Regulation and financing of prenatal screening and diagnostic examinations for fetal anomalies in selected European countries (Policy Brief)

Duration: December 2021 – March 2022
Language: English with German summary
Suggested by: Federal Ministry of Social Affairs, Health, Care and Consumer Protection

Background
There are several prenatal screening and diagnostic tests to detect fetal structural and chromosomal anomalies, which can be classified as non-invasive (e.g., ultrasound examinations, first-trimester screening, non-invasive prenatal test [NIPT]) and invasive methods (e.g., amniocentesis and chorionic villus sampling) [1].

The following prenatal screening and diagnostic tests are to be considered in the planned policy brief:

• First Trimester Screening/ Combined Test
• NIPT
• Amniocentesis/chorionic villus sampling
• Ultrasound screening for fetal anomalies in the second trimester

The regulation and financing of prenatal screening and diagnostic examinations for fetal anomalies are heterogeneous across countries [2, 3]. The project aims to research and summarise the provision and the financial framework conditions of the above-mentioned tests in selected European countries.

Research questions
The following research questions (RQ) will be answered:

• RQ1: Which of the above-mentioned prenatal screening and diagnostic examinations for fetal anomalies are offered in the selected countries for all pregnant women or certain indications, risk factors or other criteria?
• RQ2: How are those tests financed in the selected countries (publicly, co-financed, privately)?
• RQ3: Where are the prenatal screening and diagnostic tests carried out in the selected countries (e.g., in hospitals, in doctor’s practices)?

Methods
A hand search of databases and relevant websites (e.g., ministries of health, specific websites of national screening programmes) will be conducted for information on the formulated research questions.

In addition, data collection will be carried out using (written) expert consultations, for which a questionnaire will be prepared.

The country representatives of the EUROCAT network [4]will be asked to act as experts; if necessary, other experts, e.g. from the administration, will be contacted. The questionnaire will be sent and answered by email; queries will be made by telephone.
After the data collection the information will be summarised in tables and analysed in a country comparison.

Selection of countries
We will select approximately 5 European countries that differ with regard to various relevant criteria (e.g. health/insurance system, geographical proximity, organisation of antenatal care/ involved professional groups, public discourse, ...) in order to illustrate the range of possible regulations and forms of financing. The expected selection includes the following countries: Germany, Switzerland, Netherlands, United Kingdom, Italy.

Schedule

References

[1]          Pschyembel online. Pränataldiagnostik (PND). 2020 [cited 20/12/2021]. Available from: https://www.pschyrembel.de/Pr%C3%A4nataldiagnostik/K0HKQ.

[2]          Gadsboll K., Petersen O. B., Gatinois V., Strange H., Jacobsson B., Wapner R., et al. Current use of noninvasive prenatal testing in Europe, Australia and the USA: A graphical presentation. Acta Obstet Gynecol Scand. 2020;99(6):722-730. Epub 2020/03/17. DOI: 10.1111/aogs.13841.

[3]          Kolleck A. and Sauter A. Aktueller Stand und Entwicklungen der Pränataldiagnostik. Berlin: Büro für Technikfolgen-Abschätzung beim Deutschen Bundestag, 2019.

[4]          European network of population-based registries for the epidemiological surveillance of congenital anomalies. [cited 20/12/2021]. Available from: https://eu-rd-platform.jrc.ec.europa.eu/eurocat_en.