Consultation on the need for a Community legal framework on human tissue engineered products

Brussels, 03 July 2002

Consultation

Tissue engineering is a new and rapidly developing technology that intends to produce viable substitutes that restore, maintain or improve the function of human tissues or organs. It differs from standard therapies by the fact that the engineered products become integrated within the patient, affording a potentially permanent and specific cure of the disease, injury or impairment. It is an inter disciplinary field that applies the principles of biology and engineering.

It is important to establish a clear regulatory framework for this area.

The attached consultation document invites contributions on the need and contents of such a framework.

Need for a legislative framework for Human tissue engineering and tissue-engineered products
Full text

Time table
The consultation is open until September 30, 2002.

Invitation to comment on this proposal: your Contribution

Please send your contribution to: ENTR-TISSUE-ENGINEERING@cec.eu.int

Please identify yourself with:
Your title, first and last name
Your function and your main domain of activities in relation of the subject of this consultation.
Name and address of your employer.
Telephone N° / Fax
E-mail Address

General information
1 - Note that anonymous answers will be not taken into consideration.
2 - Personal data will be kept confidential.
3 - Please identify clearly by its number the question you are answering.
4 - General comments can be added in a special paragraph "General comments"
5 - Please note that any part of your answer can be made public; consequently, it should not be protected by any intellectual property rights.
6 - Contributions to this consultation will be analysed with the greatest attention.

Enterprise DG
http://europa.eu.int/comm/enterprise/index_en.htm