Case C-452/06 ex parte Synthon BV [2008] ECR I-7681

Key point

  • This case demonstrated that the scope of discretion for member states under EU law can affect whether Francovich liability arises


  • The UK Licensing Authority for Medicines denied authorisation of a drug produced by Synthon
  • A reference authorisation granted by Italy was not recognised under the mutual recognition rule of Council Directive 2001/83 on the ground that the drug approved by Italy is not sufficiently similar
  • Question was referred to the ECJ on whether the refusal was contrary to Directive 2001/83 and if so, whether it gives rise to state liability to compensate the loss suffered by Synthon


  • There was a breach of Directive 2001/83 and state liability applied


  • If the member state is given reduced or even no discretion under EU provision, mere infringement of EU law may be sufficient to establish a sufficiently serious breach
  • In the current case, the Directive confers on the member state in receipt of an application for mutual recognition a very limited discretion for reasons to refuse to rely on the assessment carried out by the reference member state
  • Refusal on the ground that the medicine in question is not essentially similar to the reference product is precluded under the Directive
  • Thus the breach of the directive is enough to establish a sufficiently serious breach of Community law