The EU’s General Court on 13 November 2024 delivered its judgment in Case T-223/20, Orion v Commission.
Orion Oyj, a pharmaceutical company located in Finland, sought the annulment of the Commission’s implementing decision to grant this authorisation. The case revolves around the marketing authorisation of the medicinal product Dexmedetomidine Accord.
Background
Orion Oyj, based in Finland, developed the active substance dexmedetomidine hydrochloride in the early 1990s. This substance is used for sedation in intensive care settings.
In 1994, Orion entered into a licensing agreement with Abbott Laboratories, granting Abbott the rights to manufacture and market dexmedetomidine hydrochloride outside the Nordic countries. Abbott’s application for marketing authorization in the EU was initially withdrawn due to concerns raised by the European Medicines Agency (EMA) about the adequacy of clinical studies.
Abbott later obtained a marketing authorization for Precedex (dexmedetomidine hydrochloride) in the Czech Republic in 2002. This authorization was granted based on the same clinical data previously submitted to the EMA. After the Czech Republic joined the EU in 2004, the marketing authorization was considered compliant with EU law.
Orion challenged the European Commission’s decision to grant marketing authorization for Dexmedetomidine Accord, arguing that the Czech marketing authorization for Precedex did not comply with EU law. Orion claimed that the clinical data supporting the Czech authorization were inadequate and did not meet the requirements of Directive 2001/83/EC.
Orion has developed and marketed Dexdor, a product containing dexmedetomidine hydrochloride, which was a significant source of revenue for the company. The entry of Dexmedetomidine Accord into the market posed a direct competitive threat to Dexdor.
Applicable law
The case revolves around the interpretation and application of Directive 2001/83, which sets out the requirements for the authorisation of medicinal products in the EU. The Directive aims to safeguard public health by ensuring that medicinal products meet high standards of quality, safety, and efficacy.
Orion were seeking the annulment of Commission Implementing Decision C(2020) 942 (final) of 13 February 2020 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council [of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)] for ‘Dexmedetomidine Accord – dexmedetomidine’ (‘Dexmedetomidine Accord’), a medicinal product for human use (‘the contested decision’).
Judgment of the General Court
First was the issue of the examination of precedex’s eligibility. The General Court examined whether the Commission and the EMA had properly assessed the eligibility of Precedex as a reference medicinal product. The General Court noted that the EMA’s examination was limited to an exchange of emails with the Czech State Institute for Drug Control (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 General Court found that the Commission relied solely on SUKL’s statement, without conducting an additional examination. The General Court emphasised that the Commission had the competence and obligation to examine the eligibility of Precedex, especially when there was evidence suggesting that the Czech marketing authorization might not comply with EU law.
Second was the issue of the regulatory data protection (RDP) period. The General Court addressed the issue of the RDP period, noting that the abridged procedure for generic medicinal products does not relax the requirements for safety and efficacy. The General Court thus concluded that the eligibility of a reference medicinal product depends on its compliance with the substantive requirements of Directive 2001/83.
The General 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 suggesting that the clinical data submitted to SUKL were the same as those previously rejected by the EMA.
Third was the issue of the duty to state reasons and good administration. 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.
In light of this, the General Court annulled the Commission Implementing Decision.
Read the judgment
The judgment of the General Court (Tenth Chamber, Extend Composition) in Case T-223/20, Orion v Commission, was delivered on 13 November 2024, and can be read here.