BioWorld International Correspondent

BRUSSELS, Belgium - Although the European Union estimates world sales for tissue-engineered products at only some €60 million in 2002, European Research Commissioner Philippe Busquin has announced plans to win a major stake for European firms as the market expands to a predicted €4 billion by 2007, and subsequently to €400 billion and beyond.

"We may be years away from being able to grow replacement organs, but the progress in research has already resulted in the creation of a new commercial biotechnology sector in Europe," Busquin said, unveiling a new EU study of the sector on Jan. 22.

The study suggests there are 113 companies active in the field in Europe, with 39 based in Germany, 18 in the UK, 10 in France and Sweden, and six in the Netherlands. Most of them are biotechnology companies, with a quarter from the medical device or pharmaceuticals sectors, and most have fewer than 50 employees.

Looking beyond the current range of tissue-engineered products, such as artificial skin, cartilage and bone, the study predicts the emergence of more complex products in cardiovascular and central nervous system indications. It raises the prospect of tissue-engineered heart valves, vessel grafts and heart muscle tissue, or treatments for Alzheimer's disease and Parkinson's disease, and for damaged nerve fibers and spinal cord injury. Further ahead, the report - authored by Anne-Katrin Bock, of the EU's Institute for Prospective Technological Studies - suggests the construction in vitro of human organs to overcome the scarcity of donor organs and to improve treatment of diseased urinary bladders, kidneys, hearts, livers and pancreases.

Busquin said he is taking action to help tissue-engineering companies overcome the challenges they face because of uncertainties in market development and nonreimbursement of their products by health insurance systems. He recognizes that the small biotech companies involved do not have the resources for large, long-term clinical trials to provide information on the cost-effectiveness of the treatment compared to conventional alternatives. And, the study said, the lack of cost-effectiveness data is the main reason insurance companies refuse to reimburse treatment with tissue-engineered products.

The key difficulty, in Busquin's view, is the lack of a coherent European regulatory framework, saying divergent European regulations are "an obstacle to the growth of tissue-engineering markets in Europe." His staff is starting to prepare legislation to harmonize authorization procedures for products and processes based on human tissue engineering. The plan is to provide a set of common rules to clarify the situation for business operators, as well as guaranteeing safety for users and patients. Common rules will allow tissue-engineered products to circulate freely within the EU market.

The European biotech industry welcomed the report.

"This is the first European report of its kind and shows hope for novel biotechnology treatments," said Hugo Schepens, secretary general of EuropaBio.

"Patients cannot obtain treatments or get reimbursed, and companies have great difficulty in offering them as, there are no consistent rules governing these products in Europe," Schepens added.

Yet Another European Review Of GMOs

Senior European Union officials are scheduled to hold yet another in-depth review of genetically modified organisms today. At their regular weekly meeting, the 20 commissioners that are responsible for EU policy formation will take stock of the progress made in standardizing EU rules governing the GM sector. New EU labeling and traceability laws are due to come into force in April, which largely completes the web of biotechnology legislation the EU has constructed over recent years. But the commission also will be reflecting on the failure of EU member states to implement the new rules they have agreed to put into their statute books. One of the items on the agenda will be whether the EU should authorize BT11 corn - the latest challenger to the five-year-old informal EU moratorium on GM approvals.

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