BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament will start formal discussions today of another proposal for European legislation on biotechnology.

Its committee on the environment, public health and consumer policy will examine plans for a new regulation on the transboundary movement of genetically modified organisms. And according to Jonas Sjöstedt, the member of Parliament who has drafted a report on the subject for the committee, the EU proposal is not yet tough enough. He has proposed changes to give the rule more impact because the EU is "failing to grasp the opportunity to take a lead in this new and fundamentally important aspect of trade policy."

The new legislation is linked to EU efforts to implement the Cartagena Protocol on Biosafety - adopted in Montreal in January 2000 as a framework for international trade in what it terms "living modified organisms resulting from modern biotechnology" where these may have "adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health."

But the current draft text fails to adapt EU law to the demands of the Protocol "at a number of crucial points," Sjöstedt said. "As the world's largest single market, and as a community of relatively prosperous nations, the European Union is well placed to set an example to the rest of the world in the correct, precautionary and effective regulation of the products of an emerging technology," he said just days before the debate.

In particular, the draft does not make the precautionary principle sufficiently explicit, and the EU "should use its considerable influence to ensure that, as an international regulatory system for trade in genetically modified organisms is developed, measures are based, where definite and unequivocal scientific evidence is lacking, on the precautionary principle." He also highlighted the lack in some developing or transition countries of the capacity to implement the Protocol's requirements even where the will to do so exists; the gap could be usefully filled by assistance from the EU, with its "enormous wealth of scientific and administrative expertise."

In particular, one of his proposed amendments would tighten the scope of the blanket exclusion that pharmaceuticals enjoy from the legislation in the wording of the current draft. He urged that the draft provision "pharmaceuticals for human use are excluded from the scope of this regulation" be replaced with the following text: "GMOs which are pharmaceuticals for human use and which are addressed by other relevant international agreements to which the EU is party, or organizations of which it is a member, are excluded from the scope of this regulation."

In his view, this more precise definition "is particularly important, as technological advances, some of them biotechnological in nature, are blurring the distinction between pharmaceuticals and food. The reference to international agreements and organizations thus serves two purposes, avoiding the unnecessary and perhaps confusing duplication of regulation whilst at the same time referring to negotiated, consensual definitions of pharmaceuticals prevailing in international law and practice."