College of American Pathologists
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December 2007
Feature Story

bullet "Stifling or stimulating?" Congress warned of gene patent dangers

The CAP told Congress that exclusive or restrictive license agreements on gene-based tests have been used to prevent physicians and clinical labs from performing genetic tests as diagnostic procedures and that current practices in patenting and licensing of genetic sequences must be reexamined.

The Oct. 30 statement was submitted to the U.S. House of Representatives Judiciary Committee's subcommittee on courts, the Internet and intellectual property. It outlined the impact of gene patents on medicine and health care and urged support for recently introduced legislation that would prohibit patents from being obtained that would impede patient access, quality of care, and training of providers.

The CAP's statement was provided for a hearing titled "Stifling or Stimulating—the Role of Gene Patents in Research and Genetic Testing." It said, "When patents are granted, subsequent exclusive license agreements, excessive licensing fees, and other restrictive licensing conditions prevent physicians and laboratories from providing genetic-based clinical testing services." Most discoveries of human or pathogen genes, the CAP said, can be translated into gene-based diagnostic test services without the incentives provided by patents or exclusive license agreements.

The Frist-Ganske law protects physicians from patent infringement lawsuits but does not extend the same protection to laboratory personnel. Because of the oversight, the CAP told Congress, labs have received letters from gene patent holders saying that continued patient testing would be an infringement. Testing for breast cancer and Alzheimer, Canavan, and Charcot-Marie-Tooth diseases, for example, has been halted because of patent enforcement. The CAP supports efforts to amend the Frist-Ganske law to provide infringement protection to pathologists and other laboratory professionals.

The CAP also supports the Genomic Research and Accessibility Act, H.R. 977, introduced by congressmen Xavier Becerra (D-Calif.) and Dave Weldon (R-Fla.). It would prohibit patents from being obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies.

"We are facing the unprecedented situation in which a single patent owner can prevent physicians throughout the country from performing diagnostic procedures that use certain gene-based tests," the CAP told Congress. "This sets an extraordinary and dangerous precedent for patients and all of medicine…"

bullet Groups support health IT, but ask that it be done right

The CAP joined the American Medical Association and 34 other medical and health care organizations in recommending improvements to the Wired for Health Care Quality Act of 2007, aiming to help create a national health information technology network that is functional, interoperable, and addresses barriers to adoption.

The letter, sent Nov. 9 to the bill's sponsors, commends the senators' interest in optimizing the provision of high-quality patient care but warns that they must ensure that safeguards are met.

The Wired for Health Care Quality Act, S. 1693, seeks a nationwide interoperable health information network that would improve the quality and reduce the costs of health care in the United States.

To achieve this, the College and other organizations urged that several issues be addressed. First, reports generated from limited available data must portray an accurate and useful picture of the quality of care provided. Title III of the bill would provide for public disclosure of federal health care data that would include quality and efficiency measures, but it requires a reporting infrastructure that hasn't yet been fully developed, the groups wrote.

Second, the quality measures used must be developed in a transparent consensus process. Title III, the groups say, allows the secretary of HHS too much discretion to develop such measures. "The physician community has already made significant advances in measure development," they wrote, "and any related legislation must incorporate these advances." The Physician Consortium for Performance Improvement, which has representatives of physician and health professional specialty organizations, has already developed more than 200 physician quality measures.

Third, physicians must have input into the development of mandatory standards for federal health information exchange. Though the bill contains provisions that require provider participation, the groups say, greater physician representation is needed, especially from small medical practices.

Fourth, patient confidentiality and security of health information must be ensured before collecting and electronically exchanging such information can be required.

Finally, adequate and direct funding must be in place to meet the needs of physicians who will bear the financial burden of implementing HIT while other sectors—insurers and integrated health care systems—benefit the most financially from the technology.

S. 1693 was introduced June 26 and referred to the Senate Committee on Health Education, Labor and Pensions, where it was approved by unanimous consent June 27. It is now ready for consideration by the full Senate, though no date for its consideration has been set.

bullet For genetic testing oversight, no need to look beyond CLIA

The CAP submitted a statement to the Department of Health and Human Services' Secretary's Advisory Committee on Genetics, Health and Society at its Nov. 19 meeting, recommending that any changes to federal oversight of genetic laboratory tests be made within the context of the Clinical Laboratory Improvement Amendments. The CAP statement, submitted in response to the draft SACGHS report, "U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS," says CLIA provides the necessary framework and standards to ensure quality laboratory testing that's widely available and affordable for the greatest public benefit. The draft SACGHS oversight report concludes that genetic information is not fundamentally different from other health information, but it assumes that genetic testing is different. The CAP asked the advisory committee to review the impact that recommendations in the draft report will have on the ability of pathologists to practice medicine in the best interests of their patients. More comprehensive comments were to be submitted to the advisory committee this month.

Justin Herman is CAP manager, Communications for Advocacy, Washington, DC.