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orlistat (Roche’s Xenical and GlaxoSmithKline’s over-the-counter product Alli) and rimonabant (Sanofi-Aventis’ now-withdrawn Acomplia).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 maladministration.”
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.
