On 22 December 2010, the European Court of Justice (“ECJ”) issued a judgment in European Commission v. The Republic of Poland (C-385/08) in which it found that Poland was in breach of European Union law. The breach involved generics of the medicine Plavix being introduced to trade and marketed after Poland’s accession to the European Union. These generics were not covered by the transitional period and their marketing authorisations issued prior to 1 May 2004 had not been “harmonised”.

The ECJ dismissed the arguments raised by Poland’s attorneys-in-fact that no breach had occurred as Poland was not obliged to apply Community law prior to EU accession and thus the marketing authorisations should be assessed solely in the light of Polish law. The ECJ noted that the breach involved the marketing authorisations being retained in force after 1 May 2004 and therefore in the period when Poland was in fact bound by Community law.

The fact that in Polish law the data exclusivity period for Plavix was 3 years and ended prior to 1 May 2004 is of no significance, as the medicine was registered in a central procedure and to 15 July 2008 was covered by the data exclusivity period. This means that between 1 May 2004 and 15 July 2008 Poland was not entitled to issue marketing authorisations for Plavix generics in a simplified procedure or retain in force marketing authorisations issued earlier.

Although there was no transitional period for the medicines covered by the ECJ judgment, the ECJ’s reasoning can also be applied to non-harmonised medicines that as an exception could be marketed until the end of 2008. It seems therefore that if a marketing authorisation was not harmonised by the end of 2008, then under Community law it is illegal for the medicine to continue to be marketed.

prof. Marcin Matczak

prof. Marcin Matczak
Radca Prawny, Partner



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