European Regulatory Agencies

Peter O'Donnell .Applied Clinical Trials, Dec 1, 2005 .
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The year 2005 has seen the European pharmaceutical environment become an even more complex combination of political and technical tensions.

At the political level, the European Commission has been trying to stimulate innovation and to promote an enterprise culture, in the face of persistent major divergences among EU member states about the right way for Europe to respond to the new pressures of globalization. These discussions have repeatedly degenerated into polarized views about whether Europe should focus on protecting the jobs it has, or on creating new ones—and are still, towards the end of the year, totally unresolved.

Although pharmaceuticals is demonstrably one of the most successful of Europe's industrial sectors and continues to create high-quality jobs, it is a victim of this strategic confusion. Thus the commission's announcement of a new industrial strategy for Europe, angled towards innovation and enterprise, ran straight into heavy fire from French President Jacques Chirac, determined to demonstrate to his electorate that he was going to make no concessions to a policy that did not pay as much attention to job protection as job creation.

Similarly, the ambitious earlier drafts of new commission strategies specifically for pharmaceuticals and biotechnology had to be watered down to a shadow of their initial aims to avoid offending sensitivities in key member states. As a result, both of these supposedly major plans turned out to be very little more than repetitions of earlier formulae adorned with lavish expressions of pious hope and empty rhetoric.

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