Data Exclusivity And Euro Drug Registration

The European Court of Justice is to consider the way in which medicinesare licensed in Europe, and this could have major implications for the pharmaceutical industry, says Anthony Warnock-Smith, a partner at Morgan Bruce Solicitors. In his assessment, he makes particular reference to the implications of the Court's ruling to the UK.

Although the question was referred to the Court in October 1996, under normal time frames of operation, no final decision can be expected for at least two years, Mr Warnock-Smith told the Marketletter.

The review, he says, is a result of proceedings brought against the UK's Medicines Control Agency, which processes applications by drugmakers for marketing authorizations (MAs), and concerns the interpretation of European Union legislation relating to the licensing of medicines.