BioWorld International Correspondent

BRUSSELS, Belgium - The European Union is targeting its financial support for orphan drug products more closely on the pre-approval phase beginning this year. The European medicines agency in London on Jan. 9 said that nearly $5 million was being made available in 2006 to fund eligible products, but that it was tightening the rules to focus on preparatory development. Other assistance for orphan products now is to be limited to just the first 12 months after marketing authorization has been granted.

Under the new rules, fees for scientific advice on protocol design and pre-authorization inspections of premises are fully waived, and companies need pay only 50 percent of the fees for new applications marketing authorization. Subsidies on post-authorization costs - such as fees for annual marketing authorization or for variations - are limited to the first year after authorization, except for very small firms.

But at the same time, another 2006 rule change for the EU has delivered what smaller biotech firms are seeing as a new blow. In 2006, European medicines agency rules will require all biotech product applications to be translated into Icelandic.

The move already has irritated some smaller firms, who see this as an unduly onerous imposition. Iceland is not an EU member state (it is linked to the EU through an extended trade agreement covering Norway and Liechtenstein), and most professionals in its 200,000 population also are fluent in English or Danish. The new rule applies to all marketing authorization applications through the EU's centralized procedure - and since all biotech products are required to use it, they also will be required to translate the relevant parts of their application dossier into Icelandic.

Luxembourg's Second Warning On EU Patents

The European Union is losing patience with Luxembourg's delays in implementing the 1998 directive on biotechnology patents. It sent a formal warning on Jan. 10, and if the legislation is not brought into effect rapidly, Luxembourg could be subject to daily fines.

The EU court already ruled that Luxembourg is in breach of its duty by not introducing EU law on legal protection of biotechnological inventions, which - the EU said in a statement - provides clarifications that are "essential in order to exploit fully the medical, environmental and economic potential of biotechnology in line with high ethical standards." Latvia, which joined the EU in May 2004, is the only other of the 25 member states not to have implemented the biotech patent rules.

"Non-implementation creates trade barriers and puts the European biotechnology sector at a serious disadvantage," said the EU announcement.

The EU warning came at the same time as Charlie McCreevy, the EU commissioner responsible for trade matters within the EU, pointed to serious deficiencies in many aspects of member states' compliance with EU rules for creating a single market and boosting EU business.

"Some member states still lag behind and are effectively denying citizens and businesses across Europe the full benefit of the single market and of measures their governments have themselves agreed," he said. "I must reiterate that the commission will do all it can to help member states implement laws on time, but will continue to take remedial action where necessary."

More Monsanto Maize Wins EU Approval

Three of Monsanto's genetically modified maize lines received European Union marketing authorization on Jan. 13. GA21 and MON863 obtained authorization for use as food and food ingredients, and MON863x810 was authorized for import and industrial processing. None were authorized for cultivation in the EU.

The authorizations were granted against the wishes of several EU member states, which had objected on environmental grounds, but who were unable to muster sufficient support among other member states to obtain an outright ban.

Biotech opponents reacted with hostility to the decision, claiming it "ignored environmental and health concerns of member states," and flew in the face of recent studies arguing that farmers see no benefits in introducing biotech crops.