CELEX: 62015TJ0235
Access to documents
Regulation (EC) No 1049/2001
Documents held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Vantobra
Decision to grant a third party access to the documents
Exception relating to the protection of commercial interests
No general presumption of confidentiality

Background to the dispute
The applicant, Pari Pharma GmbH, is a pharmaceutical company which focuses its activity on the optimisation of aerosol delivery platforms with established or new liquid medicines for inhalation use. It is primarily in the business of developing and commercialising nebuliser devices and drug formulation methodologies, and has developed its proprietary ‘eFlow’ nebulisation technology for tailored inhalation therapies in respiratory diseases.
In 1999, a competing pharmaceutical company, Novartis Pharmaceutical UK Ltd, which belongs with the intervener, Novartis Europharm Ltd, to the Novartis Group, obtained marketing authorisation (MA) for its tobramycin-based medicinal product, TOBI, following a national authorisation procedure.
In 2003, a biotechnology company, Chiron Cooperation Ltd, pursuant to 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
), obtained designation as an orphan medicinal product for a medicinal product containing tobramycin and intended for the treatment of pulmonary infection in patients with cystic fibrosis.
In 2006, Chiron Corporation was acquired by the Novartis Group and that group thus became the holder of the designation of the tobramycin-based orphan medicinal product.
On 20 July 2011, the intervener obtained MA for the tobramycin-based orphan medicinal product ‘TOBI Podhaler’. To that end, it was required to show that its orphan medicinal product was of significant benefit to patients when compared with existing treatments, including TOBI. Having obtained MA for its orphan medicinal product, it benefited from 10 years of market exclusivity granted to the medicinal products designated as orphan medicinal products under Article 8(1) of Regulation No 141/2000.
On 26 July 2012, the applicant submitted, by means of the centralised procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (
OJ 2004 L 136, p. 1
), an application for MA for a competing medicinal product, Vantobra, for the same therapeutic indication as TOBI Podhaler.
In order that Vantobra could be placed on the market, a derogation from the market exclusivity referred to in paragraph 5 above which TOBI Podhaler enjoyed was necessary. In order to obtain such a derogation, Vantobra had to satisfy the condition laid down in Article 8(3) of Regulation No 141/2000, namely that it be both similar and clinically superior to TOBI Podhaler. Thus, during the MA procedure for Vantobra, the Committee for Medicinal Products for Human Use (CHMP) assessed the similarity of the abovementioned medicinal products and examined whether Vantobra was clinically superior to TOBI Podhaler. The CHMP then issued an opinion recommending that Vantobra be granted MA.
On 18 March 2015, the European Commission adopted a decision authorising the marketing of Vantobra.
The intervener submitted a request to the European Medicines Agency (EMA), on the basis of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (
OJ 2001 L 145, p. 43
), for access to the documents listed in the file relating to the MA application for Vantobra. By decision of 24 April 2015 (‘the contested decision’), the EMA granted the intervener access to the CHMP assessment report on the clinical superiority of Vantobra and the CHMP assessment report on the similarity of Vantobra to TOBI Podhaler.
Procedure and forms of order sought
The applicant brought the present action on 15 May 2015. By a separate document of the same date, it brought an application for interim measures pursuant to Article 278 TFEU, for the suspension of operation of the contested decision.
By order of 1 September 2015, Pari Pharma v EMA (
T‑235/15 R
,
EU:T:2015:587
), the President of the General Court suspended the operation of the contested decision.
By orders of 14 October 2015 of the President of the Fourth Chamber of the General Court, the French Republic and the intervener were granted leave to intervene in support of the form of order sought by the EMA.
On 30 October 2015, having been requested to submit its observations on the application for confidential treatment of certain parts of the application for annulment submitted by the applicant, the intervener claimed that its key interest in the disclosure of these documents was that they formed an integral part of the statement of reasons for the decision granting MA for Vantobra and against which it had brought an action for annulment (Case T‑269/15). The intervener stated that it should have access to these documents in order to be able to exercise its fundamental right to an effective remedy and that it would defer to the decision of the General Court on the application for confidential treatment submitted by the applicant.
Subsequently, the applicant informed the General Court that it had succeeded in concluding an agreement in principle with the intervener under which the latter had undertaken, in any event, to keep the documents in question confidential and not to communicate them to third parties.
By way of measures of organisation of procedure, as provided for in Article 89 of its Rules of Procedure, the Court, by letter of 12 December 2016, put written questions to the parties to which they replied within the prescribed period. Subsequently, by letter of 10 January 2017, the Court requested the main parties to submit their observations on the replies to the questions.
By letter of 3 February 2017, the applicant requested that it be allowed to deploy technical broadcasting means at the hearing in order to enable the Vice-President of its pharmaceutical unit to make a presentation with various slides.
At the hearing of 14 February 2017, the EMA stated that it had no objection to that presentation and Novartis did not submit any observations on that presentation. The EMA requested that it be allowed to lodge a written response after the hearing on the presentation. The President of the Second Chamber authorised the applicant’s Vice-President to make the presentation, under the supervision of the applicant’s lawyer, and requested that the applicant lodge the presentation documents at the Court Registry to enable it to forward them to the EMA and the interveners so that they could submit their possible observations.
On 24 April 2017, the EMA provided its written observations on the applicant’s presentation document.
By decision of 4 July 2017, the President of the Second Chamber of the Court closed the oral part of the procedure.
The applicant claims that the Court should:
–
annul the contested decision;
–
order the EMA not to disclose the documents whose disclosure is provided for in the contested decision;
–
in the alternative, order the EMA not to disclose the information identified on pages 9, 11, 12, 14 and 17 to 23, contained in the CHMP assessment report relating to the clinical superiority of Vantobra, and that identified on pages 9 to 12 of the assessment report by that committee relating to the similarity of Vantobra and TOBI Podhaler;
–
order the EMA to pay the costs.
The EMA, supported by the French Republic and the intervener, contends that the Court should:
–
dismiss the action as inadmissible in so far as it concerns the second head of claim;
–
dismiss the action;
–
order the applicant to pay the costs.
Law
Preliminary considerations and the contested decision
As a preliminary point, it should be made clear that Vantobra is a hybrid product which was authorised under the centralised procedure in accordance with Article 10(3) of 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
), read in conjunction with Article 6 of Regulation No 726/2004. MA applications for hybrid medicinal products rely in part on the pre-clinical tests and clinical trials of a reference medicinal product and in part on other data. In the present case, the MA application for Vantobra designated TOBI as the reference medicinal product and therefore relied in part on the data regarding that medicinal product.
In the contested decision, the EMA states first of all that the documents at issue concerned by the request for access are the following ones: the CHMP Assessment Report on the clinical superiority of Vantobra and the CHMP Assessment Report on the similarity of Vantobra to TOBI Podhaler (‘the CHMP reports’).
The EMA then states that it conducted a specific and individual examination of each of the applicant’s comments in relation to the information contained in the documents concerned by the request for access. It states that it agrees with some of the proposed redactions regarding information related to choice of commercial strategy which includes names of the companies which performed surveys and countries involved in those surveys. Lastly, it refers to an annex containing two tables — one relating to the report on clinical superiority, the other to similarity — in which the reasons justifying its refusal to take account of the proposed redactions of the applicant aimed at limiting disclosure to certain information are set out.
As regards the report on clinical superiority, the EMA states that several pieces of information for which the applicant claims confidentiality are in the public domain. In that regard, it mentions the following documents which, in its view, are publicly accessible:
–
analyses carried out by [
confidential
] (
) in connection with the application for authorisation of TOBI Podhaler. Those data are available on its website;
–
certain information on cases of intolerance to TOBI Podhaler which forms part of the data examined by the CHMP in order to enable Vantobra to be marketed and thus derogate from the market exclusivity of TOBI Podhaler. That information is published in the European Public Assessment Report (‘the EPAR’);
–
information on the side effects of TOBI Podhaler. That information is published in the summary of the product characteristics set out in the EPAR;
–
various analyses which refer to [
confidential
]. That information is available on the internet.
In the report on clinical superiority, the EMA examines other information which is not publicly accessible. As regards the market survey conducted by the applicant for the purposes of replying to the CHMP’s first question, although the EMA agrees that the words [
confidential
] should be omitted, it refuses by contrast the omission of other information referred to by the applicant, on the ground that that information relates to descriptions of cases of intolerance to TOBI Podhaler and that that information represents some of the data assessed by the CHMP in concluding that Vantobra is clinically superior to TOBI Podhaler. The EMA points out that the references to the report containing the assessment of Vantobra’s clinical superiority and the derogation from TOBI Podhaler’s market exclusivity appear in the EPAR. As regards the other unpublished information, the EMA takes the view that the applicant has failed to show how, given that most of the information is in the public domain, disclosure of those few items of further information would undermine its commercial interest and its competitive position. The EMA adds that, even if that information could be considered commercially confidential, the scientific evidence of the clinical benefit of Vantobra for a part of the target population and the proof that the conditions enabling derogation from market exclusivity for TOBI Podhaler are met constitute information on which the CHMP relies in its assessment report on Vantobra’s clinical superiority. The EMA thus takes the view that such information has to be released in order to understand how the CHMP came to such a conclusion. It therefore concludes that there is an overriding public interest in disclosure.
With respect to the report on similarity, the EMA states the following:
–
as regards the information contained in the market survey submitted by the applicant, the information concerning the reference to the countries and undertakings which carried out those surveys can be redacted;
–
the EMA refuses by contrast to redact the information on the number of cystic fibrosis centres involved in the surveys, the number of patients that were switched from TOBI Podhaler treatment to alternative treatment as well as the reasons for that switch (namely adverse events mainly relating to respiratory, thoracic and mediastinal disorders). First, information on the side effects of TOBI Podhaler is available on the EMA’s website. Second, as regards the information not accessible to the public, not only has the applicant failed to show how, given that other information was publicly accessible, the disclosure of the few items of information which are not accessible would undermine its commercial interest and competitive position, but, in addition, that there was an overriding public interest in its disclosure;
–
certain information relates to cases of intolerance to TOBI Podhaler which form part of the data examined by the CHMP to enable Vantobra to be marketed and thus derogate from the market exclusivity of TOBI Podhaler. That information is published in the EPAR;
–
information on the side effects of TOBI Podhaler is published in the EPAR.
The EMA makes a finding similar to that regarding the information in the assessment report of Vantobra’s clinical superiority to TOBI Podhaler. It takes the view that the applicant has failed to show how, given that most of the information was publicly accessible, the disclosure of the few items of information which were not accessible would undermine the applicant’s commercial interest and competitive position. The EMA adds that, even if that information could be considered commercially confidential information, the scientific evidence of the clinical benefit of Vantobra for a part of the target population and the proof that the conditions enabling derogation from market exclusivity for TOBI Podhaler are met constitute information on which the CHMP relies in its assessment report on Vantobra’s similarity to TOBI Podhaler. The EMA thus takes the view that such information has to be released in order to understand how the CHMP came to such a conclusion. It therefore concludes that there is an overriding public interest in disclosure.
Admissibility
By its second head of claim, the applicant requests the Court to order the EMA not to disclose the CHMP assessment report on the similarity of Vantobra with TOBI Podhaler or the CHMP Assessment Report on the clinical superiority of Vantobra to TOBI Podhaler.
The EMA disputes the admissibility of that second head of claim on the ground that the formulation of injunctions or of interim measures does not fall within the scope of the procedure referred to in the fourth paragraph of Article 263 TFEU.
It is sufficient to note that, according to settled case-law, in an action for annulment, the jurisdiction of the EU judicature 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, to that effect, order of 12 March 2014, PAN Europe v Commission,
T‑192/12
, not published,
EU:T:2014:152
, paragraph
and the case-law cited).
Accordingly, the application for an order not to disclose the CHMP reports must be rejected as inadmissible, as must, for the same reasons, the application for an order made in the alternative, in the third head of claim, not to disclose certain information in those reports.
Substance
In support of its action, the applicant puts forward four pleas, alleging (i) infringement of Article 339 TFEU, Articles 7, 16 and 17 of the Charter of Fundamental Rights of the European Union and Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), (ii) lack of justification for disclosure under Regulation No 1049/2001, (iii) implementation, by the EMA, of a policy of dealing with information which does not comply with either Article 15 TFEU or Regulation No 1049/2001 and, (iv) raised in the alternative, the need to redact several pieces of information before disclosure of the documents, on the ground that that information is clearly confidential for the purposes of Article 4(2) of Regulation No 1049/2001.
It should be noted that, in the context of the second plea, the applicant adopts the position that the general presumptions of confidentiality justifying refusal to grant access which apply to certain categories of documents also apply to the CHMP reports drawn up in the context of the MA procedure for a medicinal product which is governed, in the present case, by Regulations Nos 726/2004 and 141/2000. Accordingly, the applicant submits that the disclosure of those documents would in principle undermine commercial interests.
In view of its potential impact on the outcome of the dispute as a whole, the Court considers that it is necessary to consider first, as a separate plea, the question whether the CHMP reports are protected by a general presumption of confidentiality. It is then necessary to consider, before the first plea, the second plea, by which the applicant claims in essence that the whole of the CHMP reports are confidential, on the ground that all the information set out therein falls within the scope of commercial interests within the meaning of Article 4(2) of Regulation No 1049/2001.
The separate plea, alleging the existence of a general presumption of confidentiality of the CHMP reports drawn up in the context of the MA procedure for a medicinal product pursuant to Regulations Nos 726/2004 and 141/2000
In the applicant’s submission, the EMA should have taken the view that the whole of the information in the CHMP reports — namely the proprietary confidential raw data, the compilation of publicly-accessible clinical data, and the analysis of those data by various third parties, as well as the overall authorisation strategy — was covered by a general presumption of confidentiality. The applicant submits that protection of confidentiality should not only extend to the parts of the reports containing the most sensitive confidential information, but to the reports as such, because the most sensitive parts are integrated in a line of arguments which include matters relating to its proprietary strategy, and which form with other public elements of the reports an inseparable whole with economic value.
The EMA, supported by the intervener, disputes those arguments.
In the context of that plea, the applicant submits in essence that the general presumptions of confidentiality justifying refusal of access applying to certain categories of documents also apply to the CHMP reports presented in the context of the MA procedure for a medicinal product similar to an orphan medicinal product, but clinically superior to that product, provided for in Regulations Nos 141/2000 and 726/2004, and accordingly, that the disclosure of those documents would in principle undermine commercial interests. Thus, the general presumption of confidentiality on which the applicant relies is based on the exception relating to the protection of its commercial interests, which is referred to in the first indent of Article 4(2) of Regulation No 1049/2001.
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. Moreover, 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
).
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
). 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
).
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, laid down in 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
, and of 3 July 2014, Council v in’t Veld,
C‑350/12 P
,
EU:C:2014:2039
, paragraph
) —, 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
).
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.
First, it is apparent from a number of judgments of the Court of Justice that, in order for a general presumption 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
, and of 17 October 2013, Council v Access Info Europe,
C‑280/11 P
,
EU:C:2013:671
, paragraph
).
Moreover, the application of general presumptions may be dictated by the overriding need to ensure that the procedures at issue operate correctly and to guarantee that their objectives are not jeopardised. Accordingly, 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 such procedures and 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 Joined Cases LPN and Finland v Commission,
C‑514/11 P and C‑605/11 P
,
EU:C:2013:528
, points
,
,
and
).
To that effect, for example, the Court has held that, so long as, during the pre-litigation stage of an inquiry carried out as part of an EU Pilot procedure, there is a risk of affecting the nature of the infringement procedure, altering its progress or undermining the objectives of that procedure, the application of the general presumption of confidentiality of the documents exchanged between the Commission and the Member State concerned is justified (see, to that effect, judgment of 25 September 2014, Spirlea v Commission,
T‑306/12
,
EU:T:2014:816
, paragraphs
to
).
Moreover, in all the cases which gave rise to the judgments establishing such presumptions, 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
to
; 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
; and of 27 February 2014, Commission v EnBW,
C‑365/12 P
,
EU:C:2014:112
, paragraphs
and
).
Lastly, 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 also 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
, and Opinion of Advocate General Cruz Villalón in Council v Access Info Europe,
C‑280/11 P
,
EU:C:2013:325
, point
). 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.
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 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 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 of Justice concluded from this 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
,
,
and
).
It is also on the basis of that criterion that the 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
).
In the present case, the documents at issue do not relate to ongoing administrative or judicial proceedings. Thus, even if the case-law cited in paragraphs 44 and 45 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 an MA procedure, disclosure of the documents at issue cannot alter that procedure, since MA for Vantobra was issued on 18 March 2015 and the contested decision authorising access to the CHMP reports is dated 24 April 2015.
Similarly, unlike the situations in which the Court of Justice and the General Court have accepted that the general presumptions of confidentiality justifying refusal of access to documents apply, Regulations Nos 141/2000 and 726/2004 do not restrict the use of documents in the file relating to an MA procedure for a medicinal product and do not provide, by contrast with Regulations Nos 1/2003 and 773/2004, that access to the file is limited to the ‘parties concerned’ or to ‘complainants’.
More specifically, Regulation No 141/2000 does not contain any specific provision on access to documents.
As regards Regulation No 726/2004, it provides in Article 73 thereof that Regulation No 1049/2001 is to apply to documents held by the EMA and that the EMA’s Management Board is to adopt the arrangements for implementing Regulation No 1049/2001. 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.
Regulation No 726/2004 requires the EMA, in Article 11, Article 13(3), Article 36, Article 38(3) and Article 57(1) and (2) thereof, to publish three documents, namely the 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.
Articles 11, 12, 36 and 37(3) of Regulation No 726/2004 also reflect the legislature’s intention that the MA procedure should be transparent, even where that procedure does not result in a decision or leads to a decision refusing MA. Those provisions provide that both information relating to an MA application that an applicant has withdrawn before an opinion has been given by the EMA and information concerning an MA application which has been refused must be made publicly accessible.
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 are 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 41 above, it must be held that the EU legislature took the implicit view that the integrity of the procedure is not undermined in the absence of such a presumption of confidentiality.
In view of all the foregoing, it must be held that there is no general presumption of confidentiality of the CHMP reports arising from the application of the combined provisions of Regulations Nos 141/2000, 1049/2001 and 726/2004. Those 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 MA applicants. It is thus for the EMA to satisfy itself, by means of a concrete, individual examination of each document in the administrative case file, 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.
Moreover, it should be added that, pursuant to Article 73 of Regulation No 726/2004, the EMA adopted the arrangements for implementing Regulation No 1049/2001. 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 No 1049/2001 is considered to be applicable.
It should also be observed 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 was added to as the EMA gained more experience in the field of requests for access to documents. That table was supplemented by, first, 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 MA procedure, which could be published once a decision had been adopted. It is apparent from that table that, as regards the CHMP reports, the EMA considers them to be public and, therefore, publishes them as soon the MA procedure for a medicinal product has ended.
Accordingly, the view cannot be taken that the CHMP reports enjoy a priori and automatically the general presumption of confidentiality. It follows that the plea alleging the existence of such a presumption must, in any event, be rejected.
The second plea, alleging infringement of Article 4(2) of Regulation No 1049/2001
In the context of the second plea, the applicant claims that the EMA infringed Article 4(2) of Regulation No 1049/2001 by authorising disclosure of the CHMP reports. This plea consists, in essence, of two parts. In the first part, the applicant claims that the CHMP reports are confidential in their entirety, on the ground that they fall within the scope of commercial interests within the meaning of 4(2) of Regulation No 1049/2001. In the second part, the applicant submits that, for the disclosure of that confidential information to be permissible, an overriding reason in the public interest for its disclosure was necessary. However, the EMA failed to demonstrate the existence of such a reason in the public interest. In addition, the EMA failed to show how the publication of the information in the EPAR did not suffice to satisfy the requirement of an overriding public interest in its disclosure.
–
The first part, based on the confidential nature, for the purposes of Article 4(2) of Regulation No 1049/2001, of the CHMP reports on similarity and clinical superiority
The applicant submits that disclosure of the information contained in the CHMP reports on similarity and clinical superiority would undermine the protection of its commercial interests.
According to the applicant, the CHMP reports contain proprietary confidential raw data, compilation of publicly-accessible clinical data and their analysis by various third parties which reveal the applicant’s overall strategy for obtaining an MA. Those data form part of the applicant’s know-how and strategic trade secrets for the purposes of Article 39(2) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 15 April 1994 (
OJ 1994 L 336, p. 214
; ‘the TRIPS Agreement’) that forms Annex 1 C to the Agreement establishing the World Trade Organisation (WTO) (
OJ 1994 L 336, p. 3
). They give it a competitive advantage over its competitors who do not have its strategic know-how. It emphasises in this respect that it was its strategic know-how which enabled it to obtain a derogation from market exclusivity pursuant to Article 8(1) of Regulation No 141/2000. The applicant relies in that regard on the fact that it drew up questions to gather data on the actual use of tobramycin to treat cystic fibrosis in order to reply to the list of questions put by the CHMP relating to the derogation from the market exclusivity of TOBI Podhaler. The applicant adds that Article 4(2) and (6) of Regulation No 1049/2001 does not authorise the EMA to disclose elements of a document — even if they are in the public domain — that form an inseparable part of an assessment which, in itself, is confidential and has commercial value. The applicant refers in that regard to the order of 1 September 2015, Pari Pharma v EMA (
T‑235/15 R
,
EU:T:2015:587
), according to which it cannot be ruled out that a specific use of confidential and non-confidential information could be confidential, inasmuch as an inventive strategy of that kind bestows a scientific added value on the non-confidential elements taken in isolation.
The EMA, supported by the French Republic and the intervener, disputes all those arguments.
As a preliminary point, it should be recalled, in the first place, 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. The purpose of Regulation No 1049/2001, as indicated in recital 4 and Article 1 thereof, is to give the public a right of access to documents of the institutions that is as wide as possible (judgments of 28 June 2012, Commission v Éditions Odile Jacob,
C‑404/10 P
,
EU:C:2012:393
, paragraph
, and of 28 June 2012, Commission v Agrofert Holding,
C‑477/10 P
,
EU:C:2012:394
, paragraph
; see also, to that effect, judgment of 14 November 2013, LPN and Finland v Commission,
C‑514/11 P and C‑605/11 P
,
EU:C:2013:738
, paragraph
).
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 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
; of 28 June 2012, Commission v Agrofert Holding,
C‑477/10 P
,
EU:C:2012:394
, paragraph
; and of 14 November 2013, LPN and Finland v Commission,
C‑514/11 P and C‑605/11 P
,
EU:C:2013:738
, paragraph
).
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 (see, to that effect, judgments of 21 July 2011, Sweden v MyTravel and Commission,
C‑506/08 P
,
EU:C:2011:496
, paragraph
, and of 3 July 2014, Council v in’t Veld,
C‑350/12 P
,
EU:C:2014:2039
, paragraph
).
It must also be noted that the system of exceptions laid down in Article 4 of Regulation No 1049/2001, particularly in Article 4(2), is based on a weighing of the opposing interests in a given situation, that is to say, on the one hand, the interests which would be favoured by the disclosure of the documents in question and, on the other, those which would be jeopardised by such disclosure. The decision taken on a request for access to documents depends on which interest must prevail in the particular case (judgments of 14 November 2013, LPN and Finland v Commission,
C‑514/11 P and C‑605/11 P
,
EU:C:2013:738
, paragraph
, and of 23 September 2015, ClientEarth and International Chemical Secretariat v ECHA,
T‑245/11
,
EU:T:2015:675
, paragraph
).
The Court points out that, in order to justify refusal of access to a document, it is not sufficient, in principle, for that document to fall within an activity or an interest mentioned in Article 4 of Regulation No 1049/2001. 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 that article (see, to that effect, judgments of 28 June 2012, Commission v Éditions Odile Jacob,
C‑404/10 P
,
EU:C:2012:393
, paragraph
; of 28 June 2012, Commission v Agrofert Holding,
C‑477/10 P
,
EU:C:2012:394
, paragraph
; and of 27 February 2014, Commission v EnBW,
C‑365/12 P
,
EU:C:2014:112
, paragraph
) and that the risk of that interest being undermined is reasonably foreseeable and not purely hypothetical (judgments of 13 April 2005, Verein für Konsumenteninformation v Commission,
T‑2/03
,
EU:T:2005:125
, paragraph
, and of 22 May 2012, Sviluppo Globale v Commission,
T‑6/10
, not published,
EU:T:2012:245
, paragraph
). The same applies in respect of a third party where he 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
,
and
).
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 the 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
, and of 9 September 2014, MasterCard and Others v Commission,
T‑516/11
, not published,
EU:T:2014:759
, paragraph
).
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 at issue contain elements which may, if disclosed, seriously undermine the commercial interests of a legal person. That is the case, in particular, where the requested documents contain commercially sensitive information relating, in particular, to the business strategies of the undertakings concerned or to their commercial 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
to
).
In the second place, in order to examine the second plea, it is first necessary to recall the legal context and the factual circumstances surrounding the MA application for Vantobra. In order to obtain that MA, the applicant was required to show, pursuant to Article 8(3)(c) of Regulation No 141/2000, that its medicinal product, although similar to the orphan medicinal product, TOBI Podhaler, already authorised, was clinically superior to the latter. To that end, the applicant, pursuant to Article 3(3)(d)(2) of Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (
OJ 2000 L 103, p. 5
), sought to show that Vantobra was more advantageous in therapeutic terms than TOBI Podhaler, in that it was shown to provide greater safety in a substantial portion of the target population.
In order to show the greater safety of its medicinal product, the applicant inter alia referred to a comparative clinical study between TOBI and TOBI Podhaler, entitled ‘Establish a new Gold standard efficacy and safety with tobramycin in cystic fibrosis 2006-2009’ (‘the EAGER study’), contained in the MA file relating to TOBI Podhaler and in the EPAR for that file. That study revealed that certain adverse effects such as a cough were much more frequent in the patient group treated with TOBI Podhaler than in the patient group treated with TOBI. Nonetheless, the EMA considered that, although there were indications that Vantobra was capable of providing a safety benefit to patients not tolerating dry powder inhalation, the available data were limited and difficult to interpret, and therefore not sufficiently convincing to justify a derogation under Article 8(3) of Regulation No 141/2000. That is why it put two questions to the applicant. By the first question, the applicant was requested to provide it with additional data on the clinical relevance of the adverse events recorded during the clinical study and provide further evidence on the differences observed as regards the EAGER study in terms of the incidence of coughing and of withdrawals from trials on account of adverse events, by reference to the available data of the study concerning the gravity of the adverse events, patients’ quality of life, etc. The purpose of the second question was that the applicant provide the EMA with additional information aimed at substantiating the assertion that the part of the target population that might benefit from greater safety with Vantobra could be considered significant. In order to reply to those questions and thus show that Vantobra fulfilled the requirement of Article 3(3)(d)(2) of Regulation No 847/2000, the applicant performed information searches in published studies and conducted a market survey with [
confidential
] on dry powder use and nebuliser use.
It is in the light of the case-law cited in paragraphs 65 to 71 above and of the legal and factual context noted in paragraphs 72 and 73 above that it is necessary to consider the applicant’s arguments that the EMA infringed the first indent of Article 4(2) of Regulation No 1049/2001 by adopting the contested decision, by which it refused to consider the whole of the CHMP reports to be confidential.
First, it is apparent from the contested decision, the content of which was recalled in paragraphs 25 and 27 above, that the CHMP reports include extensive data which have been published in articles, studies or scientific reports and that those data are therefore publicly accessible. In that regard, it is useful to recall that, in the context of an MA application for a hybrid medicinal product, the MA file for Vantobra includes a large amount of published data relating to the reference medicinal product TOBI (see paragraph 22 above).
Accordingly, it should be pointed out that the mere fact that those published data were compiled together cannot, as such, suffice to show that all those data reveal the content of the applicant’s strategic know-how and are thus confidential. Nor can the fact that the applicant performed a search of published information and compiled that information lead to the automatic conclusion that all the data are particular to that undertaking and reveal its expertise, for the purposes of the case-law cited in paragraph 71 above.
In order to reach a finding that such know-how falls within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001, it is for the applicant to show that the compilation of those data which are accessible to the public and its assessments on those data provide added value — consisting of, for example, new scientific conclusions or considerations relating to an inventive strategy — giving the undertaking a commercial advantage over its competitors (see, to that effect, orders of 13 February 2014, Luxembourg Pamol (Cyprus) and Luxembourg Industries v Commission,
T‑578/13 R
, not published,
EU:T:2014:103
, paragraph
, and of 25 July 2014, Deza v ECHA,
T‑189/14 R
, not published,
EU:T:2014:686
, paragraph
).
However, the applicant has failed to show that performing searches on public scientific data and the assembly of those data reflected an inventive strategy and provided added value for the purpose of the case-law cited in paragraph 77 above. That is all the more true because, in the present case, the public data concerned were submitted in order to reply to the specific questions of the EMA (see paragraph 73 above), are easily identifiable in the CHMP reports and come from bodies or associations — such as the EMA itself, [
confidential
] — which are well known to pharmaceutical undertakings. Searches for that type of information are moreover facilitated by IT tools such as search engines. It is not therefore apparent that the discovery of that information required any particular inventiveness and was time-consuming and expensive. These findings thus qualify the commercial value of compiling publicly-available information. In view of those factors, it must be held that none of the arguments put forward by the applicant permits the conclusion that the disclosure of the publicly-accessible information that it compiled would undermine its commercial interests.
Second, the question arises whether, in the present case, the applicant, which relies on the order of 1 September 2015, Pari Pharma v EMA (
T‑235/15 R
,
EU:T:2015:587
), has shown that there was a specific use of confidential and non-confidential information, that that method of use constituted an inventive strategy which bestowed a scientific added value on the non-confidential elements taken in isolation and that that strategy may consequently be considered confidential. That amounts, in other words, to considering whether the applicant has demonstrated that all the material in the reports, even that which was publicly accessible, formed an inseparable whole of a confidential assessment. It was all the more necessary for the applicant to adduce precise and proper explanations since, as has been pointed out in paragraph 67 above, the exceptions provided for in Article 4 of Regulation No 1049/2001 must be interpreted and applied strictly because they derogate from the principle that the public should have the widest possible access to documents and since, as was noted in paragraph 69 above, it is for the applicant to show how access to that document could specifically and actually undermine the interest protected by an exception laid down in that article.
For that last reason, it is necessary at the outset to reject the argument essentially put forward by the applicant that obtaining the derogation from the market exclusivity of TOBI Podhaler would itself be sufficient to show that all the information contained in the CHMP reports on similarity and clinical superiority revealed an innovative strategy and fell entirely within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001.
As regards the explanations put forward by the applicant to show that it was its ‘strategic know-how’ which enabled it to obtain a derogation from market exclusivity under Article 8(1) of Regulation No 141/2000, the applicant claims that, in order to reply to the list of questions put by the CHMP relating to the derogation from the market exclusivity of TOBI Podhaler, it developed with its outside consultants a questionnaire comprising 20 questions to gather data about the actual use of tobramycin to treat cystic fibrosis compared to inhalation solutions with a dry powder inhaler, and that it provided detailed results which were incorporated in the reports on clinical superiority covering fields such as allocation of age groups, observed side effects and assumed benefit of a fast-to-administer tobramycin inhalation solution.
First of all, as the EMA observes, the provisions of Regulation No 141/2000 and those of Regulation No 847/2000, and the Guideline on aspects of the application of Article 8(1) and (3) of Regulation No 141/2000, entitled ‘Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity’, set out in detail the scientific information, in particular that relating to the ‘similar active substance’, required to show that a medicinal product is similar and also prescribe the type of evidence required to substantiate a claim regarding the efficacy of two different medicinal products. It follows that that type of procedure is highly regulated, and guided by the CHMP questions.
Next, as was noted in paragraph 73 above, it must be stated that, in the present case, the information provided by the applicant was submitted in response to the specific questions put to it by the CHMP during the procedure for obtaining the derogation pursuant to Article 8(3) of Regulation No 141/2000. It was by replying to those specific questions that the applicant was able to convince the CHMP of the similarity of Vantobra and TOBI Podhaler and of Vantobra’s clinical superiority to TOBI Podhaler. The CHMP clearly guided the applicant in its action by requesting it to provide the items of information which the CHMP lacked. Such circumstances weaken the applicant’s argument that the publicly-accessible information and the other information in the CHMP reports proceed from an innovative strategy on its part which entails considering that information as an inseparable whole. In actual fact, the claimed strategy was part of a specific regulatory process and was developed in the context of a dialogue between the applicant on the one hand and the EMA and the CHMP on the other.
Lastly, it is apparent from the parties’ answers to the questions put by the Court that a distinction may easily be drawn between the information which comes from publicly-accessible sources, on the one hand, and the information which falls within the scope of the applicant’s market survey and which proceeds from the conclusions that it drew from that information, on the other.
In that regard, two examples from among the numerous examples contained in the CHMP reports may be highlighted. First, page 13 of the CHMP report on clinical superiority, under the heading [
confidential
], contains information from [
confidential
], and thus publicly-accessible information, and some unpublished information, in the third paragraph, relating to [
confidential
]. Second, the information in the first three columns of tables Nos 8 and 9, on pages 17 and 18 of the CHMP report on clinical superiority, is publicly-accessible information which was presented in the form of columns in order to facilitate its interpretation. Only the fourth column contains information which emanates directly from the applicant.
It follows from the foregoing that applicant has failed to show that, in the present case, all the information was the result of an innovative strategy which bestowed a scientific added value on the non-confidential elements taken in isolation, or, a fortiori, that that strategy and the entirety of the documents which outlined that strategy could be considered confidential for the purposes of Article 4(2) of Regulation No 1049/2001.
The fact that, in the present case, the compilation of the public and non-public information is not confidential as a whole is entirely without prejudice to the possibility that one or more of the specific items of information identified by the applicant in its pleadings might possibly be confidential, on the ground that such items fall within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001. That question will be specifically examined in the context of the fourth plea, raised in the alternative.
Third, relying in that regard on the judgment of 23 October 2014, Olainfarm (
C‑104/13
,
EU:C:2014:2316
), and on the Opinion of Advocate General Wahl in Olainfarm (
C‑104/13
,
EU:C:2014:342
, point
), the applicant submits that the CHMP reports should be protected from possible copying by a generic competitor and that they should therefore be considered confidential. It should be recalled that the judgment cited above relates to the concept of ‘reference medicinal product’ within the meaning of Directive 2001/83 and to the ‘judicial remedy’ of the holder of an MA for a reference medicinal product against the MA decision for the generic medicinal product. The judgment states that a hybrid medicinal product may be designated as a reference medicinal product. The applicant infers from this that an applicant for a generic medicinal product could merely copy the file for Vantobra, since, as a ‘hybrid’ product, that reference medicinal product does not enjoy data exclusivity or market exclusivity. It therefore submits that it is necessary to protect the information at issue from copying. However, those arguments cannot succeed.
The judgment does not contemplate the question of access to documents contained in an MA file under Regulation No 1049/2001. Such a question is separate from that of data exclusivity and of market exclusivity. The applicant cannot therefore rely on the lack of an exclusivity period for the data concerning Vantobra to justify non-disclosure of the CHMP reports. Moreover, as the EMA rightly states, the release of documents in accordance with Regulation No 1049/2001 cannot undermine data exclusivity granted to a medicinal product in accordance with Directive 2001/83 and Regulation No 726/2004. It should also be pointed out that Regulation No 1049/2001 provides, in Article 16 thereof, that that regulation is to be without prejudice to any existing rules on copyright which may limit a third party’s right to reproduce or exploit released documents.
In light of the foregoing, the first part of the second plea must be rejected.
–
The second part, alleging that there is no public interest in the disclosure of the CHMP reports and relying on the fact that the EPAR is the result of a balancing of public and private interests in disclosure and confidentiality, respectively
The applicant submits that there is no overriding reason in the public interest in disclosure, since the information contained in the EPAR is sufficient to serve the public interest. It submits as follows:
–
the EPAR, prepared by the CHMP, and published under Article 13(3) of Regulation No 726/2004, after redaction of the confidential commercial information, includes information on the derogation from market exclusivity pursuant to the legislation on orphan medicinal products;
–
the EPAR mentions the content of the CHMP reports, as well as the fact that the derogation from market exclusivity of orphan medicinal products was successfully requested, without disclosing any detailed information on the arguments and data provided;
–
the scope of the disclosure in the context of the EPAR is already the result of a balancing of public and private interests. Wider implementation of Regulation No 1049/2001 in favour of greater transparency would endanger the balance established by Regulation No 726/2004 between the confidentiality of the bilateral authorisation procedure and the publication of information on the content of that procedure;
–
the present case differs from those relating to requests for access to clinical studies. That is because, in that situation, the private interest of the companies requesting access is combined with the public interest in the transparency of the clinical information to facilitate pharmacovigilance activities; however, the CHMP report on similarity and that on clinical superiority relate only to the comparison with TOBI Podhaler and that comparison was made only for purely legal reasons, namely for the purposes of obtaining a derogation from the market exclusivity provided for in Article 8(1) of Regulation No 141/2000.
The EMA, supported by the French Republic, dispute that second part of the second plea.
In the first place, it should be pointed out that, contrary to the applicant’s submission, there is nothing in the contested decision to show that the EMA might have considered that the CHMP reports in their entirety should be disclosed due to an overriding public interest. In the contested decision, the disclosure of the information in the CHMP reports is founded on the basis that that information is not confidential inasmuch as it does not fall within the scope of the exception provided for in the first indent of Article 4(2) of Regulation No 1049/2001. Thus, the applicant’s line of argument is based on factually erroneous considerations.
On the other hand, it is only in certain parts of the contested decision that the EMA observed in respect of certain well-identified information that, although that information was commercially confidential, it was in any event necessary to disclose it, since it fell within the scope of the overriding public interest. It should in addition be made clear that that finding that there was an overriding public interest in respect of certain well-defined information was made only in the alternative. In that regard, it should be pointed out that, in the context of its fourth plea, the applicant contests the existence of an overriding public interest in the disclosure of the information that it identified. The applicant’s arguments regarding that specific information will therefore be analysed in the context of that plea.
Accordingly, the complaint that there is no overriding reason in the public interest in the disclosure of all the information contained in the CHMP reports is ineffective and must therefore be rejected.
In the second place, in that context, it is necessary to consider the applicant’s argument that, in essence, the information from the CHMP reports which appears in the EPAR is sufficient. The applicant claims in that regard that the EPAR is already the result of a balancing of public and private interests and that, accordingly, the EPAR satisfies on its own that requirement of disclosure on grounds of the overriding public interest.
That argument must be rejected. First of all, as was noted in paragraph 93 above, the EMA did not rely in a general manner on the existence of an overriding public interest in order to justify the disclosure of the CHMP reports.
Next, as was noted in paragraph 54 above, the EPAR represents only a summary — practical for professionals and understandable for the general public — of the characteristics of the medicinal product and the grounds of the CHMP’s positive opinion for issuing MA and contains in that regard only the minimum information that the EMA is required to proactively present. Article 13(3) of Regulation No 726/2004 cannot therefore be interpreted as meaning that the EU legislature envisaged that the EPAR is the result of a balancing of public and private interests, that only the information contained in that report could be publicly accessible and that, accordingly, the overriding public interest itself could not justify disclosure of information other than that of the EPAR.
Moreover, in view of the abovementioned objective for which the EPAR was provided for, the information that it contains cannot in itself satisfy the requirement of transparency laid down in Regulation No 1049/2001. In the field of medicinal products, that requirement of transparency is justified by the need for supervision of the EMA’s activities and, in particular, for supervision, by healthcare and research professionals, of the issuing of an MA.
Lastly, contrary to what the applicant suggests by its argument, the information mentioned in the CHMP reports which does not appear in the EPAR does not automatically constitute information which falls within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001 and which is therefore confidential.
In the third place, it is also necessary to analyse the argument based on the alleged difference between the nature of the clinical studies, on the one hand, and that of the CHMP reports, on the other. The applicant submits in essence that it is conceivable that there might be an overriding public interest in the disclosure of clinical studies submitted in the context of an MA application for a medicinal product on the ground that such disclosure would facilitate pharmacovigilance activities. By contrast, as regards the CHMP reports, the applicant states that there is no overriding public interest in their disclosure since its reports are drawn up for a purely legal purpose, namely that of obtaining a derogation from market exclusivity pursuant to Article 8(3) of Regulation No 141/2000.
Such a line of argument cannot succeed. The information in the CHMP reports was submitted to that committee with the aim of convincing it to issue a positive opinion so that derogation could be granted from the market exclusivity of TOBI Podhaler. That necessarily implied the CHMP’s analysing the content of that information from a purely medical angle. The reports drawn up thus contain clinical information on Vantobra, namely that it contains one or more active substances similar to those contained in TOBI Podhaler and is significantly more advantageous from a therapeutic or diagnostic perspective than TOBI Podhaler. The applicant was thus required to provide evidence to show that its medicinal product provided a significant therapeutic or diagnostic advantage for the patient population over and above that provided by TOBI Podhaler. To that end, it sought to show that Vantobra provided greater safety in a substantial portion of that patient population. Such information falls within the scope of pharmacovigilance on the same basis as that contained in the clinical studies and cannot therefore be considered to be information drawn up for a purely legal purpose.
It follows from all of the foregoing that the second part of the second plea must be rejected, and that the plea must therefore be rejected in its entirety.
The first plea, alleging infringement of Article 339 TFEU, Articles 7, 16 and 17 of the Charter of Fundamental Rights and Article 8 of the ECHR
The first plea is based on the assertion that several fundamental rights of the applicant have been infringed:
–
first of all, the EMA adversely affected the applicant’s right to private life, enshrined in Article 7 of the Charter of Fundamental Rights and Article 8 of the ECHR; the disclosure of the reports which contain proprietary or confidential information facilitates, for other pharmaceutical companies, the development and marketing of another inhalation solution to the detriment of the applicant, while, in its submission, the effort that it had to make to obtain the MA for Vantobra notwithstanding the market exclusivity granted to TOBI was considerable;
–
next, the EMA infringed Article 339 TFEU on the grounds that the content of the reports is not in the public domain and reveals the applicant’s strategy for obtaining MA for Vantobra;
–
moreover, for the same reasons, the freedom to conduct a business laid down in Article 16 of the Charter of Fundamental Rights has been violated; the premature market entry of other competitors during the period of market exclusivity would lead to a loss of market share and would seriously harm the applicant’s competitive position;
–
moreover, the disclosure of the reports affects the applicant’s right to intellectual property laid down in Article 17(2) of the Charter of Fundamental Rights; that right also applies to non-registered know-how with an economic value on the basis of proprietary technical or business information; the applicant refers in that regard to Article 39(2) of the TRIPS Agreement and to the definition of ‘trade secrets’ in the Proposal for a Directive of the European Parliament and of the Council on the protection of know-how; it follows from those provisions that non-registered know-how is recognised as a trade-related aspect of intellectual property; the applicant states that the information contained in the CHMP reports — namely raw data generated on its behalf or the compilation and analysis of publicly-accessible data — constitutes a trade secret within the meaning of that provision and is therefore protected by Article 17 of the Charter of Fundamental Rights; the applicant specifies that the combination of new market research data, the compilation of clinical data and of their analysis by various third parties as well as the conclusions drawn by the applicant made it possible to obtain MA for Vantobra; the applicant thus draws attention to the decisive nature of that information and, therefore, to the fact that its disclosure would reveal its strategy to the advantage of its competitors;
–
lastly, the applicant submits that, contrary to the contention of the EMA, the assessment of whether a piece of information constitutes confidential information within the meaning of Article 4(2) of Regulation No 1049/2001 should not depend on whether or not that piece of information was used for regulatory purposes in administrative procedures; the EMA moreover recognises itself that certain information contained in clinical reports and the combination, compilation and presentation of findings for regulatory purposes may be considered commercially confidential information; in that context, the applicant specifies that it did not receive any detailed guidelines from the CHMP on the additional information and data which it was required to provide to demonstrate that the conditions for derogation from the market exclusivity of TOBI Podhaler were satisfied; the applicant thus states that it spent six months, without any further regulatory guidance, on the development and performance of a market survey as well as evaluating and summarising the results thereof; the applicant states that it has developed its own strategy to prove the non-similarity and clinical superiority, for the purposes of Article 8(3) of Regulation No 141/2000, of Vantobra and submits that that strategy should be protected.
The EMA, supported by the French Republic, disputes all those arguments.
It should be stated at the outset that, in order to examine the plea alleging infringement of Article 339 TFEU, Articles 7, 16 and 17 of the Charter of Fundamental Rights and Article 8 of the ECHR, the legal and factual context noted in paragraphs 72 and 73 above must be taken into account.
First, it should be observed that the applicant’s reasoning in its pleadings is based on the assumption that the entire contents of the CHMP reports are confidential. However, as is apparent from paragraph 75 above, a significant part of the information contained in those reports is in the public domain and cannot by definition be regarded as falling within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001. Similarly, as was noted in paragraphs 76 to 86 above, the applicant has not shown that, in itself, the compilation of all the information consisted, for example, of new scientific conclusions or considerations relating to an inventive strategy which gives the undertaking a commercial advantage over its competitors and that it therefore provided added value. As was pointed out in paragraph 57 above, there is no general presumption of confidentiality of the CHMP reports. The applicant cannot therefore invoke in a general manner an infringement of Article 339 TFEU, Articles 7, 16 and 17 of the Charter of Fundamental Rights and Article 8 of the ECHR, since it does not appear that all the data to which it refers are confidential. It is thus for the applicant to identify and show which information, in its submission, falls within the scope of commercial interests within the meaning of 4(2) of Regulation No 1049/2001.
Thus, the applicant cannot merely plead the existence of inherent confidentiality, or merely allege infringement of fundamental rights in abstract terms. It is for the applicant to describe in specific terms the professional and commercial importance for it of the information and the utility of that information for other undertakings which are liable to examine and use it subsequently (see, to that effect and by analogy, order of 28 November 2013, EMA v AbbVie,
C‑389/13 P(R
), not published,
EU:C:2013:794
, paragraphs
to
). In other words, as required by the case-law noted in paragraph 69 above, it is for the applicant to show specifically and actually how, once the documents have been disclosed, competitors would be able to enter the market of tobramycin-based therapies for the treatment of cystic fibrosis. However, the applicant’s explanations are vague in that regard, to say the least. The applicant merely puts forward a very general line of argument according to which the combination of new market research data, the compilation of clinical data and of their analysis by various third parties as well as the conclusions drawn therefrom by the applicant enabled it to obtain MA for Vantobra and thus reveal its strategy. However, that line of argument does not stand up to the analysis set out in paragraphs 72 to 86 above.
Second, as regards, more specifically, the complaint alleging breach of the right to intellectual property enshrined in Article 17(2) of the Charter of Fundamental Rights, the applicant claims that non-registered know-how is recognised as a trade-related aspect of intellectual property and refers in that regard to Article 39(2) of the TRIPS Agreement.
However, information that is available in the public domain cannot be considered ‘non-registered know-how based on proprietary technical and business information’, as the EMA correctly points out. That is especially true in the present case since, first, the MA application concerns a hybrid medicinal product and that application thus relies on a substantial part of the data of the reference medicinal product, TOBI. Moreover, most of the information submitted in response to the two questions from the CHMP originated from sources known to pharmaceutical undertakings and was easily identifiable in view of the precision of the questions put by the CHMP. The applicant cannot therefore claim any intellectual property over that publicly-accessible information.
As regards Article 39(2) of the TRIPS Agreement, to which the applicant refers, although it cannot as such be relied upon to challenge the validity of the contested decision, Regulations Nos 1049/2001, 726/2004 and 141/2000 must nonetheless 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
and the case-law cited).
It should be borne in mind that Article 39(2) of the TRIPS Agreement and the definition of ‘trade secret’ in the proposal for a directive on which the applicant relies — which now appears in Article 2 of Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (
OJ 2016 L 157, p. 1
) — provide 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.
However, as is apparent from the analysis set out in paragraphs 83 to 86 above, the information was assembled, in the present case, in accordance with the regulatory requirements and was guided by the EMA’s precise questions. Similarly, that information, relating to a very specific subject matter (that of intolerance to dry powder of patients with cystic fibrosis and the improvement in their treatment by the use of a nebuliser) and coming from bodies or associations well known to pharmaceutical undertakings, could be obtained without difficulty and without any particular inventiveness. In addition, a distinction may easily be drawn between the publicly-accessible information and that which falls within the scope of the market survey and the applicant’s own conclusions.
It is not therefore apparent that that assembly could thus be regarded as not being ‘generally known’ within the meaning of Article 39(2) of the TRIPS Agreement and Article 2 of Directive 2016/943.
Even if it were accepted that the applicant’s work of assembling public information could have some commercial value, it must still be shown that that systematisation of that information provides in itself added value, which the applicant has been unable to do. Moreover, account should be taken that the way in which publicly-accessible information is searched for is facilitated by IT tools such as search engines. In addition, it was found inter alia in paragraph 84 above that a distinction may easily be drawn between the information which comes from sources accessible to the public and information particular to the applicant. These three findings qualify the commercial value of compiling publicly-accessible information.
Lastly, the applicant has failed to show that the publicly-accessible information is in itself sufficient to reveal the content of its commercial strategy or that it reveals its know-how or expertise, for the purposes of the case-law cited in paragraph 71 above.
It is therefore apparent from the foregoing that the EMA applied EU law in line with Article 39(2) of the TRIPS Agreement and that it did not infringe Article 17(2) of the Charter of Fundamental Rights.
Third, the complaints alleging infringement of Articles 7 and 16 of the Charter of Fundamental Rights and of Article 8 of the ECHR must also be rejected. As is apparent from paragraphs 107 to 116 above, it does not appear, first of all, that all the information to which the applicant refers is confidential. Next, the information in the CHMP reports could be obtained without any difficulty or any particular inventiveness. Lastly, the applicant has failed to show specifically and actually how competitors would be able to enter the market of tobramycin-based therapies for the treatment of cystic fibrosis, once the documents have been disclosed.
The first plea must therefore be rejected.
The third plea in law, alleging that the EMA’s policy does not comply with Article 15 TFEU and Regulation No 1049/2001
The applicant claims that, under Article 15(3) TFEU, only regulations govern the right of access to documents and that the EMA’s policy does not constitute such a regulation and cannot override Regulation No 1049/2001. The applicant notes that the EMA relies solely on its disclosure policy and, in particular, on the concept of ‘commercially confidential information’ to justify its disclosure decision. The EMA defines that concept as all ‘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’. The applicant states that Article 4(2) of Regulation No 1049/2001 does not refer to ‘commercially confidential information’ but to ‘commercial interests of a natural or legal person, including intellectual property’. The applicant thus claims that that change in terminology led the EMA to interpret the concept of commercial information which cannot be disclosed in a way which does not comply with Article 4(2) of Regulation No 1049/2001. The applicant states in that regard that the words ‘commercial interests of a natural or legal person, including intellectual property’, which appear in Article 4(2) of Regulation No 1049/2001, cannot be defined more restrictively than the concept of ‘trade secrets’ defined in Article 2 of the Proposal for a Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure. The applicant specifies that the definition of the concept of ‘trade secrets’ corresponds to that in Article 39(2) of the TRIPS Agreement.
The EMA disputes all those arguments.
In the context of this third plea, the applicant seeks to show that, both by its documents disclosure policy and the reference to the expression ‘confidential information’, the EMA has an interpretation of the concept of ‘commercial interests of a natural or legal person, including intellectual property’, which is not consistent with Article 4(2) of Regulation No 1049/2001, inasmuch as that interpretation amounts to defining the concept set out in Article 4(2) of that regulation more restrictively than the concept of ‘trade secrets’ defined in Article 2 of the Proposal for a Directive.
It is apparent in the first place from the analysis of the preceding pleas that, by refusing to take the view that the reports on similarity and clinical superiority are confidential as a whole, the EMA did not infringe any provision of Regulation No 1049/2001. Thus, the disclosure policy that it applied in the present case is consistent with the requirements imposed on it by Article 339 TFEU and that regulation.
Similarly, the applicant has failed to show that, by referring to the concept of ‘commercially confidential information’ instead of the concept of ‘commercial interests … including intellectual property’, the EMA interpreted the concept of ‘trade secret’ too restrictively and thus misapplied Article 4(2) of Regulation No 1049/2001.
A significant part of the information in the CHMP reports was publicly accessible, as the EMA stated in the contested decision. Similarly, a significant part of those data came from the MA file for the reference medicinal product and from comparison of that medicinal product with TOBI Podhaler. In addition, the analysis of the preceding pleas reveals that the applicant has not succeeded in showing that the combination of those items of information proceeds from an innovative strategy and, therefore, that the information in the reports should have been regarded as confidential in its entirety.
Lastly, it is apparent from the examination set out in paragraphs 111 to 114 above that the EMA took account of the concept of ‘trade secret’ as set out in Article 39(2) of the TRIPS Agreement and that it applied EU law in line with that provision. It should moreover be noted that, even though Article 2 of Directive 2016/943 does not apply in the present case, the concept of ‘trade secret’ adopted by the EMA is consistent with that provision.
It follows that, in the present case, EMA’s policy with regard to the CHMP reports was exercised in a manner consistent with Article 15 TFEU and with Regulation No 1049/2001.
Consequently, the third plea must be rejected as unfounded.
The fourth plea, raised in the alternative, alleging that several pieces of information are confidential
In the context of the fourth plea, raised in the alternative, the applicant lists several pieces of information which, in its submission, cannot be disclosed under any circumstances, failing which its commercial interests within the meaning of the first indent of Article 4(2) of Regulation No 1049/2001 would be harmed.
In the first place, it is necessary to analyse the information identified by the applicant as confidential, which is set out in the CHMP report on clinical superiority.
First, it is necessary to examine the argument that the information which appears in the report on clinical superiority — concerning the superior respiratory tolerability of Vantobra in relation to Tobi Podhaler — falls within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001. The applicant claims that those data were used to determine the populations most affected by coughing when using TOBI Podhaler and the safety benefit derived from the new treatment by those populations. The applicant states that the precise definition and quantification of these patient sub-groups was a decisive factor for the positive CHMP opinion for the purposes of obtaining derogation from market exclusivity and for the grant of MA for Vantobra. In that context, the applicant submits that the EMA’s defence that those data are in the public domain is based on too narrow an interpretation of the abovementioned provision.
It should be observed that the information on page 9 of the report on clinical superiority, which the applicant claims should be redacted, concerns the severity of coughing according to whether the reference medicinal product TOBI or the orphan medicinal product TOBI Podhaler is used and according to patient age.
It must be stated, first of all, that that information is based directly on an analysis, carried out by the [
confidential
] in the context of the MA procedure for TOBI Podhaler [
confidential
], comparing tobramycin inhalation powder (TOBI Podhaler) and tobramycin inhalation solution (TOBI). It must be pointed out that that information is publicly accessible and is not therefore confidential. In that regard, first of all, the mere fact that the applicant performed a search in order to find that publicly-accessible information does not render that information confidential.
Next, it must be stated, in line with the EMA’s observations on the presentation made by the applicant at the hearing, that the percentage which accompanies the sub-group of patients is simply [
confidential
]. That result was thus obtained in the context of a process which follows the requirements of [
confidential
] on comparison of values.
Lastly, the applicant has not stated how, specifically, disclosure of the abovementioned information would undermine its commercial interests and give its competitors a competitive advantage.
Accordingly, it must be held that the applicant has failed to show that that information at issue is confidential for the purposes of Article 4(2) of Regulation No 1049/2001.
Second, the applicant identifies, as confidential data, those data taken from the market survey which appear in the section on ‘the Extrapolation of tolerability from TOBI to Vantobra’. The applicant specifies that that survey, conducted on its behalf, is a key element to show that its medicinal product is clinically superior to dry powder inhalation.
However, the data in question [
confidential
]. That information was submitted — in the legal and factual context noted in paragraphs 72 and 73 above — by the applicant for the purpose of replying to a question from the EMA relating in particular to the criterion — referred to in Article 3(3)(d)(2) of Regulation No 847/2000 — of the size of the population concerned by a greater safety of Vantobra. It should be recalled in that regard that the purpose of the market survey was to determine, as regards patients sensitive to dry powder use, the extent to which TOBI treatment was more effective than TOBI Podhaler treatment, to use the survey’s findings derived from the reference medicinal product for the benefit of its own medicinal product and thus to demonstrate the size of the population concerned by a greater safety of Vantobra.
It should be further noted that there are references to those data on the assessment of the similarity and the clinical superiority of Vantobra in the EPAR. As the contested decision mentions (see paragraph 25 above), the information relating to the adverse events of TOBI Podhaler was published in the EPAR.
As regards the other information as such which was not published, the EMA states that it forms part of the objective data (including both published and unpublished information) which were assessed by the CHMP and on which the CHMP based its findings on similarity and on the derogation from market exclusivity arising therefrom.
The unpublished information in question includes inter alia [
confidential
]. Apart from the fact that [
confidential
] constitutes in reality a refinement of information which already existed — such as that from the 2010 Annual Report of the European Cystic Fibrosis Society Patient Registry — on the beneficial effects of the replacement of a treatment consisting of a dry powder inhalation by a treatment consisting of a solution administered by a nebuliser, the applicant would have had to show how disclosure of that information would have undermined its commercial interests or impaired its competitive position.
Accordingly, it must be held that the applicant has not submitted convincing evidence to show the alleged confidential nature of the information at issue.
In any event, even if that information is confidential in nature, it is necessary to examine the reason put forward by the EMA in the contested decision to justify moreover the existence of an overriding public interest in its disclosure. The EMA claims that that information is scientific evidence of the clinical benefit of Vantobra for a part of the target population and evidence that the conditions enabling derogation from market exclusivity for TOBI Podhaler are met and that the information must therefore be published due to that public interest. As was stated in paragraph 94 above, the applicant disputes that there is an overriding public interest in disclosure.
In accordance with 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, and setting out purely general considerations cannot provide an appropriate basis for establishing that an overriding public interest prevails over the reasons justifying the refusal to disclose the documents in question (see, to that effect, judgment of 14 November 2013, LPN and Finland v Commission,
C‑514/11 P and C‑605/11 P
,
EU:C:2013:738
, paragraphs
and
). In the present case, although the reasons put forward by the EMA and noted in paragraph 143 above are admittedly succinct, they do constitute specific circumstances and not purely general considerations justifying disclosure. As regards those specific circumstances, it is necessary to uphold the EMA’s position that they are sufficient to establish the existence of an overriding public interest in disclosure of the abovementioned information.
Third, it is necessary to examine the applicant’s argument that the information in the CHMP report on clinical superiority mentioned in the reply to question No 1 is confidential. The applicant claims that those data were used to determine the populations most affected by coughing when using TOBI Podhaler and the safety benefit derived from the new treatment by those populations. The applicant states that the precise definition and quantification of these patient groups, on the one hand, and the summary of the publicly-accessible data on the benefit and the method enabling the populations that would derive particular benefit to be identified, on the other, were decisive factors which led the CHMP to issue a positive opinion for the purposes of obtaining derogation from market exclusivity and for the grant of MA for Vantobra. In that context, the applicant submits that the EMA’s defence that those data are in the public domain is based on too narrow an interpretation of Article 4(2) of Regulation No 1049/2001.
It should be noted that the CHMP had drawn attention to the difficulties in drawing any conclusions on the clinical superiority of Vantobra to TOBI Podhaler on account of the lack of comparative data. The CHMP nonetheless recognised the potential benefit of a nebuliser treatment for patients intolerant to dry powder inhalation and asked the applicant to provide it with further comparative data (preferably direct comparative data) on the potential superiority of Vantobra to TOBI Podhaler. The EMA specified in that regard that that information could include quality-of-life data, available treatment recommendations from learned societies concerning choice of nebuliser versus dry powder inhalation in different age groups or age-related prescription data, in addition to conventional clinical study data.
The information at issue identified by the applicant on pages 17 to 19 of the report on clinical superiority in order to reply to question No 1 of the EMA contains [
confidential
]. Those data originate [
confidential
].
Similarly, on pages 17 to 19, [
confidential
]. The conclusion drawn by the applicant — [
confidential
] — could be obtained from following [
confidential
] reasoning from publicly-accessible data.
As regards table No 10 on page 18 of the CHMP report on clinical superiority, the data that it contains originate entirely from the EAGER study.
Accordingly, it must be held that the applicant has not demonstrated how, specifically, the disclosure of that information would undermine its commercial interests within the meaning of Article 4(2) of Regulation No 1049/2001.
Even if the view should be taken that the abovementioned unpublished information falls within the scope of the protected commercial interests under Article 4(2) of Regulation No 1049/2001, it is necessary to examine the reason put forward by the EMA in the contested decision, according to which there is moreover an overriding public interest in its disclosure. The EMA justifies the existence of that interest on the ground that that information is scientific evidence of the clinical benefit of Vantobra for a substantial part of the target population and proof that the conditions enabling derogation from market exclusivity for TOBI Podhaler are met. In the same way as was noted in paragraph 144 above, that position of the EMA that there is such an interest must be upheld.
Fourth, the applicant identifies passages on pages 19 to 23 of the report on clinical superiority. Those passages relate to the second question, namely whether, in accordance with Article 8(3) of Regulation No 141/2000, a substantial part of the target population will benefit from greater safety with Vantobra. The passages include figures on the ‘adult’ and ‘child’ populations concerned by cystic fibrosis. The applicant submits that, even though the estimate of the size of the target population is based on publicly-available information, the translation of that information into actual percentages to explain the size of the target population falls within the scope of a commercial interest which must be protected. The applicant states that the results of the patient group analysis have not been published and are derived from various sources, in particular the 2010 Annual Report of the European Cystic Fibrosis Society.
As the EMA correctly points out, the applicant does not dispute the fact that a significant part of the information that it proposes to be redacted emanates from the European Cystic Fibrosis Society Patient Registry Annual Data Report dated 2010. The EMA refers in that regard to pages 19 and 39 of that report.
In addition, as the EMA correctly pointed out, the considerations which stem from that publicly-accessible data and the percentage of patients [
confidential
], that the applicant inferred from those data, result from the application of [
confidential
]. Accordingly, it has not been demonstrated that the combination of that publicly-accessible and non-publicly accessible information should be regarded as an innovative and proprietary strategy which can be classified as commercially confidential. Moreover, the applicant has failed to show how, specifically, the disclosure of the non-publicly accessible data would undermine its commercial interests within the meaning of Article 4(2) of Regulation No 1049/2001.
As regards the information set out in the assessment of the applicant’s response and in the part entitled ‘Conclusion and Recommendation’, it is a repetition of the applicant’s inferences based on the publicly-accessible data examined on pages 19 to 21 of the CHMP report on clinical superiority.
Lastly, the mention of the year of the TOBI Podhaler assessment report and the reference to a [
confidential
] document on page 24 of the CHMP report are publicly-accessible pieces of information which are in no way confidential. The applicant has not moreover provided any explanation to substantiate the alleged confidential nature of that information.
In the second place, it is necessary to examine the applicant’s argument that certain information in the report on similarity of Vantobra to TOBI Podhaler must not be disclosed, on the ground that it would reveal its commercial strategy. More specifically, the applicant’s request relates to two excerpts from that report. Those excerpts allegedly contain several pieces of commercially sensitive information which are set out in the section entitled ‘Therapeutic indication’, on the one hand, and the section entitled ‘Claimant’s position Q.2, Assessment of the Response, 3. Conclusion and Recommendation’, on the other.
First, as regards the information in the ‘Therapeutic indication’ section, the applicant requests the redaction of data from the market survey conducted on its behalf by an independent body in cystic fibrosis treatment centres in several EU countries (see section 2.3, pages 9 and 10 of the report on similarity). In essence, the purpose of that study was to demonstrate Vantobra’s superior safety in relation to two other medicinal products available on the market, in particular by the identification of the percentage of the target population of TOBI and of TOBI Podhaler intolerant to dry powder inhalation. The applicant specifies also that that study is a key element to show superior safety of Vantobra over dry powder inhalation treatment. In the applicant’s submission, the fact that the side effects of TOBI Podhaler were known before its survey was compiled does not justify disclosure of the information in question.
It should be observed at the outset that the market survey is an additional study conducted at the request of and on behalf of the applicant, which was submitted in the context of the MA procedure for Vantobra to the EMA, after the EMA had concluded that the data on the characteristics of TOBI Podhaler provided in the initial application for authorisation were insufficient.
Next, it should be noted that the information on pages 9 and 10 of the report on similarity, whose redaction the applicant requests, relates to an analysis of the need to replace inhalation powder for patients who are intolerant to that form of administering tobramycin by the applicant’s product, that is to say a product in nebuliser form containing the same substance.
The information in question concerns the results of the survey conducted in several [
confidential
]. The information identified by the applicant as confidential data relates to the statistical data revealing the percentage and the medical reasons underlying the possible replacement of dry powder inhalation by a solution administered by a nebuliser in patients with cystic fibrosis, on the one hand, and the replacement options for patients who are intolerant to TOBI Podhaler, on the other.
It must be stated that the information and figures set out in the relevant excerpts of the CHMP report on similarity are descriptive of the situation of patients using different existing medicinal products. The information shows the percentage of patients who have stopped using TOBI Podhaler and started using another medicinal product and their reasons for opting for such a change in treatment. Apart from the fact that those data constitute in reality a refinement of information which already existed — such as that from the 2010 Annual Report of the European Cystic Fibrosis Society Patient Registry — on the beneficial effects of the replacement of a treatment consisting of a dry powder inhalation by a treatment consisting of a solution administered by a nebuliser, it must be observed that the applicant has not shown how, specifically, the disclosure of the information mentioned in paragraph 169 above would undermine its commercial interests within the meaning of Article 4(2) of Regulation No 1049/2001.
Even if that information at issue could be considered confidential, it is necessary to uphold, in the same way as was noted in paragraph 144, the reason put forward in the alternative by the EMA in the contested decision, according to which there is an overriding public interest in its disclosure. The EMA correctly contends that, since it is evidence designed to substantiate scientifically the clinical benefit of Vantobra for a part of the target population and proof that the conditions enabling derogation from market exclusivity for TOBI Podhaler are met, that information must be disclosed on grounds of the overriding public interest.
Second, the applicant regards as confidential the information in the section entitled ‘Claimant’s position Q.2, Assessment of the response, 3. Conclusion and Recommendation’, concerning the superior respiratory tolerability of Vantobra in relation to powder inhalation, amongst the TOBI and TOBI Podhaler target populations. The applicant claims that the reasons put forward by the EMA to justify disclosure are insufficient.
It should be observed at the outset that the information described by the applicant in paragraph 69 of the application does not correspond to the information on pages 19 to 23 of the report on similarity. In that regard, it must be pointed out that the applicant corrected, in the reply, that page identification error by thereafter referring to the information on pages 13 and 14 of the report on similarity.
The applicant states that the information on the abovementioned pages 13 and 14 contains an analysis of proprietary market survey and a combination of results with published available data in order to describe and quantify the group of patients eligible for Vantobra.
It should be pointed out that most of the information referred to on pages 13 and 14 is from publicly-accessible surveys or registries. The determination of the number of patients eligible for Vantobra is inferred from that data. Its disclosure cannot constitute an infringement of commercial interest as protected by Article 4(2) of Regulation No 1049/2001. In addition, the applicant has not provided precise and proper explanations in that regard.
Therefore, the fourth plea must be rejected.
In view of all the foregoing, the action must be dismissed in its entirety.
Costs
Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. In the present case, since the applicant has been unsuccessful in the main proceedings, it must be ordered to pay the EMA’s costs, in accordance with the form of order sought by the latter, including those relating to the application for interim measures.
The French Republic is to bear its own costs pursuant to Article 138(1) of the Rules of Procedure.
Novartis Europharm Ltd is to bear its own costs pursuant to Article 138(3) of the Rules of Procedure.

On those grounds,
THE GENERAL COURT (Second Chamber, Extended Composition)
hereby:

1.
Dismisses the action;

2.
Orders Pari Pharma GmbH to bear its own costs and to pay those incurred by the European Medicines Agency (EMA), including those relating to the application for interim measures;

3.
Orders the French Republic to bear its own costs;

4.
Orders Novartis Europharm Ltd to bear its own costs.

Prek
Buttigieg
Schalin
Berke
Costeira
Delivered in open court in Luxembourg on 5 February 2018.
E. Coulon
Registrar
M. Prek
President
Table of contents

Background to the dispute

Procedure and forms of order sought

Law

Preliminary considerations and the contested decision

Admissibility

Substance

The separate plea, alleging the existence of a general presumption of confidentiality of the CHMP reports drawn up in the context of the MA procedure for a medicinal product pursuant to Regulations Nos 726/2004 and 141/2000

The second plea, alleging infringement of Article 4(2) of Regulation No 1049/2001

– The first part, based on the confidential nature, for the purposes of Article 4(2) of Regulation No 1049/2001, of the CHMP reports on similarity and clinical superiority

– The second part, alleging that there is no public interest in the disclosure of the CHMP reports and relying on the fact that the EPAR is the result of a balancing of public and private interests in disclosure and confidentiality, respectively

The first plea, alleging infringement of Article 339 TFEU, Articles 7, 16 and 17 of the Charter of Fundamental Rights and Article 8 of the ECHR

The third plea in law, alleging that the EMA’s policy does not comply with Article 15 TFEU and Regulation No 1049/2001

The fourth plea, raised in the alternative, alleging that several pieces of information are confidential

Costs
(
*1
)	Language of the case: English.
(
)	Confidential data omitted.