EU: Interim measures awarded against EMA, preventing the Agency from disclosing clinical trial data to third parties

13 May 2013

Trevor Cook

On 25 April 2013 the President of the General Court of the EU Court of Justice made an order granting interim measures in favour of AbbVie and InterMune against the European Medicines Agency which prevent the Agency from disclosing to third parties certain clinical data that these companies had filed relating to already authorised medicinal products (respectively Humira (INN adalimumab)and Esbriet (INN pirfenidone)) before the two companies' respective challenges to the Agency's proposed actions have been fully examined by the Court.

The President considered that both companies had mounted a prima facie case that the EMA's decisions to disclose such documents were in breach of Article 4(2) of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents, of the fundamental right to the protection of information covered by business secrets and being of a confidential nature under Article 7 of the EU Charter of Fundamental Rights, and of the obligation on the part of EU institutions under Article 339 of the Treaty on the Functioning of the EU not to disclose information of the kind covered by the obligation of professional secrecy.

Given the prima facie case, and the fact that premature disclosure would do irreparable harm to the companies if their substantive challenge proved to be well founded, the President regarded the requirement of urgency to be met and ordered the interim measures that the companies had sought. The grant of interim measures by the Court is rare but the orders in this case recognise that if the data in issue were to be released the substantive challenges to such action would be deprived of any real purpose.

Article 4(2) of Regulation (EC) No 1049/2001 requires that institutions such as the Agency refuse access to a document where disclosure would "undermine the commercial interests of a natural or legal person, including intellectual property … unless there is an overriding public interest in disclosure" The Agency's new guidelines, which have been in place since 2010, treat the following as commercially confidential information: detailed information concerning the quality and manufacturing of the medicinal products; information concerning the development of the product, including detailed information on the synthesis and manufacturing of the active substance; formulation, test procedures, validation, as well as manufacturers and suppliers of the active substance and excipients; and detailed descriptions of the manufacturing and control processes for the finished product. In contrast, information encompassing clinical and non-clinical development of a medicinal product is not regarded as per se commercially confidential, and thus as a rule the Agency regard data included in clinical trial reports as data that can be disclosed.

However, the President observed that it was not obvious from the documents before him that, following the necessary weighing up of interests that the Court would have to undertake when hearing the substantive challenges, the balance would clearly be in favour of the public interest defended by the Agency. He noted however that there is no case-law enabling an answer to be given easily to the question which the Court will have to determine, which is whether the contested decisions, based on the Agency’s new disclosure policy, infringes the companies' rights on the ground that the information at issue is confidential in nature and must therefore be protected against any disclosure, and this involved "a question of principle affecting the functioning of the pharmaceuticals and biotechnology sector in Europe and worldwide." The wider significance of the substantive challenge is reflected in the applications to intervene in the cases that have been made by pharmaceutical industry associations, medical publishers and the European Ombudsman (whose recommendations in 2010 had led to the Agency's change in approach to freedom of information requests under which clinical trial data such as that in issue here was, along with non-clinical information, to be disclosed).

In both cases the clinical trial data that the Agency proposed disclosing had initially been sought by commercial competitors, although in the AbbVie case this was then followed by a request by a university science student in connection with the preparation of a master’s thesis. Moreover, InterMune had when notified of the request for its clinical data provided the Agency with a copy of the documentation sought which it had redacted to remove information that it regarded as confidential, a constructive approach on the part of the company which the Agency appears to have disregarded, and the order made by the President allows this redacted version only to be disclosed.

The substantive challenges to the Agency's actions as to which the General Court will now in due course have to determine take place against a background of a controversial trend on the part of the Agency in recent years to grant under freedom of information legislation an increasing amount of access to the data that is filed with it. This is not just a question of the trend towards increasing transparency in relation to clinical trials, although a majorconcern with these is, unlike these cases, those trials which never lead to the authorisation of a medicinal product. But where, as here, the clinical trials in issue have led to the authorisation of a medicinal product (or an authorisation for a new indication of an already authorised product) even though, within Europe, data as to these disclosed for reasons of transparency cannot be relied on to undermine the regulatory data protection afforded such products by supporting applications by third parties seeking abridged marketing authorisations for generic or biosimilar products, there can of course be nothing under European law which could prevent such data, once disclosed, from being so used in non-European jurisdictions.