Brussels, 03/04/2014 (Agence Europe) - Clinical trials are to benefit from clearer, more standardised rules and patients will be better protected. On 2 April, the European Parliament's plenary session adopted the compromise text on the regulation on clinical trials on medicinal products for human use by 594 votes in favour, 17 against and 13 abstentions. An agreement was reached on 12 December by the Council of Ministers-EP-Commission trialogue (see EUROPE 10989).
“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 treatment and boost the number of skilled research jobs here in Europe”, said the rapporteur Glenis Willmott (S&D, UK). Thanks to cross-border clinical trials, which are promoted under the new legislation, patients suffering from rare diseases can hope for new treatments for their conditions. “By working at EU level we can reduce the huge cost and burden of conducting trials across borders”, the MEP explained.
The text provides for specific provisions for low-intervention clinical trials, clarifies the roles of ethics committees in the authorisation process and provides details on obtaining the enlightened consent of patients. (IL)