Legal Issues
Based on genetic information:
- employers may use it as a reason not to hire an individual (e.g. too many health problems) (24)
- employers may use it to discriminate against workers (24)
- economic incentive to discriminate based on genetic information may increase (24)
- discrimination against a healthy individual because of the possibility of them having a genetic condition (24)
- insurers may use it to determine the cost of coverage, enrollment, and premiums (24)
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There are two main issues with patenting genes — “what is patented by a human gene patent” and “what [can] a patent [enable] one legally to do”. Because patents on human genes legally cannot apply to the genes that occur naturally in our bodies, many believe that human gene patents are of no threat to the “bodily integrity” of the individual. Having said this, human genes can only be patented if they can be distinguished from the genes that naturally occur in human bodies. “To be patentable in the U.S. an object or process must count as an invention, not a discovery, in addition to meeting further legal tests such as those for novelty, non-obviousness and usefulness. It is, therefore, a legal fact about patents that they do not apply to objects that occur naturally, unless these have been sufficiently altered by human effort as to count as ‘made by man’ for legal purposes.” Therefore, human genes can only be legally patented if they have been altered significantly enough to be legally distinguishable form naturally occurring genes. (50)
Environmental Regulation
"As awareness of the critical role of epigenetics in both normal and abnormal cell development has grown, so too has the realization of the potential importance of the disruption of epigenetic mechanisms as a toxicity mechanism and an environmental regulatory priority." (45)
Food and Drug Regulation
"Epigenetic knowledge has many potential applications in health care, including both therapeutic and diagnostic uses. The Food and Drug Administration (FDA) regulates several categories of products including drugs, medical devices, biologics, foods, and cosmetics, for the most part under authority provided by the Federal Food, Drug and Cosmetic Act (FFDCA)." (45)
