BRUSSELS, Belgium - The Organization for Economic Cooperation and Development and the World Health Organization said international surveillance is needed for xenotransplantation activities, to minimize potential risks to public health.
Officials at a consultation meeting in Paris on Monday agreed there should be obligations on those running trials to detect rapidly and report any infectious disease event, particularly a rare event, should it occur; to share information and cooperate; and to facilitate xenogenic disease event verification and response coordination.
The monitoring does not need new mechanisms for international coordination, but rather should operate through existing links between countries and other interested parties. National facilities with dedicated resources to collect, analyze and report back international data will, however, need designating. The meeting also agreed that an international consensus must be established on minimal reporting requirements and processes, and even on the definition of xenotransplantation. Not all countries consider xenotransplantation to include cellular transplants from nonhuman animal sources or human body fluids, cells, tissues or organs that have had extracorporeal contact with live nonhuman animal cells or tissues, such as through bio-artificial organs or in cell cultures.
European Medicines Agency Names New Chief
The European Union's agency responsible for authorizing biotechnology-derived pharmaceuticals is to be run by a Swede. Thomas Lvnngren, currently deputy director general of the Swedish National Medicines Agency, was appointed to take over from Fernand Sauer at the European Medicines Evaluation Agency in London.
Selected on Monday from among five candidates, the 49-year-old will pilot the EU agency through the review of European Union medicines legislation that is due to take place in 2001. By training a chemist, an engineer and a pharmacist, his background in regulatory affairs has ranged widely, but he has more experience in medicine in the developing world and in essential drugs and herbal medicines than in biotechnology.
EU Boosts Funding For Alternative Crops
The European Commission awarded EUR778,000 (US$654,000) to the UK Central Science Laboratory's Alternative Crops & Biotechnology Group, to enable it to expand its work. The laboratory has been a lead player on a biotechnology crop development project known as the Interactive European Network for Alternative Crops and their Application, funded by the European Commission since February 1997.
The new financing will enable it to look at the opportunities for - and obstacles to - alternative crops in different parts of Europe, increasing its coverage from 11 countries to 25. UK Agriculture Minister of State Joyce Quin welcomed the increased EU funding. She said it would help growers, processors, and manufacturers, as well as governments and researchers. The new project will start by January.
New Concerns On GM Safety Tests
"I wouldn't drink milk from cows fed GM maize," Bob Orskov, director of the International Feed Resource Unit in Aberdeen, UK, told a UK government public hearing last week about Chardon LL, the first GM maize to be licensed for sale in the UK.
Appearing as an expert witness for Friends of the Earth, Orskov, a respected British scientist, said: "The scientific case put forward for this GM maize is not adequate" and "if the GM maize was approved for commercial growing in the UK then people would be justified in turning their back on consuming milk derived from it."
His views were backed by Vyvyan Howard, head of the Fetal and Infant Toxico-Pathology Group at the University of Liverpool, UK, who said: "My interpretation is that this GM maize has not been tested thoroughly."
Critics of the safety data presented by Aventis, the firm that owns the maize, alleged that the product had not been tested on cattle, even though it is intended for their use. According to Orskov, "We need to carry out proper, long-term tests both on the effect of the maize silage for the microbes in the stomach of the ruminants which digest the feed and on the host animals. This has not been done."
Continued Discussion On New Biotech Rules
The draft version of the new rules for European biotechnology products was due for further intensive discussion this week.
The European Parliament's Committee on Environment, Public Health and Consumer Policy was scheduled Tuesday to have a hearing with two of the European commissioners at the sharp end of the debate: Margot Wallstrvm, responsible for environment, and David Byrne, responsible for food safety and public health. The committee planned to grill the commissioners on the Commission's strategy on GMOs.
And the Commission's Scientific Steering Committee - composed of top-level national experts - also has GMO regulation on its agenda for its meeting later this week. "Issues requiring scientific advice: the case of genetically modified plants," is one of the priority subjects they will review, along with more general items relating to emerging health issues, and the harmonization of risk assessment procedures.