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EMA launches consultation on clinical trials

Published on 22/01/15 at 11:27am
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The EMA is asking companies and stakeholders if the proposal meets requirements

The European Medicines Agency has invited pharma to comment on its proposals to ramp up transparency in the industry and force companies to publish the results of clinical trials.

The EU Clinical Trial Regulation was voted into law in April 2014 and states that information from clinical trials should generally not be considered commercially confidential. It will mandate pharma to release more of its clinical trial data, and comes into force in May next year.

This consultation document sets out the EMA’s proposals for how to apply the transparency rules of the regulation, “in order to achieve a correct balance that respects both, the patients’ and public’s entitlement to extensive and timely information on clinical trials, and developers’ and researchers’ need to benefit from investments”.

This, the EMA says, will “enhance the EU as a destination for innovative, cutting edge research and development of novel products and research into new and better uses of existing products”.

The regulation allows companies to protect data that is ‘commercially confidential’, and the document defines what information should be excluded in order to allow investors to ‘protect their investments’. But firms will have to publish such data if there is an overriding public interest.

“Commercially confidential information can be considered as meaning any information contained in the data or documents submitted to the database that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the sponsor,” the document says.

It continues: “Overriding public interest can be considered, in this context, as meaning that the general public interest in having information made publically available may outweigh considerations that the same information should remain confidential.”

The EMA is asking companies and other stakeholders to “comment on whether this proposal meets the requirements and objectives of the regulation”, and is seeking views on the applications of the exceptions to the regulations.

Along with commercially confident information, personal data and private communication between member states and data relating to clinical trials supervised by member states, will also be exempt. The consultation is open until 18 February.

The move toward transparency has not been uniformly popular across the industry. The European pharma lobby group EFPIA has criticised the plans, but the EMA has vowed to press ahead and “increase trust in its regulatory work as it will allow the general public to better understand the Agency’s decision-making”.

Lilian Anekwe

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