The HFEA’s response to the government consultation on the 10-year plan

The Human Fertilisation and Embryology Authority (HFEA) is the UK wide regulator of fertility treatment and embryo research.

Q1. What does your organisation want to see included in the 10-Year Health Plan and why?

The HFEA would like to see a cross-disciplinary approach to fertility across the health service, from primary care to treatment in specialist fertility services, to maternity care and beyond.

Every year over 52,500 people have IVF in the UK and over 3,000 donor insemination at HFEA licensed clinics. The proportion of NHS funded IVF cycles is now at its lowest level since 2008 with 17% of IVF cycles funded in England by the NHS.

Infertility affects around 1 in 6 people. Many do not require treatments such as IVF but referrals to specialist service at an early stage. With more people delaying starting a family, the speed of referral is crucial, and we know from the Royal College of Obstetrics and Gynaecology (RCOG) that waiting list for gynaecology services are longer than ever. If referral is delayed, then the likelihood of successful treatment is reduced and there is a greater cost to the public purse.

Since the HFEA was set up in 1991, we have seen changes in the demographics of who is having fertility treatment, with the average age of first time IVF now over 35 years old, compared to the average age that women had their first baby of around 29 years old.

We also know there are wide inequalities in access to and outcomes from fertility treatment based on ethnicity and family type. Black patients have nearly 10% lower success rates from IVF than white patients and IVF cycles funded by the NHS have declined most among Black patients. IVF funding is less likely for single patients and female same-sex couples. Different patient groups are having quite different experiences of fertility treatment and therefore different approaches to reducing inequalities are needed.

Assisted reproduction is an unusual area of healthcare in England, as the majority of patients have to pay for treatment themselves. This is for several reasons including, differences in funding by ICB (adherence to NICE guidelines is low), patients falling outside eligibility criteria (e.g. BMI), inequalities based on ethnicity or family type. In all these cases, accessing fertility related diagnostic tests and screening, and treatment if needed, is most cost effective at a younger age when success rates are at their highest.

To effectively enable people to access treatment earlier and therefore provide more cost-effective fertility treatment when needed, patients need informed primary care services who can refer them for specialist screening, diagnostics and treatment. Given the pressures on general practice, this may be best performed in a women’s health hub or neighbourhood centre. Having fertility services situated within a specialist centre or wider gynaecological service can often lead to more streamlined experiences for patients where they can be seen by the right specialist at right time, sometimes avoiding the need for more costly and invasive IVF all together.

Better links between fertility services and maternity services more broadly would provide continuous care for fertility patients from first diagnosis to treatment, to outcome which is often missing at present.

As the majority of people do not receive any NHS funded fertility treatment, they have to pay for their own treatment and make complex decisions involving thousands of pounds at a time when they may be vulnerable. Most NHS fertility centres treat self-funded patients and vice versa in private centres.

Q2. What does your organisation see as the biggest challenges and enablers to move more care from hospitals to communities?

Access to diagnosis and relevant tests before accessing specialist fertility services would likely be cost effective for the NHS as it would enable people to access fertility services at a younger age, which would lead to greater success rates from treatment and better use of public money. Reducing the waiting list for gynaecological services is crucial to this as waiting for a treatment (e.g. fibroid removal) can be a key barrier to starting fertility treatment at a younger age.

The challenge to this is ensuring the right facilities (ultrasound, referrals for testing etc) and expertise (e.g. specialist fertility nurse) are available in the community either at a women’s health hub or neighbourhood hub.

Q3. What does your organisation see as the biggest challenges and enablers to making better use of technology in health and care?

For fertility patients the greatest barrier to getting ‘joined up’ healthcare is the law relating to the sharing fertility data (which dates to 1990) between the clinic where treatment takes place and the wider healthcare system. This law means that non-fertility providers (including GPs, hospital care etc) are unable to know of the information relating to a patient’s fertility treatment.

Under the Human Fertilisation and Embryology Act 1990 (as amended) (the HFE Act) the disclosure of information about an individual’s fertility treatment, within the normal bounds of medical confidentiality, could result in identifying information about their partner, or child born from treatment, being disclosed to other healthcare professionals without their consent.

The difficulty of sharing fertility treatment details within other clinical settings makes joined-up patient care more difficult. This can have a direct negative effect on patient care. At present, obtaining consent from each patient can be complex, and may cause a delay when urgent treatment might be necessary.

An example of the issues which the current legal framework gives rise to is Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious side effect which some patients develop in reaction to the drug treatment necessary for IVF. Due to the gravity of OHSS, the HFEA requires licensed clinics to report all ‘severe’ and ‘critical’ cases of OHSS to us. The confidentiality provisions of the HFE Act mean that fertility clinics may not know about all such cases. They must rely on building relationships and data sharing agreements with their local NHS hospitals to get a clear picture of the number of OHSS cases amongst their patients. This is inadequate as not all patients with OHSS will attend a local hospital that has a data sharing agreement with their clinic. The high number of patients that are treated in private fertility clinics can make the issue of confidentiality with NHS providers more complex.

More generally, if health professionals are unable to find out about a patient’s fertility treatment, access their medical notes or contact their GP, patients may not receive the right ongoing care or follow-up support for their fertility treatment outcome.

A further challenge is in the out of date provisions in the HFE Act, which haven’t been substantially updated since 1990, meaning that patients may be charged for the use of technology as part of the treatment packages when the benefits are not clear in relation to the claims and charges applied. The HFEA lacks the powers to act in these instances under the current terms of the law.

Q4. What does your organisation see as the biggest challenges and enablers to spotting illnesses earlier and tackling the causes of ill health?

Although the HFEA lacks the powers to act in this area, there are long term benefits to society of ensuring those who may need to access fertility services are able to access services as soon as possible to ensure treatment has the best chance of success.

In recent years, embryo testing for the avoidance of serious inherited conditions has improved in accuracy and reduced in cost. Going forward there may be possibilities for the NHS to link embryo testing which is usually undertaken as part of a consultation at the fertility clinic to the regional clinical genetic service. The upfront costs of embryo testing are dramatically smaller than the costs to the NHS of seriously ill babies, or of caring for children growing up with serious diseases that may be life limiting.

Earlier referral for anyone seeking fertility treatment is crucial to success.

Q5. Please share your specific policy ideas for change. Please include how you would prioritise these and what timeframe you would expect to see this delivered in, for example:

Quick to do, that is in the next year or so

Enable anyone going to their GP with concerns about fertility or access to fertility services to access advice from a specialist within a women’s health hub or similar.

In the middle, that is in the next 2 to 5 years

Reduce the time taken from advice in primary care to specialist fertility treatment where needed to see success at younger age groups maximised. Take actions to reduce inequalities in access to and outcomes of fertility treatment. Ensure the HFEA has up to date powers to enable patients to be protected in a competitive fertility market.

Long term change, that will take more than 5 years

Situate fertility services within wider gynaecological units to ensure streamlined care from start to finish. Reduce or remove the inequalities affecting access to and outcomes of fertility treatment for Black and ethnic minority groups and different patient and family types.