Shaping Fertility Treatment in the 21 st century: the best care and the right information within the law Sally Cheshire HFEA Chair www.hfea.gov.uk
The birth of Louise Brown 1978 “People generally want some principles or other to govern the development of the new techniques. There must be some barriers that are not crossed, some limits fixed beyond which people must not be allowed to go. A society which had no inhibiting limits, especially in the areas of birth, death, the setting up of families and the valuing of human life, would be a society without moral scruples, and this nobody wants.” Baroness Mary Warnock
The creation of the HFEA 1991 Our legislation and powers Our organisation • • UK-wide regulatory scope Board of 14, with majority lay • • Incorporates EU legislation Executive of c.65 • • Policy-making powers Annual budget of c.£7 million • No remit over pricing in the private sector Our role • Regulate just over 130 clinics and research laboratories in the UK • Publish standards and guidance for clinics • Keep the HFEA register of treatments (>1 million cycles) • Disclose information about donors to donor-conceived people • Publish information for patients about treatments and services • Approve individual uses of PGD & mitochondrial donation
Shaping the future As we approach 10 years since the HFE Act was last amended in 2008: • Time for an update, potentially on quality of care, storage periods, 14 day rule, consent to research? • Lack of legislative time means we must promote high quality care with the regulatory framework we have now • How do we tackle long standing sector issues such as commissioning, treatment costs, fertility tourism and political/media interest?
Research and innovation We have a reputation for robust yet flexible regulation where research can flourish 1. Our approach to regulation and engagement maintains public confidence 2. This is good for UK plc and the reputation of biosciences sector 3. Cutting edge basic research: HFEA- licensed genome editing research at the Francis Crick Institute 4. Ground-breaking translational research: mitochondrial from lab to clinic at Newcastle Centre for Life 5. Innovative treatments: 400+ genetic diseases can now be avoided through IVF embryo testing
Tackling treatment add-ons Our actions What is an ‘add - on’? • • optional extras, that are being Consensus statement charged for, which claim to • Introduction of traffic light improve the chances of system having a healthy baby • Code of practice update • cover a range of • Digital & media campaign interventions: genetic tests, drugs, surgery and equipment • The majority of the add-ons currently offered are not evidenced / have limited evidence of effectiveness
Who is having treatment? • Long term trend shows fertility treatment increasing by c.2% per year on average. • Patients aged under 37 make up 65% of people having IVF treatment cycles and 73% of those undergoing DI. • The overwhelming majority of our patients are still heterosexual couples with a fertility issue • But…………..
Rising usage by ‘alternative’ families A) IVF treatment cycles by partner status Key changes: • Shift in kinds of families using ART • 12% increase in same-sex from 2016 • 22% increase in no partner from 2016 Possible reasons: • Social acceptance of LGBTQ B) DI treatment cycles by partner status • IVF as a first step • Later family starting • Lower NHS-funding
Rising IVF and lower DI treatment cycles A) IVF and DI treatment cycles Key changes: • 2.5% rise in IVF treatments from 2016 • DI cycles lower generally but a recent 3% rise in DI treatments from 2016 • Plateaux in IVF and DI success rates Possible causes: B) IVF and DI birth rates • Higher IVF success rate • NHS funding (in Scotland) • Later family creation • Tendency to use more medicalised treatment options more quickly
Increase in frozen treatment cycles A) Number of fresh and frozen treatment cycles Key changes: • 11% rise in frozen cycles from 2016 • 2% decrease in fresh cycles from 2016 • 24% and 22% frozen and fresh birth rates Possible causes: • Improved embryo preservation and B) Birth rates PET for fresh and frozen cycles freezing technology • Increased single embryo transfer • Improvements in egg retrieval processes.
The impact of donation and fertility preservation Donation: • Use of donor eggs and sperm in 13% of treatment cycles, up 3 percentage points from 2016 • Use of donor sperm increasing fastest, up by almost 2,000 treatment cycles since 2012, although still small at 5% of overall treatment cycles • Patients in same sex relationships now account for 1/3 of donor sperm cycles (up from 10% in 2005) Fertility preservation: • More widespread use of fertility preservation for medical issues and transgender patients • More prevalent freezing for social reasons with egg freezing the fastest growing treatment type (almost 4 times higher in 2017 than 2012, although still representing around 2% of overall treatments)
Where are UK patients being treated? • There are 134 active fertility clinics in the UK. Figure 3: Clinics active in UK in 2018/19 • About 80% of clinics are issued a four-year licence, indicating good overall compliance. • Two-thirds of clinics are standalone. The rest are owned by 10 private clinic groups. 10 Figure 2: Clinics active in UK in 2018/19, by clinic type 6 3 Treatment with 7 12 5 storage 9 Research only 12 7 12 12 5 Storage only 14 37 15 Treatment 10 92 only Treatment with storage and research
How is the treatment being paid for? • The proportion of NHS-funded treatment cycles varies across the nations of the UK. • Today, 62% of patients in Scotland receive NHS funding compared with just 39% in England.
Positive achievements We have much to be proud of: • Treatment outcomes improving (if slowly) • Multiple birth rate has reached 10% target • Inspections show improved compliance • Improved data and website informing patients • First mito patients approved for treatment • Longer term issues being tackled (commissioning and benchmark price) • Focus on emotional support reaping benefits • Focus on leadership improving partnership and ultimately patient outcomes
Difficult dilemmas We also have more to do : • Quality of care and treatment outcomes are still not consistent between clinics • Common areas for improvement arise right across the sector (legal parenthood) • Commissioning/price remain difficult to influence • Add-on treatments are controversial • We can influence media stories but also face soundbite fatigue in the hunt for stories Clinic and sector leadership will be key to raising the bar and delivering improvements for patients
In the media
In the media
HFEA strategy 2017-2020 New HFEA strategy 2020-23 in preparation focusing on: • The best care • The right information • Shaping the future
HFEA strategy 2020-2023 The best care • Treatment that is effective, and both ethically and scientifically robust • Improved recognition of partners’ importance (of the same or opposite sex) in the care process. The right information • Improved access to information at the earliest (pre-treatment) stage • High quality information to support decision-making during and after treatment or donation. Shaping the future • Preparing for future legislative and operational changes. • Responding to scientific and social changes, particularly in modern family creation and the fields of genetics and artificial intelligence (AI).
Putting the patient first In July 2017, we launched a new patient information service, comprising: 1. Information about fertility treatment options 2. A new patient experience rating tool 3. Rounded performance information about each provider 4. Clear presentation of outcome data – with a new measure reflecting patient safety Designed with input from patients and other users, the website supports patients and encourages providers to improve the quality of their services
Working with the NHS IVF commissioning is informed by a Key points to commission cost- effective fertility treatment NICE clinical guideline 1. Most CCGs lack detailed knowledge about IVF to commission intelligently 2. Only 20% of English CCGs meet the guideline and provision is falling 3. There is no tariff in IVF; commissioners pay different prices for the same service 4. We’ve worked with NHS England and others to set a benchmark price and provide commissioning guidance for CCGs 5. This work won’t resolve all the problems with commissioning but it should mean that scarce NHS resources are spent more wisely
Defining leadership Acting ethically and responsibly: Do clinics : • Reach the minimum inspection standards for quality of care? • Proactively engage with suggested improvements and demonstrate progress? • Act on patient feedback to improve services? Across the wider sector do they : • Take a lead in promoting responsible behaviour in their group, region or nationally (on multiple births, add-on treatments, treatment costs)? • Contribute to the UK’s international reputation as a global leader in fertility?
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