The HFEA has today published the results of their consultation seeking the public’s views on mitochondria replacement. They found broad support for mitochondria replacement being made available to families at risk of passing on a serious mitochondrial disease.
They conducted this consultation at the request of the Secretary of State for Health to inform him as he decides whether to introduce regulations to allow this technique to be available for affected families. Research into these techniques is underway at the moment.
On the basis of this consultation and further updated advice on the safety and efficacy of this potential treatment, the HFEA has advised the Secretary of State of this broad support and suggested certain policies and safeguards that should be put in place if he decide to introduce Regulations.
An estimated 6,000 people in the UK have a mitochondrial disease. Two novel IVF-related techniques have been developed to avoid these heritable conditions being passed down the maternal line (for more detail see this great POSTnote). These are controversial because they involve a child receiving DNA from three people and, unlike any other genetic therapy so far approved for use, the genetic changes they introduce will be passed down the generations.
At present, the HFEA has the power to license these techniques for research, but if this research proves successful, they cannot license treatment by these techniques. But in the Human Fertilisation and Embryology Act 2008, Parliament recognized the potential of this research and put in place regulation-making powers so at a future date, regulations could be made to license this treatment for use in people.
In March 2011, recognising progress having been made towards a treatment ready for affected couples, the then Health Secretary, Andrew Lansley asked the HFEA to review the current scientific knowledge, informing him on the safety and effectiveness of these methods. They looked solely at the science, not the ethics surrounding this technique, and reported in April the same year calling for additional experiments to be undertaken to further demonstrate the safety of these techniques. Subsequently, the Wellcome Trust announced funding for such research and it is underway in the UK.
And then in 2012, the Nuffield Council on Bioethics tackled the ethical framework. We gave evidence in a joint submission with Muscular Dystrophy Campaign. The Council's working group concluded that if the procedure were proven to be scientifically safe then it would be ethical to offer these therapies to patients provided they had the appropriate information and support.
Finally, in September 2012, the HFEA launched a public consultation seeking views on the use of the technique via an online form and two face to face meetings. AMRC responded to this consultation jointly with Genetic Alliance UK. They reported today.
What did the HFEA say today?
The HFEA considered mitochondrial replacement at their open meeting today. They looked at the results of their consultation seeking the public's views on mitochondria replacement and updated advice on the safety and efficacy of this potential treatment. They decided to issue formal advice to Jeremy Hunt, the Secretary of State for Health stating that:
There is broad public support for mitochondria replacement being made available to families at risk of passing on a serious mitochondrial disease
Should Regulations be drafted to permit the technique, the following policies and safeguards should be put into place:
- Clinics wishing to offer mitochondria replacement should be specifically licensed by the HFEA to do so.
- The HFEA should approve each use of mitochondria replacement, though Regulations should provide the flexibility to modify this in the future.
- Clinics should ensure that follow-up research on the children born takes place.
- Mitochondria donors should be thought of as a kind of tissue donor: the resulting child should not have a right to identifying information about the donor, although information exchange and contact could be arranged locally by mutual consent.
- A further assessment of the safety and efficacy should be commissioned by the HFEA once a clinic has submitted an application to carry out one of the techniques. This follows advice from an expert scientific panel that there is no evidence to suggest that mitochondria replacement is unsafe, but that further specific experiments should be conducted.
Now Jeremy Hunt has this advice, he is in a position to decide whether to introduce regulations which, if passed by parliament, would make this technique available for affected families.
Currently, there are few effective treatments for those affected by mitochondrial disease. Today's consultation shows that there is strong public support for these techniques to be made available to families at risk of passing on a serious mitochondrial disease to their children. We believe this regulation should be introduced as soon as possible so that once the technique is proved safe and effective, there are no delays in making this available to affected families.