HFEA Chair, Julia Chain, on the HFEA’s law reform proposals – regulating for the future

The HFEA’s law reform proposals – regulating for the future

The Human Fertilisation and Embryology Act was the first of its kind anywhere in the world. We should all be proud that the UK has long been a world leader in regulating fertility treatment, and research involving human embryos.

But as Peter said the Act is more than 30 years old while science, medicine and societal attitudes have come on in leaps and bounds. Two years ago, at this conference, I set out the HFEA’s ambitions to change the HFE Act. Our proposals are now published and I want to say now we are grateful to all of you who took the time to share your views with us, as they were instrumental in shaping our recommendations.

Given the short time available today, I’m going to assume most of the audience will have seen our proposals for change, so I’m going to focus on the key issues where there is more to do.

Before I do, it is worth remembering that fertility treatment and embryo research was originally considered so distinct, as Peter mentioned in fact, that it required its own regulatory regime and that view has been maintained over the past 33 years and I am delighted that now our Public Bodies Review which was published in November confirmed once more that this discrete and specialised area of medical practice and scientific research should continue to be separately regulated by us at the HFEA.

Now going back to our proposals – I know many of you here agree that now is the time for the Act to be updated and modernised.

But I also want to tell you why we want to “Future Proof” the Act and what we mean by that.

Since the HFEA was established, not only has the number of patients undergoing fertility treatment increased ninefold and most treatment is now provided by the private sector, but the sector itself is changing too – it’s moving away from clinician-owned clinics towards large clinic groups, funded by private equity. And there are diverse sources of both care and information with aspects of patient care moving online, for example initial consultations, and yet, we have a law that is based around licensed, physical premises. So we need a law that can protect patients not only in the sector as it now is, but the sector as it’s going to be in years to come – and we haven’t even begun to appreciate the effect of international sources of patient care, or AI or numerous other things that are now becoming commonplace in the UK.

The government has asked the HFEA to review the Act and make recommendations for change and we have done that with an eye on not what only doesn’t work now, but where we believe the challenges for the future are. Our 15 proposals cover four areas where we believe the law should be modernised in the interests of patients, professionals and researchers: patient safety and promoting good practice, access to donor information, consent and scientific developments and innovation. And I’m going to look briefly at each of them in turn.

Patient safety and protection

Fertility patients are now consumers as well as patients. And this changes their relationship with their clinic in subtle ways.

Patients are having to make difficult and expensive choices about medical care – in contrast with most medical treatment which can be accessed on the NHS.

In recent weeks you’ll have seen media coverage about the cost of fertility treatment in the UK, and about people seeking treatment abroad. Fertility Network UK’s survey on the cost of living crisis set out the stark decisions patients are having to make and you will know obviously that delaying treatment will have an impact on the chances of success.

Now the HFEA has no interest in intervening in the relationship between doctor and patient. However, patients do expect us to act where they feel they are at risk of being mis-sold for example treatment add-ons or other services which may have a financial or other cost. This is one of the reasons why we propose the HFEA having a broader and more proportionate range of regulatory enforcement powers.

As things stand, the only formal sanction available to us is to suspend a clinic’s licence with immediate effect, revoke the licence or apply additional conditions, like requiring a clinic to stop donor treatment temporarily. And this leaves us out of step with other regulators and modern regulatory practice.

Good regulation should try to achieve the greatest impact with the most proportionate sanction. For example, it might be more proportionate to impose a financial penalty, which could be a useful tool to shape clinic behaviour, or to address serious or repeated non-compliance. And any monies collected would be passed to HM Treasury. I hasten to add, it’s not kept sadly by the HFEA.

And on the other side, we want to reduce the ‘burden’ of regulation for those clinics that are most compliant, for example, less frequent inspections could be a good idea.

Access to donor information

Perhaps unsurprisingly, most media attention on our proposals has focused on donor anonymity, and differing views have been put forward on how we should approach this.

When the Act was first introduced, there was a general presumption that donation should be anonymous. Now, professional advice is to tell children from a young age that they were conceived using donated gametes.

The Act designates the HFEA Register as a repository for verified donor information and as the single access point to it. Currently, people conceived from donations made from 2005 onwards can contact the HFEA to access identifiable information about their donor on turning 18. 2023, of course, is a landmark year and the first of those donor conceived individuals are becoming old enough now to request that information.

Earlier on, I mentioned the pace of change in scientific research and societal attitudes. Nowhere in this field has the pace of change been more rapid than in the growing popularity of direct-to-consumer DNA testing and also social media.

The availability of direct-to-consumer DNA testing kits, as well as social media, means that the anonymity of a donor cannot be guaranteed until a donor-conceived individual turns 18. The current system is just being overtaken by other means.

And this is why we now propose that the Act should be amended to enable the removal of donor anonymity from the birth of any child born from donation.

We know this is a significant departure from current practice. And tt may therefore be appropriate to take a gradual approach.

But we do need to balance the law with what is taking place on the ground in reality.

We know some are calling for retrospective removal of anonymity for donors who donated before 2005 but we at HFEA believe we need to respect the consent of donors at the time they consented.

In terms of concerns that any change could lead to a fall in donors: history has shown that after the changes in 2005, there was an initial fall in the number of donors but this has now recovered.

We have also heard views about opening the Donor Sibling Link service to under-18s and we think this is something that we should consider when we explore this in more detail.

Consent

Currently, the consent requirements of the Act are more detailed and stringent than for any other types of human tissue. Indeed, the BFS has described them as “impractical and cumbersome”.

But we must remember that, unlike other medical procedures, consent to fertility treatment involves more than one person. Patients also need to think about potentially challenging scenarios, including what might happen in the event of their death, or if they were to lose mental capacity.

We are proposing an overhaul of the consent regime in the Act, reducing complexity where we can. We note the useful contributions others have made in the debate around consent in fertility treatment, for example the work of Professor Emily Jackson and as Peter alluded to Emily and Sarah Franklin are about to publish a book on the 14 day rule. Fertility consent will always be more complex than most medical consents, but we think that consent could be simpler than at present.

We also propose updating consent in the Act to require automatic record-sharing between clinics and the NHS central records system. And this is to support more joined-up and safer care.

The other area in which we propose modernising the consent regime is around embryo banking. The Act should be amended to allow consent for donating embryos to be extended. This would allow patients to give consent to research embryo banking. In turn, this would mean more patients are likely to donate their precious embryos, thus increasing the number available for important research.

Scientific development

The Act sets out several significant limitations on scientific research, which I’m sure are going to be discussed by other speakers and include the well-known 14-day rule. The Act also predates new ‘categories’ of cells, such as in vitro derived gametes, embryo like entities and stem-cell based embryo models.

Here, science is developing at pace. Three months ago today actually, for example, it was announced that scientists at the Weitzman Institute in Israel had grown an embryo model using stem cells.

And we know that many scientists have called for change. There is good work already going on in this regard, for example the recent HDBI public dialogue on the 14-day rule.

The varied views in this area also came through in our consultation, and illustrated the need for continued public engagement on this.

And this is why we believe – and have said throughout – that the Act should be amended to future-proof it. Now is not the time for detailed prescriptions. Rather we need to stand back and consider how we can recast the Act so that it strikes a better balance between flexibility and accountability.

Of the many things we have learnt from the last 33 years, it is that change can be rapid and developments can be unexpected. At the moment, the entire Act must be re-opened to accommodate scientific developments or changes in clinical practice and pressure on Parliamentary time means that change like this is rare.

A greater use of secondary legislation in these areas could mean parliamentary oversight is combined with greater flexibility. This would offer an adaptable regulatory mechanism, that could be efficient and command public support.

We know that, for some people, our proposals don’t go far enough. The Economist said our proposed reforms on embryo research should be bolder and they said that even before they were published.

Regulating for the future, then, in this most sensitive of areas, is why we have proposed flexibility rather than new specific limits, so that the law can keep pace with the scientific, social and technological changes that we can’t even begin yet to imagine.

Conclusion

So, when will change happen?

Government said our proposals raised important issues about how regulatory powers can better protect fertility patients and the quality of the service they receive.

We know that many of you here think changes to the Act are long overdue.

And while that is a decision for government and ultimately parliament, we are not going to rest on our laurels.

We will be working on some of the detail in various areas and we hope you will work with us to share your expertise and views going forward. Now that our proposals are published, we will continue the momentum on why these changes are needed.

Today is a good opportunity to hear from others and start that work to take these changes forward. And I look forward very much during this day to discussing this further with you.