Overview

1
Overview

• Global
• National
• Vauxhall

2
(No Transcript)
3
President Obama

• Before
• As president, I will lift the current
  administrations ban on federal funding of
  research on embryonic stem cell lines created
  after August 9 2001 through executive order
• Now
• So were still examining what things well do
  through executive order, but I like the idea of
  the American peoples representatives expressing
  their views on an issue like this.

4
(No Transcript)
5
EU Overview
6
EU Overview
7
NHS Ethical Review Bodies (UK)
Human Tissue Authority
UK Ethics Committee Authority
National Patient Safety Authority
Human Fertilization and Embryology Authority
Medicines and Healthcare Products Regulatory
Agency
Gene Therapy Advisory Committee
National Research Ethics Service
Authorized Research Ethics Committee
Recognized Research Ethics Committee
Institutional Ethics Committee
Institutional Ethics Committee
Clinical Gene Therapy
Medicines, Devices, Tissue Engineering, Blood
Gene Therapy
ART Human Embryo
Human Tissue Organs
Clinical Trials
Vulnerable Groups
8
UK Regulation

• Human Fertilisation and
• Embryology Authority (HFEA)
• Human Tissue Authority (HTA)
• Medicines and Healthcare
• products Regulatory Agency
• (MHRA)

9
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 HFEAs 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
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
HFEA the 2008 Act
12
HFEA the 2008 Act
13
HFEA the 2008 Act
14
HFEA the 2008 Act

• Aug 2000 Donaldson Report - recommends ban
• 2001 HFE (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
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
HFEA the 2008 Act

• Jan 2008
• HFEA grants licences to both
• Newcastle and Kings College
• April 2008
• Judicial Review proceedings
• issued

17
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
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
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
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
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 It 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
HFEA the 2008 Act

• The Governments 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
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.