European biotechnology companies will invest more money infacilities in the U.S. than in Europe over the next two to fiveyears.
During this period, the European biotechnology industry isexpected to invest $450 million in American facilities,compared with about $400 million on the Continent, accordingto figures from the Senior Advisory Group on Biotechnology,the European trade association, which has 85 membercompanies.
During the previous decade, European companies spent $1billion in the U.S., creating 5,600 jobs, while in Europe theyspent $1.2 billion, Leonard Guarraia, director of policy analysisfor the Monsanto Company, told BioWorld.
This was the big news at BioEurope '93, an internationalconference held in Brussels, Belgium, last week and attendedby the U.S. Biotechnology Industry Organization (BIO) and theindustry trade associations of Canada, Europe and Japan.
The main subject of the conference was regulations, and itwas obvious to all that the U.S. has by far the superiorregulatory system. "In many ways, it is perceived to be a moredifficult regulatory system to satisfy," Guarraia said. "But itis predictable and it is science-based."
As a result, "the U.S. continues to be substantially ahead ofEurope in the development of biotechnology, both inagricultural products and pharmaceuticals, and it is likely toremain so if the Europeans keep insisting on -- from our pointof view -- the wrong regulation," Richard Godown, senior vicepresident of the Industrial Biotechnology Association (IBA),told BioWorld following his return from Brussels.
"Doing business in Europe is a full-time job, just in theregulatory arena," said Guarraia. When it comes to food,chemicals, and related products, "you not only have to get theEuropean Community's permission, but each country'spermission as well."
In what Guarraia described as a highly political andunpredictable system, the government makes a judgment onwhether the product is needed rather than letting the marketdecide. Worse, the European countries look askance at anythingthat might eliminate jobs by improving either productivity orproduction, particularly in agriculture.
"We were talking about three years ago with a major politicalleader about BST (bovine somatotropin)," Guarraia toldBioWorld, "and we said, 'It sounds as if you would not approvethe milking machine today.' And he said he would not, becausethat would keep more people employed."
Representatives of the European biotechnology industryunderstand the problem all too well. Martin Bangerman, vicepresident of the European Commission, stated that "Europe hadto become competitive because it could not afford to throwaway jobs," Guarraia said. But "there are some in thecommission who do not want to do anything to disturb thestatus quo, especially in agricultural policy."
Certainly in the short run, the European situation offersopportunities in the U.S. "It will create potentials for alliancesbetween academia and industry, and will create a much greaterU.S. presence around the world of the products ofbiotechnology," said Guarraia.
However, "the Europeans will inevitably wake up and changetheir regulations in order to staunch the flow of capital," saidGodown.
During the conference, Len Condon, deputy U.S. traderepresentative for agricultural affairs in the U.S. TradeRepresentative's Office, said that a solution to the GATT(General Agreement on Trade and Tariffs) Treaty would benecessary to resolve the European problem.
Meanwhile, the Clinton administration sent signals ofencouragement to the U.S. industry. Greg Simon, Vice PresidentGore's senior adviser on domestic policy, endorsed the FederalGovernment's Coordinated Framework for the Regulation ofBiotechnology, which specifies that there shall be no prejudicewithin regulations against the process of biotechnology.
And Terry Medley, head of the Animal and Plant HealthInspection System of the U.S. Department of Agriculture, saidthat hundreds of large-scale field tests of geneticallymodified plants had taken place each year "with no untowardeffects, no unanticipated products," Guarraia told BioWorld.
-- David C. Holzman Washington Editor
(c) 1997 American Health Consultants. All rights reserved.