The Burden of Enforcing GINA: EEOC v. Nestle Illustrates One Challenge in Pursuing Genetic Discrimination Claims

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law making it illegal for insurers and employers to acquire and to use genetic information in certain contexts. Specifically, Title II of GINA prohibits employers with more than 15 employees, employment agencies, labor organizations, and joint labor-management training and apprenticeship program committees from using genetic information when making employment decisions (e.g. hiring, firing, promotions, placement, compensation, privileges, seniority, etc).

The employment discrimination provisions took effect on November 21, 2009, with an air of uncertainty, as the Final Rules implementing Title II of GINA were not issued by the Equal Employment Opportunity Commission (EEOC) until a year later (See 75 Fed Reg 68912-68939 [pdf], issued November 9, 2010) and did not take effect until January 10, 2011. (See previous GLR coverage of GINA Title II here and of GINA generally here).


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Filed under Genetic Testing/Screening, Genomics & Society, GINA, Legal & Regulatory, Pending Regulation, Privacy

2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:

1. Will the $1,000 genome live up to the hype?

2. Will personal genomics stay DTC?

3. How will the ongoing gene patent debate affect the progress of personalized medicine?

4. When and where will the next regulatory shoe fall?

5. Who will control the data?

A year later the question that comes first to mind is, has anything really changed?

The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.

With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.


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Filed under Bioinformatics/IT, Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, GINA, Industry News, International Developments, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation

MLB Takes Another Swing at Complying with GINA

In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA). Although GINA is arguably “the first civil rights bill of the 21st century,” we have consistently reminded Genomics Law Report readers that passing GINA into law was only the first step.

As is the case with any piece of new legislation, even after a law is passed, considerable work remains to implement that law in practice. GINA is no different. Congress provided a basic framework designed to eliminate genetic discrimination, but many of the details of the law were left to regulatory agencies.

Two and a half years after GINA’s passage, the first part of that process is still underway. Last month the EEOC issued final rules and regulations implementing Title II of Gina, which applies to employers. (Final regulations for Title I of GINA, which applies to health insurers, have yet to be issued.) With the long-awaited arrival of the EEOC’s final regulations, the next step is to begin to apply those regulations.

MLB’s Genetic Testing Program. In July of 2009 The New York Times reported that Major League Baseball (MLB) had begun using genetic testing to verify the age and identity of Latin American baseball prospects. We analyzed MLB’s genetic testing program and the potential legal concerns raised by GINA in a pair of posts: “MLB Meets GINA” and “MLB’s Genetic Testing Program at the Plate Again.”


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Digging Deeper into the EEOC’s Final GINA Regulations

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.


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Update: EEOC Issues Final Genetic Nondiscrimination Rules

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.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, GINA, Legal & Regulatory, Pending Regulation, Privacy

GINA in Action: Woman alleges genetic test led to firing

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.”


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The Unexpected Impact of Genetics on the Business World

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.


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Filed under General Interest, Genomic Policymaking, Genomics & Society, GINA, Myriad Gene Patent Litigation, Patents & IP

GINA: Coming Soon to a Workplace Poster Near You

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.

EEOC Poster (Page 1)EEOC Poster (Page 2)

Filed under Badges, Genetic Testing/Screening, Genomic Policymaking, GINA, Legal & Regulatory, Pending Regulation

Welcoming GINA into the Workplace

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.


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Filed under Badges, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Legal & Regulatory, Pending Regulation

MLB’s Genetic Testing Program at the Plate Again

Baseball65The New York Times published a follow up piece to its story on Major League Baseball using genetic testing to confirm the reported ages of some young baseball aspirants. Last week’s GLR post examined MLB’s genetic testing program in the context of the Genetic Information Nondiscrimination Act (GINA) and has prompted further internal discussion here at GLR, with our own John Conley asking a few questions:

I guess MLB would say they’re not using genetic information to discriminate in the usual sense of screening out high-risk people, but just to verify that the prospect isn’t defrauding them about an essential datum — after some notorious cases of lying and producing false documents in both directions. And in the Bulls’ defense, they said they were spooked by numerous cases of basketball players dropping dead as a result of undiagnosed heart defects that seem to afflict the very tall. I guess they were also mindful of Reggie Lewis of the Celtics, who passed out, WAS diagnosed, shopped for a favorable opinion, then died playing. Does GINA allow any sort of defensive testing like this by employees whose work creates risk to particular categories of people? Or must the employer let the employees kill themselves if they wish?

There is clearly a good practical reason for the testing in both cases that John identifies, but neither testing to confirm identity (or otherwise prevent fraud, as in the case of MLB) or to prevent even potentially fatal medical conditions (as in the case of Eddy Curry) is explicitly permitted under GINA. In the case of MLB, the result will depend, in part, on how the EEOC interprets the following pair of GINA’s definitions (from Section 201 of GINA). Again, the interpretive issue is whether “genetic information”, which may not be used for making employment decisions, covers the kind of testing in the MLB matter.


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