An International Drug Administration: Curing Uncertainty in International Pharmaceutical Product Liability

Davis, Katherine A. | January 1, 1998

This comment will demonstrate how discrepancies among product li- ability standards and different interpretations of their application have cre- ated fear and uncertainty in the pharmaceutical industry. This fear has caused distortions in the market, increased costs for both manufacturers and consumers, and chilled the research and development of new products. To combat these problems, this comment proposes that the United States, the European Union, and Japan work together to create a new international, uniform system of product liability for pharmaceutical products. Harmo- nizing the standard of liability for pharmaceuticals among these regimes has proven inadequate to stop inconsistency and uncertainty. This comment proposes the creation of an International Drug Administration (IDA), com- prised of members from different countries that would serve as an interna- tional regulatory agency promulgating registration and development requirements for new drugs on the international market. A special subset of the IDA would serve as an administrative tribunal for liability cases. The IDA tribunal would provide a uniform system of product liability, compen- sating consumers for injury but not punishing manufacturers without fault. Part II of this comment will introduce the current liability standards for pharmaceutical products in the United States, the European Union, and Ja- pan, and will explain how these standards developed and how they differ from each other. Part I will then illustrate how these differences translate into uncertainty and how that uncertainty negatively affects the pharmaceu- tical market. Part IV will introduce the concept of international regulation of the pharmaceutical industry through an IDA. Finally, Part V will explain how this IDA would act as an administrative tribunal for pharmaceutical product liability claims. This system would eliminate inconsistency and uncertainty in product liability and provide a better, more uniform system of product liability for the pharmaceutical industry.