In Europe, there are a growing number of regional and national initiatives promoting the use of real-world data (RWD) in health technology assessments (HTAs) and policymaking, reflecting the growing importance or RWD for understanding real-world outcomes and guiding healthcare decisions. However, significant challenges and considerations remain due to diverse national frameworks, legislative environments, and data platforms across Europe. 

Country-specific Considerations for RWD Integration   

European countries show significant variability in integrating RWD into healthcare decision making largely due to differing national approaches and levels of acceptance. While some countries have advanced systems for RWD integration, others lag behind, creating challenges for pharmaceutical companies and researchers seeking to generate and utilize RWD consistently across Europe. Unlike the US’s centralized approach, EU members states must navigate a multitude of complex national frameworks. (see Table 1).  

More unified and efficient RWD utilization in Europe will require harmonization of regulations and frameworks and the active involvement of HTA bodies. These harmonization efforts must also address significant country-specific barriers, especially those related to data protection regulations. In addition to complying with the General Data Protection Regulation (GDPR), each country faces its own national data protection laws, adding complexity to RWD integration. Given these dyanamics, there is a pressing need to streamline data protection requirements and standardize practices across Europe to facilitate broader adoption of RWD in healthcare decision making. 

Table 1: Overview of RWD Integration, National Frameworks, and Data Protection Regulations in EU4 and the UK

AEMPS: Spanish Agency of Medicines and Medical Devices; AIFA: Italian Medicines Agency; BfArM: Federal Institute for Drugs and Medical Devices; G-BA: Federal Joint Commission; HAS: French National Authority for Health; NICE: National Institute for Health and Care Excellence; MHRA: Medicines and Healthcare products Regulatory Agency; RCT: Randomized Control Trial; RWE: Real-world Evidence

Data Platforms for Secondary Use 

Building on the variability in national approaches to RWD integration, the development and implementation of robust data platforms play a critical role in enabling consistent, secure, and efficient secondary use of health data across Europe. Data platforms are essential for aggregating healthcare information from various sources for secondary purposes like research and policymaking, while ensuring compliance with privacy regulations such as the GDPR across Europe. 

Table 2: EU4 and UK Health Data Platforms 

These platforms strive to balance accessibility with privacy concerns, enabling studies that improve outcomes and foster collaboration. They aim to harmonize standards and enhance infrastructure to overcome obstacles in healthcare data utilization for secondary purposes. 

Complementing these national initiatives, the European Health Data Space (EHDS) seeks to enable seamless and secure exchange of health information for research and innovation by building on existing national and EU health data infrastructures. 

 Country Involvement in EHDS 

The EHDS aims to improve healthcare across Europe by facilitating the sharing and use of health data.  France and Germany are actively involved in shaping the EHDS framework to enhance cross-border healthcare collaboration and innovation. The French Health Data Hub, a national public interest platform, is leading a European consortium focused on piloting the infrastructure for the EHDS. Germany is developing HDP4Germany, a platform designed to serve as the national health data access point, and leverage infrastructures such as the Health Data Lab at BfArM to support secure data linkage and analysis. Both HDP4Germany and the Health Data Lab at BfArM are being developed in line with requirements similar to those of the EHDS.  

Spain is also positioned to lead the implementation of EHDS given the availability of data digitisation within the country. Italy is moving towards healthcare digitalization with the Health Data Ecosystem (EDS) enabling the secure exchange of health data domestically.  

These coordinated efforts across key European countries underscore the transformative potential of the EHDS to drive more efficient, secure, and innovative healthcare solutions for citizens throughout Europe. 

 Conclusion 

While the utilization of RWD is increasingly gaining traction across European countries, there are significant challenges that differentiate its integration from practices in the United States. Each member state navigates its own unique set of legal and infrastructural hurdles, which can impede seamless data sharing and utilization for healthcare improvement. Despite these obstacles, numerous initiatives at both European and national levels aim to enhance the role of RWD in health technology assessments and policymaking.  

These efforts highlight a growing recognition of the value that RWD brings to understanding real-world outcomes and informing healthcare decisions, and pharmaceutical companies will increasingly look access to European RWD. Understanding and adapting to the European ecosystem will be crucial for effectively leveraging RWD in their strategic planning and decision making processes. 

Next steps  

At Avalere Health, we partner with global RWD providers and leverage our deep expertise to help organizations navigate the evolving European health data landscape. We offer comprehensive support in evaluating data partnerships, design robust evidence generation strategies, and ensure that manufacturers can maximize the value of both public and private datasets for research, regulatory, and commercial objectives. In addition, we advise on broader applications of RWE to facilitate patient access and inform stakeholder engagement strategies, including beyond traditional national HTA and reimbursement pathways. To learn more about how we can collaborate, connect with us.