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.

BackgroundConsiderable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient/consumer perspectives of generic medicines.MethodsLiterature published between January 2003 and November 2014, which is indexed in PubMed and Scopus, on the topic of opinions of physicians, pharmacists and patients with respect to generic medicines was searched, and articles within the scope of this review were appraised. Search keywords used included perception, opinion, attitude and view, along with keywords specific to each cohort.ResultsFollowing review of titles and abstracts to identify publications relevant to the scope, 16 papers on physician opinions, 11 papers on pharmacist opinions and 31 papers on patient/consumer opinions were included in this review. Quantitative studies (n = 37) were the most common approach adopted by researchers, generally in the form of self-administered questionnaires/surveys. Qualitative methodologies (n = 15) were also reported, albeit in fewer cases. In all three cohorts, opinions of generic medicines have improved but some mistrust remains, most particularly in the patient group where there appears to be a strongly held belief that less expensive equals lower quality. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups, hence generally having lower levels of education, tend to have greater mistrust of generics.ConclusionsA key factor in improving confidence in generic products is the provision of information and education, particularly in the areas of equivalency, regulation and dispelling myths about generic medicines (such as the belief that they are counterfeits). Further, as patient trust in their physician often overrules their personal mistrust of generic medicines, enhancing the opinions of physicians regarding generics may have particular importance in strategies to promote usage and acceptance of generic medicines in the future.

In an attempt to benefit from the cost savings associated with the use of generic medicines, in June 2013 Ireland introduced generic substitution and reference pricing for the first time. However, perceptions of Irish patients towards generic medicines have not been published previously. Therefore, the objective of this study was to assess how generic medicines were perceived amongst patients in the time leading up to the enactment of the new legislation.A total of 42 patients were recruited from general practices affiliated with the Graduate Entry Medical School at the University of Limerick and from community pharmacies. Interviews were semi-structured and included quantitative assessments of opinions using 15 structured questions and a five-point Likert scale response system. Interview transcripts were coded and thematically analysed using NVivo (Version 9), for qualitative data. Quantitative data were analysed using SPSS (Version 20).Nearly one-third (31%) of patients had no knowledge of generic medicines and 39% of those exhibited confusion between the words 'generic' and 'genetic.' Almost onequarter (24%) held the view that generics were of poorer quality than originators, while 18% expressed the opinion that generics do not work as well as originator products. Approximately one-third (30%) of patients believed that generics were manufactured to a poorer quality, with 29% holding the view that generics are less expensive due to being of inferior quality. Nearly 90% of patients stated they would take a generic medicine if it were prescribed by their GP; however, 24% of patients stated a preference, if offered a choice, for the originator medication. Additionally, a majority of patients (86%) were in favour of reference pricing and generic substitution. Of the patients interviewed, 50% stated that a leaflet, or similar, with appropriate, understandable, and accessible information regarding generic medicines would be of use to them. This is the first study of patients' attitudes towards generic medicines in Ireland. Conducted in the time period leading up to the implementation of legislation promoting the use of generic medicines, it highlights variable knowledge about generic medicines among this key stakeholder group. Although patients are supportive of their more widespread use, concerns regarding safety, clinical effectiveness, and manufacturing quality of generic medicines were identified.

The provision of information to consumers that dispels myths about generics may improve confidence in generic medicines. As patients demonstrate a high degree of trust in physicians, their opinions can impact on patient/consumer opinions. Therefore, enhancing the perceptions of generics held by physicians is likely to have a positive impact on patient/consumer opinions of, and trust in, generic medications.

This study of GPs' attitudes towards generic medicines in Ireland highlights that this key stakeholder group has generally positive attitudes towards both generic medicines and the new legislation. However, variable knowledge about generic medicines and concerns regarding patient experience, clinical effectiveness and manufacturing quality were identified. GPs' opinions could negatively influence patient opinions; enhancing such opinions may prove important in successfully implementing the new legislation.