Strategies for achieving global collective action on antimicrobial resistance.

Global governance and market failures mean that it is not possible to ensure access to antimicrobial medicines of sustainable effectiveness. Many people work to overcome these failures, but their institutions and initiatives are insufficiently coordinated, led and financed. Options for promoting global collective action on antimicrobial access and effectiveness include building institutions, crafting incentives and mobilizing interests. No single option is sufficient to tackle all the challenges associated with antimicrobial resistance. Promising institutional options include monitored milestones and an inter-agency task force. A global pooled fund could be used to craft incentives and a special representative nominated as an interest mobilizer. There are three policy components to the problem of antimicrobials--ensuring access, conservation and innovation. To address all three components, the right mix of options needs to be matched with an effective forum and may need to be supported by an international legal framework.

Les dysfonctionnements de la gouvernance et du marché à l'échelle mondiale se traduisent par une impossibilité de garantir l'accès à des médicaments antimicrobiens durablement efficaces. De nombreuses personnes s'emploient à pallier ces dysfonctionnements, mais leurs institutions et leurs initiatives manquent de coordination, de direction et de moyens financiers. La création d'institutions, l'élaboration de mesures d'incitation et la mobilisation des parties intéressées font partie des options possibles pour promouvoir une action collective mondiale sur l'accès aux antimicrobiens et sur leur efficacité. Aucune option isolée ne suffira à venir à bout de tous les problèmes associés à la résistance aux antimicrobiens. Parmi les options institutionnelles prometteuses, il convient de mentionner le suivi des étapes importantes et une équipe spéciale interorganisations. Des fonds mis en commun à l'échelle mondiale pourraient être utilisés pour élaborer des mesures d'incitation et un représentant spécial pourrait être chargé de mobiliser les parties intéressées. Le problème des antimicrobiens comporte trois aspects stratégiques: garantir l'accès, la conservation et l'innovation. Pour agir à l'égard de ces trois aspects, il est nécessaire d'associer les options, harmonieusement combinées, à une structure efficace et, peut-être, de les inscrire dans un cadre juridique international.

Los fracasos de gobernanza mundial y de los mercados significan que no es posible garantizar el acceso a medicamentos antimicrobianos de efectividad sostenible. Muchas personas trabajan para solucionar estos problemas, pero sus instituciones e iniciativas no están lo suficientemente coordinadas, guiadas y financiadas. Las opciones para promocionar una acción colectiva global en cuanto al acceso a los antimicrobianos y la efectividad incluyen la creación de instituciones, la elaboración de incentivos y la movilización de intereses. Ninguna opción por sí sola es suficiente para afrontar todos los desafíos asociados con la resistencia a los antimicrobianos. Las opciones institucionales prometedoras incluyen hitos supervisados y un grupo de acción interinstitucional. Se podría utilizar un fondo combinado global para elaborar incentivos y nominar un representante especial como un movilizador de intereses. El problema de los antimicrobianos tiene tres componentes de las políticas: asegurar el acceso, la conservación y la innovación. Para abordar los tres componentes se necesita que la mezcla correcta de opciones se una a un foro efectivo, y podría necesitar el apoyo de un marco legal internacional.

Outcomes of HIV treatment from the private sector in low-income and middle-income countries: a systematic review protocol.

INTRODUCTION: Private sector provision of HIV treatment is increasing in low-income and middle-income countries (LMIC). However, there is limited documentation of its outcomes. This protocol reports a proposed systematic review that will synthesise clinical outcomes of private sector HIV treatment in LMIC. METHODS AND ANALYSIS: This review will be conducted in accordance with the preferred reporting items for systematic review and meta-analyses protocols. Primary outcomes will include: (1) proportion of eligible patients initiating antiretroviral therapy (ART); (2) proportion of those on ART with <1000 copies/mL; (3) rate of all-cause mortality among ART recipients. Secondary outcomes will include: (1) proportion receiving Pneumocystis jiroveci pneumonia prophylaxis; (2) proportion with >90% ART adherence (based on any measure reported); (3) proportion screened for non-communicable diseases (specifically cervical cancer, diabetes, hypertension and mental ill health); (iv) proportion screened for tuberculosis. A search of five electronic bibliographical databases (Embase, Medline, PsychINFO, Web of Science and CINAHL) and reference lists of included articles will be conducted to identify relevant articles reporting HIV clinical outcomes. Searches will be limited to LMIC. No age, publication date, study-design or language limits will be applied. Authors of relevant studies will be contacted for clarification. Two reviewers will independently screen citations and abstracts, identify full text articles for inclusion, extract data and appraise the quality and bias of included studies. Outcome data will be pooled to generate aggregative proportions of primary and secondary outcomes. Descriptive statistics and a narrative synthesis will be presented. Heterogeneity and sensitivity assessments will be conducted to aid interpretation of results. ETHICS AND DISSEMINATION: The results of this review will be disseminated through a peer-reviewed scientific manuscript and at international scientific conferences. Results will inform quality improvement strategies, replication of identified good practices, potential policy changes, and future research. PROSPERO REGISTRATION NUMBER: CRD42016040053.

Data, disease and diplomacy: GISAID's innovative contribution to global health.

The international sharing of virus data is critical for protecting populations against lethal infectious disease outbreaks. Scientists must rapidly share information to assess the nature of the threat and develop new medical countermeasures. Governments need the data to trace the extent of the outbreak, initiate public health responses, and coordinate access to medicines and vaccines. Recent outbreaks suggest, however, that the sharing of such data cannot be taken for granted - making the timely international exchange of virus data a vital global challenge. This article undertakes the first analysis of the Global Initiative on Sharing All Influenza Data as an innovative policy effort to promote the international sharing of genetic and associated influenza virus data. Based on more than 20 semi-structured interviews conducted with key informants in the international community, coupled with analysis of a wide range of primary and secondary sources, the article finds that the Global Initiative on Sharing All Influenza Data contributes to global health in at least five ways: (1) collating the most complete repository of high-quality influenza data in the world; (2) facilitating the rapid sharing of potentially pandemic virus information during recent outbreaks; (3) supporting the World Health Organization's biannual seasonal flu vaccine strain selection process; (4) developing informal mechanisms for conflict resolution around the sharing of virus data; and (5) building greater trust with several countries key to global pandemic preparedness.

Medical countermeasures for national security: a new government role in the pharmaceuticalization of society.

How do governments contribute to the pharmaceuticalization of society? Whilst the pivotal role of industry is extensively documented, this article shows that governments too are accelerating, intensifying and opening up new trajectories of pharmaceuticalization in society. Governments are becoming more deeply invested in pharmaceuticals because their national security strategies now aspire to defend populations against health-based threats like bioterrorism and pandemics. To counter those threats, governments are acquiring and stockpiling a panoply of 'medical countermeasures' such as antivirals, next-generation vaccines, antibiotics and anti-toxins. More than that, governments are actively incentivizing the development of many new medical countermeasures--principally by marshaling the state's unique powers to introduce exceptional measures in the name of protecting national security. At least five extraordinary policy interventions have been introduced by governments with the aim of stimulating the commercial development of novel medical countermeasures: (1) allocating earmarked public funds, (2) granting comprehensive legal protections to pharmaceutical companies against injury compensation claims, (3) introducing bespoke pathways for regulatory approval, (4) instantiating extraordinary emergency use procedures allowing for the use of unapproved medicines, and (5) designing innovative logistical distribution systems for mass drug administration outside of clinical settings. Those combined efforts, the article argues, are spawning a new, government-led and quite exceptional medical countermeasure regime operating beyond the conventional boundaries of pharmaceutical development and regulation. In the first comprehensive analysis of the pharmaceuticalization dynamics at play in national security policy, this article unearths the detailed array of policy interventions through which governments too are becoming more deeply imbricated in the pharmaceuticalization of society.

The pharmaceuticalisation of security: Molecular biomedicine, antiviral stockpiles, and global health security.

Pharmaceuticals are now critical to the security of populations. Antivirals, antibiotics, next-generation vaccines, and antitoxins are just some of the new 'medical countermeasures' that governments are stockpiling in order to defend their populations against the threat of pandemics and bioterrorism. How has security policy come to be so deeply imbricated with pharmaceutical logics and solutions? This article captures, maps, and analyses the 'pharmaceuticalisation' of security. Through an in-depth analysis of the prominent antiviral medication Tamiflu, it shows that this pharmaceutical turn in security policy is intimately bound up with the rise of a molecular vision of life promulgated by the biomedical sciences. Caught in the crosshairs of powerful commercial, political, and regulatory pressures, governments are embracing a molecular biomedicine promising to secure populations pharmaceutically in the twenty-first century. If that is true, then the established disciplinary view of health as a predominantly secondary matter of 'low' international politics is mistaken. On the contrary, the social forces of health and biomedicine are powerful enough to influence the core practices of international politics - even those of security. For a discipline long accustomed to studying macrolevel processes and systemic structures, it is in the end also our knowledge of the minute morass of molecules that shapes international relations.

Securing circulation pharmaceutically: Antiviral stockpiling and pandemic preparedness in the European Union.

Governments in Europe and around the world amassed vast pharmaceutical stockpiles in anticipation of a potentially catastrophic influenza pandemic. Yet the comparatively 'mild' course of the 2009 H1N1 pandemic provoked considerable public controversy around those stockpiles, leading to questions about their cost-benefit profile and the commercial interests allegedly shaping their creation, as well as around their scientific evidence base. So, how did governments come to view pharmaceutical stockpiling as such an indispensable element of pandemic preparedness planning? What are the underlying security rationalities that rapidly rendered antivirals such a desirable option for government planners? Drawing upon an in-depth reading of Foucault's notion of a 'crisis of circulation', this article argues that the rise of pharmaceutical stockpiling across Europe is integral to a governmental rationality of political rule that continuously seeks to anticipate myriad circulatory threats to the welfare of populations - including to their overall levels of health. Novel antiviral medications such as Tamiflu are such an attractive policy option because they could enable governments to rapidly modulate dangerous levels of (viral) circulation during a pandemic, albeit without disrupting all the other circulatory systems crucial for maintaining population welfare. Antiviral stockpiles, in other words, promise nothing less than a pharmaceutical securing of circulation itself.

Haggling over viruses: the downside risks of securitizing infectious disease.

This article analyses how the 'securitization' of highly pathogenic avian influenza (H5N1) contributed to the rise of a protracted international virus-sharing dispute between developing and developed countries. As fear about the threat of a possible human H5N1 pandemic spread across the world, many governments scrambled to stockpile anti-viral medications and vaccines, albeit in a context where there was insufficient global supply to meet such a rapid surge in demand. Realizing that they were the likely 'losers' in this international race, some developing countries began to openly question the benefits of maintaining existing forms of international health cooperation, especially the common practice of sharing national virus samples with the rest of the international community. Given that such virus samples were also crucial to the high-level pandemic preparedness efforts of the West, the Indonesian government in particular felt emboldened to use international access to its H5N1 virus samples as a diplomatic 'bargaining chip' for negotiating better access to vaccines and other benefits for developing countries. The securitized global response to H5N1 thus ended up unexpectedly entangling the long-standing international virus-sharing mechanism within a wider set of political disputes, as well as prompting governments to subject existing virus-sharing arrangements to much narrower calculations of national interest. In the years ahead, those risks to international health cooperation must be balanced with the policy attractions of the global health security agenda.