The European Commission has proposed the creation of a health-specific ecosystem that would provide a standardized framework for storing and using patients’ health data. As proponents of access to healthcare, we are encouraged by the potential direct and indirect benefits to patients of such a system. However, implementation of the EHDS must consider sustainability of the off-patent medicines industry. Off-patent medicines play a vital role in our healthcare system by ensuring that life-saving medicines are widely available. Considering the needs only of the on-patent sector in implementing the EHDS could unintentionally undermine the benefits brought by off-patent medicines.

Stakeholder Engagement

The implementation of such a large and interconnected health data ecosystem will be an unprecedented undertaking. It will create numerous new opportunities and challenges, many of which are not yet known. Stakeholders across the ecosystem should be engaged early and often to identify and mitigate any unintended consequences of the implementation of the EHDS. Particular attention must be paid to implications that could jeopardize the supply of essential medicines or off-patent competition, immediately or in the future.

Impact on Regulatory Framework

The availability of data arising from the EHDS will open new avenues for collective evidence toward authorizing new medicine products through “secondary uses of data.” Any changes to regulatory frameworks arising from these new tools should be science-based, and seek to streamline the medicine approval process, including through consideration of impact on off-patent competition. Efficiency gains, rather than additional requirements that could delay the availability of new medicines, must be prioritized.

Data Accessibility

Historically, industry access to big data has not always been equitable. Off-patent manufacturers are often unable to invest in expensive databases or software platforms for the development of off-patent medicines since budgets must be stretched across wide-ranging portfolios of low-margin products. The use of big data can be an important tool in the development of “value-added medicines,” or VAM. VAM refers to incremental innovation on existing medicines, including through repurposing or reformulation, seeking to more efficiently address patients’ unmet needs. To maximize the public health benefit of scientific research based on health data, EHDS and data access bodies should be set up in a way that ensures equitable access to the health data, without excessive costs or hurdles.

Data Flows

In scientific research arising from secondary uses of data, data analysis often occurs outside of Europe, reflecting the global interconnectivity of medicines development. The off-patent industry has narrow margins, and it is important to use cost-effective research practices to maximize the utility of data. The EHDS should not place restrictions on data flows that would hinder timely and efficient data analysis, such as restricting data flows to countries outside of Europe, or countries falling outside of the EU’s framework for adequacy decisions, as defined in the General Data Protection Regulation.

Industry’s Role in Implementation and Maintenance

Implementation and maintenance of the EHDS will require new investments and changes in practices by stakeholders across the healthcare ecosystem. Operating margins in the off-patent industry are already thin due to competition, making the industry sensitive to uncompensated additional costs. Any additional responsibilities placed on industry for the implementation and/or maintenance of the EHDS should be balanced against considerations for ongoing access and availability of off-patent medicines.