The birth of Louise Brown 1978 People generally want some - - PowerPoint PPT Presentation

www.hfea.gov.uk

Shaping Fertility Treatment in the 21st century: the best care and the right information within the law

Sally Cheshire HFEA Chair

“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

• f families and the valuing of human

life, would be a society without moral scruples, and this nobody wants.” Baroness Mary Warnock

The birth of Louise Brown 1978

The creation of the HFEA 1991

Our organisation

• Board of 14, with majority lay
• Executive of c.65
• Annual budget of c.£7 million

Our legislation and powers

• UK-wide regulatory scope
• Incorporates EU legislation
• Policy-making powers
• 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

• 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? As we approach 10 years since the HFE Act was last amended in 2008:

Research and innovation

• 1. Our approach to regulation and

engagement maintains public confidence

• 2. This is good for UK plc and the reputation
• f 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

We have a reputation for robust yet flexible regulation where research can flourish

Tackling treatment add-ons

What is an ‘add-on’?

• ptional extras, that are being

charged for, which claim to improve the chances of having a healthy baby

• cover a range of

interventions: genetic tests, drugs, surgery and equipment

• The majority of the add-ons

currently offered are not evidenced / have limited evidence of effectiveness Our actions

• Consensus statement
• Introduction of traffic light

system

• Code of practice update
• Digital & media campaign

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
• ur patients are still

heterosexual couples with a fertility issue

• But…………..

Rising usage by ‘alternative’ families

A) IVF treatment cycles by partner status B) DI 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
• IVF as a first step
• Later family starting
• Lower NHS-funding

Rising IVF and lower DI treatment cycles

A) IVF and DI treatment cycles B) IVF and DI birth rates

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:

• Higher IVF success rate
• NHS funding (in Scotland)
• Later family creation
• Tendency to use more medicalised

treatment options more quickly

A) Number of fresh and frozen treatment cycles B) Birth rates PET for fresh and frozen 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

freezing technology

• Increased single embryo transfer
• Improvements in egg retrieval

processes.

Increase in frozen treatment cycles

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)

The impact of donation and fertility preservation

Where are UK patients being treated?

• There are 134 active fertility clinics in the UK.
• 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.

Figure 2: Clinics active in UK in 2018/19, by clinic type

92 14 12 9 7 Treatment with storage Research only Storage only Treatment

• nly

Treatment with storage and research

Figure 3: Clinics active in UK in 2018/19

3 10 6 12 5 7 12 5 10 15 37 12

• 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.

How is the treatment being paid for?

Positive achievements

• 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 We have much to be proud of:

Difficult dilemmas

• 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 We also have more to do :

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
• pposite 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

• 1. Information about fertility treatment
• ptions
• 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

• ther users, the website supports

patients and encourages providers to improve the quality of their services In July 2017, we launched a new patient information service, comprising:

Working with the NHS

• 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
• thers 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 IVF commissioning is informed by a NICE clinical guideline

Key points to commission cost- effective fertility treatment

Defining leadership

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? Acting ethically and responsibly:

“ There remain certain differences between us as we have focused on the very subjects, surrogacy and research on human embryos, which arouse the greatest public anxiety. We have sought to contribute to a high standard of public debate on matters which are of deep concern to the public and [provide] a coherent set or proposals for how public policy should respond to future developments” Baroness Mary Warnock

Shaping the future within the law

www.hfea.gov.uk

Thank you

Sally Cheshire HFEA Chair