'Linkage' pharmaceutical evergreening in Canada and Australia

'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines

Mid-term review- UK Roma national integration strategy: Roma at the intersection of ethnic-inclusive, post-racial and hyper-ethnic policies

Rather than developing a specific strategy to promote Roma integration, the UK government decided to use mainstream legislation. However, the complex mechanisms of UK policy-making, means that responsibility for integration is defused. Because of the devolved governmental systems and the localisation agenda, Gypsy, Traveller and Roma (GTR) populations often find that they are subject to different forms of inclusion and exclusion depending on their specific geopolitical location. In this paper, the authors suggest that in addition to experiencing the impact of devolution, ‘mainstreaming’ approaches to Roma integration are failing because GTR communities find themselves located at the intersection of three different policy ideologies in the UK: ‘ethnic inclusive policies’ (that seek to promote Roma inclusion), ‘post racial policies’ (that obscure-specific forms of structural inequalities) and ‘hyper-ethnic’ policies, (targeted in a discriminatory manner towards certain communities). With the British about to exit from the European Union, concerns are also being raised about the future of Roma communities and the commitment to their inclusion

“Every ‘Never’ I Ever Said Came True”: Transitions from opioid pills to heroin injecting

This qualitative study documents the pathways to injecting heroin by users in Philadelphia and San Francisco before and during a pharmaceutical opioid pill epidemic. Data was collected through in-depth, semi-structured interviews (conducted between 2010 and 2012) that were, conducted against a background of longer-term participant-observation, ethnographic studies of street-based drug users and dealers in Philadelphia (2007-12) and San Francisco (1994-2007, 2012). Philadelphia and San Francisco were selected for their contrasting political economies, immigration patterns and source type of heroin. In Philadelphia the ethnographers found heroin injectors, usually white users, who had started their opiate using careers with prescription opioids rather than transitioning from other drugs. In both Philadelphia and San Francisco, most of the young heroin injectors interviewed began, their drug-use trajectories with opioid pills--usually Percocet (oxycodone and acetaminophen), generic short acting oxycodone or, OxyContin (long-acting oxycodone)--before transitioning to heroin, usually by nasal inhalation (sniffing) or smoking at first, followed by injecting. While most of the Philadelphia users were born in the city or its suburbs and had started using both opioid pills and heroin there, many of the San Francisco users had initiated their pill and sometimes heroin use elsewhere and had migrated to the city from around the country. Nevertheless, patterns of transition of younger injectors were similar in both cities suggesting an evolving national pattern. In contrast, older users in both Philadelphia and San Francisco were more likely to have graduated to heroin injection from non-opiate drugs such as cannabis, methamphetamine and cocaine. Pharmaceutical opioid initiates typically reported switching to heroin for reasons of cost and ease-of-access to supply after becoming physically and emotionally dependent on opioid pills. Many expressed surprise and dismay at their progression to sniffing and subsequently to injecting heroin. Historically and structurally these users found themselves caught at the intersection of two major developments in the opiate supply: (1) an over 500% increase in opiate pill prescription from 1997 to 2005 resulting in easy access to diverted supplies of less stigmatized opiates than heroin and (2) a heroin supply glut, following the US entry of Colombian-sourced, heroin in the early 1990s, that decreased cost and increased purity at the retail level. A nationwide up-cycle of heroin use may be occurring among young inner city, suburban and rural youth fueled by widespread prescription opioid pill use