By Lisa Seachrist
WASHINGTON — The Council of Agricultural Ministers of the European Union unanimously decided to postpone until Jan. 1, 1999, implementation of a ban on certain animal parts in foods, cosmetics and drugs as a means to prevent mad cow disease from causing a new variant form of Creutzfeldt-Jakob disease in humans.
The move comes after the European Commission recommended the ban on specified risk materials — brains, spinal cords and eyes from cows, sheep and goats over one year of age as well as the spleen from sheep and goats of any age should either be withdrawn or adopted.
The ban has engendered controversy within the European Union and threatened to cause a trade dispute with the U.S. because many pharmaceuticals exported to Europe contain material on the prohibited list.
"This essentially brings us back to where we were last July," said Jeff Trewhitt, media spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA). "We will continue to work in the U.S. and Brussels to prevent this decision from going into effect."
The ban on the books was adopted July 30, 1997, and as written could eliminate up to 85 percent of all medicines on the shelves of European pharmacies. The ban originally was set to go into effect on January 1, 1998, but was postponed for three months in late December 1997 in an attempt to provide adequate time to amend the proposal so that it would be acceptable to all European Union member states and to resolve the pharmaceutical issues.
This most recent postponement allows the European Union more time to correct flaws within the ban. In voting for the ban, the agricultural ministers asked the European Commission to come up with a new proposal that would answer external trade problems as well as be acceptable to the member states.
PhRMA has criticized the endeavor as "unscientific," noting that the European authorities have failed to evaluate the risks and benefits of their proposal as it pertains to pharmaceuticals. PhRMA has conducted its own analysis, finding that the risk of contracting a new variant of Creutzfeldt-Jakob disease from consuming three gelatin capsules a day for a year is one in 100 billion.
"This time, they will have time to conduct a risk-benefit analysis if they choose to do so," Trewhitt said.
A European Union spokesperson told BioWorld Today it is unclear how the European Commission will proceed, but many officials have questioned the risks of losing medicines in the process of implementing the ban. *