LONDON _ Europe's leading biotechnology companies havestepped up their campaign to persuade the European Union (EU),formerly known as the European Community, to overhaul itspolicies on biotechnology to allow for rapid expansion. The appealcomes from the Senior Advisory Group on Biotechnology (SAGB),whose members (with combined sales of more than $300 million)are drawn from the ranks of Europe's leading biotech companies.The SAGB wants the EU to scrap its current approach to regulatingthe industry and to create a high-level task force for biotechnology.The group's initiative is a follow- up to the EU's white paper onGrowth, Competitiveness and Employment which highlightsbiotechnology as crucial to future European prosperity.The SAGB has no argument with the white paper's analysis, but itwants those sentiments turned into action without delay."Recognition is only the first step. We now need to take decisivefollow-up action," said Jurgen Drews, chairman of the SAGB and amember of the executive committee of Hoffman-La Roche.Brian Ager, director of the SAGB, said the white paper has got theright framework. However, it does not deal with the problemsfacing Europe's biotech industry quickly enough. For example,Ager points to the long delays in harmonizing patent legislationthroughout Europe. "It has been nearly a decade since theCommunity set out to create a common patent framework in allmember countries. Legislation is still bogged down in discussionbetween the European Commission, the Union's Brussels-basedcivil service, the European Parliament, and the Council ofMinisters, a committee of ministers from member countries."The analysis in the white paper points to U.S. dominance of theindustry. The EU illustrates this by detailing the pace of patentapplications. In 1980, the Community was in a leading position, by1990 the U.S. filed 50 percent more patents than the Community.The report also points out that in 1990, 67 percent of patents wereheld by U.S.-based companies and only 15 percent by Community-based companies .The white paper highlights several other factors that obstructEurope's biotech industry: Technology hostility and social inertiawith respect to biotechnology have been more pronounced in thecommunity in general than in the U.S. or Japan. The report calls onmember states to provide additional incentives to further improvethe investment climate for biotechnology.Specific proposals in the white paper include the recommendationthat Europe's stock exchanges make it easier for biotech companiesto gain listings. Building on its general support for science parks,the white paper advocates using these to create a Europe-widenetwork of academic institutions, research laboratories and smallcompanies. In suggesting this, the commission is highlighting amajor difference between Europe and the U.S.: It is only in recentyears that Europe has recognized the role of start-up companies inbringing forward new technologies. As a consequence, smallcompanies in Europe have a hard time raising funds and attractinggood management.The SAGB is lukewarm about the white paper's call for an advisoryscientific body for biotechnology, which would draw on thescientific expertise within and at the disposal of existing committeesat national and EU level. In a recent letter to industry ministers inthe EU, Drews said that the barriers to European biotechnologycompetitiveness are not scientific. They are political, industrial andeconomic.Special Task Force NeededInstead of a scientific committee, the SAGB calls for a SpecialEconomic and Competitiveness Task Force for Biotechnology. Thiswould draw its membership from ministries of industry andeconomic affairs in member countries, executives in the biotech-industries, representatives of financial institutions, employeerepresentatives and the commission's own BiotechnologyCoordination Committee.In a new report detailing its proposals, and a five-point action plan,the SAGB says: The task force must be charged with setting its owntargets and devising a timetable for the proposed actions and it mustbe open to appropriate consultation.The SAGB launched its initiative with two reports. "We want to putsome steam under the white paper," Ager told BioWorld Today.The next opportunity for member state action is the Corfu summit(comprised of leaders of the EU) in June.The five-point action plan includes the SAGB's long-standingcriticism of the regulatory regime in the EU which, Ager said, isbasically flawed.The EU is showing signs of responding to the growing wave ofcriticism of its regulatory regime. The white paper said that thecommunity should be open to review of its regulatory frameworkwith a view toward ensuring that advances in scientific knowledgeare constantly taken into account and that regulatory oversight isbased on potential risk. It also calls for further enhancing publicunderstanding of the technology .The action plan also calls upon the EU to lower investment barriers.Europe's cycle of investment in biotechnology is breaking down,according to the SAGB. The group urges the EU to encourage riskinvestment in biotechnology innovation, offering fiscal incentivesfor start-up companies and research, among other measures.Another point in the SAGB's action plan discusses the EU's role inthe provision of labor skills and flexibility. The SAGB wants theEU to implement a measure to cover political and financial supportfor education and training, especially post-graduate research .In its final action point, the SAGB wants the EU to take measures toprovide broad-based leadership for biotechnology competitiveness.The SAGB's idea is that the task force would set its own agendawithin these five action areas.

-- Michael Kenward Special To BioWorld Today

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