The U.K. government today issued proposed regulations that would allow researchers to try a new and controversial in vitro fertilization (IVF) procedure in patients. The technique could allow women who are carriers of mitochondrial disease to have healthy, genetically related children. But it also transfers DNA from one egg or embryo into another, a form of genetic alteration that could be passed on to future generations. Altering the genes of human egg cells or embryos in IVF procedures is now forbidden in the United Kingdom.
The procedure has also been under scrutiny this week in the United States as an advisory committee to the Food and Drug Administration discussed the technique at a 2-day meeting.
Mitochondrial diseases occur when the organelles, which provide energy for cells, don’t work properly. Many such disorders result from mutations in the genes that mitochondria carry. Because mitochondria are passed on through the egg cell, the diseases are inherited from the mother.
Researchers have developed ways to transfer the genetic material from an egg cell that carries faulty mitochondria into a donor egg cell that has healthy mitochondria. The resulting embryo carries nuclear DNA from the mother and father and mitochondrial DNA from an egg donor.
Studies in animals and in cell models have had enough success that some scientists say they would like to try the technique in patients. In 2011, the U.K. government started a process to evaluate the scientific and ethical issues surrounding the procedure. Those panels gave the technique a cautious green light, and last year the government said it would propose regulations that would allow the technique.
The proposal released today would permit the procedure only for women who are highly likely to pass on mitochondrial disease to their children. It also stipulates that the mitochondrial donor would have no claim to parental rights to any resulting child. Donors and recipients would be kept anonymous, although clinics could arrange for meetings if both parties agreed.
The draft regulations are open for public comment through 21 May. The Department of Health will take comments into consideration before presenting a final proposal to the Parliament.