Whether it is the news that scientists have created mice with two fathers, the endless debate over whether gene editing has a role in reproductive medicine, or discussions about how long embryos should be grown in the lab, reproductive science has come a long way since the birth of the first ‘test tube baby’, Louise Brown, in 1978.
It was Baroness Mary Warnock, an English philosopher of morality and education, who in 1984 led a committee which explored the borderlands that lie between acceptable and unacceptable research on the human embryo. By building consensus, she became the architect of fertility regulation, first enshrined in the UK in the Human Fertilisation and Embryology Act in 1990 and regulated by the HFEA.
But the law itself has largely stood still. It does not reflect modern fertility practice, and is inflexible in responding to scientific innovation or shifting social attitudes.
Through the HFEA’s recently launched consultation, which is about standing back and looking at the big picture, the regulator ‘aims to put patients at the heart of fertility law and future-proof the HFE Act.’
Children born to sperm or egg donation, for example currently still have to wait until adulthood to find out about their parents – though one of the regulator’s areas of review is on whether parents and donors should have the choice to opt for anonymity until age 18 (as now), or whether identifiable information could be made available on request after the birth of a child.
The Human Fertilisation and Embryology Act has provided a robust but flexible framework that has fostered public trust in a sometimes-contested area of scientific and clinical work.
However, though millions of babies have been born through IVF, the method is still more likely to fail than to work, so a search is on for ways to improve success rates. There was, for example, the technique of ‘endometrial scratch’ during which a scratch or tissue biopsy is made to the lining of the uterus before IVF is carried out. This add-on treatment was offered—at a cost—to IVF patients to improve their chance of success but was subsequently shown in a large randomized trial to be of little or no value.
The law remains ambiguous about the circumstances in which the HFEA is able to approve add-ons in the clinic, especially where more clinical evidence may be needed to establish their efficacy. If the law explicitly provided for the HFEA to pilot novel processes for a trial period, with appropriate controls and conditions, then regulation would nurture innovation and protect patients from, at best, the scientific insights that fail to translate into the real world, and at worst expensive quackery.
One way to test IVF add-ons is through the use of trials or regulatory ‘sandboxes’, which encourage innovation while minimising risks. Sandboxes have been described as ‘controlled experiments in which new products, services, or ways of doing things can be placed into a real-world environment’. They allow regulators to place conditions on doctors using a newly approved process (or one under assessment), to ensure that it is only used in a limited, specific, monitored setting. They can also build in review points to examine risk, allowing for the regulator to step in if a new process is not shown to be sufficiently safe and effective in practice.
Demand for new treatments is also driven by advances in genetics and genomics, which offer hope for families affected by serious genetic conditions and we are entering an era in which science could rewrite the gene pool of future generations.
Any change in the regulation of an advance, from gene editing to growing embryos for longer to novel ways to select ‘healthy’ embryos, would require wider public debate prior to parliamentary amendment but the hope is that, by making the law better able to flex to scientific developments, Parliament could approve significant new scientific and clinical developments by means of regulation without re-opening the Act every time.
The consultation is open until 5pm on 14 April and will inform the recommendations that the HFEA will submit to the Department of Health and Social Care. As ever, any decision to update the law is for the Government and ultimately Parliament. Even so, this is a golden opportunity for everyone to have their say in the future of reproduction.