BioWorld International Correspondent

BRUSSELS, Belgium - While the European Union agonizes over whether to allow stem cell research and how to regulate innovative therapies, the European parliament is now preparing to cast a shadow over a further high-technology approach to medicines development.

In September the parliament will vote on nanosciences and nanotechnologies - and the preparatory debates in the parliament's committees suggest caution and constraint might predominate over enthusiasm and enterprise.

Miloslav Ransdorf, a Czech member of the parliament, has drafted a report on behalf of the parliament's committee on industry and research, which emphasizes the need to respect high ethical principles, and recommends taking a precautionary approach to the new possibilities.

Ransdorf, a scientist, is not negative about the prospects for nanomedicine. He describes it as "a promising interdisciplinary domain with breakthrough technologies," capable of offering "impressive benefits for the early diagnosis and smart and cost-effective treatment of diseases such as cancer, cardiovascular problems, diabetes, Alzheimer's and Parkinson's."

But he insisted that while nanotechnology "is leaping technical hurdles," its ultimate success "will depend on winning over consumers." In Ransdorf's view, the novelty of the technology "raises questions about how these new substances will behave in the environment, including the human body," and he warned that public uncertainties about health, safety and environmental effects could restrict investment and prevent companies from launching products involving nanotechnologies.

"The coming years will therefore be decisive in demonstrating that researchers and industry take those concerns seriously," Ransdorf said in presenting his report.

He urged setting up ethical committees to provide independent scientific advice and informing the public to create "awareness of the possible risks and the benefits associated with the use of discoveries in the field of nanotechnologies."

Recombinant Vaccines Win EU Approval

The European Medicines Agency has recommended approval of two recombinant vaccines to combat the effects of human papillomavirus. The July 27 meeting of the agency's scientific committee on human medicines delivered a favorable assessment of Gardasil (human papillomavirus [types 6, 11, 16 and 18] recombinant vaccine), from Sanofi Pasteur MSD, and Silgard - the same product, but from Merck Sharpe & Dohme. In both cases, the product is indicated for prevention of cancer, precancerous or dysplastic lesions and genital warts caused by the human papillomavirus.

EMEA review began last December, and a formal authorization from the European Union should be granted within weeks.