Stem Cells: Emerging Legal and Stem Cells: Emerging Legal and

Ethical ChallengesEthical Challenges

Prof.. Aurora Plomer

Director SIBLE

School of Law

University of Sheffield

A.Plomer@sheffield.ac.uk

Regulation ExplosionRegulation 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

EU LawEU Law

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

Covered by EUTCDCovered 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.

Not covered by EUTCDNot 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).

Aims of UK RegulationAims 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.

Integrating EU law into UK law Integrating EU law into UK law

Stem Cell Research: Stem Cell Research: Emerging issuesEmerging 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

EU Directive Biotechnological EU Directive Biotechnological Inventions (1998): Inventions (1998):

Unpatentable InventionsUnpatentable InventionsArticle 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

Competing InterpretationsCompeting Interpretations

EPO

EGE

Sweden

UK P0

EPOEPO

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

The Bruestle Patent in EuropeThe Bruestle Patent in Europe

UK Patent OfficeUK Patent Office

Not Patentable

Human embryos Processes for

extracting stem cells from the human embryo

Totipotent hesc

Patentable

Pluripotent hesc

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

Commercialization: Commercialization: Emerging legal challengesEmerging legal challenges

Fragmentation on patent policy in EUSystemic 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