CELEX: 62016CO0406
Language: en
Date: 2016-10-18 00:00:00
Title: Order of the Vice-President of the Court of 18 October 2016.#European Medicines Agency v Pari Pharma GmbH.#Appeal — Order for interim measures — Suspension of operation of a measure challenged before the General Court — Change in circumstances — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the European Medicines Agency (EMA) submitted as part of an application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents.#Case C-406/16 P(R).

ORDER OF THE VICE-PRESIDENT OF THE COURT
      18 October 2016 (*)
      
      (Appeal — Order for interim measures — Suspension of operation of a measure challenged before the General Court — Change in circumstances — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the European Medicines Agency (EMA) submitted as part of an application for authorisation to place a medicinal
         product on the market — Decision to grant a third party access to the documents)
      
      In Case C‑406/16 P(R),
      APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 19 July
         2016,
      
      European Medicines Agency (EMA), represented by S. Marino, A. Spina, A. Rusanov, T. Jabłoński and N. Rampal Olmedo, acting as Agents,
      
      appellant,
      the other parties to the proceedings being:
      Pari Pharma GmbH, established in Starnberg (Germany), represented by M. Epping and W. Rehmann, Rechtsanwälte,
      
      applicant at first instance,
      Novartis Europharm Ltd, established in Camberley (United Kingdom), represented by C. Schoonderbeek, avocate,
      
      intervener at first instance,
      THE VICE-PRESIDENT OF THE COURT,
      after hearing the Advocate General, M. Wathelet,
      makes the following
      Order
      1        By its appeal, the European Medicines Agency (EMA) seeks to have set aside the order of the President of the General Court
         of the European Union of 23 May 2016, Pari Pharma v EMA (T‑235/15 R, not published, ‘the order under appeal’, EU:T:2016:309), by which that court rejected its application for cancellation
         of the order of the President of the General Court of 1 September 2015, Pari Pharma v EMA (T‑235/15 R, ‘the first General Court order’, EU:T:2015:587).
      
       Background to the dispute, procedure before the General Court and the order under appeal
      2        Under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures
         for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines
         Agency (OJ 2004 L 136, p. 1), certain categories of medicinal products must be approved under a centralised procedure established
         by that regulation. That procedure requires the submission of an application for marketing authorisation (‘MA application’),
         which, following an examination and an opinion of the EMA, results in a decision of the European Commission. A committee of
         the EMA, namely the Committee for Medicinal Products for Human Use (‘CHMP’), is responsible for preparing the opinions of
         the EMA on any question relating to medicinal products for human use.
      
      3        Novartis Europharm Ltd is the holder of a marketing authorisation (‘MA’) granted by the Commission, on 20 July 2011, under
         Regulation No 726/2004, for the medicinal product ‘TOBI Podhaler’.
      
      4        TOBI Podhaler was classified as an ‘orphan medicinal product’, within the meaning of Regulation (EC) No 141/2000 of the European
         Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), that is to say, medicinal
         products intended for the diagnosis, prevention or treatment of rare conditions. In order to promote the development of effective
         treatments for patients affected by rare conditions, that regulation introduces a system of incentives to encourage pharmaceutical
         undertakings to invest in orphan medicinal products. To that end, Article 8(1) of Regulation No 141/2000 provides that, where
         an MA has been granted in respect of an orphan medicinal product, no other MA is to be granted for a period of 10 years for
         the same therapeutic indication in respect of a similar medicinal product. However, under Article 8(3), a similar medicinal
         product may be granted an MA for the same therapeutic indication if the second applicant [for an MA] can establish that its
         medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise
         clinically superior.
      
      5        It was on the basis of that derogating provision that Pari Pharma GmbH applied for an MA in respect of its medicinal product
         ‘Vantobra’.
      
      6        The Commission granted that application on 18 March 2015, following the favourable opinion of the CHMP of 22 January 2015.
         That opinion is based on two CHMP reports issued on the same day, namely Assessment Report EMA/CHMP/702525/2014 for Vantobra
         on similarity with Cayston and TOBI Podhaler, and Assessment Report EMA/CHMP/778270/2014 on clinical superiority to TOBI Podhaler
         (together ‘the reports at issue’).
      
      7        On 13 April 2015, the EMA informed Pari Pharma that it had received a request for access to the reports at issue, submitted
         on the basis of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public
         access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43). It emerged in the course of the procedure
         that the person requesting access was Novartis Europharm. The EMA informed Pari Pharma of its intention to disclose those
         reports with a few redactions concerning personal data, while setting it a deadline for requesting additional redactions.
         On 20 April 2015, Pari Pharma requested that the EMA not disclose the reports at issue.
      
      8        By Decision EMA/271043/2015 of the EMA of 24 April 2015 (‘the decision at issue’), the EMA decided to disclose the reports
         at issue to Novartis Europharm pursuant to Regulation No 1049/2001.
      
      9        On 15 May 2015, Pari Pharma brought an action before the General Court seeking annulment of that decision (Case T‑235/15).
      
      10      By separate document, lodged at the General Court Registry on the same day, Pari Pharma submitted an application for interim
         relief, in which it asked the President of the General Court, in essence, to suspend operation of the decision at issue and
         order the EMA not to disclose the reports at issue.
      
      11      The EMA asked the President of the General Court to dismiss that application.
      
      12      By order of 22 June 2015, Novartis Europharm was granted leave to intervene in the interim relief proceedings in support of
         the form of order sought by the EMA.
      
      13      In parallel to Pari Pharma’s action, on 28 May 2015, Novartis Europharm brought an action before the General Court seeking
         annulment of the decision of 18 March 2015 by which the Commission had granted the MA for Vantobra, on the ground that that
         decision infringed the market exclusivity which it enjoyed, under Article 8(1) of Regulation No 141/2000, in respect of TOBI
         Podhaler. That action was registered as Case T‑269/15.
      
      14      By the first General Court order, it was decided, first, to suspend operation of the decision at issue in so far as that decision
         granted a third party access to the reports at issue, pursuant to Regulation No 1049/2001, and, second, to order the EMA not
         to disclose those reports.
      
      15      By application lodged at the Registry of the Court of Justice on 23 October 2015, the EMA brought an appeal against that order.
      
      16      In the proceedings before the Court of Justice, in its response lodged on 23 November 2015, Pari Pharma contended that the
         Court of Justice should dismiss the appeal. The reports at issue were included in the annexes to that response.
      
      17      On 24 November 2015, the response lodged by Pari Pharma and the annexes thereto were served on the other parties to the appeal
         proceedings, including Novartis Europharm, the intervener at first instance.
      
      18      On 25 November 2015, Pari Pharma submitted a request for confidential treatment in order that the reports at issue not be
         served on Novartis Europharm. However, because that request for confidential treatment was submitted out of time, those reports
         had already been served as they stood.
      
      19      Subsequently, Pari Pharma informed the Court of Justice that it had succeeded in concluding an agreement with Novartis Europharm,
         under which the latter had undertaken to keep the reports at issue confidential and not to disclose them to third parties.
         Novartis Europharm would be authorised to use those documents only for the purposes of the case pending between it and the
         Commission, registered with the General Court as Case T‑269/15. In addition, Novartis Europharm had agreed to make limited
         use of those documents; such use was in particular not to affect the proceedings in Case T‑235/15 which were pending before
         the General Court.
      
      20      Having asked the EMA, by letter of the Registrar of 3 December 2015, to clarify whether, given the circumstances, it considered
         that there was still a need to adjudicate on its appeal, the Vice-President of the Court of Justice, by order of 17 March
         2016, EMA v Pari Pharma (C‑550/15 P(R), not published, ‘the order on the appeal’, EU:C:2016:196), held that there was no need to adjudicate on the
         EMA’s appeal, on the ground that the EMA no longer had an interest in bringing proceedings, since the appeal was no longer
         capable, if successful, of procuring an advantage for the EMA.
      
      21      In particular, at paragraphs 38 to 41 of that order, the Vice-President of the Court held as follows:
      
      ‘38      … the fact that Novartis Europharm now has access to the reports at issue clearly deprives the interim measures obtained by
         Pari Pharma through the order under appeal of all effect.
      
      39      In that regard, it should be noted that the assessment of an applicant’s interest in obtaining the measures sought takes on
         particular importance in proceedings on an application for interim relief. The judge hearing an application for interim relief
         may order suspension of operation of an act or other interim measures only if it is established, inter alia, that such an
         order is urgent inasmuch as, in order to prevent serious and irreparable harm to the applicant’s interests, it must be made
         and produce its effects before a decision is reached in the main action. Interim measures which would no longer serve to prevent
         the serious and irreparable harm feared by the applicant cannot, a fortiori, be necessary for that purpose (see, in particular, order of the President of the Court of 27 February 2002, Reisebank v Commission, C‑477/01 P(R), EU:C:2002:126, paragraphs 22 and 23 and the case-law cited).
      
      40      Regardless of the assessments which could be carried out by the President of the General Court concerning the possibility
         of cancelling or modifying the order under appeal upon application by one of the parties to that effect pursuant to Article 159
         of the Rules of Procedure of the General Court, it must be held that the fact that those interim measures serve no purpose
         also deprives the EMA of any interest in bringing proceedings in the present appeal proceedings.
      
      41      Indeed, whatever the outcome of the present proceedings, no advantage will be procured for the EMA. In particular, if the
         appeal were to be upheld and the EMA could therefore implement the decision at issue, the sole effect thereof would be to
         enable the EMA to communicate to Novartis Europharm the reports at issue which it already holds. If, by contrast, the appeal
         were to be dismissed, the EMA would, admittedly, not be entitled to communicate those reports to Novartis Europharm. However,
         the fact that Novartis Europharm has in any event obtained access to those documents means that the EMA is deprived of any
         interest in the immediate implementation of the decision at issue.’
      
      22      In those circumstances, by document lodged at the General Court Registry on 31 March 2016, the EMA submitted an application
         based on Article 159 of the Rules of Procedure of the General Court, seeking cancellation of the first General Court order
         following the change in circumstances that has arisen in the present case.
      
      23      Having held, in paragraphs 29 to 35 of the order under appeal, in essence, that the order on the appeal had not called into
         question the assessments set out in the first General Court order and that the relations between the EMA, Novartis Europharm
         and Pari Pharma were in essence taken into account therein, the President of the General Court, at paragraphs 36 to 41 of
         the order under appeal, held as follows:
      
      ‘36      That being said, it is clear that the interim measures granted to [Pari Pharma] in the first General Court order have in fact
         become ineffective if the sole effect of the [decision at issue] is “to enable the EMA to communicate to [Novartis Europharm]
         the reports at issue which it already holds” and “if the fact that [Novartis Europharm] has in any event obtained access to
         those documents means that the EMA is deprived of any interest in the immediate implementation of the [decision at issue]”.
         In other words, if [Novartis Europharm] were content to use the reports at issue solely for the purposes of protecting its
         interests in the context of Case T‑269/15, and the EMA regarded the [decision at issue] as having become devoid of purpose
         since [Novartis Europharm] already had those reports, [Pari Pharma] would no longer have need for the protection of interim
         measures.
      
      37      That is not the case, however, given that the status quo which enabled the Vice-President [of the Court] to find that there
         was no need to adjudicate on the EMA’s appeal would not continue if the first General Court order were cancelled.
      
      38      In response to the questions asked by the judge hearing the application for interim relief, first, [Novartis Europharm] stated
         that it was maintaining its request based on Regulation No 1049/2001 seeking to obtain access to the reports at issue, on
         the ground that such access granted pursuant to that regulation would allow it to use those reports without the restrictions
         on it under the confidentiality agreement concluded with [Pari Pharma]. Second, according to the EMA, the fact that [Novartis
         Europharm] obtained access to the reports at issue has no influence on the [decision at issue], since the request for access
         was specifically not withdrawn.
      
      39      It follows that, in the event that the first General Court order were cancelled, with the result that [Pari Pharma] would
         be deprived of the protective effect of the interim measures granted, the EMA would proceed to implement the [decision at
         issue] and grant [Novartis Europharm] access to the reports at issue pursuant to Regulation No 1049/2001, which would have
         an erga omnes effect in the sense that those documents could be communicated to other persons requesting access and that any person would
         have the right to access them (see, to that effect, judgment of 21 October 2010, Agapiou Joséphidès v Commission and EACEA, T‑439/08, not published, EU:T:2010:442, paragraph 116). Furthermore, [Novartis Europharm] would be in a position to use
         them for its pharmaceutical activities and, therefore, as a competitor of [Pari Pharma].
      
      40      It should be recalled that it is precisely in consideration of the erga omnes effect, in view of which the judge who heard the application for interim relief found, in paragraphs 95 to 97 of the first
         General Court order, that it would place [Pari Pharma] in a vulnerable situation capable of causing it serious and irreparable
         damage, that the condition relating to urgency was regarded as having been met.
      
      41      It follows from all the foregoing that there is nothing in the order on the appeal such as to call into question the assessment
         of the judge who heard the application for interim relief as to the conditions to which the grant of the interim measures
         adopted in the first General Court order was subject, with the result that the condition relating to a change in circumstances,
         as referred to in Article 159 of the Rules of Procedure, is not satisfied.’
      
      24      On the basis of those considerations, the President of the General Court rejected the EMA’s request.
      
       Forms of order sought and procedure before the Court of Justice
      25      By its appeal, the EMA asks the Court to set aside the order under appeal and cancel the first General Court order, and order
         Pari Pharma to pay all the costs of the proceedings, including the costs before the General Court.
      
      26      Pari Pharma asks the Court to dismiss the appeal and the application for cancellation of the first General Court order, and
         order the EMA to pay the costs of the proceedings, including the costs of the proceedings before the General Court.
      
      27      At the request of the Court of 24 August 2016, Pari Pharma lodged a copy of the confidentiality agreement that it had concluded
         with Novartis Europharm, referred to in paragraph 19 of the present order, at the Court Registry on 25 August 2016.
      
       The appeal
       Arguments of the parties
      28      The EMA puts forward, in essence, three grounds of appeal in support of its appeal.
      
      29      By its first ground of appeal, the EMA claims that the order under appeal is at odds with the order on the appeal.
      
      30      The second and third grounds of appeal, for their part, allege that the President of the General Court was in error in holding,
         at paragraph 37 of the order under appeal, that ‘the status quo which enabled the Vice-President [of the Court] to find that
         there was no need to adjudicate on the EMA’s appeal would not continue if the first General Court order were cancelled’.
      
      31      In the context of those latter two grounds of appeal, the EMA claims that the President of the General Court artificially
         restricted, within limits not present in the order on the appeal, his assessment of the change in circumstances in question.
         It is submitted that the conclusion set out in paragraphs 38 to 41 of the order on the appeal is not conditional on the existence
         of any ‘status quo’.
      
      32      In any event, the President of the General Court, it is claimed, did not take into consideration the new circumstances and,
         in particular, the fact that Novartis Europharm had agreed to make limited use of the documents in question.
      
      33      As regards the allegedly erga omnes effect of the decision at issue, the EMA has, furthermore, stated in its appeal that, ‘in practice, and in line with … settled
         case-law, … any future request for access to the Documents will result in a notification of such request being sent by the
         EMA to [Pari Pharma] and [Pari Pharma] will be given again the opportunity to challenge the new release decision in the same
         manner the [decision at issue] was challenged, including by way of seeking interim relief’.
      
      34      Pari Pharma contends, by contrast, that, as long as the decision at issue has not been withdrawn, the first General Court
         order is not devoid of purpose, since that decision would have an influence on the future decisions to grant access to the
         reports at issue to third parties which the EMA might adopt in respect of requests pending before it. Pari Pharma states that
         the fact that Novartis Europharm has obtained access to those reports in the proceedings that gave rise to the order on the
         appeal, without Pari Pharma’s consenting thereto, is not such as to call into question the reasons set out in that regard
         in the first General Court order.
      
      35      In the first place, it is submitted that Novartis Europharm has indicated that it has a continuing interest in obtaining unrestricted
         access to the reports at issue without obligations of confidentiality, which can be granted only by way of a decision taken
         on the basis of Regulation No 1049/2001 and, therefore by maintaining its request for access which gave rise to the decision
         at issue.
      
      36      In the second place, it is submitted that the EMA considered that it could not withdraw the decision at issue in the absence
         of a withdrawal by Novartis Europharm of its request for access to the reports at issue. Furthermore, in the proceedings that
         gave rise to the order on the appeal, the EMA claimed that it still had an interest in bringing proceedings because of the
         erga omnes effect of decisions to grant access to documents under Regulation No 1049/2001. Similarly, it is submitted that, without
         expressly repeating the argument in its appeal in the present proceedings, the EMA has not excluded the erga omnes effect of the decision at issue.
      
      37      In this connection, Pari Pharma states that the erga omnes effect of a decision adopted under Regulation No 1049/2001 is confirmed by Article 8(3) of the Rules for the implementation
         of Regulation No 1049/2001 on access to EMEA documents of 19 December 2006 (‘the rules on access’), which states as follows:
      
      ‘The [EMA] shall grant the application without consulting the third-party author where the document requested has already
         been disclosed either by its author or under Regulation … No 1049/2001 or similar provisions’.
      
      38      The EMA’s statement to the effect that, in the event of future requests for access to the reports at issue, Pari Pharma would
         be given again the opportunity to challenge the new release decision therefore contradicts both the line of argument put forward
         by the EMA in the proceedings that gave rise to order on the appeal and the rules on access.
      
      39      In the third place, Pari Pharma contends that it still has a definite interest in the first General Court order being maintained
         and in the EMA’s application for cancellation thereof being rejected inasmuch as that order deprives the decision at issue
         of its erga omnes effect.
      
       Findings of the Court
      40      In adjudicating on the second and third grounds of appeal, which it is appropriate to deal with first and together, it must
         be recalled that, in paragraph 36 of the order under appeal, the President of the General Court stated that if Novartis Europharm
         were content to use the reports at issue solely for the purposes of protecting its interests in the context of Case T‑269/15,
         and the EMA regarded the decision at issue as having become devoid of purpose since Novartis Europharm already had those reports,
         Pari Pharma would no longer have need for the protection of interim measures.
      
      41      However, at paragraph 37 of the order under appeal, the President of the General Court held that that was not the case given
         that the status quo, which enabled the Vice-President of the Court to find that there was no need to adjudicate on the EMA’s
         appeal, would not continue if the first General Court order were cancelled.
      
      42      In reaching that conclusion, the President of the General Court took into consideration, in paragraph 38 of the order under
         appeal, the responses that Novartis Europharm and the EMA gave to the questions, set out in paragraph 25 of that order, addressed
         to them by the President of the General Court.
      
      43      Thus, in that paragraph 38, the President of the General Court simply noted, first, that Novartis Europharm stated that it
         was maintaining its request based on Regulation No 1049/2001 for access to the reports at issue, on the ground that such access
         granted pursuant to that regulation would allow it to use those reports without the restrictions on it under the confidentiality
         agreement concluded with Pari Pharma, and, second, that according to the EMA, the fact that Novartis Europharm had access
         to the reports at issue has no influence on the decision at issue, since the request for access was not withdrawn.
      
      44      However, it must be stated that both Novartis Europharm maintaining that request and the fact that the EMA has not withdrawn
         the decision at issue concern the substance of the action for annulment of that decision. In that context, those factors are
         to be considered in particular in the light of the EMA’s potential liability following a possible annulment of that decision
         at the end of the procedure dealing with the substance of the case in that action.
      
      45      On the other hand, those factors do not prove that the interim measures in question continue to serve a purpose, given the
         change in circumstances that has arisen in the present case and that consists, in particular, in Novartis Europharm having
         obtained access to the reports at issue and the conclusion of the confidentiality agreement between Novartis Europharm and
         Pari Pharma.
      
      46      That is a fortiori true since it is clear from paragraph 3 of that confidentiality agreement that Novartis Europharm may use the reports at issue
         only for the purposes of Case T‑269/15 and ‘without affecting the proceedings currently conducted before the General Court
         in Case T‑235/15’. It follows that Novartis Europharm is required to make limited use of those reports until such time as
         the General Court has ruled on the action for annulment of the decision at issue that is the subject matter of the proceedings
         in Case T‑235/15.
      
      47      Indeed, the President of the General Court ought to have taken those circumstances into consideration in adjudicating on the
         purpose served by the measure suspending operation of the decision at issue since that decision granted a third party, namely
         Novartis Europharm, access to those reports.
      
      48      Consequently, since the factors taken into consideration by the President of the General Court were not sufficient to exclude
         that the change in circumstances that arose subsequently to the first General Court order might warrant its cancellation,
         the second and third grounds of appeal must be upheld and the order under appeal must be set aside, and it is not necessary
         to rule on the first ground of appeal.
      
       The application for cancellation of the first General Court order
      49      Under the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court may, where
         the decision of the General Court has been set aside, either itself give final judgment in the matter, where the state of
         the proceedings so permits, or refer the case back to the General Court for judgment. That provision also applies to appeals
         brought under the second paragraph of Article 57 of the Statute of the Court (orders of the Vice-President of the Court of
         7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraphs 36 and 37, and 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 59).
      
      50      Since the state of the proceedings so permits, it is appropriate to adjudicate on the EMA’s application for cancellation of
         the first General Court order.
      
      51      In this connection, it should be recalled that it was found, in that first order, that it was urgent to grant the interim
         measures applied for in order to prevent Pari Pharma suffering serious and irreparable damage. According to paragraphs 93
         to 101 of that order, that damage might occur if, first, Novartis Europharm had access to the reports at issue, and, second,
         if those reports were disclosed to other third parties.
      
      52      However, since Novartis Europharm has the reports at issue in its possession, the interim measures in question are no longer
         capable of preventing the occurrence of harm resulting from possession thereof. Furthermore, as the President of the General
         Court stated in paragraph 36 of the order under appeal, Pari Pharma would no longer have need for the protection of interim
         measures if Novartis Europharm were content to use those reports solely for the purposes of protecting its interests in the
         context of Case T‑269/15.
      
      53      In that regard, as stated in paragraph 19 of the present order, it is clear from the confidentiality agreement concluded between
         Pari Pharma and Novartis Europharm that Novartis Europharm is required to make limited use of the reports at issue, such use
         being limited to the protection of its interests in the context of Case T‑269/15 until such time as the General Court has
         ruled on the substance of the action in Case T‑235/15. Against that background, and given the circumstances of the present
         case, that agreement suffices to protect the interests of Pari Pharma against any detrimental use of the reports at issue,
         other than for the purposes of Case T‑269/15, by Novartis Europharm.
      
      54      As regards the claimed erga omnes effect of the decision at issue, it should be pointed out that, even if it is true that the EMA has claimed, in the context
         of the present proceedings, that such an effect attaches to decisions adopted on the basis of Regulation No 1049/2001 in order
         to maintain that there is still a need to adjudicate on its appeal, the fact remains that, in its appeal, it has expressly
         stated that, ‘in practice, and in line with … settled case-law, … any future request for access to the Documents will result
         in a notification of such request being sent by the EMA to [Pari Pharma] and [Pari Pharma] will be given again the opportunity
         to challenge the new release decision in the same manner the [decision at issue] was challenged, including by way of seeking
         interim relief’.
      
      55      Indeed, even if decisions adopted on the basis of Regulation No 1049/2001 enable access to documents to be granted to third
         parties — other than the initial applicants to whom those decisions apply — who wish to have access to them, that does not
         mean that any third party automatically has a right of access to those documents. In other words, the institution in question
         is still required to carry out a specific and individual examination of any request for access to documents, irrespective
         of whether those documents have already been disclosed and must, should the case arise, provide the reasons justifying a different
         decision for the purpose of protecting one of the interests referred to in Article 4 of that regulation.
      
      56      Since the examination required for the purpose of processing a request for access to documents must be specific in nature,
         if the institution concerned decides to refuse access to a document which it has been asked to disclose, it must, in principle,
         explain how disclosure of that document could specifically and actually undermine the interest protected by the exception —
         among those provided for in Article 4 of Regulation No 1049/2001 — upon which it is relying. Moreover, the risk of the interest
         being undermined must be reasonably foreseeable and must not be purely hypothetical (judgment of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 31 and the case-law cited).
      
      57      Consequently, the fact that the reports at issue have already been disclosed in the present case cannot prevent the EMA from
         examining any other request for access concerning the same reports by subjecting that request to the procedure laid down in
         Regulation No 1049/2001 and thereby enabling Pari Pharma to oppose any disclosure under one of the grounds provided for in
         Article 4 of that regulation.
      
      58      Moreover, it cannot be claimed that the rules on access prohibit the EMA from proceeding in that manner, since, in the present
         case, access to the reports at issue was provided without the consent of the author of those documents and outside of that
         regulation or of any similar provision.
      
      59      Regardless of what the EMA claimed in the context of the proceedings that gave rise to the order on the appeal or to the order
         under appeal, the fact remains that, as noted in paragraph 54 of the present order, in its appeal, the EMA expressly stated
         before the Court that it intended to subject any request for access to the reports at issue to the procedure laid down in
         Regulation No 1049/2001.
      
      60      It follows that, even in the absence of the interim measures in question, first, Novartis Europharm may use the reports at
         issue only within the limits agreed in the confidentiality agreement concluded with Pari Pharma, and only until the end of
         the proceedings on the substance. Second, since the EMA has undertaken before the Court to subject any request for access
         to the reports at issue to the procedure laid down in Regulation No 1049/2001, no erga omnes effect can be attached to the decision at issue.
      
      61      In the light of those circumstances, the interim measures in question no longer serve their purpose and the first General
         Court order must be cancelled.
      
       Costs
      62      Under Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is well founded and the Court itself
         gives final judgment in the case, the Court is to make a decision as to costs. Under Article 138(1) of those rules, which
         applies to the procedure on appeal by virtue of Article 184(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.
      
      63      In the present case, since Pari Pharma has been unsuccessful in its contentions and the EMA has applied for costs, Pari Pharma
         must be ordered to pay the costs incurred in the appeal proceedings and at first instance.
      
      On those grounds, the Vice-President of the Court hereby orders:
      1.      The order of the President of the General Court of the European Union of 23 May 2016, Pari Pharma v EMA (T‑235/15 R, not published, EU:T:2016:309), is set aside.
      2.      The order of the President of the General Court of the European Union of 1 September 2015, Pari Pharma v EMA (T‑235/15 R, EU:T:2015:587), is cancelled.
      3.      Pari Pharma GmbH is to pay the costs incurred in the appeal proceedings and in the proceedings at first instance.
      [Signatures]
      * Language of the case: English.