BRUSSELS, Belgium  Europe¿s already-difficult climate for biotechnology continues to get more complex each week. The latest two setbacks for everyone seeking a clear view ahead are a Dutch attempt to overturn the hard-won biotech patents directive (adopted just weeks ago after 10 years of debate), and a dispute in which a biotech firm received a critical review from a European Union (EU) scientific committee for one of its products, then invoked data protection legislation to prevent the EU from publishing the full findings of the committee.

The Dutch government this week went to the EU¿s supreme tribunal, the European Court of Justice, to challenge the EU directive on the legal protection of biotechnological innovations  the measure to strengthen EU patent protection for biotech products, which had finally won approval this June. The Netherlands, which was the only country to vote against the proposal when it came before EU ministers in its final stages of adoption, is basing its formal challenge on purely legal grounds. It says the measure should have been handled through a procedure that requires unanimous approval by all 15 EU member states. But the Dutch government, which has a strong environmentalist emphasis, is understood to be hostile to the measure on ethical grounds, because it comes close to conferring patents on life forms.

European environmentalists, who have consistently opposed the biotech patents directive, have seized upon this Dutch initiative with glee. Green Euro-MPs applauded the Dutch action when it was announced, and are claiming that it is the result of their lobbying. They are now trying to persuade Belgium and Italy (which were both critical of the measure during its drafting) to add their voices to the Dutch legal challenge, and are also hoping that Germany, with its newly formed Socialist-Green coalition government, will look at the measure again. If the legal action succeeds, the attempt to create a new EU biotech patent regime will yet again be stillborn. The risk is real enough to have provoked European biotech industry leaders to issue new warnings that the future of European biotech research is again at stake.

The other setback this week for EU biotech regulators arose when controversy flared over the opinion from the EU¿s Scientific Committee on Plants, an independent advisory body, that a transgenic potato application left room for doubt about safety. It was not so much the committee¿s Oct. 2 conclusion as the fact that the firm in question, Avebe, of the Netherlands, said it would sue the commission if it released details of the committee¿s evaluation of its genetically modified high-amylopectin potatoes, named Apriori and Apropos.

The committee said of the product application: ¿Insufficient risk assessment has been carried out with respect to specific genes or gene elements (some of unknown function) incorporated into the GM [genetically modified] lines under the control of bacterial promoters. This is particularly the case for the nptIII gene, which confers resistance to amikacin, a clinically important antibiotic. Without an adequate risk assessment of the potential consequences of horizontal gene transfer from the GM plants to humans, animals and the environment, the committee considers that it is not possible to fully assess the safety of the transgenic potato lines in question.¿

The committee¿s opinion is not binding, and is only part of the assessment the 1990 EU directive on deliberate release requires to be conducted on genetically modified organisms that are to be used in the world outside a contained laboratory. But it is influential, and this is understood to be the first time that any EU advisory committee of this type has given a warning like this on a biotech application.

The European Commission planned to release the committee¿s opinion in full, to satisfy public curiosity. But the firm stepped in with a threat of legal action, saying its data were covered by EU rules on data protection. This left the commission in an acutely difficult position. The commission wants to boost public confidence in biotech, to ensure a regulatory climate which favors research, so that innovative capacity stays in Europe. To boost confidence, it knows it has to provide information and be seen as providing all relevant information  ultimately so as to win public support for biotech processes and products, including foods. In this spirit the committee¿s findings should be published, the commission said. But the firm¿s objections frustrated this ambition.

It comes at a particularly sensitive time, because public concern over the safety of genetically modified food and food ingredients has led three EU member states to openly defy the EU and refuse market access to biotech products that have been duly approved. So the commission compromised on Oct. 21 and published extracts from the committee¿s opinion, preceded by an ¿important notice for readers¿ that stated: ¿The Commission regrets that at present it is unable to publish the full opinion due to claims for confidentiality by the notifier, Avebe, for reasons of data protection. In order to allow a better understanding of the extent of the evaluation carried out by the Scientific Committee on Plants in reaching its conclusion, the paragraph headings of the deleted text have been retained.¿

The truncated document lists under ¿Opinions of the Committee¿ nothing but titles: ¿molecular/genetic aspects¿ (¿transformation technique,¿ ¿vector constructs¿ and ¿transgenic constructs¿), ¿safety aspects¿ (¿potential for gene transfer,¿ ¿safety of gene products¿ and ¿substantial equivalence¿) and ¿environmental aspects¿ (¿potential for gene transfer/escape,¿ ¿treatment of volunteers¿ and ¿safety to non-target organisms¿). But no information is given on any of the findings. The consequent effect on public opinion is, therefore, likely to be anything but reassuring, as commission officials ruefully admit in private. And the overall impact of these further elements of confusion in European biotech rules will do nothing to reassure biotech firms that were hoping the European climate was on the way to improvement.

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