Genetic engineering

Genetics will increasingly enable health professionals to identify, treat, and prevent the 4,000 or more genetic diseases and disorders that our species is heir to. Genetics will become central to diagnosis and treatment, especially in testing for predispositions and in therapies. By 2025, there will likely be thousands of diagnostic procedures and treatments for genetic conditions.
Genetic diagnostics can detect specific diseases, such as Down’s syndrome, and behavioral predispositions, such as depression. Treatments include gene-based pharmaceuticals, such as those using antisense DNA to block the body’s process of transmitting genetic instructions for a disease process. In future preventive therapies, harmful genes will be removed, turned off, or blocked. In some cases, healthy replacement genes will be directly inserted into fetuses or will be administered to people via injection, inhalation, retro viruses, or pills. These therapies will alter traits and prevent diseases.
Although genetics will be the greatest driver of advances in human health in the twenty-first century, it will not be a panacea for all human health problems. Health is a complex of interacting systems. The benefits of genetics will also be weighted more heavily to future generations, because prevention will be such an important component. Genetic therapies will ameliorate conditions in middle-aged and older people, but those conditions will not even exist in future generations. For example, psoriasis may be brought under control for many via gene therapy; if an effective prenatal diagnosis can be developed, then no future child would ever need be born with the condition.
1.
“Natural” Rights
Within the long history of rights discourse, rights have also been essentialized as “natural” rights. Natural rights have historically been used in both conservative and radical defenses of what is perceived as given in the human condition. The right to procreate has been conceived as a natural right, and, by extension, technological reproduction has been recently promoted as the means to fulfill one’s natural right to procreate. Thus the male-dominant tradition of property rights converges with a version of natural rights proclaiming a natural right to procreate, a natural right to a child, a natural right to use any means necessary to procreate, and thereby a natural right to use any person necessary to procreate.
When procreation is defined as a natural right, it is viewed as deriving from a natural instinct, comparable to eating and sleeping. Attempts to institutionalize procreation as a natural right divest the person procreating of moral responsibility, so that anything a man or woman does to reproduce is treated as an instinctive response beyond the control of human will and human relations. One way that the right to procreate becomes a law of nature is that, as a right, it becomes grounded in a natural need, that is, a compelling paternal urge or maternal instinct that demands an outlet. The right to procreate, portrayed as a natural right, renaturalizes motherhood and reproduction and grounds men’s rights to “their” children in the natural order.
The challenge is to recognize the material contribution that women make to reproduction and pregnancy while at the same time not essentializing that contribution as natural female destiny. The challenge is also to argue that this contribution alone does not constitute the primary action or agency of female reproduction but grounds, in unique ways, the relationship of woman to fetus. The challenge is not to expand men’s already prevalent rights over women’s bodies by reinstitutionalizing male “genetic fulfillment” as a justification for reproductive technologies and contracts
1.
Genes and Environment
All of this research is being done in the hope of finding a predictive test for a “predisposition” to develop a condition that many people could avoid by changing their diets and getting regular exercise. It would surely be better to educate everyone about the importance of diet and exercise and to work towards providing the economic and social conditions that could enable more people to live healthily, rather than spending time and money to try and find “aberrant” genes and to identify individuals whose genetic constitution may (but then again, may not) put them at special risk.
The susceptibility to Type 1 diabetes appears to cluster in families and in specific populations, for example, among people of northern European origin. If one child in a family has Type 1 diabetes, the probability of a sibling developing it is about 6 per cent, or twenty times the rate for the general population. While this might seem to indicate a genetic component, it turns out that an identical twin of someone who develops Type 1 diabetes has only a 36 per cent probability of developing the condition. This is higher than the probability for ordinary siblings, but proves that genes cannot be the sole determining factor. Indeed, since toxic environmental agents and viral infections are thought to provoke Type 1 diabetes, family correlations need not point to a genetic origin. Siblings who live together are often exposed to the same environmental agents
1.
Human Life is Sacred
Our candid presupposition is that both humans and animals are more than the sum of their genetic code. In our view, genetic patenting of Homo sapiens is, however, a separate issue in some respects from patenting other organisms. Both are problematic, but for slightly different reasons.
Opposition to patenting human beings and their genetic parts is grounded in the unique nature of Homo sapiens. Human beings, alone among living organisms, bear the imago Dei. “So God created man in His own image, in the image of God He created him” (Genesis 1:27). Human life is therefore sacred and possesses unique value derived from the Creator. Thus, as Philip Edgcumbe Hughes has said, “It is the image of God in which man was created, rather, which pervades his existence in its totality and is the cause of his transcendence over the rest of God’s creation.”The distinction between human life and animal life, as well as the prohibition against the unjustifiable taking of human life, is foundational to Jewish and Christian anthropology.
Human beings are pre-owned.We belong to the sovereign Creator.We are, therefore, not to be killed without adequate jus- tification (e.g., in self-defense) nor are we, or our body parts, to be bought and sold in the marketplace.Yet the patenting of human genetic material attempts to wrest ownership from God and commodifies human biological materials and, potentially, human beings themselves. Admittedly, a single human gene or a cell line is not a human being; but a human gene or cell line is undeniably human and warrants different treatment than all nonhuman genes or cell lines. The image of God pervades human life in all of its parts. Furthermore, the right to own one part of a human being is other things being equal, the right to own all the parts of a human being. This right must not be transferred from the Creator to the creature.
Imagine a society in which patented human cells, cell lines, and tissues are bought and sold in the scientific marketplace. If such a scenario seems impossible to conceive, consider that Nobel laureate Kary Mullis has bought the rights to extract a part of Elvis Presley’s DNA from a lock of the rock idol’s hair using a “genetic amplification” technique that Mullis himself invented. Mullis intends to make millions of copies of Presley’s genes, according to a September 1995 Washington Post article, “and preserve these minuscule globs inside artificial gemstones, to be made into a line of necklaces, earrings, and other collectables.” While Mullis’ good sense may be questionable, the commodification of human genes is not inconceivable with only a naturalistic anthropology to guide genetic science.
Potential Abuse
We argue that the current status of U.S. patent law is incapable of dealing with the potential abuse of human genetic materials. When the framers of the Constitution established congressional power “to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries,” it was impossible to envisage the patenting of human genetic materials. Even in 1952, when Congress passed the Patent Act, intending patentable subject matter to include “anything under the sun that is made by man,” it is unlikely that they foresaw human “biopatents.”We, therefore, conclude that human genetic materials should not be patentable matter.
We further maintain that a moratorium should be placed on animal patenting on slightly different grounds. In the case of animal patents, social justice issues rise to the fore. Animals, like human beings, are pre-owned entities. Every part of God’s creation is owned by the Sovereign. Most Jews and Christians would, however, interpret the mandate of Genesis 1:28 to permit animal ownership. “God blessed them and said to them, Be fruitful and increase in number; fill the earth, and subdue it. Rule over the fish of the sea and the birds of the air and over every living creature that moves on the ground.'” Responsible stewardship of the created order is not only allowed, it is imperative.
Under U.S. patent law, patentable subject matter is defined as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Rebecca S. Eisenberg, Professor of Law at the University of Michigan, observes that “although products of nature may not be patented as such, patents have been issued on such products in human-altered form.” This is exceedingly troublesome in our view. Oncomice are, in fact, human-altered forms, but are they really “compositions of matter”? Do they truly constitute an “improvement thereof”?
Not an Invention
Philosopher Ned Hettinger has rightly said, “There is a substantial disanalogy between these biopatents and the traditional subject matter of patents. Edison really did invent the light bulb. The Wright brothers created a flying machine. But Harvard did not invent or create the oncomouse. Biotechnicians alter, modify, assist, and manipulate nature. They are not inventors of novel organisms or genes that could be appropriate objects for patents.”
In truth, the patent on the Harvard mouse constitutes a monopoly on an entire subclass of animal. Again, according to the OTA report, “The actual patent coverage is broad, embracing virtually any species of transgenic nonhuman mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage.'” Since there are about forty known cancer-causing genes, the patent covers an inordinately wide variety of potentially patentable mammalian life.
1.
What is a Patent?
According to the United States patent laws, a patent is a legal permission granted by the PTO that gives the patent holder the right to exclude others from making, using, or selling an invention within the United States, its territories, or possessions for a 20-year period. Patents cannot be renewed. To obtain a patent, one must “reduce the invention to practice,” which involves making the invention or a model of it, and submit an application to the PTO. The invention must “work”i.e. it must do what it is supposed to do. The patent application becomes public people can study the inventionalthough rights to control the invention remain private. In most cases, the PTO will grant a patent if the inventor provides a specification of the invention that will allow someone skilled in the relevant technical field to make and use it. In the last 200 years, the courts and legislatures have refined and developed patent laws. A useful summary of these laws is that a patent is new, useful, and nonobvious invention. United States courts have ruled that some types of things cannot be patented, such as ideas, scientific principles or theories, or mere results. Things that are not useful or original also cannot be patented, nor can inventions designed for the sole purpose of violating the legal rights of others. . . .
Patent Laws
Given this thumbnail sketch of patent . . . laws in the United States, one can see that there is a legal basis for some forms of ownership pertaining to human genes, including (1) ownership of artificial human genes or artificial combinations of genes; (2) ownership of works describing human genes or scientific ideas or principles pertaining to human genetics; and (3) ownership of processes for analyzing, sequencing, copying, fabricating, or manipulating human genes.
As far as patent rights are concerned, there is a legal basis for patenting originali.e., invented, non-naturally occurring human genes, DNA sequences, parts of chromosomes, or combinations thereof; processes for manufacturing, analyzing, sequencing, or recombining human genes would also be patentable. However, patent laws would not allow anyone to own naturally occurring human genes or combinations thereof; nor would patent laws allow anyone to own scientific principles pertaining to human genetics, such as the central dogma of molecular biology. . . .
Thus, it would appear that there is a legal basis for extending intellectual property laws to the realm of human genetics and for allowing human gene patents on original (or artificial) human genes. Thus far, individuals and corporations have found patents to be the most profitable and advantageous form of protection for genetic discoveries and innovations, and most of the controversies relate to gene patents. But should current patent laws be applied to human genetics? Are human gene patents immoral even if they have a legal basis? . . .
Human Gene Patents and Human Dignity
The remainder of the viewpoint will examine three nonutilitarian arguments against human gene patents. All of these argu- ments hold that the practice of patenting human genes is morally wrong, regardless of its benefits or harms for society.The first argument takes a Kantian perspective on human gene patents and proceeds something like this: (1) the practice of patenting human genes treats persons as property; (2) it is morally wrong to treat persons as property; thus, (3) the practice of patenting human genes is morally wrong. Gene patenting is wrong because it treats persons as things that can be bought, sold, traded, or modified. For the purpose of discussing this argument, this viewpoint will assume a Kantian perspective on personhood: a person is a rational, autonomous, moral agent. This perspective assumes that a human person is not the same thing as a human body, since there might be human beings that are not autonomous, moral agentse.g., zygotesand there might be autonomous, moral agents that are not human beingse.g., dolphins. Human beings are members of the species Homo sapiens, but not all members of this species are persons.
Although this Kantian perspective merits consideration as an objection to the practice of patenting human genes, it does not offer a sound argument against this practice because the practice of patenting human genes does not treat persons as property. Gene patenting does not treat persons as property because it only allows individuals or corporations to own inventions for analyzing, sequencing, manipulating, or manufacturing human genes. Ownership of a process for making or manipulating a part of a human body does not (automatically) constitute ownership of a person. A human gene patent would be analogous to a patent for making or manipulating other kinds of human body parts, such as hair, bones, or hearts. If the patenting of technologies for transplanting, growing, analyzing, or modifying bone marrow is morally acceptable, then the patenting of human genetic technologies should also be morally acceptable