BioWorld International Correspondent

BRUSSELS, Belgium - The European Union could start pumping as much as $3 billion a year in biotechnology and health research beginning next January if its new seven-year support program wins approval.

The program, already delayed as heads of EU governments try to agree on the total funding, faces new challenges in the European Parliament, which has to endorse the plan, too. This week, the parliament’s powerful public health committee is due to vote on the proposal - and its members already are signalling disquiet over stem cell research and other provisions on biotech and health research.

Satu Hassi, the Finnish Green party member of parliament who has compiled the committee’s report, said in the run-up to the debate that she wants to switch the emphasis away from therapeutic research and further into disease prevention. And she urged a ban on EU funding for embryonic stem cell research: Support should be given "only for adult stem cell research, umbilical stem cell research and other such alternatives, which do not use embryos as their raw material," she said.

On agricultural biotechnology, she stressed "the protection of non-GMO biodiversity and research into the environmental impact of GMOs."

Her draft report removes proposals on "increasing the competitiveness of European health-related industries and businesses," and speaks instead of "contributing to the performance of the European health sector." She justified her shift in the orientation of the proposals on the grounds that "special emphasis should be given to research in the public interest, such as emerging epidemics and neglected diseases (diseases, which mainly affect people in poor countries and consequently fall outside the scope of the drug industry’s research and development efforts)."

Similarly, her report underlines that epidemiological research should not be focused on "the genomic and molecular level, but needs to be completed by the societal level."

Biotech Sees Little Incentive In Accelerated Review

The European Union’s plans for accelerated review of marketing authorization applications are not ambitious enough, according to Emerging Biopharmaceutical Enterprises (EBE), the European lobby group of smaller biotech companies. The plans, based on the EU’s 2004 update of its pharmaceutical regulation in order to promote early launch of medicines of major public health interest, currently are being finalized. But EBE says that in their current form, they will not achieve their purpose.

One of EBE’s chief criticisms is that the new scheme does not make sufficient provision for companies to consult regulators early in the development process. Earlier interaction between the applicant and the European Medicines Agency via scientific advice and protocol assistance would "facilitate the shared development of understanding regarding the data," it said Feb. 15. EBE also objects to the provisional nature of the authorization that the new procedure will deliver. "An accelerated assessment procedure should, as a general rule, not necessarily result in a conditional marketing authorization," it added.

EU Regulators Update Rules For Cell-Based Products

Current guidance on cell-based medicines needs updating, according to the European Medicines Agency. Its recent experience in giving regulatory and scientific advice to companies and in evaluating marketing authorization applications for those products has revealed gaps, particularly in its guidance on non-clinical and clinical testing, it decided in mid-February.

"Conventional non-clinical pharmacology and toxicology studies may not be relevant for cell-based products, whereas novel animal models may be crucial for safe and successful clinical development," said the agency, announcing a consultation on how to modify the EU approach. "The heterogeneity of the products must be taken into account in the planning of safety studies." The outcome will be a new guideline on human cell-based medicines, covering development, manufacturing and quality control, as well as non-clinical and clinical development. The first draft of the guideline will be released for consultation later this year.

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