BioWorld International Correspondent

BRUSSELS, Belgium - A new biosafety agreement for international trade in genetically modified organisms has been greeted as a landmark decision by the European Union.

The agreement covers 132 countries and was reached in Curitiba, Brazil, March 17. It resolves confusion over how to manage commerce of GMOs in agricultural products.

European Environment Commissioner Stavros Dimas said: "This decision sets out documentation requirements that are clear, meaningful and practical for both exporters and importers of agricultural products, while being consistent with EU law. It provides for legal certainty for the international trade in agricultural commodities." It will allow countries to be confident of the legality of GMO imports and to establish adequate traceability.

The agreement, a compromise reached in the final hours of negotiations, establishes rules on the information that must accompany international GMO trade in agricultural commodities. Failure at the meeting would have handicapped trade and thrown an obstacle in the way of developing agricultural biotechnology, EU sources said.

Dimas praised "the political commitment" the Brazilian government showed in helping broker the final deal. The meeting, which also agreed to new procedures for risk assessment of GMOs, brought together the 132 parties to the Cartagena Protocol on Biosafety, the international treaty governing the cross-border transport of GMOs.

The European Parliament voted a resolution on March 16 urging the EU to show leadership at the conference, in the interests of protecting biodiversity domestically and internationally. It had specifically insisted on an agreement for robust documentation requirements accompanying GMO shipments. EU ministers at their March Environment Council meeting also had mandated EU officials to negotiate a deal.

EU Launches Antibiotic Research Plan

The increasing problem of resistance to antibiotics will be tackled by a new European Union scientific network launched March 16 with funding of €11.5 million (US$13 million) over the next five years. The scheme, involving academic groups from nine EU countries, will focus particularly on genomic approaches to combating resistance in lower respiratory tract infections. It aims to overcome the fragmentation in European research efforts through a novel integration of cutting-edge basic genomic science with research practitioners working in the community at the bedside and training. European Science and Research Commissioner Janez Potocnik said that by pooling skills at the European level, "we have a much better chance of finding answers more quickly."

Cyprus Cannot Require Separate GM Display

The European Union prevented one of its newest members, Cyprus, from requiring genetically modified foods to be displayed on specially designated shelves, separate from non-GM foods, in supermarkets. It ruled March 13 that Cyprus’ plans for new legislation was inadmissible under EU rules.

Final Lap For EU Pediatric Medicines Law

EU ministers gave their approval March 15 on draft regulation for pediatric medicines, aimed at boosting their development. The rule will ensure high-quality research and due authorization for use in children, while improving available information without subjecting children to unnecessary clinical trials. The regulation, under discussion since 2003, will oblige drug companies to submit a pediatric investigation plan as part of the procedure for obtaining market authorization. But incentives are provided through the extension of exclusive rights and the introduction of a new type of market authorization for generic medicines, the "pediatric use marketing authorization." The draft law now will go back to the European Parliament for a second reading.

Interest In EU Support For Biotech SMEs

More than 90 proposals have been submitted in a biotechnology call for tenders launched by the European Union in January. The invitation to tender for transnational collaborative biotechnology research projects went out to small and medium-sized enterprises in Germany, Austria, Spain, Finland and France. ERA-NET, the EU body handling the four-year program, told BioWorld International the exercise had been "a great success." By the end of April, it will start selecting winners.

"By working together, partners from the five countries involved intend to assist biotech SMEs to excel, and to develop new products and services and introduce them rapidly and effectively into international markets," it said.

ERA-NET also is working to coordinate the relevant financing programs in the countries involved. The overall budget of the call is up to €30 million (US$36 million). Further calls for tender will be opened to other EU member states.