Deliverable 5.3 - Description of regulations in remote genetic counselling in EU

Germline and somatic genetic alterations are key drivers of cancer. New next generation sequencing technologies capable of profiling these alterations provide excellent opportunities to improve preventive and clinical care but require quality genetic counselling to facilitate informed decision-making by patients and their families and accurate diagnoses. Rapidly increasing usage of clinical genetic services necessitates new strategies to ensure timely, equitable, and high-quality counselling delivery. Remote genetic counselling shows promise as a more efficient alternative to face-to-face counselling for both patients and clinicians.

This project reviewed genetic counselling and remote genetic counselling legislation through searches of national legislation databases in all 27 EU Member States to illuminate barriers to and opportunities for improving genetic counselling access and quality across Member States. Interviews with relevant experts from each Member State were conducted to validate legislation search results. Results demonstrate that genetic counselling is addressed in an international treaty (Oveido Convention) signed by 23 of 27 Member States, EU Regulation 2017/746, and in national legislation of 19 of 27 Member States. Substantial variation in legal mechanisms and prescribed details (i.e. the ‘who, what, when, and where’ of genetic counselling) exists across Member States. Remote genetic counselling is not specifically addressed in legislation, falling under broader healthcare and data protection statutes.

This review highlights substantial variability in genetic counselling legislation across EU Member States, with no specific governance of remote delivery. Future discussions and action will focus on the identification and implementation of optimal legislative, regulatory and/or strategic approaches at the EU, national, regional and/or local levels to ensure equitable, high-quality remote and in-person genetic counselling.