On 15 December 2016, the Human Fertilisation and Embryology Authority (HFEA) approved the use of a new medical technique, known as mitochondrial donation, at UK fertility clinics.
This means people at high risk of conceiving a baby with certain life-threatening genetic conditions can have the chance to conceive a healthy, genetically related child. This technique is encompassed in a range of techniques often referred to as 3-Person IVF. UK licensed fertility clinics can now apply to the HFEA for permission to offer this on a case-by-case basis to fertility patients.
This new technique works by transferring the nucleus of an affected woman's egg (or nucleus of a fertilised embryo) into the shell of another woman's egg or embryo (having first removed the nucleus). This technique creates an embryo from the genetic material of three people.
The HFEA'S decision to approve use of mitochondrial donation came after an independent scientific panel published its fourth set of findings on the technique's safety and efficacy. These findings recommended this new 3-Person IVF technique could be used cautiously in certain cases.
Parliament passed regulations allowing mitochondrial donation in February 2015. Regulatory frameworks were introduced in the UK in October 2015. However, UK fertility clinics were advised to wait until after the HFEA'S expert panel had published its findings before applying for permission to offer this to patients. The HFEA licences and regulates fertility treatment at UK fertility clinics.
The world's first baby was born in 2016 using this new 3-Person IVF technique. The US medical team travelled to Mexico to carry out the medical procedure. The baby boy was born free of the genetic condition carried by his mother called Leigh Syndrome, which could have proven fatal. The family had already experienced four miscarriages and lost two children to this disorder.
A baby girl was born in Ukraine on 5 January 2017 also using this new 3-Person IVF technique. The couple had tried to conceive for 10 years, undergoing four unsuccessful IVF treatment cycles.
Mitochondrial disease affects 1 in 5,000–10,000 people. This new 3-Person IVF technique is believed to be able to help about 15% of people affected by mitochondrial disease. Some scientists are seeking permission to use this technique more widely in fertility treatments.
Mitochondrial donation techniques continue to spark controversy. Concerns have been raised about their safety, changing the human germline and implications for identity. In the past, there has been strong international census against human genetic modification. The UK's decision to pass regulations permitting mitochondrial donation in 2015, together with the HFEA's approval last month of this new 3-Person IV technique marks a turning point in the development and use of assisted reproductive technologies.
Assisted conception and fertility treatment is a rapidly evolving area of law and practice. This is aptly demonstrated by recent developments in the use and regulation of mitochondrial donation in the UK and worldwide. This fast moving arena creates wide ranging and often complex legal, practical, financial and emotional implications for all involved. There are disparities internationally, which can leave parents, donors, surrogates and children in uncertain legal and practical situations.
Many people experience difficulties conceiving a much wanted child for a variety of reasons including: unexplained infertility, genetic disorders, cancer, successive miscarriages or inability to carry a pregnancy. In addition, modern family-building takes many forms including solo parents, heterosexual and same-sex couples together with families built through donor conception, surrogacy, co-parenting and adoption. This creates complex and wide ranging dynamics, financial, legal and medical issues and risks for those involved. It can have unintended outcomes which can leave parents without legal status for their child. It can confer unwanted legal status on others.
Improvements and developments in assisted reproductive techniques, together with the needs of modern families built through assisted conception, challenge existing legal frameworks. The HFEA requires fertility patients to give informed consent to treatment, encompassing both the legal and medical issues, implications and outcomes. It is also the consistent message of the English Family Court that all parties involved in assisted conception and modern family building should obtain specialist legal advice before establishing a pregnancy. This enables parties to understand the legal, practical, financial and emotional issues and proactively manage these to place family building on a secure footing.