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THE COURT OF JUSTICE OF THE EUROPEAN UNION ORDERS THE REVIEW OF AN INJUNCTION BLOCKING THE RELEASE OF CLINICAL STUDY DATA BY THE EUROPEAN MEDICINES AGENCY

Fabien Roy

Fabien Roy,

Brussels

Ciara Farrell

06 December 2013
On 28 November 2013, the Court of Justice of the European Union ("CJEU") set aside the order of the General Court of the European Union ("General Court") in the Case T‑44/13 R AbbVie v EMA, wherein AbbVie successfully sought the suspension of the operation of a decision by the European Medicines Agency ("EMA") to grant a third party access to AbbVie's clinical study reports in relation to the medicinal product Humira. The CJEU has referred the case back to the General Court for re-examination.

Background

In September 2012, requests were made by third parties to have access to AbbVie's clinical study reports, which were submitted to the EMA in 2006 and 2009 in their application for extension of the therapeutic use of Humira for the treatment of Crohn’s Disease.  This request was submitted by the third parties under Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents ("Regulation").

Despite AbbVie's opposition, the EMA granted the request for access to the documents on the grounds, inter alia, that "it was under no legal obligation to consider all of the information submitted in connection with an MA application as confidential information and that clinical information concerning the safety and efficacy of a medicinal product authorised for treatment in human beings need not be considered commercially confidential."

In response, on 29 January 2013, AbbVie brought an application for annulment of the EMA decision to grant access to these documents, and a separate order to suspend the operation of the EMA decision until the General Court had ruled on the annulment of the EMA decision.

In order to support their application, AbbVie argued that the EMA's decision infringed Article 4(2) of the Regulation which protects the commercial interests of a natural or legal person, including intellectual property, and that it infringed their fundamental right to protection of confidential information under Article 7 of the Charter of Fundamental Rights of the European Union, Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms and Article 339 Treaty on the functioning of the European Union.

On 25 April 2013, the General Court, satisfied that the order requested by AbbVie was justified, prima facie, in fact and in law and that it is urgent in order to avoid serious and irreparable harm to the applicant’s interests, granted an injunction in favour of AbbVie which prevented the EMA from releasing the documents.

Paragraph 45 of the order of the General Court stated:

"Since, following the weighing up of interests, the balance is thus in the applicants’ favour, there is a clear urgency in protecting the interest defended by them, provided that they are likely to suffer serious and irreparable harm in the event of their application for interim measures being dismissed. In that regard, the applicants maintain, in essence, that the situation which would result from disclosure of the disputed reports could not be undone."

However, the EMA appealed, to the CJEU, the order of the General Court to suspend the operation of the EMA's decision.

The ruling

On 28 November, the CJEU concluded that the General Court "erred in law" by relying on the very existence of AbbVie's fundamental rights as being sufficient to establish a risk of serious and irreparable harm to AbbVie if the documents were to be disclosed.

Paragraph 43 of the judgment states:

"that the alleged infringement of the AbbVie companies’ fundamental right to the protection of their business secrets, enshrined in Article 339 TFEU, in Article 8 of the ECHR, and in Article 7 of the Charter, and of their right to an effective remedy, enshrined in Article 6 of the ECRH and Article 47 of the Charter, was sufficient in itself to establish the risk of serious and irreparable harm in the circumstances of the present case."

The CJEU stressed that the applicants seeking interim measures, such as the suspension of the operation of the EMA decision, are required "to prove the facts forming the basis of its claim that serious and irreparable damage is likely".  In order to meet these requirements, the applicant must "show that damage is foreseeable with a sufficient degree of probability".

As a result, the CJEU set aside the previous order of the General Court suspending the operation of the EMA's decision, and referred the final judgment back to the General Court for a re-examination on this matter.

There is a concern that if the General Court overrules its previous order, thus granting access to AbbVie's documents, this could have significant commercial consequences for medicinal products manufacturers in the European Union.

On the same date, the CJEU also delivered a similar ruling in Case C-390/13 P(R) EMA v InterMune UK and Others.

Fabien Roy

Fabien Roy,

Brussels

Ciara Farrell

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