The public consultation draft report is the result of work that began in 2004, when SACGHS identified the effects of gene patents and licensing practices on patient and clinical access to genetic tests as a high-priority issue that warranted further study.

The task force reviewed a number of case studies to draw conclusions about how gene patents affect pricing, access to and availability of genetic tests, innovations and research related to genes, and other areas. The case studies did not reveal "widespread overpricing" of genetic tests that were patented and exclusively licensed relative to those that are unpatented or nonexclusively licensed.

So far, the panel found, patents covering genetic tests and related licensing practices do not appear to be impeding patient or clinical access to tests. The report points out that in those cases where patient access was impeded, the problems tended to be caused not by the patent itself but by the way it was licensed or used.

"Concerns about the quality and validity of genetic tests may best be addressed by enhancing the oversight system for laboratory-developed tests," notes the draft report. At the same time, the panel observes, "If regulatory oversight of genetic tests evolves, requiring some type of costly independent review before marketing, patent protection may be needed for companies to be willing to risk resources in satisfying the regulatory requirements."

The report’s final chapter provides a broad range of policy options for public consideration, including those focused on advocacy efforts by key stakeholders to ensure access to genetic tests, enhancing transparency in patents and licensing, filling data gaps, federal efforts to promote broad licensing and patient access, and improving United States Patent and Trademark Office policy.

Among the options presented for statutory change, which would apply to both the private and public sectors, are those that would limit the patenting of diagnostic tests that rely on an association of a particular genotype with a disease or disorder, create an exemption from patent infringement liability for medical practitioners who use genetic diagnostic tests in clinical care, and prohibit patents on human health-related nucleic acid sequences.