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Volume8
MonthMay
Year2007
TitleRegulatory Marketing Approval for Pharmaceuticals as a Non-Tariff Barrier to Trade: Analysis Under the WTO's Agreement on Technical Barriers to…
Author(s)Mary Hess Eliason
First Page559
AbstractAt a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, how these regulations affect developing countries who may want and/or need to establish their own pharmaceutical industries, and how the World Trade Organization's Agreement on Technical Barriers to Trade may permit sanctions against such protectionist policies.