BRUSSELS, Belgium ¿ ¿The time has come for Europe to be competitive in biotechnology,¿ according to Ernesto Bertarelli, chairman of the biopharmaceutical group of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

But ¿the upcoming biopharmaceutical industry needs clear signals if it is to be able to exploit its opportunities,¿ added Bertarelli, chief executive officer of Serono International, which describes itself as Europe¿s leading biotechnology firm. He called for removal of existing barriers for research, development and registration, and for elimination of new impediments so that Europe¿s biotechnology firms and scientists are not left behind.

There is fast growth in the European biotechnology sector, said Bertarelli. But, he said, while in the United States innovation in the health care sector is consistently fostered and rewarded, Europe does no more than ¿pay lip service¿ to the need for innovation. Bertarelli was speaking in Geneva last week during the annual meeting of the EFPIA.

He warned that government regulation of biotechnology must take into account developments in science and technology and must be careful not to overregulate the biopharmaceutical industry in such a way as to hamper its future growth. Bertarelli said European patients often have to wait as much as a year longer than those in the U.S. for new drugs, and added that approval for reimbursement by European health care programs takes even longer.

What Bertarelli and his European biotechnology CEO colleagues want is top priority for fast-track access for patients to new, innovative drugs. ¿Europe has to create an atmosphere conducive to competition, favorable market conditions and an attractive climate for investments in start-ups and new technologies,¿ he said.

The EFPIA biopharmaceutical group has grown to 30 members since it was set up a year ago. It says that it has been able to influence European policy already, with an input to the EU¿s new orphan drug regulation, the upcoming revision of the EU¿s rules on marketing authorization, and the statements of support for biotechnology by EU leaders meeting at their summit in Stockholm last March. Bertarelli said the group now plans to push for a fast-track review procedure in the EU, an early conditional release for innovative drugs and improved compassionate use procedures.

Erik Tambuyzer of Genzyme, who is an EFPIA board member as well as being chairman of the broad European biotechnology association, EuropaBio, said ¿the momentum is building in the European Union¿s institutions ¿ the Commission, the Council, the Parliament ¿ on making European biotechnology competitive.¿ And Elliot Goldstein, vice president of British Biotech, said he saw the new grouping of European biopharmaceutical companies as ¿a catalyst,¿ which, he insisted, was needed in Europe because ¿Europe is so damned slow.¿

Meanwhile, Jean-Frangois Dehecq, EFPIA president and CEO of one of France¿s major pharmaceutical firms, Sanofi-Synthilabo, noted during the EFPIA meeting that the European industry has significant strengths: 540,000 direct employees, 85,000 researchers, 2 million indirect jobs generated, EUR17 billion (US$16 billion) a year invested in research, and a trade surplus of EUR18 billion ¿ or EUR26 billion if Switzerland is included.

But the pharmaceutical industry complains that it is the victim of political indifference or neglect, saying EU rules leave it exposed to factors that could undermine its strengths. The pharmaceutical industry sales growth in the EU is heavily trailing that in the U.S. (an average of 10 percent a year since 1990, compared to 15 percent in the U.S.); Europe¿s share of the EUR392 billion world pharmaceutical market has fallen from 32 percent to 22 percent since 1990 (while the U.S. share has grown from 31 percent to 43 percent); and although European research investment has doubled over the last 10 years, this must be compared with the U.S. increase of nearly 500 percent over the same period.

What the European industry says it still wants is better European support for research, faster marketing authorization procedures, a level business playing field across the member states, and, above all, an end to what it calls Europe¿s ¿patchwork of pricing and reimbursement regulations.¿ By way of example, Bertarelli said the UK is resorting to unjustifiable pretexts to postpone making new biotechnology-based treatments for multiple sclerosis available to patients.

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