BioWorld International Correspondent

BRUSSELS, Belgium - Europe's biopharmaceutical sector is growing steadily, but remains dominated by its U.S. competitors, according to a frank admission by the European Federation of Pharmaceutical Industries and Associations in its latest compendium of figures.

Federation President Arthur J. Higgins, who is also CEO of Bayer HealthCare, focused on the need for the high-tech European industry to win the trust of European authorities when he addressed a major European Union conference on pharmaceutical innovation.

"Bold initiatives are necessary on both sides if Europe is to regain its position as global leader in medicines research and development," he said. "Establishing a more balanced, predictable and innovation-friendly environment must be a priority for European regulators."

Higgins expressed confidence that the EU's upcoming public-private partnership to boost biomedical innovation in the EU, the "Innovative Medicines Initiative," would ease the situation. In his view, that will be in place by the end of this year.

"We are committed to doing more and ask you for your honest feedback on our progress so that we can continue to rebuild your trust and to establish a constructive relationship", he told senior officials from the EU's 27 member states at the meeting.

In return, the EFPIA president called for European patients to be given better access to new discoveries, for fair rewards for innovation in terms of better prices, and for stronger intellectual property protection.

His remarks come in the wake of a European Parliament debate on the innovative medicines initiative, in which the crucially influential industry and research committee argued for dilution of some of the benefits for the pharmaceutical industry.

The parliamentarian drafting the opinion on the initiative, Francoise Grosset te of France, called for research assistance to be diverted away from specific drug candidates and more tightly limited to development methodologies, and for any type of assistance to member companies of EFPIA to be explicitly excluded.

Her rationale for those and other restrictions makes for somber reading for the biopharmaceutical industry. "The productivity of pharmaceutical research and development has been declining for three decades, although financial investment has been steadily increasing," she complained.

"In 25 years, the amount of expenditure on research and development per pharmaceutical product placed on the market rose from €54 million [US$70 million] to €880 million, equivalent to an annual increase of 11.8 percent. At the same time, there has been a significant drop in the duration of new drugs' effective profitability. The average duration of the clinical development process has risen from 2.5 years in the 1960s to 6.5 years in the 1990s. As an additional problem, there has been a rise in the failure rate of various stages of the testing process for new molecules. An increasing number of compounds is having to be tested to find one which would could be placed on the market."

Grosset te favors tweaking the initiative so that it will favor smaller firms. Its projected budget would be €2 billion for 2008-2013, with half the money coming from the EU and half from EFPIA - predominantly the lobby of big pharmaceutical firms in Europe. But Grosset te is insistent that the interests of smaller firms "must not be sacrificed to those of other, bigger sections of the industry."