Accord Healthcare Ltd & Anor v Astellas Pharma GmbH & Anor

A marketing authorisation may qualify as an initial authorisation under Article 10 of the Directive 2001/83/EC where the competent authority had the required dossier and granted the authorisation in accordance with the Directive. The Directive permits competent authorities to impose post-authorisation conditions concerning manufacturing controls and product quality. The existence of such conditions does not itself show that the dossier was incomplete or that the authorisation was non-compliant. An appeal against only part of an administrative decision suspends only the challenged part where the decision is severable. A later renunciation may terminate an authorisation prospectively, but does not retrospectively erase its existence for the purposes of Article 10.

Accord sought declarations that Astellas’s July 2005 German authorisation for Ribomustin was an initial marketing authorisation under Directive 2001/83/EC, enabling Accord to rely on the generic-product derogation in Article 10. Astellas contended that the German authorisation was not granted in accordance with the Directive because the supporting dossier was incomplete, post-authorisation conditions were impermissible, decision-making had been delegated to an expert, and a later appeal and settlement had nullified the authorisation.

The dispute also concerned the effect of German administrative law on the July 2005 authorisation and the subsequent 2011 settlement. The court decided whether the authorisation was valid for the NHL and MM indications and whether it remained the relevant initial authorisation despite the later renunciation.

1. Outcome. The court made the declarations sought by Accord and dismissed Astellas’s counterclaim.
2. Directive compliance. Astellas had not shown that the dossier submitted to BfArM failed to comply with Articles 8 and 26 and Annex 1. The conditions in Q1–Q14 did not establish non-compliance. Article 19 recognises that a competent authority may be satisfied that the submitted particulars comply with the Directive while requiring further information or testing.
3. Post-authorisation conditions. The Directive, read as a whole, permits conditions, controls and requirements to operate after authorisation, particularly in relation to manufacturing processes and product quality. Articles 112 and 116 support that conclusion. Article 22 is not an exhaustive code of the circumstances in which conditions may be imposed. The later introduction of Articles 21a and 22a did not determine the meaning of the earlier text.
4. German procedure and expert evidence. BfArM’s use of section 105(5a) of the German Medicines Act did not make the authorisation non-compliant. The July 2005 decision was made by BfArM and took immediate effect. The independent expert’s report supplied information to BfArM; it did not transfer decision-making power to the expert.
5. Appeal and settlement. The appeal challenged only the refusal of the CLL indication. The decision was severable, so the appeal did not suspend the authorisation for NHL and MM. The settlement and renunciation took effect prospectively from 31 December 2011. They did not retrospectively invalidate the July 2005 authorisation.
6. Reference request. A reference under Article 267 TFEU was premature because the German-law issue could independently determine the result and the relevance of the issues to pending judicial-review proceedings was uncertain.

First-instance decision. The judgment records separate judicial-review proceedings concerning the MHRA’s later marketing-authorisation decision, but those proceedings were not an appeal from this action.