By Randall Osborne

BRUSSELS, Belgium — The developing European biotechnology industry, troubled by controversy and public skepticism about genetically modified organisms (GMOs) in crop production, might benefit from lessons learned by companies in the U.S., said Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization (BIO).

"I do not presume that the experience we've had in the United States is translatable or transposable to Europe," Feldbaum told attendees at EuropaBio '98, the second annual European Biotechnology Congress. Still, Feldbaum said, "parts of [the U.S. industry's experience] may prove helpful."

Feldbaum said BIO's business is "the controversy business. Whenever you introduce a powerful new technology into a democratic society, you're going to get discussion, debate and criticism."

The European industry has had plenty of all three, with activist groups in a particular uproar over GMOs. Feldbaum proposed that companies, rather than deliver reassurances to the public in the form of official statements, adopt a more fundamental and direct approach.

Grass-Roots Efforts Can Overcome Fear

"We work like a presidential campaign, and our candidate is something called biotechnology," he said. "We talk to mayors, governors, members of city councils. We go to small towns and talk to editors and reporters of local newspapers — really grass-roots work."

Feldbaum said the industry is "unusual, different from the automobile industry or the coal industry or the steel industry. To represent it, you need an open mind."

With that should come flexibility, and companies ought to be as transparent about their research as they can afford, he said.

"[Our major challenge for the future] is not patents, or regulatory reform," Feldbaum said. "It's our inability to speak to, or the perception that we're neglecting or disrespecting, the concerns and views of individuals in society who now, perhaps, do not share our perspective."

Later, Feldbaum said he hoped he had not seemed condescending when he offered advice to the group.

Providing clear information about the science to the public is vital, Feldbaum told BioWorld Today, but cultural differences — the same differences that make Europe so appealing to Americans — are holding the biotechnology industry back, at least to some degree. A more sedate, settled way of life brings with it a certain aversion to risk, he said.

"There isn't the entrepreneurial risk-taking among highly educated people, particularly PhDs and MBAs, that you find in the U.S.," Feldbaum said.

"The fact that a biotech executive may be involved with their second or third company is not a black mark on their record, necessarily [in the U.S.]," he said.

Thanks to the pioneer spirit in the U.S., biotechnology leaders are "welcome to try, try again, whereas in Europe and Asia that is not the case," Feldbaum said.

"The Germans and the French laughed when I told them that a number of the 36 CEO members of my board have fired other members in the course of their careers. Now, they're not only working together on my board, but they have partnerships. There's a whole different interpersonal dynamic and assumption of professional risk."

Europeans are "trying to loosen up in that regard," he added. "It'll take a generation that's grown up with a different set of examples."

The cultural devotion to procedure and tradition may hamstring companies on the regulatory front as well, Feldbaum said.

"I don't know quite what the dynamic is between the European CEOs and the regulatory agency," he conceded. "But, in the last months of [former FDA chief] David Kessler's tenure, we would just call him up and say, 'I'd like to bring in a group of 10 CEOs, because I think it would be interesting and important for you to hear their point of view.'"

The meetings took place regularly. "It was totally non-bureaucratic," Feldbaum said. "We all got in one room around a big table, drank coffee for three hours and had at it. It was enormously useful. I don't know if that's possible [in Europe]."

European Industry Accepts Need For New Approach

Whether BIO will enjoy similar access with Jane Henney, the recently confirmed FDA commissioner, is "an important question," Feldbaum said. He noted that BIO endorsed Henney "at a moment when many people, including Henney, thought her nomination was mired in controversy."

Remarking on the "mutual astonishment" between Europe and the U.S. in the way each side's biotechnology industry operates, Feldbaum he was confident Europe's industry can change by "working within its traditions and not trampling on them" — and changing only enough to advance its products while gaining public acceptance.

"The first step is recognizing the need to change," he said, and European industry leaders have acknowledged that need. *