Slow progress for EU biotech

European Commission highlights problems delivering its strategy for life sciences and biotechnology

Apr 30, 2004
Andrew Scott(as@andrewscottweb.com.uk)

The slow and partial implementation of EU legislation by some member states remains a major obstacle to the development of the EU life sciences and biotechnology sector, according to the latest progress report on the European Commission's Life Sciences and Biotechnology Strategy.

This is severely hampering the biotech industry's development, discouraging innovators and the potential investors whose finance is so desperately needed, claims the report, released earlier this month.

That feeling is echoed by the industry itself. EuropaBio, the European Association for Bioindustries, commented in a statement: “Sadly, this year's progress report is not reporting much progress.”

“We need to keep hammering on the nail of asking the European Union to keep its promises,” Johan Vanhemelrijck, EuropaBio's secretary general, told The Scientist. “One thing that is very distressing is that many of the key [EU actions] involve stimulating research... but if the research that costs a lot of time, effort, and money does not lead to an approved product due to the fact that the legislative approval process is not ready, that is the way to make companies go broke.”

One key problem is with directive 98/44/EC on the legal protection of biotechnological inventions. The commission says that the failure of eight member states to implement this directive “leaves companies engaged in innovative biotechnology research uncertain as to whether they are fully entitled to the commercial fruits of their work.” This failure to implement EU legislation has been referred to the European Court of Justice, but the wheels of the legal process are turning very slowly.

Other problems highlighted by the commission are “the slow progress in adopting a Community Patent, [and the need for] more active cooperation from all Member States... in the implementation of the new legislation governing genetically modified organisms.”

“We fear that progress will stay slow,” Christian Siebert, deputy head of unit (biotechnology) at the European Commission told The Scientist. He felt that this is just an aspect of creating a union among different national member states.

Siebert said that taking member states to court on matters such as the directive on protecting biotechnological inventions is “a matter of credibility... demonstrating to member states that we are serious about these things.” But he cannot predict when that legal process may be complete.

Johan Vanhemelrijck did, however, find some positive developments. He commended the commission's involvement in “the recent major review of pharmaceutical rules, which has given the world the first framework legislation for biosimilar medicinal products [and] the €500 million venture capital transfer from the European Investment Bank to finance innovative biotechnology.”

Looking to the future, Vanhemelrijck pointed out that the Competitiveness in Biotechnology Advisory Group, which advises on the EU's life science strategy, has called for an EU-wide stock market to improve the access of private biotech companies to finance. “This is... of crucial importance to innovative yet fragile industries,” said Vanhemelrijck.