BioWorld International Correspondent
BRUSSELS, Belgium - A group of European Union experts issued 25 recommendations on how to deal with genetic testing, saying that "careful reflection is needed to put an appropriate strategy into place to ensure the maximum potential of health care innovation."
The main recommendation is that the European Union should create a consistent regulatory framework. At present, genetic testing services in Europe suffer from "technical error and poor reporting," the group said, and diverse quality schemes and differing national regulations "have added to the overall fragmentation of services."
The group rejected the sentiment that genetic data are different from other medical information. But it recognizes the public concerns over eugenics, the implications of predictive genetic tests for rare diseases and potential loss of control over samples. What is needed, it said, is a set of "more considered and inclusive legal and regulatory frameworks that encompass all medical data and testing, and which reflect advances made in health care provision."
Other principal needs identified include standard definitions for genetic testing and genetic data, further study of the issues raised by genetic testing for acquired genetic properties, and development of education, training and general public information on genetic testing, genetic screening and pharmacogenetics.
The report said genetic testing for human health care must be linked to informed consent. All tests must be meaningful, the condition screened for must be serious, the test highly predictive, and follow-up health care interventions must be available. The report also called for EU funding of research into the impact of genetic testing on the social, cultural and economic aspects of health care provision, and should encourage the development of pharmacogenetics.
The group was set up last year by the EU's research department to review the ethical, legal and social implications of genetic testing. It brought together patient organizations, the pharmaceutical and biotech industry, scientists, and specialists in law, philosophy, ethics and medicine.
Erik Tambuyzer, chairman of the health care board at EuropaBio, the European association of bioindustries, said genetic testing "will be a very important aspect of our future health care systems."
But EuropaBio stressed the need for a flexible regulatory framework.
Another EU No' For GM Maize
European Union member states failed to support the application by Monsanto Co. to import a new genetically modified maize. The EU's special committee on the food chain on April 30 rejected NK603, a maize for human food, genetically modified to be resistant to Monsanto's herbicide RoundUp.
In February, member states also failed to support the same GM crop for use as an animal feed. Concerns were expressed over its effects on subsequent generations, cumulative toxic effects and allergies.
Earlier in the week EU agriculture ministers deadlocked on an application for a 10-year authorization for Syngenta AG's genetically modified maize line, Bt11, as a food or food ingredient. French and Austrian reports asked for further review of the product. The application had failed to win approval from the expert committee last December, based on safety concerns.
The deadlock means the matter now passes out of ministers' hands under the EU's out-of-time rule for biotech decisions: Senior EU officials now may legally grant the application.
Commenting on the outcome of the Bt11 debate, Johan Vanhemelrijck, secretary general of EuropaBio, said: "We are disappointed that the Council failed to approve the sweet corn but now look to the EU Commission to move forward with a decision to approve this product."
EU Enlargement Widens GMO Monitoring Network
The enlargement of the EU on May 1 brought national enforcement laboratories from the 10 new member states into the network that monitors genetically modified organisms in Europe. They include the Cyprus State General Laboratory, the Czech National Institute of Public Health, the Estonian National Institute of Chemical Physics and Biophysics, the Hungarian National Public Health Center, the Lithuanian National Veterinary Laboratory, the Latvian State Veterinary Medicine Diagnostic Center, Malta's Environment Protection Directorate, Poland's National Veterinary Research Institute, Slovakia's Institute for Molecular Biology and Slovenia's National Institute of Biology.
The network helps manage the detection, identification and quantification of GMOs in food and feed samples across Europe. New EU rules that came into effect April 18 provide for a coordinated validation of detection methods, and applications for GM food or feed now can be granted only if checks demonstrate that the application's methods are accurate and effective in detecting GMOs in food and feed samples. If a screening shows the presence of one or more GMOs, regulations require that the amount be quantified, so that labeling of food ingredients can guarantee the consumer's right to information.