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Cloning and Gene Patents:
Should There Be More Regulations?
Sarah Jacques
Academic affiliation: Oklahoma State University
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Scientific patents are very perplexing ideas for the reason that there are no regulations or guidelines regarding the patenting of human genes. Doctors and researchers are able to patent parts of the human body, such as cells, organs, etc., and use them to research various things including human DNA, cancer, and human cloning. Because of these scientific patents, many medical discoveries and advances have been accomplished in the medical field due to research on human gene cells. Researchers have spent a great deal of time mapping out human DNA and understanding the "human instruction manual" (Wade 7). As a result, cures for many diseases have been discovered and many lives have been saved. For example, although a cure for cancer has yet to be found, there have been many ways of treating cancer that were discovered with the use of patented cancer cells. While an enormous amount of success has occurred as a result of the research conducted on patented human cells and body parts, the process in which cells are retrieved and the types of experiments conducted, such as mixing human and animal genes or cloning of humans, are problematic. The process of patenting cells has grown out of control. Issues such as moral ethics, protection of individual rights and questions of whether or not the process is inhumane to humans and animals begin to arise when talking about the different research in which human and animal patents are used. As a solution, doctors and researchers should not be allowed to patent human body parts without the consent of the patient from whom the parts are taken. In addition, regulations need to be placed on the process of patenting human and animal body parts and on the type of research that is conducted with the use of these parts.

The argument concerning the idea that research and experimentation with human and animal genomes is morally and ethnically wrong, and "…it is argued that to change the germline is to play God. If the phrase playing God has a serious meaning, it is that by acting to reduce genetic disease in the germline we might also be reducing the amount of a variation on which evolution works" (Wade 171). One way this type of thinking may be avoided is by giving each patient the choice of whether or not his or her cells are to be used in genome research. By giving each patient a choice, the controversy over ethics and morality would deteriorate into a smaller issue. For example, if a patient viewed genetic research as immoral, that individual would retain the rights to whether or not their bodies would be used in that research.

In order to ensure that each patient has a choice of whether or not their individual cells are to be used in genetic research, doctors, as well as researchers should be required by law to acquire the patient's permission in order to use their cells. Because there are no laws against the patenting of cells, doctors are able to patent a particular cell, they will receive all the credit for it and will attain full control of all the research that will be performed on that certain cell thereafter. In addition to this, doctors and researchers are able to sell human cells to research companies, such as Nextran, for a large amount of money. Since the patients from whom the cells were removed are oblivious to the fact that their cells are being used in human genetic research, they do not receive any of the profits that the doctors and researchers earn from the patients cells. However, if law requires doctors and researchers to have the patients consent in order to use or sell the patients genes, then that patient would be inclined to receive a share of the credit and money received for their cells.

While the research and experimentation of the human genome is a very important factor in the advancement of the medical field, "the power to reshape the human clay has no clear limits" (Wade 7). As of today, there is no Constitutional law that defines the boundaries for human genome research. As a result, "…it [human genome research] will not necessarily stop at its implied goal, the attainment of perfect health…" (Wade 7). However, one would automatically assume that there would already be Constitutional and governmental laws protecting the rules and boundaries of genome patenting, but there are none. For example, there has never been a Supreme Court ruling on patenting anything larger than a microorganism. Due to this, the playing field for human genome patenting is wide open.

The government needs to take an active role in this issue concerning the fact that there are no laws or regulations for human genome patenting. By taking an active role, the government would uphold the ideals of the Constitution by protecting individual human rights. In addition, the government should enact laws that set guidelines and limits on the types of research and experimentation that may be conducted with the human genome. Examples of the types of research that would be restricted includes the mixing of human-animal genes and human cloning. With the implementation of these laws, it will be easier to monitor the mixing of human and non-human cells, which will eventually eliminate the idea of Hylton's invented life.

Genome engineering is very delicate subject given that the research performed on patented cells can and has saved a significant amount of lives. However, it should be considered morally and ethnically wrong if patents are taken advantage of or used for the wrong reasons. Such reasons include experiments in which are not beneficial to the human race or are inhumane to the humans and animals that are used in such experiments. One example of inhuman treatment towards humans involves "the sad history of the Tuskegee experiments, in which black men with syphilis were left untreated so the course of the disease could be studied…" (Zilinskas X). Unlike the conductors of this experiment, Dr. James Watson, co discoverer of the structure of DNA and winner of the Nobel Prize in 1962 agrees that humane treatment is a very important part in gene patenting. Watson states, "Research with human beings, whether genetic or not, must always be done in accordance with humane and accepted principles of informed consent and with the subject's well-being in mind" (Zilinskas 6).

Wil S. Hylton writes about research companies who are patenting animal parts in order to mix with human genes. "Nextran is mixing human DNA with that of pigs, hoping to mutate pig livers into something a person could use" (Hylton 120). The mixing of human and animal cells should be considered morally and ethnically wrong. If the mixing of human and animal cells were to continue, the human race would eventually evolve into a type of part human/part animal species. Hylton also stated, "What happens if kids grow up in a world where the government says life is an invention?" (120). Hylton is referring to the Nextran experiment in which the DNA of pigs was used to invent something that is useful to the human species. Hylton is suggesting that if this type of human-animal mutation were to continue, human life would be an invention. Hylton is advancing an extremely ethical argument for the fact that he is arguing for the rights and humane treatment of humans and animals. It is obvious that Hylton can see the dangers involved with of human-animal mutation, as mistreatment of animals and invading the personal rights of humans.

Scientific genome patents have aided in many medical advancements throughout the past. In addition, the continuation of scientific patents promises many medical opportunities for the future. However, in order to ensure that human genome patenting will continue in a positive way, the process of patenting human cells can and should be monitored in several ways. These ways include the implication of Constitutional laws and governmental regulations on the different types of research that may be conducted with the human genome. In addition, the government needs to enact a law requiring that doctors and researchers must both have written consent from all patients in which a cell, organ, gene or etc. is taken and used for genetic research, as well as all scientific experiments. By doing this, the rights of individuals with moral and ethical beliefs against human genome experimentation will not be violated in any way. In addition, patients will be made aware of the fact that a part of their body is being kept alive and perhaps duplicated somewhere inside of a research laboratory. By enforcing laws and boundaries concerning human genome patenting and research, the continuance of mixing animal cells with human cells will be eliminated and the research will focus on issues concerning human health.

In conclusion, by placing regulations and governmental laws on human genome research and patents, the research that is conducted will be more inclined to focus on the medical related issues, such as finding cures for life threatening diseases and putting a close on the cause of infinite human health misery.

Works Cited

Hylton, Wil S. "From Who Owns This Body." Speculations: An Anthology for Reading, Writing, and Research. Eds. Jason Landrum, Matthew Wynn Sivils and Constance Squires. Kendall/Hunt, 2003. 97-100.

Wade, Nicholas. Life Script. Simon and Schuster, N.Y., 2001. Zilinskas, Raymond A. and Peter J. Balint. The Human Genome Project and Minority Communities: Ethical, Social, and Political Dilemmas. Praeger Westport, CT., 2001.

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