Worldwide: Advocate General Of The CJEU Opines That Cmss Are Co-Responsible For Marketing Authorisations Granted Under The DCP

The Opinion of Advocate General Bobek (AG) was handed down last week in case C-557/16, Astellas Pharma GmbH, regarding the role of the Concerned Member States (CMSs) in the Decentralised Procedure (DCP).1 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 (RDP), should be resolved in the CMSs, considering that national marketing authorisations (MAs) are granted at the end of the DCP.

The AG has opined that CMSs can 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.

Background

The case concerns Astellas's product, Ribomustin (bendamustine). The first medicinal product containing bendamustine obtained MA in the former German Democratic Republic (GDR) in 1971 under the tradename Ribomustin. In 1990, Germany was reunified. In accordance with transitional provisions allowing medicinal products that had been on the market in the GDR to remain on the market in Germany, Ribomustin was deemed to have a MA without the submission of any pre-clinical or clinical data. In 2005, following submission of data by Astellas, the German competent authority (BfArM) issued a re-registration of Ribomustin, but only for two of the four indications attached to the original product. However, due 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 an MA for Levact, another bendamustine product. In 2010, following the authorisation of Levact, Astellas withdrew Ribomustin from the German market.

In 2012, Helm AG submitted an application for a (generic) copy of Levact using the DCP with Denmark as the RMS and Finland and Norway as CMSs. The application cited Levact (the bendamustine product authorised in 2010) as the reference medicinal product. The Danish competent authority considered that Levact belonged to the same global marketing authorisation as Ribomustin (granted by BfArM in 2005), and therefore the RDP had expired and generic MAs could be granted.

Astellas challenged the grant of generic MAs in all three countries saying that the 2005 MA was not granted in accordance with EU law and thus could not start time running for the purposes of RDP. An originator's RDP starts to run from the date of the grant of the first authorisation in the EU granted in accordance with EU provisions in force. Astellas contended that the first such authorisation was granted in 2010 for Levact. Helm disagreed and also argued that Astellas could not properly challenge the status of the 2005 German authorisation in Finland as a CMS could only object to the assessment of the RMS on public health grounds and not on RDP grounds. 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 a CMS and their ability to question the assessment of the RMS in relation to RDP.

AG Opinion

The AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product or when the applicable RDP period started running. Rather, he confines his opinion to the role of CMSs within the DCP and the ability of CMSs' national courts to review the decision of the national competent authority.

The AG begins by distinguishing the mutual recognition procedure (MRP), which, prior to 2004, was the only procedure by which national applications for MA could be made to multiple Member States from the DCP, which was added when Directive 2004/27 modified Directive 2001/83. The AG explains that the MRP may only be used by an applicant that has already been granted an MA in one Member State, that then acts as RMS. The CMSs are under a "clear and precise" obligation to recognise the scientific assessment of the RMS, which may only be called into question on public health grounds. Conversely, the AG views the DCP as a system of "co-decision logic" by which there must first be agreement on the product-related documents (namely, the assessment report, summary of product characteristics, labelling, and package leaflet) of the medicinal product. Only then, in the second step, can the CMSs adopt their own national MA.

Once agreement concerning the product-related documents has been reached, the AG states that CMSs cannot unilaterally revisit and reassess those documents. However, in the first step, a dialogue should take place between the CMSs and RMS. The AG recognises that the only potential objection of a CMS provided for by Directive 2001/83 is a 'potential serious risk to public health.' The AG notes that the question of whether RDP has expired does not initially appear to be an issue of public health. However, he reasons that, since the authorisation of a generic product relies on the data of the reference medicinal product, if those data are protected by RDP, and thus cannot be consulted, it is impossible to conduct any scientific assessment of the generic product. As such, the AG opines that agreement of the RMS and CMSs on the expiry of RDP is a preliminary, but indispensable, part of the approval process and each CMS is co-responsible for the conclusions reached.

Further, the AG states that, although the CMSs co-approve and become co-responsible for the resulting product-related documents, the MA that the CMSs grant is a formally independent administrative decision valid exclusively in their relevant national territory. As such, the AG "fail[s] to see any option other than to affirm the possibility of parallel and full judicial review of the respective marketing authorisation(s) issued in any of the Member States as a result of the [DCP]".

The AG acknowledges that his recommended solution may result in particularism as the court of each CMS will be able to adopt its own view on questions such as the RDP period, which may result in conflicting judgments. However, he suggests that this is the inevitable consequence of a decentralised system. If decentralised judicial review is an obstacle to a unified internal market for medicinal products, the AG suggests:

"... it would perhaps be ideal to voice those needs to the European legislature and initiate the adoption of an appropriate legislative regime reflecting those needs. I find it, however, unacceptable to first embrace a legislative framework which is quite decentralised, and then to use the argument of the need for a uniform regime to effectively deprive individual applicants of legal protection within that legislatively particularised regime. Simply put, market integration is not a good reason for creating black holes in judicial protection."

He adds that the obligation of sincere cooperation means that if the competent authorities of a CMS discover an issue possibly affecting the correctness of an MA granted by other CMSs, including the RMS, that competent authority should inform its counterparts accordingly. This may lead to reconsideration of existing national MAs through, for example, an ex officio review mechanism pursuant to the applicable national law.

Finally, the AG adds that if the legality of the original MA granted in another Member State is in issue, he believes that legality must be assessed in the Member State issuing the original authorisation, but he does not expand upon the relationship between this and judicial review in other Member States.

Conclusion

In 2008, the CJEU held in case C-452/06 (Synthon) that a CMS to which an application for MA under the MRP is made 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 MAs, either via the MRP or DCP. 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.

Footnote

1 See Opinion of Advocate General Bobek in Case C-557/16, Astellas Pharma GmbH.

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