Conditional marketing authorisations in EU pharmaceuticals law

18/12/15

Accord Healthcare Ltd. v. Astellas Pharma GmbH [2015] EWHC 3676 (Ch)

The High Court has handed down an important judgment on the interpretation of the Community code relating to medicinal products for human use contained in Directive 2001/83/EC (“the Directive”).

The case concerned when the 10-year regulatory data protection period for the Defendants’ chemotherapy drug had begun. Upon expiry of the 10-year period, the Claimants wanted to use the data to market a generic version.

Complications had arisen because the product in question had been developed in East Germany and there were doubts as to whether the Nachzulassung process for converting old German marketing authorisations into EU-compliant marketing authorisations accorded with the requirements of EU law. In particular, it was suggested that the Directive gives limited scope for the competent licensing authority to grant a marketing authorisation containing conditions subsequent, as had been the practice in Germany. There were also doubts as to whether, as a matter of German law, the settlement of appeal proceedings in Germany had resulted in the annulment of the marketing authorisation upon which the Claimants sought to rely.

Mr Justice Morgan heard evidence on German law and concluded that the marketing authorisation did comply with EU law and had not been annulled. The judge held that it was acceptable under the Directive for the competent authority to impose conditions on the applicant for a marketing authorisation which were to be complied with post-authorisation. 

The judgment is here.