Wasserman Schultz’s Legislation Ensuring Access to Second Opinions for Patients Signed Into Law

WASHINGTON – President Obama recently signed into law the America Invents Act (H.R. 1249), which included an important provision sponsored by Rep. Debbie Wasserman Schultz (FL-20) for a study on patient access to genetic tests.

Congresswoman Wasserman Schultz’s part of the bill, based upon her legislation H.R. 2276, requires the U.S. Patent and Trademark Office to conduct a study on ways to remove barriers for patients to get access to second opinions on genetic testing.  Currently many patients face barriers presented by the problem of exclusive patents on genetic tests, which can limit a patient’s options when faced with the decision of having to undergo possible treatments or therapies.

In 2007, Rep. Wasserman Schultz was diagnosed with breast cancer, and through genetic testing, discovered she is a carrier of the BRCA-2 gene mutation, drastically increasing her lifetime risk of ovarian cancer and recurring breast cancer.  Unfortunately, there is only one test on the market to detect this mutation. The maker of this test not only has a patent on the gene itself, but also exclusively issues licenses to certain laboratories to administer the test.

In approximately 20 percent of all genetic tests, only one laboratory can perform the test due to patent exclusivity for the diagnostic testing, and often the actual human gene being tested.

“This study is the first step toward designing a more effective system that will finally allow for patients to have access to truly independent second opinions in genetic diagnostic testing,” said Rep. Wasserman Schultz. “Patients should not have to make life altering decisions based on the results of only one test.” Everyone deserves to have as much information as possible when having to make serious health care decisions. I look forward to working with the Patent office to ensure this study gets us the answers we need to push innovation in genetic testing and expand access to second opinions.”