Commission to propose new legislation on human tissue products

A Commission report has mapped out the present state and future prospects for human tissue engineering in the EU, calling for an EU-wide regulatory framework in this field.

Background

The Commission has published a report compiled by its Joint Research Centre which provides a comprehensive overview of commercial and research activities in the field of human tissue engineering in the EU.

Tissue engineering is a branch of biotechnology which promises faster and better healing of wounds and less need for repeated surgery. Based on the report, there are currently 113 companies in the EU engaged in tissue engineering, mainly in the UK and Germany. Products currently on the market include simple tissue products such as skin, cartilage and bone. Eventually, tissue engineering could lead to thein vitroconstruction of human organs, easing the prevailing organ shortage.

There is no harmonised legal framework at present for the marketing of tissue-engineered products. Recognising the need for an EU-wide regulatory framework, the Commission is currently in the process of drafting a proposal for common measures in this area.

A directive establishing standards of quality and safety of dealing with human tissues and cells has all but completed its legislative cycle (see also

EURACTIV 17 December 2003) - it only requires final Council approval now.

 

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