By Turna Ray
The state legislatures in California and Vermont have followed Massachusetts in introducing their own genetic information protection bills.
In the state legislature in Vermont, Progressive house member Pearson Christopher and Democratic member Suzi Wizowaty recently introduced H.368, an "Act Relating to the Privacy of Genetic Information," which extends property rights to people over their own DNA data.
"The general assembly recognizes that genetic information is a unique product of an individual’s body, the unauthorized use of which interferes with both privacy rights and property interests of that individual," the Vermont bill states. "It is the intent of the general assembly to declare genetic information the exclusive property of the individual from whom the information is obtained."
The Vermont bill also requires that any entity that seeks to use a person's genetic information for any purpose must get written consent from that person, and amends existing discrimination laws in the state to explicitly state that "genetic information" cannot be a basis for employment or housing discrimination.
Similarly, in California, Senator Alex Padilla (D-San Fernando Valley) has introduced a bill (SB 559) that would add "genetic information" to the state's existing anti-discrimination statutes, which already prohibit discrimination based on race, religious creed, color, national origin, ancestry, physical disability, mental disability, and medical condition. Specifically, the bill would forbid employment and housing discrimination based on genetic data.
These bills come after democratic legislators in Massachusetts earlier this year introduced the “Genetic Bill of Rights," which seeks to protect state residents from genetic discrimination in life insurance, auto insurance, and in establishing credit. This bill would also establish a person's genetic data as their property (PGx Reporter 02/16/11).
Although these three bills aren't exactly similar in scope, they reflect a growing sentiment at the state level that existing protections under the federal Genetic Information Non-discrimination Act don't go far enough when it comes to protecting individuals' DNA data from misuse.
The state-level bills "are not carbon copies of one another, but they do reflect a belief that certain values are universal. Chief among these is the idea that individuals need to be able to exert control and make decisions about their own genetic information, genetic material, and genetic privacy.” Steve May, executive director of the Forum on Genetic Equity, said in a statement. “There is no disputing that the introduction of these three bills represents the forward edge of a growing political movement.” The Forum on Genetic Equity sponsored the Genetic Bill of Rights in Massachusetts.
According to Jeremy Gruber, president of the Council for Responsible Genetics, although the bills have their differences, "all three bills reflect their sponsors’ belief that GINA should be the beginning, not the end of creating comprehensive genetic privacy protections for Americans."
The bill put forth in Vermont, like the one in Massachusetts, would give individuals more say over how their genetic information is used and who can access it. "Genetic material shall be considered real property subject to one’s individual control and dominion in accordance with generally held precepts of property law in Vermont," the legislation states.
Since DNA data would be considered a type of personal property in Vermont under this legislation, it would allow a person to store and manage his or her own genetic information and would permit individuals to provide instructions in a will to a surviving relative as to how to handle this data after death. Additionally, healthcare providers, researchers, or for-profit companies that wish to use a person's genetic information must inform that person that their genetic data is a commodity and "of some material value."
"If an entity collects genetic material or genetic information with the possible future intent of resale, licensure, or transfer of this material for material gain, the individual who provided the genetic material or information shall be made aware of such possibility and compensated at a fair market value," the Vermont bill states. There is similar language in the Massachusetts bill.
Also, any report or record of DNA analysis produced using a biological sample from an individual would be the "exclusive property" of that person under this bill. That record or report would not considered part of the public record unless there was a judicial order or if the data was used as part of confidential healthcare research.
Under the terms of the proposed legislation, if doctors or researchers use a person's biological sample to conduct genomic analysis, they would be required to provide options to the individual about what should be done with excess biological material. The bill instructs handlers of this biological material to follow the Centers for Medicare & Medicaid Services' rules under the Clinical Laboratory Improvement Amendments for disposing of such products, or, alternatively, to follow guidelines under "a similar subsequent regulation."
There is also a portion in the legislation stating that in order for a laboratory to perform a genetic test, that lab must receive signed authorization from the patient's doctor that the patient has consented to this testing. Such authorization is not required when the testing is part of a clinical trial, because then specific patient consent rules and international review board requirements must be followed.
[ pagebreak ]
Healthcare providers and industry players would also be restricted under this legislation to use any information garnered as a "result of genetic profiling" for marketing purposes.
"A record of a regulated transaction containing genetic information may be transferred to another entity, including to another branch or subsidiary of the same firm, only if it carries satisfactory assurance that the recipient will safeguard the records from being disclosed or used in Vermont for marketing purposes," according to H.368. Marketing and sale of people's genetic data would be allowed, however, if the information is aggregated, de-identified, and cannot be used to identify the person.
Finally, the Vermont bill restricts healthcare providers from denying services to an individual solely based on genetic data that suggests he or she might be predisposed to a disease.
The Forum on Genetic Equity's May noted that the Massachusetts bill goes a bit further than the one in Vermont by attempting to restrict discrimination in the state Medicaid program, MassHealth. The Vermont bill doesn't explicitly mention the Vermont Health Access Program, May noted, "largely because Vermont's single-payer proposal hasn't been completely fleshed out yet." Some Vermont lawmakers are trying to get a waiver to opt out of portions of the federal healthcare reform law, and implement a state-based single-payer system.
If the Vermont bill passes, those who violate an individual's genetic privacy would pay up to $5,000 in liabilities. If the violation results in monetary gain, the violator may have to pay as much as $100,000 to the person whose DNA data was misused.
For the "misappropriation of genetic information," violators can face between a year and more than five years in prison, and be fined between $2,000 and $10,000. "If the maximum penalty for the underlying crime is five years or more, the penalty for the underlying crime shall apply; however, the court shall consider the defendant’s misappropriation of the genetic information or genetic material as a factor in sentencing."
In the Massachusetts bill, those who misuse another person's genetic data could face maximum fines of $5,000 and imprisonment for two and a half years.
May noted that the legislative process is "evolutionary" and as these bills come before the state legislatures some of the proposed provisions may be cut and new ones may be added. "What is most critical is the ideological construct that patient must be empowered to act on their own in furtherance of their own interests while maintaining one's own genetic material, information, and privacy," he said.
The bill in California is not as ambitious as those in Massachusetts and Vermont since it only seeks to add "genetic information" to the existing legal language prohibiting discrimination in the workplace and housing. Unlike the other two bills, the Massachusetts legislation makes no move to make genetic data a person's property.
"It is the intent of the legislature that the definitions of physical disability and mental disability be construed so that applicants and employees are protected from discrimination due to an actual or perceived physical or mental impairment that is disabling, potentially disabling, or perceived as disabling or potentially disabling," SB 559 states.
The bill's sponsor, Padilla, two years ago advanced another key bill, SB 482, that was supported by California-based direct-to-consumer personal genomics firm 23andMe and highly controversial in the life sciences field. The bill sought to amend the California Business and Professions Code to exempt so-called "post-CLIA bioinformatics services" from certain requirements that clinical laboratory services providers have to meet under the Clinical Laboratory Improvement Amendment (PGx Reporter 06/24/09). The bill was not voted on.
Although SB 559 would make it illegal in California for employers to discriminate based on a person's genetic information, employers would not be prohibited from refusing to hire someone with a physical or mental disability who could not perform the essential tasks of the job. Additionally, employers would be still be able to discharge a person who, due to a medical condition, could not perform the job with "reasonable accommodations."
Another aspect of the bill is that it would make it illegal for any entity to use genetic data to discriminate against a person with regard to housing accommodations. This restriction under the bill would extend to banks, mortgage companies, and other institutions that provide financial aid to purchase housing.
"Each of these individual measures is evolving naturally and is a response to the individual circumstances in each state," May said.
This effort to expand anti-discrimination laws to cover genetic information explicitly in California has roots in the state's troubling history of sterilizing people thought to have genetic abnormalities.
According to the text of SB 559, in the early part of the 20th Century, as many as 30 US states, including California, enacted laws allowing the sterilization of those "having presumed genetic 'defects' such as mental retardation, mental disease, epilepsy, blindness, and hearing loss." These laws resulted in the sterilization of 64,000 people, most of whom were poor, the bill notes, admitting that nearly a third of these sterilizations were performed on California residents.
Most of these state laws "have since been repealed, and many have been modified to include essential constitutional requirements of due process and equal protection," the California legislation adds. "However, the current explosion in the science of genetics, and the history of sterilization laws by states based on early genetic science, compels legislative action in this area."
Ultimately, the bill specifically notes that although GINA provides baseline protections against genetic discrimination at the federal level, "its range of protections is incomplete for Californians."
According to Gruber of the Council for Responsible Genetics, the sponsors of the California legislation are thinking about expanding the scope of its legislation. Both the Forum on Genetic Equity and the Council for Responsible Genetics are "working with them to address issues where additional genetic discrimination protections are required (such as certain forms of insurance like workers' compensation), as well as provisions strengthening protections against surreptitious collection of genetic information and possibly even addressing the ownership issue," Gruber said via e-mail.
Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.