We are disappointed that European Parliamentarians have approved the proposal for an opt-in system for the use of genetic data in the proposed European Health Data Space. While we understand the concerns about genetic privacy that underly the proposal, we believe that is perfectly feasible to alleviate such concerns by putting in place robust safeguards against misuse and re-identification. To go down the opt-in road will have a serious and negative impact on work to develop personalised treatments and cures, particularly in rare diseases where international collaboration and data-sharing is the only way forward.

Most large consortia worldwide use opt-out schemes, with the proviso that participants are properly informed of their right to refuse to participate in the sharing of their data. An opt-in approach will be significantly more time-consuming and onerous to administer than an opt-out, and risks having a negative effect on flagship European genomic research projects such as the Beyond 1 million Genomes and the Genome of Europe. We urge legislators to think again about the many disadvantages that opt-in will cause to European research as a whole.