Journal of health politics, policy and law
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J Health Polit Policy Law · Dec 2009
Policy making on data exclusivity in the European Union: from industrial interests to legal realities.
After lengthening the duration of patents to twenty years in 1984, the pharmaceutical industry has turned to data exclusivity as a major vehicle for extending market protection, even after patents expire. Such protections give companies the power to tax consumers for innovation by charging above-market prices. ⋯ Several factors influenced the outcome, including the role of the pharmaceutical unit of the Directorate General for Enterprise of the European Commission in promoting the interests of the innovative branch of the industry, the time pressure to find a viable compromise before EU enlargement, and the heterogeneous preferences of the other actors. The case illustrates the inherent tension between the desire of both health care administrators and patients for high-quality, low-cost medicines and the objective of the innovator pharmaceutical industry to find and approve new drugs that are price protected and sell them in a way that maximizes revenues.