Case C‑178/18 P

MSD Animal Health Innovation GmbH
and
Intervet international BV

v

European Medicines Agency (EMA)

Judgment of the Court (Fourth Chamber), 22 January 2020

(Appeal — Access to documents of EU institutions, bodies, offices or agencies — Regulation (EC) No 1049/2001 — First indent of Article 4(2) — Exception relating to the protection of commercial interests — Article 4(3) — Protection of the decision-making process — Documents submitted to the European Medicines Agency in the context of a marketing authorisation application for a veterinary medicinal product — Decision to grant a third party access to the documents — General presumption of confidentiality — No obligation for an EU institution, body, office or agency to apply a general presumption of confidentiality)

1. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Strict interpretation and application — Requirement that the institution should examine the documents specifically and individually — Scope — Exclusion from the obligation — Possibility to base reasoning on general presumptions applying to certain categories of documents — Limits

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2))

   (see paragraphs 51-57)

2. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Assessment of the risk of the protected interest being undermined by one of those exceptions — Obligation on the part of the institution to rely on a general presumption of confidentiality — None

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2))

   (see paragraphs 58-64)

3. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Scope — Application to documents submitted in the context of a marketing authorisation procedure — Risk of misuse of the data — Burden of proof — Scope

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent)

   (see paragraphs 80-82, 93-96)

4. Appeal — Grounds — Inadequate or contradictory grounds — Scope of the obligation to state reasons — Reliance by the General Court on implied reasoning — Whether permissible — Conditions

   (Art. 256 (1) TFEU; Statute of the Court of Justice, Art. 58, first para.)

   (see paragraphs 115-117)

5. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of the decision-making process — Protection of documents drawn up under a procedure already closed — Scope

   (European Parliament and Council Regulation No 1049/2001, Art. 4(3), second subpara.)

   (see paragraph 127)

Résumé

The Court confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product

An objection to such access must explain the nature, purpose and scope of the data whose disclosure would undermine commercial interests

In the judgments in PTC Therapeutics International v EMA (C‑175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C‑178/18 P), delivered on 22 January 2020, the Court of Justice was required to examine, for the first time, the question of access to European Union documents submitted in the context of marketing authorisation (MA) applications. In this instance, it dismissed the appeals brought by, on the one hand, PTC Therapeutics International and, on the other, MSD Animal Health Innovation and Intervet International against the judgments of the General Court ( 1 ) dismissing their actions for annulment of the decisions ( 2 ) by which the European Medicines Agency (EMA) had granted access to documents containing information submitted in the context of the procedure relating to MA applications for medicinal products.

Both cases concern the legality of the EMA’s decisions to grant, under Regulation No 1049/2001, ( 3 ) access to a number of documents, namely toxicology reports and a clinical study report (the reports at issue), submitted by the appellants in the context of their MA applications relating to two medicinal products, one for human use (Case C‑175/18 P) and the other for veterinary use (Case C‑178/18 P). In the present case, after authorising the placing on the market of those medicinal products, the EMA decided to disclose the content of those reports to third parties, subject to some redactions. Unlike the appellants, who claimed that those reports should benefit from a presumption of confidentiality in their entirety, the EMA contended that, apart from the information that had already been redacted, those reports were not confidential.

Thus, the Court of Justice examined, as a first step, the application of a general presumption of confidentiality by an EU institution, body, office or agency which had received an application for access to documents. In that regard, it noted that, while it is open to that institution, body, office or agency to base its decisions on general presumptions which apply to certain categories of documents, in order to enable it to decide whether the disclosure of those documents would, in principle, undermine the interest protected by one or more exceptions laid down in Article 4 of Regulation No 1049/2001, it is not required to base its decision on such a general presumption. The Court of Justice has thus concluded that the application of a general presumption of confidentiality is merely an option for the institution, body, office or agency concerned and the latter always retains the possibility of carrying out a specific and individual examination of the documents in question to determine whether they are protected, in whole or in part, by one or more of the exceptions laid down in Article 4 of Regulation No 1049/2001. Consequently, the Court of Justice rejected the appellants’ plea that the reports at issue were covered by a general presumption of confidentiality, noting that the EMA was not obliged to apply such a presumption to those reports and that the EMA had carried out a specific and individual examination of those reports, which had led it to redact certain passages.

As a second step, the Court of Justice addressed the question whether the EMA’s decision to grant access to the reports at issue had undermined the appellants’ commercial interests, an exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001. Thus, the Court of Justice stated, first of all, that a person seeking application of one of the exceptions laid down in Article 4 of Regulation No 1049/2001 by an institution, body, office or agency to which that regulation applies must provide, as must the institution, body, office or agency concerned where it intends to refuse access to documents, explanations as to how access to those documents could specifically and actually undermine the interest protected by one of those exceptions. Next, the Court of Justice held that the existence of a risk of misuse of the data contained in a document to which access is sought must be established and that a mere unsubstantiated claim relating to a general risk of misuse cannot lead to those data being regarded as falling within the exception relating to the protection of commercial interests, where the person seeking the application of that exception has not adduced, prior to the institution, body, office or agency in question taking a decision in that respect, additional details, concerning the nature, purpose and scope of the data, that are capable of enabling the Courts of the European Union to understand how disclosure of those data would be likely concretely and reasonably foreseeably to undermine the commercial interests of the persons concerned thereby. Finally, the Court of Justice concluded, upholding the reasoning of the General Court, that the passages in the reports at issue which had been disclosed did not constitute information capable of falling within the exception relating to the protection of commercial interests. As regards the appellant in Case C‑175/18 P, the Court of Justice found that it had not provided the EMA, before adoption of the decision, with explanations concerning the nature, purpose and scope of the data at issue which supported the conclusion that there was a risk of misuse of the data contained in the reports at issue and had not specifically and precisely identified before the EMA which passages of the reports at issue could undermine its commercial interests if disclosed. As regards the appellants in Case C‑178/18 P, the Court of Justice noted that they had not provided such explanations before the General Court or specifically and precisely identified the passages in the reports at issue which could undermine their commercial interests in the event of disclosure.

As a third step, the Court of Justice pointed out that the General Court was entitled to rely on implicit reasoning when addressing arguments, raised by a party, that were not sufficiently clear and precise. In that regard, it stated that it was for the appellants to submit to the EMA, during the administrative procedure before that agency, explanations concerning the nature, purpose and scope of the data whose disclosure would undermine their commercial interests and that, in the absence of such explanations, the General Court was fully entitled to conclude, implicitly but necessarily, that the witness statements submitted by the appellants after the EMA adopted the decisions were not relevant for the purposes of assessing the legality of those decisions. The Court of Justice noted that the legality of such a decision relating to the disclosure of a document may be assessed only on the basis of the information available to the EMA on the date on which it adopted that decision.

As a fourth and final step, the Court of Justice analysed the exception to the right of access to documents relating to the protection of the decision-making process, as provided for in the first subparagraph of Article 4(3) of Regulation No 1049/2001. As regards the appellants’ criticism of the General Court, to the effect that disclosure of the reports at issue during the data exclusivity period would seriously undermine the decision-making process relating to potential MA applications for generic medicinal products during that period, the Court of Justice held that they relate to decision-making processes that are separate from the decision-making process concerning the MA for the medicinal products concerned, which, as was found by the General Court, was closed on the date of the request for access to the reports at issue.

( 1 ) Judgments of the General Court of 5 February 2018, PTC Therapeutics International v EMA (T‑718/15, EU:T:2018:66) and MSD Animal Health Innovation and Intervet international v EMA (T‑729/15, EU:T:2018:67).

( 2 ) Decisions of the European Medicines Agency (EMA) of 25 November 2015, EMA/722323/2015 and EMA/785809/2015.

( 3 ) 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).