BioWorld International Correspondent

BRUSSELS, Belgium - The European Parliament found a new subject on which it can exercise its familiar concerns over the potential risks of biotechnology. A proposal to harmonize the European Union rules for advanced therapies has provoked some members of parliament into vigorous denunciations of what they see as dangerous innovation.

When the parliament's health and environment committee debated the proposal July 12, a volley of hostile amendments were proposed. Urszula Krupa, of Poland, demanded special measures to control products in the biotechnology sector "to prevent improper use - particularly in ethical terms - being made of advanced therapies." Elsewhere, she claimed that "given the specific nature of advanced therapies, emphasis should be placed on the significance of bioethical principles."

Miroslav Mikol ik, the draftsman for the committee's opinion, insisted that "rapid developments in biotechnology and biomedicine must not be allowed to compromise the protection of fundamental rights," and proposed tighter controls on the supply of tissue and cells. French socialist member Anne Ferreira urged that marketing authorizations should be made conditional on creating a new risk management system, "owing to the inherent nature of advanced therapy."

However, not all members of the committee shared the desire to limit research and innovation. Some specifically urged amendments to respect the freedom of therapeutic research and EU financing of research on the use of adult and embryonic stem cells. Others advocated that the new rule should not be used to limit the use of existing techniques that are allowed by national regulations.

The overall objective of the proposed measure is to standardize market access procedures for gene therapy, somatic cell therapy and tissue engineered products. It envisages a centralized marketing authorization procedure similar to the EU system for pharmaceuticals, operated by a new committee of experts within the European Medicines Agency. It also proposes incentives for smaller firms. The proposal attempts to sidestep the difficulties of discussing ethical questions at the European level, making clear that it would not interfere with national legislation prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicines based on such cells.

But European industry executives have watched in some dismay as the debate in the European Parliament has shifted further toward demands for the imposition of new controls. That could inhibit rather than promote the innovation that advanced therapies depend on, one executive told BioWorld International after the debate. There also is European industry concern that protectionist tendencies - driven particularly by pressures from smaller German firms - risk sabotaging the concept of a single European marketing authorization. The debate will resume in the European Parliament in autumn. Meanwhile, European industry ministers - who will have an equal say in the final outcome - also are reviewing the proposal.

European Assessment Of Hybrid GM Plants

The European Food Safety Authority has launched a consultation on the approach adopted by its expert panel on genetically modified organisms in assessing the potential human health and environmental effects of hybrids derived from combining two genetically modified plants that previously have been assessed and authorized. The consultation document spelled out how the panel evaluates the potential interactions in terms of their toxicity, allergenicity, nutritional value and environmental impact. It also described what type of information and test results it expects applicants to deliver.

OECD Consults On Genetic Testing Guidelines

The OECD also initiated a public consultation on its proposed new guidelines for quality assurance in molecular genetic testing on July 12. The guidelines offer principles and best practices for human genetic testing by encouraging high-quality laboratory practices in the collection and handling of samples and data, result reporting, education and training, and where possible, the clinical validity and use of the tests. They are intended to encourage quality assurance systems for human genetic and genomic testing, guarantee the international exchange of clinical samples and access to data on rare disease testing, and help meet OECD member countries' efforts to supply high-quality health care to their citizens.