EFPIA statement on the legislative proposal on the European Health Data Space (EHDS)
EFPIA is delighted to see Europe moving forward in the critical area of health data through the publication of the legislative proposal on the EHDS. Talking about the proposal, EFPIA Director General said. “Our industry strongly supports the European Union’s efforts to increase citizen and patient control of, and access to, their health data, while at the same time giving researchers and innovators the opportunity to realise the potential of health data in a trusted and secure way. Removing the barriers to health data for scientific research will mean patients can benefit from the discovery of innovative treatments, medical devices and diagnostics enabled by access to health data.”
The legislative proposal on the EHDS and respective horizontal proposals (GDPR, draft Data Act, the proposed Data Governance Act (DGA) and draft NIS) provide an unprecedented opportunity to shape the future health data and digital ecosystem. It is a critical component in ensuring that Europe remains an innovator and world leader in the development and manufacture of medicines, supporting faster access to care for patients. Tomorrow’s breakthroughs in medicine and broader healthcare solutions rely on an appropriate framework that supports research today.
Access to health data is critical to the research-based industry’s mission to discover, develop and deliver new treatments for patients. We support the proposed participatory governance model with the right to request access to data for secondary re-use (under strong safeguards for security and privacy) not limited by the type of user, as long as the request to access data is in line with the purposes set out in the Regulation which includes scientific research, development and innovation activities.
EFPIA welcomes the mandatory creation of health data access bodies in Member States. They are a key step to enable the vision set out in the EHDS draft; to promote and facilitate the reuse of health data whilst ensuring strong safeguards for security and privacy. However, EFPIA believes coordination and harmonisation of this approach at the European level across these bodies will be critical to enable the success of the EHDS venture. A fragmented approach to interpretation and implementation of the regulation could hinder the goals of the EHDS and scientific research. Overall, consistency with other data related initiatives (AI Act, Data Governance Act, Data Act etc.) is imperative to avoiding additional bureaucracy.
EFPIA welcomes the proposal to create the European Health Data Space Board that will facilitate he cooperation between digital health authorities and health data access bodies and contribute to the consistent application of the EHDS regulation throughout the EU. Involvement in the Board for all stakeholders, including industry should be ensured. There are many organisations working on developing solutions to challenges in establishing the data and digital ecosystem. Their expertise and learnings should be upscaled. EFPIA remains available to work alongside others to foster a harmonised approach. We share the goal of improving the health of European citizens through the power of data.
EFPIA applauds the emphasis on promoting interoperability and data portability. Setting aside pure research interests, interoperability will allow exchange of health records across borders and enable EU citizens to have more continuous, well-informed healthcare regardless of their point of interaction with healthcare system in EU Member States. It is also key in delivering personalised healthcare and achieving more sustainable healthcare systems overall. It is essential to increase awareness and cooperation among all stakeholders and to develop a shared understanding of the relevant requirements in digital health. EFPIA believes that connecting data requires an agreed format and approach (a common data model) to allow data to be accessed, pooled, compared and used, while ensuring strong safeguards for security and privacy. This is a critical step in enabling the benefits connected data can offer to the health of European citizens. Data does not always need to be transported or transformed to have broader use. It can remain distributed (federated) so that it can be used for its original purpose. Privacy by Design principles should apply.
EFPIA stresses the importance of maintaining the international data flows for research purposes, via international data transfers and access to health data. Research divisions are located all over the world, the ability to exchange data can lead to unprecedented discoveries and improvements in the safety and efficacy of medicine. The demographic diversity of patient volunteers in clinical studies of new medicines and medical devices as well as the training of AI algorithms is important. Ideally, a study population should mirror that of the population as a whole and whom the drug or device is intended to treat. Diversity in participation serves to increase the chance that adverse drug or device reactions in a particular subpopulation will be identified in the course of clinical study, as opposed to after approval when the drug or device is in widespread use. To this end, the EHDS should not discourage sharing of data outside of the EU. Additionally, coordinated approaches and common principles across member states must be established, to avoid a patchwork of interpretations of the EHDS regulation that inhibit the international data flows for research purposes.
EFPIA stands ready to support the European Commission, the Council and the European Parliament and all other stakeholders in creating measures which would support an innovation friendly ecosystem across the EU, including through health data, that allows pharmaceutical companies together with other stakeholders to create a sustainable, resilient healthcare system paving the way for more preventive, personalised healthcare.