Revision of the General Pharmaceutical Legislation: Impact Assessment of European Commission and EFPIA proposals

The European Commission has proposed revisions to the Pharmaceutical Legislation, with the view to tackle unmet medical needs, competitiveness, access and affordability. This update represents a once-in-a-generation opportunity to strengthen the European biopharmaceutical ecosystem, if fit-for-purpose policy options are implemented in response to the ambitious goals set.

That is why EFPIA commissioned the present Impact Assessment, which aims to complement the evidence base supporting proposed policy revisions developed by Technopolis. This study relies on risk-adjusted net present value modelling to assess the potential impact of key legislative changes (changes to regulatory approval, modulation of regulatory data protection, introduction of an unmet medical need definition and of launch-and-supply conditionalities).

Revision of the General Pharmaceutical Legislation – Impact Assessment (pdf)