* United Kingdom, High Court of Justice, Queen’s Bench Division, Administrative Court, 21 March 2019 CO/471/2018

Identification of the case

• Right to an effective remedy and to a fair trial (art. 47 CFREU)

• Section 3(1) of the European Communities Act 1972

• Arts. 6, 8, 10, 28, 29(1) of Directive 2001/83/EC
• Directive 2012/26/EU
• Art. 47 Charter of Fundamental Rights of the European Union
• Regulation No 726/2004 which replaced Regulation No 2309/93
• Art. 1(2), 2, 10, 24, Annex 12 of the Treaty of Accession 2003
• Art. 267 of the Treaty on the Functioning of the European Union

Summary of the case

The Orion Corporation is the holder of a marketing authorisatoin (MA) for Dexdor, a medical product. This product was granted an MA by the European Commission in 2011, and was granted eight years of marketing protection under EU law, during which the data could not be used for assessing the safety and efficacy of a generic product. DexEP, a medical product belonging to Ever Neuro Pharma GMBH, is the generic form of Orion’s product, Dexdor, and was granted a MA in 2017, while the marketing protection of Dexdor was not expired.

In 2002, in the Czech Republic, a product under the marketing name of ‘Precedex’, also found to relate to Dexdor, was granted an MA. It should be considered a MA under EU Law from 2004 onwards, when the Czech Republic became a Member State. Dexdor and Precedex were considered a single global MA, allowing Ever’s MA, as the eight-year protection began to run from 2004. Doubts arose as to whether the Czech Republic’s MA was in accordance with EU law requirements.

The Courts of the United Kingdom are entitled to determine whether this MA was accomplished in accordance with EU law. The review of compatibility of a MA granted in another Member State with EU law, however, would be inconsistent with the Astellas Pharma case, therefore both the defendant and applicant agreed that a reference to the Court of Justice was unnecessary.

Quash or set aside the MA granted by the defendant (Ever Neuro Pharma GmBH) on 19 October 2017.

The Court characterised the principal issues as being: (1) Is this court able to undertake a judicial review of the Czech marketing authoris ation because an exception applies to the ruling in Astellas?; and (2) Does the answer to that question require the reference of questions to the Court of Justice for a preliminary ruling under Article 267 of the TFEU?

The court started by analysing the meaning and scope of the Astellas ruling, which the claimant held distinguishable and not applicable in this particular case, because it claimed inter alia that the ruling is inconsistent with previous case law and it only applies to decisions of the competent authority in another Member State. The decision here was taken in the Czech Republic in 2002 before the Czech Republic became a Member State of the European Union on 1 May 2004, so the claimant held that the Czech authority was not a competent authority within the meaning of the case.

The court cited that Astellas establishes that the holder of a marketing authorisation may bring legal proceedings to protect the exclusivity of its data and, in particular, to challenge an error in the calculation of the period of protection conferred by Article 10 of the Directive. That, however, does not extend to enabling the holder of the marketing authorisation to challenge in the courts of one Member State the compatibility with EU law of marketing authorisations granted by the competent authorities in another Member State. This means in the case in hand, that while the claimant has the right of access to court, the claimant cannot bring a challenge before this court seeking to establish that a marketing authorisation granted by the competent authorities in Czech Republic is not compatible with EU law because it does not satisfy the requirements of the Directive.

Regarding the second issue and the applicant’s claim that the case should be referred to the Court of Justice for a preliminary ruling, the court held that it had complete confidence to resolve the issues and the meaning of the decision of the Court of Justice in Astellas was clear. The court held that no reference to the Court of Justice for a preliminary ruling was appropriate. In conclusion, the court held that in the light of Astellas, it wa s not open to this court to review the marketing authorisation for Precedex granted by the Czech authorities to determine whether that marketing authorisation wa s compatible with the requirements of the Directive. Moreover, the claimant may bring legal proceedings to protect the exclusivity of its data and to challenge an error in the calculation of the period of protection conferred by Article 10 of the Directive in respect of that data, but such a challenge must be brought before a court of the Member State that granted the marketing authorisation in accordance with the relevant rules of national procedure, including any applicable time limits for bringing such a challenge. Consequently, this claim for judicial review was dismissed.

Role of the Charter and role of the general principles on enforcement

Article 47 of the Charter was applied by the court regarding the dispute of the relevant court having jurisdiction over the matter. The court cited the Astellas case, where the Court of Justice interpreted Article 47 in the light of a Member State’s involvement in a decentralised procedure for marketing authorizations and explicitly stated that a court has jurisdiction when the initial marketing authorization is granted in the same Member State, but not in another Member State.

• Explicit reference to Art. 47, CFREU (right to an effective remedy and a fair trial)
• Right to access a court
• Right to an effective remedy before a tribunal
• Right to a fair trial

Art. 47 of the CFREU provides a right to an effective remedy and to a fair trial before a tribunal. The claimant says that in case the national court would not review whether the initial marketing authoris ation of the Czech Republic was compatible with Directive 2001/83/EC, it would fail to respect their right to an effective remedy regarding their rights to protect their data. The national court answered that this could only be reviewed by a Czech court subject to Czech law.

• Effectiveness

The principle of effectiveness of EU Law wa s applied in this judgement in order to give effect to a previous decision of the CJEU on matters almost identical to those put before the English domestic court. It is a classic example of a domestic court using an interpretation of EU legislation already established by the CJEU.

What is interesting in this particular case is that the claimant invoked the obligation of the domestic court to provide effective judicial remedy when it comes to the application of EU Law in order to have their case heard. However, the domestic court deferred to the already established CJEU decision of Astellas to determine which questions regarding the applicable EU legislation are to be provided with a judicial remedy (i.e. the domestic court used the CJEU judg ment to determine whether it had jurisdiction to adjudicate on specific matters pertaining to the application of a specific EU legislation in a cross-border situation).

Elements of judicial dialogue

• Dialogue among same level national courts within the same Member State
• Dialogue among national courts of different Member States

• Direct dialogue between CJEU/ECtHR and National court (out of preliminary reference procedure)

• Case C‑557/16, Astellas Pharma v Helm AG
• Case C-104/13, Olainfarm AS v Latvijas Republikas Veselības ministrija and Zāļu valsts aģentūra
• Case C-350/08, European Commission v Republic of Lithuania
• Case C-527/07, Generics (UK) Ltd v Licensing Authority

Conform interpretation with EU law as interpreted by the CJEU;

Citation of foreign domestic judgment.

The purpose of the judicial dialogue in the current case was to find the effective and already established interpretation of the relevant EU legislation in order to come up with a decision. The domestic court used an already existing CJEU decision on an identical or almost identical matter in order to issue a decision. Furthermore, the domestic court analysed a judgment already given by itself some years ago and also referred to a judgment adopted by a Dutch court.

The reference to the Dutch and Swedish decisions served the purpose of confirming the interpretation of the domestic court in regards to matters regarding the accession of the Czech Republic to the EU and whether permits issued by its authorities prior to that are to be viewed as EU conforming. In essence, the English domestic court used the Dutch decision to, in a way, confirm its own reasoning or at the very least possibly consult with said Dutch decision in order to come up with an interpretation that it could apply in the case at hand.

The reference to the previous case law of the same English court that issued the decision at hand is done in order to determine the consistency of it with the judgment of the CJEU in Astrellas.

The only outcome of the judicial dialogue that could, perhaps, be expected is for future decisions by English domestic courts made on this subject to consult with already established decisions (either by foreign domestic courts or the CJEU) when it comes to EU Law related matters. However it is hard to know whether this is the case because with the new Brexit agreement, the question of to what extent and how English courts will apply EU law remains open.

Furthermore, due to the nature of judicial dialogue in this case of not actually requesting a preliminary ruling but rather using existing decisions and lines of legal reasoning, it is hard to claim or state what effects this use of already established case-law (domestic, foreign and that of the CJEU) by the English court will have in the future.

Additional notes on the decision