Brussels, 23 Jan 2004
The European Commission is looking into new legislation to enhance research in human tissue engineering.
This emerging field of biotechnology is set to revolutionise the medical world by regenerating unhealthy tissues and organs and improving the healing process for wounds. Developing this unique technology will not only improve a patient's quality of life by decreasing the need for surgery; it also introduces numerous opportunities for superior treatment. More importantly, human tissue engineering could be the answer to the scarcity of donor organs.
At present, a lack of adequate European legislation in this field hampers both the free movement and the market growth of tissue-engineered products. A report by the Joint Research Centre's Institute for Prospective Technological Studies, calling for an EU-wide authorisation process, is set to change the situation.
'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,' said European Enterprise and Information Society Commissioner, Erkki Liikanen. 'Such common rules will ensure that tissue-engineered products circulate freely within the EU, thus making innovative therapies available to those who need them.'
Currently, there are 113 European companies specialising in tissue engineering, 54 of them producing in vitro tissues. As in the US, they tend to be small and lacking the resources necessary for expensive clinical trials. This often means they cannot put forward comparative data on the cost-effectiveness of the treatment compared to conventional alternatives. The lack of data available means that insurance companies are unwilling to reimburse recipients of treatment involving tissue-engineered products.
Many of those products are still in the early stage of development, but it is already envisaged that they will eventually treat illnesses like cardiovascular diseases, neurodegenerative diseases (for example, Alzheimer's and Parkinson's), damaged nerve fibres and spinal cord injuries that cannot be cured using conventional methods. Ultimately, tissue engineering will allow the creation of in vitro human organs for transplantation.
Encouraging research in this field is therefore essential. In response to the report on 'Human tissue-engineered products: Today's markets and future prospects', the EU institutions are now working on a directive on 'standards for quality and safety of human tissues and cells', as well as measures for consumer protection and product marketing. To download the JRC report, please visit: http://www.jrc.es/home/publications/publ ication.cfm?pub=11
For further information on life sciences, genomics and biotechnology for health in the Sixth Framework Programme (FP6) please visit: http://www.cordis.lu/lifescihealth/home. html