The International Conference for Harmonization (ICH) will reconsider a proposal for further work on gene therapy at its major meeting in San Diego, Calif., Nov. 9-11.
Following discussions in Brussels in late July among the ICH steering committee and its technical expert working groups - including examination of a report from a brainstorming meeting held in mid-July - and in view of the interest expressed by all parties in this topic, the decision was made that gene therapy research and regulation would benefit from development of an ICH paper. ICH - which brings together drug regulatory authorities and the drug industry from the EU, Japan and the U.S. - already has produced nearly 100 guidelines standardizing drug-development requirements around the world.
Along with the discussion on gene therapy, the major item at the San Diego meeting will be a Common Technical Document, on which outline agreement also was reached at the Brussels meeting of the steering group. This document brings nearer the possibility of submitting a single drug application for marketing authorization around the world. It will define a standard format for all aspects of drug marketing applications. An electronic version also will be developed to allow submissions to be made without the hundreds of kilograms of paper evidence normally required.
Enterprise Directorate Shifts Priorities
The newly-revamped Enterprise directorate general in the European Commission - which has responsibility for industry, including the pharmaceutical and biotechnological industries - has finalized its internal restructuring. The unit responsible for the regulatory environment for biotechnology "is shifting the balance of its priorities to measures that promote competitiveness and innovation," says a late-July statement from the commission.
"The competitiveness of consumer goods industries and their potential for innovation, for example in biotechnology, is largely dependent on Europe's legislative approach to them," it says. But at the same time, it says that while the EU biotechnology industry, with over 1,000 companies and growing rapidly, "is already bringing us health and wealth benefits," it may also "pose risks." So "legislation must keep pace with biotechnological progress and its potential applications, so as to maximize the benefits they deliver whilst protecting the citizen."
GMO Detection Course Planned In Italy
The International Center for Genetic Engineering and Biotechnology is organizing a course on detection of genetically modified organisms (GMOs) in food and feed in Trieste, Italy, on Oct. 2-6, 2000, in collaboration with Techna Srl and Bio-Rad Laboratories Srl. The course will be held in the ICGEB laboratories in Trieste and is directed at scientists and laboratory technicians involved in food and feed analysis in the private and public sector.
ICGEB is an autonomous, international, intergovernmental organization formed by 62 signatory countries, and dedicated to advanced research and training in molecular biology and biotechnology. Its mandate is to promote the safe use of biotechnology worldwide, with special regard to the needs of the developing world.
Environmentalists: Greek Ministry Decision Too Late
The decision by the Greek Ministry of the Environment to order the destruction of cotton plants contaminated with an illegal genetically modified variety has come too late to prevent genetic pollution on a grand scale, according to Nea Ecologia/Friends of the Earth Greece.
Vice Minister for Environment Elias Efthimiopoulos said on July 20 that cotton crops containing GM material would be destroyed "before the plants flowered." But Vangelis Stogiannis, president of Nea Ecologia, said it was "incredible" that the ministry made such a declaration when the crops already had been in flower for some time. "The bees already have been transferring genetic pollution to all cotton crops for a month now," he said. To prove the point, Nea Ecologia and other environmentalists occupied the Prefecture of Trikila, the center of the main cotton-growing area in Greece.
About 14,000 tons of cotton seed planted in Greece this spring were discovered to be contaminated with a GM variety - contrary to European Union rules. Friends of the Earth groups across Europe are participating in a joint campaign to stop GMO pollution.