CELEX: 62011TJ0669
Access to documents
Regulation (EC) No 1049/2001
Document originating from Germany in the context of an EU Pilot procedure
Article 4, paragraphs 4 and 5
Article 4, paragraph 2, third indent
Refusal of access
Infringement of essential procedural requirements
Obligation to carry out a specific, individual examination
Partial access
Overriding public interest

Legal context
Access to documents
Article 15(3) TFEU provides:
‘Any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State, shall have a right of access to documents of the Union’s institutions, bodies, offices and agencies, whatever their medium, subject to the principles and the conditions to be defined in accordance with this paragraph.
General principles and limits on grounds of public or private interest governing this right of access to documents shall be determined by the European Parliament and the Council, by means of regulations, acting in accordance with the ordinary legislative procedure.
Each institution, body, office or agency shall ensure that its proceedings are transparent and shall elaborate in its own Rules of Procedure specific provisions regarding access to its documents, in accordance with the regulations referred to in the second subparagraph.
…’
Article 42 of the Charter of Fundamental Rights of the European Union, entitled ‘Right of access to documents’, provides:
‘Any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State, has a right of access to documents of the institutions, bodies, offices and agencies of the Union, whatever their medium.’
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
) defines the principles, conditions and limits governing the right of access to documents of those institutions provided for in Article [15 TFEU].
Recitals 4 and 11 of the preamble to Regulation No 1049/2001 state:
‘(4)
The purpose of this regulation is to give the fullest possible effect to the right of public access to documents and to lay down the general principles and limits on such access in accordance with Article 255(2) of the EC Treaty.
…
(11)
In principle, all documents of the institutions should be accessible to the public. However, certain public and private interests should be protected by way of exceptions. The institutions should be entitled to protect their internal consultations and deliberations where necessary to safeguard their ability to carry out their tasks. In assessing the exceptions, the institutions should take account of the principles in Community legislation concerning the protection of personal data, in all areas of Union activities.’
Article 1 of Regulation No 1049/2001 provides:
‘The purpose of this Regulation is:
(a)
to define the principles, conditions and limits on grounds of public or private interest governing the right of access to European Parliament, Council and Commission (hereinafter referred to as “the institutions”) documents provided for in Article 255 of the EC Treaty in such a way as to ensure the widest possible access to documents,
(b)
to establish rules ensuring the easiest possible exercise of this right, and
(c)
to promote good administrative practice on access to documents.’
Article 2 of Regulation No 1049/2001 provides:
‘1.   Any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State, has a right of access to documents of the institutions, subject to the principles, conditions and limits defined in this regulation.
…
3.   This regulation shall apply to all documents held by an institution, that is to say, documents drawn up or received by it and in its possession, in all areas of activity of the European Union.
…’
Article 4(2) of Regulation No 1049/2001 provides:
‘The institutions shall refuse access to a document where disclosure would undermine the protection of:
…
—
the purpose of inspections, investigations and audits,
unless there is an overriding public interest in disclosure.’
Paragraphs 4 to 6 of Article 4 of Regulation No 1049/2001 provide:
‘4.   As regards third-party documents, the institution shall consult the third party with a view to assessing whether an exception in paragraph 1 or 2 is applicable, unless it is clear that the document shall or shall not be disclosed.
5.   A Member State may request the institution not to disclose a document originating from that Member State without its prior agreement.
6.   If only parts of the requested document are covered by any of the exceptions, the remaining parts of the document shall be released.’
The EU Pilot procedure
The EU Pilot procedure is a procedure for cooperation between the European Commission and the Member States aimed at establishing whether EU law is being complied with and correctly applied in the Member States. Its objective is the effective resolution of possible infringements of EU law, as far as possible without having recourse to the formal initiation of infringement proceedings under Article 258 TFEU.
The operational aspects of the EU Pilot procedure were initially described in the Commission’s communication of 5 September 2007 entitled ‘A Europe of Results — Applying Community Law’ (COM(2007) 502 final). In particular, point 2.2 of that communication, headed ‘Improving working methods’, states the following:
‘… As is the case now, enquiries and complaints raising a question of the correct application of Community law sent to the Commission would continue to be registered and acknowledged … Where an issue requires clarification of the factual or legal position in the Member State, it would be transmitted to the Member State concerned. ... the Member States would be given a short deadline to provide the necessary clarifications, information and solutions directly to the citizens or business concerned and inform the Commission. When the issue amounts to a breach of Community law, Member States would be expected to remedy, or offer a remedy, within set deadlines. When no solution is proposed, the Commission would follow-up, taking any further action, including through infringement proceedings, in accordance with existing practice. ... The outcome of cases would be recorded to enable reporting on performance and any follow-up, including the registration and initiation of infringement proceedings. This reporting would identify the volume, nature and seriousness of problems remaining unresolved, indicating if additional specific problem-solving mechanisms or more tailored sector initiatives are needed. All of these measures should contribute to a reduction in the number of infringement procedures and improved efficiency in managing them. The Commission suggests a pilot exercise involving some Member States in 2008, which could, after evaluation of the first year of operation, be extended to all Member States ...’
Background to the dispute
The applicants, Darius Nicolai Spirlea and Mihaela Spirlea, are the parents of a child who died in August 2010, allegedly as a result of a therapeutic treatment involving the use of autologous stem cells that was administered in a private clinic in Düsseldorf (Germany) (‘the private clinic’).
By letter of 8 March 2011, the applicants lodged a complaint with the European Commission’s Directorate-General for Health in which they claimed, in substance, that the private clinic had been able to provide therapeutic treatment as a result of the inaction of the German authorities, which had thereby infringed the provisions of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (
OJ 2007 L 324, p. 121
).
Following that complaint, the Commission initiated an EU Pilot procedure under the reference 2070/11/SNCO and contacted the German authorities in order to establish to what extent the events described by the applicants in their complaint and relating to the practices of the private clinic might infringe Regulation No 1394/2007.
On 10 May and 10 October 2011, the Commission sent the Federal Republic of Germany two requests for information, with which the latter complied on 7 July and 4 November 2011 respectively.
On 11 August 2011, the applicants requested access, under Regulation No 1049/2001, to information on the processing of the complaint. In particular, they asked to consult the observations lodged by the Federal Republic of Germany on 7 July 2011 (‘the document at issue’).
On 12 August 2011, the Commission informed the German authorities of the applicants’ request for access to the document at issue.
On 19 August 2011, the Federal Republic of Germany informed the Commission that it objected to the applicants being granted access to the document at issue on the basis of the exceptions relating to the protection of international relations, provided for in Article 4(1)(a), third indent, of Regulation No 1049/2001, and to the protection of the purpose of inspections, investigations and audits, provided for in Article 4(2), third indent, of the same regulation.
On 22 September 2011, the Commission refused the applicants’ request for access to the document at issue.
On 27 September 2011, the applicants lodged a confirmatory application with the Commission, in accordance with Article 7(2) of Regulation No 1049/2001.
On 9 November 2011, the Commission confirmed its earlier decision and refused to grant the applicants access to the document at issue on the basis of Article 4(5) of Regulation No 1049/2001 read together with Article 4(2), third indent, of that regulation (‘the contested decision’).
First of all, the Commission explained that, after it consulted the German authorities, the latter had objected to disclosure of the document at issue and had done so, inter alia, in reliance on the exception relating to the protection of the purpose of investigations provided for in Regulation No 1049/2001. The Commission went on to state that, since that ground of objection appeared, prima facie, to be well founded, it had to refuse access to the document at issue in accordance with Article 4(5) of Regulation No 1049/2001. Furthermore, it considered that partial access to the document at issue under Article 4(6) of Regulation No 1049/2001 was not possible in this case. Finally, it stated that there was no overriding public interest, within the meaning of the last clause of Article 4(2) of the regulation, justifying disclosure of the document.
On 27 September 2012, the Commission informed the applicants that EU Pilot procedure 2070/11/SNCO had been definitively closed.
Procedure and forms of order sought
By application lodged at the Registry of the General Court on 27 December 2011, the applicants brought the present action.
Following a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Eighth Chamber and the present case was therefore reallocated to that Chamber.
By order of 3 February 2014, in accordance with Article 65(b), Article 66(1), and the third subparagraph of Article 67(3) of the Rules of Procedure, the Court ordered the Commission to produce the document at issue, but provided that that document should not be communicated to the applicants in the present proceedings. The Commission complied with that request within the prescribed period.
On 4 February 2014, by way of measures of organisation of procedure provided for in Article 64 of the Rules of Procedure, the Court invited the applicants and the Commission to submit their observations on the consequences, for the solution of the present dispute, to be drawn from the Court’s judgment of 21 June 2012 in
IFAW Internationaler Tierschutz-Fonds
v
Commission
(Case C‑135/11 P, ECR). The parties complied with that request within the prescribed period.
Upon hearing the Report of the Judge-Rapporteur, the Court decided to open the oral procedure.
The parties presented oral argument and replied to questions put by the Court at the hearing on 6 March 2014.
The applicants claim that the Court should:
—
annul the contested decision;
—
order the Commission to pay the costs.
The Commission contends that the Court should:
—
dismiss the action as unfounded;
—
order the applicants to pay the costs.
Law
The applicants put forward, in substance, three pleas in law, alleging infringement of essential procedural requirements and breach of the duty to state reasons, infringement of the last clause of Article 4(2) of Regulation No 1049/2001, and infringement of Article 4(6) of that regulation.
The first plea, alleging infringement of essential procedural requirements and breach of the duty to state reasons
Arguments of the parties
The applicants complain, in substance, that, in the contested decision, the Commission took the view that the mere fact that the Federal Republic of Germany opposed the disclosure of the document at issue provided sufficient grounds for the rejection of their request for access under Regulation No 1049/2001. In this connection they submit that the Commission made a number of errors in processing their request for access and failed to provide an adequate statement of reasons for the contested decision.
The applicants argue, first of all, that, where a request for access concerns a document originating from a Member State, as in the present case, Article 4(4) of Regulation No 1049/2001 allows the Commission a margin of discretion in applying the exceptions provided for in Article 4(1) and (2). Accordingly, the Commission is not required immediately to consult the Member State concerned about access if it is clear that the document in question must be disclosed. The applicants submit that, in the present case, there was nothing in the contested decision to indicate that the Commission exercised that discretion in connection with their request for access.
Next, the applicants maintain that, even after consulting the Federal Republic of Germany with regard to Article 4(5) of Regulation No 1049/2001, the Commission should have considered carefully whether the facts and reasoning on which that Member State relied in opposing the disclosure of the document at issue were well founded. In the applicants’ view, it was for the Commission not only to check whether the Member State had formally stated the reasons for its objection, but also to check whether those reasons related to the exceptions laid down in Article 4 of Regulation No 1049/2001 and to assess whether those objections and reasons actually applied to the document at issue.
Moreover, the applicants complain that the Commission invited the Federal Republic of Germany to invoke the exceptions laid down in Article 4 of Regulation No 1049/2001. They submit that, in order to prevent them from gaining access to the document at issue, the Commission directly enjoined that Member State to object to disclosure and that it even offered guidance on how to invoke the exceptions in Regulation No 1049/2001. Such conduct runs counter to the objective of that regulation, which is to ensure the transparency and objectivity of decisions of the EU institutions.
Furthermore, the applicants allege that the Commission breached the principle of the equality of arms and infringed their right to be heard in the procedure leading to the adoption of the contested decision. They state that the Federal Republic of German was informed of the grounds on which they had made their application for access, whereas they were not informed of the grounds on which that Member State opposed disclosure of the document at issue. That being so, they were prevented from expressing their position on the merits of the Member State’s opposition with regard to the exceptions laid down in Article 4 of Regulation No 1049/2001. Finally, they submit that, as parties to the procedure for the purposes of the regulation, they should have been allowed access to the Federal Republic of Germany’s reply.
Lastly, the applicants maintain that the Commission mistakenly extended the scope of Article 4(5) of Regulation No 1049/2001 to include ‘German authorities’, whereas the Commission’s only valid interlocutor for the purposes of that provision was the ‘Federal Republic of Germany’.
The Commission contests the applicants’ arguments.
Findings of the Court
In the context of their first plea, the applicant put forward, in substance, two complaints, respectively alleging infringement of essential procedural requirements arising, in particular, from Article 4(4) and (5) of Regulation No 1049/2001, and breach of the duty to state reasons.
– Preliminary remarks
It is appropriate to recall at the outset that Regulation No 1049/2001 is intended, as is indicated in recital 4 of the preamble and in Article 1, to give the public a right of access to documents of the institutions which is as wide as possible (Joined Cases
C-39/05 P and C-52/05 P
Sweden and Turco
v
Council
[2008] ECR I-4723
, paragraph 33, and Case T‑63/10
Jurašinović
v
Council
[2012] ECR, paragraph 28). Pursuant to Article 2(3) of the regulation, that right extends not only to documents drawn up by an institution but also to documents received by an institution from third parties, including the Member States, as is expressly stated in Article 3(b) of the regulation.
However, that right of access is none the less subject to certain limits based on grounds of public or private interest (Case
C-266/05 P
Sison
v
Council
[2007] ECR I-1233
, paragraph 62, and
Jurašinović
v
Council
, paragraph 29). In particular, Article 4(5) of Regulation No 1049/2001 provides that a Member State may request an institution not to disclose a document originating from that Member State without its prior agreement (
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 50).
In the present case, the Federal Republic of Germany made use of the option given to it by Article 4(5) of Regulation No 1049/2001 and asked the Commission not to disclose the observations which it had sent to the Commission on 7 July 2011 in the context of EU Pilot procedure 2070/11/SNCO. That Member State based its objection, inter alia, on the exception relating to investigations laid down in the third indent of Article 4(2) of the regulation. Consequently, in the contested decision, the Commission based its refusal to grant access to the document at issue on the objection voiced by the German authorities in accordance with Article 4(5) of Regulation No 1049/2001.
It is appropriate to point out in this connection that the Court has already had occasion to clarify, in its judgment of 18 December 2007 in
Sweden
v
Commission
(Case C‑64/05, ECR I‑11389) and in
IFAW Internationaler Tierschutz-Fonds
v
Commission
, the scope of the objection raised by a Member State pursuant to that provision.
The Court has emphasised that Article 4(5) of Regulation No 1049/2001 is procedural in nature, since it confines itself to requiring the prior agreement of the Member State concerned where that State has made a specific request to that effect, and that it is a provision dealing with the process of adoption of an EU decision (
Sweden
v
Commission
, paragraphs 78 and 81, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 53).
Unlike Article 4(4) of Regulation No 1049/2001, which gives third parties only a right to be consulted, with respect to documents originating from them, by the institution concerned as regards the application of one of the exceptions in Article 4(1) and (2), Article 4(5) of the regulation makes the prior agreement of the Member State a necessary condition for the disclosure of a document originating from it, if that State so requests (
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 54).
The Court has thus held that, where a Member State has made use of the option given to it by Article 4(5) of Regulation No 1049/2001 to request that a specific document originating from that State should not be disclosed without its prior agreement, disclosure of that document by the institution requires the prior agreement of that Member State to be obtained (
Sweden
v
Commission
, paragraph 50, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 55).
It follows, conversely, that an institution which does not have the agreement of the Member State concerned is not entitled to disclose the document (see
Sweden
v
Commission
, paragraph 44, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 56).
However, Article 4(5) of Regulation No 1049/2001 does not confer on the Member State concerned a general and unconditional right of veto, such that it might oppose, in an entirely discretionary manner and without having to give reasons for its decision, the disclosure of any document held by an institution simply because it originates from that Member State (
Sweden
v
Commission
, paragraph 58, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 57).
Indeed, the exercise of the power conferred by Article 4(5) of Regulation No 1049/2001 on the Member State concerned is delimited by the substantive exceptions set out in Article 4(1) to (3), with the Member State merely being given in this respect a power to take part in the institution’s decision. The prior agreement of the Member State referred to in Article 4(5) thus resembles not a discretionary right of veto but a form of assent confirming that none of the grounds of exception under Article 4(1) to (3) is present. The decision-making process thus established by Article 4(5) therefore requires the institution and the Member State involved to confine themselves to the substantive exceptions laid down in Article 4(1) to (3) (
Sweden
v
Commission
, paragraphs 76 and 83, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 58).
Consequently, Article 4(5) of Regulation No 1049/2001 entitles the Member State concerned to object to the disclosure of documents originating from it only on the basis of the substantive exceptions laid down in Article 4(1) to (3) and only if it gives proper reasons for its position (
Sweden
v
Commission
, paragraph 99, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 59).
With regard, in the present case, to the scope of Article 4(5) of Regulation No 1049/2001 as regards the institution to which a request for access to a document has been made, it must be recalled that the Court has already held that, from the point of view of the person requesting access, the Member State’s intervention does not alter the fact that the decision subsequently addressed to him by the institution in reply to his request for access to a document in its possession is in the nature of a European Union act (
Sweden
v
Commission
, paragraph 94, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 60).
The institution to which a request for access has been made, as the maker of a decision to refuse access to documents, is therefore responsible for the lawfulness of that decision. The Court has therefore held that the institution cannot accept a Member State’s objection to disclosure of a document originating from that State if no reasons at all are given for the objection or if the reasons relied on by that State for refusing access to the document in question do not refer to the exceptions listed in Article 4(1) to (3) of Regulation No 1049/2001 (
Sweden
v
Commission
, paragraph 88, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 61).
It follows that, before refusing access to a document originating from a Member State, the institution concerned must examine whether that State has based its objection on the substantive exceptions in Article 4(1) to (3) of Regulation No 1049/2001 and has given proper reasons for its position. Consequently, in the procedure for the adoption of a decision to refuse access, the institution must make sure that those reasons exist and refer to them in the decision it makes following that procedure (
Sweden
v
Commission
, paragraph 99, and
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 62).
On the other hand, according to the case-law, the institution to which a request for access to a document has been made does not have to carry out an exhaustive assessment of the Member State’s decision to object by conducting a review going beyond the verification of the mere existence of reasons referring to the exceptions in Article 4(1) to (3) of Regulation No 1049/2001 (
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 63).
To insist on such an exhaustive assessment could lead to the institution to which a request for access to a document has been made being able, after carrying out the assessment, wrongly to communicate the document in question to the person requesting access, notwithstanding the objection, duly reasoned in accordance with paragraphs 52 and 53 above, of the Member State from which the document originated (
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 64).
It is in the light of those principles that the Court must examine the two complaints put forward by the applicants in the context of the first plea.
– The alleged infringement of essential procedural requirements
By their complaint alleging infringement of essential procedural requirements the applicants argue, first, that Article 4(4) of Regulation No 1049/2001 must be interpreted as meaning that, before consulting the Member State concerned in accordance with Article 4(5), the Commission is required to exercise its discretion and check whether the document to which access is sought must or must not be disclosed, in light of the exceptions laid down in the regulation.
It must be observed that that allegation seeks to call into question the assertion which the Commission made both in the contested decision and in its pleadings before the Court that, where a request for access concerns a document originating from a Member State, it must then seek the Member State’s agreement to its disclosure.
The applicants are right to take issue with that assertion of the Commission’s, since Article 4(4) of Regulation No 1049/2001 provides that, as regards documents received from third parties, including the Member States (see paragraph 40 above), the institution to which a request for access to a document has been made is to consult the third party with a view to assessing whether an exception in Article 4(1) or (2) is applicable unless it is clear that the document must or must not be disclosed.
It must also be pointed out that the Court of Justice has established in its case-law that, in accordance with Article 4(4) of Regulation No 1049/2001, if the institution concerned considers that it is clear that access to a document originating from a Member State should be refused on the basis of the exceptions in Article 4(1) or (2), it will refuse the request for access without even having to consult the Member State from which the document originates, whether or not that Member State has already made a request under Article 4(5) of the regulation (see, to that effect,
Sweden
v
Commission
, paragraph 68).
Accordingly, as the applicants maintain, if the document originating from a Member State to which access has been sought is not in any way covered by the exceptions in Article 4 of Regulation No 1049/2001, the Commission cannot be obliged to consult the Member State and must disclose the document directly, without the consent of the Member State. It is important to emphasise in this connection that, in accordance with the case-law mentioned in paragraph 48 above, the Member States do not have any general and unconditional right of veto such that they might oppose the disclosure of any document held by an institution simply because it originates from them.
In the present case, however, no infringement of Article 4(4) of Regulation No 1049/2001 may be ascribed to the Commission because, as it stated in the contested decision, the document at issue related to an EU Pilot procedure and it was therefore likely that the exception laid down in the third indent of Article 4(2) of Regulation No 1049/2001 would be invoked by the Federal Republic of Germany.
It must be observed at the outset that the applicants do not dispute that the document at issue relates to an ‘investigation’ within the meaning of the exception laid down in Article 4(2), third indent, of Regulation No 1049/2001.
In any event, it is clear from the communication of 5 September 2007 (see paragraph 10 above) that the purpose of EU Pilot procedures is to establish whether EU law is being complied with and correctly applied in the Member States. To that end, the Commission habitually addresses requests for information to the Member States concerned as well as to concerned citizens and undertakings. In particular, in the specific context of EU Pilot procedure 2070/11/SNCO, the Commission examined whether the facts described by the applicants in their complaint might indeed constitute an infringement of Regulation No 1394/2007 by the Federal Republic of Germany. In this connection, it first of all sent requests for information to that Member State. It then proceeded to evaluate the answers obtained. Finally, it set out its conclusions, provisionally, in a report addressed to the applicants.
It follows that, contrary to the applicants’ assertion, the Commission was acquitting itself of its obligations under Article 4(5) of Regulation No 1049/2001 by consulting the Federal Republic of Germany on the question of whether, in the view of that Member State, the exceptions laid down in Article 4(1) and (2) of the regulation applied to the applicants’ request for access. Moreover, it must be held that the Commission’s decision on the request for access depended on the decision taken by the German authorities as part of the process of adoption of the contested decision (see, to that effect,
IFAW Internationaler Tierschutz-Fonds
v
Commission
, paragraph 56).
Secondly, the applicants complain that the Commission enjoined the Federal Republic of Germany to object to disclosure of the document at issue. However, it must be observed that that allegation is not supported in any way. Indeed, it is clear from the Commission’s letter of 12 August 2011 (see paragraph 16 above) that the Commission informed the Federal Republic of Germany of the applicants’ request for access to the document at issue and, in doing so, restricted itself to seeking its opinion on the document’s disclosure. Contrary to the applicants’ argument, that cannot be taken as an invitation to oppose their application for access, since the Commission’s aim was in fact to acquit itself of its obligation under Article 4(4) of Regulation No 1049/2001 to consult the Member State concerned by the application.
Thirdly, the applicants maintain that the Commission erred in addressing itself to the ‘German authorities’, rather than to the ‘Federal Republic of Germany’. Suffice it to observe in this connection that that allegation is based on a misunderstanding of the wording of the contested decision. In its statement of reasons for the decision, the Commission used the expression ‘German authorities’ as the equivalent of ‘the Federal Republic of Germany’. Inasmuch as those two expressions refer, in this case, to the Member State from which the document that was the subject of the request for access originated, within the meaning of Article 4(5) of Regulation No 1049/2001, no infringement of that provision can be imputed to the Commission. It must be borne in mind that that provision concerns all documents originating from the Member States and sent by them to an institution, irrespective of who, in accordance with the national division of competences, is the author of the document within the Member State concerned (see, to that effect,
Sweden
v
Commission
, paragraph 61).
Fourthly, the applicants complain, in substance, that the Commission breached the principle of the equality of arms and did not let them know the opinion which the Federal Republic of German proffered on being consulted in accordance with Article 4(5) of Regulation No 1049/2001.
In this connection, the Court must first of all point out, as the Commission has pointed out, that that institution’s task in applying Article 4(5) of Regulation No 1049/2001 is not to adjudicate on a dispute between an applicant for access to a document and the Member State from which that document emanates, and in so doing to have regard to the principle of the equality of arms. In the present case, the precise task of the Commission, as the competent institution to decide the matter of access to the document at issue, was to consider whether the Federal Republic of Germany had given reasons which, in light of the exceptions in Article 4 of Regulation No 1049/2001, were capable of justifying, prima facie, a refusal to grant access.
Next, contrary to the applicants’ submission, it must be observed that the Commission did not restrict itself in the contested decision to stating the position maintained by the Federal Republic of Germany with regard to the application for access. It also set out the literal tenor of extracts from the opinion which the latter had sent it following the consultation (section 3 of the contested decision). The passages in question are those in which the Federal Republic of Germany explained, in substance, that it was, in its view, necessary in an EU Pilot procedure for there to be an atmosphere of mutual trust with the Commission, to enable a process of negotiation and compromise to be engaged with a view to a swift and complete resolution of the matter. It is also clear from those extracts that, in the Federal Republic of Germany’s view, disclosure of the document at issue would only undermine the sincere cooperation between it and the Commission which it was necessary to maintain during the ongoing investigation.
Consequently, it must be held that the Commission did allow the applicants to know the reasons put forward by the Federal Republic of Germany in opposing the disclosure of the document at issue.
Moreover, the Court must also reject the applicants’ argument according to which, in substance, the Commission infringed their right to be heard inasmuch as it did not allow them an opportunity to express their views on the answer given by the Federal Republic of Germany.
It is appropriate to point out in this connection that provision is made in Regulation No 1049/2001 so that, following an initial refusal on the part of the institution to which a request for access has been made, applicants for access may make a confirmatory application, pursuant to Article 7(2) of the regulation. On that occasion they will, in appropriate cases, have an opportunity to convey their views on the position adopted by the institution. In particular, in the event that a Member State has, in accordance with Article 4(5) of Regulation No 1049/2001, opposed the disclosure requested, invoking the exceptions laid down in Article 4(1) and (2), applicants will, by means of the confirmatory application, have an opportunity to express their opinion on the reasons put forward by that Member State.
In the present case, following the Commission’s decision of 22 September 2011 refusing the applicants’ request for access to the document at issue (see paragraph 18 above), the applicants lodged a confirmatory application with the Commission, in accordance with Article 7(2) of Regulation No 1049/2001 (see paragraph 19 above). It must be held, therefore, that, contrary to their allegations, they did have an opportunity to challenge both the Commission’s consultation of the Federal Republic of Germany pursuant to Article 4(5) of the regulation and the position which that Member State adopted in opposition to their application. It is also important to emphasise that, in the statement of reasons which it gave, the Commission specifically answered the allegations and observations made by the applicants in their confirmatory application (section 4 of the contested decision).
Fifthly, although the applicants complain that the Commission failed properly to identify the document to which they sought access, it must be held that, on the contrary, the Commission correctly referred to that document, both when consulting the Federal Republic of Germany and in the contested decision, as being the reply which that Member State had sent the Commission on 7 July 2011 following the request made in the context of EU Pilot procedure 2070/11/SNCO. The applicants’ argument must therefore be rejected.
Consequently, given that the Commission fulfilled its obligations under Article 4(4) and (5) of Regulation No 1049/2001, as interpreted by the Court of Justice in its case-law, the applicants cannot successfully argue that it breached essential procedural requirement in processing their application for access.
The first complaint must therefore be rejected.
– The alleged breach of the duty to state reasons
As regards the complaint alleging breach of the duty to state reasons, the applicants put forward a series of arguments criticising the Commission for restricting itself to a superficial examination of the reasons put forward by the Federal Republic of Germany in support of its refusal of the request for access. They submit that, in accordance with settled case-law, the Commission was required to examine specifically and individually the reasons put forward and that, in the event of refusal of the request, it should have explained the reasons for which access to the document at issue might have conflicted with the provision on which the Federal Republic of Germany relied, namely Article 4(2), third indent, of Regulation No 1049/2001.
As a preliminary point it may be observed that, by this complaint, the applicants raise the question of the nature and intensity of the examination that must be carried out and of what statement of reasons must be given by the Commission when it decides to invoke an exception in Article 4 of Regulation No 1049/2001.
The applicants correctly state, in this connection, that the Court of Justice has established that, in principle, in order to justify the refusal of access to a document the disclosure of which has been requested, it is not sufficient for that document to fall within an activity mentioned in Article 4(2) of Regulation No 1049/2001. The institution concerned must also supply explanations as to how access to that document could specifically and effectively undermine the interest protected by an exception laid down in that article (Case
C-139/07 P
Commission
v
Technische Glaswerke Ilmenau
[2010] ECR I-5885
, paragraph 53, Joined Cases
C-514/07 P, C-528/07 P and C-532/07 P
Sweden and Others
v
API and Commission
[2010] ECR I-8533
, paragraph 72, and Joined Cases C‑514/11 P and C‑605/11 P
LPN
v
Commission
[2013] ECR, paragraph 44).
However, it must be observed that the obligation to carry out a specific and individual examination which stems from the principle of transparency as developed in the abovementioned case-law does not apply where the request for access concerns a document originating from a Member State, as referred to in Article 4(5) of Regulation No 1049/2001.
As was made clear in paragraphs 53 and 55 above, the Court has held that, in the procedure leading to the adoption of a decision to refuse access, the Commission must do no more than ensure, first, that the Member State in question has based its objection on the substantive exceptions listed in Article 4(1) to (3) of Regulation No 1049/2001 and, secondly, that it has given proper reasons for its position.
Moreover, the Court has also held, in response to arguments similar to those put forward by the applicants in the present case, that the institution to which a request for access to a document has been made does not have to carry out an exhaustive assessment of the Member State’s decision to object, by conducting a review going beyond the verification of the mere existence of reasons referring to the exceptions in Article 4(1) to (3) of Regulation No 1049/2001.
It must be held that, in the present case, the Commission did check that the Federal Republic of Germany’s objection referred to the substantive exceptions laid down in Article 4(1) to (3) of Regulation No 1049/2001 and that the Member State had given proper reasons for its objection. Indeed, the Commission first of all pointed out that the German authorities had objected to disclosure of the document at issue on the basis of the exception in the third indent of Article 4(2) of the regulation, which relates to the protection of the purpose of investigations, and then even went as far as to quote the Federal Republic of Germany’s reply verbatim. Secondly, it pointed out that the explanations which the latter had offered appeared, prima facie, to be well founded, as the Court had, in its view, required in its judgment in
Sweden
v
Commission
. Finally, it answered the points made by the applicants in their confirmatory application of 27 September 2011 (see paragraph 19 above) and taking issue with the consultation of the German authorities.
It follows that the Commission acquitted itself of its obligation to conduct a diligent examination of the level of intensity required by the Court in its case-law relating to Article 4(5) of Regulation No 1049/2001 and that it fulfilled its duty to state reasons.
The second complaint must therefore be rejected.
In light of the foregoing considerations, the first plea must be dismissed in its entirety.
The second plea, alleging infringement of the last clause of Article 4(2) of Regulation No 1049/2001
Arguments of the parties
The applicants’ main argument is that the Commission failed to provide an adequate statement of reasons in its decision regarding the absence of any overriding interest, within the meaning of the clause of Article 4(2) of Regulation No 1049/2001. They also submit that the Commission did not correctly weigh the opposing interests in the present case, and they therefore take issue with the conclusion that there was no interest outweighing the interests of the EU Pilot procedure such as might justify the disclosure of the document at issue. In substance, they argue that the objective of protecting health ought to have outweighed the Commission’s particular interest in pursuing its investigation.
The Commission contests the applicants’ arguments.
Findings of the Court
It is appropriate to observe, as a preliminary point, that in a case, such as the present, in which the Commission relies on Article 4(5) of Regulation No 1049/2001 in order to refuse access to the documents requested, the possibility of demonstrating that there is an overriding public interest which justifies the disclosure of the documents, in accordance with the last clause of Article 4(2) of the regulation, is not ruled out. Indeed, as is clear from the case-law mentioned in paragraph 49 above, the decision-making process established by Article 4(5) of Regulation No 1049/2001 requires the institution and the Member State involved to confine themselves to the substantive exceptions laid down in Article 4(1) to (3) of the regulation, which provisions necessarily include the last clause of Article 4(2).
However, according to the case-law, it is for the person alleging the existence of an overriding public interest to state the specific circumstances which justify the disclosure of the documents concerned (see, to that effect, Case C‑477/10 P
Commission
v
Agrofert Holding
[2012] ECR, paragraph 68,
Commission
v
Technische Glaswerke Ilmenau
, paragraph 62,
Sweden and Others
v
API and Commission
, paragraph 103, and
LPN
v
Commission
, paragraph 94).
Moreover, a statement of purely general considerations is not sufficient to establish that an overriding public interest outweighs the reasons justifying a refusal to disclose the documents in question (see, to that effect,
LPN
v
Commission
, paragraph 93).
Furthermore, the overriding public interest capable of justifying the disclosure of a document need not necessarily be distinct from the principles which underlie Regulation No 1049/2001 (see, to that effect,
Sweden and Turco
v
Council
, paragraphs 74 and 75, and
LPN
v
Commission
, paragraph 92).
In the present case, the Commission concluded in the contested decision that no overriding public interest justified the disclosure of the document in accordance with the last clause of Article 4(2) of Regulation No 1049/2001, since the best way of serving the general interest in this case was for it to complete the EU Pilot procedure with the Federal Republic of Germany. According to the Commission, which essentially adopted the reasons expressed by the Germany authorities in their letter of 19 August 2011 (see paragraph 17 above and paragraphs 3 and 6 of the contested decision), that would make it possible to check whether EU law had in fact been infringed in the light of the facts put forward by the applicants in their complaint against the German authorities.
That assessment by the Commission is not vitiated by any error.
Indeed, it must be observed, first, that, as is clear from paragraph 94 above, the Commission stated the reasons for its conclusion that disclosure of the document at issue could not, in this case, be justified by an overriding public interest, within the meaning of the last clause of Article 4(2) of Regulation No 1049/2001. The applicants’ allegation that the contested decision is not adequately reasoned in this regard cannot, therefore, succeed.
Secondly, it is important to point out that, other than their general arguments concerning the need to protect public health and their assertion that treatments at the private clinic have led to the death of a number of patients in Germany, the applicants do not put forward any specific, substantiated reasons which would justify the disclosure of the document at issue in this case. In particular, they have not explained in what way the disclosure to them of the document at issue, that is to say, the Federal Republic of Germany’s answers to the questions asked by the Commission in the context of the EU Pilot procedure in question, would serve the interest of protecting public health. However, it must be emphasised that, as is clear from the case-law cited in paragraphs 91 and 92 above, while the burden of proof, when applying the exception in the third indent of Article 4(2) of Regulation No 1049/2001, rests on the institution invoking that exception, in so far as concerns the last clause of Article 4(2) of the regulation, it is, by contrast, for the party alleging an overriding public interest, within the meaning of that clause, to prove that interest.
Thirdly, even if the applicants’ general allegations concerning the existence of an overriding public interest in health protection were to be accepted, the disclosure of the document sought in the present case could not be regarded as helping to serve that interest. Indeed, it must be observed that it is not for the applicants to establish to what degree EU law, and Regulation No 1397/2007 in particular, was being complied with by the German authorities, in the light of the factual context set out in their complaint. On the contrary, the Court would confirm the Commission’s view that it is in the public interest for it to clarify for itself whether EU law has been complied with by the Federal Republic of Germany, that being the best way to protect public health.
Fourthly, the applicants argue that the document at issue could form the basis of a possible action in non-contractual liability which they might bring before the national courts in Germany. In substance, their request is aimed at obtaining documentary evidence to support such an action for damages, using, to that end, the Commission and the powers of investigation which it enjoys as guardian of the FEU Treaty. However, any interest that the applicants might have in producing documentary evidence before a national court cannot be regarded as constituting an ‘overriding public interest’ for the purposes of the last clause of Article 4(2) of Regulation No 1049/2001, for it is a private interest (see, to that effect,
Commission
v
Agrofert Holding
, paragraph 86). It cannot, therefore, be accepted that the Commission should be made the instrument by which to obtain access to evidence that is not available through other channels.
It is appropriate to observe in this connection that, while the facts which gave rise to the applicants’ actions before the German and European Union courts are clearly unfortunate and regrettable, the Commission was right to emphasise that, in so far as they institute legal proceedings, the applicants must pursue legal remedies that are recognised by the national legal order and adhere to the methods for obtaining evidence that are prescribed by that legal order.
Fifthly, the applicants complain that the Commission did not allow them access to the document at issue, in view of the public interest to which they refer, even after the conclusion of EU Pilot procedure 2070/11/SNCO.
Suffice it to recall in this connection that, according to settled case-law, in an action for annulment under Article 263 TFEU, the legality of the contested measure must be assessed on the basis of the facts and the law as they stood at the time when the measure was adopted (see judgment of 30 September 2009 in Case T‑432/07
France
v
Commission
, not published in the ECR, paragraph 43 and the case-law cited).
However, EU Pilot procedure 2070/11/SNCO was brought to a close after the contested decision was adopted. Consequently, the applicants’ argument must be rejected.
In any event, as is suggested by paragraph 12 of the judgment in
LPN
v
Commission
and by the information provided by the Commission at the hearing, it cannot be ruled out that full or partial access to the documents in the present case might be granted to the applicants, since the exception in the third indent of Article 4(2) of Regulation No 1049/2001 would cease to be applicable once the Commission has decided to close the file on the complaint, provided that the documents are not covered by any other exception in that regulation. That could only happen, however, if a fresh application for access were made to the Commission.
It follows that, in the present case, the Commission did not breach its duty to state reasons or make any error of assessment when applying the last clause of Article 4(2) of Regulation No 1049/2001.
The second plea must therefore be dismissed.
The third plea, alleging infringement of Article 4(6) of Regulation No 1049/2001
Arguments of the parties
The applicants complain that the Commission failed to recognise their right to partial access to the document at issue.
The Commission contests the applicants’ arguments.
Findings of the Court
Under the first paragraph of Article 21 of the Statute of the Court of Justice, which applies to the procedure before the General Court by virtue of the first paragraph of Article 53 of that statute, and under Article 44(1)(c) of the Rules of Procedure of the General Court, all applications must indicate the subject-matter of the dispute and contain a summary of the pleas in law on which the application is based. The information given must be sufficiently clear and precise to enable the defendant to prepare the defence and the General Court to decide the case. In order to ensure legal certainty and the sound administration of justice, it is necessary for the essential facts and points of law on which the action is based to be apparent from the text of the application itself, even if only stated briefly, provided that the statement is coherent and comprehensible (order in Case
T-85/92
De Hoe
v
Commission
[1993] ECR II-523
, paragraph 20, and order in Case
T-294/04
Internationaler Hilfsfonds
v
Commission
[2005] ECR II-2719
, paragraph 23).
It must be observed that, in the present case, other than the abstract statement in the application of a plea alleging infringement of Article 4(6) of Regulation No 1049/2001 (see, in particular, paragraph 91 of the application), the applicants develop no argument in support of that plea. Indeed, they merely allege that ‘the Commission should have indicated precisely the author of the document at issue, its length and the length of its annexes, its reference number, and so on, so that the document could be identified’ and that ‘[i]n the absence of such identification of the [document at issue] by the “German authorities”, … the procedure was unfair’.
Since that allegation bears no relation to the application of Article 4(6) of Regulation No 1049/2001 in the present case, and relates instead to the duty to state reasons, as examined in paragraphs 78 to 86 above, it must be regarded as nor relevant for the purpose of supporting the present plea.
Moreover, it must be held that arguments put forward by the applicants in their reply cannot be examined by the Court, in particular, since they are based on aspects of the contested decision that were known at the time when the action was brought (see, to that effect, judgment of 21 October 2010 in Case T‑474/08
Umbach
v
Commission
, not published in the ECR, paragraph 60).
Consequently, the third plea must be dismissed as inadmissible.
The action must accordingly be dismissed in its entirety.
Costs
Under Article 87(3) of the Rules of Procedure, the Court may order the costs to be shared or the parties to bear their own costs if each party succeeds on some and fails on other heads, or where the circumstances are exceptional.
In the circumstances of the present case, it is appropriate to decide that each party must bear its own costs.

On those grounds,
THE GENERAL COURT (Eighth Chamber)
hereby:

1.
Dismisses the action;

2.
Orders each party to bear its own costs.

Gratsias
Kancheva
Wetter
Delivered in open court in Luxembourg on 25 September 2014.
[Signatures]
(
*1
)	Language of the case: German.