Genetic Bill of Rights Proposed in Massachusetts

On January 21, 2011, the Massachusetts Genetic Bill of Rights (MA GBR) (pdf) was introduced before the Massachusetts state legislature. At its core, the proposed legislation establishes property and privacy rights for genetic information and genetic material, while providing protections designed to shield individuals from genetic profiling and other misuses of genetic information.

Taken as a whole, the legislation, if enacted, would confer upon Massachusetts residents a significantly expanded set of genetic rights than exist under current federal law. Below we examine several of the bill’s most noteworthy proposals.

The MA GBR addresses perceived gaps and limitations in the coverage provided by major federal statutes, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Genetic Information Nondiscrimination Act of 2008 (GINA), and the Constitution of the Commonwealth of Massachusetts, by seeking to place genetic information on a par with medical records.

The MA GBR’s provisions set basic limitations on the use, including the commercial use, of personal genetic information that would go above and beyond the user agreements and privacy policies employed by some commercial services. For example, the MA GBR prohibits the use of genetic information for marketing or determining credit worthiness. With the proliferation of genetic information, particularly in consumer or commercial contexts, such basic limitations would help address concerns about the lack of mandatory restrictions regarding the sale, transfer or other use of personal genetic data.

The Personal Property Theory of Personal Genomes. But the MA GBR goes much further than mere consumer protection reforms. Section 1 of the proposed legislation explicitly declares genetic information to be “the exclusive property of the individual from whom the information is obtained.” (emphasis added)

Granting individuals express property rights in their genetic information would be significant. Not only does the MA GBR contemplate genetic information being controlled from the grave – individuals may bequeath to a surviving spouse or family member authorization to use their genetic information under the terms and conditions of their will – but the MA GBR also recognizes the inherent monetary value of genetic information. For example, the proposed bill would require that, prior to entering into a contract to share one’s personal health information, genetic material or genetic information, the individual must be notified, orally and in writing, that “their donation is a commodity and is of some material value.” (Section 1(b)) Further, if the collecting entity has a possible future intent to commercialize the genetic information, the individual donor “must be made aware and compensated at a fair market value.” (Section 1(b))

Supporting these and other MA GBR restrictions on the use of genetic information are the bill’s proposed civil and criminal penalty provisions, which are likely to generate considerable discussion as the bill works its way through the legislature. On the civil side, violations of the MA GBR are automatically violations of the state’s unfair or deceptive practices act (Chapter 93A Section 2), and violators additionally are subject to statutory damages of $5,000 ($100,000 if the MA GBR violation resulted in profit or monetary gain to the violator). The bill provides for both a private and public right of action, and it carves out only limited exceptions for violations by members of law enforcement, employees of the state DNA database, and those working under judicial order. On the criminal side, Section 16 of the MA GBR amends the Commonwealth’s Identity Theft Law (Chapter 266 Section 37E) to add genetic information to the list of “personal identifying information” protected from identity thieves. The identity theft law currently defines “personal identifying information” to include, among others, a person’s social security number, mother’s maiden name, financial account numbers and computer passwords. If the MA GBR is passed, those found guilty of identity theft stemming from the misappropriation of genetic information could face maximum fines of $5,000 and imprisonment for two-and-one-half years.

While individual citizens may have little chance of detecting or deterring larger entities from illicitly obtaining or using genetic information, the MA GBR provides at least the possibility of government action in the face of such violations. The civil and criminal penalties provided by the MA GBR, if enacted, would offer one of the strongest set of protections yet against surreptitious genetic testing.

The Next Generation of GINA? The MA GBR also seeks to expand upon the protections afforded by the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA comes in two parts and prohibits genetic discrimination by healthcare insurance providers (Title I) and employers (Title II).

Despite its broad protections, which are still being implemented, GINA has several widely recognized gaps. Most notably, Title I of GINA does not proscribe genetic discrimination in the areas of long-term care, life or disability insurance.

The MA GBR seeks to expand on Massachusetts’ already broad protections against the use of genetic information by insurers while plugging some of the gaps left by GINA. Section 2 strikes language in Massachusetts law that currently allows insurers to use genetic information submitted on an insurance application to set terms for the applicant’s disability or long term care insurance policy. (See Chapter 175, Section 108I(c)) Section 3 similarly addresses life insurance. (See Chapter 175, Section 120E) Section 4 addresses auto insurance. Taken as a whole these provisions would significantly revise current Massachusetts insurance law and create what would appear to be, at least with respect to the use of genetic information, the most insured-friendly climate in the entire country.

It should come as no surprise that Massachusetts, of all states, would have an interest in addressing the gaps in GINA’s coverage. The widely-publicized Risk Evaluation and Education for Alzheimer’s Disease (REVEAL) study, led by researchers at the Boston University School of Medicine, has for years published data suggesting that genetic information (in this case genes associated with Alzheimer’s susceptibility) can have a material effect on an individual’s decision to purchase long-term care or life insurance. Though such a genetic test is not currently common, or thought to be commonly requested or utilized by insurers in determining coverage or setting rates, Massachusetts residents and lawmakers are clearly aware of the issue and the potential consequences of GINA’s limitations.

A Bill of Rights or a Barrier to Progress? The merits of the MA GBR will be heavily debated on Beacon Hill over the course of the coming months. Turna Ray of Pharmacogenomics Reporter noted last week that, as of early February, the bill had the support of six Massachusetts state senators and 13 state representatives. Despite speculation that private interests, particularly insurers, might seek to block the bill’s passage – or at least scale back its protections – Steve May, the executive director of the Forum on Genetic Equity, the advocacy group which crafted the bill, is confident that the MA GBR will pass.

Whether the MA GBR passes in its current form, or indeed whether it passes at all, one fact is inescapable – the MA GBR’s efficacy will be inherently limited by geography. And that geographic limitation could also produce unintended effects on personalized medicine innovation, both within Massachusetts and more broadly.

While the MA GBR would provide an unprecedented degree of security and control to Massachusetts’ residents and their genetic data, has it struck the proper balance against other considerations? For example, while the bill carves out minor exceptions for law enforcement, employees of the state DNA database and those acting upon judicial orders, those safe harbors are probably not broad enough to protect all legitimate scientific and research activities. Further, such a dramatic increase in the proscribed uses of genetic data, and in the restrictions and costs imposed even on lawful uses, could well erect unintended barriers to the type of innovative genetic research conducted at numerous Massachusetts institutions – both non-profit and for-profit. For example, would the added compliance and compensatory costs of the MA GBR (just what is the fair market value of an individual’s genome these days anyhow?) discourage academic or commercial users of genetic data from seeking out or even accepting Massachusetts residents?

This is a delicate line to walk. On the one hand, thanks to a decade of progress since the first human genome was sequenced, widespread personalized genetic data is not only possible – something we could not say as recently as a few years ago – it is more meaningful and, yes, more valuable than ever before. On the other hand, as we are frequently reminded, we have a long way to go in our understanding of human genomics, including how to use personal genetic data to bring about truly meaningful improvements in our health and quality of life.

In addition to the myriad scientific and technological challenges which must be overcome, for the next decade of human genomics to be a successful one, law and policy makers must work with the public to balance individual rights against societal interests. The push to create strong individual rights in genetic data, and to couple those rights with robust privacy protections, must also acknowledge the vital importance of broadly collecting and sharing genetic and other health data in research, clinical and commercial settings. The trick will be to design systems strong enough to prevent abuse but flexible enough to promote innovation and adapt to not only changing scientific, medical and commercial practices but also to evolving social attitudes around genetic data.

While it is clear that change in our legal and regulatory structures is needed, it is not clear if the MA GBR represents the right sort of change. On the one hand, as the Forum on Genetic Equity’s press release (pdf) and the legislation’s name itself declares, the Genetic Bill of Rights may represent fundamental and needed change that will pave the way for sweeping federal changes. On the other, and just like the New York bill we discussed last month, the bill may be an overly protectionist “legislative band-aid” that would grant excessive genetic rights and privacy protections to a minority of individuals at the expense of more meaningful commercial, scientific and clinical innovation.

Just as important as the potential effect of the Massachusetts legislation on Massachusetts residents and researchers is its effect on the ongoing national conversation about these issues. Certainly, legislation that takes effect in Massachusetts would have an outsized effect on biomedical research, investment and innovation, given the prominence of Massachusetts in these areas. But ultimately a patchwork of state regulations cannot be the answer. Whatever the balance to be struck between individual genetic rights and privacy and the needs of genomic research, medicine and commerce, this is an issue that is by its very nature national – and even global – in scope.

Credit the Forum on Genetic Equity and its Beacon Hill supporters for aggressively pursuing these issues, and continuing to push the dialogue forward. Ultimately, however, for the next decade of genomics to be anywhere near as successful as the previous one, meaningful regulation will require much more than the MA GBR, or similar state-level efforts. It will require a major and coordinated national and international effort to replace our current patchwork scheme with one that protects personal genomic data while providing the clarity and flexibility researchers, clinicians and companies need to unlock the potential of those data.