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Draft regulations on mitochondrial replacement techniques echo Council recommendations
The Government has today published a consultation on draft Regulations to allow the use of new treatments to avoid inherited mitochondrial DNA disorders.
This follows a consultation and review held by the HFEA between June and December 2012, which concluded that “there is general support for permitting mitochondrial replacement in the UK, so long as it is safe enough to offer in a treatment setting and is done so within a regulatory framework”.
The Council welcomes the draft regulations, which echoes many of the key recommendations made in its 2012 report. This report explored the ethical implications of these techniques to provide a carefully considered background for public debate and national policy.
It concluded that the techniques offer an ethically acceptable treatment option for families affected by mitochondrial disorders, provided research shows they are likely to be sufficiently safe and effective, and that families are offered appropriate information and support. The Council also stated that any treatment offered would need to be provided under strict regulation, and that long term follow up of any children born as a result of this method would be vital.
Regulation of clinics
Under the proposed Regulations, any clinic wishing to provide this treatment would first need to seek licence from the HFEA, which would approve it on a case-by-case basis. We would expect the HFEA to ensure that research shows the treatment to be sufficiently safe and effective before any treatment licence is issued.
Monitoring and follow up
The Government recognises that mitochondrial transfer techniques constitute germline therapies, meaning that changes resulting from the replacement of mitochondrial DNA would be passed on to future generations, and that therefore ongoing monitoring of the use of these treatments and long-term follow-up will be vital. It considers that clinics providing this form of treatment should encourage the families involved to participate in follow up research, and envisions that the HFEA check what arrangements a clinic has in place for follow up studies before authorising a treatment.
To support follow-up research, the Council’s report further recommended the creation of a centrally funded register of any such procedures performed in the UK, accessible to researchers over several decades.
Status of the donor
It is emphasised in the proposed regulations that a mitochondrial donor would not have the same status as a reproductive egg or embryo donor. This reflects the Council’s report, which recommended that mitochondrial donors should not be mandatorily required to be identifiable to the adults born from their donation.
Prospective treatments
Only the use of embryological techniques to avoid mitochondrial disease would be licensable under proposed new regulations. If any other embryological technique is developed in future, it would require new regulations to be made and approved by Parliament before it could be used in treatment.
The Council will look carefully at the draft Regulations and respond to the Government consultation in due course.
What are inherited mitochondrial DNA disorders?
This follows a consultation and review held by the HFEA between June and December 2012, which concluded that “there is general support for permitting mitochondrial replacement in the UK, so long as it is safe enough to offer in a treatment setting and is done so within a regulatory framework”.
The Council welcomes the draft regulations, which echoes many of the key recommendations made in its 2012 report. This report explored the ethical implications of these techniques to provide a carefully considered background for public debate and national policy.
It concluded that the techniques offer an ethically acceptable treatment option for families affected by mitochondrial disorders, provided research shows they are likely to be sufficiently safe and effective, and that families are offered appropriate information and support. The Council also stated that any treatment offered would need to be provided under strict regulation, and that long term follow up of any children born as a result of this method would be vital.
Regulation of clinics
Under the proposed Regulations, any clinic wishing to provide this treatment would first need to seek licence from the HFEA, which would approve it on a case-by-case basis. We would expect the HFEA to ensure that research shows the treatment to be sufficiently safe and effective before any treatment licence is issued.
Monitoring and follow up
The Government recognises that mitochondrial transfer techniques constitute germline therapies, meaning that changes resulting from the replacement of mitochondrial DNA would be passed on to future generations, and that therefore ongoing monitoring of the use of these treatments and long-term follow-up will be vital. It considers that clinics providing this form of treatment should encourage the families involved to participate in follow up research, and envisions that the HFEA check what arrangements a clinic has in place for follow up studies before authorising a treatment.
To support follow-up research, the Council’s report further recommended the creation of a centrally funded register of any such procedures performed in the UK, accessible to researchers over several decades.
Status of the donor
It is emphasised in the proposed regulations that a mitochondrial donor would not have the same status as a reproductive egg or embryo donor. This reflects the Council’s report, which recommended that mitochondrial donors should not be mandatorily required to be identifiable to the adults born from their donation.
Prospective treatments
Only the use of embryological techniques to avoid mitochondrial disease would be licensable under proposed new regulations. If any other embryological technique is developed in future, it would require new regulations to be made and approved by Parliament before it could be used in treatment.
The Council will look carefully at the draft Regulations and respond to the Government consultation in due course.
What are inherited mitochondrial DNA disorders?
Maternally-inherited mitochondrial disorders are progressive illnesses that can cause a wide spectrum of severe health problems including heart and other major organ failures, stroke, dementia, blindness, deafness and premature death.There is currently no cure for these disorders, but researchers are developing new variations of IVF techniques that aim to replace damaged mitochondria by using part of a donated egg from a healthy individual. The intention is to allow women carrying disorders of mitochondrial DNA the chance to have healthy children that are genetically related to them, but born free of those disorders.The techniques are currently only permitted in research settings, but existing legislation means that Parliament could vote to allow these techniques to be used in treatment.
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