AMA House of Delegates

"Genes are not legitimately patentable matter," says Raymond Lewandowski, MD, a delegate from the American College of Medical Genetics. Photo by Judy Fidkowski-Tetzlaff

AMA meeting: Patents should not be issued for human genes

Delegates say such patenting may interfere with the availability of affordable genetic tests and inhibit the development of new ones.

By Victoria Stagg Elliott — Posted June 28, 2010

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The American Medical Association opposes the patenting of human genes and related naturally occurring mutations, according to policy adopted June 15 at the organization's Annual Meeting.

"Genes are not legitimately patentable matter," said Raymond Lewandowski, MD, of Corpus Christi, Texas, who proposed the policy as a delegate from the American College of Medical Genetics.

The policy also states that patents that already have been issued should be licensed in a way that allows broad access by physicians and patients. The AMA will support legislation making those who use patented genes for medical diagnosis and research exempt from claims of infringement.

"Gene sequences are part of the practice of medicine and should be widely available," said Edmund Donoghue, MD, of Savannah, Ga., a delegate from the American Society for Clinical Pathology. "When patents are exclusive or prevent physicians and clinical laboratories from using certain tests, when [patents] limit access to medical care and raise costs, that is not in the public interest."

The patenting of genes has long been controversial, with those opposed saying that this practice limits medical research and prevents patients and physicians from accessing competitively priced genetic testing services.

On March 29, the U.S. District Court for the Southern District of New York invalidated patents on breast and ovarian cancer genes held by Myriad Genetics Inc. on the basis that they violated the prohibition of patenting natural phenomena. The American College of Medical Genetics was a plaintiff in that case. The Litigation Center of the American Medical Association and the State Medical Societies, along with a group of other medical organizations, filed a court brief challenging these gene patents. (See correction)

The ruling is expected to be appealed, and some of the delegates expressed concern that prohibiting these kinds of patents could hinder rather than help medical research.

"It takes a lot of time and money to develop genetic tests. Who is going to spend that money if they do not have some assurance of recouping their investment later?" said Kenneth Crabb, MD, an obstetrician-gynecologist and a delegate from the Minnesota Medical Assn., who was speaking personally.

In a related development, the AMA Council on Science and Public Health released a report on genomic-based personalized medicine. The AMA says it will continue to develop educational resources and point-of-care tools on the subject.

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Meeting notes: Medical ethics

Issue: Men who have had sex with men since 1977 are banned from donating blood. A previous AMA report concluded that medical evidence supports allowing men to donate five years after their last same-sex contact, but said the ethical aspects of such a change should be explored.

Proposed action: Study the societal and ethical consequences of moving to a five-year deferral policy and report back at the 2011 Annual Meeting. [Adopted]

Issue: Few adults age 18 to 24 have completed advance directives or named health care proxies, making it difficult for physicians and loved ones to make care decisions on their behalf.

Proposed action: Educate young adults about the importance of advance directives and health care proxies and encourage physicians to talk with their younger adult patients about such planning. [Adopted]

Issue: A growing number of for-profit hospice care organizations have helped double the number of patients in hospice since 2000, to more than 1 million, and nearly quadrupled Medicare hospice costs to $11.2 billion.

Proposed action: Reaffirm physicians' responsibility to authorize hospice care in appropriate circumstances, develop educational materials and call on CMS to study the hospice benefit's structure, pay methodology and quality assurance. [Adopted]

Issue: Industry funding of continuing medical education and CME faculty with financial conflicts may compromise the independence of educational content.

Proposed action: Adopt ethical guidance saying physicians should expect conflict-free CME when possible and that, when unavoidable, the conflicts should be scrutinized closely and disclosed in detail. [Referred]

Issue: Commercial sponsorship of clinical practice guidelines and guideline-committee members with financial conflicts may improperly influence the recommendations made to physicians.

Proposed action: Support the position that physician organizations should not receive industry support for writing or promoting practice guidelines and call for independent review of guidelines before publication. [Referred]

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This article has been corrected from an earlier version. The original article incorrectly identified the court that invalidated patents on breast and ovarian cancer genes held by Myriad Genetics Inc. The case was decided by the U.S. District Court for the Southern District of New York. American Medical News regrets the error.

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