On 1 March 2017, the Vice-President of the Court of Justice of the European Union (CJEU) dismissed two appeals by the European Medicines Agency (EMA) against interim Orders of the President of the General Court in Case C-512/16 P(R) European Medicines Agency (EMA) v MSD Animal Health Innovation GmbH and Intervet International BV (Intervet v EMA) and Case C-513/16 P(R) European Medicines Agency (EMA) v PTC Therapeutics International Ltd (PTC Therapeutics v EMA).
The effect of these Orders is to suspend the release of certain documents submitted in support of marketing authorisation (MA) applications to third parties following requests made pursuant to Regulation (EC) No 1049/2001 (Transparency Regulation) and the EMA’s 2010 policy (ie policy/0043) on access to documents until the General Court's judgments in the main proceedings. The main proceedings concern the annulment of the EMA’s decisions to grant access to the relevant documents.
The EMA published a press release shortly after the Orders on 14 March 2017 in which it stated that it would not release the relevant documents until the General Court ruled in the main proceedings. However, it would continue to process requests for access to documents concerning medicinal products in accordance with the Transparency Regulation and its 2010 policy on access to documents in the meantime.
Background
Regulation (EC) No 276/2004 concerns the authorisation and supervision of medicinal products for human and veterinary use through the centralised procedure and established the EMA. Article 73 of the Regulation states that the Transparency Regulation applies to documents held by the EMA.
However, the Regulation also provides that the EMA must adopt rules to ensure the availability to the public of regulatory, scientific or technical information relating to the authorisation or supervision of medicinal products which is not of a confidential nature.
The EMA adopted rules for the implementation of Transparency Regulation on 19 December 2006. Under these rules, the EMA could refuse access to documents where disclosure would undermine the protection of (among other things) the commercial interests of a natural or legal person, including intellectual property, unless there was an overriding public interest in the disclosure.
The EMA adopted a new policy (Policy/0043) in December 2010 to enhance the transparency of its operations. The Policy/0043 provided that documents submitted to the EMA in connection with an MA application may be disclosed from time to time when the decision-making of the concerned procedure had been finalised. It was adopted following a public consultation and took recommendations made by the European Ombudsman into account.
The document requests in the Intervet v EMA and the PTC Therapeutics v EMA were made against this background and the facts of these cases are briefly summarised below.
Intervet v EMA
Intervet held an MA for Bravecto, a veterinary medicinal product used to treat flea and tick infestations in dogs. It submitted five toxicology studies sponsored by MSD Animal Health Innovation GmbH (MSD) in its MA application to the EMA. MSD is part of the same group of companies as Intervet.
MSD was informed by the EMA in August 2015 of a request from a third party for those toxicology study reports pursuant to the Transparency Regulation and was invited to propose redactions to those documents. MSD prepared copies of the documents where certain passages were redacted on the basis of confidentiality, but maintained that the reports were legally protected in their entirety by a general presumption of confidentiality.
The EMA rejected the vast majority of the redactions on the grounds that MSD had failed to show that disclosure of the reports would undermine its economic interests, competitive position or the decision-making process, and there was therefore a general presumption in favour of disclosure.
By its decision of 25 November 2015, the EMA granted the third party access to the reports, redacting only certain passages.
PTC Therapeutics v EMA
The facts of this case are broadly similar to that of Intervet v EMA.
PTC Therapeutics sought an MA for Translarna, an orphan medicinal product for the treatment of Duchenne muscular dystrophy and the European Commission issued the company with a conditional MA for the product on 31 July 2014.
The EMA informed PTC Therapeutics on 13 October 2015 that it had received a request from a pharmaceutical company pursuant to the Transparency Regulation for access to a clinical study report that was included in the MA application dossier. The document in question set out the main clinical study conducted prior to the granting of the conditional MA.
PTC Therapeutics requested that the entire report was to be treated as confidential. However, the request was rejected by the EMA on two occasions and it granted access to the third party (subject to certain redactions made of its own initiative) by its decision of 25 November 2015.
In both cases, the claimants lodged applications to the General Court seeking the annulment of the EMA decisions. They also filed applications for interim measures suspending the EMA's respective decisions and the disclosure of the relevant documents.
During the interim proceedings, the applicants argued that the release of the requested documents would infringe their right to protect commercially confidential information contained in their respective MA applications.
The applications for interim measures were granted by orders issued by the President of the General Court on the basis of the following:
- It was not obvious that the relevant documents were not confidential when taken as a whole and that it was necessary to find that there was a prima facie case as regards the pleas alleging confidentiality and infringement of their rights under certain EU legislation.
- The balance of the interests in the cases weighed in favour of granting the interim measures sought, since public interest in transparency raised by the EMA was sufficiently satisfied, pending the ruling on the substance, by the publication of the products' summary of product characteristics (SmPCs), patient/user information leaflets and the European public assessment reports (EPARs).
- The condition as to urgency was met having regard to the harm that disclosure of the documents would cause the respective applicants.
The EMA appealed to the CJEU asking the Court to set aside the Orders of the President of the General Court's Orders and dismiss the claimants' respective applications for interim measures.
CJEU decisions
The two recent Orders of the Vice-President represent the first time that the CJEU has upheld an interim Order in relation to an EMA decision to release documents to a third party.
The CJEU’s findings in PTC Therapeutics v EMA are briefly summarised below:
- The President of the General Court did not err in law by considering that the argument advanced by PTC Therapeutics that there was a general presumption of confidentiality covering the report at issue was not manifestly unfounded. Challenging the President of the General Court’s findings on the facts would only be permissible on appeal if the evidence had been distorted, which EMA did neither establish nor allege.
- Regarding the questions whether there was a prima facie case, the Vice-President of the CJEU emphasised that the purpose of interim proceedings was to guarantee the full effectiveness of the final future decision in order to ensure that there was no lacuna in the legal protection provided by the CJEU. The President of the General Court did not err in law in the assessment in finding there was a prima facie case.
- The President of the General Court did not err in law in the finding of urgency in granting the interim order. In order to establish the existence of serious and irreparable damage, it was not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage was foreseeable with a sufficient degree of probability. The annulment of the decision at issue would not reverse the effects of disclosure of the report at issue as such disclosure would allow the third party applicant immediately to take cognisance of the report and to use it straightaway for any purpose it deemed useful.
Consequently, the President of the General Court was fully entitled to find that the applicants’ interests in obtaining suspension of the operation of the decisions at issue outweighed that of the EMA in obtaining the immediate implementation of the decisions.
The CJEU's findings in Intervet v EMA are broadly similar.
Context of the CJEU decisions
The first legal proceedings concerning the disclosure of documents relating to an MA by the EMA pursuant to the Transparency Regulation were Case T-44/13R AbbVie, Inc and AbbVie Ltd v EMA (AbbVie v EMA) and Case T-73/13R InterMune UK and others v EMA (InterMune v EMA).
In InterMune v EMA, the Vice-President of the CJEU set aside the Order of the President of the General Court to suspend the operation of the EMA's decision to grant a third party access to documents pursuant to the Transparency Regulation and referred the case back to the General Court for assessing the possibility of a partial disclosure of information.
The main findings of the CJEU were that claiming a violation of fundamental rights of the EU was not sufficient to substantiate the threat of a serious and irreparable damage as the commercial value of the information and usability for third parties (competitor) is decisive.
The extent to which the disclosure of such information causes serious and irreparable harm depends on a combination of circumstances, such as, (among other things), the professional and commercial importance of the information for the undertaking which provides it and the utility of that information for other undertakings which are liable to examine and use it subsequently.
However, the application for annulment of the EMA’s decision to disclose the information was withdrawn in March 2014 as the Parties agreed on certain redactions in the concerned documents before the disclosure. Therefore, the opportunity did not arise for the CJEU to give a final decision on the matter at the time.
The next notable case was Case T-189/14 Deza a.s. v European Chemicals Agency (ECHA), (Deza v ECHA) which concerned the ECHA's decision to allow a third party under the Transparency Regulation access to documents it held containing information submitted by an undertaking in support of its application for authorisation to use a chemical substance.
The General Court did not annul the ECHA's decision in its judgment of 13 January 2017; however, it is the first judgment in main proceedings in which the General Court has laid out the criteria under which documents filed by an applicant to an EU regulatory agency can be protected against disclosure according to the Transparency Regulation.
The judgment is yet to be published in English at the time of writing, but is available in a number of other European languages.
The General Court confirmed in Deza v ECHA the position expressed by several legal commentators that the Transparency Regulation should be interpreted in accordance with Article 39(2) and (3) on the protection of know-how and secrets of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Specifically, in order for a document not to be disclosed the information contained within 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."
This raises questions as to the EMA’s earlier position to request every single element of a document to be confidential, as otherwise only redaction of passages in the document would be possible. According to Article 39(2) TRIPS, information can be protected against disclosure even if individual components are publicly known, as long as the precise configuration and assembly of the components has been kept secret.
Therefore, according to the judgment in Deza v ECHA, it may be argued that a protection of documents is permitted even if those documents have been created by a compilation from information partially publicly accessible (e.g. published clinical trials).
Outlook
The CJEU Orders of 1 March 2017 provide further clarity regarding the grounds for obtaining interim orders against an EU regulatory authority’s decision to disclose documents to third parties under the Transparency Regulation.
It is also notable that more weight was given in these Orders to the effect of a possible ruling of the General Court to annul the EMA's decision to disclose in the absence of interim measures than in AbbVie v EMA and InterMune v EMA (ie the potential harm caused by disclosure could not be reversed).
As the CJEU’s latest decisions acknowledged the General Court’s assessments in deciding the applications for interim measures in proceedings concerning the granting of access to documents by regulatory authorities, they might lead the way to a more restrictive approach to the full disclosure of documents by EU regulatory authorities under the Transparency Regulation.
It is worth noting that a hearing took place before the General Court on 14 February 2017 in a separate case on the access to documents according to the Transparency Regulation (T 235/15 Pari Pharma GmbH v EMA). In addition, EMA published a new revised draft policy on 15 February 2017 for a 3 month public consultation.
It is expected that the outcome of the EMA's consultation on the new draft policy and the possible outcome of the main proceedings in the Deza v ECHA and Pari Pharma v EMA will further shape the criteria by which the commercially confidential nature of documents will be assessed.
