The European Medicines Agency (EMA) has tightened up its rules on clinical trials in order to counter the damaging effects of globalisation.
From 1 May 2012, clinical trials used to support EU marketing authorisation applications will require the informed consent of participants.
The trial protocol will also need to be submitted to an independent ethics committee before the trial takes place.
According to the EMA’s reflection paper, a trial will be disqualified if non-compliance “significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported”.
The EMA said these measures were necessary to address the globalisation of clinical trials: “No matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting.”
The agency said it will work to improve international co-operation on trial regulation and help regulators to gain assurance that ethical and good clinical practice standards are applied.
In recent years the pharma industry has used 178 countries for clinical trials, with China, Russia, India, Brazil, Poland and South Africa becoming key locations.
While all trials used in EU marketing authorisation applications are expected to meet the same ethical standards as trials conducted in Europe, there have been a number of alleged breaches of standards.
The case of Pfizer’s 1996 trial in Nigeria of its meningitis drug Trovan, in which 11 children died, reflects the legal complexity of such cases. Pfizer finally reached a settlement with the families involved in 2009.
This year, GSK denied claims that it failed to secure consent from the parents of children enrolled in an Argentinian study of its pneumococcal vaccine Synflorix.
Unethical overseas drug trials were the subject of a high-profile film, The Constant Gardener, based on a novel by John le Carre – who claimed that the pharma industry was guilty of worse crimes than those he had depicted.