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Case C64/20

UH

v

An tAire Talmhaíochta, Bia agus Mara and Others

(Request for a preliminary ruling from the Ard-Chúirt)

 Judgment of the Court (First Chamber), 17 March 2021

(Reference for a preliminary ruling – Article 288 TFEU – Directive 2001/82/EC – Community code relating to veterinary medicinal products – Articles 58, 59 and 61 – Information to be provided on outer packaging, immediate packaging and the package leaflet for veterinary medicinal products – Obligation to provide information in all the official languages of the Member State in which the product is marketed – National legislation providing that the information may be provided in one or other of the official languages of the Member State – National court hearing an action for a declaration that the Member State had failed correctly to transpose Directive 2001/82/EC and that the competent national authorities must amend the national legislation)

Acts of the institutions – Directives – Implementation by Member States – Need to ensure that directives are effective – Duty of national courts and tribunals – National court having found that a national law on the languages in which information on outer packaging, immediate packaging and the package leaflet for veterinary medicinal products is to be provided is incompatible with a directive – Refusal by that court to make a judicial declaration to the effect that that directive was incorrectly transposed – Unlawful – National legislation compatible with another instrument of EU law, intended soon to replace that directive – Irrelevant

(Art. 288 TFEU; European Parliament and Council Directive 2001/82)

(see paragraphs 32-39 and operative part)


Résumé

A court of a Member State is required to exercise the power conferred on it by national law to make a judicial declaration that that State has not correctly transposed an EU directive and is required to take remedial steps in that regard.

That court cannot disregard that Member State’s obligation to transpose a directive on the ground that that transposition is purportedly disproportionate as a result of the future amendment of the requirements of EU law.

UH, an Irish citizen and a native Irish speaker from the Galway Gaeltacht (the Irish-speaking region of Galway, Ireland), found that the information accompanying veterinary medicinal products was written exclusively in the English language. He takes the view that Directive 2001/82 (1) requires that that information be provided in the two official languages of Ireland, namely Irish and English. On 14 November 2016, UH requested that the Ard-Chúirt (High Court, Ireland) declare that Ireland had incorrectly transposed that directive and was under an obligation to amend its legislation accordingly.

The Ard-Chúirt (High Court) found that Irish legislation on the labelling and package leaflet of veterinary medicinal products does not comply with the language requirements laid down by the directive and is, therefore, in contravention of Article 288 TFEU. (2) Nevertheless, that court observed that Regulation 2019/6, (3) which is due to come into force on 28 January 2022, does allow for the information to be provided on outer packaging, immediate packaging and the package leaflet for veterinary medicinal products to be drafted in Irish or in English. It therefore took the view that the applicant would derive only a limited and temporary benefit from an amendment to Irish law in order to comply with the directive, whereas suppliers and distributors of veterinary medicinal products would be faced with difficulties likely to have serious consequences for animal health and on economic and social circumstances in Ireland.

Having been requested to give a preliminary ruling by that court, the Court holds that Article 288 TFEU must be interpreted as precluding a national court – which, in the context of proceedings laid down in national law for that purpose, finds that the Member State to which it pertains has failed to fulfil its obligation correctly to transpose Directive 2001/82 – from refusing, on the ground that it regards the national legislation as consistent with Regulation 2019/6 which was adopted in order to repeal that directive and will be take effect from 28 January 2022, to make a judicial declaration that that Member State has not correctly transposed that directive and is required to take remedial steps in that regard.

Findings of the Court

The Court recalls that the Member States’ obligation to achieve the result envisaged by a directive and their duty to take all the appropriate measures is binding on all the authorities of Member States including, for matters within their jurisdiction, the courts. (4) Moreover, the Court finds that Irish law allows individuals to obtain a judicial declaration that Ireland has not correctly transposed an EU directive and is required to transpose that directive, while leaving it open to the national courts to refuse to make such a declaration, on the grounds established by that law.

In the present case, the referring court found that Directive 2001/82 was incorrectly transposed. The Court observes in that regard that the fact that the Irish legislation is already compatible with Regulation 2019/6, which will apply with effect from 28 January 2022, cannot call into question the finding that that legislation is incompatible with EU law before that date or, a fortiori, justify such incompatibility. Until the time of the repeal of Directive 2001/82 by that regulation, its provisions preserve their binding nature. The Court alone may, exceptionally and for overriding considerations of legal certainty, grant a provisional suspension of the effects of a rule of EU law with regard to a national law that is contrary to it.

Consequently, the Court holds that Article 288 TFEU precludes a national court of a Member State from disregarding the obligation imposed on that Member State to transpose a directive on the ground that that transposition is purportedly disproportionate as it might prove costly or serve no purpose in view of the forthcoming repeal of that directive. It is therefore for the referring court to take all the appropriate general and particular measures to ensure that the result prescribed by that directive is attained and to therefore make the declaration sought.


1      Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p. 1), as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 58). Directive 2001/82 provides, inter alia, that outer packaging or containers of veterinary medicinal products must include mandatory particulars relating to medicinal products, for example the name, strength, form, constituents, manufacturer's batch number, authorisation number, species of animal and dose. Article 58(4) of the Directive provides that those particulars shall appear ‘in the language or languages of the country in which they are placed on the market’.


2      Article 288(3) TFEU provides that ‘a directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods’.


3      Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ 2019 L 4, p. 43). Article 7(1) of that regulation provides that the compulsory particulars are to be in ‘an official language or languages of the Member State where the veterinary medicinal product is made available on the market’.


4      In that regard, it should be recalled that the second subparagraph of Article 4(3) TEU provides that ‘the Member States shall take any appropriate measure, general or particular, to ensure fulfilment of the obligations arising out of the Treaties or resulting from the acts of the institutions of the Union’.