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SACGHS to Streamline Genetics-related Goals for Sebelius

NEW YORK (GenomeWeb News) – Members of the health policy committee that focuses on genetics and personalized medicine for the Department of Health and Human Services met last night to identify a core set of issues in genetics policy, which they plan to submit to HHS Secretary Kathleen Sebelius after a meeting this fall.

At a quarterly meeting yesterday, the Secretary's Advisory Committee on Genetics, Health, and Society decided to form a small group that would identify a short set of concise bullet points that it believes the secretary should be aware of. The list could include areas such as health information technology, biobanks, coverage and reimbursement issues, the role of genetics and genomics in healthcare reform, comparative effectiveness, physician education about genetic technologies, direct-to-consumer genetic testing, or other issues, committee members said.

The committee agreed to whittle down these issues to a group of three or four that it plans to bring to Sebelius' attention, but does not plan to provide specific recommendations to the secretary. Rather, the aim is to identify the set of issues related to genetics policy that should be in Sebelius' sights as the Congress and the White House take aim at America's health care policy.

The committee also plans to deliver a final report on gene patents and licensing to Sebelius' desk sometime after its October meeting, by which time it will have reviewed and integrated public comments on its "Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests."

A public comment period on the report, which closed in mid-May, generated a wide range of opinions from "all over the spectrum," according to committee member James Evans.

"[The report] was criticized at times … but the criticism came from opposite ends, both side of the spectrum — from the ones that have little desire to see the changes, and from the ones who care about seeing the whole genetic landscape," said Evans, who is a clinical professor in the Department of Genetics at the UNC School of Medicine at the University of North Carolina, Chapel Hill.

That report proposed several things that government and other stakeholders might do in the gene patenting area in order to optimize patient access to genetic tests, including a establishing a "code of conduct" to encourage access. The draft report proposed enhancing transparency in patents and licensing, the establishment of an advisory board for the HHS secretary to assess how gene patenting and licensing impacts public health, and the creation of a reporting system for users of genetic tests that would make studying that impact easier, among others.

Evans, who is leading the task force for the patenting and licensing effort, said the group will "go through each of the policy options that are going to be thrown out to the public," identify those that have general support and those that generate the most dissent, and decide which options to strike and which to leave for the full committee discussion.

"I anticipate there is going to be disagreement," Evans said of the proposals, adding that the discussion "is not going to be like genetic discrimination," where there was consensus that it "was a bad thing."

"There are going to be people who do not agree" with the patenting and licensing proposals, he said.

The SACGHS committee yesterday heard reports and comments from industry, the medical community, and patient advocates on health information infrastructure, and how genetics fits into certain areas of the healthcare system, including pediatrics and cancer diagnosis and treatment.

The committee on Thursday also heard updates on how genomics and epigenetics studies are beginning to influence cancer treatment through the development of optimal dosing and other pharmacogenomic uses, about how these technologies can be used to develop early interventions for pediatric diseases, and about how the patient advocacy groups may be able to work with genomics researchers and industry partners.

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