Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.

The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.

Background of the Astellas case

The case concerns Astellas’s product, Ribomustin (bendamustine). Astellas obtained a national MA for Ribomustin in East Germany, prior to the reunification of Germany in 1990. That MA was maintained following reunification and renewed in 2005. However, owing to certain deficiencies in the renewal procedure, Astellas always believed that the MA was not granted in accordance with the relevant EU pharmaceutical law. Astellas, therefore, applied for a MA for Levact, another bendamustine product, via the DCP. In 2010, following the authorisation of Levact, Astellas withdrew Ribomustin from the German market.

In 2012, Helm AG submitted a generic application for bendamustine via the DCP. Denmark acted as the RMS; Finland and Norway, as CMSs. The application used Levact (the recently authorised product) as the reference medicinal product, which the assessment by the Danish competent authority, as RMS, stated belonged to the same global marketing authorisation as Ribumustin (the old German product). The RMS, therefore, considered that regulatory data protection had expired and generic marketing authorisations could to be granted.

Astellas challenged the grant of generic MAs in all three countries based on the fact that the old, non-compliant, authorisation could not be used as the reference medicinal product against which the data protection period is calculated. In Finland, the Higher Administrative Court referred a number of questions to the Court of Justice of the European Union (CJEU) about the role of the national competent authority, and the national court, in the CMSs and their ability to question the assessment of the RMS in relation to regulatory data protection.

Views of the parties

The parties and interveners (including the competent authorities of Finland, Republic of Ireland, Spain, the UK, and Norway) put forward a range of conflicting opinions about the DCP process, role of the CMS, and how disputes as to regulatory data protection should be addressed.

However, the views of the European Commission prompted most discussion. In its view, the competent authorities of the CMSs have no discretion. They can raise questions about the start and expiry of the data protection period during the validation stage, and can alert the RMS to any issues arising. However, the decision of the RMS on validation is final. This seems to be consistent with the current practice during the DCP. Further, once the assessment is concluded, they are required to implement its outcome nationally. However, the holder of the MA for the reference medicinal product is entitled to challenge the outcome before the courts of either the CMSs or the RMS, both of which have authority to review the legality of the assessment on the data protection period and of the MA. However, if either of these courts has doubts about the legality of the decisions, it must refer questions to the CJEU.

The Judge Rapporter asked why it was not sufficient that the MA and assessment report can be challenged in the RMS. In response, the Commission explained that as it is a national decision that causes a MA to have legal effect in a Member State, that decision must be challenged in the national courts of the same Member State. The courts of a RMS have no authority in other Member States. Further, the rules on standing to be able to bring a challenge are very different across the EU, meaning it may not always be possible to bring an effective challenge in the RMS.