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Ownership of Genetic Information and Patenting

The term "Genetic information" refers to an individual's unique genetic code present in their DNA. This information is the determining factor for a person's inherited characteristics, for example, physical appearance, inherited diseases (diabetes, cancer, etc), and response to medication.

The ownership of one's DNA and genetic information is a topic of legality, practicality, and ethics that has long been debated throughout the history of the field of genomics. Many corporations have attempted to claim ownership of unmodified genetic data present in all humans, though these attempts were met with legislation and protest preventing patents from proceeding.

With the advent of the Human Genome Project, and thus the public release of genome sequence information, concerns from both the public and the government in regard to who owns this data have arisen.

Legal and Ethical Concerns of DNA Ownership

A graph showing the number of DNA Profiles contained in the National DNA Data Bank (NDDB) throughout the years.

The ownership of DNA is a legally gray area that is still developing throughout our time. According to Rivard (2022), in most nations, DNA is the belonging of the individual it is within. This however changes when said DNA leaves the body, for instance, spit, hairs, and other DNA-containing materials are no longer considered to be your possession after they leave your body (p.3). For this reason, governments around the world have been able to create a library of DNA profiles to better assist in cases of crime, for example, Canada's National DNA Data Bank, containing a collection of over half a million DNA profiles, was created in 2000, following years of legislative process proving that the DNA bank would be beneficial to both the government and the public in increasing safety through crime prevention.

DNA Identification Act

DNA is a very stable molecule that is found in most human cells. Because each person's DNA sequence is entirely unique, DNA samples have become a significant type of evidence at a crime scene. Following the beginning of the Human Genome Project, its work received widespread attention from the public as a means to track criminals through DNA fingerprint. The Government of Canada devised a new piece of legislation to permit law enforcement and RCMP to use the National DNA Data Bank to convict criminals through DNA and genetic material found at a crime scene. The DNA Identification Act of 1998 states that The National DNA Data Bank can be used as a crime scene index, a convicted offenders index, a victims index, and a missing persons index. The benefits of such an act are that criminals could now be tracked through their DNA, missing people could be linked to known DNA relatives, and paternity cases could be easily solved. While many clear benefits exist, some concerns also arise with this idea. Law enforcement and others in power with access to the National DNA Data Bank could misuse genetic data, or mishandle it, contaminating the DNA and potentially convicting the individuals of a crime they had not committed. Another concern brought into question comes from Canada's Indigenous population. According to Kolopenuk (2017), many people from this community have shown dismay at the idea of the RCMP, a group with a history of systemic racism towards Indigenous people, controlling and having direct access to their DNA profiles, out of fear of discrimination. Many believe that the communities themselves should be the ones to collect and store their DNA for use in investigating reports of missing persons, however, their pleas have largely been ignored by the federal government (p.11).

Genetic Non-Discrimination Act

In Canada, the Genetic Non-Discrimination Act of 2016 prevents the use of genetic information to discriminate against an individual. An employer of a job, for example, is not allowed to require an individual to undergo a genetic test if it is to provide goods to that individual, enter a contract with that individual, or grant special terms or conditions to the person being tested. It is also prohibited for an employer to require an individual to disclose the results of a genetic test unless the employer has specific written consent. The only groups of people immune to the Genetic Non-Discrimination Act are healthcare practitioners (eg. Physicians, pharmacists), and a person conducting medical, pharmaceutical or scientific research on someone partaking in said research. Any individual who breaches this act is subject to up to $1,000,000 in fines, imprisonment for a term of up to 5 years, or both.

Legislation differences between countries

According to Harrap (2016), Canada was one of the last major western countries to implement legislation on genetic discrimination being put in place during late 2016. France however was one of the first to implement a non-discrimination act, being put in place in 2002, and is the most strict of any country that uses a similar law, preventing all forms of genetic discrimination with no exceptions. The United Kingdom, on the other hand, put the act in place in 2010 and is the most lenient on restrictions. The United Kingdom allows employers to request test results if they deem the employee's ability to work is at risk, and insurance companies can request results in certain situations. The most similar legislation to Canada's is the United States, preventing the use of genetic information in health insurance, but permits it for life insurance, unlike Canada. (p.6).

Association for Molecular Pathology v. Myriad Genetics, Inc.

From September 25th, 2012 to June 13th, 2013, a Supreme Court case was active in the United States of America. According to the Cornell Legal Information Institute (2013), The lawsuit challenged the validity of gene patents in the United States, targeting patents of isolated DNA sequences owned by Myriad Genetics. The Association for Molecular Pathology argued that Myriad's patents were invalid as they isolated DNA that exists abundantly in nature, and thus cannot be claimed by an organization as their property. At the time of the ruling, the Supreme Court decided that isolated DNA that does not exist alone in nature could not be patented, and thus Myriad's claims to isolated genes were deemed invalid. From the date of the end of the trial onward, the United States no longer allowed the patenting of genes due to being a product of nature and not human manipulation; however, modified genes are still patentable (pp. 1-6). In Canada however, the current practice for the Canadian Intellectual Property Office is to permit patents for cases of isolated genomic DNA (Chromosomal DNA), and complementary DNA (Artificially produced and non-naturally occurring). This means that in Canada, most all genes can be patented so long as they also meet other standards for patents.

Privacy in DNA Collection Services

23andMe logo

In the last 20 years, services like AncestryDNA and 23andMe that revolve around sending a sample of your DNA in saliva to a company for processing have seen widespread popularity. These companies will tell you what your DNA says about you, for example, where your bloodline comes from, what diseases you are likely to have, and what medication you may have adverse reactions to. A common concern amongst those who question these services is what protection is there for your DNA, and what these companies do with your DNA after obtaining it.

Science of DNA Testing

Microarray technology showing how gene analysis is performed

According to AncestryDNA, The general process for a DNA processing company is to take a saliva sample and survey the user's genome from this sample at 700,000+ locations using microarray autosomal DNA testing. Autosomal DNA tests are a method for looking at the code that is present within every human's cells. This data from the aforementioned locations are then related to the data of others to form population data about the user and others who purchase the product (p.2). This means that the process behind AncestryDNA as well as 23andMe relies on other users' saliva samples and thus DNA. Once the user's DNA is received by these companies, it is stored for use in future testing. In addition, AncestryDNA's Informed Consent (2018), states that "all information and Biological Samples that you share with us...can be collected and used for research consistent with our projects." (p.3).

Security for DNA Samples

According to AncestryDNA (2018), despite the informed consent paper stating that the user's DNA will be used in future testing, rigorous security measures are in place to ensure that the DNA of an individual using the service. The company claims that they use "multiple layers of physical, technical, and administrative procedures to protect Data from unauthorized access while conducting business." (p.7) All data stored through these DNA collection services are intended to be used to fund future endeavours in the field of genomics, with the goal of bettering the future of health care.

Disputes of DNA Ownership

UCLA Reagan Medical Center

According to Lewis (2013), an individual, John Moore, was treated for hairy cell leukemia by a cancer researcher at the UCLA medical center in 1990, and in the process had his spleen removed. After his treatment, Moore discovered that the cancer cells extracted from his treatment, as well as his spleen itself, were used by the University of California to develop a cell line, which was then commercialized to turn a profit. Upon discovering this information, John Moore took his case to the supreme court, arguing that he was entitled to shares. While Moore argued that the cancer cells were his, and thus deserved a division of the profits made from said cells, the court determined that Moores's discarded blood and tissue samples are no longer his property, and thus Moore was not entitled to any share from the profits made in the commercialization of the cell line derived from his body. (p.5)

Impact on Society

As a result of Moore's supreme court case, discarded hospital patient cells and tissues could now be used for research and potential financial gain through the development of research with the use of the discarded cells, without being required to divide shares to the patient. This can be a positive impact on society as it allows for more funding in health care at no significant expense to the patient, though it can also be seen as a negative due to the apparent exploitation of patients who might require the health care performed upon them.