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

https://doi.org/10.1136/jme.2007.022657

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    A failure to provide a comprehensive and cohesive regulatory system to govern stem cell research and application will hinder the development of treatments for serious diseases and undermine the UK’s attempts to become a global leader in this field

    Stem cells are the source cells in the human body from which all other cells develop and have the remarkable ability to heal damaged tissue and to grow new tissue and, potentially, organs. In the UK, researchers are striving to harness these capacities to develop stem cell therapies for conditions such as macular degeneration, liver disease, infertility, spinal cord injury, Parkinson disease, diabetes and many more. The government is keen to ensure the UK’s global pre-eminence in this area, and in May 2004, £16.5 million of public sector funding was allocated to stem cell research.1 In 2005, the UK Stem Cell Initiative (UKSCI) was established to develop a 10-year research and development strategy for 2006 to 2016, aiming to ensure that the UK is “the most scientifically and commercially productive location for this activity over the coming decade, and which commands the support of public and private research funders, practitioners and commercial partners”.2 The UKSCI has recommended that the government should provide increased funding of £11 million to £74 million a year over the 10 years to 2016 and set up public/private partnerships to coordinate and develop stem cell research and technology.2

    To match the pace of scientific progress in stem cell research,3 4 it is critical that UK law is clear, consistent and capable of application by those working in the field, from the moment of obtaining tissues from which stem cells will be derived to their use in clinical applications. Unfortunately, this is far from the case. A plethora of legislation and other guidance, both …

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    Footnotes

    • ↵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). http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsLegislation/DH_074718 (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:
      EUTCD
      European Union Tissues and Cells Directive 2004
      hESCs
      human embryonic stem cells
      HFEA
      Human Fertilisation and Embryology Act
      HTA
      Human Tissue Authority
      MHRA
      Medicines and Healthcare Products Regulatory Agency
      UKSCI
      UK Stem Cell Initiative