BRUSSELS, Belgium - Health care and health research in the European Union may become even more regulated in the wake of a new report released in Helsinki by the EU's advisory committee on ethics in science.
The influential group, which has in the past produced crucial opinions on biotechnology patents, tissue banks, cloning and embryo research, is recommending the EU bring in specific new legislation on medical data protection. It also is calling for a European patient's charter backed by EU legislation.
Rapid growth in the use of information and communication technologies in health care has led the group to draw up a number of principles. The growth in the use of electronic data on personal health, through telemedicine, the health "smart" card, and the transmission of data via the Internet, creates the need for new safeguards, it said. They include protection of privacy, a duty of confidentiality on all holders of information, informed consent from data subjects, and patient access to his records.
The committee's new report, titled "The ethical aspects of the information society," was presented in late July in Helsinki, the capital of Finland - which holds the rotating presidency of the EU - because "Finland is at the forefront of the implementation of information and communication technologies," the group said.
Noelle Lenoir, the French lawyer who chairs the group, recently said she saw the group's role as dedramatizing sensitive ethical issues in health care and science, by providing additional information and perspective.
"It is not our role to solve problems," she said. On biotechnology, for instance, "It is not for us to say whether it is safe or unsafe. But we should make it possible for informed debate to take place, particularly in the face of growing patient and consumer power."
Lenoir said her group's involvement in the long- running debate that led up to the adoption last year of an EU regulation providing for biotechnology patents was emblematic of what ethics experts should be doing in the EU.
"Normally, patents have nothing to do with ethics, but because of this symbolically explosive link between life and money, our committee offered its opinion," which suggested it was not unethical to patent human genes. "We played a role in helping the new rule through," Lenoir said.
Now there is a need to bring greater clarity to the use of information technology, too, she said. "In prenatal diagnosis, the data belong to the woman, and not to her family, even if the data reveal an inherited genetic defect," she said.