The policy environment has become particularly favourable for the use of generic medicines in many countries, precisely because of their perceived cost advantages in relation to brand-name originator drugs. Stimulating generics competition leads to price reductions, which, in turn, should lead to greater savings to health insurers.

This article discusses some of the research papers covering the area of general policies for generics that have been published during the period of January to August 2012. Topics investigated by researchers included barriers to generics use, availability of essential medicines, and effects of generics policies on use of proton pump inhibitors (PPIs) and lipid-lowering drugs.

Policies in general
In a review carried out by Kaplan et al., the impact of policies designed to enhance uptake of generic medicines in low- and middle-income countries was studied. Publications related to generic medicines policies published between January 2000 and March 2010, in addition to an analysis of studies evaluating the impact of pro-generic policies, were analysed. The authors also repeated a subset of the larger search in January 2012 [1].

The authors found that there is little policy evaluation to determine which pro-generics policies increase generic medicines utilisation in low- and middle-income countries. They also concluded that in order to promote the use of generics it was essential to ensure that there was a functioning medicines regulation authority, a reasonably robust market of generic medicines and that incentives for physicians, consumers and drug sellers were aligned.

Kaplan et al. found that key barriers to the implementation of generic medicine policies are negative perceptions of stakeholders, for example, generics are of lower quality, plus perverse private sector financial incentives to sell products with the highest profit margin. Other relevant barriers are legal/regulatory issues such as the absence of generics substitution regulations. There also exists a general difficulty in promoting generics due to a lack of transparency in the pharmaceutical supply and distribution system, for example, a lack of price information provided by healthcare provider organisations to physicians [1].

In a study carried out by Bertoldi et al., medicine prices, availability and affordability in Brazil were evaluated, considering the differences across three types of medicines – originator brands, generics and similar medicines (comparable to branded generics); and different types of facilities – private pharmacies, public sector pharmacies and ‘popular pharmacies’ [2]. Popular pharmacies are a Brazilian Government initiative to help members of the population who have difficulty buying their medicines in private pharmacies.

Data on prices and availability of 50 medicines were collected in 56 pharmacies across six cities in Southern Brazil using WHO/Health Action International methodology.

The results showed that the availability of medicines in the public sector does not meet the challenge of supplying essential medicines to the entire population, as stated in the Brazilian Constitution. Bertoldi et al. believe this has unavoidable repercussions for affordability, particularly amongst the lower socio-economic strata [2]. Suggestions made by the authors of ways for the Brazilian Government to improve this situation were:

• maintain its commitment of providing a list of essential medicines free of charge at public facilities
• increase use of generics and reduce prices of generics through the tendering process, so that generics become cheaper than similar products
• routines of acquisition, stock and distribution of medicines in the public sector need to be re-evaluated, ensuring adequate and timely distribution of essential medicines.
• the list of medicines regulated by the government should be expanded to include all medicines provided by the Brazilian Universal Health System
• expand the ‘popular pharmacy’ programme, by increasing the number of facilities and the number of medicines available
• tighter regulation of the private market, so that only over-the-counter medicines are dispensed without a prescription.

The research highlights the importance of having policies in place to promote the use of generic medicines. Introducing policies which stimulate greater generics competition and use leads to price reductions, which, in turn, leads to greater savings to governments, health insurers and patients alike.

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Related article

Overview of clinical research on generics in 2012

References

1.  Kaplan WA, Ritz LS, Vitello M, Wirtz VJ. Policies to promote use of generic medicines in low and middle income countries: a review of published literature, 2000-2010. Health Policy. 2012;106(3):211-24.

2.  Bertoldi AD, Helfer AP, Camargo AL, Tavares NU, Kanavos P. Is the Brazilian pharmaceutical policy ensuring population access to essential medicines? Global Health. 2012;8(1):6.

3.  Abuelkhair M, Abdu S, Godman B, Fahmy S, Malmström RE, Gustafsson LL. Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi. Expert Rev Pharmacoecon Outcomes Res. 2012;12(1):115-24.

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