R (Synthon BV) v Licensing Authority of the Department of Health Case C-452/06, [2008] ECR I-7681

Synthon obtained Danish marketing authorisation for a medicinal product under the generic-product procedure. It then sought recognition in the United Kingdom under the mutual-recognition framework. The UK authority rejected the application because it disagreed with the Danish assessment of essential similarity where the products involved different salts of the same active substance. Synthon challenged the refusal and sought damages. The High Court referred questions about the receiving authority’s powers under Directive 2001/83 and whether refusal outside the prescribed framework could constitute a sufficiently serious breach for state liability.

Could the receiving authority revisit the reference state’s generic-product assessment outside the directive’s prescribed procedure, and could its refusal constitute a sufficiently serious breach?

The Court held that the receiving authority could not reject recognition by conducting the unrestricted reassessment relied on. The directive established a procedure for recognition and for resolving relevant public-health concerns, which the authority had to follow. Where the legal obligation left no relevant discretion, refusal on an unauthorised ground could constitute a sufficiently serious breach. That conclusion did not dispense with the other state-liability conditions, including a rule intended to confer rights and a direct causal link to damage. The national court had to determine the consequences. The judgment did not establish automatic compensation for every unsuccessful medicines application or prevent use of the directive’s legitimate objection procedure.

A medicines authority must comply with the prescribed mutual-recognition procedure rather than substitute an unauthorised reassessment. Breach of a clear obligation leaving no relevant discretion may be sufficiently serious for state liability, subject to the remaining conditions.

Synthon provides a practical application of the sufficiently serious breach test where administrative discretion is tightly confined. It should be distinguished from complex policy decisions allowing a wider margin of judgment. The case also shows why the exact legislative procedure matters more than a general preference for mutual recognition. Current medicines authorisation and UK arrangements require separate verification before applying the historical framework.