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Debating Small Differences

Executive Summary

The European Court of Justice has been wrestling with a set of sticky questions: to what extent should the existence of a new version of a drug influence what becomes of a previous version? The case that is raising these issues was filed by Rhone-Poulenc Rorer in June 1997, as a protest against a decision by the UK Medicines Control Agency, which granted a parallel import license for an old version of RPR's insomnia treatment zopiclone.

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