Is the Genetic Rights Movement Picking Up Steam?

The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible Genetics has termed a “groundswell for genetic privacy building in states,” state legislators in both California and Vermont have introduced new legislation that would confer greater protection upon individuals’ genetic information.

What should we make of this three state “groundswell?” Although not identical in scope or substance to the Massachusetts Genetic Bill of Rights (“MA GBR”), both the Vermont and California proposals appear to reflect a concern (shared by the MA GBR) that, at least when it comes to the use and misuse of genetic information, the current system of federal oversight is inadequate. Then again, as the legislative findings section of the California proposal (pdf) puts it, perhaps “the current explosion in the science of genetics” simply “compels legislative action in this area.”

Today we’ll dig into Vermont’s proposed H.368: “An act relating to privacy of genetic information” (pdf) (the “Vermont Act”). Next week, we’ll tackle California.

The Value of a Genome. In many respects the Vermont Act closely resembles the MA GBR we covered in detail last month and shares its emphasis on genetic information as a personal property right.

Nowhere is this clearer than where, matching the MA GBR word-for-word, the Vermont Act proposes the insertion of a new provision into Vermont’s existing genetic testing statute, declaring “genetic information the exclusive property of the individual from whom the information is obtained.” 18 V.S.A §9330 The Vermont Act goes on to confer upon genetic material the status of “ real¹ property subject to one’s individual control and dominion in accordance with generally held precepts of property law in Vermont.” 18 V.S.A. §9336(a)

After codifying property rights in genetic information, the Vermont Act, just like the MA GBR, goes on to require that any individual engaged in genetic research or commerce be “made aware both orally and in writing that his or her donation is a commodity and is of some material value.” And if the transaction of genetic information occurs in a for-profit context, the individual would be entitled to “compensation at fair market value.” 18 V.S.A. §9336(c) To be sure, we’re still no closer to articulating a valuation method for genetic information than when the idea was first proposed in Massachusetts earlier this year.

Ambition vs. Reality. There are also a few areas where, in its zeal to protect individual genetic rights, the Vermont Act goes a step too far and appears to conflict with federal law, with potentially problematic (or at least confusing) results.

For example, the addition of 18 V.S.A. §9336(d) would provide that:

Any report or record produced by or stored at a hospital; dispensary; laboratory; hospital-affiliated registry; physician; commercial genetic testing company, agency, or association; or insurance institution or its representative pertaining to any genetic information is the exclusive property of the individual sampled or analyzed. Such report or record shall not be considered to be a public record, and the contents thereof shall not be divulged by any person having charge of or access to the report or record without informed written consent… (emphasis added)

While there are three minor exceptions to §9336(d), none would save the provision from a nasty conflict, at least on its face, with other federal laws, including the Health Insurance Portability and Accountability Act (HIPAA).

Under HIPAA, covered entities (including healthcare providers, such as hospitals and physicians) and their business associates are not required to obtain prior consent for certain uses and disclosures (e.g., for treatment, payment and health care operations) of protected health information, including genetic information. The prior consent requirement was removed under HIPAA in certain instances due to its unintended effect of preventing “timely, quality health care to individuals in a variety of circumstances.” The Vermont Act’s supporters should take another look to ensure that §9336(d) would not produce the same unintended effect under Vermont law.

Next is §9336(e), an even broader and more confusing provision:

Information derived from the sequence of the human genome shall be part of the public domain and shall not be considered the property of any individual. Nothing in this chapter shall be construed to grant an ownership right to any individual or entity utilizing the publicly held information from the sequence of the human genome in the furtherance of the creation of a venture or enterprise, including any genetic goods, products, or services.

At first blush, this appears to be more of a statement of policy by the Vermont Act’s sponsors than a statement of law. §9336(e) refers to “the sequence of the human genome,” not a sequence of a human’s genome, and the term “genome” does not appear in the Vermont Act (or in Chapter 217 of the V.S.A.) outside of this single proposed provision.

While efforts to place genomic information in the public domain – including the work of Genomes Unzipped, the Personal Genome Project, SNPedia and The Sage Commons, to cite several such public genomics projects in which we are actively involved – are laudable, mandatory public genomics is not exactly the provenance of the Vermont state legislature.

Or perhaps this is just Representatives Pearson and Wizowaty’s way of asserting their support for the plaintiffs in the ongoing Myriad gene patent litigation by asserting, more than a decade after the fact, that none of the Human Genome Project’s fruits shall be patentable. (Although here, too, Vermont would be treading far outside the scope of its legislative authority.) Either way, this is one provision of the Vermont Act that will need to be either clarified or axed before passage.

Consumer Protection. The Vermont Act comes back to earth, and in line with the MA GBR, in proposing the addition of 18 V.S.A. §9339 and §9340, which together restrict the use of genetic information in marketing and instruct the “consumer protection unit in the office of the attorney” to “investigate and prosecute complaints relating to genetic goods, products, and services.”

As we have argued in the past, when it comes to the burgeoning field of genetic and genomic commerce, one logical and welcome form of regulation would be increased oversight from consumer protection agencies, including both state-level enforcement, as proposed by the Vermont Act, and increased national-level oversight from agencies like the Federal Trade Commission (FTC). (While the possibility of FTC oversight for genomic commerce was back in the news last week, specifically in conjunction with the FDA’s public meeting to discuss direct-to-consumer genetic testing, there are also numerous other areas of genomic commerce that might benefit from increased oversight from consumer protection agencies.)

§9339 also explicitly prohibits “genetic profiling,” which includes any effort to link an individual’s “demographic information” to her “genetic information or genetic material for marketing purposes.” However, the provision would not prohibit marketing on the basis of genetic data if those data were aggregated, did not contain identifying information and could not be used, “directly or indirectly, to obtain identifying information.” That would seem to be a fairly broad safer harbor for would-be “genetic profilers,” but given the inherent difficulty in ensuring that seemingly de-identified genetic information, even when aggregated, won’t be re-identified, this marketing safe harbor might prove to be rather limited in practice.

GINA’s Gaps, Again. As we noted in examining the MA GBR, the Genetic Information Nondiscrimination Act of 2008 (GINA) contains several gaps in its prohibition of insurance discrimination. Notably, while prohibiting healthcare insurers and employers from discriminating on the basis of genetic information, GINA does not address the use of genetic information in long-term care, life or disability insurance.

Even prior to GINA’s passage, Vermont was one of a handful of states with relatively robust statutory protections against genetic discrimination in insurance. Under current Vermont law (18 V.S.A. §9334), no insurance policy—including long-term care, life and disability insurance policies—may be “underwritten or conditioned on the basis of” a required genetic test of an individual insured or the results of a genetic test of any member of the individual’s family. §9332, however, currently permits insurers to require genetic testing in situations where doing so would not violate §9334.

The Vermont Act would revise §9332 to prevent insurers from requiring genetic testing in any setting, regardless of whether it would violate §9334. In combination with §9332(d), the Vermont Act would prevent any insurer from soliciting genetic testing without first obtaining “prior written authorization and informed consent,” including providing a warning that the results of such test might become part of the individual’s permanent medical record or materially impair the availability of insurance benefits. The Vermont Act would not, however, deny such solicitations by insurers outright.

The Vermont Act would also prohibit places of public accommodation (9 V.S.A. §4502) and financial institutions supplying credit (8 V.S.A. §10403) from discriminating on the basis of genetic information.

What does it mean? As with the MA GBR, it is crucial to emphasize that the Vermont Act is a legislative proposal and not current state law. We do not know what level of support the Vermont Act enjoys within the state legislature but, should it pass, the implications—both good and bad—would be substantially similar to those we discussed in our review of the MA GBR.

Next week we’ll examine another legislative proposal, from California, and ask whether these recent developments represent a groundswell of support for more robust genetic privacy legislation.

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¹ The text of the Vermont Act says “real property,” although this would seem to be a clear mistake as real property or real estate refers to land and not to personal or intangible property.

Filed under: General Interest, Genomic Policymaking, Genomics & Society, GINA, Legal & Regulatory, Pending Regulation, Privacy
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