Case C-452/14, Doc Generici – one change to 62 marketing authorisations [judgment 2015, ECLI:EU:C:2015:644]

Before a medicine can be put on the EU market, it needs a ‘marketing authorisation’. The details on this certificate can be changed at a later date but a fee is charged. In this case, Doc Generici moved its corporate seat and its 62 marketing authorisations were varied by the relevant Italian body. The legal problem is the calculation of the bill. Should it be for one change repeated 62 times, as Doc Generici contends? Or should the fee be calculated per marketing authorisation, and thus the price of making a change to 62 marketing authorisations?

Facts
Doc Generici is a pharmaceutical company. It possesses 62 certificates for the medicines which it puts on the market. These certificates, known as marketing authorisations, were issued by the Italian Pharmaceutical Agency, the Agenzia Italiana del Farmaco (‘AIFA’) .

Doc Generici moved its corporate seat. In that context, it wrote to the AIFA requesting that changes be made to its 62 marketing authorisations in order to reflect this new fact. The AIFA made the necessary changes and sent them the bill. Charging the standard statutory rate of 600 euro for varying a Type I marketing authorisation, the AIFA billed Doc Generici 37 000 euro.

Doc Generici believed that only 600 euro should be owing. Only one change had been made, and it had been made repeatedly. It was possible to group identical changes.

Because the AIFA’s decision was a matter of administrative law, Doc Generici challenged what it considered to be an excessive, disproportionate bill before Rome’s District Court for Administrative Law. Doc Generici accompanied its legal challenge with a claim for damages. Doc Generici was successful. The AIFA appealed the matter up to the Italian Council of State.

In essence, the Italian Council of State recognised that there were rules for grouping identical changes but those rules related to changes made to pharmaceutical concentrations or pharmaceutical packaging – they were group changes made to a single marketing authorisation. That was not the case here: the change related to a corporate seat, and the change was made to every single marketing authorisation.

The Council of State also noted that the Italian charging rules corresponded to those of the European Medicines Agency (‘the EMA’). In that context, it was salient to recall what the EMA had expressed in their 2013 “Explanatory note on fees Payable to European Medicines Agency”. Under the heading, “Grouping of extensions and/or variations notified or submitted under the terms of Article 7 (2) of Commission Regulation n. 1234/2008”, the EMA had explained:

In the case of grouping of the same Type IA variations to the terms of several marketing authorisations owned by the same holder (as set out in Article 7(2)(a) of Commission Regulation (EC) No 1234/2008), the applicable fee shall be payable for each individual Type IA variation and for each marketing authorisation in the grouping.

Consequently, the Council of State seemed persuaded of the correctness of the AIFA’s bill.

Nevertheless, the Council of State wondered whether it could make a reference to the CJEU: there was doubt surrounding the correct approach to be taken (the parties were making divergent submissions); the law was incoherent after the TAR Lazio’s first instance judgment departed from the approach of the EMA’s guidance; and the matter was of considerable economic importance owing to the numbers of marketing authorisations which are issued.

Moreover, there was also a discrete problem perplexing the Council of State. It arose from the fact that neither party wanted a preliminary reference being made to the CJEU. The issue was this: the Council of State was the tribunal of last resort so was it obliged to make a reference to the CJEU?

Judge Cirillo, President of the Italian Council of State, decided to make a reference to the CJEU.

Questions Referred
According to the Curia website, the Italian Council of State has asked:

1. Must Article 3(2)(a) of Council Regulation (EC) No 297/95 of 10 February 1995, […] in the version currently in force, be interpreted as meaning that Type I marketing authorisation variations — and, in particular, in respect of the case in the main proceedings, Type IA variations — where an identical variation affecting several authorisations belonging to the same holder are concerned, are subject to a single fee, to the extent specified therein, or to as many fees as there are authorisations affected by the variation?

2. In the circumstances in the present proceedings, may or must, as held by this Chamber, the question be referred to the Court of Justice?