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Gaps and overlaps: improving the current regulation of stem cells in the UK

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  • i The UK government announced a review of the 1990 Act in 2004 and held a public consultation on it between August and November 2005. As a result, the Human Tissues and Embryos (Draft) Bill was published on 17 May 2007 and is intended to revise the law on assisted reproduction and embryology and to establish the Regulatory Authority for Tissue and Embryos (RATE). (accessed 6 Sep 2007).

  • ii There are many others—for example, hybrid embryos, artificial gametes and disposal of stem cells.

  • iii A blastocyst is a fertilised egg that has divided and is usually used when it has reached the 8-cell stage, at around 6 days post fertilisation.

  • iv For example, in relation to consent to research use in Schedule 3 and the stage of development up to which research can be carried out in sections 3(3)(a) and 4.

  • v The EUTCD, as transposed into UK law by the Human Fertilisation and Embryology Act (Amendment) Regulations 2007.

  • vi The second set of regulations transposing the EUTCD and its two technical directives into UK law.

  • vii aboratories operating to recognised standards of good manufacturing practice (GMP), incorporating Grade B environments for derivation and culture to ensure cells are clean enough to be used therapeutically.

  • viii Centre of Excellence for Life Sciences (CELS) research indicates an approximate timeline of 23 years from initial concept to product on the market.19

  • Competing interests: None.

  • Abbreviations:
    European Union Tissues and Cells Directive 2004
    human embryonic stem cells
    Human Fertilisation and Embryology Act
    Human Tissue Authority
    Medicines and Healthcare Products Regulatory Agency
    UK Stem Cell Initiative

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