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EMA to widen public access to documents

Published on 01/12/10 at 12:10pm

The European Medicines Agency has agreed to give greater access to documents on medicines for human and veterinary use, after heavy criticism from the European Ombudsman.

The regulator’s new policy will give access to all business-related documents, unless there is a need to respect arrangements with non-EU regulators or international organisations, or to protect the privacy and integrity of a natural or legal person.

Documents submitted to the EMA as part of a marketing authorisation application, such as clinical trial reports, can now also be released, provided the decision-making process for the application in question is finalised.

In a statement the EMA said that, as a general rule, it would only release documents once a procedure concerning a medicine had been finalised, in order to protect the decision-making process itself.

Noël Wathion, head of patient health protection at the EMA, said: “Openness and transparency are enshrined as fundamental values in the Agency’s regulatory framework.

“They allow our stakeholders to understand the basis for the Agency’s scientific decision-making and provide for the basis on which patients and healthcare professionals can have confidence in our opinions and information relating to medicines.”

But unlike US regulator the FDA, most of the EMA’s decision-making has not been made public to date.

The EMA’s new policy will be implemented in two phases. The first will allow documents to be disclosed in response to written requests.

During this phase, the EMA said it would ensure that implementation of this new policy “will not conflict in any way with the ability of the Agency to perform its core functions of authorisation and supervision of medicines”.

In the second phase, the EMA will gradually fill its electronic register with documents it deems can be disclosed.

If only parts of a document can be disclosed, the EMA says it will edit the document to protect personal data and commercial confidential information, and release the non-confidential parts.

The EMA has produced general guidance on the types of documents it holds, whether they can be made available and whether they will have to be edited an can be found in the form of an ‘output table’ on the EMA’s website.

EMA transparency criticised

In May, the European Ombudsman, led by P. Nikiforos Diamandouros, investigated complaints about EU bodies, including the EMA.

In one case, the ombudsman focused on an Irish patient who in 2008 had their request for information on the adverse drug reactions for Roche’s acne medicine Roaccutane turned down by the regulator.

At the time Diamandouros called on the EMA to give access to the relevant documents, especially over such reactions seen in Roaccutane, in the name of patient safety.

In June he went further, saying the body should grant access to blocked clinical study reports and trial protocols for three anti-obesity drugs, after new safety concerns about the drugs’ link to suicidal thoughts and depression were found.

The EMA has long argued that it could not disclose such documents because of the risk to confidentiality and that the publication of such documents could result in people seeing data that was “misleading or unreliable”.

Ben Adams

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