BioWorld International Correspondent
BRUSSELS, Belgium - The European biotechnology industry dismissed on April 23 the European Union's latest efforts to boost innovative companies.
The EU claimed in an official report released earlier the same day that it was giving "a new impetus for European biotechnology," and "bringing coherence to EU biotechnology policies." It boasted that "progress has been made" on a European strategy for life sciences and biotechnology. But Feike Sijbesma, chairman of EuropaBio, the European association for bioindustries, said the "progress report is not reporting much progress."
The EU said there has been real action among "biotechnology sector players, as well as the public and business stakeholders." The report said highlights for the last 12 months were "the launch of a high-level advisory group on Competitiveness in Biotechnology,' the completion of an EU regulatory framework for genetically modified organisms and initiatives to boost research and increase the number of scientists in the biotech sector."
EuropaBio took a harsher view of progress in the two years since EU leaders adopted it. Its chairman pointed out that seven of the EU's 15 member states still have not put the EU's 1998 rules on biotech patents into force, and eight of them have not implemented the 2001 rules on GMOs. The EU merely is "repeating, yet again, that member states have to implement rules they agreed a long time ago," Sijbesma complained. He accused the EU also of failing to attract smaller biotech firms to take part in its medium-term research program, and underlined that there is "no progress" on the planned Community Patent, which was intended to make it easier for smaller firms to get protection for intellectual property, but which remains deadlocked at the ministerial level.
Johan Vanhemelrijck, EuropaBio's new secretary general, also took a tough line in his first public pronouncement.
"EU member states need to give more support" to efforts to develop a genuinely helpful European framework for the industry, he said. He insisted that "Europe needs real progress in the field of the Community Patent, the moratorium [a de facto blockade by EU ministers, which has kept new biotech products off the EU market for five years], the patents directive and the fostering of young enterprises." An EU-wide stock market to improve the access of private biotech companies to finance is "of crucial importance to innovative, yet fragile industries, and policymakers need to have the courage to tackle it urgently," he added.
Even the EU report acknowledged that the picture is less than perfect.
"Decision-makers in both government and the private sector have to play a more active role in its implementation," it said. "Disappointments included member states' lack of agreement on a Community Patent and the ongoing failure of many member states to implement agreed legislation to clarify intellectual property rights concerning biotechnology inventions." And while the financial situation for smaller biotech firms "is less critical than previously feared," it "still needs to be carefully watched for signs of improvement."
EU Ready To Back One Monsanto Maize, But Not Two
Monsanto Co.'s MON 863 maize, genetically modified to confer protection against certain insects, is as safe as conventional maize, said European Union food safety experts.
A scientific panel on genetically modified organisms said April 19 that placing MON 863 on the market - for import, processing and food or feed use - is unlikely to have an adverse effect on human or animal health, or the environment.
MON 863 maize is genetically modified to provide protection against certain coleopteran pests, principally corn rootworm.
But for another Monsanto application, for a hybrid maize - MON 863xMON 810 - experts could not agree on a position, because of anxieties among some members over safety data. The EU's food safety authority now will request an additional study and then refer the issue back to the GMO expert panel.
The hybrid maize was produced by a conventional cross between inbred maize lines in order to combine the rootworm-resistant trait with the trait present in MON 810 protecting against lepidopteran pests. MON 810 maize and derived food and food ingredients previously have been approved for the EU market.
Scientific assessments of the products already have been carried out by German authorities, but review by other EU member states led to further questions, so the food safety authority was asked to carry out further risk assessment and provide a scientific opinion on both products.