Early this month, a US federal district court in New York began deciding a landmark case as to whether individuals have a “right to know” about how their own genomes can dictate their future health. The case, American Civil Liberties Union v. Myriad Genetics, may have a tremendous impact on medicine and science.
The questions on which the case turns are whether genetic patents help or hamper research, and whether patients should have to pay a license fee to a biotechnology corporation to be tested for predisposition to disease.
One of the plaintiffs is Lisbeth Ceriani, a 43-year-old woman with breast cancer whose doctors recommended that she be tested for two genetic mutations involved in some hereditary forms of the disease. Myriad Genetics, the sole test provider in the US — it holds a patent on the genes themselves , not just on the diagnostic test — did not accept her insurance, and Ceriani could not afford to pay for the test. So she remained ignorant, as did her physicians — with possible ramifications for her clinical care. Five other plaintiffs , along with major medical bodies, tell similar stories.
Those who oppose genetic patents claim that they also deny US constitutional rights, making this the first time a genetic patent has been challenged on human rights grounds. As so often happens in biotechnology, what looks at first like an abstruse technical issue raises many questions that cut to the core of our humanity.
One human gene out of approximately every five is now the subject of a patent, the majority of which are held by private firms. This case concerns two such genes, BRCA1 and BRCA2. Women with the “wrong” version of these genes have a heightened risk of developing breast cancer (up to 85 percent, against the normal 12 percent, although the genes account for only a minority of breast cancers). These women also run a greater risk of ovarian cancer.
Myriad Genetics has also tried to pursue patent rights in Europe, but there its claims have been largely rejected. Although the gene’s function in causing breast and ovarian cancer was uncovered by Cancer Research UK in 1995, Myriad, along with nearly 30 other defendants, argues that the patent is a necessary reward for its research costs. In fact, without patent protections, the firm and its allies claim, medical research would shudder to a halt.
But whatever the merits of the claim that genetic patents benefit research and treatment, that is a practical, rather than a legal, argument. In order to gain legal standing to sue Myriad Genetics, critics of genetic patents — including the American Medical Association, the American Society of Human Genetics and the American Civil Liberties Union — had to find an issue that could be adjudicated on a constitutional basis. Their innovative strategy is to draw on the First Amendment, which protects freedoms such as speech and religion, to argue that patents restrict patients’ freedom of access to information that might enable us to take action to protect our health.
That is a clever argument, but is it really the source of people’s profound disquiet about genetic patenting? In researching my recent book, Body Shopping, I have heard many shocked reactions to the growing commodification of human tissue, but none more generally shared than this one: How can you take out a patent on life?
Is a genetic variant a “product of nature” or a “discovery”? While the plaintiffs assert that “genes are identified, not invented,” the defendants claim that the basis of patent law is precisely the opposite. Their argument is that what is patented is not the gene as it occurs in our bodies, but rather a sort of “cloned” version produced in the laboratory. Rather than a “patent on life,” the companies say, they are patenting something more like a chemical.
If that is true, how can Ceriani rightfully be kept in the dark about what form the gene takes in her body? This is not just a problem for people who think — wrongly, in legal terms — that they own their bodies, as most people do. With a few limited and recent exceptions, there is no such thing as property in tissue once it has left your body. We know that from such cases as that of John Moore, who tried unsuccessfully to claim property rights in a valuable cell line developed from his immune cells.
But what about a gene that has not left my body? Don’t I somehow still “own” it? Don’t I have rights of control over my own body? How can a commercial firm not only deny me the right to know my own genetic profile unless I pay their fee for the diagnostic test, which might be fair enough, but also to prevent any other firm from offering me a similar test unless those firms pay it a license fee?
Proprietary rights for commercial firms over the most basic element of an individual’s genetic identity should not be enforceable. We do not have to believe in genetic determinism to find that argument compelling.
Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London, was the 2006 winner of the International Spinoza Lens Award for contributions to public debate on ethics.
Copyright: Project Syndicate
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