European bishops want tighter controls on clinical drug trials

(May 22, 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.
The report was issued in advance of the planned May 29 European Parliament vote on the proposed rules. "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 of the person," it said. Medical research has long caused controversy in some parts of the world, where Western pharmaceutical companies have faced accusations of high-handed attitudes toward people in developing countries.
On April 13, The Hindu, an Indian daily, reported that the country's clinical trials industry, estimated at $1 billion annually, faced cutbacks after a growing death rate
On May 14, Germany's Der Spiegel weekly said 50,000 hospital patients in the former communist-ruled East Germany were used as guinea pigs, often without consent, by European and U.S. drug companies in the 1980s.
The COMECE report said the EU was right to "simplify and harmonize" procedures for clinical trials in member states, but that the rules should also uphold "the value of voluntary participation" and prohibit "making the human body and its parts a source of financial gain."
COMECE represents more than 1,000 European bishops.
Source CNS: