BioWorld International Correspondent

BRUSSELS, Belgium - Only days after the Danish minister responsible for business signaled to the European Parliament his determination to help the European biotechnology industry, his colleague responsible for agriculture put out an opposite message.

Adequate control of genetically modified organisms is vital, Agriculture Minister Mariann Boel insisted at the first meeting of EU farm ministers since Denmark took over the rotating presidency of the European Union July 1.

Setting out her program for the six months of the Danish presidency, Boel said one of her priorities in the agriculture sector would be food safety, and particularly bringing in new rules for genetically modified food and feed stuffs. "It's important that the consumer can feel confident that food is healthy, safe and of high quality," she said. Her remarks are being read by biotechnology industry executives as indicating that she will take a tough line on one of the most contentious packages of legislation on the EU's current agenda - the labeling and traceability rules for genetically engineered food.

The European biotechnology industry already was nervous about those proposals in their initial form. But when the European Parliament voted to make them even stricter on July 3, the industry expressed deep anxiety over the impact on innovation and investment. The Parliament rejected the idea of a "GM-free" label on food, sought to tighten requirements for accidental contamination, opposed allowing a 1 percent threshold for adventitious contamination with non-authorized genetically modified organisms and called for a cut from 1 percent to 0.5 percent for the permissible level of authorized GMOs.

Some EU member states - notably the UK - are resisting the call for tougher controls, abetted by major lobbies of the biotechnology industry and related industries such as the CIAA, the European confederation of the food and drink industry, which says it hopes that ministerial talks between member states during the Danish presidency will deflect the Parliament's amendments. But Boel's early declaration of enthusiasm for tough controls has renewed industry anxieties.

Biotech Products Hit Trademark Problems In Europe

Biotechnology-based medicines are running into problems with the European Union over trademarks, according to European drug manufacturers. They complain that the EU's regulatory authorities are unfairly restricting the use of trademarks for products authorized through the EU's medicines agency in London - through the authorization procedure that is obligatory for all biotechnology-based products. The EU is insisting that the same trademark be used throughout the 15 EU member states and is rejecting applications for a product with more than one trademark. But the industry says that it must be able to use different trademarks or variations of them for each product.

The European Federation of Pharmaceutical Industries and Associations says the innovative industry has no difficulty in principle with using a single mark, and generally favors "global branding" where possible. But in practice it is not always feasible. Smaller firms that are not present in all EU member states often need to be able to use different trademarks for one product because they have to strike licensing deals with other companies. Sometimes a mark is simply not available or appropriate across all member states. Problems arise because of trademark infringement cases, a shortage of available trademarks, or linguistic and phonetic difficulties.

A new draft EU guideline for applicants now seeks to impose a single name "valid throughout the EU." EFPIA says the requirement for a single trademark has no legal foundation and that requirement should be deleted. "There is no legal basis in community law or European Court of Justice case law to support the requirement of a single trademark per application," it said. And now the European Union is now being challenged in its own Court of Justice. One firm that has suffered a refusal to entertain a marketing authorization application because it wanted to use a different trademark, Thomae of Germany, is fighting back on the grounds that the EU's behavior is disproportionate and unjustified.

GM Animal Models Useful' In EU Drug Testing

Genetically modified animal models can be useful for carcinogenicity assessment in new drug development, European Union safety experts have concluded. The safety working party at the EU's European medicines agency in London has examined the findings from early trials with various genetically modified animal models, and has decided that using the TgrasH2 transgenic mouse and the p53 knockout mouse models "can be accepted for regulatory purposes and are likely to have an additive value to carcinogenicity assessment if the experiment is properly designed."

But the TG.AC transgenic mouse reacted "inconsistently and incompletely to known human carcinogens" and "cannot be recommended for oral studies with the forestomach as reporter site'" - although it could be "useful for screening the carcinogenic properties of dermal administered pharmaceuticals." The XPA and XPA-35 assays with the repair-deficient mouse "appear to be promising models, but more data from studies using acceptable protocols are needed," it said.

No Comments