.
[126] Council for Responsible Genetics "No Patents on Life!", <http://www.essential.org/crg/ nopatents.html>
[127] Another argument concerning the 'commercialisation' point is that "the pursuit of basic knowledge is limited at the source by the often easier availability of support for short- term, commercially useful, than for long-term basic research" (see Brody, Biomedical Technology and Human Rights (Cambridge: Dartmouth Publishing, 1993), p 135. Others maintain that scientific research materials become more expensive and difficult to purchase if one corporation owns the rights to the material (see the Council for Responsible Genetics, "No Patents on Life!", <http://www.essential.org/crg/nopatents.html> ). Further, Jayaraman writes that many fear , (in light of the symbolic nature of the gift of blood), that the gift relationship, including donations by individuals of samples for use in medical research, may be corrupted by the intrusion of financial interests into the genetic information field - (Jayaraman, "Whose genes are they anyway?" Nature, Vol 381, 2 May [1996] , 12 at 12).
[128] Others argue that such secrecy "will result in shifting academic agendas away from education- oriented objectives toward more commercially lucrative projects." (Sellers, "Patenting Nonnaturally Occurring, Man-Made Life: A Practical Look at the Economic, Environmental, and Ethical Challenges Facing 'Animal Patents'", 47 Arkansas Law Review[269] at 288).
[129] Sheppard, "Patent and be damned!" Bull Med Eth, January 1997, 16 at 17.
[130] Los Angeles filmmaker Jon Shestack acquired an insiders view of such an academic struggle when "he tried to persuade researchers who have collected genetic data on autism, a disorder that's been diagnosed in his own 5-year old son, to share their collections. Shestack hoped that sharing might speed the pace of research. But when he approached some of the best and brightest researchers in the field, he says, they told him they'd rather keep control of their own materials." (In Marshall, "Whose DNA Is It Anyway?" Science, Vol. 278, 24 October 1997, 564 at 564).
[131] Op cit n 117.
[132] The effectiveness of these protections may need to be balanced against the ability of skilled lawyers to delay the process and to disclose as little as possible in the body of the patent document.
[133] The most frequently given example of a product which has had to be protected by trade secrecy is Coca-Cola.
[134] Chaucer, "Life, the Patent Office and Everything: Patenting of Lifeforms Created Through Bioengineering Techniques" 1988, 9 U Bridgeport L Rev 413 at 441.
[135] Ibid at 443.
[136] Op cit n 105.
[137] W P Alford, "How Theory Does - And Does Not - Matter: American Approaches to Intellectual Property Law in East Asia" (1994) 13 Pacific Basin LJ 8 at 17 - quoted in McKeough and Stewart, op cit n 112.
[138] Discussed above under heading "Should 'Life-Forms' be Patentable?"
[139] Jayaraman, 'Whose genes are they anyway?" Nature, Vol 381, 2 May 1996, 12 at 13.
[140] Bartha Knoppers is a professor of law at the University of Montreal in Canada.
[141] Quoted by Jayaraman, op cit n 139.
[142] In the words of Aroha Mead, "We must respect the different visions of Indigenous peoples, acknowledge there are differences, identify the commonalities and work towards constructive agreements that do not predetermine how Indigenous peoples throughout the world will realise their right to self-determination." (Mead, 'Cultural and Intellectual Property Rights of Indigenous Peoples of the Pacific', reproduced in
[143] Rights: Economics, Politics and Colonisation Volume Two (1997), p 22).
[144] The Project has been viewed as similar to plant prospecting, which enriched the genetic stock available to pharmaceutical companies, and ultimately their profits, without providing any benefit to the peoples who had nurtured the plants.
[145] Swinbanks states that, in general, Indian scientists fall into this category (Swinbanks, "Indian researchers press for stricter rules to regulate 'gene-hunting"' Nature, Vol 379,
[1] February 1996, 381 at 382).
[145] Op cit n 125 at 238.
[146] Greely, "The Control of Genetic Research: Involving the Groups Between" 1997, 33
Hous L Rev 1397, at 1401.
International Research Institute for Maori and Indigenous Education, Cultural and Intellectual Property
[147] Op cit n 24, at 1465.
[148] RAFI, "Bioprospecting/Biopiracy and Indigenous Peoples" RAFI Communique November 1994, p 9.
[149] It must also be highlighted that royalty agreements often do not give any return. If indigenous peoples are not fully made aware of this reality then this could lead to them having false expectations and signing contracts which are not in their best interests.
[150] To quote from Professor Bereano, "The technology of genetic engineering is not developing democratically and, indeed, is leading to the exacerbation of power differentials within our societies." (Bereano, "Some Environmental and Ethical Considerations of Genetically Engineered Plants and Foods" <http://weber.u.washington.edu/~radin/phil.htm>
[151] The General Agreement on Tariffs and Trade: Trade Related Aspects of Intellectual Property Rights.
[152] McNeill "Intellectual Property Law Reform and the Marginalisation of Maori" - a thesis submitted in partial fulfilment of the requirements for the degree of Master of Arts, University of Auckland, 1995 - p 1.
[153] In the words of Buchanan, "The new mode of property is 'information', and, once again, those who are on the cutting edge and in control of the technologies are defining and delimiting what will and will not count as informational property well in advance of those who lack the development to see the long-term implications." (Buchanan, "Between Advocacy and Responsibility: The Challenge of Biotechnology For International Law" 1995 1 Buffalo Journal of International Law 221 at 235).
[154] Op cit n 59.
[155] As it applies to populations.
[156] CIOMS, "International Guidelines for Ethical Review of Epidemiological Studies", quoted in HGDP's North American Regional Committee, "Proposed Model Ethical Protocol For Collecting DNA Samples", op cit n 24.
[157] The Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous People, Whakatane, June 1993.
[158] Discussed above under heading "Recent Attempts to Patent Human Genetic Materials".
[159] Op cit n 44.
[160] Such as Dr Janelle Noble of 'Roche Molecular Systems Incorporated' who says: "I think the value of the Human Genome Diversity Project is very great in that I think we need to have access to these samples to be able to look at how genes have evolved in populations that are isolated before these populations are no longer isolated. I think that by having these wonderful peoples who haven't mingled with the rest of [society],we can really see what happened in that population and then apply it to the mixed populations that we live in. [F]or the greater good of mankind we need to have all these samples and be able to look at what's happened." quoted in "The Gene Hunters", op cit n 44.
[161] Op cit n 63, at 2.
[162] Op cit n 24, at 1441.
[163] Ibid at 1442. Hopefully this belief applies also to previous or existing samples which might otherwise have been incorporated into the Project.
[164] The issues will need to be addressed on a case-by-case basis.
[165] Op cit n 146, at 1418.
[166] Op cit n 59.
[167] Discussed above under "Financial Benefits".
[168] Macer (1991), referred to in UNESCO International Bioethics Committee, Bioethics and Human Population Genetics Research: Report of the Subcommittee on Bioethics and Population Genetics, op cit n 4, at 2.2.1.
[169] Op cit n 24, at 1447.
[170] Ibid at 1448.
[171] Ibid.
[172] Op cit n 15.
[173] Op cit n 59.
[174] Ibid.
[175] For further information, see Butler, "Genetic diversity proposal fails to impress international ethics panel" Nature, Vol 377, 5 October 1995, at 373.
[176] National Research Council, Evaluating Human Genetic Diversity, Prepublication Copy, 1997. The full report is due to be released in March, 1998.
[177] Ibid at 1.
[178] Butler, "Genetic diversity proposal fails to impress international ethics panel" Nature, Vol. 377, 5 October 1995, 373.
[179] Pennisi, "NRC Oks Long-Delayed Survey of Human Genome Diversity" Science, Vol 278, 24 October 1997, 568.
[180] Doble is the assistant director of the Morrison Institute For Population and Resource Studies.
[181] Doble, personal communication to author.
[182] Op cit n 4, at 4.1.
[183] Ibid at 2.2.1.
[184] Ibid at 4.1.
[185] Ibid at 4.2.
[186] Ibid.
[187] Ibid at 4.3.
[188] Suzuki and Knudtsen, Genetics: The Clash Between the New Genetics and Human Values (1989) at 348, quoted in Wells, "Patenting New Life Forms: An Ecological Perspective" [1994] 3 EIPR 111.
[189] Bereano, "Patent Nonsense", <http://bioc09.uthscsa.edu/natnet/archive/nl/9511/0014.html>
[190] Ibid.
[191] GATT:TRIPS comes up for review in 1999.For this reason, indigenous peoples' organisations are working hard to rouse concerned parties and raise public consciousness so as to maximise their chances of being heard at the review negotiations.
[192] McNally and Wheale, "Biopatenting and Biodiversity: Comparative Advantages in the New Global Order" The Ecologist, Vol 26, No 5, Sept/Oct 1996, 22 at 228.
[193] RAFI, "Gene Hunters in Search of 'Disease Genes' Collect Human DNA from Remote Island Populations"RAFI Communique May/June 1995, <http://www.rafi.ca/communique/fltxt/19953.html>
[194] Ibid.
[195] Roht-Arriaza, "Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities" 1996, 17 Mich J Int Law 919 at 965.
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