Review of CRA’s Report “Assessing the Economic Impacts of Changing Exemption Provisions During Patent and SPC Protection in Europe”

The CRA Report has an underlying assumption that the EU is as globally competitive in generics and biosimilars as it is in innovative products. There is no evidence to support this. The correct industrial strategy for the EU may well be to focus on the development, manufacture and export of innovative products, rather than on lower value generics where EU global competitiveness appears to be weaker.

The CRA report makes estimates of effect using a number of assumptions, data and calculations that we do not find to be correct or which are not explained. Until these anomalies are addressed, our view is that the CRA analysis is not a fit basis for an impact assessment to guide policy.