Boris Ignachkov Legal Principles and Key Points
- The case of Case C-452/06 ex parte Synthon BV [2008] ECR I-7681 concerned the Francovich principle of state liability. The scope of discretion for member states demonstrated its applicability; the European court reaffirmed Brasserie: where the breach was sufficiently serious with a causal connection, it shall apply.
Facts of Case C-452/06 ex parte Synthon BV [2008] ECR I-7681
- Danish company Synthon BV, C, were granted market authorisation for their drug by the Danish Medicines Authority after they successfully compared it to another drug with the same active molecule
- Relying on this authorisation, Synthon made an application to the Licensing Authority of the Department of Health for the UK (D) for mutual recognition of the marketing authorisation of the drug
- The UK Licensing Authority denied the authorisation of the drug produced by Synthon, this was based on their general policy that medicine containing different salts from the same active moiety would not be considered similar
- A second application was made based on Article 28 of Directive 2001/83 but was denied on the same grounds
- C then brought proceedings before the English High Court for an annulment of the second refusal by the D, and claimed damages
- The High Court referred questions to the European Court of Justice for a preliminary ruling
Issues in Case C-452/06 ex parte Synthon BV [2008] ECR I-7681
- Was the refusal contrary to Directive 2001/83/EC?
- If so, did this give rise to state liability to compensate the loss suffered by the C?
Held by the European Court of Justice
- Yes to both: there was a breach of the Directive, and state liability to compensate the C, Synthon, applied.
Findings of the Court
In respect of the breach of the Directive, the European court found:
- “it cannot be accepted … that the Member State in receipt of an application for mutual recognition is entitled – outside of the situation where there is a risk to public health referred to in Article 29 – to carry out a fresh assessment of the data on essential similarity which the reference Member State relied on in accepting an abridged application” [31]
- “not only would such an interpretation run counter to the very wording of Articles 28 and 29 of Directive 2001/83, but it would render those provisions redundant. If a Member State which was asked to recognise an authorisation already granted by another Member State could make that recognition subject to a second assessment of all or part of the application for authorisation, that would deprive the mutual recognition procedure established by the Community legislature of all meaning and seriously compromise the attainment of the objectives of Directive 2001/83 such as, in particular, the free movement of medicinal products in the internal market, referred to in paragraph 25 above.” [32]
- “Article 28 … precludes a Member State to which an application is made for mutual recognition of a marketing authorisation of a medicinal product for human use granted by another Member State under the abridged procedure provided for in Article 10(1)(a)(iii) of that directive from refusing that application on the ground that the medicinal product in question is not essentially similar to the reference product.” [32]
For the Member State to be find liable of the damages incurred by the C:
- “a Member State to incur liability for damage caused to individuals by a breach of Community law it is necessary that:
- the rule of law infringed should be intended to confer rights on individuals;
- the breach should be sufficiently serious;
- there should be a direct causal link between the breach of the obligation incumbent on the State and the damage sustained by the injured parties.” [35]
- However, “the mere infringement of Community law may be sufficient to establish the existence of a sufficiently serious breach” [38]
The breach in the present case was “enough to establish a sufficiently serious breach of Community law” [43]