In Germany, a mandatory early benefit assessment (EBA) by the Federal Joint Committee (G-BA) is required for reimbursement of new marketing-authorised medicines. Additional benefit is based on patient-relevant endpoints in mortality, morbidity and health-related quality of life (HRQoL). We aimed...

Dramatic increases in health expenditures have led to a substantial number of regulatory interventions in the markets for devices over the last years. However, little attention has been paid thus far to the regulation of medical devices and its effects. This article explores the policies pursued...

In 2011, the EU Directive on Patients’ Rights in Cross Border Healthcare was approved, including a regulation on mutual recognition of prescriptions.

This paper proposes a framework for analyzing arrangements set up to facilitate cross-border mobility of patients in the European Union. Exploiting both conceptual analysis and data from a range of case studies carried out in a number of European projects, and building on Walt and Gilson's model...