HFEA agrees advice to Government on the ethics and science of mitochondria replacement
20 March 2013
The HFEA has today agreed its advice to Government on the ethics and science of new IVF-based techniques designed to avoid serious mitochondrial diseases.
In January 2012, the Government asked the HFEA, with the support of Sciencewise, to use its considerable experience of public engagement on controversial scientific developments to seek the public’s views on mitochondria replacement. It also asked for updated advice on the safety and efficacy of this potential treatment.
In a meeting observed by members of the public, the Authority considered the findings of the public dialogue, which showed broad support for mitochondria replacement being made available to families at risk of passing on a serious mitochondrial disease. The Authority also agreed to advise Government that, 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.
Professor Lisa Jardine, chair of the HFEA, said:
“The Government has asked us to take the public temperature on this important and emotive issue and that is what we’ve done. We’ve found that there is broad support for permitting mitochondria replacement, to give families at risk of mitochondrial disease the chance of having a healthy child.
Although some people have concerns about the safety of these techniques, we found that they trust the scientific experts and the regulator to know when it is appropriate to make them available to patients.”
The HFEA will now formally pass the advice to the Government, which will decide whether or not to seek Parliamentary permission to allow mitochondria replacement in treatment.
Notes to editors
- The HFEA is the independent regulator for IVF treatment and embryo research. Our role is to protect patients and the public interest, to drive improvement in the treatment and research sectors and to provide information to the public and policymakers about treatment and research.
- The consultation and public dialogue, carried out between June and December 2012, was guided by an independent oversight group, made up of experts and those with a personal interest in the issue. The group was chaired by Professor Neva Haites, who also chaired the expert scientific panel.
- Around 1 in 200 children are born each year with a form of mitochondrial disease. Some children have mild or no symptoms but others can be severely affected and have a shortened life expectancy. Symptoms include muscle weakness, intestinal disorders and heart disease.
- The first assessment of the safety and efficacy of mitochondria replacement was carried out in April 2011. The report, along with the updated assessment, can be found at: http://www.hfea.gov.uk/6372.html
- The findings of the public dialogue and the report considered by the Authority can be found at: http://www.hfea.gov.uk/7784.html
For further information please contact the HFEA press office on 020 7291 8226 or email email@example.com
Page last updated: 20 March 2013