Overview

1. Genome Canada - 23 October 2008 0 Overview Global National Vauxhall

2. Genome Canada - 23 October 2008 1

3. Genome Canada - 23 October 2008 2 President Obama Before: “As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines created after August 9 2001 through executive order” Now: “So we’re still examining what things we’ll do through executive order, but I like the idea of the American people’s representatives expressing their views on an issue like this.”

4. Genome Canada - 23 October 2008 3

5. Genome Canada - 23 October 2008 4 EU Overview

6. Genome Canada - 23 October 2008 5 EU Overview

7. Genome Canada - 23 October 2008 6

8. Genome Canada - 23 October 2008 7 UK Regulation Human Fertilisation and Embryology Authority (HFEA) Human Tissue Authority (HTA) Medicines and Healthcare products Regulatory Agency (MHRA)

9. Genome Canada - 23 October 2008 8 Joint Statement HFEA Regulates procurement of gametes and associated processing involved in creation of an embryo Remit includes use of embryos in derivation of stem cell lines but does not extend to regulation of cell lines themselves HTA Regulates processing, storage and distribution of stem cell lines intended for human application During cell line derivation, embryo is dissociated and at this processing stage the HTA regulatory remit begins and HFEA’s remit ends MHRA Once ‘Master Cell Banks’ are created with a reasonable expectation of clinical utility in a medicinal product, they fall within remit of MHRA (updated May 2008)

10. Genome Canada - 23 October 2008 9 HTA Guidance Stem-cell (gamete-derived) cell based products that involve the destruction of a human embryo in their formulation are initially licensed by the HFEA. At the point where the embryo has been destroyed and cells are harvested these human cells would fall under the remit of the HTA. The development of a product using these cells is under the remit of the HTA until such time as the MHRA classifies the product as an Investigational Medicinal Product (IMP) or the product is classified as an ATMP. Once this classification has been confirmed the Manufacture, Clinical Trial Approval and Marketing approval (for IMPs) are under the remit of the MHRA and not the HTA.

11. Genome Canada - 23 October 2008 10 HFEA: the 2008 Act

12. Genome Canada - 23 October 2008 11 HFEA: the 2008 Act

13. Genome Canada - 23 October 2008 12 HFEA: the 2008 Act

14. Genome Canada - 23 October 2008 13 HFEA: the 2008 Act Aug 2000: Donaldson Report - recommends ban 2001: HF&E (Research Purposes) Regs Feb 2002: HL Select Comm - questions distinctions Mar 2003: R (on app Quintavalle) v Sec of State for Health Mar 2005: HC Select Comm – recommends hybrids be permitted Nov 2005: HFEA response to Govt consultation - “The creation of human-animal hybrids is permitted until the two cell stage under the current Act” May 2006: HFEA Ethics & Law Comm – agreed Nov 2006: Newcastle and Kings submit licence applications

15. Genome Canada - 23 October 2008 14 HFEA: the 2008 Act Dec 2006: White Paper proposes ban Jan 2007: HFEA announce - cybrids are human embryos and therefore within their remit another public consultation no licence decision until Autumn April 2007: HC Select Comm calls for research to be permitted May 2007: Draft Bill follows White Paper but Govt statement indicates intention to allow certain categories Aug 2007: Joint Select Comm supports all categories Sept 2007: HFEA policy decision that hybrids within their remit Nov 2007: New Bill allowing all categories

16. Genome Canada - 23 October 2008 15 HFEA: the 2008 Act Jan 2008 HFEA grants licences to both Newcastle and Kings College April 2008 Judicial Review proceedings issued

17. Genome Canada - 23 October 2008 16 HFEA: the 2008 Act JR Ground 1 “The Act did not seek to define "human embryo". What is "human" will be dependent on the particular facts of any case and informed by scientific knowledge at the time. I do not accept the claimants' submission, that the fact that this technique is in a separate category under the new Act, means that Parliament did not intend it to fall within the definition of "human embryo" under section 1 of the 1990 Act.” “As for what Parliament intends, we now know this. It is to be found in the new Act; an Act which recognises the need to move on with the development of science and which allows for amending regulations to be made to reflect developments when they occur within the intention of the Act. The technique in this case called human animal embryos is to be regulated. This is in keeping with the approach taken by the defendant when it granted the licences in January 2008.”

18. Genome Canada - 23 October 2008 17 HFEA: the 2008 Act JR Ground 2 “As for the decision to grant the licence while the Bill was going through Parliament, the defendant as the regulatory body, is entitled to act on the law as it stands and as it understands it. A decision had been made based on scientific evidence that the technique fell to be regulated, and thus the defendant was obliged to consider the necessary pre conditions to granting or refusing a licence. This ground, in my judgment, is unarguable.”

19. Genome Canada - 23 October 2008 18 HFEA: the 2008 Act Prohibitions: 3(1) No person shall bring about the creation of an embryo except in pursuance of a licence. … (2) No person shall place in a woman - (a) an embryo other than a permitted embryo (as defined by section 3ZA), or (b) any gametes other than permitted eggs or permitted sperm (as so defined).

20. Genome Canada - 23 October 2008 19 HFEA: the 2008 Act Stem cell derived gametes: (2) A permitted egg is one - (a) which has been produced by or extracted from the ovaries of a woman, and (b) whose nuclear or mitochondrial DNA has not been altered. (3) Permitted sperm are sperm - (a) which have been produced by or extracted from the testes of a man, and (b) whose nuclear or mitochondrial DNA has not been altered.

21. Genome Canada - 23 October 2008 20 HFEA: the 2008 Act Licences for therapy “The problem with the current Bill is that if, one day, the research works, and it is possible to derive from embryos stem cells that could be used to treat, say, diabetics by providing new, insulin-producing cells, or Parkinson disease, it is not clear whether it would be possible to create embryos and use or store them for the purpose of therapy. Clearly, clinical trials are covered by the term research, so it will be possible to create, store and use an embryo to provide stem cells for use in clinical trials. One cannot keep doing clinical trials once a treatment is known to work … [I]t is not clear whether the original embryo, from which the new stem cells are derived, will be covered, under the HFEA, by a licence, because one can get a licence only for treating infertility or for research.” Dr Evan Harris MP 19 May 2008

22. Genome Canada - 23 October 2008 21 HFEA: the 2008 Act “The Government’s view is that the 1990 Act does not act as a legal barrier to the creation of an embryonic stem cell line for therapeutic application. Any embryonic stem cell line intended for therapeutic use will need to be subjected to considerable research activity, including rigorous safety assessment before entering into pre-clinical studies. The cell line would need to be ‘characterised’ to form an understanding of the innate characteristics of that specific line.”

23. Genome Canada - 23 October 2008 22 HTA October 2007: Following a number of enquiries, we have been liaising with NHS Blood and Transplant (NHSBT) about their washed bone and tendon products. NHSBT deem that tendons and washed bone products, which have undergone their processes, are acellular. This means that they are not classed as ‘relevant material’ under the HT Act. December 2008: The HTA does not currently license establishments storing or distributing acellular products, but we have been in close communication with the European Commission … on this issue.