The Genetic Information Nondiscrimination Act (GINA) was signed into law in May 2008 after 13 years of debate. Title I of GINA prohibits health insurers from using genetic information to deny coverage or to set premiums or payment rates. Title II prohibits employers from requesting genetic information or using genetic information in hiring, firing and other employment-related decisions. This page aggregates all of the Genomics Law Report’s GINA coverage, including the Act’s implementation by regulatory agencies, courts and businesses.
The top news story the past two weeks: the release of hundreds of thousands of confidential American diplomatic cables by WikiLeaks. While dissecting diplomatic maneuvering is not a traditional area of expertise for the Genomics Law Report, a pair of cables did catch our eye.
The first is primarily a curiosity: the allegation that Chinese authorities are spying on deCode Genetics, Iceland’s most prominent genetic research company and provider of the direct-to-consumer genetic testing service, deCODEme. Nobody seems to know exactly what China is looking to gain by clandestinely exploring Iceland’s genetic genealogy. You are welcome to speculate in the comments.
The second raises broader issues: the revelation that the State Department’s ongoing human intelligence collection directives include requests for “biometric information” on key world leaders, including United Nations arms inspectors, the Director General of the World Health Organization (WHO) and key advisors and aides to United Nations Secretary General Ban Ki-moon. A separate cable detailing intelligence collection priorities in Africa’s Great Lakes region clarifies that “biometric information” includes “health [data]…fingerprints, facial images, DNA, and iris scans.”
Not disclosed in the WikiLeaked cables: why the State Department wants the biometric data or whether any have been successfully obtained.
Surreptitious Testing: An Overview. The cables are, however, a reminder that the law surrounding the surreptitious collection and testing of biometric data, including DNA, remains extremely murky.
As we wrote yesterday, last week the Equal Employment Opportunity Commission (EEOC) issued definitive rules and regulations (pdf) with respect to Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). In our previous post we offered a brief overview of the new regulations, as well as some preliminary suggestions for employers just now coming to grips with GINA.
We also promised to take a closer look in today’s post at several substantive features of the EEOC’s new regulations.
Defining the Terms. The EEOC, the government agency generally responsible for enforcing federal employment nondiscrimination laws, was the logical choice to promulgate regulations under GINA’s Title II, which governs the use of genetic information by employers and similar entities. But not all of GINA’s statutory provisions were within the EEOC’s area of expertise.
The Equal Employment Opportunity Commission (EEOC) has issued its final rules and regulations implementing the employment provisions of the Genetic Information Nondiscrimination Act of 2008 (GINA). Signed into law in 2008, GINA took effect in two stages in 2009, with Title I (which applies to health insurers and plans) effective in May and Title II (which applies to employers) effective in November.
When GINA was passed, Congress instructed the EEOC to issue final rules and regulations no later than May of 2009 describing how the agency intends to interpret and enforce the legislation. Although the EEOC missed that deadline by a full 18 months, the Commission did issue definitive rules and regulations (pdf) for Title II of GINA last week. (In its defense, the departments responsible for the Title I – Labor, Health and Human Services and the Treasury – have yet to issue final regulations of their own.) The regulations take effect January 10, 2011.
Reintroducing GINA. Last November, we reported that Title II of GINA had joined ranks with the other federal antidiscrimination laws (the Americans with Disabilities Act of 1990 (ADA), Title VII of the Civil Rights Act of 1964 (Title VII) and The Family and Medical Leave Act (FMLA), to name a few), to provide federal protection against workplace discrimination, in this case on the basis of genetic information. Title II of GINA prohibits the use of genetic information in the employment context, and also restricts employers from acquiring or disclosing genetic information.
Recently the Genomics Law Report discussed a legal action brought by an employee alleging she was dismissed from her job when her employer learned of her genetic test results. The claim is that the employer’s action was in violation of the Genetic Information Nondiscrimination Act (GINA), and is the first publicly reported action of its kind. As GINA, which was enacted in 2008 and is still being implemented by regulatory agencies, becomes an established part of the legal landscape, more claims are bound to follow. The following article discusses a hypothetical set of facts that raise questions for an employer under GINA as well as other employment laws.
Another Monday morning, another administrative headache. Your marketing VP has taken fifteen minutes complaining – again – about Julie. In short, her performance has been in the tank for weeks. She’s missed numerous internal meetings and deadlines, and customer feedback has gone from highly favorable to “please send someone else next time, if there is a next time.”
In what appears to be the first publicly identified case of its kind, a Connecticut woman has accused her employer of violating the recently enacted federal Genetic Information Nondiscrimination Act (GINA). According to a story in the Boston Herald (discovered thanks to a tip from Matt Mealiffe), 39-year-old Pamela Fink received an elective double mastectomy last year after testing positive for mutations in her BRCA2 gene associated with an increased risk of breast cancer. Fink alleges that, despite giving her “glowing evaluations for years,” her employer, MXenergy, “targeted, demoted and eventually dismissed her when she told them of the genetic test results.”
GINA, which was passed by Congress in 2008 and took effect last year, represents the most comprehensive effort to date to regulate the use of genetic information by employers (Title II) and health care insurers (Title I). Under Section 201(a)(i) of GINA, employers with more than 15 employees may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment…because of genetic information.”
Recent advances in genetic science are remarkable. In 2003 the first full human genome was sequenced after 13 years of work at a cost of over $3 billion. Today, the cost to sequence any individual’s entire genome is approaching $1,000. Genetic tests for specific genes linked to cancer and other diseases exist today and many more are being developed. We hear of a new era of “personalized medicine” in which drugs and therapies will be prescribed based on the individual patient’s specific genes.
All of this may seem to have little direct relevance to companies outside of biotechnology. However, the development of genetic knowledge and technology already has spawned new laws, regulations and patent uncertainties that impact almost all businesses in some way.
Privacy and Nondiscrimination. The federal Genetic Information Nondiscrimination Act of 2008 (GINA) represents the most comprehensive effort to date to regulate the use of genetic information. GINA initially only prohibited health insurers and group health plans from using genetic information to deny coverage or set payment rates. Another section, which just became effective in November 2009, affects all private and public employers with more than 15 employees.
Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010.
1. Will the $1,000 genome live up to the hype? Affordable whole-genome sequencing is coming, possibly as early as this year depending on whom you ask. But when the day inevitably arrives, after the media frenzy has subsided, will the $1,000 genome prove anti-climactic?
Whole-genome sequencing is a means to an end and not an end in itself. The understandable excitement surrounding Complete Genomics’ November announcement that it had sequenced three genomes for an average cost of $4,400 often neglected to focus on what the price tag did not cover: the substantial costs associated with interpreting the genomic data.
For genomics researchers, the falling cost of whole-genome sequencing is a continuing cause for celebration, enabling increasingly ambitious research projects. But the success of personal genomics, which is what really matters to consumers, patients and healthcare providers, requires more than inexpensive genomic data. The real breakthrough in personal genomics will come when we can offer individuals affordable access to their whole-genome sequence as well as to the genomic tools and knowledgebase necessary for those individuals to put that data to use.
As we reminded you last week, Title II of the Genetic Information Nondiscrimination Act (GINA) took effect on November 21st. Title II prohibits genetic discrimination and restricts the collection of genetic information by all private, state, and local government employers with more than fifteen employees. (Title I prohibits health insurers and group plans from using genetic information to deny coverage or set payment rates.)
For all the attention that GINA has achieved, many Americans will soon learn of its existence for the first time in break rooms and at water coolers across the country, courtesy of the Equal Employment Opportunity Commission’s (EEOC) new workplace poster (pdf). The poster is required to be displayed by all employers covered by federal anti-discrimination laws.
The most recent layer of federal antidiscrimination law took effect this past weekend – to the ADA, Title VII, FMLA and other federal and state laws, employers can add another: the Genetic Information Nondiscrimination Act. Title I of this new law (called GINA) took effect in May 2009, prohibiting health insurers and group plans from using genetic information to deny coverage or set payment rates. Title II now joins the fray, and with it brings prohibitions that make their way into almost every workplace. Under Title II, an employer may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment … because of genetic information.”
While a long time in the making (13 years of (often procedural) debate), in the end, there was little argument in Congress that this law was needed – the Senate approved it unanimously, and the House of Representatives had only one vote against it. As early as January 2001, the Council for Responsible Genetics claimed hundreds of documented cases of genetic discrimination and/or fear of genetic discrimination in its Genetic Discrimination: Position Paper (pdf). In a 2007 survey (pdf), the Genetics and Public Policy Center found that 92% of participants expressed concerns that a genetic test could be used in harmful ways against a person. Last summer, we reported on Major League Baseball’s genetic testing to verify the reported ages of certain Latin American prospects. This past month, the University of Akron made headlines over a new policy requiring job applicants to turn over DNA samples, and in the process energized the Ohio chapter of the ACLU.
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by David Gurwitz, Tel-Aviv University Department of Human Molecular Genetics and Biochemistry.
The age of personal genomics has arrived faster than most have expected. While the purchase of full genome sequencing services may today be too costly for most to consider, full genome sequencing costs are projected to fall under US$1000 within less than a decade. But are we ready for the personal genomics age and its far-reaching societal implications? There are countless ELSI matters that need to be considered in the context of readily available personal genomes. One key aspect is the need for more comprehensive genetic information non-discrimination legislation.
Legislation is a notoriously slow process; when it comes to handling new technologies, legislators may take many years to catch up. Israel was among the first States to pass – already in 2000 – a comprehensive genetic information non-discrimination law; some European States soon followed. In the US, however, a similar legislation process suffered a lengthy birth: The Genetic Information Nondiscrimination Act (GINA) of 2008 has been in the making for over a decade (1), in spite of strong support from research associations and groups such as the NIH Pharmacogenomics Research Network (2). GINA, finally signed into law on May 21, 2008, protects Americans against discrimination in health coverage and employment based on individual genetic information (3). However it does not protect individuals against misuse of genetic information by life or disability insurance providers, banks, schools, or immigration authorities (4-6). Amending GINA for assuring wider protections seems urgent: personal genome sequences coming from proliferating electronic health records and government forensics databases, and other sources of personal sequences, including Facebook-like websites, are being contained in innumerable internet-based resources. Safeguards are typically in place to ensure that only qualified persons may access personal genetic profile records, but no safeguards are failsafe (7).
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