Background and Importance In the European Union (EU), access to medicines is established as a fundamental right, enforceable through the judicial system. However, equity to access has become increasingly challenging, with Member States adopting different healthcare models seeking to attain cost-containment quality of care and improved patient outcomes. As a result, patients experience disparate levels of access to medicines. Ensuring enhanced, timely and equitable access is acknowledged as an important goal. This study sought to identify access enablers which may be embedded in the wider health system domain and flexibly adopted by EU Member States.
Aim and Objectives To identify and evaluate factors which impact medicines' access and propose a methodology enabling sound decision-making strategies optimising timely patient access to effective medication.
Material and Methods The study consisted of four phases. Phase 1 addressed pharmacists and healthcare professionals, intended to obtain their feedback on access to medicines through unstructured open-ended questionnaires. In phase 2, structured interviews were held with pharmaceutical policymakers and experts. Phase 3 consisted of a questionnaire to pharmaceutical regulators and prescribers. In Phase 4, a focus group discussion was organised with policymakers and regulators to collate qualitative and quantitative data and propose the factors impacting medicines access and obtain consensus on the developed access framework.
Results The developed access framework consists of four dimensions that highlight indicators supporting strategies to optimise timely patient access to medication. The domains and the respective indicators are: 1) Uptake (reimbursement, affordability, sustainability); 2) Utilisation (shortages, rational use through protocols, educational material); 3) Audit (utilisation studies, prescribing databases and patient registers); and 4) Re-evaluation (re-appraisal, actioning of audit results).
Conclusion and Relevance The developed access framework can be implemented across different healthcare ecosystems and in different EU countries to identify strategies and actions that improve timely patient access to good quality, safe and effective medicines. A structured generic framework that provides a common decision-making platform, but which may be flexibly adopted by the Member States offers an opportunity to strengthen the effectiveness and resilience of European health systems and provide improved patient care. Access to effective medication is a multi-faceted issue which, unless appropriately understood and managed, has the potential for grave repercussions to public health.
Conflict of Interest No conflict of interest
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