Generics Policies: A Systematic Review Of Their Effectiveness

Abstract

A generic medicines policy mix, stands as an aggregate of several measures that cover different aspects of the pharmaceutical market. They promote an internal generic medicines market and influence the relation between generic and reference medicines. This systematic review’s aim was to assess the impact and effectiveness of these policies and examine several obstacles arising when promoting generics. A literature search was conducted between September to October 2016. The PICOS (Population, Intervention, Comparator, Outcome and Study design) principle was used to develop and approach a focused research question. Two electronic bibliographic databases were searched; ScienceDirect and PubMed. The included studies, identified through pair consensus, were primary research studies published during the period of January 2006 to October 2016, in either English or Greek. A qualitative evidence synthesis was chosen, as inconsistency of type of intervention and outcome being reported was highly evident among studies. Risk of bias was assessed by one reviewer, with the use of the 2011 Mixed Method Appraisal Tool. 2,188 articles were found, after removing duplicates, checking for language and access to full articles. From those articles, 2,109 were excluded. According to the analysis of the 79 included studies, educational and informative interventions on the advantage of generic medicines use, created the basis for making other generics policy measures effective. Furthermore, the effectiveness of regulatory interventions is reinforced by accompanying financial incentives to key stakeholders, affecting prices and market competition conditions. Finally, patients’ treatment non-adherence, generic medicines availability and deficient monitoring of stakeholders’ behaviour have been identified as key obstacles when promoting generics. The study showed how different measures can increase generics’ use and market share in the pharmaceutical market. However, it also brought forward several impeding factors arising when planning and implementing generic medicines policies that need to be closely monitored.