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High Court declines to determine compatibility with EU law of pre-accession marketing authorisation, refuses reference to the Court of Justice


The Administrative Court (Lewis J) has today rejected a claim for judicial review brought by the manufacturer of a medicinal product against the decision to grant a marketing authorisation (MA) to a generic applicant, which relied upon an MA granted by the Czech Republic before it acceded to the EU: R(Orion) v Secretary of State for Health and Social Care, acting as the Licensing Authority (EVER Neuro Pharma GmbH, interested party).

Orion is the MA holder for Dexdor, a specialised form of sedative, whose active ingredient is dexmedetomidine hydrochloride. Its MA was granted by the European Commission in September 2011 under the centralised procedure.

Orion challenged the decision of the UK competent authority, the MHRA, to grant an MA to EVER (the interested party) to market DexEP, a generic dexmedetomidine hydrochloride product, in the United Kingdom.

EVER had applied for its MA under the decentralised procedure, nominating Denmark as the reference Member State and the United Kingdom as one of the concerned Member States. In its MA application, EVER relied on data from the Dexdor dossier, on the basis that Dexdor’s data exclusivity had expired. The basis for this was that Dexdor’s MA formed part of a global MA with an MA granted by the Czech Republic in October 2002 for another dexmedetomidine hydrochloride product called Precedex. Precedex’s data exclusivity had expired long ago. The Czech Republic later stated that it had applied EU law when granting the Precedex MA.

Orion contended that the Precedex MA did not comply with EU law and so could not commence a GMA (which it otherwise could have done once the Czech Republic acceded to the EU on 1 May 2004). This meant that Dexdor was entitled to a full period of data exclusivity, which had not expired when EVER made its application. This, in turn, rendered the MHRA’s decision unlawful.

The MHRA and EVER contended that the decision to grant the Precedex MA became a decision of an EU Member State upon Czech accession and that the judgment of the Court of Justice in Astellas, C-557/16, EU:C:2018:181, precluded an inquiry by the Administrative Court as to the compatibility of the Precedex MA with EU law. Orion sought a reference to the Court of Justice to determine whether the rule in Astellas applied on the facts of this case.

Following a three-day hearing, the Administrative Court dismissed Orion’s claim for judicial review and declined to make a reference to the Court of Justice. The Court examined the Treaty of Accession and Act of Accession governing Czechia’s accession to the EC (as it then was). It concluded that the Precedex MA became a decision of a Member State on the date of accession. Subject to national procedural requirements, including as to limitation, that decision was liable to be challenged in the Czech courts for non-compliance with EU law. But Astellas precluded the Courts of England and Wales from conducting the same inquiry.

The judgment is here.

Jemima Stratford QC and Emily MacKenzie appeared for Orion, instructed by Arnold & Porter Kaye Scholer LLP

David Scannell appeared for EVER Neuro Pharma GmbH, instructed by Bristows LLP