Non-invasive prenatal testing for Down’s, Edwards’ and Patau’s syndromes is an additional test to be offered as part of the current NHS Fetal Anomaly Screening Programme, and as it does not fundamentally alter the choices already available to women, we consider that there will be no impact on race, age, disability, gender reassignment sex or sexual orientation, religion or belief, marriage and civil partnership or pregnancy and maternity for the purposes of the Public Sector Equality Duty under the Equality Act 2010. The Department also considers that the programme is compliant with the Equality Act because it is not discriminatory and, with regard to the three elements of the Public Sector Equality Duty in s.149 of that Act, it has a neutral impact.

The Department considers that adding this optional alternative procedure to the current screening programme is compliant with the United Nations Convention on the Rights of Persons with Disabilities, as the test is intended to allow pregnant women to identify possible abnormalities in a foetus with more accuracy and in a less intrusive way than is possible through other screening procedures. Pregnant women will then be able to make a better informed choice in the light of the screening results.

All relevant equality duties will be further considered by Public Health England during the evaluative roll-out.

NHS England is working with primary care support providers to develop a new cervical screening call and recall system. We expect the new cervical screening call and recall system to be introduced by April 2019. In addition, NHS England is working closely with Public Health England to align implementation plans for human papillomavirus (HPV) primary screening. We expect HPV screening to be rolled out from April 2019.

NHS England closely monitors the coverage rates for cervical screening in all age groups and is committed to improving coverage. Local NHS England commissioners analyse coverage rates within their area and work with healthcare professionals to improve coverage. This includes sharing and implementing best practice such as cervical screening guides for general practitioner practices or targeting practices with low coverage rates. At a national level NHS England is working with Public Health England to make evidence based improvements such as improving invitation letters to patients to encourage more to attend their cervical screening appointment.

NHS England is working in partnership with Cancer Research UK and Macmillan Cancer Support on the ACE (Accelerate, Coordinate, Evaluate) Programme aiming to generate knowledge about effective approaches to achieve earlier diagnosis. A number of ACE test sites are evaluating approaches to increase screening rates in a range of groups, including black and ethnic minority women, women with learning disabilities and women from disadvantaged backgrounds.

NHS England is working with primary care support providers to develop a new cervical screening call and recall system. We expect the new cervical screening call and recall system to be introduced by April 2019. In addition, NHS England is working closely with Public Health England to align implementation plans for human papillomavirus (HPV) primary screening. We expect HPV screening to be rolled out from April 2019.

NHS England closely monitors the coverage rates for cervical screening in all age groups and is committed to improving coverage. Local NHS England commissioners analyse coverage rates within their area and work with healthcare professionals to improve coverage. This includes sharing and implementing best practice such as cervical screening guides for general practitioner practices or targeting practices with low coverage rates. At a national level NHS England is working with Public Health England to make evidence based improvements such as improving invitation letters to patients to encourage more to attend their cervical screening appointment.

NHS England is working in partnership with Cancer Research UK and Macmillan Cancer Support on the ACE (Accelerate, Coordinate, Evaluate) Programme aiming to generate knowledge about effective approaches to achieve earlier diagnosis. A number of ACE test sites are evaluating approaches to increase screening rates in a range of groups, including black and ethnic minority women, women with learning disabilities and women from disadvantaged backgrounds.

The Gold Standards Framework Centre that was developed by Dr Keri Thomas is a private, non-profit organisation that provides training to National Health Service and care home staff in improving the quality of end of life care. There is not an equivalent gold standard framework for detecting group B streptococcus (GBS) infection.

The Enriched Culture Medium (ECM) test is used for detecting GBS carriage at 35-37 weeks of pregnancy and is included in Public Health England’s UK Standards for Microbiology Investigations: Detection of Carriage of Group B Streptococci. In June 2015, Public Health England, in response to requests to introduce the ECM test into Public Health England laboratories, published an advisory position paper which sets out that within current accepted clinical guidelines, there are no indications for testing women using ECM methods. The position paper is available on the gov.uk website at:

https://www.gov.uk/government/publications/group-b-streptococcus-infection-enriched-culture-medium-test

The UK National Screening Committee (UK NSC), the body which advises Ministers in all four United Kingdom countries on all aspects of screening, recommended in 2012 that antenatal screening for GBS carriage at 35 -37 weeks of pregnancy should not be offered because currently there is insufficient evidence to demonstrate that the benefits to be gained from screening would outweigh the harms. The UK NSC is currently reviewing its recommendation on antenatal screening for GBS carriage. A public consultation on the UK NSC’s review opened on 28 October 2016 and will close on 25 January 2017. A copy of the consultation is available at:

https://legacyscreening.phe.org.uk/groupbstreptococcus

A recommendation is expected from the UK NSC following its meeting in February 2017.

Non-invasive prenatal testing for Down’s, Edwards’ and Patau’s syndromes is an additional test to be offered as part of the current NHS Fetal Anomaly Screening Programme, and as it does not fundamentally alter the choices already available to women, we consider that there will be no impact on race, age, disability, gender reassignment sex or sexual orientation, religion or belief, marriage and civil partnership or pregnancy and maternity for the purposes of the Public Sector Equality Duty under the Equality Act 2010. The Department also considers that the programme is compliant with the Equality Act because it is not discriminatory and, with regard to the three elements of the Public Sector Equality Duty in s.149 of that Act, it has a neutral impact.

All relevant equality duties will be further considered by Public Health England during the evaluative roll out.

The decision to accept the UK National Screening Committee’s (UK NSC) recommendation of the non-invasive prenatal testing was formally communicated as a matter of public record via the Guardian and Press Association, and subsequently reported by several media organisations, this is usual practice.

Following subsequent conversations with the Nuffield Council on Bioethics, an agreement was made to amend statements made to reflect their preferred wording. The Department did not contact the Guardian to amend this article.

The decision to accept the UK National Screening Committee’s (UK NSC) recommendation of the non-invasive prenatal testing was formally communicated as a matter of public record via the Guardian and Press Association, and subsequently reported by several media organisations, this is usual practice.

Following subsequent conversations with the Nuffield Council on Bioethics, an agreement was made to amend statements made to reflect their preferred wording. The Department did not contact the Guardian to amend this article.

The UK National Screening Committee (UK NSC) has not reviewed the evidence for screening pregnant women for vitamin B12 deficiency. Following a review of the UK NSC in 2014/15 the UK NSC is now carrying out a call for new screening proposals. Information on how to submit a screening proposal to the UK NSC is available on their website:

https://www.gov.uk/government/publications/uk-nsc-evidence-review-process/appendix-d-how-to-submit-a-proposal-to-the-uk-nsc

Information on vitamin B12 deficiency is available on the NHS Choices website and can be accessed using the following link:

http://www.nhs.uk/Conditions/Anaemia-vitamin-B12-and-folate-deficiency/Pages/Symptoms.aspx

The diagnosis and treatment for B12 deficiencies is well established and reported in the British Committee for Standards in Haematology (BCSH) guidance document, ‘Guidelines for the diagnosis and treatment of Cobalamin and Folate disorders’. The guidance was last updated in May 2014 and can be found at the following link:

http://onlinelibrary.wiley.com/doi/10.1111/bjh.12959/epdf

The BCSH provides up to date advice to both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease by the production of evidence-based guidelines. The Committee operates independently of Department and NHS England and produces evidence based guidelines for both clinical and laboratory haematologists on the diagnosis and treatment of haematological disease, drawing on the advice of expert consultants and clinical scientists practicing in the United Kingdom. It would be for the BCSH, not the Department, to consider whether any adjustments to current best practice, were needed.

A full blood count is not intended as a diagnosis tool for specific health conditions. The test assesses a number of different components in the blood, including red blood cell count, haemoglobin levels and platelet levels and is designed to help a clinician assess the overall health of the patient as part of the overall clinical picture. However, the test often gives important clues to specific conditions and this can help doctors to reach a diagnosis, alongside any other tests or investigations the doctor thinks necessary. For example, it can detect anaemia, which is symptom of B12 deficiency.

Ministers plan to meet stakeholders in the coming months to discuss concerns about the introduction of new technologies such as non-invasive prenatal testing which have the potential to increase the safety of screening tests.

At its 19 November 2015 meeting, the UK National Screening Committee (UK NSC) recommended that non-invasive prenatal testing (NIPT) for Down’s, Edwards’ and Patau’s syndromes should be introduced as an additional test into the NHS Fetal Anomaly Screening Programme as part of an evaluation. The UK NSC held a three month public consultation on the GOV.UK website before making its recommendation. At its meeting in November 2015, the UK NSC reviewed all the responses to the consultation, including the ethical concerns raised before making its recommendation.

The Nuffield Council on Bioethics (NCOB) subsequently convened a roundtable in January 2016 to discuss clinical, ethical, social, legal and policy issues raised by recent developments in wider non-invasive prenatal diagnosis, testing and screening. The meeting was attended by 31 people, including healthcare professionals, academic researchers, policy makers, representatives of charities and patient groups, as well as members and officers of the UK NSC, including its ethicist.

Following the roundtable, the NCOB set up a working group in March 2016 to consider the ethical issues that would be raised by introducing NIPT into the National Health Service antenatal screening programme.

The UK NSC formally considered the NCOB’s write up of the roundtable at its meeting on 15 June 2016. In accordance with its terms of reference and as part of the ongoing evaluation the UK NSC will consider any significant new peer reviewed evidence, so will consider the report from the NCOB alongside any other new evidence when it becomes available.

Public Health England (PHE) is working through the procurement and the evaluative roll out process for non-invasive prenatal testing (NIPT) for Down’s, Edwards’ and Patau’s syndromes. It is estimated that the test will cost £200-300 per test and PHE has estimated that approximately 10,000 tests will take place per year. The overall cost is expected to be cost-neutral with less invasive procedures being undertaken.

Information is not available centrally on laboratory costs.

In June 2015, Public Health England (PHE), in response to requests to introduce the enriched culture medium (ECM) test into PHE laboratories, advised and published a position paper which sets out that within current accepted clinical guidelines, there are no indications for testing women using ECM methods. The position paper is available on the gov.uk website at:

https://www.gov.uk/government/publications/group-b-streptococcus-infection-enriched-culture-medium-test

My Rt. hon. Friend the former Parliamentary Under Secretary of State for Health (Ben Gummer) met representatives from the charity Group B Strep Support (GBSS) and my Rt. hon. Friend, the Member for Mid Sussex (Sir Nicholas Soames), patron of GBSS to discuss group B streptococcus (GBS) in December 2015.

The Department’s Chief Scientific Adviser held two workshops on 19 September and 20 October this year with leading experts from a wide range of organisations, including the charity GBSS to agree workable research questions on early-onset GBS to improve knowledge of the infection. The first workshop discussed evidence gaps in relation to early-onset GBS and the second workshop developed science-based research questions for funders to consider.

On 17 November officials met with GBSS to discuss recent policy developments including the publication of Safer Maternity Care, and the Maternity Transformation Programme.

The UK National Screening Committee (UK NSC) is currently reviewing its recommendation on antenatal screening for GBS carriage as part of its three yearly review cycle. A public consultation is being held which will close on 25 January 2017. Following the closure of the consultation, the UK NSC will review its recommendation on screening for GBS carriage in pregnancy and a recommendation will be made to Ministers.

The cost analysis considered by the UK National Screening Committee (UK NSC) related solely to providing choice and did not take into account the lifetime costs of caring for children and adults with Down’s syndrome.

Thirty stakeholders responded to the UK NSC’s consultation, including the Royal College of Obstetricians and Gynaecologists. The UK NSC considered carefully all the responses to the consultation. However, as is standard practice there are no plans to respond to individual representations.

The Nuffield Council on Bioethics plans to publish the findings of its project on non-invasive prenatal testing in March 2017.

A number of published studies indicate selective enrichment broth culture of vagino-rectal swabs is superior to non selective plate culture to improve the recovery of group B streptococcus (GBS) and avoid the overgrowth by vaginal and rectal flora. Public Health England is not aware of any studies that have compared these tests’ ability to predict early onset GBS infection.

On 29 October 2016 the Department announced the evaluative roll out of non-invasive prenatal testing (NIPT) for Down’s, Edwards’ and Patau’s syndromes. NIPT will be introduced as an additional test into the NHS Fetal Anomaly Screening Programme in England. The evaluative roll out will provide further information to ensure the full national implementation is optimised and safe. This will include, but not be limited to, test turnaround times, numbers of women accepting the offer of screening, impact on invasive procedures, and; information and training materials required.

Public Health England (PHE), which leads National Health Service Screening Programmes in England, is currently working through the procurement and the evaluative roll out process for NIPT for Down’s, Edwards’ and Patau’s syndromes, including the development of tender documents specification and criteria for tendering. The expectation is that laboratories will be contracted to provide NIPT for Down’s, Edwards’ and Patau’s syndromes as part of the NHS Fetal Anomaly Screening Programme as part of the evaluative roll out during financial year 2018-19.

PHE is working through the procurement and the evaluative roll out process for non-invasive prenatal testing (NIPT) for Down’s, Edwards’ and Patau’s syndromes. It is estimated that the test will cost £200-300 per test and PHE has estimated that approximately 10,000 tests will take place per year. The final additional cost or saving will depend on actual uptake rates (i.e. how many women take the test) and on the actual unit costs of tests which NHS England will need to agree with providers.