Comment on: Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe by Johnston et al.[1

Abstract

Another view on the complex and fascinating subject of generic and therapeutic substitution [1] is welcome. The initiation of a group by Novartis adds to this topical debate [2], although for such documents the background and interests of the authors will influence the conclusions. Complete concordance within Europe should not be expected for groups as diverse as the European Federation of Pharmaceutical Industries and Associations, the European Generic Medicines Association, the European Medicines Agency, the British National Formulary, Cochrane Reviews, national regulatory agencies and health technology assessment organizations. Each group will have responsibilities to their respective constituencies, and the term ‘consensus statement’ fails to reflect this diversity. Here, we add another view, with comments from a regulatory perspective.