The Human Genome and Patient Privacy: A Proposal to Expand Protections for Patients and Family Members
Policy Proposal: Genetic Privacy Enhancement Act of 2010
Part One: Personal Autonomy
In order to address the unique privacy considerations of genetic information with regard to personal autonomy, an informed consent model should be established for physicians who wish to give genetic testing results to their patients. A medical professional shall not collect genetic information from a patient for testing purposes without that patient’s consent, and must honor a patient’s desire to receive or not receive the results of such tests. The patient must be informed of the predictive nature of genetic testing, and the limitations on accuracy of such predictions. Additionally, if a patient wishes only to obtain that genetic information which directly pertains to their reason for seeing a medical professional, those wishes must be respected to the greatest extent possible.
A requirement of informed consent will raise the question of whether a patient’s consent is sufficient for release of genetic information, due to its predictive and hereditary nature. For example, an individual’s genetic profile may reveal information about their parents’ or children’s present, past, or future health status; would a physician need to obtain those individuals’ consent as well? I would argue that the obtainment of one’s own genetic information bears significant similarities to disclosure of someone else’s personal information in the course of telling one’s own story. For example, see Bonome v. Kaysen (Solove, 2007, 3), in which the court held that Kaysen’s First Amendment right to share her story (in an autobiography) outweighed Bonome’s privacy interests. The right of an individual to obtain their own genetic information cannot be compromised for the sake of other individuals who it may reveal information about.
Patients who do not wish to know what their genetic information reveals about themselves and their families should still have the ability to contribute to clinical trials and other forms of genetic research. Therefore, the law should specify that researchers must allow individuals to submit samples for genetic testing on an anonymous basis, and that those materials shall still be subject to the same privacy protections as other medical information under HIPAA.
Part Two: Property Rights
The question of property rights should be resolved by Congress through a two-prong test: whether genes and genetic information are eligible for property rights conferred to third parties (such as researchers), and whether individuals have a legitimate property interest in their own genes.
To determine whether third parties should be able to assert property rights over genes and genetic information, I turn to patent law and the Constitution, which disallow the application of patents (and property rights) to products of nature and natural laws. U.S. policy on patent law finds much of its basis in the 1887 case Hartranft v. Wiegmann, 121 US 609, which held that patents may only be issued for “a non-naturally occurring manufacture or composition of matter – a product of human ingenuity ‘having a distinctive name, character, [and] use.’ (National Women’s Health Network, 2009, 5).” Article I, Section 8 of the U.S. Constitution gives Congress the power to “promote the Progress of Science…by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” Genes are naturally occurring substances which exist in all human beings, and are not a product of human ingenuity, the creation of an inventor, or distinctive in character (due to their ubiquity). Therefore, the government has no basis to grant researchers and scientists a property interest in genes and related genetic information. This should be clearly established in legislation.
Congress should, however, maintain the right of companies to develop, patent, and profit off of their respective methods of testing and examination, invalidating only their ability to assert property and patent rights over sequences of the human genome. Existing gene patents shall be invalidated, with the profits companies have already made off of these patents determined to be more than fair compensation for the companies’ expenses in applying for and defending their patents.
The question of property rights for individuals over their genetic information is less clear. On one hand, the government faces the same constitutional and legal obstacles as it does with corporations: unlike the pre-embryo material in Davis, individuals did nothing to find or create the genetic material existing in their bodies. On the other, individual persons have a level of integrity and security of their bodies. Like the courts, I am hesitant to establish property rights over the materials of the human body – to do so would create a precedent for a market for blood, bone marrow and organs, which our society has rejected. Rather, I recommend turning again to an informed consent model: researchers who wish to use an individual’s genetic material to create new tests, including those from which they may profit, must explain this to the individual and obtain consent to use their genetic material for such purposes. If an individual does not choose to consent to such usage, corporations have the option of entering into a contract with an individual for such usage (as established in York). However, this should be established in the law as consent (and compensation, as appropriate) for the violation of bodily integrity, rather than the sale of property. This compromise will appropriately balance individuals’ rights not to be used for the profit of another without consent and corporations’ right to rely on willing individuals to be part of their research and development.
Penalties and Remedies for Violation Of Personal Autonomy
Congress should establish legislatively that the breach of confidentiality tort (through which individuals can pursue redress for violations of HIPAA) shall also apply to the provisions of the Genetic Privacy Enhancement Act which pertain to personal autonomy. Essentially, this would merely expand the prohibition against disclosure of medical information to include disclosure of one’s genetic information to oneself without consent. Congress could also consider strict liability for psychological and emotional harm, though this may be unlikely to pass.
Remedying property rights in the law requires two parts: changes in patent law, and establishment of damages for misuse of genetic information. For the first, Congress must simply establish that naturally occurring genetic sequences are considered products of nature rather than products of scientific design. With a retroactivity clause, this measure will eliminate the obstacle which gene patents pose to genetic research, and establish an appropriate lack of property rights over genetic code and data. The second, damages for misuse of genetic information, would also be tied to the restrictions in HIPAA, mirroring civil and criminal penalties for inappropriate use of medical information. This will adequately protect individual rights without adding an extra layer of legislation for health corporations to wrestle with.
Congress should also grant civil immunity to corporations who currently hold gene patents, to prevent lawsuits by patients who have been forced to pay for expensive genetic tests monopolized by patent holders. While the exorbitant fees charged for testing by gene patent holders are highly offensive to normal sensibilities, the corporations are operating within the law as it stands and should not face financial penalties for taking legal action in this case.
It goes without saying that much of the healthcare industry will be unhappy with such changes in legislation. However, there are more pressing interests at hand here: the right of individuals to privacy and personal autonomy, a state interest in promoting scientific development (which is currently stifled due to the practice of gene patenting), and the need for clarity over genetic and biological property rights. Indeed, the latter will be quite beneficial to researchers and health corporations, who will no longer need to fear lawsuits based on property-rights arguments. Passing this Genetic Privacy Enhancement Act, or one like it, is truly in the best interests of the American people, and would have a positive impact on scientific research and individual rights for generations to come.
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