Impact assessment

Equality impact assessment: screening for Edwards’ syndrome using the antenatal quadruple test

Published 5 January 2026

The general equality duty that is set out in the Equality Act 2010 requires public authorities, in the exercise of their functions, to have due regard to the need to:

• eliminate unlawful discrimination, harassment and victimisation and other conduct prohibited by the act
• advance equality of opportunity between people who share a relevant protected characteristic and those who do not
• foster good relations between people who share a relevant protected characteristic and those who do not

The general equality duty does not specify how public authorities should analyse the effect of their existing and new policies and practices on equality but doing so is an important part of complying with the general equality duty.

This equalities analysis examines the potential impact of the addition of the quadruple test to the antenatal screening pathway for Edwards’ syndrome in accordance with section 149 of the Equality Act 2010.

We recognise that not all pregnant people identify as women. In this publication, we use the terms ‘woman’ and ‘women’ to refer to anyone able to become pregnant, including trans men and non-binary people.

Summary of policy

UK National Screening Committee

The UK National Screening Committee (UK NSC) is the independent scientific committee that advises ministers and the NHS in all 4 UK countries about all aspects of screening and supports implementation of screening programmes.

Using research evidence, pilot programmes, economic evaluation, expert stakeholders and consultation, UK NSC assesses the evidence for national screening programmes against a set of internationally recognised criteria covering the:

• condition
• test
• treatment options
• effectiveness, ethics and acceptability of the screening programme

It is only where the offer to screen provides more good than harm that a screening programme is recommended.

In December 2025, the government approved the recommendation from UK NSC’s March 2024 meeting that the quadruple test is accurate enough to be added to the antenatal screening pathway for the rare but serious condition Edwards’ syndrome.

Screening programmes in England

NHS screening programmes offer health screening to millions of people each year. The 11 end-to-end managed and quality assured programmes cover screening for:

• breast, bowel, lung and cervical cancer
• diabetic eye disease
• abdominal aortic aneurysms
• some conditions in pregnancy and newborn babies

Most screening programmes aim to find people at increased chance of a health condition before symptoms appear and/or at a stage when treatment can improve outcomes. Antenatal screening for the 3 trisomies (T21 Down’s syndrome, T13 Patau’s syndrome and T18 Edwards’ syndrome) is offered to all pregnant women as part of the NHS Fetal Anomaly Screening programme (FASP). In FASP, the purpose of screening is to provide information to support informed choices about the pregnancy. Screening is a choice, and individuals can accept or decline the offer. This choice is supported by their healthcare team.

Screening tests form one step in a systematic pathway that involves many different healthcare professionals across different settings. There are 7 screening pathway steps common to all screening programmes. They are:

1. Identify the people to invite.
2. Discuss and offer screening.
3. Carry out screening test.
4. Provide and discuss results and options.
5. Carry out diagnostic or confirmatory test if required.
6. Provide and discuss results and options.
7. Offer advice and treatment.

No screening test is perfect and there will always be some incorrect results. These ‘false negative’ or ‘false positive’ results can be harmful, as someone may either be falsely reassured or be unnecessarily worried and perhaps have invasive or harmful tests or treatments that they do not need.

False negative results occur where someone is told they have a low chance of having a health condition when in fact they do have the condition. False positive results occur where someone is told they have a high chance of having a condition when in fact they do not have the condition.

Screening is not diagnosis. Screening finds people at higher chance of a condition, and diagnosis establishes whether the condition is actually present. Individuals can often make better informed decisions about their health or reproductive choices when a diagnosis is made as early as possible as it may make any treatment or intervention more effective and therefore lead to better health outcomes.

In a population screening programme, the screening offer is universal to the eligible population. There are mechanisms to monitor and quality assure the completeness of the offer, the policy and associated implementation. This is important to advance equality of opportunity and reduce inequalities in screening. 

All UK NSC-recommended screening programmes aim to support a personal informed choice for people offered screening.

The UK NSC definition of a personal informed choice is:

A decision made to accept or decline a screening test based on access to accessible, accurate, evidence-based information covering the:

• condition being screened for
• testing process
• potential benefits, harms, limitations and uncertainties
• potential outcomes and ensuing decisions

Antenatal screening

Screening tests are offered in pregnancy to enable earlier, potentially more effective treatment and to support informed choice by providing accessible and unbiased information that supports decision making during pregnancy or after the baby is born.

There are 3 NHS antenatal screening programmes offered in England. They are the:

• infectious diseases in pregnancy screening (IDPS) programme
• sickle cell and thalassaemia (SCT) screening programme
• fetal anomaly screening programme (FASP)

Different screening tests are offered at different times during pregnancy. The tests offered are ultrasound scans, blood tests and a family origin questionnaire. If the test results indicate a higher chance of a condition, then diagnostic testing is offered to obtain a definitive result.

Antenatal screening is always a choice. However, screening for infectious diseases in pregnancy is both offered and recommended to reduce the number of babies infected with hepatitis B, human immunodeficiency virus (HIV) and syphilis and to safeguard the health of mothers.

NHS Fetal Anomaly Screening Programme

In England, the NHS FASP offers screening opportunities at specific points in a woman’s pregnancy, to assess the chance of the baby having Down’s syndrome, Edwards’ syndrome or Patau’s syndrome in addition to a 20-week scan that screens for 11 physical conditions.

Pregnant women are provided with accessible information to help them to make a personal informed choice whether to accept or decline fetal anomaly screening.

FASP offers women a screening test called the ‘combined test’ between 10 and 14 weeks of pregnancy. The screening test for Down’s syndrome, Edwards’ syndrome or Patau’s syndrome (see the FASP handbook) combines the following elements to determine the chance of the baby having any of the conditions:

• maternal age
• biochemical markers - free beta human chorionic gonadotropin and pregnancy associated plasma protein-A
• ultrasound measurements - nuchal translucency (fluid at the back of the baby’s neck) and crown rump length (measurement from the top of the head to the bottom the buttocks)

Sometimes it is not possible to complete the ultrasound measurements because:

• the baby is lying in a position where the nuchal translucency cannot be measured
• the baby’s crown rump length (top of the head to the bottom of the buttocks) does not meet the measurements required
• it can be difficult to measure the nuchal translucency in women with a raised body mass index (BMI)

The combined test cannot be offered after 14 weeks as it is not possible to measure the nuchal translucency after this time. Data from FASP (see section 4 of the consultation document ‘Edwards’ syndrome screening quadruple test consultation’) shows that approximately 14% of women are deemed ineligible for combined testing for some reason - for example if they present after 14 weeks of pregnancy.

If the combined test is not possible, FASP offers the quadruple test between 14 and 20 weeks of pregnancy. Currently, FASP only offers the quadruple test for Down’s syndrome. The test is not offered for Edwards’ syndrome and Patau’s syndrome. The quadruple test uses maternal age and 4 biochemical markers of maternal blood which are:

• alpha-fetoprotein
• human chorionic gonadotropin
• inhibin-A
• unconjugated oestriol

Screening for Down’s syndrome is offered to all eligible pregnant women and takes place between 10 and 20 weeks of pregnancy.

Screening for 11 physical conditions as part of the 20-week scan is offered to all pregnant women and takes place between 18 and 20 weeks (plus 6 days) of pregnancy. Scans can be completed up to 23 weeks of pregnancy.

Screening for Edwards’ syndrome and Patau’s syndrome is offered to all eligible pregnant women and takes place between 10 and 14 weeks (plus 1 day) of pregnancy.

Fetal anomaly screening test results

Chance cut-off determines whether a woman has a lower chance or higher chance result. The cut-off is based on a chance at term, rather than a chance at the time of the screening test.

The chance cut-off is 1 in 150 at term for both the combined and quadruple tests, as defined by the NHS FASP (see the FASP handbook chapter on screening for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome, section 9).

A lower chance result is less than or equal to 1 in 151.

A higher chance result is greater than or equal to 1 in 150 (between 1 in 2 and 1 in 150).

FASP information for parents (see the Screening tests for you and your baby (STFYAYB) chapter on Down’s syndrome, Edwards’ syndrome and Patau’s syndrome) explains that around 97% of screening test results are lower chance.

Following a higher chance result from the combined or quadruple test, women have a discussion with their obstetrician and/or midwife about their results. A woman can choose to have:

• no further testing and continue with routine antenatal care
• non-invasive prenatal testing (NIPT) - a blood test which analyses cell-free DNA (cfDNA) circulating in the mother’s blood which offers a further screen (but not diagnosis) for conditions such as Down’s syndrome, Edwards’ syndrome and Patau’s syndrome
• an invasive diagnostic test such as chorionic villus sampling (CVS) or amniocentesis

Note that NIPT is not considered invasive as it does not involve procedures which carry a risk of miscarriage. It is currently part of an in-service evaluation in the NHS FASP.

Edwards’ syndrome

Edwards’ syndrome (also known as trisomy 18 or T18), is a rare but serious condition that affects the way a baby grows. It is caused by an additional (third) copy of chromosome 18 in some or all cells. Edwards’ syndrome affects around 1 in 1,500 pregnancies. There is no cure for this condition. Approximately 70% of pregnancies with T18 result in spontaneous miscarriage or stillbirth. The risk of miscarriage decreases as the pregnancy progresses, but there is still a risk of stillbirth.

Survival rates are low, and of those babies born alive, only around 13% live past their first birthday. Some babies may survive into adulthood, but this is rare.

All babies born with Edwards’ syndrome will have a learning disability and a wide range of health challenges. They may have problems with their heart, respiratory system, kidneys and digestive system.

The chance of having a baby with T18 increases with maternal age and after a previous pregnancy with Edwards’ syndrome.  

UK NSC recommendation

In 2019 a proposal was submitted to UK NSC to modify NHS FASP to screen for Edwards’ syndrome on the quadruple test in the second trimester.

UK NSC commissioned a rapid review to synthesise the evidence on the diagnostic accuracy of the quadruple test to detect Edwards’ syndrome. See ‘UK NSC external review of FASP modification Jan 2021’ in the consultation Addition of quadruple test to Edwards’ syndrome screening pathway. It was presented to UK NSC’s Fetal, Maternal and Child Health (FMCH) expert group in January 2021. This suggested that further work was required to understand the accuracy of the test to align with UK screening practice.

Using retrospective FASP data, in 2023 a paper was presented to the FMCH group summarising modelling of the existing data on the detection of Edwards’ syndrome using the quadruple test.

UK NSC consulted on the rapid review of modelling data and sought views from stakeholders and the public on the question:

Does the evidence from this rapid review demonstrate that the quadruple test is accurate enough to be added to the antenatal screening pathway for Edwards’ syndrome (Trisomy 18)?

The public consultation on the rapid review opened on 21 February 2024 and ended on 6 March 2024. The total number of consultation responses received was 10.

At its March 2024 meeting (see ‘UK NSC minutes March 2024’), UK NSC recommended a modification to the screening pathway for Edwards’ syndrome in FASP. This means an additional point in the antenatal screening pathway for Edwards’ syndrome could be added to the second trimester quadruple test.

Intended aims of modifying the screening pathway for Edwards’ syndrome

The policy offers an additional point in the antenatal screening pathway to identify pregnancies with Edwards’ syndrome. Women who have not completed the combined test in the first trimester could be offered the quadruple test to screen for Edwards’ syndrome. This would enable an earlier opportunity for diagnosis in some cases and would support women’s equitable screening choices.

Early diagnosis of a congenital condition gives women greater choice about their pregnancy and enables better planning for the delivery of babies where specialist intervention or palliative care (relief of symptoms rather than treatment of the condition) may be required soon after birth.

Of the 600,000 pregnant women eligible for fetal anomaly screening each year around 500,000 take up the offer. Of the 500,000 about 85% have the combined test and 15% have the quadruple test.

Around 70,000 women a year would be eligible for a quadruple test. Modelling data provided for the quadruple test consultation (see section 4 of the consultation outcome) indicates that of these, 78 would have a pregnancy with Edwards’ syndrome.

If Edwards’ syndrome is confirmed, the pregnant woman is offered the opportunity to discuss with her obstetrician and/or midwife what this may mean for her and her baby and to receive further information and support. She may decide to continue with the pregnancy or end the pregnancy.

Effect on NHS staff

Most healthcare professionals involved in the NHS FASP will already be aware of Edwards’ syndrome due to the existing FASP screening pathway and supporting screening resources. However, they will need to be made aware of this modification to the Edwards’ screening pathway, with updates to all relevant training material.

NHS FASP information, leaflets and guidance on the NHS England, GOV.UK and NHS.UK websites will need to be updated. This will need to include the translated and accessible versions. The documents are held online so updating is relatively straightforward.

Offering testing for Edwards’ syndrome using the quadruple test will increase referrals to specialist fetal medicine units and use of their specialist screening and/or genomic counselling resources. Of the estimated 78 families a year that are likely to find out from the quadruple test that their baby has Edwards’ syndrome, many may have found out later at the 20-week scan. This suggests that referrals may be made earlier, rather than creating additional referrals for specialist and fetal medicine teams.

Effect on laboratories

There are 9 screening laboratories that currently test blood samples received for quadruple screening. It is estimated that screening for T18 in addition will not create a significant amount of additional work. However, the laboratory protocols will need to be updated and laboratory staff made aware of the modification to the screening pathway. The one-off IT infrastructure and software changes would require laboratory staff time to complete.

NIPT is offered to parents when the result of the combined or quadruple test indicates a higher chance of Down’s syndrome, Edwards’ syndrome or Patau’s syndrome (between 1 in 2 and 1 in 150). Parents may choose to accept NIPT to help decide on having a diagnostic test. Diagnostic tests are higher risk than NIPT. NIPT is a maternal blood test whereas diagnostic tests are invasive and involve taking a sample of cells from the amniotic fluid (amniocentesis) or placenta (chorionic villus sampling) which carries a risk of miscarriage of 0.5%. Including testing for Edwards’ syndrome on the quadruple test is estimated to increase the number of NIPT tests performed by around 80 tests annually. This will marginally increase the workload of NIPT test takers.

Effect on women and parents

The addition of screening for Edwards’ syndrome to the second trimester quadruple test enables an earlier opportunity for diagnosis in some circumstances. It supports informed choice and equitable screening choices. Women who have missed or were unable to complete the combined test in the first trimester, or were not eligible for any reason, will have an opportunity to participate in screening. This potentially gives parents more time to make informed decisions on next steps and enables better planning.

It is likely there will be a small increase in the number of women who decide to terminate their pregnancy. The National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) Congenital Anomaly Official Statistics Report for England (1 January and 31 December 2021) shows that in 89% of pregnancies with Edwards’ syndrome a decision was made to end the pregnancy.

Effect on employers

It is possible that an early diagnosis of Edwards’ syndrome would lead to an increase in clinic appointments to accommodate additional NIPT tests, counselling and diagnostic testing. This may adversely affect a small number of employers of pregnant women. However, it must be noted that pregnant women have a legal right to paid time off work for antenatal care.

Evidence

The evidence relating to this policy is referenced and linked to throughout this equality impact assessment. It includes UK NSC meeting minutes, consultation documentation and links to GOV.UK, NHS.UK, official statistics, research articles and third sector websites.

Analysis of impacts

Disability

Women with physical disabilities may be restricted in where they can attend for screening or follow-up appointments unless there are facilities to accommodate them. If access is not facilitated this could deter individuals from accessing quadruple screening or attending subsequent appointments. 

However, contractually, providers of NHS screening services are required to make reasonable adjustments to ensure that their services are accessible to people with a disability. There is guidance for providers of antenatal and newborn screening on reducing barriers to attendance.

Some individuals and organisations view screening for conditions such as Down’s syndrome, Edwards’ syndrome and Patau’s syndrome as ableist and do not agree screening should be offered by the NHS. It is important that NHS screening providers are clear that fetal anomaly screening is an offer and that women are not pressured into accepting, and their choices and decisions will be respected.

It is likely that the addition of an extra opportunity to screen for Edwards’ syndrome will result in a small increase in the number of pregnancies ending in termination. The purpose of screening is not to offer an end to a pregnancy but to allow parents to be informed about their reproductive choices. For some this may involve an opportunity to contact support charities, gather information and understand their baby’s condition before they are born. Offering this additional opportunity to screen between 14 and 20 weeks, may allow parents additional time to make a personal informed choice that is right for them and their family.

Sex

As the quadruple test is offered to pregnant women, the burden of this screening test falls predominantly on women. If the pregnant woman has a partner, she is likely to have discussions about antenatal screening with them. However, from a legal viewpoint, the offer of screening is for her to accept or decline, as are decisions regarding reproductive choice.

Sexual orientation

There is no evidence to suggest that the performance of the quadruple screening test is impacted by the pregnant woman’s sexual orientation.

Research relating to the healthcare experiences of lesbian, gay, bisexual and transgender (LGBT) people indicates that they are more likely to have had negative experiences of using healthcare system. This may impact their choices when deciding whether to engage with FASP.

In the case of individuals having a child through surrogacy, the surrogate is offered all NHS screening tests in the usual way (as set out in Department of Health and Social Care (DHSC) ‘Care in surrogacy’ guidance available from Having a child through surrogacy). However, decisions about the pregnancy remain with the surrogate until after the baby is born. It is likely that the intended parent or parents using a surrogate might wish to be involved in the screening offer, but it is not up to them to accept or decline screening tests. They cannot make decisions about the pregnancy following a higher chance test result because this legally rests with the surrogate. Although the intended parent or parents may not have a direct say about antenatal screening, and subsequent decisions relating to the pregnancy, this is a broader issue about the laws surrounding surrogacy and is not specific to same sex couples or FASP. 

Healthcare professionals should consider and accommodate requests made between the surrogate and the intended parent or parents where possible and should be satisfied that the surrogate consents to sharing of information and who attends appointments.

Race

Although Roma, Gypsy and Traveller people are distinct populations, there is some crossover in health inequalities for these groups due to their nomadic lifestyle, culture and beliefs and their experiences and mistrust of health professionals. Gypsy and Traveller people have poor access to healthcare generally, with difficulty in registering with GPs and poor access to services as a result, including health screening, home visits and access to secondary health care. There have been reports of breaches in equality laws where Gypsy, Roma and Traveller community members were refused care by British GP practices. There are some reports of lack of trust in health services - this could mean these populations are more likely to decline screening. Experience of discrimination with healthcare workers might also deter people from accessing healthcare around pregnancy and not accessing or declining screening. Possible mitigations would need to be broader than screening. Existing mitigations include midwives with training and awareness of Gypsy, Roma and Traveller culture.  

An audit of late referral and antenatal booking across London in 2015 to 2016 showed that Black and ethnic minority women (particularly Bangladeshi or Black African ethnicity), women living in deprived communities, women whose first language was not English, and women of Jewish religion were among those associated with later booking, likely to be after 10 weeks gestation. NHS Digital Maternity Services Monthly Statistics for July to August 2024 indicate that 64% of booking appointments were at or before 10 weeks’ gestation. Booking after more than 20 weeks of pregnancy accounted for 7% of booking appointments.

Possible mitigations here will need to be wider than screening, working with local ethnic minority women’s groups, asylum seekers and refugees to inform and educate on pre-conception health and antenatal care. In addition, midwives providing antenatal care need to communicate to women the importance of engaging early with maternity services as this may benefit future pregnancies.

For those groups of women who do engage with maternity services later in their pregnancy, the addition of another point in the antenatal screening pathway to test for Edwards’ syndrome will offer greater reproductive choice.

Women who do not speak English as their first language may be less able to access health services due to language barriers. Evidence on language as a barrier to healthcare access and equality shows that there are several ways in which access to primary care may be challenging for people with limited spoken English. People who do not speak English report greater barriers accessing primary care than those who do not, have a poorer patient experience and are more likely to be in poor health. Language barriers may impact people’s ability to make an informed choice about taking up the screening offer, as well as accurately relaying information to clinicians and their ability to ask questions about the programme. To help people make an informed choice in the current NHS screening programmes, information leaflets and videos in English and 12 other languages are available (see STFYAYB), and these will be updated for the addition to the quadruple screening test. Another mitigation is to offer the use of interpreters during appointments, either in person or over the telephone.

Age

NHS Maternity Annual Statistics for England in 2021 to 2022 show that at booking, the greatest total number of women were in the 30 to 34 age group, while those in the under 20, and 45 or over age groups represent the smallest number of women.

NHS information for parents about Edwards’ syndrome explains that the chances of having a pregnancy with Edwards’ syndrome increases with maternal age. Having an additional point in the antenatal screening pathway to screen for Edwards’ syndrome would enable an earlier opportunity for diagnosis and may give parents more time to make personal informed choices.

Gender reassignment (including transgender)

It is possible in some circumstances for trans men to become pregnant and have babies. It is known that the LGBT community is less engaged with screening. Therefore, it is possible that trans men might be less likely to engage with FASP as set out in the blog article Ensuring pregnant trans men get equal quality care. A mitigation would be for all maternity departments to review their own policies in readiness to make sure they are inclusive of trans people.

Trans men who are pregnant should be offered the same antenatal and newborn screening tests as other pregnant individuals. There is no evidence to indicate the clinical effectiveness of the tests differs within this population.

Trans people may also be more likely to use a surrogate to birth a child, therefore information in the ‘sexual orientation’ section above relating to the use of a surrogate would also apply here.

Religion or belief

Many faiths do not support termination of a pregnancy at all, or only support termination in some circumstances. For this reason, people of these faiths may decline a screening offer during pregnancy. It is important that health professionals explain that screening provides information that can help with choices, including around place and timing of birth, care after birth and how to care for a child with a condition such as Edwards’ syndrome. Screening should therefore not be seen as a route to terminating a pregnancy. Women should be given adequate information about the tests (including the additional quadruple test for Edwards’ syndrome) so that they can make a personal informed choice.   

Pregnancy and mental health

The Maternal Mental Health Alliance states that 1 in 5 women experience a mental health problem during pregnancy and after giving birth, and for some women, pre-existing mental health conditions can get worse. Decision-making following screening results may be difficult during pregnancy and women should have the opportunity to talk through their concerns with a healthcare professional. Mitigations such as access to perinatal mental health teams may need to be put in place to ensure ongoing support is provided to women whether they make the decision to continue the pregnancy or terminate the pregnancy.

Marriage and civil partnership

We have no data to suggest that marriage or civil partnership of the parents has any impact on participation in FASP.

Legally, choices relating to screening in pregnancy are for the pregnant woman to make. It does not make a legal difference whether a woman is in a marriage or a civil partnership. The decisions to accept the test or not are legally hers alone.  

Engagement and involvement

Evidence and testing

Between 21 February and 6 March 2024, UK NSC opened a public consultation on whether the quadruple test was accurate enough to be added to the antenatal screening pathway for Edwards’ syndrome.

The consultation was freely available on GOV.UK for any individual or organisation to participate. Emails were sent to more than 30 organisations with an interest in antenatal screening, including charities and professional organisations. The consultation received a total of 10 responses, 4 of which were from organisations that had been directly contacted by the UK NSC secretariat. The responses were from:

• Society of Radiographers
• Antenatal Screening Wales, Public Health Wales
• Illumina
• Genetic Alliance on behalf of Genetic Alliance, SOFT UK and Antenatal Results and Choices (ARC)
• The Royal College of Midwives
• a professor of preventative medicine
• an antenatal and newborn specialist screening midwife
• an antenatal and newborn screening co-ordinator on behalf of an antenatal and newborn screening team
• 2 antenatal and newborn screening co-ordinators

Main points raised by stakeholders

All the antenatal and newborn screening co-ordinators and midwives who responded stated they were supportive of the introduction of the quadruple test to the Edwards’ syndrome screening pathway. Reasons cited included that this would enable early diagnosis, support women’s choice and enable equitable screening.

The Society of Radiographers was also supportive of the change. The Society’s response included the suggestion for additional training to explain the rationale for the quadruple test being included in the Down’s syndrome and Edwards’ syndrome screening pathways but not the Patau’s syndrome pathway.

Genetic Alliance said that the introduction of the quadruple test to the Edwards’ syndrome screening pathway would enable earlier diagnosis, which is important to parents.

The response from Antenatal Screening Wales noted the differences between the screening pathways in England and Wales, but confirmed the rapid review demonstrated that the quadruple test is accurate enough to be added to the antenatal screening pathway for Edwards’ syndrome.

The response from Illumina requested that NIPT be considered as the primary screening test at different points in the FASP pathway and cited published literature to support this. This was outside the scope of the consultation.

In summary, the number of responses received was small, but stakeholders were supportive of the proposed policy because it offered another opportunity for screening for Edwards’ syndrome.

Shaping the policy

UK NSC has 3 subgroups made up of subject matter experts. The FMCH expert group includes professionals with expertise in public health, paediatrics, clinical ethics, implementation science, rare diseases, neonatal screening, midwifery, obstetrics, genetics and fetal medicine who can use their knowledge to advise on issues related to screening and fetal anomalies.

In developing the policy, the FMCH group was first consulted in 2021 for its views on a summary of international research evidence regarding the use of the quadruple test in screening for Edwards’ syndrome. The group suggested that further work was needed to understand how accurate the test was for UK screening practice. NHS England used data from FASP to model how the quadruple test would work for screening for Edwards’ syndrome in the UK and presented its findings in a paper to FMCH in 2023 to seek its views. The FMCH group was content with the evidence presented and agreed this could go to the UK NSC to consider and make a recommendation.

On 21 March 2024, this paper, together with the consultation responses discussed in the ‘evidence and testing’ section above was presented to UK NSC to request a recommendation in support of the policy. UK NSC made a recommendation for the quadruple test to be added to the screening pathway for Edwards’ syndrome.

Ministers considered the recommendation alongside cost effectiveness data and this equality impact assessment and agreed the policy. The policy will be implemented by the NHS and overseen by DHSC.

Summary of analysis

Overall impact

Overall, the introduction of an additional point in the antenatal pathway to screen for Edwards’ syndrome between the first trimester combined test and the 20-week ultrasound scan would appear to benefit many people with protected characteristics. This is because it offers those who have missed, or did not complete, the combined test an opportunity to make an informed reproductive choice. These groups include Black and ethnic minority women who are associated with having their first midwife appointment after 10 weeks of pregnancy, and women whose first language is not English who find it difficult to access healthcare because of the language barriers. Mitigations here could include leaflets translated into different languages and using interpreters at appointments.

We acknowledge that there will be organisations and members of the public who may perceive that this policy is discriminatory to disabled people. The policy could be viewed as perpetuating ableist attitudes where a pregnancy could be terminated because of a diagnosis of Edwards’ syndrome. However, the overarching principle of screening is personal informed choice. Women are provided with accurate information about the condition being screened for so that they can make a decision that is right for them.

This policy may not benefit groups who are generally less likely to engage with healthcare such as Roma, Gypsy and Traveller people, and some LGBT people. Some of these groups may choose not to engage with fetal anomaly screening and wider screening services because of previous negative experiences of healthcare services.

Sometimes, decisions along the screening pathway can be difficult and cause anxiety. Therefore, women should be supported throughout, including having access to specialist support where needed.

Addressing the impact on equalities

Mitigations for addressing the impact the policy may have on equalities have been proposed in earlier sections of this equalities impact assessment. These include access to accurate and accessible information that helps women decide whether to take up the offer of screening or not. Information needs to be provided in various formats to benefit women with learning disabilities, or women who do not speak English.

Involving intended parents having a child through surrogacy should be considered where appropriate and with the consent of the surrogate. The surrogate makes the decision to accept or decline screening and should be provided with antenatal care as usual.

Screening services must be inclusive of LGBT people to improve their experiences of healthcare services.

Screening services must have links with perinatal mental health teams so that women can be referred for specialist help where required.

The NHS FASP screening standards look at 4 themes to assess the pathway and 3 key performance indicators (KPIs).This provides screening services with a high-level overview of how they are performing at specific points on the screening pathway. This gives them information they can use to implement appropriate mitigations on a localised basis where necessary.

Monitoring and evaluation

The quality assurance support service for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome screening (DQASS) monitors and supports the quality and effectiveness of screening in England. The analyses provided by DQASS are used to improve the performance of the screening programme through feedback on all aspects of the test to laboratories, ultrasound departments and commercial suppliers.

The annual report for FASP standards are published on GOV.UK.

NCARDRS quality assures and publishes annual data on congenital anomalies and rare diseases in England.

Conclusion

Adding the quadruple test to the antenatal screening pathway for Edwards’ syndrome is a positive modification to the NHS FASP. While this equality impact assessment shows the policy could discriminate against or unfairly impact on some groups of society, mitigations have been suggested which, if appropriately implemented, will avoid this.

It is possible that some may view this policy as a test to screen out people with disabilities. Sadly, around 70% of babies with Edwards’ syndrome will be miscarried or stillborn. Most babies born with Edwards’ syndrome will die during their first year of life. Only around 13% of babies with Edwards’ syndrome live past their first birthday. NHS information for parents about Edwards’ syndrome explains that survival to adulthood is rare. Screening is a choice. Information is provided before the screening test so that women understand what condition is being screened for and what to expect when having a child with the condition. Having a screening result earlier than the 20-week scan means women have more time to plan for potentially caring for a baby with a wide range of serious health issues.

There are groups of people for whom the policy may have no benefit because of existing barriers to engaging with screening and wider healthcare. However, evidence set out in this equality impact assessment suggests that, on the whole, this policy will have a net positive impact which benefits women who miss or do not complete the combined test. Personal informed choice, proposed mitigations, supporting services and ongoing monitoring can guide screening teams to provide the best care possible to women, parents and families.