By Lisa Seachrist

Washington Editor

WASHINGTON—The European Union (EU) appears to be re-evaluating its decision to ban all "specified risk materials" from medicines in Europe in an attempt to prevent mad cow disease from affecting humans, and to be assessing the impact that the planned ban would have on patients' access to drugs they need.

The European Commission (EC) asked the Pharmaceutical Research and Manufacturers of America (PhRMA) to conduct the risk benefit analysis of the ban in order to evaluate the study before the ban is set to take effect April 1.

"We have provided the commission our risk benefit analysis," said Jeff Trewhitt, media spokesperson for PhRMA. "And it is our understanding that the commission intends to conduct there own risk benefit analysis to see if the ban would adversely affect more patients than it would protect from [mad cow disease]."

The ban, which has served as the subject of a U.S.-European trade summit, was set to go into effect Jan. 1. However, the veterinary committee of the EC postponed the ban for three months while the EU member countries established how to certify that their herds weren't affected by mad cow disease or bovine spongiform encephalopathy (BSE).

The ban is an attempt by the EU to address the potential threat of transmitting 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.

In response, 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.

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

PhRMA has been particularly vocal in criticizing the EU plan for banning up to 85 percent of all medicines on the shelves of European pharmacies without conducting a risk benefit analysis to determine if the measures would result in protecting public health overall.

Trewhitt said PhRMA is pleased the EC is examining its risk benefit analysis and heartened it is considering such an analysis; however, the report is unlikely to be complete in time for the April 1 deadline.

"It is going to take some time for the commission to conduct a risk benefit analysis—it took us a year," Trewhitt said. "It is very late in the day to try to produce such an analysis before April 1. If they want their own analysis, it is safe to say they will need to postpone their deadline once again."

The PhRMA analysis found the risk of contracting BSE from taking three gelatin capsules a day is 1 in 1 billion. By comparison, the risk of getting cancer from eating a peanut butter sandwich every day for a year is 1 million times higher. *

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