Source: EURLEX
Language: en
Format: md

JUDGMENT OF THE GENERAL COURT (Second Chamber)

25 September 2018 ([\*](#Footnote*))

(Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA and submitted as part of the request for authorisation to place the medicinal product Galafold on the market — Decision to grant a third party access to a document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)

In Case T‑33/17,

**Amicus Therapeutics UK Ltd,** established in Gerrards Cross (United Kingdom),

**Amicus Therapeutics, Inc.,** established in Cranbury, New Jersey (United States),

represented by L. Tsang, J. Mulryne, Solicitors, and F. Campbell, Barrister,

applicants,

v

**European Medicines Agency (EMA),** represented by N. Rampal Olmedo, S. Marino, A. Spina, A. Rusanov and T. Jabłoński, acting as Agents,

defendant,

ACTION under Article 263 TFEU for the annulment of EMA Decision ASK‑22072 of 14 December 2016, granting to a third party, pursuant to 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), access to a document containing information submitted in the context of a request for marketing authorisation for the medicinal product Galafold,

THE GENERAL COURT (Second Chamber),

composed of M. Prek, President, F. Schalin (Rapporteur) and M. J. Costeira, Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure and further to the hearing on 8 March 2018,

gives the following

**Judgment**

**Background to the dispute**

1        Amicus Therapeutics UK Ltd is a pharmaceutical company specialised in the development of therapies to treat rare diseases. In May 2016, it was granted marketing authorisation for the medicinal product Galafold. Moreover, in 2016, Galafold was designated an ‘orphan’ medicinal product in the European Union. That medicinal product can be used to treat Fabry disease, a genetic form of a lysosomal storage disorder.

2        Amicus Therapeutics, Inc. is the parent company of Amicus Therapeutics UK. It was the sponsor of the clinical trials undertaken to support the request for marketing authorisation for the medicinal product Galafold.

3        On 1 August 2016, the European Medicines Agency (EMA) informed Amicus Therapeutics UK that it had received, from a pharmaceutical company, a request pursuant to 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), seeking access to several documents relating to the request for a marketing authorisation for the medicinal product Galafold. Those documents had been divided into six batches for the purpose of obtaining the comments of Amicus Therapeutics UK.

4        On 16 November 2016, the EMA invited Amicus Therapeutics UK to submit its comments on the fifth batch, namely Clinical Study Report AT 1001‑011 (‘the report at issue’).

5        On 23 November 2016, Amicus Therapeutics UK proposed limited redactions to the report at issue, so as to remove certain personal data.

6        On 30 November 2016, the EMA informed Amicus Therapeutics UK of its decision to disclose the report at issue to the pharmaceutical company requesting access, taking into account certain redactions proposed by Amicus Therapeutics UK. The EMA also expressed its intention to implement that decision at the earliest 10 working days after it was sent to Amicus Therapeutics UK.

7        By email of 7 December 2016, Amicus Therapeutics UK informed the EMA that it considered the report at issue to be commercially confidential in its entirety and that, therefore, that report could not be disclosed. In that email, it also referred to the proceedings pending before the Court in the case *PTC Therapeutics* v *EMA* (T‑718/15) and requested that the EMA suspend the disclosure of the report at issue and another clinical study report (from the sixth batch) to which access had also been requested, until the Court had had the opportunity to consider fully the issues relating to the lawfulness of the EMA’s access to documents policy and its interpretation of the concept of commercial information.

8        On 12 December 2016, in a teleconference with Amicus Therapeutics UK, the EMA indicated its position that, as a general rule, the contents of a request for a marketing authorisation could be disclosed and that the exceptions set out in Article 4 of Regulation No 1049/2001 were to be interpreted strictly. Moreover, it refused to grant a deferment pending the judgment of the Court in Case T‑718/15, *PTC Therapeutics International* v *EMA*.During that teleconference, Amicus Therapeutics UK requested that the EMA communicate its official position by letter. Consequently, the EMA sent it a letter on 14 December 2016 (‘the contested decision’) in which it addressed the points raised in the email of 7 December 2016 and the additional points raised during the teleconference held on 12 December 2016.

9        In support of the contested decision and in rejecting the application of a general presumption, the EMA referred to Article 4(6) of Regulation No 1049/2001 according to which access to the whole of the document requested could be refused only if one or more exceptions set out in Article 4 apply to the entire contents of the document. However, Amicus Therapeutics UK did not provide any evidence to show that each and every element of the report at issue was commercially confidential. In its email of 7 December 2016, Amicus Therapeutics UK merely claimed that the whole of the report at issue was covered by the exception set out in Article 4(2) of Regulation No 1049/2001, without providing any specific, concrete or detailed arguments in support of that claim. In addition, the EMA also referred to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1) and, in particular, to Articles 37(4), 80 and 81 and recitals 67 and 68 thereof, as well as to its policy on the publication of clinical study reports according to which such reports are not considered, as a general rule, to be confidential. Finally, the EMA contended, for the reasons already set out in its letter of 30 November 2016, that there were no grounds warranting non-disclosure of the report at issue.

**Procedure and forms of order sought**

10      By application lodged at the Court Registry on 20 January 2017, the applicants, Amicus Therapeutics UK and Amicus Therapeutics, brought the present action. By separate document lodged on the same date, they brought an application for interim measures seeking the suspension of operation of the contested decision.

11      On 10 April 2017, the EMA submitted its defence.

12      By letter of 11 April 2017, the applicants withdrew their application for interim measures on account of the EMA confirming that the report at issue would only be disclosed 60 days after the final decision of the Court in the present case. By order of 30 May 2017, *Amicus Therapeutics UK and Amicus Therapeutics* v *EMA* (T‑33/17 R, not published, EU:T:2017:403), Case T‑33/17 R was removed from the register of the General Court.

13      The reply was received at the Court Registry on 25 July 2017.

14      The rejoinder was received at the Court Registry on 11 September 2017.

15      The parties presented oral argument at the hearing held on 8 March 2018.

16      The applicants claim that the Court should:

–        annul the contested decision;

–        in the alternative, remit the contested decision to the EMA in order to re-examine it, after having given the applicants an opportunity to make specific submissions on whether to redact certain parts of the clinical study report prior to disclosure;

–        order the EMA to pay the applicants’ costs and other expenses in relation to the present case.

17      The EMA contends that the Court should:

–        dismiss the application;

–        order the applicants to pay the costs.

**Law**

**The jurisdiction of the Court with regard to the second head of claim**

18      By their second head of claim, the applicants request the Court, in the alternative, to instruct the EMA to re-examine the contested decision, after having given the applicants an opportunity to make specific submissions on whether to redact certain parts of the report at issue prior to its disclosure.

19      In that regard, it is sufficient to note that, according to settled case-law, in an action for annulment, the jurisdiction of the Courts of the European Union is limited to reviewing the legality of the contested measure and the Court may not, in the exercise of its jurisdiction, issue directions to EU institutions. It is for the institution concerned to adopt, under Article 266 TFEU, the measures necessary to implement a judgment given in proceedings for annulment (see order of 12 March 2014, *PAN Europe* v *Commission*, T‑192/12, not published, EU:T:2014:152, paragraph 15 and the case-law cited).

20      Therefore, the application for an injunction made in the alternative must be rejected on grounds of manifest lack of jurisdiction of the Court.

**Substance**

21      In support of their application, the applicants invoke two pleas in law, the first alleging that the report at issue attracts a general presumption of confidentiality for the purposes of Article 4(2) of Regulation No 1049/2001 and, the second, that the only legally permissible outcome of a proper balancing exercise, under Article 4 of Regulation No 1049/2001, would have been a decision not to release the report at issue.

 The first plea, alleging that the report at issue attracts a general presumption of confidentiality for the purposes of Article 4(2) of Regulation No 1049/2001

22      The applicants claim that clinical study reports are a category of documents attracting a general presumption of confidentiality. They rely, in that regard, on the relevant sectoral regulations, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 15 April 1994 (OJ 1994 L 336, p. 214) (‘the TRIPS Agreement’), which forms Annex 1 C to the Agreement establishing the World Trade Organisation (WTO) (OJ 1994 L 336, p. 3) and fundamental rights.

23      As regards the sectoral regulations, the applicants consider that 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) contains concrete and detailed provisions on the information held by the EMA which should or should not be made available to the public.

24      In that regard, the applicants submit that in the context of a competitive and highly innovative pharmaceutical industry, characterised by significant investments, Regulation No 726/2004 and the other relevant regulations establish a very delicate balance between, on the one hand, the interests of transparency, legitimate public interest considerations and the opportunity to avoid duplication of research activities and, on the other, private rights and interests (confidentiality). That delicate balance should not be disturbed by the disclosure of clinical study reports unless there is an overriding public interest in disclosure.

25      As for the TRIPS Agreement, the applicants consider that, given the risk of unfair use of commercial data, especially with regard to clinical study reports, Article 39(3) of the TRIPS Agreement precludes the disclosure of such data.

26      As regards fundamental rights, the applicants claim that their right to respect for private life, as laid down in Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) and in Article 7 of the Charter of Fundamental Rights of the European Union (‘the Charter’) as well as for their right to property (Article 17 of the Charter) have not been respected. The applicants invoke also an infringement of Article 339 TFEU. According to them, the general presumption of confidentiality reflects the importance of those fundamental rights and requires the EMA to justify the disclosure of confidential data on the ground that there is an overriding public interest in disclosure.

27      The EMA disputes the applicants’ arguments.

28      In the context of the first plea, the applicants submit, in essence, that the general presumptions of confidentiality applying to certain categories of documents also apply to the report at issue presented in the context of the marketing authorisation procedure for the medicinal product Galafold, provided for in Regulation No 726/2004, and, accordingly, that the disclosure of that report would in principle undermine commercial interests. Thus, the general presumption of confidentiality on which the applicants rely is based on the exception relating to the protection of their commercial interests, which is referred to in the first indent of Article 4(2) of Regulation No 1049/2001.

29      It should be borne in mind that, under Article 2(3) of Regulation No 1049/2001, the provisions on public access to EMA documents apply to all documents held by that agency, that is to say, all documents drawn up or received by it and in its possession in all its areas of activity. Although that regulation is intended to give the fullest possible effect to the right of public access to documents of the institutions, that right is nonetheless subject to certain limitations based on grounds of public or private interest (judgment of 27 February 2014, *Commission* v *EnBW*, C‑365/12 P, EU:C:2014:112, paragraph 85).

30      It must also be noted that the Court of Justice has recognised that it is open to the institutions and agencies concerned to base their 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 1 July 2008, *Sweden and Turco* v *Council*, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 50).

31      The existence of such a presumption does not exclude the right of the person concerned to demonstrate that a document whose disclosure has been requested is not covered by that presumption (judgment of 21 September 2010, *Sweden and Others* v *API and Commission*, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 103).

32      However, it must be pointed out that the existence of a general presumption of confidentiality of certain categories of documents constitutes an exception to the obligation, imposed by Regulation No 1049/2001 on the institution concerned, to make a specific and individual examination of each document which is the subject of an application for access in order to determine whether it falls within the scope of one of the exceptions provided for in Article 4(2) of that regulation. In the same way that the case-law requires that the exceptions to disclosure referred to in the abovementioned provision be interpreted and applied strictly — inasmuch as they derogate from the principle of the widest possible public access to documents held by EU institutions (see, to that effect, judgments of 21 July 2011, *Sweden* v *MyTravel and Commission*, C‑506/08 P, EU:C:2011:496, paragraph 75, and of 3 July 2014, *Council* v *in ’t Veld*, C‑350/12 P, EU:C:2014:2039, paragraph 48) — the recognition and application of a general presumption of confidentiality must be considered strictly (see, to that effect, judgment of 16 July 2015, *ClientEarth* v *Commission*, C‑612/13 P, EU:C:2015:486, paragraph 81).

33      The Courts of the European Union have therefore identified, in several judgments, certain criteria for recognising such a presumption depending on the type of case.

34      First of all, it is apparent from the case-law that, in order for a general presumption of confidentiality to be validly relied upon against a person requesting access to documents on the basis of Regulation No 1049/2001, it is necessary that the documents requested belong to the same category of documents or be documents of the same nature (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, paragraph 50, and of 17 October 2013, *Council* v *Access Info Europe*, C‑280/11 P, EU:C:2013:671, paragraph 72).

35      Secondly, it is apparent from the case-law cited in paragraph 34 above that the application of general presumptions is essentially dictated by the overriding need to ensure that the procedures at issue operate correctly and to guarantee that their objectives are not jeopardised. Therefore, a general presumption may be recognised on the basis that access to the documents involved in certain procedures is incompatible with the proper conduct of those procedures and that the risk that those procedures could be undermined, on the understanding that general presumptions ensure that the integrity of the conduct of the procedure can be preserved by limiting intervention by third parties (see, to that effect, Opinion of Advocate General Wathelet in *LPN and Finland* v *Commission*, C‑514/11 P and C‑605/11 P, EU:C:2013:528, points 66, 68, 74 and 76).

36      Moreover, in general, the cases which gave rise to the judgments establishing general presumptions of confidentiality, the refusal of access in question related to a set of documents which were clearly defined by the fact that they all belonged to a file relating to ongoing administrative or judicial proceedings (see, to that effect, judgments of 29 June 2010, *Commission* v *Technische Glaswerke Ilmenau*, C‑139/07 P, EU:C:2010:376, paragraphs 12 to 22; of 21 September 2010, *Sweden and Others* v *API and Commission*, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 75; and of 27 February 2014, *Commission* v *EnBW*, C‑365/12 P, EU:C:2014:112, paragraphs 69 and 70).

37      Finally, the Courts of the European Union consider that the application of specific rules provided for by a legal measure relating to a procedure conducted before an EU institution for the purposes of which the documents requested were produced is one of the criteria for recognising a general presumption (see, to that effect, judgment of 11 June 2015, *McCullough* v *Cedefop*, T‑496/13, not published, EU:T:2015:374, paragraph 91, and Opinion of Advocate General Cruz Villalón in *Council* v *Access Info Europe*, C‑280/11 P, EU:C:2013:325, point 75).

38      The exceptions to the right of access to documents contained in Article 4 of Regulation No 1049/2001 cannot be interpreted without taking account of the specific rules governing access to those documents, which are laid down in the relevant regulations.

39      Accordingly, the Court of Justice has pointed out that, under a procedure for the application of Article 101 TFEU, certain provisions of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101 TFEU and 102 TFEU] (OJ 2003 L 1, p. 1) and Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles [101 TFEU and 102 TFEU] (OJ 2004 L 123, p. 18) lay down restrictive rules for the use of documents in the file relating to that procedure, since they provide that the parties to a proceeding under Article 101 TFEU do not enjoy an unlimited right of access to the documents in the Commission’s file and that third parties, with the exception of complainants, do not, under such proceedings, have the right of access to the documents in the Commission’s file. The Court of Justice has held that allowing generalised access, on the basis of Regulation No 1049/2001, to the documents in a file relating to a proceeding under Article 101 TFEU would jeopardise the balance which the EU legislature sought to ensure in Regulations Nos 1/2003 and 773/2004 between the obligation on the undertakings concerned to submit to the Commission possibly sensitive commercial information to enable it to ascertain whether a concerted practice was in existence and to determine whether that practice was compatible with Article 101 TFEU, on the one hand, and the guarantee of increased protection, by virtue of the requirement of professional secrecy and business secrecy, for the information so provided to the Commission, on the other. The Court concluded therefrom that the Commission, for the purpose of applying the exceptions provided for in the first and third indents of Article 4(2) of Regulation No 1049/2001, is entitled to presume, without carrying out a specific, individual examination of each of the documents in a file relating to a proceeding under Article 101 TFEU, that disclosure of those documents would, in principle, undermine the protection of the commercial interests of the undertakings involved in such proceedings (see, to that effect, judgment of 27 February 2014, *Commission* v *EnBW*, C‑365/12 P, EU:C:2014:112, paragraphs 86, 87, 90 and 93).

40      It is also on the basis of the criterion mentioned in paragraph 37 above that the General Court, on the contrary, found that no general presumption of confidentiality is to be inferred from the provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1), since that regulation does not restrict the use of the documents in the file relating to an authorisation procedure for the use of a chemical substance, unlike the situations in which the Court of Justice and the General Court have accepted that the general presumptions justifying refusal of access to documents apply (see, to that effect, judgment of 13 January 2017, *Deza* v *ECHA*, T‑189/14, EU:T:2017:4, paragraph 39).

41      In the present case, on 25 June 2015, the applicants requested a marketing authorisation for the medicinal product Galafold, in accordance with Article 4(1) of Regulation No 726/2004. The administrative procedure relating to that application was closed, on 26 May 2016, by the granting of the marketing authorisation applied for. The request for access based on Regulation No 1049/2001 was made only in summer 2016 and the contested decision is dated 14 December 2016. Accordingly, the report at issue does not relate to an ongoing administrative procedure. It follows that, even if the case-law cited in paragraph 35 above, according to which the application of a general presumption may be justified by the overriding need to ensure that the procedure concerned operates correctly, applies in the context of a marketing authorisation procedure, disclosure of the report at issue cannot alter that procedure.

42      Likewise, unlike the situations in which the Court of Justice and the General Court have accepted that the general presumptions justifying refusal of access to documents apply, Regulation No 726/2004 does not restrict the use of documents in the file relating to a marketing authorisation procedure for a medicinal product. It does not provide that access to the file is limited to the ‘parties concerned’ or to ‘complainants’.

43      More precisely, Article 73 of Regulation No 726/2004 provides that Regulation No 1049/2001 is to apply to documents held by the EMA and that the latter’s Management Board is to adopt the arrangements for implementing that regulation. No other provision of Regulation No 726/2004 can be interpreted as evidence of the intention of the EU legislature to set up a system of restricted access to documents by means of a general presumption of confidentiality of documents.

44      Articles 11, 13(3), 36, 38(3) and 57(1) and (2) of Regulation No 726/2004 require the EMA to publish three documents, namely the European Public Assessment Report (EPAR), a summary of the characteristics of the medicinal products concerned and the user package leaflet, after deletion of all information of a commercially confidential nature. Those provisions mention the minimum information, by means of the three abovementioned documents, that the EMA is required to make publicly available in a proactive manner. The objective of the EU legislature is, first, that the characteristics of the medicinal product concerned and the manner in which it should be prescribed to patients should be indicated as intelligibly as possible to healthcare professionals and, second, that the non-professional public should be informed in understandable language of the optimal method of using the medicinal product and of that product’s effects. That proactive scheme of publishing a minimum amount of information does not therefore constitute a specific regulatory scheme on access to documents which should be interpreted as meaning that all data and information not contained in the three abovementioned documents is presumed to be confidential.

45      Articles 11, 12, 36 and 37(3) of Regulation No 726/2004 also reflect the legislature’s intention that the marketing authorisation procedure should be transparent, even where that procedure does not result in a decision or leads to a decision refusing marketing authorisation. Those provisions provide that both information relating to a marketing authorisation application that an applicant has withdrawn before an opinion has been given by the EMA and information concerning a marketing authorisation application which has been refused must be made publicly accessible.

46      It follows that the prevailing principle in Regulations Nos 726/2004 and 1049/2001 is that of public access to information and that the exceptions to that principle relate to those referred to in Article 4(2) of Regulation No 1049/2001, including the exception relating to commercially confidential information. In view of the requirement of a strict interpretation recalled in paragraph 32 above, it must be held that the EU legislature took the implicit view that the integrity of the marketing authorisation procedure is not undermined in the absence of a presumption of confidentiality.

47      In view of all the foregoing, it must be held that there is no general presumption of confidentiality of the documents of a file submitted in the context of a marketing authorisation application for a medicinal product, and in particular of clinical study reports, arising from the application of the combined provisions of Regulations Nos 1049/2001 and 726/2004. Clinical study reports cannot therefore be considered to enjoy a general presumption of confidentiality on the implicit ground that they are, as a matter of principle and in their entirety, clearly covered by the exception relating to the protection of the commercial interests of marketing authorisation applicants. It is thus for the EMA to satisfy itself, by means of a concrete, individual examination of each document in the application file for marketing authorisation, whether the document is covered in particular by commercial secrecy for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001.

48      Moreover, it should also be added that, pursuant to Article 73 of Regulation No 726/2004, the EMA adopted the detailed rules for implementing Regulation No 1049/2001, entitled ‘Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMA documents’. Similarly, in order to strengthen its policy on access to documents, the EMA adopted, on 30 November 2010, document EMA/110196/2006, entitled ‘[EMA] policy on access to documents (related to medicinal products for human and veterinary use)’. It is stated in that document that, whilst providing adequate protection of commercially confidential information, personal data and other specific interests, access to a requested document is to be denied only if one of the exceptions listed in Article 4 of Regulation (EC) No 1049/2001 is considered to be applicable.

49      It should be noted, in addition, that, in applying its policy on access to documents, the EMA drew up document EMA/127362/2006, in which the output of its policy on access to documents related to medicinal products for human and veterinary use is set out. That document contains a table of output which is added to as the EMA gains more experience in the field of requests for access to documents. That table was supplemented, first, by document EMA/484118/2010 on the recommendations of the Heads of Medicines Agencies on transparency and, second, the joint guidance document of the EMA and the Heads of Medicines Agencies on the identification of commercially confidential information and personal data within the structure of the marketing authorisation procedure, which could be published once a decision had been adopted. It is apparent from that table that, as regards the clinical study reports, the EMA considers them to be public and publishes them as soon as the marketing authorisation procedure for a medicinal product has ended. Similarly, it is apparent from point 3.2 of the abovementioned joint guidance document that, ‘ … [i]n general, the data included in clinical trial study reports is considered as data that can be released as such data is not considered either commercially confidential or personal data that should be protected’ and that ‘[i]n the case of exceptional and substantiated cases, particularly where innovative study designs and/or innovative analytical methods have been used, consideration will be given to the need for redaction’.

50      Moreover, it should be pointed out that even though Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1), is not applicable in the present case, it is also an indication that a general presumption of confidentiality is not intended by the legislature. That regulation is based on the principle, as is apparent from recital 68 thereof, that clinical study reports are in principle publicly accessible once a marketing authorisation has been granted.

51      It follows that the plea alleging that there is a general presumption of confidentiality in respect of the documents submitted in the context of a marketing authorisation application, and in particular of the clinical study reports, must be rejected.

52      None of the arguments put forward by the applicants can call that conclusion into question.

53      As regards the argument that Article 39 of the TRIPS Agreement precludes *erga omnes* disclosure, it must be noted that, although Article 39 of the TRIPS Agreement cannot as such be relied upon to challenge the validity of the contested decision, Regulations Nos 1049/2001 and 726/2004 must nevertheless be interpreted in such a way as to ensure that they comply with the content of that provision. The provisions of the TRIPS Agreement, which is part of the WTO Agreement, signed by the European Community and subsequently approved by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ 1994 L 336, p. 1), constitute an integral part of the European Union legal order. Where there are EU rules in a sphere concerned by the TRIPS Agreement, EU law will apply, which will mean that it is necessary, as far as possible, to adopt an interpretation in keeping with the TRIPS Agreement, although no direct effect may be given to the provision of that agreement at issue (see judgment of 11 September 2007, *Merck Genéricos — Produtos Farmacêuticos*, C‑431/05, EU:C:2007:496, paragraph 35 and the case-law cited).

54      It should be borne in mind that Article 39(2) of the TRIPS Agreement provides that commercially valuable information is protected against use and disclosure by third parties if it is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question. Paragraph 3 of that article obliges the Member States to protect undisclosed test or other data against unfair commercial use when requiring, as a condition of approving the marketing of pharmaceutical products which utilise new chemical entities, the submission of that data, the establishment of which involves a considerable effort.

55      Article 39(2) and (3) of the TRIPS Agreement cannot mean, however, that protection granted to intellectual property rights must be given absolute precedence over the principle of disclosure of the information submitted in the context of a marketing authorisation application for an orphan medicinal product. To that effect, the approach advocated by the applicants of considering that the entirety of the information that they submitted is confidential amounts to disregarding the balance established by Regulations Nos 1049/2001 and 726/2004 and to not applying the mechanism which provides, in essence, for the disclosure of information relating to medicinal products which are the subject of an authorisation procedure with the exception of information of a confidential nature. Such an approach must be rejected, since, in reality, it challenges the legality of those provisions in the light of Article 39(2) and (3) of the TRIPS Agreement.

56      Moreover, it suffices to note, to the extent that the applicants’ line of argument suggests that there is no mechanism for protecting intellectual property, that, first, holders of data enjoy a period of protection of those data under Article 14(11) of Regulation No 726/2004 and that, secondly, they enjoy, pursuant to the exceptions provided for in Article 4 of Regulation No 1049/2001, protection of commercially confidential information contained in a marketing authorisation application dossier, including information about the manufacturing of the product and other technical and industrial specifications of the quality processes adopted to manufacture the substance.

57      The arguments that the contested decision does not take into consideration the applicants’ fundamental rights and that it is for the EMA to establish the existence of a relevant interest justifying disclosure, a position resulting from the application of the presumption of confidentiality, cannot succeed.

58      In that regard, it should be noted that it follows from the judgment of 13 January 2017, *Deza* v *ECHA* (T‑189/14, EU:T:2017:4, paragraph 163), that Article 8 of the ECHR and Article 17 of the Charter cannot be interpreted as laying down an automatic exception to the principle of disclosure for documents drawn up in the course of a private entity’s commercial activity. In the case of a request for access made by a third party to such documents, a proper and specific examination of each of them is required, except in cases where the Court of Justice and the General Court have accepted a general presumption of refusal of access to the documents in question. As has been stated in paragraph 47 above, there is no general presumption of refusal of access to documents submitted in connection with the authorisation procedure provided for in Regulation No 726/2004.

59      The lack of a general presumption of confidentiality implies that the EMA must specifically examine the various data concerned by the request for access. It follows from the case-law that, in order to justify a refusal to grant access to a document, it is not sufficient, in principle, for that document to fall within an activity mentioned in Article 4 of Regulation (EC) No 1049/2007. The institution concerned must also show how access to that document could specifically and actually undermine the interest protected by an exception laid down in Article 4 of Regulation No 1049/2001 and that the risk of that interest being undermined is reasonably foreseeable and not purely hypothetical (see, to that effect, judgment of 21 July 2011, *Sweden* v *MyTravel and Commission*, C‑506/08 P, EU:C:2011:496, paragraph 76 and the case-law cited). That also applies in the case of third-party documents where that third party is consulted in the context of the consultation procedure provided for in Article 4(4) of Regulation No 1049/2001, since the purpose of that article is to enable the institution to assess whether an exception laid down in paragraph 1 or 2 of that article should apply (see, to that effect, judgment of 30 January 2008, *Terezakis* v *Commission*, T‑380/04, not published, EU:T:2008:19, paragraphs 54, 60 and 61).

60      In so far as there is no general presumption of confidentiality in respect of clinical study reports, the applicants cannot invoke in a general manner an infringement of Article 339 TFEU, of Article 8 of the ECHR and of Articles 7 and 17 of the Charter since it does not appear that all the data to which they refer are confidential. It is therefore for them to identify the information which, according to them, falls within the scope of commercial interests within the meaning of 4(2) of Regulation No 1049/2001.

61      Thus, the applicants cannot merely plead the existence of inherent confidentiality, or merely allege infringement of fundamental rights in abstract terms. It is for them to describe in specific terms the professional and commercial importance for them of the information and the utility of that information for other undertakings which are liable to examine and use it subsequently. In other words, as required by the case-law noted in paragraph 59 above, it is for the applicants to show specifically and actually how, once the report at issue has been disclosed, that fact could harm their commercial interests. That question is examined in the context of the second plea.

62      Therefore, it follows from the foregoing that the first plea must be rejected.

 The second plea, alleging that the only legally permissible outcome of a proper balancing exercise, under Article 4 of Regulation No 1049/2001, would have been a decision not to release the report at issue

63      According to the applicants, the disclosure of the report at issue would harm their commercial interests.

64      In that regard, they claim that:

–        the disclosure of the report at issue allows competitors to take advantage of their investments in order to be granted an authorisation, both within the internal market and outside the EU, for a product competing with the medicinal product Galafold;

–        the disclosure undermines their ability to obtain an authorisation outside the EU;

–        the disclosure compromises their ability to recoup their investment in research by licensing the valuable know-how contained in the report at issue to partner companies around the world.

65      Moreover, the EMA failed to establish that there is a public interest in the disclosure of the report at issue capable of overriding the need to protect the applicants’ commercial interests from the prospective harm which would be caused by such disclosure. According to the applicants, on the contrary, there are good grounds to conclude that disclosure would, in the present case, be contrary to the broader public interest. The public interest in transparency has to be balanced against the commercial interests of innovative research-based companies such as the applicants, and, indeed, against the public interest in allowing such companies to recoup the costs of their research through the marketing of life-saving and life-enhancing medical treatments. The sectoral legislation already contains various mechanisms, for example the EPAR, which ensure a high degree of transparency. Accordingly, the contested decision would undermine the public policy rationale underlying the designation of orphan medicinal products.

66      The applicants add, in the reply, that Regulation No 536/2014, as the EMA acknowledges, provides for the possibility of withholding clinical study reports from publication if this is warranted by the interests of commercial confidentiality. Therefore, their arguments put forward under the second plea are still valid even if the report at issue falls within the scope of Regulation No 536/2014.

67      The EMA disputes the applicants’ arguments.

68      As a preliminary point, it should be recalled that Article 15(3) TFEU provides that 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 European Union’s institutions, bodies, offices and agencies subject to the principles and the conditions defined in accordance with the ordinary legislative procedure. Regulation No 1049/2001 seeks, as indicated in Article 1 and recital 4 thereof, to give the public a right of access to documents of the institutions which is as wide as possible.

69      The principle that the public should have the widest possible access to the documents is nonetheless subject to certain limits based on reasons of public or private interest. Regulation No 1049/2001, in particular in recital 11 and Article 4 thereof, provides for a system of exceptions requiring institutions and bodies not to disclose documents in the event that such disclosure would undermine one of these interests (see, to that effect, judgments of 28 June 2012, *Commission* v *Éditions Odile Jacob*, C‑404/10 P, EU:C:2012:393, paragraph 111; of 28 June 2012, *Commission* v *Agrofert Holding*, C‑477/10 P, EU:C:2012:394, paragraph 53; and of 14 November 2013, *LPN and Finland* v *Commission*, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 40).

70      Nevertheless, since the exceptions provided for in Article 4 of Regulation No 1049/2001 derogate from the principle that the public should have the widest possible access to the documents, they must be interpreted and applied strictly (judgments of 1 February 2007, *Sison* v *Council*, C‑266/05 P, EU:C:2007:75, paragraph 63; of 1 July 2008, *Sweden and Turco* v *Council*, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 36; and of 21 July 2011, *Sweden* v *MyTravel and Commission*, C‑506/08 P, EU:C:2011:496, paragraph 75).

71      Therefore, the mere fact that a document concerns an interest protected by an exception to the right of access laid down in Article 4 of Regulation No 1049/2001 is not sufficient to justify the application of that exception (judgments of 3 July 2014, *Council* v *in ’t Veld*, C‑350/12 P, EU:C:2014:2039, paragraph 51; and of 13 April 2005, *Verein für Konsumenteninformation* v *Commission*, T‑2/03, EU:T:2005:125, paragraph 69).

72      First, if the institution concerned decides to refuse access to a document that it has been asked to disclose, it must, in principle, explain how disclosure of that document could specifically and actually compromise the interest protected by the exception, among those provided for in Article 4 of Regulation No 1049/2001, upon which it relies. Moreover, the risk of that undermining must be reasonably foreseeable and not purely hypothetical (see judgment of 21 July 2011, *Sweden* v *MyTravel and Commission*, C‑506/08 P, EU:C:2011:496, paragraph 76 and the case-law cited).

73      Second, if an institution applies one of the exceptions provided for in Article 4 of Regulation No 1049/2001, it is for that institution to weigh the particular interest to be protected through non-disclosure of the document concerned against, inter alia, the public interest in the document being made accessible, having regard to the advantages stemming, as noted in recital 2 of Regulation No 1049/2001, from increased openness, in that it enables citizens to participate more closely in the decision-making process and guarantees that the administration enjoys greater legitimacy and is more effective and more accountable to the citizen in a democratic system (judgments of 1 July 2008, *Sweden and Turco* v *Council*, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 45; of 17 October 2013, *Council* v *Access Info Europe*, C‑280/11 P, EU:C:2013:671, paragraph 32; and of 3 July 2014, *Council* v *in ’t Veld*, C‑350/12 P, EU:C:2014:2039, paragraph 53).

74      As regards the concept of commercial interests, it is apparent from the case-law that it is not possible to regard all information concerning a company and its business relations as requiring the protection which must be guaranteed to commercial interests under the first indent of Article 4(2) of Regulation No 1049/2001 without frustrating application of the general principle of giving the public the widest possible access to documents held by the institutions (judgments of 15 December 2011, *CDC Hydrogene Peroxide* v *Commission*, T‑437/08, EU:T:2011:752, paragraph 44, and of 9 September 2014, *MasterCard and Others* v *Commission*, T‑516/11, not published, EU:T:2014:759, paragraph 81). It should also be pointed out that the joint guidance document of the EMA and the Heads of Medicines Agencies on the identification of commercially confidential information and personal data within the structure of the marketing authorisation procedure defines ‘commercial confidential information’ as any information which is not in the public domain or publicly available and where disclosure may undermine the economic interest or competitive position of the owner of the information.

75      Consequently, in order to apply the exception provided for by the first indent of Article 4(2) of Regulation No 1049/2001, it must be shown that the documents requested contain elements which may, if disclosed, undermine the commercial interests of a legal person. That is the case, in particular, when the requested documents contain commercially sensitive information relating, inter alia, to the commercial strategies of the undertakings involved or to their customer relations or where those documents contain information particular to that undertaking which reveal its expertise (see, to that effect, judgment of 9 September 2014, *MasterCard and Others* v *Commission*, T‑516/11, not published, EU:T:2014:759, paragraphs 82 to 84).

76      It is in the light of the considerations set out in paragraphs 68 to 75 above that it is necessary to analyse the applicants’ arguments that the disclosure of the report at issue would undermine their commercial interests, so that the only acceptable outcome of a balancing of the interests at stake, under Article 4(2) of Regulation No 1049/2001, would have been a decision not to release the report at issue.

77      As a preliminary point, it should be recalled that the analysis of the first plea revealed that there was no general presumption of confidentiality protecting the report at issue in its entirety from disclosure. It follows that, in order for it be found that the report at issue is commercially confidential in its entirety for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001, it is necessary that all the data in that report constitute commercially confidential information.

78      Next, it is not disputed that the report at issue contains a number of items of information that were disclosed in the EPAR, the latter being accessible to the public and containing data emanating directly from that report. As the applicants acknowledge, the EPAR was extremely detailed in the case of the medicinal product Galafold. Consequently, in order to be able to claim confidential treatment in respect of the entire report at issue, it is for the applicants to show that the assembly of the publicly accessible data together with the data which is not publicly accessible constitutes a commercially sensitive item of data whose disclosure would undermine its commercial interests.

79      The claim that the disclosure of the report at issue provides a ‘roadmap’, which can be used by competitors, is too vague. As the EMA correctly notes, all the clinical trials included in applications for marketing authorisation for human medicines in the European Economic Area (EEA) must have been carried out in accordance with the requirements set out in Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67). Likewise, it is necessary to take into account the fact that the EMA published scientific guidelines on the clinical trials and, in particular, on clinical safety, the clinical study reports, and dose-response studies. It also published guidelines for clinical evaluation following agreement on a harmonised approach between the European Union, Japan and the United States of America. Those public guidelines, built up gradually over many years, now constitute an extensive body of guidelines which seek to guide the pharmaceutical industry in conducting the studies required for approval of a medicinal product.

80      In the present case, it should be noted that the applicants have not disputed that they followed the protocol provided for in the guidelines mentioned in paragraph 79 above. They acknowledge that the process which led to the drawing up of the report at issue was conducted in accordance with harmonised international standards for the data required to be provided in support of an application for a marketing authorisation. They also have not called into question the fact that the stages defined in the guidelines were followed and that the whole of that process is based on known principles largely available in the scientific community. Moreover, the applicants have failed to establish the novelty of their models, analyses or methodologies. That fact tends to confirm the conclusion of the EMA that that report does not reveal an innovative roadmap and that it therefore is not novel.

81      Moreover, the report at issue does not contain any information on the composition or manufacturing of the medicinal product Galafold. Accordingly, disclosure of the report at issue would not provide any valuable insight to the applicant’s competitors on the long-term clinical development strategy and study design in addition to the information already available to the public for the medicinal product Galafold.

82      Furthermore, it must be held that the risk of misuse of the report at issue by a competitor is not in itself a ground for considering information to be commercially confidential under Regulation No 1049/2001. In that regard, it should be borne in mind that, according to the EMA’s own policy, the latter does not disclose commercially confidential information such as detailed information on the quality and manufacturing of medicinal products. In the present case, as was stated in paragraph 81 above, the EMA did not disclose such information. Moreover, the possible use, by a competitor, of information included in the report at issue in the way claimed by the applicants is limited by the fact that that competitor must always conduct its own corresponding studies and trials and successfully develop its own medicinal product. Furthermore, the medicinal product Galafold benefits, under Article 8(1) 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), from a period of market exclusivity preventing a similar medicinal product from being marketed for a 10-year period after marketing authorisation has been issued. It follows that the claim relating to the confidentiality of the report at issue on account of the profit which could be derived by competitors by making use of their application for marketing authorisation is not demonstrated and must be rejected.

83      In addition, the purpose of the period of market exclusivity, which prevents a similar medicinal product from being marketed, is to enable the author of the data to recover the investments made in developing the medicinal product, and disclosure of the report at issue pursuant to Regulation No 1049/2001 cannot in any way run counter to that objective. Therefore, it is difficult to see how the use of information almost 10 years after the placing on the market of the medicinal product Galafold could undermine the applicants’ commercial interests.

84      In the last place, the applicants refer to a risk of immediate loss of the benefit of the period of data exclusivity in the event of disclosure of the report at issue on the ground that that report could be used by competitors in third countries that permit such use. However, apart from the fact that that argument is vague, there is nothing to permit the conclusion that access to the information — which is not confidential from the point of view of the applicants’ commercial interests — in the report at issue, would on its own make it easier for a competing pharmaceutical undertaking to obtain marketing authorisation in a third country. That is all the clearer because the relevant data, such as the data on the composition or manufacture, remain confidential. The applicants have not put forward any specific argument to show that the alleged danger in certain third countries is real. Moreover, the non-disclosure of all studies in order to prevent the authorities of a third country from granting market access to a manufacturer without that manufacturer being required to submit its own studies would amount to depriving the public of the right — granted by EU law — to have access to documents containing information relating to authorised medicinal products.

85      Finally, in so far as the applicants criticise the EMA for not having mentioned any specific and compelling interest in disclosure capable of overriding the prospective harm to their commercial interests, such an argument cannot succeed. As the EMA correctly observes, it is apparent from the combined application of Regulations Nos 1049/2001 and 726/2004 that any citizen has a right to have access to documents of the EMA, including those submitted by pharmaceutical companies for the purposes of obtaining a marketing authorisation, subject to the exceptions laid down by Regulation No 1049/2001. In the present case, the EMA has merely applied those provisions. In view of the absence of any general presumption of confidentiality of the clinical study reports, it was thus entitled to refuse access to the entirety of those reports only if all the information in them had been considered commercially confidential information whose disclosure could undermine the applicants’ commercial interests, which the latter have not demonstrated.

86      In that context, it is also worth noting that Article 4(6) of Regulation No 1049/2001 provides that, if only parts of the requested document are covered by any of the exceptions, the remaining parts of the document are to be released. Examination of partial access to a document of the EMA must be carried out in the light of the principle of proportionality (see, to that effect, judgment of 6 December 2001, *Council* v *Hautala*, C‑353/99 P, EU:C:2001:661, paragraphs 27 and 28).

87      Moreover, on several occasions during the consultation procedure under Article 4(4) of Regulation No 1049/2001 and even after the contested decision, the EMA requested the applicants to indicate which parts of the report at issue could potentially contain information that could be considered commercially confidential. The applicants have not at any moment of the consultation procedure or of the present action provided details on that issue. As has already been stated in paragraph 59 above, it is for the applicants to provide such details. Likewise, the witness statements included in the application provide only a general description of the Union system and of certain systems outside the Union concerning the marketing of medicinal products and do not indicate the relevant passages of the report at issue which deserve protection for the purposes of the first indent of Article 4(2) of Regulation No 1049/2001. In addition, the fact that the applicants’ company is a small or medium-sized enterprise and that the medicinal product Galafold is the only product which they market is not relevant to the question whether certain elements contained in the clinical study report are covered by the exception provided for in the first indent of Article 4(2) of Regulation No 1049/2001.

88      Moreover, the EMA is required to assess the existence of an overriding public interest in disclosure of the document only where it found that the information contained therein is covered by one or more of the exceptions provided for in Article 4 of Regulation No 1049/2001. In the present case, it considered that that was not so. As a result, it was under no obligation to determine or assess the public interest in the disclosure of the report at issue or to weigh it against the applicants’ interest in keeping that report confidential.

89      In the light of all the foregoing considerations, it is necessary to reject the second plea as unfounded and, therefore, to dismiss the action in its entirety.

**Costs**

90      Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay the EMA’s costs, as applied for in the latter's pleadings.

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby:

1.      **Dismisses the action;**

2.      **Orders Amicus Therapeutics UK Ltd and Amicus Therapeutics, Inc. to pay the costs.**

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| Prek | Schalin | Costeira |

Delivered in open court in Luxembourg on 25 September 2018.

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| E. Coulon |  | M. Prek |

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| Registrar |  | President |

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[\*](#Footref*)      Language of the case: English.

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