ARLINGTON, Va. -- The European Community (EC) is tryinghard to become a player in international biotechnology. Thatwas the message nearly 40 representatives of companies,academia, and U.S. and international institutions took home lastweek from the 1993 Agricultural Biotechnology Conferencehere.
The Treaty of Maastricht, finally signed on Nov. 1, transformedthe EC into the European Union (EU), a major step towardintegrating economies, said Adriaan van der Meer, secretary ofthe High Level Biotechnology Coordination Committee of the EC.The 12-member country EU -- population 342 million -- isalready the largest trading power in the world, said van derMeer, and three new countries, Austria, Finland and Sweden,are expected to join by 1995.
"Around 2,300 companies are involved in some aspect ofbiotechnology in the Community," said van der Meer. And theregulatory environment for biotechnology is thawing, he added.
Regulation procedures work as follows: The EC initiateslegislation within the confines of the treaty, the EuropeanParliament can amend proposals, and the Council of Ministersmakes final decisions.
"The implementation of the Community Biotechnology Policy ...is largely in the hands of member states," said van der Meer.
Efforts to reduce the regulatory burden include a set ofprinciples for biotechnology regulation. Legislation must beshown to be necessary "by a thorough case-by-caseexamination of the characteristics inherent to specificbiotechnology products," said van der Meer.
Furthermore, he said, "biotechnologically derived products willonly have to go through one assessment and notificationprocedure before being placed on the market."
Under a final principle of adaptation to progress, the EC hasdeveloped simplified procedures for release of transgenicplants, which it hopes to apply before next year's plantingseason. It is also evaluating the need to reduce regulatoryprocedures for microbial release.
Nonetheless, the number of field trials in Europe has remainedstagnant since 1991, while it has increased in the U.S. toroughly double the number of European trials, said Brian Ager,director of the European trade association the Senior AdvisoryGroup on Biotechnology (SAGB). Over the next two years, SAGBmembers are planning to increase their investments in Japanand the rest of Asia by more than 100 percent, compared with40 percent in the U.S. and just over 30 percent in Europe.
One reason is that Germany's Gene Technique Law,implemented in July 1990, has created an intimidatingbureaucracy, said Hans-Christophe von Heydebrand, firstsecretary of agriculture and forestry at the Embassy ofGermany. Massive paperwork, public hearings and lengthyproceedings delay approval of research projects andinstallations, and, not surprisingly, only five field tests havebeen approved.
A reform bill is in the German Federal Parliament and "will bepassed probably this year," said von Heydebrand. However,Germany's high wages, high taxes and social benefits dampeninvestors' enthusiasm, said von Heydebrand, althoughcorporate taxes have recently been reduced.
Meanwhile, the Organization for Economic Cooperation andDevelopment, an intergovernmental organization with 24member countries that have advanced market economies, istrying to lower trade barriers through a project that wouldcoordinate regulation of moving agricultural biotechnologycrops to market.
And The Comite Europeen de Normalisation (CEN) is developingstandards for the products of biotechnology, said Ager, who ischairman of the CEN Technical Committee 233. He invitedindustry to become involved in standards development.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.