Studies have shown that around half of all clinical trials are never published, and negative results are less likely to be reported than positive results.
“The current situation is unacceptable,” said Labour MEP Glenis Willmott, who is steering the legislation through the European Parliament. “It can lead to unnecessary or dangerous trials being repeated, and can give a biased picture of the safety and efficacy of the medicines we are prescribed.”
The draft legislation negotiated between Glenis Willmott and EU governments includes the creation of a publicly accessible clinical trials database. All trials in the EU must be registered on the database, a summary of results must be uploaded one year after the end of the trial, and the full Clinical Study Reports must be uploaded if a medicine is submitted for marketing authorisation.
“Finally patients, doctors and researchers will have access to the results of all clinical trials; positive, negative and inconclusive. That’s good for patient safety, good for scientific progress and good for public trust in medicines.”
Under the deal EU Member States must impose fines on companies and researchers that do not fulfil these transparency requirements. “We have seen from the US, where financial penalties are not enforced, that transparency rules are often disregarded. We do not want the same situation here in Europe,” said Glenis Willmott.
The vote comes at a crucial time in the transparency debate, with the European Medicines Agency currently fighting a legal battle against pharmaceutical companies who object to their data being published.
“The new law will support the European Medicines Agency’s transparency policy, and help ensure that data from old trials is also published.”
“I hope all MEPs will support this huge step forward tomorrow, which will set the global gold standard in clinical trial transparency.”