(SLB-001) European perspectives on ethical aspects around utilization of patient registries for medicines decision-making

Background: The use of patient registries in regulatory, Health Technology Assessment (HTA), and payer decision-making has gained increasing attention in recent years. Assessing ethical aspects is therefore essential to effectively leverage registry-based Real-World Data (RWD) use in medicines decision-making.

Objectives: To describe ethical considerations for using patient registry data to inform medicines decision-making.

Methods: European regulators, Health Technology Assessors (HTAs), payers, patients, academia, industry, and healthcare professionals (HCPs) were invited through email and social media to complete an online survey (Dec 2024 – Jan 2025), including participants’ demographics and perspectives regarding ethics-related aspects of patient registry usage (based on 5-point Likert scales). Data were analyzed descriptively.

Results: Included were 382 participants (159 regulators/HTA/payers, 41 industry, 42 patient representatives, 140 academics/HCPs/others). Participants represented 31 countries, had a mean age of 48 years (SD±11) and 56% were women. Most participants (65%) indicated that registries should collect identifiable data and process pseudonymized data, 51% preferred an ‘opt-out’ consent for this. For secondary use of registry data, 34% of respondents chose transfer of anonymized data as the preferred method, and ‘opt-out’ consent was preferred for this by 61%. Respondents perceived information on a registry’s use-and-access policy most important (mean 4.2; 95% CI: 4.1-4.3) and information on funding sources least important (mean 3.9; 95% CI: 3.8-4.0). Most participants (83%) preferred to find such information on a registry’s website, followed by the European Medicines Agency – Heads of Medicines Agencies Catalogues of real-world data sources (66%). Participants on average considered 51% (scale:0-100%; SD±32) funding of registries by industry acceptable.

Conclusions: Participants opted for higher granularity for data collection and processing by a registry, compared to data granularity for secondary use. Generally, ‘opt-out’ was preferred as a method for obtaining consent.