The purpose of the project was to delver an external report that evaluates the broader economic and societal impact of the Orphan Medicine Product (OMP) Regulation in Europe
CRA Approach
- Set out a range of indicators to be used to assess the impact of the Regulation on society by improving the treatment and health of patients
- Reviewed the existing literature on the impact of the Regulation
- Analysed the existing studies on the impact of the Regulation
- Compared the experience of the US and EU
- Carried out a literature review using academic and open source databases
- Conducted 14 interviews with wider stakeholder groups
Client Impact
- Provided an evaluation of the societal and economic impact of the European Union (EU) Regulation on Orphan Medicinal Products (OMP)
- Provided recommendations for the future of OMP regulation to ensure rare diseases remain a priority going forward
- Report published on EFPIA website
