Pharmaceutical regulation, policy and access to medicines

Abstract

Access to Medicines has become core to the European debate. Whilst complex legislation targets medicines’ quality, safety and efficacy, patients experience disparate levels of access to these therapies. Paradigms for improvement mainly focus on an individual barrier. This study looked beyond standard, isolated criteria and explored access determinants in the wider and dynamic health system context, by addressing following research aims. - To identify and evaluate factors which may impact on Access to Medicines. - To propose methodologies which enable sound decision-making strategies to be adopted in the area of Access to Medicines. Using primarily qualitative techniques, stakeholders’ perceptions of barriers to medicines’ access were investigated and the influence of policy and regulation examined. A systematic mixed-method, step-wise approach was adopted with each stage of study informing the next. The results of a literature review, and unstructured interviews and questionnaires with health care professionals, were used to design semi-structured interviews seeking experts’ perspectives on health care provision, payer advocacy, health economics, pharmaceutical policy and regulation. A focus group was used to consolidate and validate the study proposals. The findings demonstrate that more concerted and concrete action is necessary at Member State and European Union level. Deterrents to medicines’ access are entrenched and often replicated at various health system strata. The results endorse the need for a tool-kit which seamlessly bridges regulatory and health care needs. Through the identification of core determinants, a supportive framework coordinated at European level was developed to evidence and optimise medicines’ access. It enables Member States to adopt a transparent, cohesive and documented national policy which explicitly upholds Access to Medicines and provides direction towards fostering this goal. Whilst allowing for country-specific customisation, the gradual realisation of the framework can facilitate progressive harmonisation of scientific norms and processes. The access framework developed through this study creates an integrated evaluation cycle embedded in European health systems, streamlining best-practice guidelines to medicines’ access.