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EU introduces proposals to speed up drug approval to benefit patients and industry
By Paul Geitner, AP Writer, from https://www.individual.com/frames/story.shtml?story=h0718092.101&level3=552&date=20010719&inIssue=TRUE
7/23/01
BRUSSELS, Belgium (AP) The European Union's head office introduced proposals Wednesday aimed at halving the time it takes to get new medicines to patients and slightly easing the ban on public advertising for prescription drugs.

EU Enterprise Commissioner Erkki Liikanen said the measures, if adopted, would benefit not only patients, but Europe's pharmaceutical industry as well.

Streamlining the regulatory process, beefing up resources and introducing a U.S.-style "fast-track" procedure for breakthrough drugs should enable the EU to cut the average time it takes to authorize a new drug to nine months to a year, from the current 18 months, he said.

The average review time for new drugs in the United States last year was 14.6 months.

Liikanen also proposed a five-year pilot project to provide information on authorized drugs upon request to people with diabetes, AIDS and asthma, conceding that the Internet had made it difficult to enforce the EU ban on direct marketing to consumers.

"Today's decision will help patients all around Europe to get new and better medicines than is the case today," Liikanen said. "It will also help them to get better information about the medicines available to them."

EU officials also hope the prospect of faster market access will help stem the tide of research and development money that has been leaving Europe for the more-profitable United States.

Liikanen called the proposed reforms "a major step toward achieving a more innovative and competitive industry in Europe, which is to the benefit of everyone."

Research and development investments by drug companies have doubled in Europe over the past decade, to 17 billion euros (dlrs 14.6 billion) in 2000. But they have quintupled in the United States over the same period to 24 billion euros (dlrs 20.6 billion), according to the European Federation of Pharmaceutical Industries and Associations.

The group's director general, Brian Ager, "broadly welcomed" the Commission's proposals as striking a "reasonable balance" between public safety and faster marketing.

However, the group noted that other factors, such as price controls in EU countries that keep profit margins tighter than in the United States, contribute to shifting investment across the Atlantic.

"Although Europe still leads the world in pharmaceutical manufacturing, the U.S. has taken the lead in pharmaceutical innovation," Ager said.

The newly formed British giant GlaxoSmithKline is even considering transferring its entire operational headquarters to the United States, he noted, calling it "not surprising."

The Commission's proposals now go to the 15 member state governments and the European Parliament for consideration, a process that usually takes at least a year.