BioWorld International Correspondent
BRUSSELS, Belgium - The European Union is planning to amend its rules on the approval of genetically modified organisms to implement a new "regulatory procedure with scrutiny." Proposals just have emerged to update the 2001 and 2003 legislation on the deliberate release into the environment of genetically modified organisms and on genetically modified food and feed.
The new mechanism was agreed in principle in October 2006, in a deal between EU officials, member state ministers and the European Parliament, in response to pressure - particularly from the parliament - for closer control over controversial technical decisions.
The operational part of the proposed new text insists that new criteria and information requirements for candidate GMOs must be "such as to ensure a high level of safety to human health and the environment and be based on the scientific evidence available on such safety and on the experience gained from the release of comparable GMOs." Before any decision, the relevant EU scientific committee must be consulted, and the public must be allowed to make comments.
According to Dr Nikolaus Tacke of Monsanto Europe, the new measures will not be applicable to purely executive measures such as individual decisions authorizing GMOs. These will continue to be dealt with by a procedure that involves the EU member states but not the European Parliament.
EU Funds Pro-Angiogenesis Agents
The European Union is giving a grant of €2 million (US$2.6 million) to a consortium developing a new class of pro-angiogenesis agents. The consortium, known as Vasoplus, includes Roche Diagnostics, of Basel, Switzerland; Geymonat of Italy; and ThromboGenics and Eurogentec, both of Belgium. The money, from the EU's research support program, will contribute over the next two years to the further development of Placental Growth Factor (PlGF) and analogues of this pro-angiogenic cytokine for treatment of ischemic heart disease, peripheral arterial occlusive disease (PAOD), tissue regeneration and wound healing.
The growth factor is a homologue of vascular endothelial growth factor, but interacts with receptors with greater specificity. In vivo toxicology and safety pharmacology studies completed by ThromboGenics and Geymonat show it to be well-tolerated even at doses much higher than needed for efficacy .
Pediatric Rules Take Effect
The European Union's new rules for pediatric medicines take effect Jan. 27. These rules, which require the submission of a special pediatric investigation plan with all marketing authorization applications for new medicines, also provides for matching incentives for companies similar to those arrangements for smaller firms. The incentives and rewards include free scientific advice and the possibility of a six-month extension of patent protection.