We were concerned to see that Article 33 of the Regulation proposal for the European Health Data Space now contains a provision for a data-sharing opt-in rather than opt-out, further restricting the communication of genomic data between researchers across the EU. As human geneticists working in an era where the collection of genomic data is so important in the further development of personalised medicine, requiring individuals to opt in to such collection rather than their being given full information on the possibility of opting out appears to us to be a retrograde step. An opt-in approach will reduce considerably the data available to researchers, and may also run the risk of under-representation of particular groups, which will in turn lead to new personalised/stratified treatments and screening being less available for them. Moreover, European research may start lagging behind the rest of the world, which generally adopts the opt-out concept, ultimately hampering innovation in the field of genomics and the related development of targeted drug therapies to a significant extent.
Opt-out schemes in other areas, for example deceased organ donation, have been shown to greatly increase contribution without affecting an individual’s right to refuse to participate. An opt-in approach will be significantly more time-consuming and complicated to administer than an opt-out. For example, the European Beyond 1 Million Genomes project (https://b1mg-project.eu/) is likely to be badly affected by data shortages, as will be the forthcoming ambitious Genome of Europe project (https://b1mg-project.eu/docs/genome-europe.pdf). For more detailed information on the potential effects of opting-in, we refer you to the statement from the BioMed Alliance (https://www.biomedeurope.org/images/news/2023/BioMed_Alliance_statement_EHDS_11.23.pdf)
Research has shown that study participants are willing to share their data with the academic sector under properly controlled conditions, and with the knowledge of the purpose for which it will be used. From an ethical point of view, opt-out schemes can offer excellent public awareness, providing everyone knows about the option and has sufficient information and time to make an informed choice.
Patients deserve the best new, innovative treatments. The increasing amounts of data available for research are making this possible. We understand the necessity of balancing privacy with improved health, and believe that an opt-out system is the best way to achieve this.