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HHS Committee Will Seek Public Comment on Upcoming Gene IP Policy Draft Report

NEW YORK (GenomeWeb News) – A government panel tasked with developing policy options about gene patenting plans to release a draft report and to open a public comment phase soon after the next presidential administration arrives in Washington.
The Secretary’s Advisory Committee on Genetics, Health, and Society said at a regular meeting this week that it plans to release the report and to begin taking comments from industry, patient rights groups, academic communities, and any other interested parties in early February.
The committee said that after comments and revisions it plans to have a final report to pass on to the Secretary of the Department of Health and Human Services in October 2009. That is expected to be former South Dakota Senator Tom Daschle, who was nominated by President-elect Barack Obama for the post two weeks ago.
SACGHS’s gene-patenting task force so far has focused on divining the positive and negative effects of current gene patenting and licensing practices, and it has covered gene patents for diagnostic, predictive, and other clinical purposes, as well as the effects on translational research. The studies have avoided studying drug and other therapeutic product development.
“This has turned out to be a gargantuan task,” James Evans, the committee’s chair on gene patents and intellectual property, told the group in opening remarks on Monday.
“It's simply a very broad and deep field. There's a huge history of patent law [and] licensing issues. Patents obviously go way back to the US Constitution,” Evans explained.
Also, Evans said, “there are many stakeholders, and the stakeholders, when it comes to patents and licensing,” sometimes are not “in sync with their own interests,” which “are sometimes mutually exclusive.”
For now, Evans explained, the task force came up with a range of possible policy recommendations for the committee to consider developing and passing on to the secretary.
SACGHS developed the recommendations by commissioning a series of case studies to be conducted by Duke University’s Center for Genome Ethics, Law and Policy. The center reviewed and analyzed a number of case samples, including those relating to BRCA1 and BRCA2 for hereditary breast and ovarian cancers, as well as tests for Alzheimer’s disease, hearing loss, Tay-Sachs and Canavan diseases, Long QT syndrome, and other diseases.
From this range of studies, the panel drew a number of preliminary conclusions. The case studies suggest that the use and enforcement of IP rights, and not so much whether a gene is patented or unpatented, could potentially create barriers to clinical use of the gene.
“There is no clear relationship between patents, license exclusivity, and price of a genetic diagnostic test,” the group found.
Regulation of IP rights may not be the best action for fixing problems regarding the quality of genetic testing, the group found, as these issues may be better addressed through evaluation and regulation of genetic tests and by coverage and reimbursement systems.
The group developed a number of draft policy options covering a variety of related areas. These policies would address advocacy efforts by stakeholders that would ensure access and those that would enhance transparency in patents and licensing.
Some policy recommendations are related to how research agencies should handle data related to genetic intellectual property and report it to federal funding agencies, and some are aimed at guiding agencies such as the National Institutes of Health as they promote adoption of best practices for genomic and genetic inventions.
The NIH in particular could consider the feasibility of making compliance with its best practices for licensing genomic inventions a consideration in future grants awards.
The public comment period will last until April, Evans said at the meeting. The committee will analyze the comments and discuss them at its June meeting, and then develop a revised report that incorporates public comments in the late summer.
At the October meeting, the committee will discuss the final report and hold a vote to pass it on to the new HHS secretary.

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