(Appeal— Order for interim relief— Directive 2001/83

ORDER OF THE VICE-PRESIDENT OF THE COURT

26February 2020(*)

(Appeal— Order for interim relief— Directive 2001/83/EC— Medicinal products for human use— Variation of a marketing authorisation for medicinal products for human use containing Omega‑3 acid ethyl esters— Urgency— Serious and irreparable harm to the health of third parties— Damage to reputation)

In Case C‑773/19P(R),

APPEAL under the second paragraph of Article57 of the Statute of the Court of Justice of the European Union, brought on 21October 2019,

BASF AS, established in Oslo (Norway), represented by E.Wright, Barrister-at-Law, and H.Boland, avocate,

appellant,

the other party to the proceedings being:

European Commission, represented by L.Haasbeek and A.Sipos, acting as Agents,

defendant at first instance,

THE VICE-PRESIDENT OF THE COURT,

after hearing the Advocate General, M.Szpunar,

makes the following

Order

1By its appeal, BASF AS seeks the setting aside of the order of the President of the General Court of the European Union of 19August 2019, BASF v Commission (T‑472/19R, not published, EU:T:2019:555; ‘the order under appeal’), by which that court dismissed its application seeking suspension of the operation of Commission Implementing Decision C(2019)4336 final of 6June 2019 concerning, in the framework of Article31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use containing ‘Omega‑3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction (‘the decision at issue’).

Background to the dispute, procedure before the General Court and the order under appeal

2BASF claims to be the holder of national marketing authorisations for certain medicinal products for human use containing Omega‑3 acid ethyl esters for oral use in secondary prevention after myocardial infarction (‘the medicinal products concerned’).

3On 15March 2018 the Kingdom of Sweden requested the European Medicines Agency (EMA) to initiate the procedure referred to in Article31(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L311, p.67).

4On 6June 2019 the European Commission adopted the decision at issue. Pursuant to that decision, the Member States must, in essence, vary the marketing authorisations for medicinal products for human use containing Omega‑3 acid ethyl esters by removing from those authorisations the therapeutic indication relating to the oral use of those medicinal products in secondary prevention after myocardial infarction.

5By application lodged at the Registry of the General Court on 9July 2019, the appellant brought an action for annulment of the decision at issue.

6By separate document lodged at the Court Registry on the same day, the appellant lodged an application for interim relief pursuant to Articles278 and 279 TFEU, seeking, in essence, suspension of the operation of the decision at issue and an order for the Commission to pay the costs.

7By the order under appeal, the President of the General Court dismissed that application for interim relief.

8In order to give a ruling on that application, the President of the General Court began by examining whether the condition relating to urgency was satisfied.

9In that regard, the President of the General Court recalled, in paragraph17 of the order under appeal, that, inter alia, the condition relating to urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief.

10In that context, in the first place, the President of the General Court rejected the appellant’s line of argument according to which the serious and irreparable harm that would be suffered by patients currently being treated using the medicinal products concerned as a result of the implementation of the decision at issue justified suspending the operation of that decision.

11In that regard, first, in paragraph28 of the order under appeal, the President of the General Court noted that the Court of Justice had, in paragraph43 of its order of 20November 2017, Commission v Poland (C‑441/17R, EU:C:2017:877), recalled the requirement for the condition relating to urgency to be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief.

12Secondly, in paragraphs29 and 30 of the order under appeal, he recalled that actions do not have suspensory effect and that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision in order to prevent a lacuna in the legal protection afforded by the EU judicature.

13The President of the General Court inferred from this, in paragraph31 of the order under appeal, that ‘only if the applicant requesting interim relief can demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage does a situation exist in which there could be a lacuna in its legal protection if no interim measures were accorded’.

14Thirdly, having recalled, in paragraph32 of the order under appeal, that, according to settled case-law, harm to the general interest or the rights of third parties is not entirely irrelevant in the examination of an application for interim relief, as it can be taken into account, where appropriate, in weighing up the interests involved, the President of the General Court held, in paragraph33 of that order, that the appellant’s arguments could nevertheless not be accepted in so far as the requirement relating to the personal nature of the alleged serious and irreparable harm is inherent in the very logic of the system of interim measures and cannot consequently be regarded in such a way as to render the procedure for interim relief ‘devoid of purpose or meaningless’.

15In the second place, in paragraph35 of the order under appeal, the President of the General Court rejected the appellant’s line of argument according to which the implementation of the decision at issue would cause damage to its reputation, in so far as it is possible that patients using the medicinal products concerned would hold the appellant responsible for the fact that those medicinal products were no longer available. In that regard, he considered, in paragraph36 of that order, that such damage appeared to be ‘highly speculative’. He also pointed out, in paragraph37 of that order, that the appellant was not claiming that it was prevented from explaining to patients currently being treated using the medicinal products concerned that the removal of the therapeutic indication in question from the national marketing authorisations for those medicinal products was the result of the decision at issue.

16In those circumstances, the President of the General Court considered, in paragraph38 of the order under appeal, that the condition relating to urgency was not satisfied and, consequently, dismissed the appellant’s application for interim relief, without examining the condition relating to a prima facie case or weighing up the interests involved.

Forms of order sought

17By its appeal, the appellant claims that the Court should:

–set aside the order under appeal; and

–order the Commission to pay the costs.

18The Commission contends that the Court should:

–dismiss the appeal;

–in the alternative, dismiss the application for interim relief; and

–order the appellant to pay the costs.

The appeal

Admissibility

19The Commission contends that the appeal should be dismissed as inadmissible in its entirety. First, the forms of order sought by the appellant are not in line with the requirements stemming from Article170(1) of the Rules of Procedure of the Court of Justice. Secondly, the appellant has no interest in bringing proceedings against the order under appeal.

20In the present case, it is appropriate to rule at the outset on the substance of the appeal (judgment of 7March 2013, Switzerland v Commission, C‑547/10P, EU:C:2013:139, paragraph47).

Substance

21In support of its appeal, the appellant argues that the President of the General Court made several errors of law in his assessment of the condition relating to urgency.

Arguments

22In the first place, the appellant submits that, in order to dismiss its application for interim relief, the President of the General Court relied on the order of 20November 2017, Commission v Poland (C‑441/17R, EU:C:2017:877). However, while indicating that it was unable to gain access to that order, the appellant maintains that the circumstances of the case which gave rise to that order are not the same as those of the present case, in so far as the implementation of the decision at issue would create a foreseeable risk for the health, safety and well-being of patients currently being treated using the medicinal products concerned. The implementation of that decision would therefore cause those patients serious and irreparable harm. According to the appellant, the case-law of the Court of Justice referred to by the order under appeal was irrelevant for the assessment of an exceptional situation such as that at issue in the present case.

23In the second place, the appellant argues, more generally, that the settled case-law of the Court according to which, in the examination of an application for interim relief, the condition relating to urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief is not applicable to the circumstances of the present case.

24In that regard, it submits that the assessment of the condition relating to urgency in the present case must take account of the serious and irreparable harm that will be caused to the health, safety and well-being of patients currently being treated using the medicinal products concerned as a result of the implementation of the decision at issue.

25Thus, the fact that that serious and irreparable harm will be suffered not by the appellant but by those patients should not lead to the conclusion that the condition relating to urgency has not been satisfied. If that were the case, the provisions of Article278 TFEU and Article156 of the Rules of Procedure of the General Court would be rendered devoid of purpose and meaningless. The appellant notes that neither of those provisions requires urgency to relate to serious and irreparable harm for the party seeking the interim relief. It infers from this that those provisions do not rule out the possibility that the condition relating to urgency may be satisfied where it relates to the protection of the interests of third parties, such as the high-risk patients who are currently being treated using the medicinal products concerned.

26In the third place, the appellant criticises the President of the General Court for having failed to provide a statement of reasons for the assertion set out in paragraph36 of the order under appeal that the risk of damage to its reputation ‘[appeared] to be highly speculative’.

27In the fourth and last place, the appellant submits that the President of the General Court erred in law in finding, in paragraph37 of the order under appeal, that there was nothing to prevent it from explaining to patients currently being treated using the medicinal products concerned that the unavailability of those products was not a situation of its own making, but was the result of the decision at issue.

28In that regard, it notes that, according to EU law, communication between pharmaceutical companies and patients is prohibited as regards medicinal products that can be issued only on prescription, such as the medicinal products concerned. In particular, Article88 of Directive 2001/83 clearly prohibits the promotion of such medicinal products to patients and to the general public. Accordingly, the appellant is not permitted to promote the medicinal products concerned to patients.

29Furthermore, it specifies, relying on paragraph19 of the judgment of 2April 2009, Damgaard (C‑421/07, EU:C:2009:222), that the concept of ‘promotion’ includes the dissemination of any information on the availability or the properties of a medicinal product which is intended to influence patients’ behaviour or which may, directly or indirectly, have such an influence. Such dissemination is considered promotional and must therefore comply with the requirements of Directive 2001/83.

30It follows that the appellant was unable to communicate with patients concerning the availability of the medicinal products concerned, in so far as such information would be perceived as intended to influence, directly or indirectly, patients’ behaviour.

31The Commission contests the appellant’s arguments.

Assessment

32In the first place, it should be noted that the appellant, while emphasising that it was unable to gain access to the order of 20November 2017, Commission v Poland (C‑441/17R, EU:C:2017:877), referred to by the President of the General Court in the order under appeal, maintains that the circumstances of the case which gave rise to that order of the Court of Justice are not the same as those of the present case.

33That line of argument must be rejected as being manifestly unfounded.

34Indeed, it must be pointed out that the order of 20November 2017, Commission v Poland (C‑441/17R, EU:C:2017:877), has been published in full in the Reports of cases before the Court of Justice of the European Union, so that that order was accessible to the appellant. Consequently, the appellant cannot validly contest the case-law derived from that order on the basis that— according to the appellant— it was unable to familiarise itself with the content of that order.

35In the second place, the appellant’s line of argument, set out in paragraphs23 to 25 above, seeking to call in question the settled case-law of the Court of Justice pursuant to which the condition relating to urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief must be rejected as inadmissible, in so far as it is simply repeating the arguments already put forward by the appellant before the President of the General Court.

36According to settled case-law, the requirements as to reasons stemming from Article256 TFEU, the first paragraph of Article58 of the Statute of the Court of Justice of the European Union, and Article168(1)(d) of the Rules of Procedure of the Court of Justice are not satisfied by an appeal which, without even including an argument specifically identifying the error of law allegedly vitiating the judgment or order under appeal, simply repeats or reproduces the pleas in law and arguments already put forward before the General Court (order of the Vice-President of the Court of Justice of 7February 2020, Walker and Others v Parliament and Council, C‑789/19P(R), not published, EU:C:2020:85, paragraph32 and the case-law cited).

37In the third place, regarding the appellant’s line of argument according to which the President of the General Court failed to provide a statement of reasons for the assertion set out in paragraph36 of the order under appeal that the damage to the appellant’s reputation ‘[appeared] to be highly speculative’, it should be borne in mind that, according to settled case-law, the requirement that the General Court give reasons for its decisions does not mean that it is obliged to respond in detail to every single argument put forward by the applicant. The reasoning adopted by the General Court may therefore be implicit, on condition that it enables the persons concerned to understand the grounds for the General Court’s judgment and provides the Court of Justice with sufficient information to exercise its powers of review (judgment of 14June 2016, Marchiani v Parliament, C‑566/14P, EU:C:2016:437, paragraph69).

38In the present case, the President of the General Court began by recalling, in paragraph18 of the order under appeal, that, according to settled case-law, there is urgency only if the serious and irreparable harm feared by the party requesting the interim measures is so imminent that its occurrence can be foreseen with a sufficient degree of probability, and that that party remains, in any event, required to prove the facts that form the basis of its claim that such harm is likely, it being clear that purely hypothetical harm, based on future and uncertain events, cannot justify the granting of interim measures.

39Next, the President of the General Court noted, in paragraph23 of the order under appeal, that it was in the light of, inter alia, those criteria that it was necessary to examine whether the appellant had succeeded in demonstrating the imminence of serious and irreparable harm in the case at hand.

40Lastly, the President of the General Court set out, in paragraph34 of the order under appeal, the appellant’s line of argument according to which it would suffer damage to its reputation, in so far as it was possible that the patients currently using the medicinal products concerned would be unaware of the decision at issue and that they would hold the appellant responsible for the fact that those medicinal products were no longer available.

41In order to respond to that line of argument, the President of the General Court held, in particular, in paragraph36 of the order under appeal, that the damage to reputation claimed by the appellant ‘[appeared] to be highly speculative’.

42It is thus clear from the grounds of the order under appeal that the President of the General Court considered that the risk of damage to reputation claimed by the appellant did not satisfy the conditions set out in paragraph18 of that order, in so far as that damage ‘[appeared] to be highly speculative’.

43It follows that the appellant’s line of argument according to which the President of the General Court failed to provide a statement of reasons for the assertion set out in paragraph36 of the order under appeal must be rejected.

44In the fourth and last place, regarding the appellant’s line of argument according to which the President of the General Court erred in law in finding, in paragraph37 of the order under appeal, that there was nothing to prevent the appellant from explaining to patients currently being treated using the medicinal products concerned that the unavailability of those products was not a situation of its own making, but was the result of the decision at issue, it should be noted that, pursuant to Article88(1) of Directive 2001/83, Member States are to prohibit the advertising to the general public of medicinal products which are available on medical prescription only.

45Under Article86(1) of Directive 2001/83, the ‘advertising of medicinal products’ includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

46The Court of Justice has held that it is clear from the wording of that provision that the purpose of the message constitutes the fundamental defining characteristic of advertising, and the decisive factor for distinguishing advertising from mere information (judgment of 5May 2011, MSD Sharp & Dohme, C‑316/09, EU:C:2011:275, paragraph31).

47It has inferred from this, in particular, that material which is purely informative, without promotional intent, is not covered by the provisions of Directive 2001/83 relating to advertising of medicinal products (judgment of 5May 2011, MSD Sharp & Dohme, C‑316/09, EU:C:2011:275, paragraph32).

48In the present case, the President of the General Court found, in paragraph37 of the order under appeal, that the appellant was not claiming that it was impossible for it to explain to patients currently being treated using the medicinal products concerned that the unavailability of those products was not a situation of its own making, but was the result of the decision at issue.

49It must therefore be held that the dissemination of such information, inasmuch as it is in no way designed to promote the prescription, supply, sale or consumption of the medicinal products concerned, is not covered by the provisions of Directive 2001/83 relating to advertising.

50Consequently, the appellant’s line of argument according to which the President of the General Court erred in law in paragraph37 of the order under appeal must also be rejected as unfounded.

51In the light of all of the foregoing, the appeal must be dismissed in its entirety.

Costs

52Under Article184(2) of its Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs.

53Under Article138(1) of those rules, applicable to appeal proceedings by virtue of Article184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

54Since the Commission has applied for costs and the appellant has been unsuccessful, the appellant must be ordered to pay the costs.

On those grounds, the Vice-President of the Court hereby orders:

1.The appeal is dismissed.

2.BASF AS is ordered to pay the costs.

Luxembourg, 26February 2020.

*Language of the case: English.