How do experts shape regulatory science? Designing a genetic screening program for pregnant women in France

When biomedical innovations are assessed by regulatory agencies, competing bodies of knowledge concerning their benefits and limits pre-exist the assessment process. This knowledge is taken into account to varying extents by agency employees and by the experts invited to take part in the process. How do these two groups of actors interact to ensure that certain aspects of knowledge prevail? This article provides a number of answers to this question, based on a case study of the assessment of fetal DNA testing, also known as non-invasive prenatal testing, in France in 2016-17. The National Health Authority set the terms and conditions for public funding of a national program to screen for fetal trisomy 21. The author of this article was invited to participate in the evaluation as a social science expert. This article analyses why the agency’s staff have adopted the conception of what constitutes good prenatal genetic screening proposed by certain biomedical experts. The agency’s staff prioritized evidence-based medicine, epidemiology and economics, excluding other areas of knowledge, to construct proof of the future utility of the innovation. Its econometric models were instrumentalized by biomedical experts. They succeeded in imposing a local biomedical consensus, which had been developed in professional associations prior to the evaluation, and which was aligned with the interests of industry. The interests of certain groups of healthcare users and healthcare professionals have not been taken into account.