Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.

Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.

A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).

Given the federal Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits acquisition and use of genetic information in health insurance contexts, it is likely the bill in its current form would be preempted except to other forms of insurance (e.g. disability and life insurance). In other words, because GINA sets a floor of protections for individuals nationwide, if the Alabama proposed statute is an attempt to permit health insurers to acquire genetic information inconsistent with GINA’s prohibition on such activity, the direct vertical conflict will be resolved in favor of GINA and against the Alabama proposed statute.

There are currently six exceptions to the informed consent requirements contained in the bill, though these exceptions are phrased with potentially controversial or confusing language. The bill states (Page 6, Lines 1-15) that the informed consent requirements

…shall not apply to genetic information obtained:

(1) By a state, county, municipal, or federal law enforcement agency for the purposes of establishing the identity of a person in the course of a criminal investigation or prosecution.

(2) To determine paternity.

(3) To determine the identity of deceased individuals.

(4) For anonymous research where the identity of the subject will not be released.

(5) Pursuant to newborn screening requirements established by state or federal law.

(6) As authorized by federal law for the identification of persons.

As written, it is unclear whether there are any actor constraints on exceptions (2) or (3) (for example, there is no limiting language such as that found in exception (1)). Additionally, the language of exception (4) may create vertical conflicts of law with existing federal human subjects research protections (e.g. such as those imposed by the Department of Health and Human Services, such as regulations pursuant to 45 CFR 46 also known as the “Common Rule”) that govern the acts of scientific investigators at the major research universities and institutions in the state of Alabama. And, of course, the ability to conduct anonymous research using an individual’s genetic information remains open for debate.

Additionally, in its current state, the bill might implicate the personal genomics industry, as it requires verbal interactions prior to DNA collection and, though the language of the bill is unclear, possibly signatures on written informed consent documents prior to DNA collection. (See Page 6, Line 16 to Page 7, Line 21). While it’s possible that some personal genomics companies currently satisfy one or both of these requirements with respect to their customers, it is safe to say that neither practice is currently widespread in an industry that is conducted largely online and through the mail.

Alabama’s proposed bill goes on to stipulate specific prerequisites for valid verbal and written informed consent (Page 8, Lines 4-26): among the disclosures required is an identification of the facilities that will collect and perform the analysis and “a description of all authorized uses of the DNA sample” (emphasis added). This suggests blanket consents, particularly consents intended to cover as-yet-unknown future uses, may not be sufficient in Alabama if this bill is signed into law.

Beyond Informed Consent. The proposed Alabama bill also takes direct aim at surreptitious testing. Section 3 would make it unlawful for any individual to “…collect or cause to be collected an individually identifiable DNA sample for genetic analysis without the written authorization of the sample source…” (Page 5, Lines 23-26).

Ultimately, Alabama’s proposed legislation would make violations of the law Class A Misdemeanors (Page 11, Lines 9-10) and would impose financial penalties to those found in violation. Noncompliance with the restrictions imposed on retention of genetic information would result in a minimum $1000/ maximum $10,000 fine (Page 10, Lines 13-17); noncompliance with restrictions on collection or disclosure of genetic information would result in a minimum $5000/maximum $50,000 fine (Page 10, Lines 18-21); and noncompliance with the disclosure restrictions also would subject the violator to liability for all actual damages proximately related to the disclosure (Page 10, Lines 22-26).

Finally – and significantly – the bill as drafted would make all DNA samples and any genetic information obtained through the analysis thereof “the exclusive property of the person sampled or analyzed.” (Page 11, Lines11-13).

Looking Past the State Houses. Alabama’s proposal resembles in many ways those that appeared in early 2011, particularly in Massachusetts and Vermont, but have not yet been codified into law. Consistent themes include a focus on informed consent and privacy, the creation of (typically ill-defined) property rights in DNA and an attempt to provide protection for individuals in areas where federal law is arguably not adequate (e.g., genetic nondiscrimination) or non-existent (e.g., surreptitious testing).

As we’ve written before (see, e.g., here and here), however, current legal and regulatory oversight in the field of personalized medicine – particularly when it comes to the access and use of personal genomic information – is a messy, patchwork affair. The industry would benefit from clearer guidance that transcends state lines. Despite a flurry of federal activity and publicly accessible discussions emanating from Washington D.C. in the first half of 2010, meaningful guidance for the future of personalized medicine and genomics has yet to take shape. A variety of factors – including political elections and budget shortfalls whose implications reach far beyond personal genomics – may explain why serious (public) talks have faded to near silence.

There is clear value in permitting the personal genomics industry to have period with which to “work out the kinks” and to establish industry customs (under the careful eyes of so many interested regulators-in-waiting). However, a prolonged waiting period – as well as the real possibility that states like Alabama will step into the void with new laws that may be inconsistent with each other and with federal law, thereby ultimately increasing legal and regulatory uncertainty – may carry with it significant costs that could hamper personal genomics’ growth and innovation.

One solution would be for key governmental regulatory and funding bodies, particularly the NIH and the FDA, to play a much more active role in setting personal genomics policy. While these administrative agencies may lack the present authority to implement a new and coherent system of oversight without Congressional action (pdf), they can nonetheless play a critical role in shaping the debate and pressing national and international decision-makers, including Congress, to develop clear, forward-looking policies and laws that will allow the field of personal genomics to continue to advance. Recently, however, leaders in Washington seem content to rely on bioethics commissions and similar groups lacking any regulatory or financial authority to drive the debate, a strategy which – particularly after so many prior recommendations have been left to wilt on the vine – seems highly unlikely to serve as the catalyst for meaningful change.

The need for leadership extends beyond agencies like the FDA and NIH to the world stage, where international policy leadership is an increasingly urgent need, particularly in light of far-reaching privacy regulations being considered by Europe that could reshape what personal genomics means for Europeans as well as American companies seeking to do business in Europe. Personal genomics is and should be a global undertaking and, in that context, consistent federal-level oversight that conflicts with what is happening in Europe and elsewhere is ultimately little better than the ambiguous and inconsistent state-level laws under consideration in Alabama and elsewhere. The need to improve the system of oversight for personal genomics is clear, as is the need for international leadership in doing so. Unfortunately, with the continued absence of such leadership, personal genomics’ companies and consumers may find that proposals like Alabama’s represent the only option on offer.