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[e-drug] PharmaTimes - EMA widens public access to documents

E-DRUG: PharmaTimes - EMA widens public access to documents
[EMA is becoming more transparent - see news item below. This is a welcome 
development. Who is next? Copied as fair use. Thanks to Terri for spotting. WB]

EMA widens public access to documents 

World News | December 01, 2010 
by Lynne Taylor 

The European Medicines Agency (EMA) has adopted a new policy which will, it 
says, provide the public with wider access than ever before to documents in its 
possession related to medicines for human and veterinary use. 

It will, however, ensure that personal data and commercial confidential 
information remain adequately protected, the Agency adds.

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

The European Ombudsman, Nikiforos Diamandouros, has twice this year criticised 
the EMA for failing to provide EU citizens with access to documents in its 
possession. In May, he called on the Agency to reconsider its refusal to 
provide Irish citizen Liam Grant with information on suspected adverse drug 
reactions (ADRs) associated with Roche's acne treatment Accutane 
(isotretinoin). The Agency's refusal was based on its belief that EU 
transparency rules did not apply to reports of serious ADRs, but the Ombudsman 
disagreed, stating that the transparency rules apply to all documents held by 
the Agency.

Then in June, Mr Diamandouros again rapped the agency for rejecting a request 
made in 2007 by Danish researchers for clinical study reports and trial 
protocols relating to the obesity drugs orlistat (Roche's Xenical and 
GlaxoSmithKline's over-the-counter product Alli) and rimonabant 
(Sanofi-Aventis' now-withdrawn Acomplia).

The EMA had said that granting access to the data would undermine the 
commercial interests of the drugs' manufacturers. However, following his 
investigation, Mr Diamandouros concluded that as the documents did not contain 
information on the drugs' composition or any other commercially confidential 
information, their disclosure would not undermine commercial interests, and he 
described the Agency's failure to provide the documents as "an instance of 

Announcing its new policy this week, the Agency said that, as a general rule, 
it will release documents once a procedure concerning a medicine has been 
finalized in order to protect the decision-making process.

Access will be given 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," it 
says. Documents submitted to the Agency as part of a marketing authorisation 
(MA) application, such as clinical trial reports, can now also be released, 
provided the decision-making process for the application is finalised. Where 
only parts of a document contain information that cannot be disclosed, the 
Agency will redact 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 redacted, 
in the form of an output table which is available on the Agency's website.

Implementation of the policy will be in a two-step approach. The first phase 
will focus on reactive disclosure of documents in response to written requests. 
During this phase the Agency will put in place arrangements to ensure that 
implementation of the new policy will not conflict in any way with its ability 
to perform its core functions. In the second phase, the Agency will gradually 
populate the electronic register with documents held which can be disclosed, a 
process which is expected to take about five years. 


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