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Tough talk from Commission


All Member States must fully and swiftly implement the 1998 European Directive on the legal protection of biotechnological inventions or Europe will fall behind its competitors in this crucial sector - so the European Commission warned Member States on Friday.

In a statement, the Commission claimed that any moves to block biotechnology would damage Europe's "overall efforts to becoming the most competitive economy in the world".

Strong words that form the main conclusion of the European Commission's first report on the implementation of the Directive - itself the fruit of a hard 10-year debate on biotechnology in both the Council and the European Parliament.

The report also addresses key provisions of the Directive, such as the potential patenting of plants and animals and the patenting of elements isolated from the human body or otherwise produced, including stem cells. In order to address this controversial, and sensitive, concern, the Commission announced that it will set up a group of experts in economics, law and natural sciences to examine issues linked to biotechnology patenting and to help it prepare future annual reports.

The report is in line with the Commission's Communication of 23 January 2002 called 'Life Sciences and Biotechnology - A strategy for Europe', which aims to promote biotechnology within a flexible regulatory framework and ensure consistency across policies, sectors and biotech stakeholders.

Stakeholders in biotechnology would have been disappointed not to see a decision regarding the current European moratorium on genetically modified organisms, in place since 1998. Member States are still refusing to lift the moratorium prior to the adoption of the traceability and labelling regulations, which is unlikely before2003.

Earlier this year the Commission proposed new regulations whereby all products produced with GMOs and their derivatives must be approved by EU authorities for sale in EU markets, and be labelled as genetically-modified products. Crucially the regulations require that the "accidental" presence of GMO materials amount to less than 1 per cent of a product. Certain Member States maintain that this should be reduced to zero per cent - a further obstacle to any moves towards lifting the moratorium.

The Commission's report, announced last week, is the first in a series of annual Commission reports to the European Parliament and the Council, as required by article 16c of the Directive.

It looks at the development and implications of patent law in the field of biotechnology and genetic engineering, and elaborates on some of the controversial issues currently under discussion at international, European and national level. A heated discussion that is, arguably, set to become more vociferous in the coming months.

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