Generic medicine authorisation procedure under EU law

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Apr 16, 2018
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Court of Justice of the European Union
Published: April 16, 2018
Proceedings brought by Astellas Pharma GmbH (Case C-557/16)
Before M Ilesic, President of the Chamber and Judges A Rosas, C Toader, A Prechal and E Jarasiunas (Rapporteur)
Advocate General M Bobek
Judgment: March 14, 2018

In a decentralised marketing ­authorisation procedure for a ­generic medicinal product, the competent authority of a member state concerned by that procedure could not itself determine the point in time from which the data exclusivity period for the reference medicinal product started to run when adopting its decision on the placing on the market of that ­generic medicinal product in that member state.

A court of a member state, hearing an action against a marketing authorisation for a generic medic­inal product taken by the competent authority, had jurisdiction to review the determination of the point in time from which the data exclus­ivity period for the reference medicinal product started to run, but did not have jurisdiction to review ­whether the initial marketing ­authorisation for the reference medicinal product granted in another member state was granted in accordance with European Union law.

The Court of Justice of the European Union so held on a reference from the Supreme Administrative Court of Finland in proceedings brought by Astellas Pharma GmbH with regard to the decision of the second joined party, Lääkealan turvallisuus-ja kehittämiskeskus (the Finnish Medicines Agency), authorising the marketing of a generic medicinal product produced by the first joined party, Helm AG. The United Kingdom government, inter alios, submitted observations.

The Court said that on July 19, 2005 the German Federal Institute granted to Astellas Pharma, in ­accordance with national law, a marketing authorisation for the medicinal product known as Ribomustin, the active substance of which was bendamustine, for two indications, non-Hodgkin ­lymphoma and multiple myeloma.

After completion of a decentralised procedure, as provided for in article 28 of Directive 2001/83 on the Community code relating to medicinal products for human use, for which Germany was the reference member state, France was the first member state to grant, on July 15, 2010, a marketing authorisation to Astellas Pharma for a medicinal product known as “Levact’”, the ­active substance of which was also bendamustine, with indications for non-Hodgkin lymphoma, multiple myeloma and chronic lymphocytic leukaemia.

On November 7, 2012 Helm ­applied for a marketing authorisation for a medicinal product called Alkybend by way of a decentralised procedure, in which the reference member state was Denmark and the member states concerned were Norway and Finland.

In its application Helm stated that Alkybend was a generic medicinal product, the active substance of which was bendamustine hydrochloride, and the reference medicinal product was Levact, but that ­Ribomustin, however, ought to be regarded as the reference medicinal product with respect to the determination of the data exclusivity period.

Following that procedure, which concluded on January 17, 2014, the Finnish Medicines Agency granted Helm the marketing authorisation for Alkybend on March 28, 2014, in accordance with the conclusions of the assessment report drawn up by the Danish competent authority.

According to that report, the marketing authorisation granted for Levact was to be regarded as part of the authorisation granted to ­Ribomustin in 2005 and the latter medicinal product constituted, for the purpose of assessing the data ­exclusivity period, the reference medicinal product.

Astellas Pharma brought an action challenging that decision before the Administrative Court, Helsinki, Finland, which dismissed that action, taking the view that that company had obtained the first marketing authorisation on ­July 19, 2005 and that, given that the duration of the protection period for Levact was six years as a consequence of the application of the transitional provisions, the Finnish Medicines Agency was fully ­entitled to grant a marketing authorisation to Helm in respect of ­Alkybend on March 28, 2014.

Taking the view that the data ­exclusivity period started not on July 19, 2005, but on July 15, 2010, the date of the first marketing ­authorisation granted for Levact, Astellas Pharma brought the matter before the Supreme Administrative Court, Finland, requesting it to set aside the decision of the court of first instance and to annul the ­decision of the Finnish Medicines Agency.

In the opinion of the court, having regard to the scheme of ­Directive 2001/83, in the specific case of disagreement between the member states involved in the  decentralised procedure for marketing authorisations for a generic medicinal product concerning compliance with that precondition, a member state had to be able not to approve the assessment report for that medicinal product if it ­ considered that that condition was not satisfied.

Therefore, a member state could refuse to approve the assessment ­report for the generic medicinal product in the event of disagreement on compliance with the precondition relating to the expiry of the data exclusivity period for the reference medicinal product.

Consequently, the procedure that concluded with the acknowledgement of general agreement, in which all the member states in which a marketing-authoris­ation application was submitted participated, involved verifying the expiry of the data exclusivity period for the reference medicinal product, so that the competent authorities of those member states could not, after acknowledgement of that agreement, repeat such verification.

In the light of those considerations, articles 28 and 29(1) of ­Directive 2001/83 meant that, in a decentralised marketing-authorisation procedure for a generic medicinal product, the competent authority of a member state concerned by that procedure could not itself determine the point in time from which the data exclusivity period for the reference medicinal product started to run when ­ adopting, under article 28(5) of that ­directive, its decision on the placing on the market of that generic ­medicinal product in that member state.

In the system for the decentralised procedure, provided for in ­article 28 of Directive 2001/83, each of the member states in which an application had been submitted adopted a marketing-authorisation decision for the generic medicinal product at the end of the procedure which concluded with the acknowledgement of the general agreement of those member states.

That directive did not provide for the adoption, during that procedure in which the holder of the marketing authorisation for the reference medicinal product did not take part, of other measures against which the holder of the marketing authorisation could bring an action or court proceedings enabling it to assert its rights before the adoption, by the competent authority of one of those member states, of a marketing ­authorisation decision.

It followed that effective judicial protection of the rights held by the holder of a marketing authorisation for the reference medicinal product regarding the data exclusivity of that medicinal product could be ­ensured only if that holder could rely on those rights before a court of the member state in which the ­competent authority adopted a marketing-authorisation decision for the generic medicinal product and if it could plead before that court an error relating to the determination of the point in time from which the exclusivity period, affected by that decision, started to run.

However, that requirement of ­effective judicial protection did not mean that the holder of the marketing authorisation for the reference medicinal product could call into question before that court the ­compatibility with Directive 2001/83 of marketing-authorisation decisions for that medicinal product taken in other member states.

That holder of the marketing ­authorisation had a right to a ­judicial remedy, which it could ­exercise, or which it could have ­exercised within the time limits set, against those decisions before the courts having jurisdiction to review the legality of the decisions adopted by the competent national authorities in each member state.

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