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Abstract
Pharmaceutical drugs are pillars of modern medicine and enshrined in the human right to health. Upholding the right to access such essential medicines requires systems that not only incentivize drug development, but that also audit new drugs for adequate safety and efficacy. In the United States, patent protection is widely recognized as a central incentive mechanism for drug-based innovation, while the Food and Drug Administration (FDA) is tasked with evaluating whether the benefits of new drugs outweigh their risks. For the FDA to approve a new drug, a designated sponsor—often, a large pharmaceutical firm—must conduct clinical trials to demonstrate that the drug is safe for human consumption and effective for a specific purpose.
Amidst a growing antibiotic resistance crisis, current approaches to both patent protection and clinical trial design are failing to adequately support new antibiotic development while upholding the human right to health. This Note argues that pharmaceutical policy proposals aimed at encouraging innovation or protecting human rights need to better consider the differences between pharmaceuticals. Using a health and human rights framework, this Note examines how antibiotic development implicates a specific set of intellectual property rights of drug developers and human rights of clinical trial participants. It then proposes refined perspectives specific to the unique landscape of antibiotic development.