The role of the regulator: UK perspectives
The HFEA 30 years on - what needs to change?
Speech by Julia Chain, HFEA Chair, at Progress Educational Trust conference
Intro - 30 years… what has changed
The HFEA is the first regulator of its kind in the world, and we are recognised as the global gold standard for innovative and effective regulation. And for those original campaigners in the audience, I salute you and I thank you While our 30th anniversary is a cause for celebration, it should also be a prompt for reflection. Today I want to talk to you about some of the key changes we believe are necessary if we are to remain at the forefront of regulation in the years to come.
So a few stats, it is quite remarkable to note just how much has changed over the last 30 years. In 1991 there were under 7,000 IVF cycles; today there are around 70,000. In total, there have been around 1.3 million IVF cycles and over 260,000 donor insemination (DI) cycles, resulting in around 390,000 babies born.
But this is not just a story of about more treatment. People are using treatment in different ways. Take gamete storage for example, where improved freezing technologies have enabled more women to make decisions about when to start a family. And I want to take this opportunity to extend my thanks to the many people here and many of you in the audience, who have long campaigned for a change in the law to extend storage limits for gametes and embryos.
The last 30 years have also seen a remarkable increase in the use of embryo testing and IVF techniques to enable families to avoid serious inherited illnesses through the use of PGT M and hopefully in time mitochondrial donation.
Act is out of date
But as the Chair of the HFEA my dilemma is this: given the extraordinary medical advances and changes in social attitudes to fertility treatment over the last 30 years, how is it possible to regulate effectively with a law that is largely 30 years old? The Human Fertilisation and Embryology Act was passed in 1990 and although the Act was amended in 2008, it left the basic regulatory scheme untouched. These Acts were revolutionary for their time – but time has moved on!
The detail of the Act makes for fascinating reading but I cannot see any words in it relating to patients, patient safety, or even outcomes of treatment. To me, the role of the regulator must be to keep all those three things at the front of our work.
To say that we desire change is not to say that we can’t regulate effectively with the tools we have currently at our disposal. But we need constantly to be looking ahead and always look to improve where we can.
Use the current model well
- Our inspection regime provides patients with the assurance that clinics meet high essential standards of care.
- Our Code of Practice provides clinics with guidance that if followed will ensure good practice.
- Our website and Choose a Fertility Clinic tool provide patients with clear, impartial information about the performance of licensed clinics and the treatments on offer and our new Patient Forum, I’m delighted to say, will also give a direct voice to patients’ concerns.
- And we have been able to make real progress on issues where we lacked formal powers. To give just two examples. The incidence of multiple births in the UK has reduced from 25% to a national average of 6% in just 12 years. That is a remarkable achievement in public health and a testimony to co-operative action by the HFEA, the professional bodies and clinics. And on treatment add-ons, we have agreed a consensus statement with all the key professional groups about their ‘responsible’ use. Much remains to be done on add-ons I know, but this is an essential starting point.
But we are at the limits of what is possible with those regulatory tools and the way in which the fertility sector is developing means that we now urgently need to think about the future.
Changes since Warnock
There have been many big changes since Mary Warnock first considered these issues in the 1980s. Changes in the types of treatment offered and the technologies used. The rise to dominance of commercially operated fertility clinics. The range and types of family relationships that assisted reproduction can now reflect or even make possible. And the ground-breaking advances that UK scientists have been able to make with potential for healthcare and family formation in the future. These changes could not have been foreseen by those who first understood, rightly, that the fertility sector needed its own regulation.
We have to regulate a sector that is also unique in the UK health care system for its inconsistent funding model. In England, more than 65% of patients are now self-funding and NHS funding is very patchy, with the availability of even partial NHS funding largely dependent on where a patient lives – the so-called postcode lottery. The UK has over 100 licensed clinics and most of them are successful, well-run businesses, providing high quality services. But we will always need to ensure that the regulator has the powers it needs to ensure that commercial interests do not outweigh robust scientific evidence and good medicine; this is very hard to do under a 30-year-old Act which feels as though it primarily envisaged provision of fertility care by the NHS.
So, what I want to do today is set out the areas of the Act that I think need to change. But I want to preface this with two statements. First, that much of the Act remains fit for purpose, what is needed is a selective modernisation of the Warnock settlement as reflected in the Act not its wholesale rejection. Secondly, and I’m sure quite obviously, any changes to the Act will be a matter for Parliament — but we need to make our own case clear.
Three areas of focus
I want to focus on three areas of the Act:
The Act has much of importance to say about the embryo but is silent on the patient and does not reflect patient centred care as being a cornerstone of good treatment. We know that patients want to feel involved in their care and have a real say in what happens to them. Where care falls short, we all expect regulators to be able to respond as effectively as possible to support patients as best they can. But 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 also expect regulators to be empowered to head off foreseeable problems before they arise or escalate, or to take proportionate action quickly. However, the Act makes it very difficult to use enforcement mechanisms to drive improvement when addressing poor performance. The sanctions in the Act range from the mild and often ineffective; a sort ‘slap on the wrist’ if you will, to the severe and potentially disproportionate – for example the removal or suspension of a licence with potentially negative consequences for patients in treatment. What is striking is the absence a graduated ladder of enforcement, including powers to use economic sanctions such as fines to encourage compliance. In a commercialised sector such powers could drive improvement quite effectively. Moreover, our existing powers are anything but agile – in a world where feedback on clinics, individual doctors and comparisons between clinics takes place all the time, the powers we have make it difficult to move quickly when we spot something of concern. I just want to mention that you may have seen some recent press headlines about treatment add-ons. And I just want to be very clear. I am not advocating that we fine clinics for providing treatment add-ons. For specific patient groups, some treatment add-ons can increase the chances of pregnancy or reduce the incidence of miscarriage. What we are saying however is that where clinics miss-sell products or services including but not exclusively treatment add-ons , we will be seeking economic sanctions such as fines to hold those clinics to account.
In sum, our regulatory powers are limited, they do not cover any economic sanctions, are blunt and do not work flexibly in the modern regulatory environment.
The Act also fails to reflect the fact that fertility treatment in the UK is an increasingly commercial market and unlike most aspects of healthcare the majority of treatment is provided by the private sector. That is not to say that private healthcare is inferior or less trustworthy than that provided by the NHS, but the reality is that in fertility treatment, as in all other areas of healthcare, the financial imperative of commercial provision, presents different regulatory challenges.
- First, the Act currently assumes an ownership model where the clinician is in charge, and if it’s in the private sector, is the owner of the business. This is increasingly not the case. Many private clinics are moving to a structure grouping several clinics often under one brand, with a range of shareholders and often with private equity funding. Currently, the HFEA’s regulatory levers apply to the ‘person responsible’ not the financial owners.
- Second, fertility patients find themselves in a position where they are having to make complex and expensive purchases at a very stressful time in their lives. And this is made more difficult by the increasing offering of so-called treatment add-ons, where some clinicians disagree about the effectiveness of certain tests or treatments, with the result that patients may be confused and even vulnerable to exploitation. The very welcome work from the Competition and Markets Authority and Advertising Standards Authority will help here. But we need to ask whether it would make more sense for the regulation of all aspects of fertility treatment to be in one place, rather than split between different regulators. Improving our own regulatory powers could help patients better navigate this area of healthcare and greater transparency and will help ensure prices are kept fair and competitive. I reiterate my earlier remarks that this is to enable clinics to be held accountable where great practice is rewarded. For me an end – to – end fertility regulator would make much more sense than the present situation where other regulators have to support our work.
- Third, the Act is overly prescriptive about the methods of compliance and enforcement – for example it requires the HFEA to inspect the licensed premises “at an interval not exceeding two years”. The lack of discretion in the Act means that the HFEA cannot, for example, ‘reward’ high performing clinics with fewer inspections, as is the case with many other regulators.
So moving to the second area which is scientific development, 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. This leaves some areas of the Act simply out of date. The International Society for Stem Cell Research has already called for a debate on the so-called 14-day rule. But let me be very clear, 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.
Also the Act is overly prescriptive in terms of process which limits its flexibility for future proofing. The Regulations, for example, that allow mitochondrial donation set out two allowable techniques. Should a third unspecified technique be invented that would not be allowable under current legislation, even if it were clinically more effective and it would require a change in the law before it could be used. Legislative change should not be required every time science develops.
The Act has few controls over new treatments or tests and lacks any means to encourage innovation through conditional or trial approvals – and while the Act allows the HFEA to approve novel treatments, it is limited in its scope and lacks a mechanism, where the regulator could approve a treatment for a specified period of time before assessing real world evidence. This acts as a potential brake on innovation and a ‘regulatory sandbox’ type power that some regulators have used would potentially help here.
Consent, data sharing and anonymity…
Consent is the cornerstone of the Act and is central to modern medicine generally. However various aspects of the current rules around consent are overly complicated, for example, the taking of consent is more costly than it needs to be for clinics and increases the risk of errors for patients, some of which have had a significant impact on parental rights, requiring court action.
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 the patient transfers, for example, from the IVF unit to maternity care. It is increasingly an aim of modern medicine that a patient’s data can move with them around the system and although the correct consents can deal with this, it is time to modernise some of the restrictions on data sharing in the HFE Act.
Enacted at a time when the whole idea of fertility treatment was considered controversial and often stigmatised, the Act assumes a degree of fertility treatment-specific data confidentiality which is increasingly out of date. The HFEA Register has to meet higher standards of confidentiality than is typical in other healthcare records, at considerable cost. This can create barriers to sharing the data that we hold on treatments for important purposes such as research. New thinking is required to understand what data confidentiality is essential to support patient care without either prejudicing that care or putting up an unnecessary barrier to much needed research.
The absolute anonymity of donors in the original HFE Act reflected concerns at the time but is no longer how we look at this. Regulations modernised this position to an extent in 2005 to allow a managed identifying information release to donor conceived adults in future (and we welcome the first cohort of these young adults in 2023). However, the reality is that donor anonymity as we knew it has gone. It has long been overtaken by shifts in social attitudes about fertility treatment and donation and the growth in affordable direct to consumer DNA tests, which allow individuals to ‘match’ and establish their genetic relationships with an increasing degree of accuracy, much of which can be provided with, or provide inference of, named individuals. New thinking is required to both 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.
There is much to explore in the areas I have just outlined, and I am sure some of the other speeches today will touch upon them.
30 years in, it’s now is a good time to reflect and update the Act arising from Mary Warnock’s legacy. We need a modernised law and during my tenure as Chair, this will be one of my main priorities. I recognise that this will take time and it will require detailed discussions with all of you. But I would hope we are able to make relatively quick progress. After all we are not starting with a blank sheet of paper and much of the Act remains fit for purpose. My aim is to reach an outline agreement with the Department for Health and Social Care next year on what needs to change.
So, when we call you to ask for your views – please make time to help us move this forward. I am not embarrassed about being impatient for change – we want to remain at the forefront of regulation, but we need to change to be able to provide that end-to-end regulation to continue to act in the best interests of patients in another 30 years from now.
Review date: 3 December 2023