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Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics, in some cases more than a decade. To exemplify the current status of biosimilars in Mexico, a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly, a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries. [ABSTRACT FROM AUTHOR]

Background: There is increasing interest in provision of essential surgical care as part of public health policy in low- and middle-income countries (LMIC). Relatively simple interventions have been shown to prevent death and disability. We reviewed the published literature to examine the cost-effectiveness of simple surgical interventions which could be made available at any district hospital, and compared these to standard public health interventions. Methods: PubMed and EMBASE were searched using single and combinations of the search terms 'disability adjusted life year' (DALY), 'quality adjusted life year,' 'cost-effectiveness,' and 'surgery.' Articles were included if they detailed the cost-effectiveness of a surgical intervention of relevance to a LMIC, which could be made available at any district hospital. Suitable articles with both cost and effectiveness data were identified and, where possible, data were extrapolated to enable comparison across studies. Results: Twenty-seven articles met our inclusion criteria, representing 64 LMIC over 16 years of study. Interventions that were found to be cost-effective included cataract surgery (cost/DALY averted range US$5.06-$106.00), elective inguinal hernia repair (cost/DALY averted range US$12.88-$78.18), male circumcision (cost/DALY averted range US$7.38-$319.29), emergency cesarean section (cost/DALY averted range US$18-$3,462.00), and cleft lip and palate repair (cost/DALY averted range US$15.44-$96.04). A small district hospital with basic surgical services was also found to be highly cost-effective (cost/DALY averted 1 US$0.93), as were larger hospitals offering emergency and trauma surgery (cost/DALY averted US$32.78-$223.00). This compares favorably with other standard public health interventions, such as oral rehydration therapy (US$1,062.00), vitamin A supplementation (US$6.00-$12.00), breast feeding promotion (US$930.00), and highly active anti-retroviral therapy for HIV (US$922.00). Conclusions: Simple surgical interventions that are life-saving and disability-preventing should be considered as part of public health policy in LMIC. We recommend an investment in surgical care and its integration with other public health measures at the district hospital level, rather than investment in single disease strategies. [ABSTRACT FROM AUTHOR]

The World Bank is an important external funder of health aid to developing countries. However, many accounts of health sector change and reform do not account for the role that international financial institutions may play in these policy changes. In this paper, I review the World Bank's health policies since 1975, discussing its changing role and policies for developing countries' health policies. I then summarize the existing empirical evidence for the effect of the World Bank in developing countries' health sectors, focusing on Latin American countries. [ABSTRACT FROM AUTHOR]

Studies on developed countries demonstrate that an increase in women legislators leads to a prioritization in health, an increase in social policy spending, and a decrease in poverty. Women representatives could therefore improve development trajectories in developing countries; yet, currently, no cross-national and longitudinal studies explore this possibility. Using random effects panel regression, we examine the influence of women's representation on child health (one development indicator) across 102 developing countries from 1980 to 2005. Compared to countries with no women in parliament, countries meeting a 20-percent threshold experience increased rates of measles immunizations (10 percentage points), DPT immunizations (12 percentage points), infant survival (0.7 percentage points) and child survival (1 percentage point). Incremental increases in women's representation show that child health improves most in socially and economically disadvantaged countries, and in countries less integrated in the world polity. Our findings reveal the importance of increased women's representation, particularly in less developed and less globally embedded countries. [ABSTRACT FROM PUBLISHER]

"Health promotion" is one of the main paradigms of communication for development, which has been constant over time and has had a notorious influence in various regions of the world, probably because it has been promoted and funded by USAID, the US cooperation agency. Although there is no one model of health promotion, the name designates strategies and actions organised from the State, with support from external agents, to reach the least favoured population, allegedly with the purpose of enabling people to actively participate in the decision making process around health policies and programmes that affect their lives. Based on reports from concrete country experiences, documents from international forums and above all from direct observation by the author, this article aims to demonstrate that there has always been a great gap between the institutional and scientific discourse on health promotion, and its real relevance in Third World countries. [ABSTRACT FROM AUTHOR]

The article discusses the effects of the selectivity of health system strengthening (HSS) strategies on the goal high-quality health systems in developing countries. It is stated that global health actors (GHAs) in the domain of HSS often use the terms global health initiative and global health partnership, which are ill defined. It notes that GHAs claim to support health systems but focus on disease-specific interventions. It also mentions the importance of an effective approach to HHS.

The article discusses the burden of environmentally-related diseases in developing countries where childhood mortality rates due to diarrhoea and acute respiratory infections are linked to poor sanitation and indoor burning of solid fuels, respectively. The authors discuss 6 specific functions that health-system agencies can develop to improve environmental health. The 6 areas involve inter-sectoral policy, regulations, disease-specific and integrated programs, health facilities, outbreak response, and epidemiological evaluations of disease.

This article reviews the public health goals and interventions developed following the Alma-Ata, Kazakhstan declaration on primary health care in 1978. The difficulties faced by public health administrators in developing health care infrastructure in line with this declaration are addressed. The challenges posed by changing economic circumstances and chronic diseases such as AIDS and tuberculosis to the development of primary health care programs are presented. The 2008 World Health Organisation report on primary health care is presented as a guiding document for continuing efforts to implement the Alma-Ata goals.