In a statement issued on June 6, Efpia joined with 31 other organisations, including disease associations and research infrastructures, to voice their opposition to the new proposals.
Drug companies and other business and health organisations have expressed concern about changes to the proposed plan of European Health Data Space to let people opt out of sharing their data for uses like research.
The establishment of the European Health Data Space was proposed by the European Commission in 2022 to facilitate individual control over their health data and to enable secondary uses of that data, such as research, innovation, and policymaking.
However, organisations like the European Federation of Pharmaceutical Industries and Associations claim that EU policymakers have been debating ideas for an opt-out mechanism that would allow individuals to stop their data from being used for unintended purposes.
In a statement issued on June 6, Efpia joined with 31 other organisations, including disease associations and research infrastructures, to voice their opposition to the new proposals.
According to the statement, “Any form of opt-in or opt-out mechanism would introduce the real risk that data bias will form a part of the EHDS from its inception and thus undermine its primary value for secondary-use research purposes.”
The inclusion of numerous and comprehensive data sets is “fundamental” to the success of the EHDS, which is intended to be made up of rules, common practises, infrastructures, and a governance framework, it was further stated.
According to the statement, the data should be representative of European citizens and their demographic, racial, and socioeconomic backgrounds.
The groups claim that there is a “substantial risk” that the use of the EHDS for research purposes will be jeopardised because it can be difficult to include particular populations, such as disadvantaged and ethnic groups, in health datasets.
They also mentioned how few healthy citizens are interested in sharing health information.
The groups said that while they still supported the initial EHDS proposal without an opt-out clause, a full impact assessment of the mechanism should be conducted as soon as possible to fully understand its implications and to guide implementation.
According to the organisations, such an opt-out should have “a limited but well-defined, consistent, and transparent scope” and should be regularly evaluated.