11:41 AM Mar 13, 1997

PROFITS AND PATENTS DRIVE HUMAN GENETIC RESEARCH

Geneva Mar (TWN/RAFI) -- Research interest in human genetic diversity isn't just about science and advancement of knowledge; it is also about patents and profits.

Such research has not only civilian components, but a military one. And while there has been some information about human genetic research for civilian benefit, much less is known about military work.

International concerns about potential application of genetic research to weapons production were underscored last year when the World Medical Association (WMA) spoke about this possible abuse of genetic knowledge.

At its 48th General Assembly in October last in South Africa, it adopted a statement, proposed by the British Medical Association, on the possible development of genetic weapons, saying "the potential for scientific and medical knowledge to contribute to the development of new weapons systems, targeted against specific individuals, specific populations, or against body systems is considerable. This could include development of weapons designed to target anatomical or physiological systems, including vision, or which use knowledge of human genetic similarities and differences to target weapons."

RAFI's investigations in the US show there are no policy controls regulating the transfer of human tissue samples between civilian and military researchers. This means that current and past collections made by civilian researchers worldwide may be used by US military researchers.

But as the WMA speaks up, and US military researchers are obtaining human tissue samples from citizens of South America, Pacific and possible African countries, some advocates of human genetic diversity research are insistent there is nothing to worry about.

HGDP spokesman points to the HGDP's 'Frequently Asked Questions' (FAQ) on internet when the question of potential military use of samples arise. The HGDP contradicts the WMA's opinion saying, "Genocidal use of genetics is not possible with any currently known technology. On the basis of what we know of human genetic variation, it seems impossible that it will ever by developed."

Just a few weeks after the WMA conference, US technology writer Ed Regis published an article in the technophilic magazine Wired that reports the US military is taking the possibility of a future world of genetic weapons very seriously.

Regis says he was an invited participant in an US Army conference, organized by the wargames division of defence contractor Science Applications International Corp. (SAIC), where invitees discussed military biotechnology possibilities including how "enemy leaders, for e.g., may be knocked off by means of genetically engineered super-pathogens that are so selective in their behaviour they're capable of targeting specific individuals" and how biological weapons "could selectively wipe out crops and livestock, and could it with plausible deniability."

That SAIC would be organizing such a discussion is no surprise. The company is active in developing military and bioinformatics technologies, principally under US government contracts, often with US government intelligence agencies. At Fort Detrick (near Washington) SAIC manages human and plant tissue collections of the US National Cancer Institute and the US Army biowarfare defence units. It also has a collaborative agreement with InCyte, a gene sequencing company with thousands of patent applications on human tissues, to develop new high-speed gene sequencing equipment.

As of 1995, there were 148 commercial or academic human tissue depositories in the US alone. Canada has atleast 75 facilities.

How secure are these banks?

A survey of Canadian facilities found that fewer than a third of the workers handling human tissue samples were aware of any institutional policies related to the management and distribution of samples, although most felt such policies were necessary.

Although 61% of the responding staff shared samples with other parties, less than half sought the consent of the original donor before doing so. Onethird of those surveyed were prepared to make samples available for research beyond the original purpose of the sample. The survey authors concluded that the "ethical integrity" of Canadian human genome research was endangered.

Although human tissue sampling is assumed to be as extensive in Europe as in North America, comparable data is not available. European scientists are taking the lead in collecting global human genetic diversity; but, alarmingly, there is no specific legislation relating to human tissue anywhere in the European Union. While tissue and data banks in London, Toulouse, Porton Down, Athens, Leiden, Geneva, Turin and other European cities add to their data and cell line collections, countries like Germany, Switzerland and the Netherlands do not even have legislation related to organ transplants.

It is among these European banks too that the greatest ethical blunders in confidentiality have been found. As the EU considers new biotechnology and intellectual property rules, governments and parliamentarians might first consider if they have their house in order as far as medical ethics and trade in human tissue is concerned.

The human tissue trade is not an issue that is going to get smaller. Failure to put in place appropriate policies and regulations will result in damage to Human Rights ,and medical research. Civil Society (especially indigenous people) and government must address the policy questions now while they are potentially manageable.

Action can be taken in several fora.

WHO: Rights to and research on human tissue; issues surrounding medical confidentiality and medical ethics, including prior informed consent, concern the WHO and non-governmental bodies such as World Medical Association. Ultimately there must be a legally binding protocol covering prior informed consent to commercialisation, patent or even immortalizing or exporting human tissue. Currently, the rules on benefit-sharing in medical research prohibit financial rewards for subjects of medical research, while allowing researchers to seek patents, royalties, and other profits from the same research. The solution is not to pay the poor for their body parts, but permit community-wide control and benefit-sharing where the tissue involved is shared by a family or community.

It is difficult to understand how medical organizations can sanction research in human tissue in the absence of internationally-acceptable and enforceable protocols... There is evidence of abuse.

UNESCO: The general issue of collection and study of biodiversity has been discussed by the UNESCO Bioethics Committee which, wisely, has refused to endorse the Human Genome Diversity Project (HGDP), although it is determined to monitor its activities. The HGDP has systematically proven incapable of managing its self-appointed mandate. It is time for UNESCO to take on the issue of human biodiversity in all its cultural, scientific and ethical dimensions.

The HGDP at the outset concluded that likelihood of commercial interest in human biodiversity was negligible. Now we know that this market could reach $80 billion within a generation and that half of all new medical research could be genome-based within a few years.

HGDP similarly concluded that possibility of IPRs on human tissues was extremely remote. Within months of this conclusion, the US government had applied for three patents on cell lines of indigenous peoples. Now there are hundreds of patents granted on human biomaterials and thousands more patent applications are pending.

HGDP continues to argue it is not possible to target specific populations for biological warfare. Yet the British Medical Association and the World Medical Association see this as a serious threat, and the US Department of Defense has even stimulated scenarios using such weapons. The HGDP is unable to keep abreast of the social, commercial and scientific applications of human genome research. It has been unable even to coordinate itself. Thus we have the confusion surrounding HGDP's pilot project and its uncertain connection with the International Histocompatibility Workshop (IHW) Anthropology Component. The IHW - including its many members active in HGDP - has not come to grips with management of movement of human tissue and associated data. There are severe and unacceptable problems of confidentiality and prior informed consent that have not been addressed. For human well-being, medical researchers need to be able to collect,document and study human diversity. This work must be done under direction of the people... who are major subjects of the research through a UN agency. The HGDP is incapable of this work.

UN Human Rights Committee: The issues addressed are fundamentally those of human rights and the UNHRC must be asked to review the various Conventions and protocols touching on ownership and control of human biomaterials in order to determine if new technologies require updates. The opinion of the UN Human Rights Commissioner may be necessary in determining the revision of work necessary for revising these covenants.

UN General Assembly: The issue of patentability and Human Rights associated with human tissues must be discussed by the UN General Assembly. The UNGA convenes in a special session to review Agenda 21 in June 1997. An outstanding concern is the place of human biodiversity within the framework of the Biodiversity Convention. Though most countries concur that human diversity should not be managed by the 1992 Convention, legal interpretation suggest that human biodiversity is part of the agreement. To correct this problem, and assign responsibility more appropriately, the UNGA should seek an Advisory Opinion of the International Course of Justice.

The ICJ should be asked to determine the position of humans within the Biodiversity Convention and whether or not patenting of human tissue, as required by the World Trade Organization, contravenes Human Rights. If the ICJ follows its normal practice of providing an opinion within an year, it will come in time for the 50th anniversary of the Universal Declaration of Human Rights - and before the review of the WTO's patent provisions (Art. 27.3.b of TRIPs) in 1999.

[This is the last of a three-part article, excerpted from the RAFI Communique of January/February 1997. The first two parts were in SUNS #3941 and 3941. RAFI is a Canada-based public interest international NGO.]