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European Biopharmaceutical Review

EU-US Parallel Scientific Advice: Same Weaknesses?

Along with the scientific uncertainty inherent in developing new drugs, companies seeking approval throughout the world for their products must deal with an additional worry: navigating the diversity of global regulatory systems.

In theory, 13th May 2008 should have been an important date for pharmaceutical companies marketing medicinal products on both sides of the Atlantic. However, in practice, the situation of these companies might not greatly improve. 13th May 2008 is the date on which US Cabinet members and European Commissioners met for a second session of the Transatlantic Economic Council (TEC) and decided to intensify the cooperation between the US and the EU in the pharmaceutical area.

The TEC was created by European Commission President José Manuel Barroso, German Chancellor Angela Merkel and US President George W Bush to foster transatlantic economic integration at the EU/US Summit in Washington in April 2007. This welcome initiative was followed by a first meeting in Washington on 9th November 2007.


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Fabien Roy, a Legal Assistant in the Hogan & Hartson Brussels office, researches and assists in drafting legal opinions in the field of pharmaceutical law, and communicates regularly with the relevant authorities. He drafts reports on fields including: paediatrics, biosimilars, authorisation and control of pharmaceuticals, regulatory initiatives, oncology and diabetes. Fabien holds a Master’s in Public Law from the University of Silesia, and a Master’s in European Law from the University of Rennes.
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