The HFEA 30 years on - what needs to change?
by Julia Chain
Over a year ago, we published our first 30th anniversary blog and set out that we would use this milestone as an opportunity to consider what changes to the law are needed. Over the last year, our blogs have looked at different aspects of our regulatory regime, from changes in society, information provision and support, to scientific progress and CRISPR mediated genome editing; together with some thought provoking pieces on donation and our vision for the future.
All these pieces have in common a reflection on wanting to maintain the principles set out in the Human Fertilisation and Embryology Act, which is now over 30 years old, while recognising that it is time to modernise this Act.
Whilst we can and do regulate effectively with the tools we have there is more to be done and although any changes to the Act are for Parliament to agree, I want to be clear about where the HFEA sees the need for change. There are three areas of the Act that I want to focus on – patient protection, scientific developments and consent, data sharing and anonymity.
Currently the Act does not reflect patient centred care as being a cornerstone of good treatment. In an increasingly commercialised area of medicine, this lack of focus on the needs and protections of the patient is out of step with modern healthcare. We need to address this.
We need an Act that enables research to be carried out in the spirit of the ‘Warnock principles’ while understanding that some of those principles have been overtaken by modern medicine and new scientific discoveries. There has been some debate about the so-called 14-day rule. I am not calling for a change to this rule now. But if there is a change to our legislation in the coming years, it must have some element of future proofing to accommodate future scientific developments.
Consent is fundamental to our law, however various aspects of the current rules are overly complicated. The Act also makes it difficult to share data and there are particularly restrictive rules relating to the sharing of patient data, which can be problematic when a patient transfers from the IVF unit to maternity care.
As we know, the need for donor anonymity has been overtaken by shifts in social attitudes about fertility treatment and donation and the growth in affordable direct to consumer DNA tests. New thinking is required to understand exactly what data confidentiality makes sense in the current environment and the role of the regulator in supporting individuals who find out they are donor conceived.
Progress is already being made towards modernising the law with the amendment to the Health and Care Bill to change the statutory storage limit for gametes. We are fully supportive of this, and it will bring UK law in line with advances in science, changes in modern society and individuals’ reproductive choices giving patients more time to make important decisions about planning their family.
Finally, there are a number of inequalities present in access to and provision of fertility treatment today. Not all are within the remit of the HFEA but our research and data highlights them and any discussion of changes must look to resolving these. We know there are major differences in access to funding for same sex couples and in access to funding and outcomes for Black and ethnic minority patients. This is in addition to the so-called postcode lottery, which means that where you live can be a main determinator of whether you have access to NHS funding for treatment or not. With fertility treatment costing many thousands of pounds, many of those who cannot pay themselves are excluded from treatment. For all these reasons, I will want to ensure that any discussion about the modernisation of fertility laws takes place within a wider discussion on reducing and eliminating these inequalities.
Modernising the Act will be one of my main priorities during my term as Chair of the HFEA. I am delighted that today I will Chair the first meeting of an advisory group set up to help advise me on these changes. My aim is to reach an outline agreement with the Department for Health and Social Care before the end of 2022 on what needs to change. I want to ensure the UK remains at the forefront of fertility regulation, and that means the law needs to change to provide the kind of end-to-end regulation that will act in the best interests of patients for another 30 years.
Review date: 29 March 2024