June 3, 2013

Catholic bishops from the European Union’s 27 member states said draft rules on clinical drug trials are too lax and urged legislators to ensure the tests are carried out only with the consent of patients.

The Brussels-based Commission of the Bishops’ Conferences of the European Community, COMECE, said in a May 17 report that the rules need tighter safeguards and must include measures that ensure that benefits learned from the trials are shared with the communities where tests were conducted.

“Clinical trials are necessary before any new medicine is put on the market; however, many people who are unable to give consent, as well as people from less-developed countries, often participate in such trials,” said the report from COMECE’s Bioethics Reflection Group.

“Respect for human dignity implies a person must not be reduced to the status of an object for research and that no act on the human body may be carried out without having first obtained the true consent, free and informed, of the person,” it said.