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By Peter O'Donnell

BioWorld International Correspondent

BRUSSELS, Belgium - There is a slowdown in the volume of useful new drugs on the European market, and biotech is in part to blame, according to the leading European pharmaceutical industry association.

"The biotech revolution, while promising many new advances, has been a costly period of retooling for the industry, which has not yet translated into a mature pipeline of products," noted the European Federation of Pharmaceutical Industries and Associations (EFPIA).

"The increasing information on the genetic basis of disease and the inherent diversity of human biology means that we are discovering new disease targets which push the boundaries of our knowledge and make the development of drugs difficult and costly," EFPIA added.

The statement appears within a 1,000-page defense document that the industry has submitted to the European Union competition authorities.

The industry is fighting back against suggestions that the slowdown in new drugs is the consequence of antitrust activity by drug firms. EFPIA's principal contention is that the complexity and cost of modern research - together with excessive regulation - is to blame.

"The biotechnology revolution has been just that, a revolution," the EFPIA document said. "It has presented pharmaceutical companies with so many promising targets and opportunities for innovation that identifying the best candidates is costly and results in many blind alleys. Translating new discoveries into marketable products has taken the industry longer than expected. Breakthroughs, such as genomics, remain vital sources of innovation, but the new products are in large part still to be developed," it added.

The European competition commissioner, Neelie Kroes, has launched an inquiry into the industry's behavior because, she said, of "indications that competition in pharmaceutical markets in Europe may not be working well." Kroes said the fact that "fewer new pharmaceuticals are being brought to market, and the entry of generic pharmaceuticals sometimes seems to be delayed."

Her inquiry aims to assess whether drug companies in Europe are guilty of restrictive business practices, creating artificial barriers, or abuse of dominant position - in simple language, whether they have been conspiring to sabotage competition in Europe so they can fill the market with nothing more than overpriced and overhyped copy products. If the EU finds them guilty, fines could be levied and new tighter regulations could be imposed, which could, at worst, constrain the industry's research autonomy.

The robust EU investigation commenced with dawn raids on half a dozen pharmaceutical companies, and the EU has initiated further action against Sanofi-Aventis Group for obstructing the unannounced inspection of its premises - illegally, the EU is suggesting. But EFPIA maintained that if the output of new medicines is not keeping pace with the explosion of medical progress, "this is for reasons other than alleged anticompetitive practices."

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