Europe moves to speed up approval of new drugs

The European Commission has proposed accelerating the approval of new drugs, which could reduce by up-to-half the time it takes for new medication to reach markets and patients.

The commission, an executive arm of the European Union (EU), also said it would slightly ease the ban on advertising prescription drugs, which should allow pharmaceutical companies to market some drugs directly to patients suffering from diabetes, AIDS and asthma. “Today’s decision will help patients all around Europe to get new and better medicines than is the case today,” said Erkki Liikanen, the commissioner for enterprise. “It will also help them get better information about the medicines available to them.” The announcement met a cautious welcome from drug companies like GlaxoSmithKline, Europe’s largest drug manufacturer.

A spokesperson, Alan Chandler, said, “Any proposals that help patients get their medicines more quickly are to be welcomed.” Liikanen said a new “fast-track” approval procedure, based on that of the United States, could reduce the time for companies to win approval for drugs from 18 months to 9 to 12 months, shorter than the average 14-month approval process in the United States last year. The commission proposed that patents on drugs should be protected for a standardized 10 years in the EU before competitors may seek permission to make a generic version.