Escher
Evaluating the regulatory system
Escher examines the economic, social and ethical implications of regulatory procedures. It also considers how development can be optimized, by better aligning European marketing approval applications and HTA/reimbursement application procedures.
Escher projects under this theme reveal many tensions and questions. For example, there is tension between the costs of regulating pharmaceutical development on the one hand and public health gains on the other. Escher has worked on examining how economic, social and ethical considerations play a role in medicines regulation and policies, while also taking scientific developments into account
The following projects have addressed issues in this area:
- Improvement of access and reimbursement trajectories and beyond
- Adverse drug reactions in Europe
- Evidence for the innovation crisis in pharma
- The role of medical need in drug reimbursement decision-making
- Improving the EU system for marketing authorization: learning from regulatory practice
- Pharmacovigilance of biologics – A Dutch case study