The HFEA has launched its consultation for proposed changes to the UK Fertility Law. This is a long time coming and we urge you all to complete the survey, which you can access here. Please spread this far and wide, as whilst the consultation does not equal change it is crucial we get as many as possible to take part in it.

First off, let’s just say that the U.K. is very much a trendsetter when it comes to fertility law and our existing laws have served us exceedingly well. Our 1990 law on the regulation of human embryos has been emulated globally and in many respects we’re fortunate to have a system that has afforded such preeminent thinking.

But the time is beyond ripe for a refresh. The U.K. fertility sector is experiencing a rapid uptake in demand and the U.K. remains at the forefront of IVF technology and emerging innovations. What we now need is an updated fertility law that provides a balance of catering for this fast-paced innovation whilst also ensuring the patient, and woman, who is trying to conceive remains at the forefront. No clues for guessing then whilst this consultation hits so close to home for us. 

There are so many aspects of this consultation that OVUM firmly welcomes so here’s our overview of the headline topics. Any questions or other topics you’d like us to include, please email me jenny@startwithovum.com 

Is Your Clinic Compliant? 

If a registered IVF Clinic is not complying with HFEA requirements, the only current option available to the regulator is to take action to close the clinic. This is a fairly draconian response to what is (usually) a minor infraction, and the current structure means the HFEA must show that the full requirements for taking away a licence are met (ie it’s really bad) before they can then look at what alternative action can be taken. This is contrary to how most regulatory bodies operate and has the unintended impact of allowing poorer quality services to continue being available for longer than they should up to the point that the threshold for closing a clinic is met. This is daft and needs to be remedied. It is also of no use to the woman undergoing treatment and closing a clinic is rarely in her interest.

What we need is a graduated ladder of enforcement and this is what the HFEA is arguing for. They’d like to have the power to introduce financial penalties for clinics who aren’t complying, this being a quick and immediate penalty to bring into play which would ensure clinics improved their standard of care whilst minimally impacting the patient

Here at OVUM, we agree and we very much welcome this recommendation. You have our vote.

Putting You First

Private IVF clinics are booming in the U.K with the majority of fertility treatments today being self-funded by patients. The HFEA are seeing an increase in fertility services being offered that fall outside the remit of the current laws. Not cool. Some treatments are taking place online or via satellite arrangements outside of their regulation - such as “wellness and wellbeing” clinics or introduction services are a new trend, but these should rightly fall under the remit of the HFEA. From the perspective of the patient going through fertility treatment, it is all part of their treatment journey and the HFEA should have powers in these areas.

This is where the current law is most in need of an update - it makes no mention of the patient undergoing treatment or protecting their journey and experience throughout treatment. The act is really focused entirely on the embryo which cause the main priority at the time these laws were enacted. There is zero discussion or focus on protecting the patient and that needs to change. Take part in the consultation for this reason alone if nothing else.

Science

We need regime a regulatory regime that encourages innovation and has enough flex in the system so the HFEA can better respond and sign off on the use of these innovations.

Currently, the entire law needs to be re-opened for any new developments in research or clinical practice - it’s a real faff and ultimately it’s patients that suffer as these innovations simply take longer to come into being and to be of benefit to anyone. Re-opening the law means going back to Parliament, which is a hefty task and as a result, it rarely happens - we’ve no interest in seeing the development of novel research held back and want to see new clinical techniques used in practice so we’re all for these proposals. The solution proposed here is more secondary legislation giving the HFEA more powers to sign off on treatment and research advances without going back to Parliament each time. Winner, winner.

This sign-off would come in the form of the ‘sandbox’ concept. Think of it as a controlled experiment of new products, services, or techniques, where there’s some scientific data but we also need real-life clinical evidence before these can be recommended to patients. If successful in securing these new powers, the HFEA would oversee these mini-clinical trials, this encourages the innovation we all want to see to ultimately help us bring a baby home, but minimises risks. You can read more about sandboxes here. 

This is something we at OVUM would make use of if it existed today - we soon hope to launch a clinical trial amongst an IVF cohort of 200 women and working with the HFEA on this is something we’d very much welcome. 

And finally…

The IVF sector is innovating at an incredible pace with emerging techniques and new technologies, we’re seeing an influx of new clinics open in the U.K and the HFEA needs more power to better regulate and support this sector. 

 What else to keep an eye out for? ….NICE is updating its guideline on fertility problems: assessment and treatment. This is crucial work that is ongoing, it will consider current recommendations for access to NHS-funded treatment and whether these remain appropriate. Sign up for our newsletter in the footer for updates, as stakeholders in this project we’ll provide updates as soon as we have them.