BioWorld International Correspondent

BRUSSELS, Belgium - Just before the summer recess in the European Union, the Economic and Social Committee has come out with an endorsement of EU moves to tighten rules on the transboundary movement of genetically modified organisms. The Economic and Social Committee, one of the EU institutions that has to be consulted on all new EU legislation, says the aim of the new rules is right, and the approach taken is correct - but it does urge more EU action on imposing penalties for non-compliance.

The EU proposal, which arises from the Cartagena Protocol on Biosafety, aims to set up a common system of notification and information on exports of GMOs from the EU to non-EU countries, to allow an adequate level of protection in the field of safe transfer, handling and use of GMOs. It will cover not only export but also unintentional transboundary movement of all GMOs that may have adverse effects on the conservation and sustainable use of biological diversity, or constitute risks to human health. However, it will not apply to pharmaceuticals for human use or any GMOs intended for deliberate release into the environment that are identified under the Cartagena Protocol as being unlikely to have adverse effects.

Before the first transboundary movement of any GMO intended for deliberate release into the environment, the exporter must provide notification to the national authorities, and ensure that the operator receiving the product is informed that it contains or consists of GMOs and is given the relevant identifying codes. And when any unintentional transboundary movement of GMOs occurs, the exporting member state has to inform the public, the European Commission, other EU countries and any affected or potentially affected other countries, as well as relevant international organizations.

The Economic and Social Committee said in its just-delivered opinion that the proposal is welcome "because it represents a further step toward clarifying the legislation governing GMOs." It particularly favors the plan for strict application of the precautionary principle - the concept of erring on the side of safety - that is featured in the Cartagena Protocol itself, and which is now one of the underlying principles of international environmental agreements. That is a valuable emphasis "in such a controversial sphere as the deliberate or unintentional release of GMOs," the committee said. But the committee would like the EU proposal to go further to ensure compliance. It said it wanted to see some harmonization across the EU of the definition of infringements and of the level of penalties imposed for breaches of the law.

Further Progress On EU Orphan Drugs

The European Union's strategy to boost the development of treatments for rare diseases - and particularly the development of biotechnology-derived medicines - continues to show results. The senior scientific committee of the European Agency for the Evaluation of Medicinal Products, the committee for proprietary medicinal products, recommended at its meeting July 25 that marketing authorizations be granted to two more orphan drugs. It issued positive opinions for Somavert (pegvisomant) from Pharmacia Enterprises for the treatment of acromegaly and for Zavesca (miglustat) from Oxford GlycoSciences plc for mild to moderate Type 1 Gaucher's disease. Both drugs were officially designated as "orphans" since the new system came into operation in 2000, and they constitute the sixth and seventh orphans to receive a positive opinion for marketing authorization from the CPMP.

Meanwhile, at the mid-July meeting of the EU's Committee for Orphan Medicinal Products - which is responsible for recommending products to be designated as orphans so they can benefit from the incentives offered under the EU scheme - four further positive opinions were issued, for products for paroxysmal nocturnal haemoglobinuria, hepatocellular carcinoma, non-ketotic hyperglycinaemia and adrenal cortical carcinoma. Overall, of the 191 applications made since the scheme started, 114 such designations have been recommended in total so far (of which 105 have been formally granted by the European Union). Two applications have been turned down by the committee, and 54 applications were withdrawn. There are currently another 47 applications expected to be made shortly.

Environmental Organizations Judge EU On GMOs

On genetically modified organisms, the European Commission has produced some good legislation, concluded leading European environmentalist groups, in a review of how well the European Commission has done on environmental matters halfway through the five-year term of Commission President Romano Prodi and his 19 fellow commissioners. But, the legislation has been good "only under very strong public and political pressure." In general, the influence of the biotechnology multinationals on the Commission's policies "remains too strong," warns the group of environmentalists, which includes the European Environmental Bureau, Friends of the Earth Europe and Greenpeace.

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