Unethical drug companies targeted in Europe

Photo / Thinstock

The European Parliament is pushing for greater sanctions against multinational drug companies which breach ethical standards in clinical trials conducted in poor countries.

Members of the European Parliament on the Environment, Public Health and Food Safety Committee yesterday demanded an explanation from the European Medicines Agency 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.

More than 150,000 people are involved in at least 1600 trials in India conducted on behalf of United States and British pharmaceutical giants such as GSK, Merck and AstraZeneca.

The drug trials industry has swollen in India since regulations were relaxed in 2005.

This, with the country's 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 agency promised greater transparency, making drug companies provide much more information about clinical trials conducted abroad, ethics committees, and what steps were taken to protect vulnerable participants.

The agency's compliance head, 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 he appeared to reject demands by some MEPs including Dr Peter Liese, a German Christian Democrat, and Linda McAvan, from Britain's Labour Party, as well as safety campaigners, to refuse market authorisation for ethical breaches.

- Independent