When a biologist isolates a bacterium and sequences its genome, the results are her intellectual property. She is free to publish the sequence or share it with other biologists in whatever manner she deems appropriate. When you get blood drawn and tested, the results become part of your personal health record. Your doctor shares them with you, but needs your express permission to disclose them to anyone else. In many ways, your medical records belong to you, the patient. But when the medical test in question is the sequencing of your genome,who owns the results ? As of now, the law doesn't have an answer.
President Obama recently weighed in on this issue. At a February 25th forum on his Precision Medicine Initiative to use genetic data to create individualized cures, he stated that genetic data should belong to patients. The President was speaking informally, but he suggested the direction in which the initiative might be headed. Obama has also directed the Department of Health and Human Services to publish guidelines clearly stating that patient access to medical records includes genomic testing. Still, guidelines and a passing remark by the president don't make a law.
Advocates argue that the laws should go further. The nonprofit advocacy group Genetic Alliance claims that patients who are subjects in genetic research should be treated as partners. But this goes too far -- researchers and scientists deserve to have some ownership over their work. Treating patients as partners might lead to confidentiality problems when it comes time for researchers to to publish results. A patient might not want her name attached to her medical history in such published research. If patients are partners in research, would you need an advanced degree in genetics just to be a patient?
The law seems headed in the direction President Obama has suggested. In Association for Molecular Pathology v. Myriad Genetics, (2013) the U.S. Supreme Court voted unanimously that human genes could not be patented. Myriad had isolated the BRCA1 and BRCA2 genes, linked to heightened risk of breast and ovarian cancers. The SCOTUS decision points towards patient ownership of genetic material. But for now, Myriad represents a narrow slice of the larger issue, and does not extend to who owns the results of research. The Myriad case took years to reach the Court. BRCA genes were discovered in 1995. Not until 2013did the Supreme Court ruling void the BRCA gene patents.
Medical science cannot afford another 20 years during which lower courts might have contradicting interpretations of who owns a patient's genome. When the law is unclear, companies patent anything and everything. This chaos is confusing and deters potential patients from participating in research. If gene-tailored medicine is going to become a reality, the law must be clear.
Ownership of genetic research should not be decided by the Supreme Court. Instead, Congress must strike a balance between the rights of patients and the needs of researchers. A concrete law will benefit everyone. It might even have bipartisan appeal, as it concerns privacy rights, an issue of interest to both sides of the aisle. Congress must act soon to keep medical science moving forward and protect the privacy rights of patients.