EU Adopts New Privacy Shield for Data Transfers to U.S.

Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will govern the collection and use of health data related to EU citizens. This month has brought a complementary and equally significant development, this time dealing with the transfer of personal data—including health data—from the EU to the U.S.

On July 12, 2016, the European Union announced that it had formally adopted the long-awaited EU-U.S. Privacy Shield to permit the transfer of personal data from EU countries to the United States.
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Filed under International Developments, Privacy, Privacy, Privacy

The EEOC’s Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Month

Gina name tagOn May 17, 2016, the Equal Employment Opportunity Commission (EEOC), which is the agency charged with enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), issued a final rule changing how employers can set up incentives for the wellness programs they sponsor for their employees.

As previously reported on Genomics Law Report, on October 30, 2015 the EEOC had issued a proposed rule to amend the GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs. The EEOC indicated it had received more than 3000 public comments before the close of the comment period on January 28, 2016.

In short, the final rule allows employers to offer financial and in-kind incentives for an employee’s spouse to provide information about the spouse’s current or former health status as part of a health risk assessment in connection with a voluntary employer-sponsored wellness program so long as certain requirements are met.
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Filed under Genomic Policymaking, Genomics & Medicine, GINA, Legal & Regulatory, Privacy, Privacy, Privacy

NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation

The last few days have seen two significant news items from Washington. First, the National Institutes of Health have refused—yet again—to exercise their “march-in” rights to grant third-party licenses to a patented drug developed with federal funding. The drug in question is enzalutamide, a prostate cancer treatment marketed under the brand name Xtandi by Japanese pharmaceutical company Astellas Pharma. Xtandi was derived from federally supported research at UCLA. Under such circumstances, NIH has the statutory authority to grant a license to a third party if the grantee or its assignee “has not taken, or is not expected to take within a reasonable time effective steps to achieve practical application of the subject invention.” “Practical application” means that that the invention must be “available to the public on reasonable terms.”
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Filed under Legal & Regulatory, Patents & IP, Uncategorized

Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post:

Roger-Klein-MD-JDThe Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, a broad definition of the designated medical record set could result in considerable complexity when one considers large-scale sequencing. Some excluded data can be of variable reliability, may be prospectively filtered by software, or may otherwise be omitted from the patient report because of professional interpretation and judgment. One can legitimately argue that this interpretation and judgment, as reflected in the patient report, should serve as the gateway to the official medical record.
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Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society

UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients

UNC’s Karen Weck responds to my previous GLR post:

I agree in principle that patients have the right to access their genomic data; however, in practice it is much more complicated (as things often are). Giving a patient his/her raw sequencing data would be meaningless – it is the interpretation of the clinical significance of sequence data that is important when reporting results. This latter requires the expertise of molecular genetic laboratorians and clinical geneticists. We do not return all genomic sequence variants to individuals in exome sequencing, for example when we determine that they are unlikely to be contributory to their disease or medical health. It is important to those of us doing this that we retain the ability to use our professional judgement to determine what should be reported to patients as medically relevant, primarily so as not to dilute important medical information with irrelevant information.

Karen E. Weck, MD
Professor of Pathology & Laboratory Medicine and Genetics
Director, Molecular Genetics
University of North Carolina at Chapel Hill

Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Society

ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance

MyriadJust about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.

The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
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Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

Litigating the Accountability of Clinical Genomics Laboratories

Seeking Accountability from Clinical Genomics Laboratories

A wrongful death case pending in a federal court in Columbia, SC—Williams v. Quest Diagnostics, Inc., et al.—demonstrates the very high stakes involved with clinical genomics testing. The case also underscores the ongoing struggle to (1) establish accountability when mistakes happen and (2) establish a reasonable and effective level of governmental oversight for the laboratories performing such tests. The case could have dramatic implications for the future practice of genomic medicine, and regardless of how this specific case ultimately plays out in the courtroom, the allegations should serve as a serious wake up call to those involved in genomics for clinical purposes in any way.
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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Pending Litigation

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

Safe HarborThe last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review:

1. Final Approval of Pending EU General Data Protection Regulation

On April 14, 2016, the Parliament of the European Union gave final approval to the long-discussed GDPR. It will replace the current regime of country-by-country laws under the 1995 Data Protection Directive. Whereas an EU Directive requires implementation by individual EU member states, the GDPR is a Regulation (much like a federal law in this country) that will take immediate effect in all EU countries in the spring of 2018.
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Filed under General Interest, International Developments, Legal & Regulatory, Pending Regulation, Privacy, Privacy, Privacy

Genetic information as “perceived disability”: Chadam v. PAUSD

Chadam v. PAUSD, as previously covered on Genomics Law Report, is a case in which parents of a school boy are alleging that a school district violated their son’s rights when it made the decision that it would transfer the boy to another school because of his genetic information. Specifically, the allegation is that when the boy moved to the area and registered for school, (1) the school district learned of the boy’s genetic information related to cystic fibrosis, (2)  the boy was regarded as disabled by the school district, and (3) on the basis of this perceived disability, the school district decided to transfer the boy to another school to protect two other students at the school who have cystic fibrosis. The school district’s decision was apparently based on the idea that the boy, because of his genetic markers, posed a cross-infection risk to the students with cystic fibrosis. Individuals with cystic fibrosis, because their respiratory symptoms create host environments favorable to microbiological pathogens, are often separated from one another to minimize risk of spreading germs to one another. Mere carriers of the genetic markers associated with cystic fibrosis do not pose such cross-infection risks.

This case unequivocally does not involve GINA, a federal nondiscrimination statute that has very limited scope and does not protect individuals from discrimination in education. While the facts alleged could have supported a clear claim for violation of California’s genetic nondiscrimination statute, CalGINA, which affords broader protections than the federal statute, the attorney for the Chadams did not raise that claim. Instead, this case alleges violations of two federal antidiscrimination statutes, the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act. Title II of the ADA requires public education to be free from discrimination, and Section 504 requires all federally funded programs and activities to be free from discrimination. Under both provisions, individuals cannot be excluded from participating in or enjoying the benefits of education because of disability. The statutes protect three basic classes of individuals: (1) those who have a disability (i.e., those who have a physical or mental condition that substantially limits a major life activity); (2) those with a history or record of having a disability; and (3) those with a perceived disability (i.e., those “regarded as” having a disability). (For more information, see A Guide to Disability Rights Laws published by the Civil Rights Division of the US Department of Justice)

The plaintiffs in Chadam have appealed the trial court’s decision to grant the school district’s motion to dismiss the case (a Rule 12(b)(6) motion). In granting the school district’s motion, the court basically decided that even if it assumed all of the facts alleged by the plaintiffs to be true and drew all reasonable inferences in favor of the plaintiffs, there would not be a valid claim upon which relief could be granted. On appeal, the United States Court of Appeals for the Ninth Circuit, which covers California, will focus on whether the district court erred in reaching that decision. The court of appeals will consider the motion de novo—that is, will give no deference to the trial court’s decision—and determine whether the facts alleged in the pleadings, when read in the light most favorable to the plantiffs, state a claim for relief that is plausible. The amicus brief filed by the United States (Department of Justice and Department of Education) urges the Ninth Circuit to reverse the district court’s decision and remand the case, stating that the plaintiffs have alleged sufficient facts to support a claim of intentional discrimination under Title II of the ADA and Section 504.

Is there judicial precedent for ADA protection of genetic information?

About 15 years ago, long before Congress passed the Genetic Information Nondiscrimination Act, there was a case in which individuals sought ADA protection from genetic discrimination. That case involved the Burlington Northern Santa Fe Railroad (BNSF), which allegedly had been using employees’ genetic information in connection with work-related carpal tunnel syndrome claims. The case was never decided by a court, however. In 2001 the Equal Employment Opportunity Commission (EEOC) and BNSF settled the EEOC’s request for injunctive relief to stop the company’s genetic testing, and in 2002 the EEOC and BNSF settled the request for damages with an agreement to compensate individuals with up to $2.2 million. While the settlement agreement was subject to approval by the Eastern District of Wisconsin (see 2002 WL 32155386), this case did not set judicial precedent that the ADA protects individuals from decisions based on genetic information.

Does the relevant legislative history suggest that individuals are protected from genetic discrimination because of “perceived disability”?

To answer this question, it is useful to start with legal scholar Mark Rothstein’s thorough 1992 analysis of the law regarding genetic discrimination and possible protection under the ADA as it existed at that time. See Mark A. Rothstein, Genetic Discrimination in Employment and the Americans with Disabilities Act, 29 Hous. L. Rev. 23 (1992).

In the early 1990s, in a letter to a Congressional committee chair, the EEOC actually rejected the idea that the ADA prohibits genetic discrimination against asymptomatic individuals, instead taking the position that the ADA would only protect an individual once the condition existed and symptoms were present. The EEOC’s technical assistance manual in 1992 also noted that genetic predisposition and family history are not “impairments” protected by the ADA. Nearly 10 years later, following the issuance of the Executive Order 13145 in 2000 that protects federal employees from genetic discrimination, the EEOC provided guidance indicating that instances of disparate treatment on the basis of genetic test results or family medical history would support a claim that an individual was “regarded as” having a disability and thus protected under the ADA and Rehabilitation Act.

As a matter of history, Congress and advocates alike did not believe that the ADA or Section 504 were sufficient to protect individuals from genetic nondiscrimination. In the statutory text of GINA, Congress found, “Federal law addressing genetic discrimination…is incomplete in both the scope and depth of its protections.” (PL 110-233, Finding 5).

To date, there are no direct cases on point deciding that genetic information is a “perceived disability” under the ADA and Section 504 or, conversely, ruling out that possibility.

What are the implications of this case?

Ultimately, a broad ruling in Chadam that genetic information alone is a sufficient basis to bring an action for “perceived disability” could dramatically expand individual genetic nondiscrimination protection—at least in the Ninth Circuit. Courts in other federal circuits would not be bound by a Ninth Circuit decision and could choose whether or not to follow it. That reality, combined with the strong public reactions to this case, suggests that Congress has important work to do to strengthen genetic nondiscrimination protections in education and other sectors of society currently not addressed directly by federal statutes.

Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Pending Litigation

The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California

CRISPR-Cas9 editing of the genomeThe patent dispute already called “the biggest in biotech history” is only getting started. On January 11, 2016, Administrative Law Judge (ALJ) Deborah Katz officially declared an interference over patents for the CRISPR-Cas gene editing technologies. An interference is a U.S. Patent and Trademark Office (USPTO) administrative proceeding conducted to determine which of multiple claimants to a particular invention has priority rights. Since the patents in question were filed before the March 2013 effective date of the America Invents Act, priority will be awarded to the claimant who was the first to invent the technology in question. This dispute pits Feng Zhang, the Broad Institute, and MIT against Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna. Law professor Jacob S. Sherkow has followed the case closely and has provided useful background information on Stanford’s Law and Biosciences Blog.
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Filed under Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP, Pending Litigation