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Commission must scrutinise dossier if concerned that it is defective

15/11/24

The Finnish medicines company Orion has succeeded in its application to annul a Commission decision granting a centralised EU marketing authorisation for a medicine containing dexmedetomidine. The product is used as a sedative in intensive care.

The medicine was first developed in the early 1990s. At that time, Orion’s licensee (Abbott) made an application for marketing authorisation in the EU but subsequently withdrew that application due to concerns raised by the EMA about adequacy of the studies.

Orion’s case was that its licensee, Abbott, then submitted an application for a marketing authorisation in the Czech Republic on the basis of the same data previously submitted to the EU. After the Czech Republic joined the EU in 2004, the marketing authorisation was assessed by the Czech medicines regulator as compatible with EU law. Abbott, and later a different Orion licensee called Hospira, continued to sell dexmedetomidine in the Czech Republic until 2007. At that point it was withdrawn.

Orion challenged the grant by the Commission of a marketing authorisation for a generic medicine Dexmedetomidine Accord, which relied on the Czech marketing authorisation.

Allowing the application, the General Court observed that the EMA’s examination of the application was limited to an exchange of emails with the Czech authority (SUKL), which confirmed that the Czech marketing authorisation complied with EU law from the date of the Czech Republic’s accession to the EU. The Court found that the Commission relied solely on SUKL’s statement, without conducting an additional examination. It held the Commission had the competence and obligation to examine the eligibility of Precedex, especially when there was evidence suggesting that the Czech marketing authorisation might not comply with EU law.

The General Court also noted that the abridged procedure for generic medicinal products does not relax the requirements for safety and efficacy, and the eligibility of a reference medicinal product depends on its compliance with the substantive requirements of Directive 2001/83.

The Court found that the Commission should have requested more information from SUKL to verify the compliance of the Czech marketing authorisation with EU law. It also noted that the Commission had evidence which suggested that the clinical data submitted to SUKL were the same as those previously rejected by the EMA.

Finally, the General Court held that the Commission failed to provide adequate reasons for its decision and did not carefully and impartially examine all relevant aspects of the case.

The judgment of the General Court (Tenth Chamber, Extended Composition) in Case T-223/20, Orion v Commission, was delivered on 13 November 2024, and can be read here.

Jemima Stratford appeared before the General Court on behalf of Orion, instructed by Arnold & Porter.

Tim Johnston appeared before the General Court on behalf of Accord, instructed by Pinsent Masons LLP.

Daniel Piccinin KC acted for Accord prior to the hearing in the General Court.

In earlier Judicial Review proceedings before the English Administrative Court (here), Jemima Stratford KC appeared with Emily MacKenzie for Orion and David Scannell KC appeared for EVER Neuro Pharma, instructed by Bristows.