BioWorld International Correspondent

BRUSSELS, Belgium - Europe's business leaders made a new plea to the European Union on Tuesday for greater support for innovation, particularly in the field of biotechnology and life sciences.

Representatives of the EU business and industry organization UNICE, a powerful body that represents all business sectors, told European Research Commissioner Philippe Busquin they backed the EU's stated objective of boosting European research and technological development spending from its current 1.9 percent of gross domestic product to 3 percent by 2010. But they insisted that action was needed now to make the aspiration a reality for crucial sectors such as biotechnology.

"Research and innovation are key in fostering EU economic performance," and the EU's March Barcelona, Spain, summit got it right by setting ambitious goals with a view to turning the EU into a competitive knowledge-based economy, they said. But that meant public authorities must mobilize to improve the conditions of R&D investment for companies in the EU.

The commissioner pointed out that business could also do more. Business-funded research in the EU represents only 55 percent of total EU research funding, compared to 66 percent or more in the United States, and in the best-performing EU countries. Busquin is planning a new initiative, before this summer, to launch a process of dialogue with member states, business and academia on how to increase research spending. He will be seeking improved interactions between industry, government research and academia; public support initiatives for business R&D investment; and improved human resources, financial and fiscal conditions, as well as intellectual property systems.

Meanwhile, Busquin's own advisory panel, the European group on life sciences, just delivered a strong message to him on the need for support for the biotechnology sector. In defining its 2002 work program, it particularly targeted the interaction between new biological knowledge and culture, and alerted him to the need for an EU policy response to emerging issues such as the contribution of transgenic animals to further progress in research, and the need for science-based regulations. The group's new chairman, Victor De Lorenzo of the Spanish national biotechnology center, told Busquin that while European science in this area is second to none, "urgent changes are necessary if Europe is to turn this scientific capacity into competitive and marketable products to improve EU quality of life, foster industrial competitiveness and protect the environment."

The group is organizing a conference titled "The new biology and modern cultures" in Brussels Nov. 18-19 to reflect on human values and society, the progress of knowledge and the relations between biosciences and society.

EU Designates Three More Drugs As Orphan

The European Union has designated three more biotechnology products as orphan medicines: Bryostatin-1 from GPC Biotech of Germany, for the treatment of esophageal cancer; recombinant human alpha-1-antitrypsin from Baxter of Germany, for the treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency; and pseudomonas exotoxin (domains II/III)-interleukin-13 chimeric protein, from PPD Global of the UK, for the treatment of glioma. Those products thus become eligible for the special treatment now accorded to designated EU orphan products, in terms of additional intellectual property protection, cheaper marketing authorization evaluation and special scientific advice on development from the European Medicines Evaluation Agency.

The most recent meeting of the EU's specialist committee on orphan medicines, at the EMEA in London on Monday, gave a favorable scientific opinion on a further application for orphan status, for a treatment for cystic fibrosis. However, the meeting also provided evidence that there is nothing automatic about the granting of such designation. The committee rejected an appeal from one applicant. And over the last month, five applications for orphan product designation have been voluntarily withdrawn by their sponsors.

Meanwhile, the Netherlands has just set up its own national steering committee for orphan drugs, to stimulate their development, to improve the situation of patients with rare diseases and to strengthen the transfer of information on rare diseases. This is a parallel exercise to the EU's orphan drugs procedure, and is regarded by the EU orphan drugs committee as a valuable complement rather than as a rival.

UNICE Says New Patent System Inadequate

The European business federation, UNICE, has also warned that the EU's plan for a simplified European patent application system may fall short of expectations unless further changes are made to the proposals. The new system, a "Community patent" intended to make it easier for smaller companies to obtain pan-European protection for inventions, is already five months overdue, against the deadline set by EU leaders in 2000 for adoption of a cheap and attractive instrument.

The plan moved one step forward at a May 21 meeting of EU ministers in Brussels, when an outline political agreement was reached. But UNICE said that continuing insistence by some EU member states that all or part of the patent must be translated into all 11 EU languages will make the new system unattractive. "European inventors will never have competitive tools vis- -vis their U.S. and Japanese counterparts," it said. "Support for innovation in Europe is at stake and it is now high time for member states to assume their responsibility in this matter."