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The aim of this paper is to analyse the relationship between reference prices (RPs), generic medicines and generic substitution at pharmacy level. In particular, the focus is on generic reference pricing. RPs in general aim to control reimbursement prices to reduce public pharmaceutical expenditure. In addition, generic reference pricing also aims to increase the use of generic medicines. The link between generic reference pricing and generic medicines is that the RP is usually set as a function of generic prices. Generic RPs are also linked with generic substitution because, without the possibility of substitution at pharmacy level, the potential cost savings from reference pricing will be reduced. RPs in general have been relatively successful in reducing prices, but less successful at controlling pharmaceutical expenditure. Moreover, generic reference pricing has not necessarily led to significant increases in generic drug use in those countries where such a system has been implemented. This paper analyses the reasons for these results, and discusses further issues that need to be considered when considering an RP system, concentrating in particular on generic reference pricing. [ABSTRACT FROM AUTHOR]

Over the past several years, there has been a perception in the generic industry that brand companies have been using the Citizen Petition process with the US Food and Drug Administration in order to extend the lifecycles of their brand products and prevent or delay approvals of generic applications. While these filings lend credence to this perception, it nonetheless leaves open questions regarding purpose and effect. This paper examines Petition filings since 2004 and explores their purported purpose, their likely purpose, and impact on generic market dynamics.Journal of Generic Medicines (2007) 4, 87–97. doi:10.1057/palgrave.jgm.4950060; published online 19 December 2006 [ABSTRACT FROM AUTHOR]

In relation to the development of medicinal products within Europe, the European Commission seeks to strike a balance between the encouragement of innovation and the avoidance of unnecessary research. This balance is supposedly represented by the rules that afford research-based companies a degree of protection against the use by the authorities assessing subsequent applications, of data submitted in support of the application made by the innovator. This paper reviews these rules as they presently stand, how the European Court of Justice (ECJ) and the national courts have interpreted the many `grey areas' in such rules and the proposals for change for the current regime within the overall review of pharmaceutical regulatory rules to be implemented in time for the enlargement of the Community in early 2004. [ABSTRACT FROM AUTHOR]

This article presents an overview of the implementation of key elements (Target Product Profile, Critical Quality Attributes, design space and control strategy) of Quality by Design (QbD) – a systemic approach in the case of generic drugs. The basis for this concept is that advanced understanding of variables affecting generic drug (product) quality, either obtained through historical operation or demonstrated through process modelling, justifies the replacement of the traditional process targets with acceptable operational ranges. This article also describes the steps involved in the development of generic drugs, steps through which the QbD concept can be applied, and the opportunities for and challenges to implementing QbD in generic drug development. [ABSTRACT FROM AUTHOR]

The purpose of this study was to establish regulatory trends related to competing drugs in several Latin American and Caribbean countries and to review regulations and national policies on generic drugs in these countries. Furthermore, information on the incentives to register and produce competing drugs, the promotion of international non-proprietary name (INN) use, the regulation of bioequivalence studies and the substitution of drugs prescribed by lower price alternatives to the public was also obtained. The results showed three regulatory categories: those countries that favour financing of competing drugs and the extended promotion of INN use, without restricting the substitution of innovative drugs with competitors; those that have a scheme oriented to the demonstration of the therapeutic equivalence, that is, countries that restrict the substitution of the original drugs to some authorised competing drugs; and those that are in an incipient stage of their regulation process. This variety causes difficulties in the characterisation of the pharmaceutical markets and can generate fictitious segmentations. In conclusion, harmonisation efforts should take into account the possible relationship among the definitions adopted by the countries, the national pharmaceutical markets development and their incentive policies for competition.Journal of Generic Medicines (2008) 6, 43–56. doi:10.1057/jgm.2008.32 [ABSTRACT FROM AUTHOR]

The article reports on the ways on how patent can be assured and formulated for a particular type of medicine. It discusses a particular kind of medicine patenting called formulation patent. It also mentions the importance of formulation patenting in the lifecycle management from the point of view of the innovator. Other issues in formulation patents are also discussed.

The objectives of this study were to identify the most commonly used medicines for mainly prevalent ailments and to compare retail sector prices (RSPs), public sector prices (PSPs) and international reference prices (IRPs). A convenient sampling method was employed to survey 33 households in a metropolitan city. Each family was followed once a week for eight weeks to observe their diseases and medication usage. The RSPs and PSPs for per unit doses and defined daily doses (DDDs) were compared with the IRPs. The most common ailments identified were cardiovascular and endocrine disorders followed by central nervous system and musculoskeletal disorders. Accordingly, the most common drugs used were for the treatment of the above ailments. Among 81 commonly used medicines, 63 were branded and 18 were generic. Of the 81 drugs, 26 were essential drugs. Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers and calcium channel blockers were among the most commonly used medicines. The differential between the prices of branded medicines and IRPs were found to be remarkable. This study further revealed that the majority of patients also used traditional medicines and nutritional supplements alongside their modern medicines. Wide variations were observed in RSPs and IRPs, warranting critical evaluation, regulation and emphasis on the economic aspects of drug policy. Widespread use of branded medicines in the absence of a national health insurance programme can lead to high out-of-pocket expenditures. Concomitant use of traditional medicines and nutritional supplements may have drug interaction potential, invoking detailed investigation for relevance. [ABSTRACT FROM AUTHOR]

It is widely recognised that information relating to the use of medicines in children is sorely lacking, causing substantial 'off-label use' of adult medicines in paediatric populations. Attempts have been made to address this shortfall in the USA through the introduction of specific legislation. The EU also intends to put forward legislation, but whether, or how much, EU law should reflect that of the USA is a matter of some considerable analysis and debate. [ABSTRACT FROM AUTHOR]

The article presents information on generic medicines and its development globally. Increasing patient access to pharmaceutical healthcare by improving the availability of generic medicines has been a feature of many governments' healthcare policies for some time. But the need for generic medicines has taken a more dramatic turn in recent years. Despite clear opportunities that patent expiries bring for the generics industry, the environment in which companies are operating is becoming increasingly difficult and the subsequent challenges immense.