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Explore how genetic and reproductive technologies relate to commerce.
Commerce has played a central role throughout the history of genetic and reproductive technologies, especially in the United States where the market often fills a void left by the absence of regulation. Biotechnology is a multibillion-dollar industry, and in the last few decades it has seen a steady increase in funding from the federal government. At the same time, new products and processes made possible by genetic and reproductive technologies have raised ethical, legal and social questions that seriously challenge legislatures and the courts.

Many fundamental questions are raised by the intersection of commerce and biotechnology. Several of these—and a handful of illustrative arguments—are described here.

The Body and Life:
What kind of resource are living organisms?
What kind of resource is the body? Should we consider the human genome, for instance, part of the public "commons?"
How does the human body relate to commerce?
How should the law view the body, its parts and products?

There is no clear consensus in law or society about whether we should consider ourselves as persons who own our bodies, as persons who are somehow integral to our bodies, or persons who are separate from our bodies and serve as "trustees" under God, society or something else. If a person "owns" his or her body, then the body cannot be used after death without permission (e.g., for organ donation). If, on the other hand, a person is the "trustee" of his or her body, the body's parts would be available after death for the general good. Considering the body as property, however, might allow others to own a person's body, as in slavery or indentured servitude. It also seems to increase the risk of commodifying—and so devaluing—the human body and its parts (such as sperm, eggs and embryos).

Some observers have argued that in the interest of justice, equality and dignity, we should consider the human genome part of the public commons. Since the evolution of all humankind has contributed to the genome's current incarnation, whatever benefits accrue from understanding the genome, some believe, should be shared universally. Whether or not this is possible in a market-driven economy is up for debate.

The Scientific Enterprise
Do the prerogatives and pressures of the marketplace alter the scientific process or the outcome of this process?
Which kinds of scientific exchanges are open and cost-free and which are proprietary?
Does the element of commerce affect the relationship a researcher has to his/her study population?

Leaders from many fields, including science, ethics and law, have raised concerns about the relationships in biotechnology between academic science and the private sector. Many of the researchers involved in new biotechnologies have some kind of financial stake in products of that research or in companies connected to their fields—what has traditionally been seen as a conflict of interest. The pervasiveness of this relationship compelled one major medical journal (The New England Journal of Medicine) to relax its conflict of interest policies.

Whether or not ties to industry are changing the nature or outcome of the scientific process is hotly debated. Critics argue that protecting research that is seen as proprietary—by not sharing results with other scientists, patients or the public, withholding information until a patent issues, or reducing the opportunities for research designed to replicate results—is having a chilling effect on healthy scientific debate and peer review, and may be compromising patient care. Others argue that the failure of the government to address many of the ethical and political controversies spawned by new genetic and reproductive technologies means that the private sector is the only place where important technologies will be funded and developed.

New biotechnologies raise difficult questions about how to protect human subjects, the meaning of informed consent and the adequacy of institutional review boards. For example, if you have a defective BRCA1 gene (one of the two genes most commonly associated with breast cancer), you inherited it from one of your parents, you may have passed it on to your child, and your sister, brother or cousin might also have it. Who, in this example, is the research subject? To whom is a researcher accountable now and in the future should knowledge of certain genes change? From whom should a researcher get informed consent? Future individuals can also be affected, for example, when embryos are selected prenatally for certain genes (see "Can you pick your children?") or children are created with genes from three people (see "Can you judge a good parent?"). Such interventions, critics argue, represent changes to future generations, for whom it is impossible to get informed consent and to whom we owe, perhaps, a great obligation.

The Self and Others
How should commerce interact with people?
What degree and kind of commerce is acceptable in human relationships?

Genetic and reproductive technologies introduce new pressures and potential conflicts into human relationships. The ability to enlist third parties—egg and sperm donors and surrogates—in the conception of a child forces us reconsider the meaning of kinship. For example, it offers more options for non-traditional families such as gays or lesbians. Yet, at the same time, it replaces relationships presumably born of human emotion (love, hate, ambivalence) with negotiations and contracts. Whether this new contract model makes sense or is good for human relationships is not clear.

Gamete (egg and sperm) donation and surrogacy, critics argue, also threaten to devalue human relationships and human dignity by commercializing conception. Many ethicists now refer to "donors" as "vendors," arguing that money transforms the practice into a commercial transaction.

Access and Fairness
Who should have access to the opportunities created by biotechnology?
Who should bear the costs of a technological society?
How and by whom should these questions be answered?

Money to develop and apply biotechnologies is a limited resource. So too, are the human bodies from which biotechnological procedures and products are made possible.

Some critics worry that new genetic and reproductive technologies will further aggravate existing economic inequalities, and that specific populations will be particularly vulnerable. For instance, women in need may serve as egg donors or surrogates for richer infertile couples, sick people may participate in experimental research without fully knowing the risks, or poor people may not have access to life-saving (or enhancing) technologies (and may even be deprived of baseline care as limited dollars go to technology rather than basic needs). Others argue that, unlike any other technology, biotechnology has the power to even out the economic playing field. By placing a value on human genes, for instance, populations might find themselves in control of a valuable resource. (Both Iceland and Estonia have licensed their populations' genetic codes for research.) Even more profoundly, some argue that biotechnology holds the promise of redistributing basic human "wealth" (the human genome) in a very fundamental sense, by reshuffling or fixing genes, not just by overcoming inequities such as hunger and disease.

Other Themes
Law
Ethics
Did you know?
The course of U.S. patent law in the last 25 years has had a profound impact on the development of biotechnology, both by helping define what is permissible and by providing incentives to certain kinds of commerce.

According to the U.S. Patent and Trademark Office (USPTO), a patent is "a property right granted by the Government of the United States to an inventor to exclude others from making, using, offering for sale, or selling the invention… for a limited time [20 years] in exchange for public disclosure of the invention when the patent is granted."

For the USPTO to grant a patent, "the invention must be: useful, new, not obvious, and described in the proper fashion." The goal of the patent system is to induce inventors to disclose their work publicly so that others can build on those discoveries, and so promote innovation. The USPTO states that "The patent system does not exist to benefit the individual inventor, or the companies and individuals that own patents. In a very real sense, the patent system exists to benefit the public."

Some of the most important cases and laws related to patents on life include:

Lowell v. Lewis (1817): This case on the patentability of a water pump concerns the "moral utility" of subject matter for the purposes of patenting. In Lowell, the USPTO claims there are "public policy and morality aspects" of the utility requirement. Although courts have relied on Lowell in recent years, it is usually in relation to inventions of specious utility, rather than questions of moral utility. In fact, courts have not raised moral utility as a bar to patentability even for inventions designed to circumvent the law.

Diamond v. Chakrabarty (1980): For the first time, the U.S. Supreme Court allows a patent on a living organism—a new, genetically engineered bacterium designed to eat oil slicks.

Ex parte Allen (1987): The USPTO Board of Patent Appeals and Interferences holds that a genetically engineered oyster is patentable subject matter and issues a notice saying that altered multicellular animals are patentable subject matter within the scope of the Patent Act.

U.S. Patent No. 4,736,866 (1988): The USPTO grants the first animal patent for a genetically altered mouse.

Animal Patent Bill (1988): The bill addresses three issues: it provides immunity from liability for patent infringement to farmers who purchase patented farm animals and want to reproduce them; it clarifies the USPTO's authority to require deposits of biological material from patented animals; and it excludes human beings from "patentable subject matter."

Newman "chimera" application (1998): Developmental biologist Stuart Newman applies for a patent on a creature that would be part human and part animal, a "chimera." The USPTO rejects his application in June of 1999 on the grounds that the invention embraces a human. Newman, who applied for the patent to spark public discussion on the patenting of life and has no intention of actually creating the creature, has since appealed the patent office's decision and plans to continue to do so, up to the Supreme Court if necessary. At the time of the first rejection, the USPTO issues a statement clarifying that it considers "nonnaturally occurring non-human multicellular living organisms, including animals, to be patentable subject matter."

Trade Related Aspects of Intellectual Property (TRIPS agreement 1994): An international agreement, TRIPS generally requires patent protection to be equally available for all inventions regardless of subject matter. However, it does allow some important exceptions; one such exception is that subject matter may be denied patentability if its commercial exploitation would violate public "ordre" or morality. The scope of this exception has not been conclusively determined, but because the wording mirrors the language of other patent systems, those systems are relevant in evaluating the connections between morality and patentability.

Patent No. 6,211,429 (2001): The University of Missouri receives a patent on a technique for cloning mammals and licenses the patent to the Massachusetts company Biotransplant (a leader in xenotransplantation). Critics are alarmed because the patent application does not exclude humans, and it specifically mentions human eggs. Others contend that the patent is for just the process and not the product, despite the fact that the patent says it covers "cloned products," which theoretically includes embryos, fetuses and children.