BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament resumed its debate on advanced therapies Jan. 22, when its environment committee examined a new draft report on the proposed EU legislative framework. The committee threw out an earlier draft report last October because of sharp divisions over how far the new regulation should go in imposing ethics-based constraints on the use of human cells in tissue engineering.

Miroslav Mikol ik, a physician who authored the earlier report and who favors tight ethical controls, apparently has recognized the difficulty of winning majority support for his views. He presented the committee with a revised version that omits some of the more explicit calls for a strict regime - such as the warning that "rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights," or the prohibition of "the creation of human-animal hybrids or chimeras." He said that his intention is to find the broadest possible consensus in that area, and that he is ready to work on compromises with his colleagues.

However, many members of the committee remain determined to retain tight restrictions on what they see as ethical grounds. Amendments tabled for the discussion included demands that the new rules "respect the prohibition on making the human body and its parts as such a source of financial gain," and deny the possibility of marketing authorization for products that are neither "properly subject to clinical trials . . . nor legally patentable."

The European biotech industry groups EuropaBio and Emerging Biotech Enterprises have been urging members of the parliament not to delay further progress with the draft legislation.

They also have been lobbying against amendments that would create dual systems for evaluating products according to perceived ethical sensitivity. Industry representatives said that would undermine the central objective of creating a harmonized regulatory framework for those products.

"Adopting amendments to exclude products from the scope of the regulation will not resolve the ethical concerns of members of parliament but rather mean that member states will authorize them nationally. This will create dual - or even multiple - standards for evaluation of products," read a letter the industry associations have sent to committee members.

Industry also is arguing that the ethical concerns being raised already are addressed by existing EU legislation and international conventions.