Plans for introduction of Non-Invasive Pre-Natal Testing into pregnancy screening programme: FOI release

Information requested

 

Information about the introduction of Non-Invasive Prenatal Testing (NIPT) into the Scottish Pregnancy Screening Programme.

Response

 

Has the introduction of NIPT been approved yet?

After careful consideration of the recommendation made by the UK National Screening Committee (UK NSC) and the Scottish Screening Committee (SSC), Scottish Ministers approved the evaluative roll out of NIPT into the Scottish Pregnancy Screening Programme in July 2018.

If NIPT has been approved in Scotland, can you advise where these plans have been published?

These plans have not been published. However, implementation is underway. A steering group and three working groups have been established. The Steering Group reports into the Scottish Screening Committee, which in turn advises Scottish Ministers. Stakeholders will be involved in the implementation process, and Down Syndrome Scotland (DSS) are represented on The Training, Education and Communications Working Group.

Has a decision been taken as to who the referral agencies will be for any individual found to have a probability of carrying a baby with a screened-for condition?

No decision on referral agencies has yet been made and therefore we do not hold this information.
Is there a plan in place yet to implement the recommendations made in the Nuffield Report on NIPT which addresses some ethical concerns?A Communications and Engagement Strategy is currently being developed by The Training, Education and Communications Working Group. This strategy will ensure that the recommendations in the Nuffield Report on NIPT are met i.e. that all messaging and communication around NIPT is sensitive, balanced, and non-directive. Down Syndrome Scotland (DSS) are represented on The Training, Education and Communications Working Group.

Ethical concerns centre around the introduction of genomic testing into the antenatal screening programme. To ensure due diligence, it seems evident that an Equality Impact Assessment or similar should be carried out around fetal anomaly screening. In fact, of the EHRC has recently told us that an Equality Impact Assessment would be a 'sensible way to proceed'. We would be happy to assist with this if you agree that it is a sensible way forward too and haven't already carried out an assessment?

In Scotland, the Fetal Anomaly Screening Programme is an established programme that prospective parents can choose whether to participate in. The key objective of the programme is to enable women to make informed choices, at each step of the screening pathway.

The UK NSC’s recommendation on NIPT for Down’s syndrome and other aneuploidies, including Trisomy 13: Patau Syndrome and Trisomy 18: Edwards’ Syndrome, does not change the choices available to prospective parents within the programme. The evidence suggests that adding this new test to the current screening pathway would significantly reduce the number of invasive diagnostic tests, which carries a risk of test-related miscarriages.

The UK NSC have recommended that NIPT should be introduced as part of an evaluative roll-out. Prior to making its recommendation, the UK NSC commissioned new work to look at research from around the world on the effectiveness, accuracy and costs of NIPT. It also considered ethical issues and carried out an extensive and wide-reaching consultation. The UK NSC commissioned the Nuffield Report and this also formed part of the recommendation You may wish to discuss the need for an Equality Impact Assessment with the UK National Screening Committee. Contact details can be found here:
https://www.gov.uk/government/groups/uk-national-screening-committee-uk-nsc#contact

 

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