In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.

This opinion should also be considered in the context of an earlier judgment of the Court. In 2008, the CJEU held in case C-452/06 (Synthon) that a CMS cannot call into question, on grounds other than those relating to the risk to public health, the assessment of the RMS, even where the decision of the RMS is in conflict with principles contained in the CMS’s national legislation. Generic companies have relied on Synthon in certain Member States, which has become a potential hurdle for innovative pharmaceutical companies wishing to challenge the grant of generic MAs referring to their original authorisations. If the CJEU follows the AG’s Opinion, each national competent authority that receives a generic MA application via the DCP may, as part of the process, take its own view on whether the RDP for the reference medicinal product has expired. Further, should the MA holder of the reference medicinal product disagree with the CMS’s view on RDP, he may challenge the decision of the CMS in the national court.

See our advisory for a fuller report of the Opinion.