Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

sections

Clinical trials

Concerns remain over EMA proposals on access to clinical trial data

emily-o'reilly-2014

The European Medicines Agency (EMA) has altered its draft policy on access to clinical trial data after the European Ombudsman complained that recent changes had made the policy too restrictive.

The agency had proposed that researchers and the wider public should have access to an “on-screen only” version of clinical trial data, preventing the printing, distribution or circulation of the information. 

But Emily O’Reilly, the ombudsman, wrote to the EMA’s director, Guido Rasi, saying the restrictions on data undermine a “fundamental right of public access to documents established by European Union law”.

The EMA has now indicated that it intends to make changes to its draft policy to allow the possibility of downloading documents for academic and non-commercial research purposes.

However, O’Reilly is still concerned that the EMA has imposed broad legal conditions on the access to and use of data and that it will allow only limited access to clinical trial data by redacting significant information. In a statement, she says: “The Ombudsman remains puzzled as to why EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry’s wishes.”

The European Association of Hospital Pharmacists has also written to the EMA board expressing concerns about the proposals. Its president Roberto Frontini said: “Transparency is needed for the purposes of scrutiny.

“We hope the agency will listen to what the European Ombudsman and stakeholders are saying: the transparency policy should go further.”

Ben Goldacre, physician, scientist and author of Bad Science and Bad Pharma, has also joined the debate. In a guest post on the USvsth3M blog he urged users to complain to Paola Testori, head of the European Commission’s directorate for health and consumers, which oversees the EMA.

He described the EMA’s proposals as an “affront to evidence-based medicine” which puts lives at risk. “They fly in the face of changes to EU legislation … exposing the regulator to justified mockery.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065541

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Emily O’Reilly

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.