On 27 June 2018, the EMA published a short notification on its website informing readers that "The Agency is no longer in a position to process access to documents requests issued from outside the EU."
Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only "Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents."The EMA cited its reason for this change as being due to "a high volume of requests resulting in an excessive workload and in order to avoid EMA's core business tasks and performance being jeopardised by the administrative workload related to activities under Regulation (EC) 1049/2001 regarding public access to documents."
The EMA has stated on its website that it remains "committed to ensuring the widest possible access to its documents following requests from the public. It is also committed to increasing its level of openness and transparency over its decision-making processes."
The Public Access Regulation seeks to strike a balance between the desire for increased transparency of decision-making bodies and the importance of protecting specified public and private interests. Protection of certain of these interests provided under Article 4(1) of the Public Access Regulation are absolute without the need to balance against the public interest, such as protection of public security, international relations and privacy. For others, unless there is an overriding public interest in disclosure, Article 4(2) of the Public Access Regulation allows the right of access to be denied in circumstances where disclosure would undermine, for example, the commercial interests of a natural or legal person, certain specified public or private interests, court proceedings, the purpose of inspections, investigations and audits. Balancing of these competing interests has been the subject of judicial interpretation of the European Courts.
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