Between Patents and Patients: Why Intellectual Property Alone Cannot Sustain Drug Repurposing

Abstract This paper explores why the European Union’s current intellectual property (IP) architecture provides insufficient support for the repurposing of older, often off-patent medicines. Focusing on second medical use patents and the 8+2(+1) regulatory exclusivity model, it shows how these mechanisms often fail to justify the cost of rigorous clinical trials once a drug’s primary patents expire and data/market exclusivities lapse. The analysis then turns to Art. 84 of the proposed EU Pharma Package, a measure that would introduce a non-cumulative four-year data exclusivity for repurposed indications that demonstrate substantial clinical benefit. While this legislative initiative marks an important step toward incentivizing further research into known compounds, the paper argues that IP-based solutions alone cannot overcome systemic obstacles. Chief among these are national reimbursement policies that rarely differentiate repurposed therapies from generics, conservative health technology assessments that require extensive clinical evidence, and widespread off-label prescribing that undercuts the economic rationale for formal authorization. The discussion proposes a suite of complementary reforms – such as lifecycle-driven HTA, adjusted reimbursement models and indication-based pricing, capture of treatment indication in e-prescribing/claims to support on-label use, and enhanced collaboration between academic institutions and industry – that together could create a more supportive environment for drug repurposing. By addressing both the regulatory and systemic impediments and integrating Art. 84 with payer, HTA, and prescribing reforms, the European Union may ultimately unlock greater value from existing compounds while preserving affordability and ensuring patient access.