BRUSSELS, Belgium - Martin Bangemann, European commissioner for industry, said the European Commission (EC) and other political authorities face a major challenge in convincing the public that “opportunities of biotechnology are immense - both in economic and in social terms.“

Bangemann made his comments at a pharmaceutical industry conference in Berlin late last month, locating his remarks firmly in the context of the current widespread negative sentiment toward biotechnology in Europe.

“We have to work to change the potential into reality,“ he said. “It is important to continue the dialogue to deepen the knowledge about and the comprehension for modern biotechnology among the public. Perceptions can shift in either direction.“

Public authorities “have a very important role to play: to create a sound, stable and favorable environment for companies to innovate and work within,“ he went on.

Even if ultimate responsibility rests with industry for making known the advantages of its products, the EC can also play a role here, Bangemann said.

Regulations Must Balance Safety With Innovation

Already the EC is tracking public opinion on biotechnology through its own regular opinion surveys, he observed, and is stimulating debate and disseminating knowledge about biotechnology through conferences that bring together all shades of opinion.

The European Union (EU) regulatory environment should also strike the right balance between ensuring a high level of safety for human health and the environment and avoiding “unnecessary administrative burdens and costs for the companies,“ he suggested.

The EC, he added, “currently is reviewing and completing the regulatory framework“ to ensure this balance is right. “It is becoming clear that it is time to amend both the 'horizontal' directives“ - the two basic EU rules on contained use and deliberate release of genetically modified organisms dating from 1990.

Bangemann also listed other areas he felt were key contributions the EU could and should make to this environment:

* Research and development. A new EU research program is scheduled to start running later this year.

* Innovation. The EC is launching initiatives such as benchmarking the essential factors for innovation in biotechnology and creating a “user's guide“ on biotechnology research funding.

* Venture capital. In 1997 entrepreneurial life science companies raised more than $300 million from the London Stock Exchange, Easdaq, France's Nouveau Marché and Nasdaq.

Bangemann cited European studies that estimate the market value of products and services using modern biotechnology in Europe in 1995 at about US$40 billion, with associated employment of 300,000 to 400,000.

“This is becoming big business,“ he said. “The figures clearly show what is at stake.“

He said fast development in a highly favorable business and regulatory environment, with quickly improved consumer and manufacturer attitudes, could boost the value of products to $250 billion and employment to 3.3 million by 2005. However, “failed development“ of the biotechnology sector - caused by a hostile environment, with a significant deterioration in consumer attitudes and stringent regulatory controls - could lead to the value of products declining to $30 billion and employment dropping as low as 100,000.

Comparing the European and U.S. industries, Bangemann noted the specialist biotechnology sector in the U.S. “has reached a more advanced stage than its counterpart in Europe. The good news is that the biotech sector in Europe is currently experiencing very fast growth.

“But the challenge,“ he added, “is to transform this 'activity' into products. Despite the welcome growth in activity, the European entrepreneurial life sciences sector still has to launch a blockbuster product“ - although Bangemann noted there were “several promising products in the industrial pipeline.“

Among user industries, Europe is very competitive, he said, and European firms in the pharmaceutical and agro-food sectors are “leading firms at a global level, with considerable capabilities for innovation.“ But “it is the U.S. companies that have been prominent both in developing and marketing“ biotechnology-derived medicines.

“Our sense in the EC is that, in order to have a competitive industry in the modern biotechnology field, it is important to have both a strong specialist biotechnology sector and strong user industries, with close and fruitful cooperation between the two.“

Bangemann spoke at a conference of the European Federation of Pharmaceutical Industries and Associations. *

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