EARLIER this month, UK MPs made history by agreeing to allow women with serious mitochondrial disease to conceive a genetically related embryo via in vitro fertilisation, without passing on mitochondrial errors.
The UK House of Commons voted in favour of draft regulations that will allow the use of donated mitochondria, although the regulations are ultimately contingent on approval by the House of Lords.
Mitochondrial disease affects one in 250 people, can be difficult to diagnose, has no known cure and symptoms can vary in type and severity ranging from minor to debilitating physical, developmental and mental health problems. It is a genetic disorder that can be present at birth, or develop later in life. One in 5000 babies is born with a severely disabling form of mitochondrial disease, which can cause death in infancy, childhood or adulthood.
The memorandum said one of two techniques — maternal spindle transfer (MST) or pronuclear transfer (PNT) — could be used to implant the nuclear DNA of the patient’s egg or embryo into a donated egg or embryo containing healthy mitochondria.
The techniques would be used as part of an IVF treatment, and possibly as an alternative to pre-implantation genetic diagnosis.
The UK paved the way for mitochondrial donation back in 2008 when Parliament included powers into the Human Fertilisation and Embryology Act to permit the future drafting of regulations on mitochondrial donation. In 2011, the national fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), established an expert panel to test the safety of MST and PNT.
Late last year, the panel concluded that “there is no evidence to show that mitochondrial donation is unsafe”.
The HFEA raised some concerns regarding the risk of the mother and donor having different haplotypes and recommended “as a precautionary step that consideration be given to mitochondria haplotype matching in the process of selecting donors — even though the risks of not doing so will be very low”.
In response to the HFEA’s findings, the UK Government introduced the Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, which have just been passed in the lower house.
The regulations allow for the use of MST or PNT techniques for mitochondrial disease only and prohibit any further alterations to DNA. Treatment centres will require a special licence to use these techniques.
Patients will not be automatically eligible for treatment. The HFEA will review each patient to determine eligibility, which includes that the woman has a particular risk that her eggs contain mitochondrial abnormalities and there is a significant risk that such abnormalities will lead to serious mitochondrial disease.
Children born following mitochondrial donation will be able to have access to limited non-identifying information about their donor such as family medical history, and donors will be permitted to access limited non-identifying information about the child. The applicant will be given an opportunity to seek counselling before receiving information, and the donor or child will not be notified that a request for information has been made by the other party.
The regulations make clear that donors are not related to any child born using their donation, and are not able to apply for a parental order on the basis that they are the child’s donor.
The UK decision raises questions about whether Australia will follow suit. Currently in Australia, the Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning for Reproduction Act 2002 make it an offence to create an embryo by fertilisation containing genetic material provided by more than two people.
Despite the clear advantages in eliminating debilitating diseases in future generations, mitochondrial donation is replete with moral and ethical concerns. Fears of three-person designer babies and meddling with human DNA are among concerns raised by opponents of the techniques and noted in the HFEA report.
Following a series of public consultations, surveys and workshops in the UK, the HFEA concluded that “the overall ethical concerns were outweighed by the arguments in favour of permitting mitochondria donation”.
Proponents stressed the potential health benefits and the importance of giving women the choice to seek treatment with full knowledge that “use of these techniques would be a medical first and there may be a degree of risk involved”.
The regulations, if approved by the House of Lords, which is due to debate them on 24 February, will come into force in the UK in October this year. Australian fertility experts, ethicists, lawyers and patients will be following these developments with interest.
Bianca Phillips is a Victorian lawyer and medical law academic, researching and publishing on the intersections between law, technology and medicine.