Before a medicine can be placed on the market and given to patients, it undergoes a series of tests to ensure it is effective and sufficiently safe. The volunteers who take part in clinical trial studies put their own life at the risk of possible adverse drug reactions. They do so to contribute to scientific progress for the benefit of society.

However, for too long there was little transparency of clinical trial results. Only half of the clinical studies made got published, and trials with positive outcomes were twice as likely to be published as others. This increased the risk of uninformed treatment decisions by healthcare professionals and patients and of unnecessary duplication of studies.

BEUC was part of the push to make all clinical trial studies publicly available on the bases that doing so empowers patients and promotes better quality healthcare. We lobbied the EU institutions to include ambitious pro-transparency provisions in a new Clinical Trials Regulation and supported the European Medicines Agency’s plans on proactive disclosure of clinical trial results. Our initiatives included raising understanding about the importance of clinical trials for our health (see this factsheet) and denouncing attempts to counter legislation by the pharmaceutical industry with its initiative to voluntarily share clinical trial data as too little, too late.

In 2014, the EU adopted a Clinical Trials Regulation which said that, irrespective of the outcome of a clinical trial, summary results had to be submitted to an EU database and published within one year from its end. Moreover, clinical study reports submitted to medicines agencies across the EU by marketing authorisation applicants also need to be disclosed. These reports are very important, as they contain detailed information on the methods and results of clinical trials. The Regulation applies as of 2022.