HFEA Publishes Recommendations for Reform of Fertility Law

The Human Fertilisation and Embryology Authority has recommended changes to the law that governs fertility treatment and embryo research in the UK...

The Human Fertilisation and Embryology Act 1990 established dedicated regulation of fertility treatment and embryo research in the UK, as well as establishing the HFEA itself. The HFEA now proposes modernising the law in four areas: patient safety and promoting good practice, access to donor information, consent, and scientific developments.

'The current law does not reflect the range and type of fertility treatment on offer today, nor modern regulatory standards,' said Julia Chain, chair of the HFEA. 'Our proposals would improve patient safety and protection, and maintain the UK's position as a country where scientific and clinical innovation can flourish.'

The 1990 Act was last amended in a thoroughgoing way in 2008. Since then, the fertility sector in the UK has changed significantly. The number of patients undergoing fertility treatment has increased from just over 6000 in 1991 to nearly 52,000 in 2021, and a majority of patients now privately fund their own treatment.

The HFEA's proposals follow a public consultation earlier this year, which sought the views of patients, clinic staff, and members of the public (see BioNews 1181).

One of the most notable changes to be proposed concerns donor identifiability. Previously, people conceived from donations made from 2005 onwards could access identifiable information about their donors upon turning 18. Chain described as a 'significant departure' the regulator's proposal to make donors identifiable from the birth of a donor-conceived child.

Chain said: 'Nowhere in this field has the pace of social and technological change been more rapid than in the growing popularity of direct-to-consumer DNA testing and social media, with a lasting impact on donor anonymity. We need to balance the law with what is taking place in reality.'

On the subject of embryo research, the HFEA recommended that the updated legislation be made 'future proof', giving the regulator the flexibility to adapt to future scientific developments. Potential upcoming issues include whether or not to extend the current 14-day limit on human embryo research.

The HFEA also proposes expanding its enforcement powers, including the ability to impose financial penalties, aiming to improve compliance and protect patients and consumers.

Finally, the regulator recommends 'an overhaul of the consent regime in the Act'. The changes proposed seek to simplify the consent processes that are involved in both treatment and research, and to enable automatic record sharing between clinics and NHS records in the interests of joined-up patient care.

The proposals have been awaited by many in the fertility sector. Dr Raj Mathur, chair of the Britsh Fertility Society said 'The UK is a world leader in sensible regulation of fertility treatment, but some aspects of the current law make life unduly difficult for patients and clinicians. We are keen to work with the regulator and government to make the Act fit for the 21st Century'.

The HFEA does not have the power to change the law, so it remains to be seen whether and how its proposals will be taken forward by the government and by Parliament.