title: A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.
abstract: Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.
authors.affiliation: Graduate Entry Medical School, University of Limerick, Limerick, Ireland. suzanne.dunne@ul.ie
authors.forename: Suzanne
authors.initials: S
authors.lastname: Dunne
authors.forename: Bill
authors.initials: B
authors.lastname: Shannon
authors.forename: Colum
authors.initials: C
authors.lastname: Dunne
authors.forename: Walter
authors.initials: W
authors.lastname: Cullen
mesh_terms: D000818:Animals; D003365:Costs and Cost Analysis; D004335:Drug and Narcotic Control; D016568:Drugs, Generic / Q000191:economics; D005060:Europe; D005062:European Union; D006801:Humans; D014481:United States
chemical_list: D016568:Drugs, Generic