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| REQUEST FOR PUBLIC COMMENT |
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Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests |
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DOWNLOAD PUBLIC CONSULTATION DRAFT REPORT |
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DOWNLOAD APPENDIX 1 |
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DOWNLOAD APPENDIX 2 |
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Federal Register Notice Regarding Request for Public Comment on the Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. |
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The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comments on a draft report to the Secretary of Health and Human Services, "Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests."
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This public consultation draft report is the result of work that began in 2004, when SACGHS identified the effect of gene patents and licensing practices on patient and clinical access to genetic tests as a high-priority issue that warranted further study. SACGHS activities in this area were deferred until the completion of a National Academy of Sciences (NAS) study on the granting and licensing of intellectual property rights to genetic and proteomic discoveries and the effects of these practices on research and innovation. In the fall of 2005, NAS released that study's report, Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. After reviewing the report, SACGHS decided that more information was needed regarding the effects of gene patents and licenses on patient and clinical access to genetic tests. In 2006, a task force was formed by SACGHS to guide its work in this area. The task force commissioned case studies, compiled relevant information through a review of the literature, and consulted with national and international experts and stakeholders.
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At the outset of its work, the task force decided to limit the scope of its inquiry to those genetic tests, whether used for diagnostic, predictive, or other clinical purposes, that rely on analysis of nucleic acid molecules to determine human genotype. As such, the kinds of patent claims that the Committee evaluated were nucleic acid-related patent claims associated with genetic tests for human genotype. This report does not address protein-based genetic tests or protein-related patent claims associated with tests designed to infer genotype.
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This public consultation draft report presents the Committee's preliminary findings. The draft report also includes policy options. These options do not necessarily correlate with any particular preliminary finding, but rather provide a framework within which to gather public input. The Committee developed these options to present a broad range of possible actions, but has not yet decided which, if any, of these policy options to support.
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Before SACGHS can develop specific recommendations for the Secretary, the Committee needs public input on several issues, including whether changes are needed in patenting and licensing practices that affect genetic testing, and the appropriateness, feasibility, and implications of the report�s policy options. Members of the public are also invited to recommend specific policy options not included in the presented options and any needed modifications to existing options. SACGHS also encourages the public to provide any additional information and data regarding the positive or negative effects gene patenting or licensing practices have had, are having, or may have on patient and clinical access to genetic tests.
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The Committee will carefully consider public input in finalizing its report and developing any recommendations to the Secretary.
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To submit comments to SACGHS, please e-mail them to Darren Greninger, at greningerd@od.nih.gov, by May 15, 2009. Alternatively, comments can be mailed to Mr. Greninger at the National Institutes of Health (NIH) Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 700, Bethesda, MD 20892 (20817 for non-U.S. Postal Service mail), or faxed to 301-496-9839.
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SACGHS was established in 2002 to assess the broad range of human health and societal issues raised by the development and use and potential misuse of genetic technologies. SACGHS is composed of up to 17 non-governmental national experts in a range of scientific and professional disciplines as well as 19 non-voting ex officio representatives from a number of HHS agencies and offices and other components of the Executive Branch. More information about SACGHS is available at http://oba.od.nih.gov/sacghs/sacghs_home.html.
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