P-337 Ready for polygenic risk scores? An analysis of regulation of preimplantation genetic testing in seven European countries
Authors: Siermann M , Van der Schoot V , Bunnik E , Borry P 
Published: July 2024

Abstract

Study question
Would the different regulatory approaches for preimplantation genetic testing (PGT) in Europe permit the implementation of preimplantation genetic testing using polygenic risk scores (PGT-P)?

Summary answer
While the regulatory approaches for PGT differ between countries, the latitude for potential implementation of PGT-P seems limited in all three regulatory models.

What is known already
PGT allows for the testing of embryos for hereditary genetic disorders and chromosome abnormalities before implantation. Application of PGT has been seen as ethically sensitive in many European countries. An emerging development within the field of PGT, namely PGT using polygenic risk scores (PGT-P), currently brings new ethical tensions to the forefront. It is unclear whether PGT-P may be applied within the current regulatory frameworks in Europe. A clear overview of legal and practical regulation of PGT in European countries is lacking. It is important to understand current regulatory frameworks in Europe and determine whether PGT-P fits within these frameworks.

Study design, size, duration
The aim of this study was to provide an overview of the legal and practical regulation of PGT in seven selected European countries (Belgium, France, Germany, Italy, the Netherlands, Spain and the United Kingdom) and critically analyse the different approaches with regards to regulatory applicability and opportunities for PGT-P.

Participants/materials, setting, methods
We have investigated the legal and regulatory aspects of PGT by analysing legal documents, regulatory frameworks, scientific articles, and guidelines from scientific organizations and regulatory bodies to gather relevant information about each included country. The main sources of information were national laws relating to PGT. We divided the PGT regulatory approaches of the included countries into models.

Main results and the role of chance
The regulation of PGT differs per country and can be divided into three models. Some countries require central approval of PGT for each new indication (the medical indication model: the United Kingdom, the Netherlands), some countries evaluate each individual PGT request at the local level (the individual requests model: France, Germany), and other countries largely leave decision-making about clinical application of PGT to healthcare professionals (the clinical assessment model: Belgium, Italy, Spain). In the countries surveyed that use the medical indication model and the individual requests model, current legal frameworks and PGT criteria seem to exclude PGT-P. There might be more opportunities for potential PGT-P implementation in countries using the clinical assessment model. However, the fact that healthcare professionals and scientific organizations in Europe are generally negative about implementation of PGT-P due to scientific and socio-ethical concerns, suggests that, even if it were legally possible, the chance that PGT-P would be offered in these countries in the near future appears to be low.

Limitations, reasons for caution
Our analysis focuses on seven European countries. While these countries differ in their regulatory approaches to PGT, a certain diversity may be missing from our analysis. The analysis is based on publicly available information and documents, meaning certain insights into the practical regulation of PGT might be missing.

Wider implications of the findings
Our analysis of how PGT-P fits within current regulatory models provides guidance for healthcare professionals and policymakers in navigating the possible future implementation of PGT-P within Europe. The approach used of identifying regulatory models provides a useful way to think about the regulation of reproductive genetic technologies at large.

Trial registration number
Not applicable