12:00 AM
Mar 29, 2004
 |  BioCentury  |  Politics, Policy & Law

Behind the Omnitrop curtain

Transparency is a word that apparently has been omitted from the dictionaries of any of the languages used in Brussels. Secrecy and opacity, however, are well understood concepts.

It is no surprise to anyone in the biotech or pharmaceutical business that dealing with the European regulatory and political authorities is complicated, time-consuming and discouraging. Unlike in the U.S., discussions are held and decisions made behind closed doors, and it is common all over Europe that citizens have no right to look at government documents, despite the fact that they are produced at taxpayer expense.

As a result, the hard-boiled reporter is familiar with the fact that European agencies do not reply in a timely manner or, more often, do not respond at all.

But even by these standards, last week's experience with the European Commission was extraordinary. BioCentury has been following the efforts of Sandoz to win approval of its Omnitrop human growth hormone as the first follow-on biologic in Europe (see "European Notebook,"...

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