Speech delivered by Sally Cheshire at the 2019 Progress Educational Trust Conference

Regulating for the best patient treatment

Thank you Fiona, and to Sarah and PET for asking me to speak today.

So what do patients want? It’s a fairly obvious answer isn’t it? From personal experience I can say a baby or at least the very best chance of being in the lucky 1 in 3 who do successfully create their much longed for family through fertility treatment. If you’ve ever heard Louise Brown speak, she says that her parents, Lesley and John Brown, “only ever wanted a baby” and the heartfelt wishes of patients since Louise’s birth more than 40 years ago, haven’t changed. Neither has the law much changed in that time but society, the definition of a family, and the expectations of patients have changed enormously so that as the regulator, the areas in which we operate, in the public interest – go far beyond those set out in black and white in the original HFE Act.

Fertility treatment is a highly emotional time for patients, and many are willing to do whatever it takes to achieve their goal of having a family. Underneath that overall want or desire for a baby lie a whole series of other “wants”  - honesty from the doctors, nurses and embryologists who treat you, support and empathy as you go through the process and access to the latest innovative treatment or drug which might make a difference to your chances of success. Many of these “wants” expressed by patients are simply a matter of good care, something incumbent on the whole sector to offer and us to regulate.

 But, given a majority of patients won’t get what they want in the broadest sense of a baby, I want to explore in my talk how we give them as many of their other wants as we can (the excellent care, etc) whilst also giving them what they best need to try to achieve their dream. As I’m here with the regulator’s perspective, I also want to talk about how the HFEA can regulate within the limits of the law for the best patient treatment, surely what all patients want and need? The emotional aspect of treatment itself and the financial burden can have a significant impact on any patient’s wellbeing. We want to ensure that everyone who steps into a fertility clinic, and everyone born as a result of treatment, receives the best quality care.

However, you will be aware that unlike other health treatments in this country, the majority of fertility patients have to self-fund their treatment - in England over 60% of treatment is privately funded by patients. Should that change the dynamic between want and need? In my opinion, no, and I’ll explain why.

Surely all patients are entitled to safe, effective and ethical treatment, provided to the highest standards, offered with excellent care, support, respect and dignity, wherever they are treated and however that treatment is funded. Those principles are enshrined in the Act, our guidance and our Code of Practice, and I am pleased to report that the vast majority of clinics comply for the majority of the time. There are areas we need to improve on including the consistency of outcomes but each year tends to show gradual improvements in safety.

A key area of discrepancy and one where patients aren’t really getting what they want or need is information. We and clinics have a collective responsibility to provide the best, the right information for patients so that ultimately they receive the best treatment for them as a couple or an individual. If patients are to stand a chance of making effective and economic decisions about what might give them the chance of a successful pregnancy they really should have access to the best advice before they come to a clinic, and honest, unbiased information about the particular treatments they could undergo, how suitable they may be and whether they increase the chance of a live birth.

Patients can be assured that they are protected via the UK scheme of regulation, but there are difficulties in regulating new or emerging techniques that aren’t proven (or haven’t yet been proven) to increase patients’ chances of having the baby they long for. Where these so-called add-on treatments are outside the confines of the HFE Act  - drugs, surgeries, medical devices, etc which are not regulated by the HFEA, we can offer advice but that’s why it’s crucial that patients inform themselves about the treatments they may be offered, so that they can ask the right questions, and make the right choices, when considering what treatment to have.

Where do patients get their information from?

We know that navigating fertility treatment can often be tricky for patients, but the sheer volume of information makes it difficult for many patients to cut through the noise and separate out the overall experience from what might work for them personally

A recent survey from the RCOG showed that:

• Four out of five (86%) women said information from different sources seems contradictory
• More than three quarters (76%) also said they are not sure if fertility information is impartial and unbiased
• Three out of five women (62%) said they feel overwhelmed by the sheer volume of information on offer

We continue to help patients make informed choices by giving clear, unbiased information on fertility treatments and clinics. However, we are under no illusion that it’s crucial for clinics to ensure they take their responsibility seriously to give patients the right information about their treatment and to make sure their choices are based on evidence, safety and effectiveness.

Multiple births

Experience tells us that we can collectively make a difference if the will is there and we work together in patients’ best interests – as I’ve said previously offering what they want in terms of excellent care and what they need in terms of the best treatment for them. Our ‘one at a time’ campaign to reduce multiple births from fertility treatment involved both regulatory rules and information to help patients make better choices. We know that patients desperately want a baby at the end of their treatment so the prospect of having more than one embryo transferred can appear very appealing in helping patients to get what they want. We also know that multiple births are the single greatest risk of fertility treatment and they can be avoided without affecting the birth rate.  As a result of the ‘One at a time’ campaign, the multiple birth rate decreased from 24% in 2008 to 10% in 2017 without affecting overall pregnancy rates, arguably giving patients what they wanted (the same chance of a birth) and what they needed and was in their best interests (safer care).

So back to treatment add-ons….

In our survey last year we found over three quarters of patients had at least one add-on to their routine treatment. And you have to remember that our traffic light system, simple as it is, doesn’t rate a single of the most common add-ons as green, i.e. proven to be safe and effective, So are clinics really giving patients what they need in terms of the best treatment?

As the regulator we can regulate the provision of treatment, where we have jurisdiction; or we can improve the supply of information.

Our powers on provision are somewhat limited - for a new treatment to be introduced, it doesn’t have to be proven to improve the chance of success – it has to not be harmful or unsafe. Although I firmly believe there are some treatments which do cause harm, and to be clear, they should never be offered, that’s a pretty low bar to work with. The UK has always been known for innovation, whether in creating the first IVF baby, to the work on mitochondrial donation – we want to continue to encourage research, development, and improving success rates.  But we don’t want patients to pay for something that hasn’t been proven to work, especially when it may actively cause harm.

Our powers on information are a bit wider. At the start of this year, together with 10 of the leading professional and patient organisations, we launched a joint consensus statement to make clear clinics should offer add-ons ethically and responsibly, including giving patients clear information.

Working with all those professional and patient organisations we will:

• provide more information on more add-ons – not only the 11 that we currently have a traffic light rating on our website
• provide traffic lights for the most common holistic add-ons such as acupuncture and massage
• encourage the responsible supply of treatment add-ons – doctors must be asking themselves do patients need this, will it result in any physical or psychological harm? And just as importantly should they be paying for it, potentially raising the price of an IVF cycle in the private sector from £5,000 to £10,000, £15,000 or even £20,000 and upwards, which can never be right
• Through our inspections we will look at the information clinics provide to patients to ensure informed consent is obtained
• We want to encourage further research to assess whether any current or future add-ons increase success rates
• And we will look at itemised costed treatment plans to ensure that the costs of add-ons are not lost in package prices – which are confusing enough as they are.

And yet, this won’t be enough will it.

We know that more and more patients are getting information online, whether through open or closed online forums or other social media. Added to this is the growth in fertility advice from the non-regulated sector such as nutritional therapists who are recommending particular add-ons to patients. 

At the Fertility Show last month, our team were often asked, which clinic has the best lab? Where are the newest treatments? Who has the best success rates? Almost all of the questions at our stand from patients were about improving their chances or about add-on treatments, questions like:

• My clinic has said if I don't have PGS then they won't treat me. What should I do?
• I’ve read your add-ons information, but my doctor still said I should have reproductive immunology? What should I do?
• I’m nearly 40, should I freeze my eggs?

I regret to say that fertility treatment has become a marketplace – we may not like that but that is the reality.  And in any marketplace, consumers are constantly weighing up choices – only in this case the choice is not without financial, emotional and in some cases, physical, cost. Clinicians who are selling add-ons without proven evidence are doing the profession and more importantly their patients a disservice and with the limited tools we have we want and need that to stop. I suspect the worst offenders don’t come to reasoned debates like this and close their ears, criticising their more straightforward colleagues and the regulator because it’s easier to attack others than tell your patients the truth.

When we talked about add-ons at our most recent Authority meeting, the one thing I think above all that stuck in the minds of everyone listening to that discussion, is that if ‘routine’ IVF was done more often without expensive add-ons, the money saved could be put towards further cycles of treatment, possibly a way of increasing the chances of success.

So we need to work on both the provision of treatment and the supply of information to combat the effects of the market and ensure patients get what they need (the best treatment for them) and thereby hopefully what they want (a baby). None of us have the right to tell patients what they should do and remove their choice, but all of us have a responsibility to ensure that emotional, physical and financial wellbeing are at the heart of decision-making between a clinics and patients.

The HFEA will continue to encourage world class research and clinical trials to develop the evidence base about what works to further increase success rates. We will continue to help patients make informed choices and continue the public debate about what works in treatment.  We will not step down from our responsibility to patients in this, and I hope you are with us.

Thank you.