EMA Receives Frosty Response From Ombudsman Over Clinical Trials Access

Ombudsmen and EMA clash over access to clinical trials

A change to EMA policy over public access to clinical trial data has caused concerns for The European Ombudsman.

In a letter to the EMA, The Ombudsman pointed out that it had welcomed the EMA’s announcement in 2012 of a new policy giving the broadest possible access to the public over clinical trial data. But to contradict the 2012 announcement The EMA is planning on limiting access to clinical trial data. They plan to do this by imposing strict confidentiality requirements, as well as only allowing data to be data to be seen on screen using an interface that The EMA has provided.

The concern is that it appears this significant change by The EMA policy could undermine the fundamental right of public access to documents which has been established under EU law. The Ombudsman wrote in its letter, that EU citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse.

The European Parliament also voted in April of this year in favour of legislative proposals to make clinical trial data public. This meaning that all future results of clinical trials in Europe should eventually be made public via online access.

The Ombudsman has given a deadline of 31 May, for the EMA to explain their change of policy and how it intends to deal with requests for public access to existing clinical trials. The Ombudsman has also asked EMA to list the reasons and legal basis for the new policy change.

However, an EMA spokesman told the Out-Law.com website that this is a draft policy. Terms and conditions relating to access are not designed to restrict public access to the information, and these will include agreeing not to use the information “for commercial purposes such as making medicines.”

The fall out from this change of policy remains unclear with both sides arguing there cases. I suggest we watch this space and see what are outcomes of the the May deadline.

Alex Carson

PiR Resourcing leaders in senior life science resourcing. For more news and information, you can follow us on Twitter and LinkedIn 

Leave a Reply