6:57 AM Jul 10, 1995


Geneva 10 July (Chakravarthi Raghavan) -- As 'gene hunters' roam amongst remote indigenous groups and peoples to 'collect' genetic samples for patenting and staking claims for private profit, influential non-government groups are launching a campaign to take the issue of 'life-patenting' to the International Court of Justice (ICJ) at the Hague.

The Ottawa-based Rural Advancement Foundation International (RAFI), an international NGO, in underlining the need for a global resolution of the conflicts over life-patenting has announced the launch of a campaign to take the issue to the ICJ at the Hague.

The campaign is aimed at mobilizing public opinion and engendering a political debate.

Since only a competent UN agency or sovereign states can invoke the ICJ's advisory opinion, the campaign will focus on arousing public concerns over this issue so that global civil society can act together to intervene through a competent UN agency or persuade sovereign states to seek an advisory opinion from the ICJ on the issue and its ramifications visavis the WTO's TRIPs accord, the UN Biodiversity Convention and the WIPO administered treaties.

Each of these international treaties have their frameworks and rules about patenting of life forms, genes etc and processes and products relating to them.

The WTO's TRIPs enables countries to exclude some things from 'patentability' on the ground of morality and 'ordre public'. WTO members could also exclude from patentability plants and animals, but not micro-organisms, provided an effective sui generis system is established for plant varieties. This provision is to be reviewed before 2000.

And while a WTO-member can deny patents in some of these areas in its own territory, it cannot prevent another member from providing for it on its own territory, and affect 'trade' in these in terms of imports to its own territory or third countries which have not made an exclusion.

In its May-June issue, RAFI Communique deals with the issue of Gene hunters in search of 'disease genes', collecting human DNA samples from remote inland populations and says: "There is now a silent but reckless 'goldrush' underway with incalculable stakes for humankind".

A handful of genomic companies using Bio-informatics (using proprietary, high-tech computer methods for collecting, editing, analysing and strong DNA sequence information) and their pharmaceutical partners are rushing to privatize human genes and their products. The commodity they seek to exploit is not gold, but biological information, and the raw material they need is human DNA - the blueprint of human life, RAFI says.

Access to their private genome database is sold to giant pharmaceutical companies - a "one-stop shopping for genes", as Incyte Pharmaceuticals, a California-based genome company calls it.

RAFI has found, from a search of patent databases, that more than 100 human cell liens are currently the subject of patent claims in the US. No one knows for sure how many human genes have been patented, but one of the companies has estimated that more than 1200 patents have been issued in the US on human gene sequences.

Incyte genome company has claimed that it has already identified some 35,000 unique genes -- roughly onethird of human genome -- and that it has the capacity to process some 3000 genes a day. By end of 1995, Incyte expects that its proprietary database will "contain sequences for a broad spectrum of cell and tissue types, and a representation of most human genes". In 1994, Incyte had applied for patents on over 40000 cDNA templates.

One of the latest techniques for identifying disease genes is the use of "positional cloning". This method does not depend on large-scale sequencing of random DNA fragments with unspecified correlation to disease, but with a direct genetic analysis of families affected by a specific disease.

For this, the scientists must have access to DNA from "well-characterized" populations of individuals who are "carriers" of an inherited trait -- breast cancer, baldness, obesity, Type II diabetes or asthma. By analysing the inheritance patterns of DNA markers from individuals affected by a particular disease, it is easier to isolate the most likely location of the disease gene and this is followed by rapid mapping of the implicated region and intensive analysis to pinpoint abnormalities in the gene sequence.

In recent months, RAFI says, scientists and their corporate partners have been collecting DNA samples from remote island populations in the South Atlantic, Micronesia and East China Sea. This is being presented as a powerful tool to find the genes responsible for common complex disorders affecting majority of peoples in Western countries.

But however socially desirable this goal may seem, it is really a case of genome companies and their scientists committing genetic biopiracy, and in the process violating fundamental human rights of the people from whom the DNA samples are taken, says RAFI.

The peoples targeted are giving DNA samples - blood, hair and tissue -- willingly under standard regulations of 'informed consent'. But most of them are doing so with a general understanding they are making a contribution to science that someday might improve human conditions.

"They are NOT informed that products derived from their DNA, or information gleaned from it, will be patented and commercialized, nor that they will lose control of their genetic material once its is removed from their bodies."

In September 1994, Sequana therapeutics, a California-based genomic company, announced that DNA samples extracted from nearly all of the 300 inhabitants of an isolated island in the South Atlantic (Tristan da Cunha, all of whose inhabitants are descended from seven original families and with one of the highest incidence of asthma) may give the company information needed to locate, identify and eventually patent the gene or genes that predispose people to asthma.

The company got the DNA samples through collaboration with Samuel Lunenfeld Research Institute of Mount Sinai Hospital in Toronto - one of Canada's premier biomedical research facilities.

The samples were collected by the scientists associated with the Institute in 1993, and the genetics of the asthma research is supported by Zeneca pharmaceutical corporation.

It was not until 1994 that Sequana Therapeutics announced a collaboration with the Canadian Research Institute and the DNA samples were turned over to the company. If Sequana is successful in identifying the mutant gene or genes, it will file patent claims and any patent application will be made in Sequana's name - with the economic benefits shared with the scientists of Lunenfeld Institute.

But will the inhabitants of Tristan da Cunha benefit from the discovery of the asthma gene?

The University of Toronto scientist, Patricia McClean explains that the Canadian researchers made an agreement "to leave their lung-functioning equipment on the island" when they left and that this gives the islanders the technology needed to assess their asthmatic conditions before treatment.

Citing other examples of targeted populations providing the raw material for human DNA research, RAFI says that there is an urgent need for an international protocol to protect rights of human subjects from patent claims and unjust commercial exploitation.

The widespread concept of "prior informed consent" currently has no provision for informing the individuals that their DNA or a product derived from it may become a marketable commodity or that someone stands to profit if a commercial product is someday derived from their DNA.

And there is no provision for a "no intention of consenting" -- the unconditional right of all individuals and/or communities to deny access to their genetic material.

RAFI points out that issues of national sovereignty are also at stake. When the US government applied for patents on human cell lines of indigenous peoples from Panama, Solomon Islands and Papua New Guinea, the US Commerce Secretary, Ron Brown, dismissed protests of national governments, indigenous peoples and NGOs by asserting that "Under our laws, as well as those of many other countries, subject matter relating to human cells is patentable and there is no provision for considerations relating to the source of the cells that may be subject of a patent application."

The issues of genetic expropriation, patenting and commercialization of human DNA, RAFI says, can no longer be ignored in regulations governing biomedical and human genetic research. The concept of 'informed consent' must include information about the researcher's intent to patent or commercialize human DNA and, in the case of human cell lines, disclosure and permission to "immortalize" an individual's DNA. Permission to export genetic material out of the country must also be obtained.

The Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization, in February 1992, revised its "International Ethical Guidelines for Biomedical Research including Human Subjects". But the area of human genetic research did not receive special mention in the guidelines.

The CIOMS steering committee "considered that since there is not universal agreement on the ethical issues raised by these research areas it would be premature to try to cover them in the present guideline."

Urging the CIOMS and intergovernmental bodies overseeing regulations governing human genetic research to reconvene and address urgently the issues of patenting and commercialization of human genetic material, RAFI points out that ethical guidelines governing research on human subjects prohibit large payments of money or in-kind contributions to research subjects since it could "undermine a person's capacity to exercise free choice and invalidate consent."

In the midst of widespread commercialization and patenting of human genetic material, this sound reasoning becomes supremely ironic and hypocritical, RAFI says. "Isn't the orientation and integrity of researchers similarly distorted and invalidated when they seek to patent and commercialize the human DNA that they are collecting from research subjects around the world?" it asks.

"The contradictions are undeniable. Ultimately, human genetic material must be held outside the patent system."