Brussels, 23/10/2014 (Agence Europe) - Under certain conditions, pharmaceutical companies may challenge decisions to authorise the marketing of a generic version of a drug it produces, the Court of Justice ruled in a verdict (case C-104/13) returned on Thursday 23 October.
Although the directive instituting the Community code on drugs for human usage (2001/83/EC) defines what a generic drug is and how it can be sold, it provides no rights of recourse for the holders of reference drugs. However, the Court ruled today, on the basis of the Charter of Fundamental Rights of the EU, that the holder should enjoy such rights.
However, the European judges restricted this right of recourse to the three fundamental rules of the directive. This means that companies which produce reference drugs can insist that: - its drug is not used as a reference drug by any other manufacturer within eight years from the date on which the market authorisation for its drug is granted; - once it is authorised, the generic is not sold within a period of ten years (or, depending on the case, eleven years); - its drug is not designated a reference drug if the generic does not fulfil the similarity condition demanded by the directive. (JK)