Brussels, 22 January 2004
The European Commission published a report today on prospects for commercial and research activities in the field of human tissue engineering (regeneration of tissues).
Tissue engineering is an emerging, multidisciplinary, biotechnology sector.
It promises to change medical practice profoundly, regenerating diseased tissues and organs instead of just repairing them. The development of this novel biotechnology is connected to new treatment possibilities, better quality of life of patients and, not least, the ability to gradually overcome the constant shortage of donor organs for transplantation.
The first products include artificial skin, cartilage and bone. The regulatory framework applied differs across the EU, which presents an obstacle to the growth of tissue-engineering markets in Europe. The European Commission is currently seeking to prepare legislation which will harmonise the authorisation procedures for marketing products/processes from human tissue engineering.
"The world of tissue engineering research is rapidly approaching applications that will make a big difference for a broad range of patients," points out European Research Commissioner Philippe Busquin. "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."
Due to their singularity, products derived from human tissue engineering are not adequately covered by existing European legislation.
"A specific Regulation on the conditions for placing on the market tissue-engineered products is being prepared. It will introduce a set of common rules designed to clarify the legal framework for business operators, as well as guarantee the highest level of safety for users and patients. Such common rules will ensure that tissue-engineered products circulate freely within the EU, thus making innovative therapies available to those who need them," says European Enterprise and Information Society Commissioner Erkki Liikanen.
The Commission report, elaborated by its Institute for Prospective Technological Studies at the EU Joint Research Centre (JRC) in Seville, represents the first comprehensive map of the emerging industry of human tissue engineering in Europe. The paper makes clear that the lack of such an EU-wide authorisation process is hampering the growth of a nascent knowledge-based industry.
Healing wounds faster
The current commercialised products focus on comparatively simple tissues such as skin, cartilage and bone. Researchers have not yet developed tissue-engineered products with unique life saving functions or outstanding comparative advantages regarding effectiveness or treatment costs. Alternative conventional treatments exist, which are firmly rooted in the market.
But tissue-engineered products do improve the quality of life through potentially faster and better healing of wounds and less need for repeated surgery. This situation might change in future if more sophisticated and novel tissue-engineered products become available, showing clear comparative effectiveness or allowing the treatment of diseases for which no other treatment exists. Several significant scientific and technological challenges still have to be met.
A young and growing sector
The European tissue-engineering sector is characterised by young, small, research-based and technology-oriented companies. A total of 113 European companies are now active in tissue engineering in Europe (EU25), with 54 companies engaging in in vitro production of tissues. The European structure is similar to that of the USA, regarding the number and size of companies.
The size of the tissue engineering market development and the commercial range of applications is still in its infant phase. Many of the tissue-engineered products are still in early stages of development. 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. Lack of cost-effectiveness data is the main reason for which insurance companies are reluctant to reimburse treatment with tissue-engineered products.
Specific legal framework needed
The present regulatory framework applied differs from Member State to Member State, which presents an obstacle to free movement of tissue-engineered products and hampers market growth in the EU. Some measures at European level are already on the way. A Directive on standards for quality and safety of human tissues and cells is now being examined by European institutions. Measures on marketing of products and consumer safety are currently under preparation. This new legislation should cover the marketing of tissue-engineered products to safeguard consumer and user protection and enable an effective common market for these products.
The future of tissue-engineered products
Tissue-engineered products open up a new way of treating diseases. The hope is that they deliver superior treatments, improving the speed, extent and duration of healing compared to conventional treatments. The overall aim of on-going research is to improve the performance of tissue-engineered products and to enlarge application areas.
There are new products in the pipeline, whose applications may provide treatments for diseases which could not be treated in a satisfactory manner so far, such as cardiovascular diseases (tissue-engineered heart valves, vessel grafts and heart muscle tissue) or neurodegenerative diseases (e.g. Alzheimer's and Parkinson's) and damaged nerve fibres and spinal cord injury.
The overall, but still distant goal of tissue engineering is to construct in vitro human organs to overcome the scarcity of donor organs and improve disease treatment (urinary bladder, kidney, heart, liver and pancreas).
The JRC report "Human tissue-engineered products. Today's markets and future prospects" may be downloaded at:
For the thematic priority on life sciences, genomics and biotechnology for health in the Sixth Research Framework Programme (FP6) see also: