Draft regulations on mitochondrial donation published

The UK Department of Health has published draft guidelines for the use
of new techniques to prevent mothers passing on serious mitochondrial diseases
to their children. The guidelines will be the subject of a three-month
consultation.

The techniques, for use in
IVF, use a small amount of DNA from a female donor which is passed on to the
child and have been referred to as 'three-person IVF' by the press and 'mitochondrial
transfer' or 'mitochondrial donation' by specialists. They are currently being
evaluated by researchers and are not yet allowed to be used in humans.

A public consultation by the Human Fertilisation and Embryology
Authority (HFEA) last year found that overall, the British public
supports mitochondrial donation treatments being used, although that approval is
not universal (see BioNews 698).

The techniques are controversial because they involve three people
having genetic links to any baby. Also the donated DNA that would be passed to the child would also be passed on to subsequent generations.

One in 200 babies in Britain is born with a serious mitochondrial
disease. These conditions can affect many organ systems and can be fatal. They
arise due to mutations in the small amount of DNA contained in the mitochondria,
the cell's 'batteries' that provide energy.

Mitochondrial donation techniques seek to replace all the mitochondrial
DNA with that from a donor. As mitochondrial DNA is separate
from nuclear DNA and principally controls energy generation in cells it is
thought that any child born via mitochondrial transfer would not inherit any of
the donor's physical or psychological characteristics.

Dame Sally Davies, chief medical officer for
England, said: 'Allowing mitochondrial donation would give women who carry
severe mitochondrial disease the opportunity to have children without passing
on devastating genetic disorders. It would also keep Britain at the forefront
of scientific development in this area'.

Senior biomedical researchers have voiced support for
the Government's decision to move towards regulation of the technique. Professor Jeremy
Farrar, director of the Wellcome Trust, told the Telegraph: 'Once further public consultation on the detail
of these regulations is complete, we urge the Government to move swiftly so
that Parliament can debate the regulations at the earliest opportunity and
families affected by these devastating disorders can begin to benefit'.

However, Dr David King, director of the pressure group Human Genetics
Alert and a critic of the techniques, told the newspaper: 'The techniques have not passed the
necessary safety tests so it is unnecessary and premature to rush ahead with
legalisation'.

Under the draft regulations, donors would
remain anonymous; however, if a 16-year-old or older asks the HFEA if they were
born after mitochondrial transfer, the authority is required to inform them.

Mitochondrial transfer would only be allowed when there
is a 'significant risk' of disability or serious illness.

The consultation will end on 21 May 2014.