Article shows human genome testing has wide implications on American law


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LAWRENCE — Parents screening their genetic makeup to determine their children’s physical traits, susceptibility to disease and even to ensure the gender they want may sound like something from a science fiction movie, but improving technology and declining costs are making such scenarios a real possibility. And the technology is far outpacing the law and public policy addressing it.

In a recently published article, Andrew Torrance, professor of law at the University of Kansas, examines the possibilities that improved genetic technology and legal cases currently in the court system will have on family law.

“Family Law and the Genomic Revolution,” recently published in the University of Missouri Kansas City Law Review, explores the associated legal and ethical implications of the “$1,000 genome.” The term refers to tests for sequencing an individual’s entire genome that will soon be available for as little as $1,000.

“In practice, this will enable anyone covered by medical insurance, or willing and able to pay $1,000 or less, to possess an intimate knowledge of the good, the bad and the ugly of the interpretable portions of her genome,” he wrote.

Genetic testing can have very positive results for potential parents, but as technology improves, ethical questions become more apparent.

“Parents may start by screening for very pernicious diseases like Tay-Sachs disease or cystic fibrosis,” Torrance said. “You can also take genetic tests that predict risk of breast cancer. But, unfortunately, what may begin as ethically unobjectionable can also open the door to pre-birth eugenics.”

From examining genes for disease susceptibility, the tests can quickly move on to screening for physical traits. That opens the debate about which traits are desirable or undesirable to certain parents. Various embryo screening tests already exist, and in some parts of the world they are being used primarily to determine an embryo’s gender. In countries where it is less desirable to have a daughter for cultural reasons, the tests are often an early influence on the decision of whether to carry a pregnancy to term.

“This very quickly can lead us down the road to full-blown eugenics,” Torrance said. “I don’t pretend to have ethical answers for this issue, but the law does exist to give voice to society’s ethical qualms. I feel strongly it would be best for the law to consider the implications of widely available genomic tests before any catastrophes occur.”

GENE PATENTABILITY

Cases dealing with genome sequencing and the discovery and understanding of human genes are currently working through the court system. A 1980 Supreme Court Decision, Diamond v. Chakrabarty, confirmed that human genes may be patentable subject matter. Since then, biotechnology companies, universities and other institutions have been researching, developing and patenting human genes for medical purposes.

In early 2010, a judge hearing a case commonly referred to as Myriad Genetics invalidated the titular company’s human gene patents on summary judgment. Now on appeal, perhaps eventually to the U.S. Supreme Court, the case has significant implications for patients, the law, the healthcare industry and genetics in general.

“Perhaps more significantly, this decision cast doubt on the continued validity of all gene patents,” Torrance wrote. “If not reversed, this decision has the potential to render thousands of human gene patents worthless. Those who support the patentability of genes, including, most notably, many in the biotechnology industry, worry that this decision, if not reversed on appeal, could remove an important economic incentive promoting the discovery, description and development of additional unknown or poorly understood human genes that could benefit human health. Others view the loss of gene patents as a boon to affordable healthcare partly because it could allow the development of lower cost generic versions of existing patented gene diagnostic tests, and therapeutic drugs.”

Torrance, who holds a doctorate in genetics from Harvard, says public policy should be made at the state, federal and international levels to address the legal, technical and ethical questions created by the unfolding genomic revolution. If it isn’t, courts will certainly address these issues after damage has already occurred. Genetic testing and genomic technology will only continue to improve and become less expensive. Coupled with the current flux in the law of gene patents, the dawning age of the $1,000 genome demands proactive thought, and perhaps even laws, on the matter.

“Even today, with the Human Genome Project completed, we don’t know much about what genes and genomes do. Even at this late date,” Torrance said. “It’s really an unknown universe. But the law is one of the best tools we have developed for dealing with just such unknowns.”

Torrance has authored several articles on genetics and law.

Tue, 09/13/2011

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Mike Krings

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