By Lisa Seachrist

Washington Editor

WASHINGTON — The European Commission (EC) issued a three-month reprieve on a ban of sheep, cow and goat by-products, which was to go into effect on Jan. 1, forcing removal of approximately 85 percent of all medications from the shelves of pharmacies.

The ban, which was designed to limit the risk of transmitting "mad cow" and related diseases to humans from "specified risk" animal products, got bogged down in arguments between European Union member countries on methods of certifying that their animal herds were risk free. As a result, the EC requested that its veterinary committee assess whether the ban could be postponed in order to give the commission more time to iron out disputes.

The veterinary committee ratified the postponement proposal and the EC adopted the three-month delay this month.

"Basically, the discussion had fallen into a quagmire pitting one country against another," said Gillian Woollett, assistant vice president for biologics and biotechnology at the Pharmaceutical Research and Manufacturers of America (PhRMA). "Unfortunately, the delay is only likely to result in finding ourselves in the same predicament in March."

The postponed ban is an attempt by the European Union to address the potential threat of transmitting mad cow disease, or bovine spongiform encephalopathy (BSE), to humans via consumption of animal products. In Britain — where BSE is thought to have taken hold after farmers fed their animals food products containing the offal of sheep infected with scrapie — about a dozen young people developed a form of Creutzfeldt-Jakob disease that appeared to be related to BSE.

EC Failed To Consider Impact

The commission proposed a ban on specified risk materials — the 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 — in all foods, cosmetics and pharmaceuticals.

The problem for the biotechnology and pharmaceutical industries is that most companies use either magnesium stearate from tallow, gelatin from bovine bones, or hydrolyzed bovine proteins in the production of their medicines.

However, the EC had not considered the impact of denying patients medicines that contain specified risk materials. In fact, it has yet to conduct a risk benefit analysis to determine if the measures it is taking would result in protecting public health overall.

"Many believed that the EC didn't adequately address the BSE problem and, as a result, they overshot a bit," Woollett said. "Nevertheless, we must try to help them see what is the rational way forward. We think that they should abandon these measures until they have conducted a risk benefit analysis. But, to be fair, that is no easy task."

PhRMA conducted its own risk benefit analysis which took a year to complete and found that the risk of contracting BSE from taking three gelatin capsules a day is one in one billion. By comparison, the risk of getting cancer from eating a peanut butter sandwich every day for a year is one million times higher.

Woollett pointed out that to date, PhRMA has been careful not to launch a media campaign directly to patients about the potential effect of the ban in order to avoid scaring people unnecessarily. However, Woollett said the organization will move in that direction should it appear likely that the ban will take effect in April.

That may not be necessary, as the commission already has made proposals to allow medications to stay on the shelves. In early December, the commission issued a press release stating medicines on pharmacy shelves will be exempt from the ban, and products already approved would have a one-year transition period so companies can create formulations that are free of specified risk materials. In addition, the commission suggested it would exempt tallow from the ban if appropriately heat treated.

Woollett noted those provisions are good, but don't go far enough. She said the commission needed to address gelatin in addition to addressing drugs in development that have not yet been approved.

"We are just hoping that reason prevails," Woollett said.

The proposed ban has been a topic at high level trade meetings between the U.S. and the European Union where the U.S. has voiced its strong opposition to the ban. In a reportedly unrelated move, the U.S. Department of Agriculture said Dec. 14 it will restrict the imports of cattle, sheep and specified animal products from all 21 countries of the European Union until there is proof of no mad cow disease risk from them.

"For now, we have our Christmas back," Woollett said. "It remains to be seen what next year holds." *