BioWorld International Correspondent

BRUSSELS, Belgium - In a bid to shore up the credibility of its rules on biotechnology, the European Union called its member states to Brussels last week to "try to speed up progress" in bringing the 1998 EU rules on legal protection of biotechnological inventions into force.

The legislation, designed to provide increased incentives for European biotechnology research, was due to come into effect across the EU in July 2000. But still, despite repeated admonishments, only six of the 15 EU member states have conducted the necessary implementation procedures at the national level for the directive to function: Denmark, Finland, the UK, Ireland, Spain and Greece.

The crisis meeting with the member states came in the wake of EU warnings in December to the other nine member states - Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden - saying if they did not comply, they would be brought before the European Court of Justice, the EU's supreme tribunal, which is empowered to publicly condemn member states for failings in EU duties, and even to levy fines for non-compliance.

According to an EU summary of the state of play: Austria says its planned legislation was overtaken at the last minute by its December 2002 general election; Belgium is still debating a 2001 draft in parliament, which also could be killed off by the May 2003 general election; Germany's 2000 draft also fell victim to the September 2002 general election; France is still discussing a draft in its senate; the situation in Italy, Sweden and in the Netherlands, where some parliamentary discussions have taken place on draft legislation, is described as "not clear"; in Luxembourg, after parliamentary discussions on ethics, "the situation seems to be blocked." Only in Portugal is there any definitive prospect of a solution - by July 1.

The issue is not just a matter of legal principle. European Commissioner Frits Bolkestein - responsible for the EU's single market rules - said, "Unless the 1998 directive is properly implemented, Europe's biotech sector will be working with one hand tied behind its back and will fall further and further behind." He has made clear his belief that a strong industry needs sound regulation. "We need to keep a close eye on this fast-moving field and make sure the European policy framework keeps pace with technical and legal developments," Bolkestein said.

Member states allege that political and technical obstacles continue to block their implementation of the directive, which has provoked vigorous opposition from a wide coalition of forces, ranging from environmentalists and inveterate anti-industry groups to ethicists and religious groups in Europe. But Bolkestein and other senior EU officials, including Erkki Liikanen, the European commissioner responsible for industry affairs, and Research Commissioner Philippe Busquin, have repeatedly urged action by the defaulting states. "Biotechnology is the sector of growth for the coming decades," said Busquin in the run-up to the meeting. "To ensure Europe excels in biotechnology, we need a robust European system for protecting biotech inventions. This is what the directive will give us, if properly implemented by member states."

However, to resolve the delay, the latest EU plan - which was agreed to at the Jan. 28 meeting - consisted of little more than setting up further meetings with a new group of high-level experts, the EU announced. "I am confident that the expert group will help us and member states to ensure that the directive will work for research, innovation and the public interest, and not against them," Busquin said after the meeting.