By Peter O¿Donnell

BioWorld International Correspondent

BRUSSELS, Belgium ¿ Cloning of adults or children for reproductive reasons should be ruled out completely until researchers have discovered ways of counteracting the health risks associated with the procedure, according to Guido de Wert, a senior research fellow in biomedical ethics from the Institut of Bioethics at the University of Maastricht.

He told the European Society of Human Reproduction and Embryology annual meeting in Lausanne, Switzerland, that that the reproductive cloning of adults or children was unacceptable at the present time because of the serious health risks children conceived in this way could suffer.

¿Cloning carries substantial medical risks,¿ he said. ¿As animal research shows, current methods of cloning result in high numbers of miscarriages and higher perinatal mortality and morbidity rates. Many animal clones die in the womb or develop serious deformities including diabetes, bad kidneys and enlarged tongues.

¿Even clones that look healthy may be ticking time bombs,¿ he said. ¿Human adult cloning would probably have similar adverse outcomes. Furthermore, clones might be predisposed to a decreased life span.¿

However, de Wert said there may be an argument for making it legal in the future. ¿If this technique became safe in the future, its use might be justified in some cases. It could be used, in principle, to treat some types of infertility, for instance when a man is unable to produce any germ cells in his sperm.¿

Scientific Committee Cautiously Clears GM Cotton

The European Union¿s scientific steering committee has given a prudently expressed opinion on the use of genetically modified cotton in medical and hygiene products. Since 1997 two applications have been pending in the EU for marketing authorizations for GM-cotton that could be used in feminine hygiene products, and baby or adult incontinence garments.

The committee came up with what it calls a framework for the assessment of the risk, after taking account of potential differences between genetically modified cotton fibers and those derived from non-GM cotton plants. The committee concluded that there is no reason or evidence to believe that the genetic modifications introduced in the two GM cotton lines could result in the formation of GM cotton fibers that would be different, and that on the available analytical evidence, any protein ¿ endogenous or introduced into cotton by genetic modification ¿ is denatured or removed during processing of cotton fibers and their transformation into final products. It also said it sees no reasons for any additional risk of such products from GM cotton interacting in intimate contact with the skin, vaginal mucosa, endometrium or other tissues as compared to products from non-genetically modified cotton.

Nevertheless, the committee is recommending that risk assessments should be carried out on a case-by-case basis.

EU Scientific Committees Review Biotechnology

Biotechnology remains under review in a number of European Union committees. The EU¿s scientific committee on medicinal products and medical devices is now examining xenotransplantation and tissue engineering in specialized working groups, and is to take stem cells further into account in its work. And during a recent discussion with the European Commission¿s health directorate ¿ now headed by the former director of the European Medicines Evaluation Agency, Fernand Sauer ¿ the committee noted the scope for further joint work on these issues.

Meanwhile, life sciences and genetic testing are being pursued by the European Commission¿s research directorate general in its Institute for Prospective Technological Studies, with particular emphasis on biotechnology and genetically modified organisms, and on genomics for health and agriculture. The institute is also reviewing quality assurance of genetic testing, and is examining the scope for harmonization of the quality of genetic testing services in Europe.

Biotechnology Among EU Presidency Priorities

When Belgium took over the rotating six-month chair of European Union business on July 1, it pledged to focus attention on biotechnology with its program for public health and consumer protection.

The Belgian plan is for EU ministers responsible for consumer affairs and the environment to start discussing a package of proposals the European Commission will present this autumn on genetically modified organisms, including new rules on labeling and traceability, new rules for the authorization of GM feed and updated rules for the authorization of GM food and food ingredients.

EU Citizens Speak Out On GM Issues

The European Commission has received thousands of e-mail messages from European Union citizens concerned about upcoming changes to EU law on genetically modified organisms. A specific web site was set up earlier this year to solicit public comments while the European Commission is working on the completion of a regulatory package on GM covering all aspects and sectors, a package the Commission sees as necessary to restore confidence in the process of authorization and monitoring of GMOs in the EU.

The Commission is working out the specifics of legislative proposals on traceability and labeling for ¿live GMOs,¿ as well as on the appropriate traceability for products derived from GMOs. This traceability system would cover all sectors ¿ seeds, feed and food. In addition, the Commission intends to put forward proposals to supplement the labeling requirements for GM-derived food, and to fill in the gaps in the regulation of GM feed. In the near future proposals concerning the purity criteria for conventional seeds in relation to GM seeds also will be presented.

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