The European Parliament is pushing for greater sanctions against multinational drug companies which breach ethical standards in clinical trials conducted in poor countries after The Independent last year exposed a series of violations in India.
MEPs on the Environment, Public Health and Food Safety Committee yesterday demanded an explanation from the European Medicines Agency (EMA) about allegations regarding informed consent, inadequate investigation of deaths, conflicts of interest, and the lack of compensation paid to patients in cities such as Indore and Bhopal. The EMA said it expected to see "greater difficulties" in future as more and more new players from low-income countries entered the global market.
More than 150,000 people are involved in at least 1,600 trials in India conducted on behalf of US and UK pharmaceutical giants such as GSK, Merck and AstraZeneca. The industry has swollen in India since regulations were relaxed in 2005, which, along with its vast population and cheap labour, has made it an increasingly attractive destination to Western companies trying to cut costs.
MEPs yesterday said that there was plenty of evidence that the European Clinical Trials Directive was not being implemented, which meant there were no consequences for ignoring the rules. This could endanger the lives of trial participants, and also European patients as unethical trials could lead to safety breaches, they said.
The EMA promised greater transparency in the future, making drug companies provide much more information about clinical trials conducted abroad, ethics committees, and what steps were taken to protect vulnerable participants, which will be publicly available. Dr Fergus Sweeney said much more money was needed to increase inspections abroad and increase the capacity of regulators in countries such as India.
But Dr Sweeney appeared to reject demands by some MEPs including Dr Peter Liese, a German Christian Democrat, and Labour's Linda McAvan, as well as safety campaigners, to send a clear signal to the industry by refusing market authorisation for ethical breaches.Reuse content