Should the HFEA be regulating the add‐on treatments for IVF/ICSI in the UK?

Fertility treatment ‘add-ons’ are defined as additional therapies and techniques designed to improve the chance of a live birth. As over 60% of in vitro fertilisation (IVF) treatments are self-funded, these extras usually attract a charge. There are nine fertility add-ons identified by the Human Fertilisation and Embryology Authority (HFEA) Scientific and Clinical Advances Advisory Committee, and at least one is used in up to 70% of UK clinics (www.HFEA.gov.uk). These include reproductive immunology treatments, endometrial scratching, egg activation with calcium ionophore, intrauterine culture, embryo glue, elective freeze-all, assisted hatching, pre-implantation genetic screening and time-lapse imaging. The use of fertility add-ons has been criticised openly in the medical press (BMJ 2016;355:i6434), and on television (BBC Panorama 28 November 2016), as lacking in evidence, with little or poor-quality information for patients. The implication is that some in the private medical sector make false claims of effectiveness to take financial advantage of desperate couples, who are open to exploitation. In support, recent patient surveys performed by the HFEA have revealed a need from patients for clarity of the effectiveness of add-ons, and an explanation of the science that supports their use (www.HFEA.gov.uk). For simple governance reasons alone, there is a clear need for regulation. The HFEA, established by the HFE Act in 1990, has a statutory duty to regulate clinics that offer treatments involving procurement, processing and storage of gametes and embryos. In particular, under section 17 of the HFE Act, ‘the designated Person Responsible has to secure that suitable practices are used in the course of treatment.’ More explicit instruction is to be found in the HFEA Code of Practice (CoP), under Licence Conditions, T72 (www.HFEA.gov.uk). Therefore there is a legal obligation for the HFEA to regulate such procedures. Regulation can take two forms; first, hard regulation performed by inspection and insistence on adherence to the CoP, with punitive penalties for noncompliance, and second through soft regulation, by promoting a change in mind set, and practice. An example of soft regulation is the successful HFEA multiple births reduction strategy, which through involvement of all professional bodies in the sector along with patient organisations has seen a fall in the IVF-related UK twin live-birth rate from 25% to 14%. One fundamental HFEA strategy is to ensure that patients have access to high-quality care. This requires accurate information to allow valid consent and preparation for treatment, which is deemed equally as important as the treatment processes. For fertility add-ons, the HFEA has developed a traffic light system that will populate their new website. This indicates what add-ons are of proven benefit (green), which have some scientific evidence but larger studies are required (amber), and finally those add-ons that are still under research or have not been shown to be of material benefit (red). I believe that the HFEA through this pragmatic dual approach, is best positioned to regulate this ethical conundrum. Full disclosure of interests available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.