News and Analysis
Nature Reviews Drug Discovery 6, 257-258 (April 2007) | doi:10.1038/nrd2293
Price controls seen as key to Europe's drug innovation lag
Peter Mitchell1
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Abstract
Pharmaceutical innovation is not only occurring faster in the United States than in Europe, but the gap is getting wider.
For those hoping that Europe might be redressing the imbalance in R&D innovation compared with the United States, two recent reports make gloomy reading. According to a competitiveness report published in November 2006 by the European Commission's high-level Pharmaceutical Forum, the US has established itself firmly as the key innovator in pharmaceuticals since 2000. "That dominant position continues to expand... a disproportionate share of pharmaceutical R&D is performed in the US," it laments.
The discouraging conclusion for European R&D is backed up by Kenneth Kaitin, Director of the Boston-based Tufts Center for the Study of Drug Development, which released a study on drug approval times and new drug availability in Europe and the US earlier this year. He says pharmaceutical companies are increasingly submitting their new drug applications in the US long before they apply in Europe ? and as a direct result, they are focusing their R&D efforts in the US too.
Of the 71 drugs receiving marketing clearance both in the European Union and the US between 2000 and 2005, 73% (that is, 52 drugs) received approval first from the US FDA (Fig. 1). On average, the FDA approval came 1 year ahead of clearance by the European Medicines Agency (EMEA).
Complete article at
Nature