Written By: Kira Gill
I. Introduction
Beginning in the 1990s, the Information Age expanded upon the available molecular tools used for genetic research. Accompanying this expansion of tools was a revolution and rise of systems biology. The development of genetic engineering allowed manipulation, creation, and reparation of genetic material and cellular behavior. [1] On October 1, 1990, a group of researchers started the Human Genome Project, an effort to sequence and map all of the human genome. [2] This project was completed in April 2003, taking almost 13 years which led to a complete genetic blueprint for building a human being. [3] Who knew that just three years later, 23andMe would come about, allowing for at-home genetic testing?
II. 23andMe
23andMe is a company founded in Silicon Valley which aims to use genetic testing to boost personalized healthcare and allow individuals to learn more about their heritage. [4] 23andMe charges $99 to customers to take a saliva test at home and receive information about the individual’s ancestry. [5] For $199, customers will not only receive ancestry traits, but also information of one’s health predispositions. [6] After 23andMe receives your sample, it takes just 2-3 weeks for the results to come back, compared to the 13 years it took for the Human Genome Project. [7] From human to human, the genes are about 99.5% the same; however, there are variants in the genome which include different genes passed down from parent to child. [8] 23andMe identifies the variants in the sample and analyzes them to find unique traits within the person. [9] Naturally, a plethora of legal issues have stemmed from this new technology.
III. Privacy Issues
There has been a long list of privacy issues which have occurred due to the highly accessible genetic information offered by 23andMe. A few cases in particular pose more serious issues including sperm donors who were typically offered the option to remain anonymous. [10] Using 23andMe’s services, offspring of sperm donors have been able to track those who had wished to remain anonymous. [11] One woman violated her contract by trying to find her sperm donor through 23andMe. [12] She was successful, but the sperm bank ordered a cease-and-desist against her and revoked the use of the other gametes she had purchased from the same donor. [13]
Another issue that remains is the use of the DNA collected from at-home tests by police to match DNA samples in current cases. [14] Although these test results are extremely beneficial to the police for solving open cases within their database, for example, the Golden State killer, the use raises concerning issues. [15] A class action lawsuit was also filed against 23andMe in regard to the data being stored in a large database and its use by third parties. [16] Since the technology is so new and the development occurred so rapidly, there is not much legal precedent regarding genetics and privacy.
IV. Genetic Information Nondiscrimination Act of 2008
Currently, there is only one prominent law that regulates genetic privacy, the Genetic Information Nondiscrimination Act of 2008 (GINA). [17] GINA is a federal law which passed due to increasing concerns about the accessibility of genetic information. [18] GINA prohibits health insurance companies from requesting, requiring, or using genetic information to make decisions about an individual’s eligibility for health insurance. [19] Also, GINA prohibits employers from discriminating against their employees based upon their genetic information. [20] In essence, GINA only offers minimal protection as it applies only to health insurance and employment issues.
V. Conclusion
Overall the accessibility and publicity of private genetic information brings up a series of legal issues. Per its advertisements, 23andMe has taken action by becoming FDA approved. [21] It also addressed privacy concerns by stating the genetic information is not given to other databases without explicit consent from consumers and cannot be taken by law enforcement unless demanded by a subpoena or court order. [22] The legislature has started intervening but has been limited to GINA thus far. As issues with genetic privacy continue, the legislature will have to adapt and balance the public interest of privacy, as well as the benefits that this data produces, such as steps towards personalized healthcare and cures to genetically predisposed diseases.
[1] D. Ewen Cameron, Caleb J. Bashor & James J. Collons, A brief history of synthetic biology, 12 Nature Rev.: Microbiology. 381, 381-90 (2014).
[2] The Human Genome Project, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, https://www.genome.gov/human-genome-project [https://perma.cc/XQ5T-P5TQ].
[3] Id.
[4] 23andMe, https://www.23andme.com/howitworks/ [https://perma.cc/ZZ9G-FXKQ].
[5] Id.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Meghana Keshavan, ‘There’s no such things an anonymity’: With consumer DNA tests, sperm banks reconsider long-held promises to donors, Stat. (Sept. 11, 2019), https://www.statnews.com/2019/09/11/consumer-dna-tests-sperm-donor-anonymity/ [https://perma.cc/R3DT-YZAF].
[11] Id.
[12] Id.
[13] Id.
[14] Christi J. Guerrini, Jill O. Robinson, Devan Petersen & Amy L. McGuire, Should police have access to genetic genealogy databases? Capturing the Golden State Killer and other criminals using a controversial new forensic technique, 16 PLOS Biology1, 1-9, Oct. 2, 2018.
[15] Id.
[16] CBS News/AP, Class-action lawsuit filed against 23andMe over misleading marketing, CBS NEWS (Dec. 4, 2013, 12:32 PM), https://www.cbsnews.com/news/class-action-lawsuit-23andme/ [https://perma.cc/CZM5-RMRD].
[17] Genetic Discrimination, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, https://www.genome.gov/about-genomics/policy-issues/Genetic-Discrimination [https://perma.cc/U55N-FPPV].
[18] Id.
[19] Id.
[20] Id.
[21] 23andMe, https://www.23andme.com/howitworks/ [https://perma.cc/ZZ9G-FXKQ].
[22] Id.
