EU Parliament, ministers agree to more clinical trial transparency in clinical trials

  

MEPs reached on Friday (20 December) an agreement with member states on the clinical trials directive.

Under the new agreement, pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database.

The deal also include that a publicly accessible EU database will be set up and run by the European Medicines Agency (EMA) which will contain a register of all trials carried out in the EU, a summary of results for all trials, uploaded one year after the end of the trial at the latest.

A summary understandable to a layperson would also have to be included from the pharmaceutical companies as well as clinical study reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn.

The pharmaceutical industry has come under fire over recent years over lack of transparency on clinical trials. Those accusations were epitomised in a book, Bad Pharma by Ben Goldacre, a research fellow of epidemiology at the London School of Hygiene and Tropical Medicine, and a co-founder of the transparency campaign All Trials.

Earlier this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) made new commitments, which include improving data sharing with researchers, enhancing public access to clinical study information, sharing results with patients who participate in clinical trials, certifying producers for sharing clinical trial information and publishing clinical trial results.

But EFPIA emphasised that full transparency would hurt the industry, which relies on protection of trade secrets to compete in Europe and across the world.

Under the agreement, member states and MEPs say that Clinical Study Reports should, in general, not be considered commercially confidential and member states can impose fines over non-compliance with the transparency requirements.

Timeline: 
  • March 2014: The overall deal to be approved by the Environment, Public Health and Food Safety (ENVI) committee, and then the whole Parliament.
Advertising

EurActors