BioWorld International Correspondent

BRUSSELS, Belgium - European Union member states moved one step closer to a more coherent view of biotechnology Thursday, when senior diplomats reached an outline agreement on some of the sensitive issues still dividing Europe.

One of the key conclusions was that "the success of a competitive biotechnology sector in the EU demands a global and coordinated approach covering all the major domains where biotechnology is applied." This perception - reached after months of debate by the powerful EU committee of member state ambassadors that prepares ministerial meetings - is a breakthrough for EU thinking on biotechnology.

Effective decision making has been seriously hampered by the fragmented responsibilities among member states and the different European Union bodies, which have been further broken down into separate departments dealing with pharmaceutical, agricultural, industrial and health-related applications, each with environmental or ethical considerations.

Across 13 pages, the draft conclusions that ambassadors have painstakingly put together make an attempt to weave the industrial imperatives of biotechnology research into the broader political picture that the EU also has to take account of - with its emphasis on health and environmental protection and respect for ethics. As the document makes clear, if European research and development spending is to rise, it is the private sector that will have to foot most of the bill.

It tries to give some substance to the familiar proposition repeatedly endorsed by EU prime ministers and presidents at their regular meetings over the last two years, that biotechnology is an important potential contributor to EU prosperity and growth. Crucially, it gives strong support to the concept of a blueprint to stimulate EU actions that will boost the international competitiveness of the sector. And it argues for a strict timetable, with a detailed monitoring process of the effectiveness of the actions in place from 2003.

The blueprint should build in provisions for adequate training and recruitment policies, exchanges between industry and academia, stronger intellectual property protection, and more focused but more accessible research financing, according to the EU ambassadors. They also recommend much closer cooperation between EU member states in fostering biotechnology research - with active participation of industry and other interested parties. At the same time, they urge an expansion throughout 2003 of public debate, to allow anxieties about biotechnology to be aired and answered at national and European levels.

But it is in their reflections on the regulatory domain that the EU ambassadors confront the toughest difficulties. EU rules in this field are already strict, but nonetheless nearly half the 15 EU member states have been maintaining their own veto on new GMO authorizations - and particularly GM crops - for four years now. The ambassadors' suggested formula for resolving this issue is to encourage co-existence of different agricultural practices, "given the need to guarantee the viability and diversity of agriculture in Europe, and to retain choice for economic operators and for consumers."

The acid test will come when the ambassadors' draft is put before member state ministers for full political endorsement.

Parliament Backs Better Biotech Support

The European Parliament recommended Thursday that the EU should develop a more supportive environment for the biotechnology industry, with particular emphasis on the needs of Europe's 1,800 small and medium-sized life science and biotechnology companies.

Meeting in Strasbourg, France, for a plenary session of all its members, the Parliament gave a warm welcome to the report from Portuguese Euro-MP Elisa Maria Dami o, with its clear support for life sciences and biotechnology as a strategic choice for Europe (see BioWorld International, Nov. 20, 2002). The Parliament also agreed with her that it was time to end the four-year de facto moratorium on genetically modified organisms - which provoked immediate jubilation from EuropaBio, the European association of bioindustries.

"Such a move would allow the sale of new plant varieties developed through biotechnology specifically for European farmers to be offered to the market," said Simon Barber, director of EuropaBio's plant biotechnology unit.

EU Environmentalists Decry Morphogenics'

Friends of the Earth expressed alarm at late-November reports in the European press that Morphotek Inc., a U.S.-based biotechnology company, was planning to use the genes that cause colonic cancer in humans to generate new crops varieties by speeding up the evolutionary process.

"For many people in Europe, the use of human cancer genes in producing crop plants will be a step too far," Geert Ritsema, GMO campaign coordinator for Friends of the Earth Europe, said in Brussels Monday. He warned against what he called U.S. laxity in accepting "any GM development without question. The EU has a vital role in ensuring that GM technology is controlled, and rejected if unethical or high risk."

He expressed the hope that morphogenics - as this procedure is known - will not be taken on board by Europe's biotechnology companies, or waved through by the European Commission and the European Parliament. "We urge the EU to organize a public debate on morphogenetics and scrutinize this new gene technology very carefully. Only after consultation of the public and thorough scientific research a decision can be taken whether to allow morphogenetics in the EU," Ritsema said.