The Human Genome Diversity Project searches for cures, not profits
This is part of a series of essays on bioprospecting and biopiracy. The other essays are: “Bioprospecting or Biopiracy?”; “High-Tech Piracy”; “Pharmaceutical Giant Shares the Wealth”; “Transnationals With a Conscience”; and “Biodiversity Resources”.
“Bioprospecting” raises its most important issues when the “bio” is human. The Human Genome Diversity Project, an international effort to learn more about the 5.5 billion different human genomes, has proposed some innovative ways to deal with these issues. Although the project has been branded a “biopirate,” it is in fact part of the solution, not part of the problem.
Start with “human-based biotechnology.” There have for decades been medical and scientific “inventions” derived from human biological materials. In recent years, these inventions have led to patents on human genetic sequences, human proteins, and human cell lines, which are self-reproducing sets of particular kinds of human cells. These are all patents on biological materials derived from humans that were discovered, purified, and found to have some plausible use. They are not patents on humans. No one seems to have tried to patent a “genetically altered” human; there are good legal reasons (and better political ones) to doubt that such a patent would ever be granted.
This human-based biotechnology has become more important with the explosion of knowledge about human genes. The Human Genome Project, begun in 1990, is a planned 15-year international cooperative effort to first map and then sequence—spell out—all 3 billion base pairs (letters) of the human genetic code. The project receives nearly $200 million per year in funding from the U.S. government alone. Through the Human Genome Project and other research, we now know a great deal about human genes and human disease. Some of that knowledge will be translated into products that will help save or improve lives—and generate profits for private companies.
So far, most work on the human genome has involved Europeans or North Americans of European descent, largely because that is where the research has been done. If, however, a researcher is trying to find a particular rare gene variant—say a variant that causes a disease—the researcher will look for it among people who have a high rate of the disease. Usually, that has meant family studies; in some situations, it may mean studies of discrete cultural groups, including indigenous peoples. For example, much work in looking for a genetic link to non-insulin-dependent diabetes has been done with the Pima Indians of Arizona—a group that suffers disproportionately from this disease.
Several thousand human genes, proteins, and cell lines have been patented. As far as I know, only three patent applications concerning “inventions” derived from indigenous peoples have been filed. All three patent applications were for cell lines (not genes); two of the three were withdrawn without being granted. The third application, for a cell line derived from blood from Papua New Guinea, was nearly dropped, but ultimately was granted only because researchers speaking for the donor population requested it.
The Human Genome Diversity Project is an effort to expand our knowledge of all 5.5 billion human genomes, moving beyond the small minority of the world’s population that has recent roots in Europe. The project hopes to collect, preserve, and analyze DNA samples from about 500 populations around the world—big and small, indigenous and nonindigenous—that have not been extensively studied. The resulting data should be an invaluable resource for studying how closely different peoples are related and, therefore, the history of our species.
The project currently consists entirely of several committees—regional and international—of geneticists, anthropologists, and other interested people. These committees are planning work in their regions and trying to raise, from governments and other noncommercial sources, the roughly $25 million to $35 million it would take to do this work in five to seven years. Apart from pilot projects in Europe and China that may eventually become affiliated with the project, no DNA collection is going on anywhere in the world under the project’s auspices.
The Diversity Project is about our shared human history, not about commercially valuable genes, but it has to confront the possibility that samples it collects might generate commercial products. The project has vowed that it not reap any commercial gain from the samples it collects and will seek to ensure that, should anyone make money as a result of the samples, a fair share of the benefits return to the participating populations. Its North American Regional Committee has gone farther in suggesting direct protections for participating populations.
Specifically, the North American committee has proposed requiring participating researchers to obtain the informed consent of the population, as well as individual participants, before sampling. As part of this group informed-consent process, the population would set the terms for use of its samples. The terms might include no patenting, patenting only with the negotiated consent of the population, or patenting only with the consent of a third party “trustee” for the population. Researchers have access to the samples or data only if they agree, by contract, to respect the conditions.
The system under discussion by the Diversity Project’s North American committee would thus put control over commercial use in the hands of those populations that decided to take part in the project—where we, and, we think, they, believe it should rest. “Biocolonization” is a legitimate concern, but the Diversity Project is part of the answer, not part of the problem.
Hank Greely, a professor of law at Stanford University, specializes in health law and policy. He serves on the North American committee of the Human Genome Diversity Project, and chairs the committee’s ethics subcommittee. He also chairs the steering committee of the Stanford University Center for Biomedical Ethics.