Emory International Law Review


The Hatch-Waxman Act created the modern pharmaceutical regulatory approval process in the United States. The drafters of Hatch-Waxman sought to balance incentives for branded pharmaceutical company investment in innovative therapies with incentives for accelerated market entry of generic pharmaceuticals. Today, thirty years after enactment, the Hatch-Waxman balance has shifted. Branded pharmaceutical companies routinely exploit Hatch-Waxman loopholes to block generic competitors from entering the market. After much public outcry, United States officials have prioritized closing these loopholes. This Comment proposes Hatch-Waxman reforms which follow South Korea's pharmaceutical regulatory approval process. South Korea modeled its system on Hatch-Waxman yet made it more difficult for pharmaceutical companies to delay generic competitors. The United States need not adopt South Korea's system verbatim. Rather, South Korea's system should be used as a guide for restoring the intended Hatch-Waxman balance, promoting competition in the marketplace, and lowering drug prices in the United States.