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Stem Cells: Emerging Legal and Ethical Challenges

Stem Cells: Emerging Legal and Ethical Challenges. Prof.. Aurora Plomer Director SIBLE School of Law University of Sheffield A.Plomer@sheffield.ac.uk. Regulation Explosion. Since 2001: EU 6 Directives with technical annexes UK - HFEA Bill (2007)

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Stem Cells: Emerging Legal and Ethical Challenges

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  1. Stem Cells: Emerging Legal and Ethical Challenges Prof.. Aurora Plomer Director SIBLE School of Law University of Sheffield A.Plomer@sheffield.ac.uk

  2. Regulation Explosion Since 2001: EU 6 Directives with technical annexes UK - HFEA Bill (2007) - Clinical Trials Regulations (2006) - Medicines for Human Use Regulations (2004) - Human Tissue Act (2004) + Reg. - HFE Act (1990) + SI

  3. EU Law Advanced Therapies Regulation (2007) Good Clinical Practice 2005/28/EC Human Tissue & Cells (2004 + TA. 2006) Blood 2002/98/EC Medicinal Products for Human Use 2001/83 Clinical Trials 2001/20/EC

  4. Covered by EUTCD • Haematopoeietic peripheral blood & progenitor cells • Umbilical-cord (blood) • Bone-marrow cells • Reproductive cells (eggs, sperm) • Foetal tissues and cells • Adult and embryonic stem cells Only when intended for human application e.g. tissues and cells applied to human body in clinical trials, and manufactured products derived from human tissues and cells for human application.

  5. Not covered by EUTCD • Research on human tissue and cells other than application to the human body, e.g. in vitro research or animal models. • Tissues and cells used as an autologous graft within the same surgical procedure • Blood and blood components • Organs or part of organs (if it is their function to be used for the same purpose as the entire organ in the human body).

  6. Aims of UK Regulation • HFE Act (1990) Ethical/Legal vacuum – IVF treatment • Human Tissue Act (2004) Inadequacy of law on post-mortem storage/use of organs.

  7. Integrating EU law into UK law

  8. Stem Cell Research: Emerging issues Regulatory Uncertainty: - Definitional boundaries (eg ‘gametes’, ‘embryo’ (HFE Act), ‘tissue’ (HTA Act) Regulatory Fragmentation - HFEA, HTA, Stem Cell Bank, RECs, MHRA, EMEA Regulatory overlap - Multiplication & Duplication of Ethical controls

  9. EU Directive Biotechnological Inventions (1998): Unpatentable Inventions Article 6(1) Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality … Article 6(2) (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) Uses of human embryos for industrial or commercial purposes

  10. UK P0 Sweden EGE EPO Competing Interpretations

  11. Not Patentable Human embryos … not only industrial or commercial use of human embryos but also ES cells retrieved therefrom by destruction of human embryos Patentable EPO

  12. The Bruestle Patent in Europe

  13. Not Patentable Human embryos Processes for extracting stem cells from the human embryo Totipotent hesc Patentable Pluripotent hesc UK Patent Office

  14. GB2415781B2 Genes that are up- or down-regulated during differentiation of human embryonic stem cells GB2412379B2 Hematopoietic cells from human embryonic stem cells GB2393734B2 Cells of the cardiomyocyte lineage produced from human pluripotent stem cells GB2393733B2 Dopaminergic neurons and proliferation-competent precursor cells for treating parkinson's disease GB2386120B2 Differentiated cells suitable for human therapy GB2379447B2 Neural progenitor cell populations

  15. Commercialization: Emerging legal challenges • Fragmentation on patent policy in EU • Systemic duplication and/or conflict between national & european research laws and patent laws. • Broad, dominant Geron patents in US and UK Plomer, Taymor, Scott CellStemCell, Jan. 08

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