The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) has voted to urge Secretary of Health and Human Services (HHS) Kathleen Sebelius to limit the ability of gene patent holders to keep others from using those genes for diagnostic and research purposes. The report included a statement of dissent from three members of SACGHS, which advises the HHS Secretary on the broad range of human health and societal issues raised by the development and use and potential misuse of genetic technologies.

The committee concludes its Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests with six formal recommendations, beginning with statutory changes that would exempt from liability for gene patent infringement “anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes” and those who use patent-protected genes in research.

Subsequent recommendations, which could be accomplished more quickly than the proposed legal changes, include promoting adherence to norms (such as non-exclusive licensing) that are designed to ensure access. Additionally, the committee recommends enhancing transparency in licensing, establishing an advisory body on the health impact of gene patenting and licensing practices, and working closely with the United States Patent and Trademark Office to provide expertise related genetic testing issues.

Finally, SACGHS recommends that the Secretary work to ensure equal access to clinically useful genetic tests. “Our advocacy for equal access here is part of this committee’s longstanding concern about ensuring equality in the provision of genetically related tests and services,” noted the authors.

For more on this story, see the March issue of Diagnostic Testing and Technology Report.