LONDON -- When the European Parliament reconvenes today inBrussels, Belgium, several new biotechnology initiatives will beon THE lawmakers' agendas.

The European Community is expected to ratify directives thataddress the safety of workers exposed to biological agents andthe protection of intellectual property for plant breeding.Legislative staffers also are drafting new directives to regulatethe transport of genetically modified organisms, as well as themarketing of transgenic plants and animals and novel foods.

More than 20 EC directives that affect biotechnology are eitherunder consideration or are being implemented by nationalagencies within the community's 12 member nations, accordingto Louis Da Gama, the executive director of the BioIndustryAssociation, a trade group located here. "The whole of Europe isundergoing a revolution," said Da Gama. "Biotechnology justhappens to be one of the industries that will be affected."

The parliamentarians in Brussels are debating directivesgeared to the 1992 lifting of trade barriers that will allow thefree movement of people, goods and capital.

The revolution will affect the way American biotech companiesdo business in Europe. Two U.S. biotech companies, Cetus Corp.of Emeryville, Calif., and Centocor Inc. of Malvern, Pa., alreadyhave European production plants. Cetus in 1987 formed itsEuroCetus subsidiary in Amsterdam, the Netherlands, opening a50,000-square-foot manufacturing facility in 1989. In 1987,Centocor opened its own large plant in the Netherlands.

Philip W. Anderson, president of the international consultingfirm P.W. Anderson & Partners Inc. of Vienna, Va., said thatmany U.S. biotechnology companies intend to establish aEuropean presence this year. These companies intend to cash inon a vast post-1992 EC market with 320 million people.Anderson said he is talking with a dozen U.S. biotech companiesthat would like to open European operations.

Anderson said most biotech companies would like to openEuropean sales offices. But, he said, less than 15 percent ofindependent biotech companies can afford the capital requiredto build manufacturing operations there.

Last year the EC ratified two directives to regulate thecontainment and deliberate release of genetically modifiedmicroorganisms. Developers of modified organisms must provethat the environment will not be harmed. The regulations alsocall for a period of public comment.

"People are concerned with what's going to happen in 1992,"said Anderson. Added Da Gama, "It will completely change howwe do business."

-- Rachel Nowak and Carol Ezzell BioWorld Staff

(c) 1997 American Health Consultants. All rights reserved.