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2016   |   Book 2

Case

E-33/15

EFTA Surveillance AuthorityVIceland

(Failure by an EEA/EFTA State to fulfil its obligations – Failure to implement – Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)

Table of contents


SummaryPage
695
of the Judgment

1 Under Article 7 EEA, the Contracting Parties are obliged to implement all acts referred to in the Annexes to the EEA Agreement, as amended by decisions of the EEA Joint Committee. Furthermore, Article 3 EEA imposes upon Contracting Parties the general obligation to take all appropriate measures, whether general or particular, to ensure fulfilment of the obligation arising out of the EEA Agreement.

2 The question of whether an EFTA State has failed to fulfil its obligations must be determined by reference to the situation in that State as it stood at the end of the period laid down in the reasoned opinion.

3 Iceland failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the EEA Agreement, that is Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance, as adapted to the EEA Agreement by Protocol 1 thereto, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed.

JudgmentPage
696
of the Court

2 August 2016

(Failure by an EEA/EFTA State to fulfil its obligations – Failure to implement – Directive 2012/26/EU amending Directive 2001/83/EC as regards pharmacovigilance)

In Case E-33/15,

EFTA Surveillance Authority, represented by Carsten Zatschler, Clémence Perrin, and Íris Ísberg, Members of the Department of Legal & Executive Affairs, acting as Agents,

— applicant,

V

Iceland, represented by Jóhanna Bryndís Bjarnadóttir, Counsellor, Ministry for Foreign Affairs, acting as Agent,

— defendant,

APPLICATION for a declaration that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under Protocol 1 thereto, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed, or in any event by failing to inform the EFTA Surveillance Authority thereof.

ThePage
697
Court

composed of: Carl Baudenbacher, President (Judge-Rapporteur), Per Christiansen and Páll Hreinsson, Judges,

Registrar: Gunnar Selvik,

having regard to the written pleadings of the parties,

having decided to dispense with the oral procedure,

gives the following

Judgment

I Introduction

1 By an application lodged at the Court Registry on 17 December 2015, the EFTA Surveillance Authority (“ESA”) brought an action under the second paragraph of Article 31 of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice (“SCA”) seeking a declaration from the Court that, Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (“the EEA Agreement” or “EEA”), that is Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ 2012 L 299, p. 1, and Icelandic EEA Supplement 2013 No 56, p. 535) (“the Directive” or “the Act”), as adapted to the Agreement under its Protocol 1 and under Article 7 EEA, by failing to adopt or in any event to inform ESA of the measures necessary to implement the Act within the time prescribed.

II LawPage
698

2 Article 3 EEA reads:

The Contracting Parties shall take all appropriate measures, whether general or particular, to ensure fulfilment of the obligations arising out of this Agreement.

They shall abstain from any measure which could jeopardize the attainment of the objectives of this Agreement.

3 Article 7 EEA reads:

Acts referred to or contained in the Annexes to this Agreement or in decisions of the EEA Joint Committee shall be binding upon the Contracting Parties and be, or be made, part of their internal legal order as follows:

(b) an act corresponding to an EEC directive shall leave to the authorities of the Contracting Parties the choice of form and method of implementation.

4 Article 31 SCA reads:

If the EFTA Surveillance Authority considers that an EFTA State has failed to fulfil an obligation under the EEA Agreement or of this Agreement, it shall, unless otherwise provided for in this Agreement, deliver a reasoned opinion on the matter after giving the State concerned the opportunity to submit its observations.

If the State concerned does not comply with the opinion within the period laid down by the EFTA Surveillance Authority, the latter may bring the matter before the EFTA Court.

5 EEAPage
699
Joint Committee Decision No 160/2013 of 8 October 2013 (OJ 2014 L 58, p. 13, and EEA Supplement 2014 No 13, p. 15) (“Decision 160/2013”) amended Annex II (Technical Regulations, Standards, Testing and Certification) to the EEA Agreement by adding the Directive to point 15q of Chapter XIII of the Annex. Constitutional requirements were indicated by Liechtenstein for the purposes of Article 103 EEA. By 29 April 2014, Liechtenstein had notified that the constitutional requirements had been fulfilled. Consequently, Decision 160/2013 entered into force on 1 June 2014. The time limit for the EEA/EFTA States to adopt the measures necessary to implement the Directive expired on the same date.

III Facts and pre-litigation procedure

6 On 17 September 2014, after correspondence, ESA issued a letter of formal notice, concluding that Iceland had failed to fulfil its obligations under the Act and Article 7 EEA by failing to adopt, or in any event, to inform ESA of the national measures adopted to implement the Directive. Iceland did not reply to the letter of formal notice.

7 On 14 January 2015, ESA delivered a reasoned opinion maintaining the conclusion set out in its letter of formal notice. Pursuant to the second paragraph of Article 31 SCA, ESA required Iceland to take the necessary measures to comply with the reasoned opinion within two months following the notification, that is no later than 14 March 2015. Iceland did not reply to the reasoned opinion within the time limit.

8 Since Iceland did not comply with the reasoned opinion by the deadline set therein, ESA decided to bring the matter before the Court pursuant to the second paragraph of Article 31 SCA.

IV ProcedurePage
700
and forms of order sought

9 ESA lodged the present application at the Court Registry on 17 December 2015. Iceland’s statement of defence was registered at the Court on 7 March 2016. By letter of 31 March 2016, ESA waived its right to submit a reply and consented to dispense with the oral procedure should the Court wish to do so. By letter of 3 May 2016, Iceland also consented to dispense with the oral procedure.

10 The applicant, ESA, requests the Court to:

1. Declare that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under its Protocol 1 thereto, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed, or in any event by failing to inform the EFTA Surveillance Authority thereof; and

2. Order Iceland to bear the costs of these proceedings.

11 The defendant, Iceland, submits that it does not dispute the facts of the case as they are set out by ESA in its application. Furthermore, it does not contest the declaration sought by ESA. Nevertheless, in its defence, Iceland indicated that an administrative regulation implementing the Directive was intended to be adopted by 1 July 2016.

12 After having received the express consent of the parties, the Court, acting on a report from the Judge-Rapporteur, decided, pursuant to Article 41(2) of the Rules of Procedure (“RoP”), to dispense with the oral procedure.

V FindingsPage
701
of the Court

13 Article 3 EEA imposes upon the EEA/EFTA States the general obligation to take all appropriate measures, whether general or particular, to ensure fulfilment of the obligations arising out of the EEA Agreement (see, inter alia, Case E-21/15 ESA v Iceland, judgment of 1 February 2016, not yet reported, paragraph 14 and case law cited).

14 Under Article 7 EEA, the EEA/EFTA States are obliged to implement all acts referred to in the Annexes to the EEA Agreement, as amended by decisions of the EEA Joint Committee. An obligation to implement the Directive also follows from its Article 2. The Court notes that the lack of direct legal effect of acts referred to in decisions by the EEA Joint Committee makes timely implementation crucial for the proper functioning of the EEA Agreement in Iceland also. The EEA/EFTA States find themselves under an obligation of result in that regard (see, inter alia, ESA v Iceland, cited above, paragraph 15 and case law cited).

15 Decision 160/2013 entered into force on 1 June 2014. The time limit for the EEA/EFTA States to adopt the measures necessary to implement the Directive expired on the same date.

16 The question whether an EEA/EFTA State has failed to fulfil its obligations must be determined by reference to the situation as it stood at the end of the period laid down in the reasoned opinion (see, inter alia, ESA v Iceland, cited above, paragraph 17 and case law cited). It is undisputed that Iceland had not adopted the measures necessary to implement the Directive by the expiry of the time limit set in the reasoned opinion.

17 SincePage
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Iceland did not implement the Directive within the time prescribed, there is no need to examine the alternative form of order sought against Iceland for failing to inform ESA of the measures implementing the Directive.

18 It must therefore be held that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under its Protocol 1, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed.

VI Costs

19 Under Article 66(2) RoP, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since ESA has requested that Iceland be ordered to pay the costs, and the latter has been unsuccessful, and none of the exceptions in Article 66(3) RoP apply, Iceland must therefore be ordered to pay the costs.

OnPage
703
those grounds,

The Court

hereby:

1. Declares that Iceland has failed to fulfil its obligations under the Act referred to at point 15q of Chapter XIII of Annex II to the Agreement on the European Economic Area (Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance) as adapted to the Agreement under its Protocol 1, and under Article 7 of the Agreement, by failing to adopt the measures necessary to implement the Act within the time prescribed.

2. Orders Iceland to bear the costs of the proceedings.

Carl Baudenbacher

Per Christiansen

Páll Hreinsson

Delivered in open court in Luxembourg on
2 August 2016.

Birgir Hrafn Búason
Acting Registrar

Páll Hreinsson
Acting President