Synthon BV, R (on the application of) v The Licensing Authority & Anor

Synthon BV, R (on the application of) v The Licensing Authority & Anor

The court held that Synthon has a good arguable case on the MRP issue, which is of general importance and unresolved by the ECJ. The Authority's arguments to avoid a reference are unpersuasive; the court's discretion to grant declaratory relief should not be foreclosed, and liability should be determined before causation. Therefore, a reference to the ECJ is necessary.

Parties
Claimant: Synthon BV; Defendant: The Licensing Authority; Interested Party: SmithKline Beecham PLC
Jurisdiction
England and Wales
Judgment Date
13 July 2006
Procedural Posture
Judicial Review / Application to Lift Stay and for Reference to ECJ
Outcome
Application granted
Legal Topics
Judicial Review, Mutual Recognition Procedure (mrp), Marketing Authorisation, Damages for Breach of EC Law, Declaratory Relief
Administrative Law European Union Law Pharmaceutical Law Judicial Review Mutual Recognition Procedure (mrp) Marketing Authorisation Damages for Breach of EC Law Declaratory Relief

Case Brief

Summary, issues, holding and outcome

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Parties

Synthon BV

Claimant

The Licensing Authority

Defendant

SmithKline Beecham PLC

Interested Party

Procedural Posture

Judicial Review / Application to Lift Stay and for Reference to ECJ

Legal Issues

  1. 1 Whether the Licensing Authority acted unlawfully by refusing to apply the Mutual Recognition Procedure (MRP) under European law
  2. 2 Whether a reference to the European Court of Justice (ECJ) is necessary to resolve the MRP issue
  3. 3 Whether Synthon is entitled to declaratory relief and damages for the period prior to authorisation

Ratio Decidendi

The court held that Synthon has a good arguable case on the MRP issue, which is of general importance and unresolved by the ECJ. The Authority's arguments to avoid a reference are unpersuasive; the court's discretion to grant declaratory relief should not be foreclosed, and liability should be determined before causation. Therefore, a reference to the ECJ is necessary.

Court Disposition

Application granted

Orders

  • The stay of proceedings is lifted.
  • A reference to the European Court of Justice is to be made in the terms sought in the draft order, subject to further representations from the parties.