Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

In keeping with our mandate to provide advice on the broad range of policy issues raised by the development and use of genetic technologies as well as our charge to examine the impact of gene patents and licensing practices on access to genetic testing, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is providing to you its report Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. The report explores the effects of patents and licensing practices on basic genetic research, genetic test development, patient access to genetic tests, and genetic testing quality and offers advice on how to address harms and potential future problems that the Committee identified. It is based on evidence gathered through a literature review and original case studies of genetic testing for 10 clinical conditions as well as consultations with experts and a consideration of public perspectives.
Based on its study, SACGHS found that patents on genetic discoveries do not appear to be necessary for either basic genetic research or the development of available genetic tests. The Committee also found that patents have been used to narrow or clear the market of existing tests, thereby limiting, rather than promoting availability of testing. SACGHS found that patients have been unable to obtain testing when a patent-protected sole provider does not accept particular payers, particularly state Medicaid insurance. SACGHS also found that when there is a patent enforcing sole provider, patients cannot obtain independent second-opinion testing, and sample sharing as a means of ensuring the quality of testing is not possible. The substantial number of existing patents on genes and methods of diagnosis also pose a threat to the development of multiplex testing, parallel sequencing, and whole-genome sequencing, the areas of genetic testing with the greatest potential future benefits.

Secretary’s Advisory Committee on Genetics, Health, and Society

Department of Health and Human Services

April 2010

External Link