Government regulators in the UK have given a green light to the creation of three-parent embryos to combat mitochondrial disease.
A regulatory framework has been in place since October 2015, but clinics had been advised to wait until after the Human Fertilisation and Embryology Authority had considered the opinion of an expert panel.
The HFEA Chair, Sally Cheshire, praised the cautious approach taken by the government.
“Although it is tempting to rush ahead with new treatments, the UK approach of testing public opinion, putting the issue to parliament and carefully monitoring laboratory research has proved to be the most responsible and sustainable of introducing new, cutting edge treatments into the clinic. Such an approach has allowed us to balance innovation with safety, maintaining public trust as we go.”
Clinics must apply for permission to offer mitochondrial donation to patients. The HFEA will first assess a clinic’s suitability, looking at existing staff expertise, skill and experience at the clinic, as well as its equipment and general environment and then grant permission on a case by case basis to treat individual patients.
A team at Newcastle-upon-Tyne Hospitals NHS Foundation Trust and Newcastle University will probably be the first group to be granted a licence. It hopes to help 25 couples every year. The government health service will fund the treatment for the first trial of three-person IVF, as long as couples agree to participate in a long-term follow up of their children.
The media in the UK was jubilant, with The Independent commenting that it was “the best possible news for many families this Christmas.” But not everyone agreed. Marcy Darnovsky, of the Center for Genetics and Society, in California, was savage in her criticism, describing it as a first step toward genetic engineering.
“The HFEA presents itself as a model of responsible regulation, but its role in encouraging this risky biological experiment is deeply troubling. It has chosen to ignore the serious health risks these procedures pose for resulting children and future generations. It has failed to require follow-up studies of any children born as a result. And it has misconstrued public sentiment, representing deep divisions as ‘broad support.’”
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“This is not about saving children. As the US National Academy of Medicine has pointed out, these techniques do not address a medical need, as they do not treat any existing person for a disease, illness, or condition. And safer options for creating families are already available.”
“The HFEA decision is part of a disturbing trend toward the normalization of an experimental technology that is still widely considered unsafe, and whose implications for future generations are unknown. Allowing mitochondrial manipulation in humans could open the door to other forms of human inheritable genetic modification, banned in more than 40 countries worldwide.”
And British bioethicist David Albert Jones lamented that the UK was out of touch with policy in other countries:
There is much to admire about the United Kingdom but, in my experience, discussion of embryo policy in this country typically lacks humility. Indeed, it tends rather to the self-congratulatory while at the same time showing no awareness of its own insularity…
To the extent that the UK has engaged with other countries on embryo policy it has been to promote its own research agenda and further its own commercial interests. Arguably, the influence of the UK in this respect has been corrupting, though happily it has not always had its own way.
“Brexit” almost certainly will lessen British influence over human embryo research policy in Europe. This is to be welcomed. Without the malign presence of the UK, countries who remain in the EU will perhaps be better able to maintain their resistance to the constant pressure to commercialise technologies that rely on the unjust destruction of embryonic human beings.