1. Manifestation of Novel Social Challenges of the European Union in the Teaching Material of Medical Biotechnology Master’s Programmes at the University of Pécs and at the University of Debrecen Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

2. ETHICAL ISSUES Dr. Judit Pongrácz Three dimensional tissue cultures and tissue engineering – Lecture 27 Manifestation of Novel Social Challenges of the European Union in the Teaching Material of Medical Biotechnology Master’s Programmes at the University of Pécs and at the University of Debrecen Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

3. TÁMOP-4.1.2-08/1/A-2009-0011 No ethical issues raised Autologous cells No life threatening conditions

4. TÁMOP-4.1.2-08/1/A-2009-0011 More ethical questions Advanced human tissue engineering therapies may also be used for life- threatening conditions Embryonic stem cells Xenogeneic cells

5. TÁMOP-4.1.2-08/1/A-2009-0011 Regulation in Europe Best regulated at European level European framework laws Directives adopted by the European Commission and the European Parliament must be incorporated in national law

6. TÁMOP-4.1.2-08/1/A-2009-0011 The most relevant documents Charter of Fundamental Rights of the EU Convention on Biomedicine

7. TÁMOP-4.1.2-08/1/A-2009-0011 Ruling in 2011 A single cell from an embryo can be considered as a human being.

8. TÁMOP-4.1.2-08/1/A-2009-0011 USA Embryonic stem cells cannot be used Only established cell lines can be used in research Adult stem cells can be applied in research

9. ECONOMIC SIGNIFICANCE Dr. Judit Pongrácz Three dimensional tissue cultures and tissue engineering – Lecture 28 Manifestation of Novel Social Challenges of the European Union in the Teaching Material of Medical Biotechnology Master’s Programmes at the University of Pécs and at the University of Debrecen Identification number: TÁMOP-4.1.2-08/1/A-2009-0011

10. TÁMOP-4.1.2-08/1/A-2009-0011 Biotechnology Medical Pharmaceutical Agricultural, etc

11. TÁMOP-4.1.2-08/1/A-2009-0011 Significance in the US In 2001, 3,300 scientists and support staff worked in tissue engineering alone Over 70 start-up companies Investment of 3.5 billion US dollars

12. TÁMOP-4.1.2-08/1/A-2009-0011 Significance in the EU Fast growing STILL No venture capital in Europe

13. TÁMOP-4.1.2-08/1/A-2009-0011 Big Pharma Refocusing to cell based therapies Novel therapeutic approaches just in treatment of diabetic patients alone