Commission Agenda Entry: Wednesday 16^th November: Medical innovation for all Europeans

Brussels, 11 Nov 2005

The news:

• Human tissue engineering is an important emerging sector of medicine whose development is currently being hampered by the absence of an EU-wide classification and authorisation process.
• It brings together aspects of medicine, biology, materials science and engineering and is used to regenerate, repair or replace diseased tissues. Current applications include treatment for skin, cartilage and bone diseases or injuries.
• Currently, however, there is no EU-wide framework for regulating this new field of medicine and the free movement of human tissue engineered products is being impaired as a result. In turn, the availability of these innovative therapies for patients is being restricted.
• Following a wide consultation with stakeholders, the Commission will present a proposal to establish the legal certainty of human tissue engineered products and to ensure the highest level of health protection across the EU.

The event:
An IP and MEMO detailing the proposals of the Commission will be released. References tbc. Technical briefing, time and place tbc.

The sources:

Ø IP/05/575

Ø MEMO/05/389

• European Commission DG Enterprise and Industry (Pharmaceuticals)

Ø http://pharmacos.eudra.org/F2/advtherapies/index.htm

Ø http://pharmacos.eudra.org/F2/advtherapies/docs/Questionnaire_2002.pdf
European Union Biotechnology site:

Ø http://europa.eu.int/comm/biotechnology/introduction_en.html

The contacts:
Gregor Kreuzhuber Tel:+32 2 296 6565; Catherine Bunyan Tel:+32 2 299 6512

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