Article 4(2) of EU Regulation 1049/2001, which governs freedom of information as to documents filed with EU agencies, requires that institutions such as the European Medicines 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". Under its new guidelines, which have been in place since 2010, the agency treats the following as commercially confidential information:
- detailed information concerning the quality and manufacture of medicinal products that it authorises;
- information concerning the development of such products, including detailed information on the synthesis and manufacture of active substances;
- formulation, test procedures, validation, 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 commercially confidential in itself; thus, as a rule, the agency regards data included in clinical trial reports as data that can be disclosed. This practice has been challenged by the pharmaceutical companies that provide the agency with clinical trial data in order to secure the authorisation of a medicinal product or authorisation for a new indication of an authorised product.
On April 25 2013 the president of the General Court of the European Court of Justice granted interim measures in favour of AbbVie and InterMune against the European Medicines Agency. The interim measures prevented 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 companies' respective challenges to the agency's proposed actions had been fully examined by the court. The president considered that both companies had mounted a prima facie case that the agency's decisions to disclose such documents were in breach of:
- Article 4(2) regarding public access to European Parliament, Council and Commission documents;
- the fundamental right to the protection of information covered by business secrets and information of a confidential nature under Article 7 of the EU Charter of Fundamental Rights; and
- the obligation by EU institutions under Article 339 of the Treaty on the Functioning of the European Union not to disclose information that is 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 granting of interim measures by the court is rare, but the orders in this case recognised that if the data at issue was to be released, the substantive challenges to such action would be deprived of any real purpose.
The president observed that it was not obvious from the documents - following the necessary weighing up of interests that the court must undertake when hearing the substantive challenges - that the balance would be clearly in favour of the public interest defended by the agency. However, the president noted that there is no case law enabling an easy answer to be given to the question of whether the contested decisions, based on the agency's new disclosure policy, infringed the companies' rights on the grounds that the information at issue was confidential in nature and must therefore be protected against any disclosure. 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 brought by pharmaceutical industry associations, medical publishers and the European Ombudsman (whose recommendations in 2010 led to the agency's change in its approach to freedom of information requests under which clinical trial data , along with non-clinical information, was 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 subsequently followed by a request from a university science student in connection with the preparation of a master's thesis. Moreover, when notified of the request for its clinical data, InterMune had provided the agency with a redacted copy of the documentation, which removed information that it regarded as confidential - a constructive approach on its part which the agency appears to have disregarded. The order issued by the president allowed only this redacted version to be disclosed.
The substantive challenges to the agency's actions - which the General Court must determine in due course - take place against the backdrop of the recent controversial trend on the agency's part 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 increased transparency in relation to clinical trials, although a major concern as to these is trials that never lead to the authorisation of a medicinal product. However, where - as in the case at hand - the clinical trials at issue have led to the authorisation of a medicinal product (or of a new indication of an already authorised product), although within Europe, data disclosed for reasons of transparency cannot be relied on to undermine the regulatory data protection afforded to such products by supporting applications made by third parties seeking abridged marketing authorisations for generic or biosimilar products, this is not necessarily the case in non-EU jurisdictions. Of course, EU law cannot prevent such data, once disclosed, from being so used in non-EU jurisdictions.
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