On February 3, 2015, Members of Parliament (MPs) in the United Kingdom (UK) debated and passed (by a vote of 382 to 128) a statutory instrument to approve the draft Human Fertilization and Embryology (Mitochondrial Donation) Regulations 2015 in the House of Commons. Mitochondrial donation is also know as three-parent in vitro fertilization, which effectively allows the conception of babies from three people. Some people fear it is the first step toward creating designer babies, where genetic characteristics could be chosen by the parents. Researchers hope that mitochondrial donation will prevent the passage of mitochondrial diseases from mother to child.
According to a House of Commons research briefing, the mitochondrial donation techniques have been subject to three scientific reviews (2011, 2013 and a further update in 2014) by a Human Embryology and Fertilization Authority (HFEA) expert panel, an ethical review by the Nuffield Council on Bioethics and a HFEA public consultation. The statutory instrument must still be approved by the House of Lords before it becomes law.
According to the Centers for Disease Control and Prevention (CDC), mitochondria are tiny parts of almost every cell in our bodies. They turn sugar and oxygen into energy that the cells need to work. In mitochondrial diseases, the mitochondria cannot efficiently turn sugar and oxygen into energy, so the cells do not work correctly. There are many types of mitochondrial disease, and they can affect the brain, kidneys, muscles, heart, eyes, ears, and other parts of the body.
To prevent the passage of mitochondrial disorders from mother to child, researchers have devised the mitochondrial donation process by which the nucleus of a woman carrying harmful mutations in her mitochondrial DNA is transferred to an enucleated egg (an egg with the nucleus surgically removed) of another woman without such defects. The hybrid egg, which carries the nuclear DNA of the mother-to-be and healthy mitochondria from the egg donor, can then be fertilized in vitro with sperm from the would-be father, and the resulting embryos implanted into the mother-to-be.
The BBC reported that the Church of England and the Catholic Church in England and Wales urged UK politicians to delay their decision in order to allow more research and debate. The BBC quotes the Reverend Doctor Brendan McCarthy, Church of England advisor on medical ethics, as saying “We need to be absolutely clear that the techniques that will be used will be safe, and we need to be absolutely sure that they will work.” Sharon Bernardi, who lost all of her seven children to mitochondrial disease, told the BBC that this was not about changing the color of a child’s eyes. “This is [about] trying to make children survive,” she said. “We are not playing God or anything. I would ask them [the Church of England] desperately to please look at the bigger picture and look at the children who have been affected by the dreadful disease. No child should be born with a disease that’s going to cut their life short. I can’t believe anybody from the Church would want that.”
In the United States, on February 25-26, 2014, the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee conducted two days of hearings on the topic of mitochondrial donation (specifically, oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility). The advisory committee panel discussed what controls might be used in trials, how a developing embryo might be monitored during those tests, and who should oversee the trials. No decisions were made at the end of the session.