Out-Law News | 04 Apr 2014 | 4:55 pm | 2 min. read
The Clinical Trials Regulation would also facilitate cross-border cooperation across the EU in an effort to make clinical trials larger, more viable and more reliable, with the aim, ultimately, to develop more targeted treatments for diseases.
According to EU health commissioner Tonio Borg, the proposals could save researchers €800 million annually in regulatory costs. Measures that the MEPs backed include a ‘one-stop’ portal and database for submitting applications, a quick and flexible assessment procedure, a simplified reporting system and clearer and simpler rules for running multinational trials, said Borg.
"Taken together, the new measures should save researchers conducting clinical trials in the EU €800 million per year in regulatory costs – removing the most significant barrier to keeping clinical research within EU borders," Borg said. "I am convinced that the new rules will ensure a big boost for research & development in the EU for the benefit of patients, and contribute to the Europe 2020 objectives of smart, sustainable growth."
The proposed Clinical Trials Regulation aims to remedy what the Commission has described as the "shortcomings" of the existing Clinical Trials Directive, by setting up a uniform framework for the authorisation of clinical trials by all the EU member states.
According to the Parliament, the measures would require member states to respond within a fixed deadline to applications from clinical trial sponsors. Detailed summaries of trials would have to be published in a publicly-accessible EU database, including full clinical study reports. These reports would be published after a decision by regulators on whether to give marketing authorisation for new drugs had been undertaken, or after any marketing authorisation application had been withdrawn. Trials sponsors who fail to comply with these requirements could be fined, under the proposals.
"Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations," said a Parliament statement. The statement did not give further details of what kind of checks the Commission would be empowered to carry out.
MEP Glenis Willmott, rapporteur to the European Parliament on the proposals, said: "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."
"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," Willmott said. "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."
Esteban Herrero-Martinez, head of regulatory affairs at the Association of the British Pharmaceutical Industry, said the organisation welcomed the outcome of the European Parliament vote, but said that the "successful implementation" of the new law "depends on appropriate member state engagement and the development of the relevant IT infrastructure by the European Medicines Agency, including a European clinical trial database".