Small feet

Image via Bridget Coila

Newcastle Fertility at Life has become the first clinic in the UK to gain approval to create ‘three-person babies.’ This follows on from the decision made by the Human Fertilisation and Embryology Authority (HFEA) in December to allow clinics to start applying to perform the procedure on a case-by-case basis.

“I can confirm today that the HFEA has approved the first application by Newcastle Fertility at Life for the use of mitochondrial donation to treat patients,” said Sally Cheshire, HFEA Chair. “This significant decision represents the culmination of many years hard work by researchers, clinical experts, and regulators, who collectively paved the way for Parliament to change the law in 2015 to permit the use of such techniques. Patients will now be able to apply individually to the HFEA to undergo mitochondrial donation treatment at Newcastle, which will be life-changing for them, as they seek to avoid passing on serious genetic diseases to future generations.”

This approval doesn’t give the clinic free rein to perform the technique; the HFEA will still need to approve women on a case-by-case basis before the procedure can go ahead. Nonetheless, this is a major step forwards in bringing the technique into our healthcare. The clinic have said that they hope to be able to treat up to 25 people a year and they already have a woman wishing to undergo the treatment. If she wins approval from the HFEA, the first three-parent baby could be born as early as Christmas 2017.

The first child to be born using this technique was born in Mexico in 2016, garnering worldwide attention and raising discussions about the legality of such a practice. The UK was the first country in the world to actively legalise the procedure, although several countries, including Mexico, do not operate active bans.

Mitochondrial diseases are often fatal, causing malformations of organs such as the brain or muscles in early development. Currently, these diseases have no effective treatment or cure. The purpose of the three-parent process is to prevent mitochondrial diseases being passed from the mother to her offspring. It works by removing the DNA from the mother’s egg and implanting it into a DNA-free egg with healthy mitochondria from a donor before the fertilisation process is completed. Once formed, the donated mitochondrial DNA will make up around 1% of the child’s genome.

Responses to the announcement have been mixed.

“We had hoped that the HFEA would have listened to the thousands of people who have expressed concern about three parent embryos,” said Mark Bhagwandin, spokesman for the UK charity Life. “Instead it has ignored the alarm bells and approved a procedure which will alter the human genome. It is at the very least reckless and irresponsible given that we have absolutely no idea what the long term consequences are to us interfering with the human genome.”

There has also been concern raised by some people about how similar this process is to gene editing, considered by many to be a ‘slippery slope’ towards designer babies. As the treatment is largely untested, some are also worried about the potential safety risks of such a procedure.

However, amongst the science community the feeling has generally been more positive.

“This is excellent news, especially for those patients in the UK who have been waiting this opportunity,” said Professor Simon Fishel, Managing Director of CARE Fertility. “We know it won’t be easy for all concerned as the technology is not straight forward and success will depend upon many factors. But it is indeed a step in the right direction following in-depth debate and consideration of all issues from the medical science to the ethics.

“Regulating this technology via the HFEA and providing the opportunity for couples to deliver children free of this devastating disease here in the UK is a milestone that all who care about medical health will welcome, and we wish the Newcastle team and their patients a very successful programme.”

Doug Turnbull, director of research at Newcastle University which helped to create this type of mitochondrial donation, agreed. “Mitochondria diseases can be devastating for families affected and this is a momentous day for patients,” he said.