Navigating increased UK regulation for IVF add-ons

Currently, regulation governing fertility clinics is focused on the core services they provide – helping women become pregnant. However, there are increasing calls for better regulation around the ‘add-on’ services which clinics can provide, such as genetic tests and other treatments provided to boost patients’ chances of becoming pregnant.

Recently a Welsh MP, Alex Davies-Jones, said she was concerned vulnerable patients were being encouraged to buy add-on treatments without proof they worked, on top of the already high costs of IVF itself.

Attention has been drawn to the concerns associated with IVF add-ons in Ireland, the UK, across the EU and indeed globally. Parents desperate to become pregnant will seek to optimise their chances by any means necessary, making them highly susceptible to offering payment with few questions asked.

According to the Irish National Maternity Hospital, in some cases, it has been reported that these extra treatments have caused adverse effects on patients. Privatisation of the fertility sector has seemingly meant less regulation and undue overcharging.

However, data suggests that where treatment is largely publicly funded, like in the Netherlands, add-ons are relatively uncommon.

Current regulation

Add-on treatments in IVF are currently lightly regulated in most jurisdictions. In the UK, the Human Fertilisation and Embryology Authority (HFEA) introduced a code of practice in 2018 which requires clinicians to explain to patients whether there is clinical evidence supporting the supplemental procedures being offered.

The HFEA has also developed a website which provides a ‘traffic light’ system rating add-ons in terms of how much evidence and information is available on a given treatment. Green means the add-on has undergone at least one high quality randomised control trial (RCT), amber symbolises add-ons with conflicting evidence from RCTs and red add-ons mean there is no evidence from RCTs available which shows the treatment as effective in improving fertility chances.

None of the 12 add-ons reviewed by the HFEA to date are rated green.

Last year, a joint statement on add-ons (7 page / 460KB PDF) was published by, among others, the HFEA, the European Society of Human Reproduction and Embryology, the Association of Biomedical Andrologists and the Association of Clinical Embryologists.

The statement said: “Practitioners have a duty of care to patients, which should separate pressure from patients and commercial interests from their best practice advice.”

The statement set out a series of principles designed to encourage clinics to practice responsible innovation when offering add-ons. Clinics with these IVF add-ons on offer should be steered by such principles in order to provide a more trustworthy service.

Regulatory changes in Ireland

In Ireland, changes are underway to increase the legislative monitoring of fertility services. Minister for Health Stephen Donnelly has received Cabinet approval for the long-awaited publication of the Health (Assisted Human Reproduction) Bill 2022.

Once enacted, this legislation will transform the regulatory framework for assisted human reproduction (AHR) in Ireland. By establishing the AHR Regulatory Authority, this far-reaching instrument will allow Ireland to modernise its provision of AHR treatment, including IVF, an area of modern medicine in significant need of heightened regulation.

A structure akin to the HFEA traffic light system website would also be helpful for Irish consumers seeking IVF treatment. This system allows consumers to be informed and less viable to buy into needless supplemental spending in attempting to become pregnant.

Change to the regulation of IVF services is needed and certainly overdue. Announcing the Irish legislation, Donnelly said it would “lead to a robust specific regulatory framework being put in place in respect of this complex, innovative and fast-moving area of medicine, which is currently predominantly provided through the private sector”.

He added that the bill would pave the way for expensive fertility treatment, currently only available via private clinics, to be provided by the public health system. The minister also noted that the proposed law will ensure that fertility treatments or AHR practices and related areas of research are conducted in a more consistent and standardised way and with the necessary oversight following the setting up of the AHRRA.

As legislation such as the Irish bill becomes law, IVF clinics will be faced with increased governance requirements. Given that add-on treatments come with substantial costs to couples, informed consent is of paramount importance for consumers seeking IVF.

Fertility clinics should prepare themselves for an evolving sectoral landscape in the coming years. Regulators are likely to focus on greater openness from clinics around the success rates of add-ons, increased information around whether a treatment is actually beneficial for a particular patient and better transparency around pricing.

Clinics would be wise to implement robust, “patient-first” systems now in an effort to future-proof their business against any regulatory scrutiny.

Additional research by Muireann Morrissey of Pinsent Masons.