The European Medicines Agency has put out for consultation its proposals for a new policy which would allow the public to access Agency documents on a day-to-day basis.

The aim of the draft EMEA Policy on Access to EMEA Documents relating to human-use and veterinary medicines is that the Agency “will ensure the widest possible access to EMEA documents concerning a matter relating to the policies, activities and decisions falling within the Agency’s sphere of responsibility, whilst guaranteeing compliance in particular with the protection of commercial confidentiality, personal data and commercial interests.”

The Agency cautions however, that implementing the new policy cannot be allowed to jeopardise its core task, which is to provide the best possible scientific advice to European Union member states and institutions. Therefore, it says. it will when necessary confer with the applicant requesting access to EMEA documents with a view to finding “a fair solution.”

Moreover, it says that it will release documents publicly only when the decision-making process has been concluded, as doing so beforehand would seriously undermine the process. Also, it will not publicly release any working documents. In cases where the Agency or anyone else believes there to be an overriding public interest in disclosure before a decision is reached, these will be will considered on a case-by-case basis.

The proposal also emphasises that the Agency will “redact,” or edit, documents prior to public disclosure in order to guarantee compliance in particular with the protection of commercial confidentiality, personal data and commercial interests. And, with respect to third-party documents, it will “strive as much as possible” to determine from the outset if a particular document shall be disclosed or not. This should mean that consultations to assess whether any exceptions apply should be kept to a minimum. In these cases, the prior agreement of member states, institutions (EU and non-EU) and third countries will always be needed before access can be granted, but the Agency also points out that any documents produced by member state scientific resources within the context of EMEA responsibilities will be considered EMEA, and not third-party, documents.

Public access to EMEA documents will be introduced in two phases. The first will concentrate on follow-up to written requests for access, while “pro-active” disclosure during this phase will be restricted t documents which are already available publicly on the Agency website and to any document for which access has been granted as a follow-up to a written request. The second phase will see “the gradual population” of EMEA documents as part of the Agency’s website.

This two-phase approach will not undermine EU citizens’ rights to the widest possible access to documents held by the EMEA, the Agency stresses. Rather, it says, it should be seen as the most cost-effective way, in particular from the perspective of workload and human resources, to implement the policy.

Comments on the proposals are requested by March 2, 2009.