Three-Person IVF UK Plans are going Forward…

Government Decision on Mitochondria Replacement Regulations

The creation of babies using sperm and eggs from three genetic parents, well considered by the UK government, which raised ethical concerns,  has moved another step closer in the UK…

Government Decision on Mitochondria Replacement Regulations

image of human cloning
The UK fertility regulator said there was no evidence that it would be unsafe, but called for extra checks. Should Parliament pass the regulations, the HFEA will need to consider how any mitochondria replacement therapies could be licensed.

The Government has today announced its intention to put regulations relating to mitochondria replacement before Parliament.

Earlier this year, the Department of Health commissioned the HFEA to reconvene its expert panel of scientists to conduct a review into the safety and efficacy of techniques relating to mitochondria replacement.The panel was clear that it had seen no evidence which suggested that mitochondrial replacement is unsafe and that good progress was being made on the science.

Dr Andy Greenfield, chair of the HFEA’s expert panel of scientists, said:

Our understanding of mitochondria has developed significantly over recent years, and scientists in the UK and the US are now close to providing new treatment options for a range of serious conditions that are inherited through the mothers’ mitochondria. In three years study the expert panel has seen no evidence which suggests that these new mitochondrial replacement therapies are unsafe. The scientific direction of travel is clear; and although we have recommended further experiments before treatment should be offered we understand that good progress on these is being made and we expect them to support the conclusions we have reached to date.”

Moving from research into clinical practice always involves a degree of uncertainty. If Parliament does change the law the regulatory processes required by the HFEA before treatment can be offered will ensure, to the extent that assurance can ever be offered, that mitochondrial replacement works and is sufficiently safe to be offered to people with serious mitochondrial disease.”

Sally Cheshire, Chair of the HFEA, said :

The HFEA was first asked by the Government to provide expert advice on this important issue in 2011. Since then we have produced three separate reports on the science and one on public attitudes. Our advice shows that the science is moving rapidly in the right direction and that a majority of the public support these new treatment options for what are serious, and sometimes fatal, inherited conditions. Taken together, these reports provide an evidence base which is a model for public policy making, especially when considering the introduction of new techniques at the cutting edge of biology and ethics.”

The decision to change the law is, quite properly, for Parliament and today the Government has signalled its intention to introduce Regulations. But even if the law is changed that doesn’t mean that treatments will be offered overnight. As the regulator, the HFEA will need to design and implement a process to ensure that clinics are licensed against rigorous standards – the public would expect nothing less.”

Should Parliament pass the regulations, the HFEA will need to consider how any mitochondria replacement therapies could be licensed. We look forward to working with the Department of Health to develop a rigorous approval process.

Sources and Six Years of BBC Press Releases:

  • Government decision on mitochondria replacement regulations,
    HFEA, press release, 22 July 2014.
  • Three person IVF plans ‘progress’ in UK,
    BBC News Health, health-28417860, 22 July 2014.
  • Three-person babies ‘in two years’ – says science review,
    BBC News Health, health-27678464, 03 June 2014.
  • Why make babies from three people?,
    BBC News Health, health-27682884, 03 June 2014.
  • Three-person baby details announced,
    BBC News Health, health-26367220, 27 February 2014.
  • UK government backs three-person IVF,
    BBC News Health, health-23079276, 28 June 2013.
  • A bold step for science and society,
    BBC News Health, health-23086162, 28 June 2013.
  • Three-person IVF: Your stories,
    BBC News Health, health-23096105, 28 June 2013.
  • Three-person IVF moves closer in UK,
    BBC News Health, health-21806911, 20 March 2013.
  • The woman who lost all seven children,
    BBC News Health, magazine-19648992, 20 September 2012.
  • Lisa Jardine: We need public opinion on 3-person IVF,
    BBC Today, newsid_9752000/9752373, 17 September 2012.
  • Ethics of using three people’s DNA to create one baby,
    BBC News Health, health-19604004, 17 September 2012.
  • ‘Three people, one baby’ public consultation begins,
    BBC News Health, health-19597856, 17 September 2012.
  • Three-person IVF ‘is ethical’ to treat mitochondrial disease,
    BBC News Health, health-18393682, 12 June 2012.
  • Three-person IVF’ technique moves closer,
    BBC News Health, health-16627043, 19 January 2012.
  • New fertility technique to be assessed by regulator,
    BBC News Health, health-12708858, 11 March 2011.
  • Three-person IVF ‘may prevent inherited disease’,
    BBC News Health, health/8619533, 14 April 2010.
  • Genetic advance raises IVF hopes,
    BBC News Health, health/8220553, 26 August 2009.
  • Three-parent embryo formed in lab,
    BBC News Health, health/7227861, 5 February 2008.

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