PTC Therapeutics International Ltd v European Medicines Agency.
Date: 2020-01-22
51


It should be borne in mind that, in accordance with recital 1 thereof, Regulation No 1049/2001 reflects the intention expressed in the second paragraph of Article 1 TEU to mark a new stage in the process of creating an ever closer union among the peoples of Europe, in which decisions are taken as openly as possible and as closely as possible to the citizen (judgments of 1 July 2008, Sweden and Turco v Council, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 34, and of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 73).
52


That core EU objective is also reflected in Article 15(1) TFEU, which provides that the institutions, bodies, offices and agencies of the European Union are to conduct their work as openly as possible, that principle of openness also being expressed in Article 10(3) TEU and in Article 298(1) TFEU, and in the enshrining of the right of access to documents in Article 42 of the Charter of Fundamental Rights of the European Union (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 74 and the case-law cited).
53


It can be seen from recital 2 of Regulation No 1049/2001 that openness enables the EU institutions to have greater legitimacy and to be more effective and more accountable to EU citizens in a democratic system (see, to that effect, judgments of 1 July 2008, Sweden and Turco v Council, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraphs 45 and 59, and of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 75).
54


To those ends, Article 1 of Regulation No 1049/2001 provides that the purpose of that regulation is to confer on the public as wide a right of access as possible to documents of the EU institutions (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 76 and the case-law cited).
55


It is also apparent from Article 4 of that regulation, which introduces a system of exceptions in that regard, that that right is, nevertheless, subject to certain limits based on reasons of public or private interest (judgments of 16 July 2015, ClientEarth v Commission, C‑612/13 P, EU:C:2015:486, paragraph 57, and of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 77).
56


As such exceptions depart from the principle of the widest possible public access to documents, they must be interpreted and applied strictly (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 78 and the case-law cited).
57


In that regard, it should be borne in mind that where an EU institution, body, office or agency that has received a request for access to a document decides to refuse to grant that request on the basis of one of the exceptions laid down in Article 4 of Regulation No 1049/2001, it must, in principle, explain how access to that document could specifically and actually undermine the interest protected by that exception, and the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 51 and the case-law cited).
58


In certain cases, the Court has acknowledged that it is however open to that institution, body, office or agency to base its decisions in that regard on general presumptions which apply to certain categories of documents, as considerations of a generally similar kind are likely to apply to requests for disclosure relating to documents of the same nature (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 51 and the case-law cited).
59


The objective of such presumptions is thus the possibility, for the EU institution, body, office or agency concerned, to consider that the disclosure of certain categories of documents undermines, in principle, the interest protected by the exception which it is invoking, by relying on such general considerations, without being required to examine specifically and individually each of the documents requested (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 52 and the case-law cited).
60


However, an EU institution, body, office or agency is not required to base its decision on such a general presumption, but may always carry out a specific examination of the documents covered by a request for access and provide reasons stemming from that specific examination (judgment of 14 November 2013, LPN and Finland v Commission, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 67).
62


Thus, the premiss on which the first ground of appeal is based is wrong as a matter of law. By arguing that ‘the application of the general presumption of confidentiality is not optional, in the sense that it applies as a matter of law where it is engaged and must be taken into account by the EMA when it takes its decision’, the appellant misconstrues the scope to be given to the rule on the examination of requests for access to documents, as set out in the judgment of the Court of Justice of 14 November 2013, LPN and Finland v Commission (C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 67), according to which, on the contrary, the application of a general presumption of confidentiality is always optional for the EU institution, body, office or agency to which such a request is addressed.
94


In that regard, it should be borne in mind that, where an EU institution, body, office or agency that has received a request for access to a document decides to refuse to grant that request on the basis of one of the exceptions laid down in Article 4 of Regulation No 1049/2001 to the fundamental principle of openness recalled in paragraph 52 above, it must, in principle, explain how access to that document could specifically and actually undermine the interest protected by that exception. Moreover, the risk of that undermining must be reasonably foreseeable and not purely hypothetical (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 51 and the case-law cited).
102


As regards the witness evidence adduced by the appellant for the purpose of establishing the risk of misuse to which disclosure of the full report would expose the appellant by making it easier for its competitors to obtain MAs, especially outside the European Union, it should be borne in mind that, according to the settled case-law of the Court of Justice, the General Court is not required to provide an account that follows exhaustively and one by one all the arguments put forward by the parties to the case. Consequently, the reasoning may be implicit on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review. In particular, the General Court is not required to respond to the arguments of a party which are not sufficiently clear and precise, in that they have not been expanded upon or accompanied by a specific line of argument intended to support them (see, to that effect, judgments of 9 September 2008, FIAMM and Others v Council and Commission, C‑120/06 P and C‑121/06 P, EU:C:2008:476, paragraphs 91 and 96, and of 5 July 2011, Edwin v OHIM, C‑263/09 P, EU:C:2011:452, paragraph 64).
111


In that regard, it must be noted, as was correctly recalled by the General Court in paragraph 62 of the judgment under appeal, and as the Advocate General emphasised in point 87 of his Opinion, that, while Article 39 of the TRIPS Agreement may not be invoked directly, the rules of EU law, and in particular Article 4 of Regulation No 1049/2001 in the present context, must nevertheless be interpreted in a manner consistent with that agreement in so far as it is possible to do so (see, to that effect, judgment of 11 September 2007, Merck Genéricos — Produtos Farmacêuticos, C‑431/05, EU:C:2007:496, paragraph 35).
125


As regards the error of law allegedly committed by the General Court through its reliance on substantially inaccurate facts for the purpose of rejecting, in paragraphs 101 and 102 of the judgment under appeal, the argument based on the report at issue being relevant in the context of a ‘full’ MA procedure, it should be borne in mind that the Court of Justice has no jurisdiction to establish the facts and that, save where the facts are distorted, the assessment of those facts does not constitute a point of law open, as such, to review by the Court of Justice on appeal (see, to that effect, judgment of 4 June 2015, Stichting Corporate Europe Observatory v Commission, C‑399/13 P, not published, EU:C:2015:360, paragraph 26).