Sanders’ Proposal Sets a Dangerous Precedent
On Monday, presidential candidate Senator Bernie Sanders joined 11 other members of Congress in sending a letter to the National Institute of Health (NIH), urging the agency to cut costs for the prostate cancer drug, Xtandi, by employing its “march-in rights.” These rights, which have never before been utilized by the NIH, were established in 1980 under the Bayh-Dole Act, which gives federal agencies the authority to license a patent when action is deemed necessary, primarily as an emergency tactic. Using this provision as their justification, lawmakers are requesting that NIH override Xtandi’s patent protection, which guarantees its manufacturers exclusive sales, in an effort to reduce the costs of the drug.
On Monday, presidential candidate Senator Bernie Sanders joined 11 other members of Congress in sending a letter to the National Institute of Health (NIH), urging the agency to cut costs for the prostate cancer drug, Xtandi, by employing its “march-in rights.” These rights, which have never before been utilized by the NIH, were established in 1980 under the Bayh-Dole Act, which gives federal agencies the authority to license a patent when action is deemed necessary, primarily as an emergency tactic. Using this provision as their justification, lawmakers are requesting that NIH override Xtandi’s patent protection, which guarantees its manufacturers exclusive sales, in an effort to reduce the costs of the drug.
This request represents an enormous overreach by the government into U.S business and a major threat to the drug development process as a whole. Senator Sanders’ proposal has the potential to undermine the entire drug development system, which is supported by the protection of intellectual property rights and the maintenance of a strong patent system.
Biopharmaceutical companies operate under a complex business model-balancing the needs of patients, the demands of investors, and the hefty regulations imposed by the government. In order to encourage the development of innovative drugs (like Xtandi), the industry relies on patent protections to justify their investments. Allowing the government to step in and alter this system would have dire consequences — namely, new drugs might not be developed.
It’s not just the biopharmaceutical industry that should be concerned. Allowing the government to intervene in patents (which every innovative industry relies on to encourage investment in new ideas) sets a dangerous precedent of government overreach into the free market. What Senator Sanders is suggesting is a complete re-interpretation of legislation that was adopted to assist in the manufacturing of products to meet need during health or other public emergencies. In 35 years, these rights have yet to be deemed necessary by the NIH.
Attacks like this on individual drugs and their manufacturers won’t fix the systematic problem of rising healthcare costs in our country, in which insurers, hospitals, and healthcare providers all play a role. Targeting Xtandi individually and asking for more government intervention is not only a clear political move by Senator Sanders that won’t actually improve access to medicines for Americans, but a play that will also dismantle the entire patent system that protects U.S. innovation and specifically the development of effective treatments. With innovators on the cusp of major advances in disease areas like cancer, diabetes, and Alzheimer’s we need to be looking towards reforms that encourage drug development and accessibility, not misguided proposals that propel unnecessary and unwarranted government intervention in the healthcare market.
