Opinion of the Advocate General — ECLI:EU:C:2021:14
Date: 2021-03-17;2021-01-14
Language of the case: Irish
Subject matter: Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Ireland

summary of the product 
characteristics and the information on the labelling and on the package 
leaflet shall, unless the Member State determines otherwise, be an official 
language or languages of the Member State where the veterinary medicinal 
product is made available on the market. 
2. Veterinary medicinal products may be labelled in several languages.  
[Emphasis added] 
AN TAIRE TALMHAÍOCHTA, BIA AGUS MARA, ÉIRE AGUS AN TARD-AIGHNE  
 
7 
[OR. 11] 
16 The court then raised the question whether it would be worthwhile granting the 
relief sought in the light of that forthcoming change, and, if it were deemed not to 
be worthwhile, whether the national court may decide not to grant the relief 
sought where Ireland is in breach of EU law. The national court requested that the 
parties present written submissions and oral argument to the court on the issue of 
whether or not a national court has discretion to grant relief in judicial-review 
proceedings if that court decides that there was a failure with respect to a 
directive, and, if it does have that discretion, on the issue of the appropriate factors 
to be taken into account in relation to that discretion and/or whether the national 
court is entitled to take into account those same factors which it would take into 
account if it were dealing with a breach of national law. 
17 A hearing on that issue was held on 16 October 2019 and the national court sought 
further submissions as to whether the question should be referred to the Court of 
Justice of the European Union as a request for a preliminary ruling. 
Arguments before the national court concerning discretion to refuse to grant 
relief 
The Applicant’s arguments concerning discretion to refuse to grant relief 
18 The Applicant argued that it is a principle of law that EU law prevails over the 
national law of the Member States and that, in the event of a conflict, national law 
must yield to EU law (Case 6/64, Costa v ENEL [EU:C:1964:66]). The Applicant 
submitted that EU law currently provides that the information on the packaging in 
question for veterinary medicinal products must be in both Irish and English and 
that the Applicant is entitled to rely on that law from now until 27 January 2022 
and to exercise the rights arising therefrom. The Applicant submitted [OR. 12] 
that nobody in Ireland (including the courts) has the power to deny him that right. 
19 As regards the terms and spirit of the Treaties to which the Court of Justice 
referred in Costa (above), the Applicant argued that the court should have regard 
to the Treaty provisions on language rights and equality (Article 3 of the Treaty on 
European Union and Articles 21 and 22 of the Charter of Fundamental Rights of 
the European Union). As regards the supremacy of EU law, the Applicant referred 
to Simmenthal (Case 106/77, [EU:C:1978:49]) and the requirement to set aside 
any provision or practice under national law inasmuch as it conflicts with EU law 
(paragraphs 21 to 23). 
20 The Applicant submitted that an effective judicial remedy must be available in the 
case where a right under EU law has been denied (Case C-249/88, Commission v 
Belgium [EU:C:1991:121]; the second subparagraph of Article 19(1) of the Treaty 
on European Union; Article 47 of the Charter of Fundamental Rights of the 
European Union). 
REQUEST FOR A PRELIMINARY RULING OF 20. 1. 2020 – CASE C-64/20 
 
8  
21 The Applicant referred to the principle of direct effect (Case 26/62 Van Gend en 
Loos [EU:C:1963:1] and Case 6/64 Costa v ENEL [EU:C:1964:66]), arguing that 
the national courts are required to set aside any part of national law or any practice 
by a national court that would impair or delay the exercise of rights under EU law 
(Simmenthal, paragraphs 17, 18, 21 to 23 and 26; R (Factortame Ltd) v Secretary 
of State for Transport [1990] C-213/89 [EU:C:1990:257], paragraph 20). 
22 The Applicant submitted that it would be incompatible with the principles of 
direct effect and supremacy of EU law to deny him effective protection and an 
effective remedy in the national court, even if it were only for a temporary period. 
[OR. 13] 
23 The Applicant submitted that he was entitled to the benefit of the current regime 
for as long as it lasts and that there was no evidence before the court that a binding 
court order would have no practical effect, even taking into consideration the 
delay that would be involved in redesigning the packaging. 
24 The Applicant submitted that he was entitled to effective judicial protection 
(Article 47 of the Charter) pursuant to the Rule of Law, the principle of direct 
effect and the supremacy of EU law and that he was entitled to the appropriate 
relief ex debito justitiae. 
25 In addition, the Applicant claimed that there was discretion whether to grant or 
refuse relief in other circumstances in judicial-review cases under Irish law, but 
that EU law does not permit such discretion owing to the direct effect of the EU 
law in question, the requirement for the national court to yield to the supremacy of 
EU law and to apply it by providing the Applicant with effective judicial 
protection (pursuant to Article 47 of the Charter) and pursuant to the Rule of Law. 
Arguments made by the Respondents concerning discretion to refuse to grant 
relief 
26 The Respondents acknowledged that, under national law, an applicant who 
successfully challenges the decision of a public authority through judicial review 
is usually entitled to relief, but they argue that this is not an absolute entitlement 
and that the court may always consider any material that might impede the 
granting of relief and, ultimately, may refuse to grant such relief. 
[OR. 14] 
27 There are long-established grounds in Irish law under which the courts may 
exercise that power, if they so decide, but may equally decide against doing so if 
they so wish. Those grounds include various factors, for example: (1) undue delay 
in bringing proceedings; or (2) failure to seek other more appropriate remedies, 
such as an appeal; or (3) a lack of candour on the part of the applicant; or (4) 
failure by the applicant to act in good faith; or (5) prejudice to third parties, and 
(6) where granting of relief would serve no useful purpose. 
AN TAIRE TALMHAÍOCHTA, BIA AGUS MARA, ÉIRE AGUS AN TARD-AIGHNE  
 
9 
28 The Respondents explained the main reasons why it would be justifiable, in their 
view, to refuse relief in these proceedings were they governed by Irish law alone. 
29 Firstly, they submitted that this case did not relate to a criminal conviction or any 
other decision that would be prejudicial to the Applicant and that would bring his 
reputation or his name into disrepute, or that would infringe his fundamental 
personal rights. As a result, in their view, none of the grounds for granting relief 
ex debito justitiae, traditionally, was present here. 
30 Second, they submitted that it is widely accepted that relief may be refused when 
it would serve no useful purpose or would be of no practical benefit to the 
Applicant. In this case, there may be some benefit were relief granted to the 
Applicant but it would be very limited in terms of its value, owing to the entry 
into force of Regulation (EU) 2019/6 of 11 December 2018 on veterinary 
medicinal products and repealing Directive 2001/82/EC and [OR. 15] the lifting 
of the requirement that the text on the product packaging must be in both official 
languages.   
31 The Respondents submitted that it was clear that a transitional period would be 
necessary to enable all of the interested parties to prepare for the requirement that 
the labelling and packaging must be printed in both official languages. Relief 
should be refused if it would be of little practical benefit to the Applicant (even if 
it were of some small benefit), particularly if the granting of such relief would 
entail a real and substantial risk of serious prejudice to many other people or to the 
general public. 
32 Third, there is a strong possibility in this case, if relief were granted, that it would 
have a serious impact on third parties. On the basis of affidavit evidence submitted 
to the court, if suppliers and distributors of veterinary medicinal products were to 
decide to withdraw from the Irish market due to the requirement to print the text 
of instruction leaflets and packaging in both official languages, it is clear that this 
would have grave consequences for animal health, as well as economic 
consequences, which would be detrimental to many individuals. The Respondents 
drew attention to the decision of the European Commission to proceed with the 
new regulation following broad consultation, during which the Commission 
identified a critical need for greater flexibility as regards the language 
requirements in relation to packaging and labelling of medicinal veterinary 
products. The Commission’s review states as follows: 
The highest burden concerns packaging and labelling. The requirements are 
that the text must be written in all the official languages of the country 
where the product is to be placed on the market.  
[OR. 16] 
33 The Respondents submitted that the new developments in Regulation (EU) 2019/6 
demonstrate clearly the legitimacy of the serious concerns expressed by the 
REQUEST FOR A PRELIMINARY RULING OF 20. 1. 2020 – CASE C-64/20 
 
10  
respondents as regards any efforts made to provide information and packaging 
materials for animal medicines in both Irish and English. 
34 Consequently, according to the Respondents, there were strong mitigating factors 
or circumstances to consider in this case. An order requiring suppliers to translate 
the important technical summary of product characteristics for a significant range 
of chemical substances and to print the packaging materials in question in Irish as 
well as in English could result in the suppliers withdrawing from the Irish market, 
and it is no exaggeration to say that this would lead to devastating economic and 
social consequences, as well as to devastating consequences for animal welfare. 
Owing to that clear risk, they submitted that, in this case, the public interest and 
the need to ensure that the widest possible range of veterinary medicinal products 
continues to be supplied to the public in Ireland far outweigh any argument that 
could be made in favour of granting relief to the Applicant as an individual. 
35 The Respondents submitted that there is no Irish authority dealing with this 
particular point, but the question has arisen in a number of cases in the United 
Kingdom, including the decision of the Supreme Court of the United Kingdom in 
Walton v The Scottish Ministers [2012] UKSC 44, stating (per Lord Carnwath, 
paragraphs 133 and 140): 
133. Accordingly, subject to any overriding principles emerging from the 
European authorities, it seems to me that, even if (contrary to what appears 
to be the effect of the statute) breach of the SEA Directive were a ground of 
challenge under the [OR. 17] 1984 Act procedure, the court would retain a 
discretion to refuse relief on similar grounds to those available under 
domestic law. 
140. Accordingly, notwithstanding Mr Mure’s concession, I would not have 
been disposed to accept without further argument that, in the statutory and 
factual context of the present case, the factors governing the exercise of the 
court’s discretion are materially affected by the European source of the 
environmental assessment regime. 
36 The Respondents submitted that they did not wish to imply that a Member State 
should be anything but diligent in the application of and compliance with 
European law, or that the principle of effective judicial protection should be 
infringed in any way. However, there may be occasions, which are likely to occur 
only rarely, where there would be strong mitigating factors or circumstances in 
relation to the public interest and the protection of the rights of other members of 
the public, in which it would be justifiable for a court to refuse relief. They 
claimed that this case comes within the scope of that exception and that this court 
may refuse to grant the relief sought and that it ought to do so. 
AN TAIRE TALMHAÍOCHTA, BIA AGUS MARA, ÉIRE AGUS AN TARD-AIGHNE  
 
11 
Decision of the High Court of Ireland to request a preliminary ruling 
pursuant to Article 267 of the Treaty on the Functioning of the European 
Union 
37 After reviewing the submissions on a preliminary ruling and hearing counsel for 
the parties on 24 October 2019, the High Court has decided to refer the questions 
set out above to the Court of Justice of the European Union pursuant to Article 
[OR. 18] 267 of the Treaty on the Functioning of the European Union. It is the 
High Court’s view that if a national court has discretion to refuse relief despite the 
fact that that court has decided that national law has failed to give effect to the 
duty under Articles 61(1), 58(4) and 59(3) of Directive 2001/82/EC to make 
packaging and labelling on veterinary products available in both official 
languages, it should exercise its discretion and refuse to grant the relief sought in 
this particular case in the light of the criteria relied on by the Respondents, but the 
court wishes to verify that this would not undermine the principle of direct effect 
or the principle of effective judicial protection.  
ANNEXES 
1. The Book of Pleadings 
2. The order for reference, dated and perfected by the Registrar of the High 
Court on the 24th day of January 2020.  
Dated: 20/01/2020 
[ANNEX - the order for reference] [OMISSIS] 
[OMISSIS]