New Rules for Clinical Trials Conducted in the EU

03 Apr 2014 --- Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament on Wednesday.

The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments, e.g. for rare diseases.

"I am delighted that the overwhelming majority of MEPs backed this deal. It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe", said Glenis Willmott (S&D, UK), who steered the legislation through the European Parliament. Her report was approved by 594 votes to 17, with 13 abstentions.

"The new law will also offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct. There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases. By working at EU level we can reduce the huge cost and burden of conducting trials across borders" she added.

The legislation will streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable trials, as well as those on products for rare diseases. It simplifies reporting procedures, and empowers the European Commission to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state will have to respond to it within fixed deadlines.

In negotiations, MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.

The Commission proposal aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorisation of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.