BioWorld International Correspondent

BRUSSELS, Belgium - Ministers from 25 European countries examined plans for boosting biotechnology at a meeting here Monday. The European Union Council responsible for industry and research, now expanded from its normal 15-member-state configuration to include the 10 new member states that will join the EU in one year, reviewed the new EU strategy for life sciences and biotechnology.

This is the first time that the European ministers with sectoral responsibility have discussed the subject since EU leaders endorsed the strategy at their summit meeting in March. The ministerial meeting did not reach any breakthrough decisions, but welcomed the new strategy, and held a preliminary discussion on how they can help put it into practice at national level. They resolved to return to the subject in more depth later this year.

European biotechnology executives are optimistic that after so many false dawns, a serious shift may be under way in European policy in this area.

Ministers were given an update of progress to date by Erkki Liikanen, the European commissioner in charge of industry policy. Liikanen said that although implementation of the strategy is still at an early stage, progress has been made - notably in agreeing to the EU's broad research plan for the next four years, and in further clarifying the EU's regulatory framework for genetically modified organisms. But he said "progress needs to accelerate in some crucial areas which might seriously risk impeding the long-term success of biotechnology in the EU," and which are "already giving cause for concern." He highlighted the need for more research and financial resources, the need to complete the system of intellectual property protection and the need to end the de facto EU moratorium on authorization of new GMOs. "Decisive action is now needed in a number of areas," he said.

The commissioner stressed that many of the actions proposed in the strategy are substantially within the scope of member states or private companies. He pointed to the "divergent and uncoordinated actions" among some member states that "seriously risk reducing the impact, effectiveness and coherence of the EU strategy in this field." Despite repeated endorsements by EU leaders of the merit of supportive action for biotechnology, "There has not always been the same clear signal when these statements are translated into binding rules and commitments," Liikanen said.

He also pointed out that during the past five years Europe has been very successful in creating new biotechnology companies, but many of them are now facing the need to renew their financing in a very difficult financial market. "There is no doubt that a number of biotechnology companies are going to disappear in the consolidation process," he warned, and "Europe runs the risk of losing not only a number of potentially viable companies but also a generation of researchers and its resulting intellectual property." The commission's advisers on biotechnology estimate a potential funding gap of up to $1 billion during 2003.

Later this week, a British Euro-MP is planning to raise during the European Parliament plenary session in Strasbourg, France, one of the delicate questions that still needs resolving to give a clear road to biotechnology development. He will ask the Commission to guarantee that the action plan ministers have been reviewing will take into account the ethical implications of biotechnology and genetic research "without delaying potentially beneficial technologies such as genetic testing and pharmacogenomics."

Most Countries Ignoring EU Biotech Rules

Despite many of the fine words being spoken in Europe about the need to stimulate biotechnology, 12 of the 15 countries that belong to the European Union have still not brought their national rules in line with key new EU biotechnology legislation, more than six months after the deadline expired. And in a bid to bring some consistency into the EU biotechnology framework, the EU itself is now threatening to take all 12 of them before the European Court of Justice to force compliance.

The EU legislation that is being ignored is the directive on the deliberate release of genetically modified organisms into the environment - the principal measure controlling the marketing of GMOs in Europe. The new rules were signed off at European level in 2001 by all the member states, after lengthy debate, and a deadline of Oct. 17, 2002, for national implementation was agreed on. But France, Luxembourg, Belgium, the Netherlands, Germany, Italy, Ireland, Greece, Spain, Portugal, Austria and Finland have not enacted the necessary national legislative changes to give effect to the directive.

That leaves a major continuing gap in EU biotechnology rules. The new directive is an update of earlier rules, dating back to 1990, which were already seen as obsolete in the light of advances in biotechnology over the past decade. The aim was to make EU legislation more precise, and better adapted to the real challenges of biotechnology regulation.

After months of gentle cajoling, the patience of European Environment Commissioner Margot Wallström snapped: "I urge member states to quickly bring their national legislation into line with the new agreed EU framework for regulating the release of GMOs into the environment," she said in Brussels last week. To back up her words, she has persuaded the European Commission - the EU civil service - to send legal warnings to the 12 recalcitrants. They set out definitively where the EU is being infringed on, and gave each country two months to rectify matters. If they do not, they can be summoned to the EU's court.

Commission officials say the member states' backsliding is symptomatic of a general European hesitancy over biotechnology, in the face of continuing popular anxiety and even hostility over the risks of new technology. Yet, officials point out, with conscious irony, the new rules were designed to refine EU regulation so that safety was even more precisely monitored.

The directive provides for a step-by-step approach to the release of GMOs into the environment, with stricter and more transparent procedures for product authorization. It introduces principles governing environmental risk assessment, mandatory post-market monitoring, including monitoring of possible long-term effects on the environment, and an obligation to communicate information to the public. It also limits the validity of authorizations to just 10 years (previously they were valid without any time limit) and requires obligatory consultation of the EU scientific experts and the European Parliament. "These countries have not delivered what they agreed to by adopting the new legislation," Wallström said.