I wasn’t able to be at the open HFEA meeting last week where decisions were made, amongst other things, about recommendations that the board would be making to the government about changing the regulations with regard to mitochondrial replacement. I have written about this subject on a couple of previous occasions (link below) but am delighted to re-print today the very clear summary that Sandy Starr of Progress Educational Trust has made. Sandy’s more in depth article in this week’s BioNews is also linked to below.
1) MODIFICATION OF EMBRYOS AND CHANGING THE GERM LINE
The HFEA will advise the government that any regulation of germline genetic modification – that is, modification that affects not only a person’s genes, but the genes of any children that person goes on to conceive (as will be the case with any females, but not males, who have been conceived using mitochondrial replacement) – should be permitted ONLY in relation to mitochondrial replacement. Furthermore, follow-up studies should be conducted to observe the health and characteristics of anyone who was conceived using mitochondrial replacement.
2) IMPLICATIONS FOR IDENTITY AND THE STATUS OF THE MITOCHONDRIA DONOR
The HFEA will advise the government that donors of the mitochondria used in mitochondrial replacement should have a status similar to that of tissue donors. Anyone who was conceived using mitochondrial replacement should NOT be entitled by regulation to access information that would identify the relevant mitochondrial donor. They SHOULD, however, be entitled to access NON-identifying information about the donor. Furthermore, mitochondrial donors and people conceived using their donation should be able to contact and identify one another – by mutual consent – if this is what they desire.
3) GENERAL VIEWS ON THE PERMISSIBILITY OF THE TECHNIQUES
Assessments by a panel of scientific experts in both 2011 and 2013 found NO evidence that either of the two mitochondrial replacement techniques currently being researched is unsafe. However, the HFEA will advise the government that further expert consideration of the safety and efficacy of these techniques should take place, as soon as the HFEA receives its first application for a license to perform mitochondrial replacement.
4) LICENSING MODELS AND FURTHER REGULATORY ISSUES
The HFEA will advise the government that mitochondrial replacement should be permitted ONLY for the purpose of avoiding serious mitochondrial disease, and ONLY in instances where clinical specialists think its use is appropriate. The HFEA thinks it should license mitochondrial replacement on a case-by-case (rather than condition-by-condition or centre-by-centre) basis to begin with, but should have the option of changing this regime further down the line if it so wishes.