October 2022: EU Seeing Success in Trial Transparency, but Some Nations Holding Back – A Center Watch Article

The article “EU Seeing Success in Trial Transparency, but Some Nations Holding BackStrong progress on trial reporting in Europe – but some players still lag behind” has been published on October 03, 2022, on Center Watch.

As per the analysis conducted by TranspariMED, Health Action International, and Transparency International Global Health, there has been an 83.6 percent increase as of July 2022, in results posting for the due clinical trials since European Medicines Agency started reaching out to the sponsors.

Additionally, individual EU countries like Austria, Belgium, Denmark, Finland, Germany, and the Netherlands are actively pushing sponsors and investigators to publicly share the results of past trials, now by passing legislation to impose the below fines upon failure to report results:

  1. Belgium: €500 to €250,000
  2. Austria: €25,000 to €50,000
  3. Germany: maximum €25,000
  4. The Netherlands’: maximum €33,500

Some countries’ fines may be multiplied by applicable surcharges and even carry jail time, while others appear to be single charges. Denmark, Sweden, and Finland have not decided on the fine amount yet.

In the future, European regulatory agencies plan to use data monitoring from CTIS to catch violations. Austria, Belgium, Finland, and Germany plan to use these data alongside GCP inspections, while Denmark will supplement these data with national monitoring efforts.

There are no updates in countries like Italy, France, and Spain regarding action on the missing drug trial results.