Shared health governance, mutual collective accountability, and transparency in COVAX: A qualitative study triangulating data from document sampling and key informant interviews.

Background: To facilitate global COVID-19 vaccine equity, the World Health Organization, the Coalition for Epidemic Preparedness Innovations, the Global Alliance for Vaccines and Immunizations, and the United Nations Children's Fund supported the COVID-19 Vaccine Global Access (COVAX) partnership. COVAX's goals may have best been pursued through shared health governance - a theory of global health governance based on six premises, in which global health actors collaborate to achieve a shared goal. Shared health governance employs a framework for accountability termed "mutual collective accountability", in which actors hold each other accountable for achieving their goal, thus relying on transparency with one another. Methods: We conducted a multi-method qualitative study triangulating document analysis and key informant interviews to address the question: To what extent did COVAX employ shared health governance, mutual collective accountability, and transparency? We thus aimed to explore the governance structures and accountability and transparency mechanisms in COVAX and determine whether these constituted shared health governance and mutual collective accountability. Results: We identified 117 documents and interviewed 20 key informants. Our findings suggest that COVAX's co-convening organisations were governed by their individual formal governance mechanisms, while each was formally accountable to its own leadership team, resulting in challenges when activities and decisions involved collaboration between organisations. Furthermore, COVAX's governance lacked transparency, as there was little public information about their decision-making processes and operations, including information about the algorithm with which they make vaccine allocation decision, possibly contributing to its inability to achieve its goals. Conclusions: The COVAX partnership only achieved four of the six premises of shared health governance. Since actors involved in COVAX did not hold one another accountable for their role in the partnership, it did not employ mutual collective accountability, while also lacking in transparency. Although these results do not entirely explain COVAX's shortcomings, they contribute to evidence about the roles of good governance, transparency, and accountability in large global health initiatives and underscore failures of the current global governance system.

Medicine donations: a review of policies and practices.

BACKGROUND: To help promote the effective delivery of drug donations, the World Health Organization (WHO) developed the Guidelines for Medicine Donations. The need for revisions is timely given the large-scale influx of medicine donations since the start of the COVID-19 pandemic. This study analyses current policies of donors and recipients that are commensurate with the recommendations in the Guidelines and examines current practices, challenges, and revision suggestions. RESULTS: A search for medicine donation policies of donors and recipients was conducted in May/June 2022 and repeated in January 2023. Potential donor countries were identified from the high-income countries on the United Nation's (UN) List of G20 Countries. Potential pharmaceutical company donors were selected from those with 2021 revenue of $30 billion or greater. Potential non-government organization donors came from the WHO list of non-governmental organizations (NGOs) and two other sources. Potential recipient countries were those on the UN List of Least Developed Countries. These four lists were supplemented with actual donors and recipients identified from the literature. All policies retrieved were screened to identify which of the 12 recommendations from the WHO Guidelines were incorporated. We identified 38 policies from 1 donor country, 6 brand-name multinational pharmaceutical companies, 6 NGOs and 25 recipient countries. Most policies incorporated all 12 recommendations. Twenty-five of the 38 policies were developed in 2010 or later. The majority of actual donors and recipients did not have policies that were publicly available. A rapid literature review for publications from 2010 onwards identified challenges in implementing the WHO Guidelines and suggested for revisions. Challenges included: (1) information management; (2) medication presentation; (3) influence from the pharmaceutical industry; (4) donation sustainability; and (5) the belief that donations are inherently good. CONCLUSIONS: Our findings suggest that both donors and recipients could further align their policies with the existing Guidelines and both groups should be consulted on any revisions to ensure that their experiences are reflected and their needs are addressed. While the current WHO Guidelines for Medicine Donations are a solid base for medical humanitarian efforts, evidence points to the need for an update to meet current challenges.

State capture through indemnification demands? Effects on equity in the global distribution of COVID-19 vaccines.

BACKGROUND: State capture by the pharmaceutical industry is a form of corruption whereby pharmaceutical companies shift laws or policies about their products away from the best interest of the public and toward their private benefit. State capture often limits equitable access to pharmaceutical products by inflating drug prices and increasing barriers to entry into the pharmaceutical industry. During the COVID-19 pandemic, the high demand and low supply of COVID-19 vaccines has put governments that manage vaccine procurement at risk of capture by COVID-19 vaccine manufacturers, both through bilateral deals and the COVID-19 Vaccine Global Access (COVAX) Facility; this threatens equity in the global distribution of these products. The purpose of this study is to determine whether COVID-19 vaccine manufacturers have been engaging in state capture and, if so, to examine the implications of state capture on equitable access to COVID-19 vaccines. METHODS: A targeted rapid literature search was conducted on state capture by the pharmaceutical industry. Results were limited to journal articles, books, and grey literature published between 2000 and 2021 in or translated to English. A literature search was also conducted for information about state capture during the COVID-19 pandemic. Results were limited to media articles published between March 2020 and July 2021 in or translated to English. All articles were qualitatively analyzed using thematic analysis. RESULTS: COVID-19 vaccine manufacturers have demanded financial indemnification from national governments who procure their vaccines. While most high-income countries are legislatively capable of indemnifying vaccine manufacturers, many low- and middle-income countries (LMICs) are not. A number of LMICs have thus changed their legislations to permit for manufacturers' indemnification demands. Amending legislation in this way is state capture and has led to delays in LMICs and vaccine manufacturers signing procurement contracts. This has critically stalled access to vaccines in LMICs and created disparities in access to vaccines between high-income countries and LMICs. CONCLUSIONS: COVID-19 vaccine manufacturers' indemnification demands constitute state capture in many LMICs though not in high-income countries; this has enhanced global COVID-19 vaccine inequities. Results underscore the need to find alternatives to financial indemnification that do not hinder critical efforts to end the pandemic.

A systematic review of digital technology and innovation and its potential to address anti-corruption, transparency, and accountability in the pharmaceutical supply chain.

INTRODUCTION: The urgent need to acquire medical supplies amidst the COVID-19 pandemic has led to bypassing of controls that govern the global pharmaceutical supply chain, increasing the risk of corruption. Hence, promoting anti-corruption, transparency, and accountability (ACTA) in supply chain and procurement has never been more important. The adoption of digital tools, if designed and implemented appropriately, can reduce the risks of corruption. AREAS COVERED: Following PRISMA guidelines, we conducted an interdisciplinary systematic review of health/medicine, humanities/social sciences, engineering, and computer science literature, with the aims of identifying technologies used for pharmaceutical supply chain and procurement optimization and reviewing whether they address ACTA mechanisms to strengthen pharmaceutical governance. Our review identified four distinct categories of digital solutions: e-procurement and open contracting; track-and-trace technology; anti-counterfeiting technology; and blockchain technology. EXPERT OPINION: Findings demonstrate an increase in research of technologies to improve pharmaceutical supply chain and procurement functions; however, most technologies are not being leveraged to directly address ACTA or global health outcomes. Some blockchain and RFID technologies incorporated ACTA mechanisms and mentioned specific policy/governance frameworks, but more purposeful linkage is needed. Findings point to the need for targeted policy development and governance to activate these innovative technologies to improve global health .

The Global Fund: why anti-corruption, transparency and accountability matter.

BACKGROUND: The creation of the Global Fund to Fight AIDS, Tuberculosis and Malaria, also known as the Global Fund, was prompted by the lack of a timely and effective global response, and the need for financing to fight against three devastating diseases: HIV/AIDS, tuberculosis, and malaria. During the formation of the Global Fund, necessary anti-corruption, transparency, and accountability (ACTA) structures were not put in place to prevent fraud and corruption in its grants, which resulted in the misuse of funds by grant recipients and an eventual loss of donor confidence in 2011. The Global Fund has instituted various ACTA mechanisms to address this misuse of funding and the subsequent loss of donor confidence, and this paper seeks to understand these implementations and their impacts over the past decade, in an effort to probe ACTA more deeply. RESULTS: By restructuring the governing committees in 2011, and the Audit and Finance; Ethics and Governance; and Strategy Committees in 2016, the Global Fund has delineated committee mandates and strengthened the Board's oversight of operations. Additionally, the Global Fund has adopted a rigorous risk management framework which it has worked into all aspects of its functioning. An Ethics and Integrity Framework was adopted in 2014 and an Ethics Office was established in 2016, resulting in increased conflict of interest disclosures and greater considerations of ethics within the organization. The Global Fund's Office of the Inspector General (OIG) has effectively performed internal and external audits and investigations on fraud and corruption, highlighted potential risks for mitigation, and has implemented ACTA initiatives, such as the I Speak Out Now! campaign to encourage whistleblowing and educate on fraud and corruption. CONCLUSIONS: From 2011 onwards, the Global Fund has developed a number of ACTA mechanisms which, in particular, resulted in reduced grant-related risks and procurement fraud as demonstrated by the decreased classification from high to moderate in 2017, and the reduction of investigations in 2018 respectively. However, it is crucial that the Global Fund continues to evaluate the effectiveness of these mechanisms; monitor for potential perverse impacts; and make necessary changes, when and where they are needed.

Intellectual property and access to medicines: mapping public attitudes toward pharmaceuticals during the United States-Mexico-Canada Agreement (USMCA) negotiation process.

BACKGROUND: Transparency and accountability are essential components at all stages of the trade negotiation process. This study evaluates the extent to which these principles were upheld in the United States' public consultation process during the negotiation of the United States-Mexico-Canada Agreement (USMCA), with respect to public comments about the pharmaceutical sector and access to medicines. RESULTS: The public consultation process occurred before the start of official negotiations and was overseen by the Office of the United States Trade Representative (USTR). It included both written comments and oral testimony about US trade negotiation objectives. Of the written comments that specifically discussed issues relating to pharmaceuticals, the majority were submitted by private individuals, members of the pharmaceutical industry, and civil society organizations. Nearly all comments submitted by non-industry groups indicated that access to medicines was a priority issue in the renegotiated agreement, with specific reference to price affordability. By contrast, more than 50% of submissions received from members or affiliates of the pharmaceutical industry advocated for strengthened pharmaceutical intellectual property rights, greater regulatory data protections, or both. This study reveals mixed outcomes with respect to the level of transparency achieved in the US trade negotiation process. Though input from the public at-large was actively solicited, the extent to which these comments were considered in the content of the final agreement is unclear. A preliminary comparison of the analyzed comments with the USTR's final negotiating objectives and the final text of the USMCA shows that several provisions that were advanced exclusively by the pharmaceutical industry and ultimately adopted in the final agreement were opposed by the majority of non-industry stakeholders. CONCLUSIONS: Negotiators could increase public transparency when choosing to advance one competing trade objective over another by actively providing the public with clear rationales for their negotiation positions, as well as details on how public comments are taken into account to form these rationales. Without greater clarity on these aspects, the public consultation process risks appearing to serve as a cursory government mechanism, lacking in accountability and undermining public trust in both the trade negotiation process and its outcomes.

Social capital and public health: responding to the COVID-19 pandemic.

BACKGROUND: As countries continue to respond to the COVID-19 pandemic, the importance of ensuring that fair and equal access to healthcare for all is more urgent than ever. Policies that promote social capital building along all levels of society may offer an important avenue for improved healthcare delivery and health systems strengthening in the COVID-19 response. MAIN BODY: In reference to the established and emerging literature on social capital and health, we explore the role of social capital in the COVID-19 health policy response. We analyse current research with respect to mental health, public health policy compliance, and the provision of care for vulnerable populations, and highlight how considerations of bonding, bridging, and linking capital can contribute to health systems strengthening in the context of the COVID-19 response and recovery effort. CONCLUSIONS: This article argues that considerations of social capital - including virtual community building, fostering solidarity between high-risk and low-risk groups, and trust building between decision-makers, healthcare workers, and the public - offer a powerful frame of reference for understanding how response and recovery programs can be best implemented to effectively ensure the inclusive provision of COVID-19 health services.

A framework for the management of donated medical devices based on perspectives of frontline public health care staff in Ghana.

Background: Transnational funders provide up to 80% of funds for medical devices in resource-limited settings, yet sustained access to medical devices remains unachievable. The primary goal of this study was to identify what factors hinder access to medical devices through the perspectives of frontline public hospital staff in Ghana involved in the implementation of transnational funding initiatives. Methods: A case study was developed that involved an analysis of semi-structured interviews of 57 frontline technical, clinical and administrative public health care staff at 23 sites in Ghana between March and April 2017; a review of the national guidelines for donations; and images of abandoned medical devices. Results: Six key themes emerged, demonstrating how policy, collaboration, quality, lifetime operating costs, attitudes of health care workers and representational leadership influence access to medical devices. An in-depth assessment of these themes has led to the development of an enterprise-wide comprehensive acquisition and management framework for medical devices in the context of transnational funding initiatives. Conclusion: The findings in this study underscore the importance of incorporating frontline health care staff in developing solutions that are targeted at improving delivery of care. Sustained access to medical devices may be achieved in Ghana through the adoption of a rigorous and comprehensive approach to acquisition, management and technical leadership. Funders and public health policy makers may use the study's findings to inform policy reform and to ensure that the efforts of transnational funders truly help to facilitate sustainable access to medical devices in Ghana.

Increasing transparency and accountability in national pharmaceutical systems.

Access to safe, effective, good-quality medicines can be compromised by poor pharmaceutical system governance. This system is particularly vulnerable to inefficiencies and to losses from corruption, because it involves a complex mix of actors with diverse responsibilities. A high level of transparency and accountability is critical for minimizing opportunities for fraud and leakage. In the past decade, the Good Governance for Medicines programme and the Medicines Transparency Alliance focused on improving accountability in the pharmaceutical system and on reducing its vulnerability to corruption by increasing transparency and encouraging participation by a range of stakeholders. Experience with these two programmes revealed that stakeholders interpreted transparency and accountability in a range of different ways. Moreover, programme implementation and progress assessments were complicated by a lack of clarity about what information should be disclosed by governments and about how greater transparency can strengthen accountability for access to medicines. This article provides a conceptual understanding of how transparency can facilitate accountability for better access to medicines. We identified three categories of information as prerequisites for accountability: (i) standards and commitments; (ii) decisions and results; and (iii) consequences and responsive actions. Examples are provided for each. Conceptual clarity and practical examples of the information needed to ensure accountability can help policy-makers identify the actions required to increase transparency and accountability in their pharmaceutical systems. We also discuss factors that can hinder or facilitate the use of information to hold to account those responsible for improving access to medicines.

L'accès à des médicaments sûrs, efficaces et de bonne qualité peut être compromis par la mauvaise gouvernance du secteur pharmaceutique. Celui-ci est particulièrement exposé aux inefficacités et aux pertes dues à la corruption, du fait qu'il implique un ensemble complexe d'acteurs aux différentes responsabilités. Une grande transparence et l'obligation de rendre des comptes sont indispensables pour minimiser les possibilités de fraude et de fuite. Durant la dernière décennie, le programme de Bonne gouvernance dans le secteur pharmaceutique et l'initiative Medicines Transparency Alliance se sont attachés à améliorer la reddition de comptes dans le secteur pharmaceutique et à réduire la vulnérabilité de ce dernier face à la corruption, en augmentant la transparence et en encourageant la participation de nombreuses parties prenantes. L'expérience de ces deux programmes a révélé que les parties prenantes interprétaient la transparence et la reddition de comptes de différentes manières. En outre, la mise en œuvre des programmes et l'évaluation des progrès ont été compliquées par un manque de clarté quant aux informations que les gouvernements devaient communiquer et à la manière dont une plus grande transparence pouvait renforcer la reddition de comptes et l'accès aux médicaments. Cet article entend expliquer en quoi la transparence peut faciliter la reddition de comptes et améliorer l'accès aux médicaments. Nous avons identifié trois catégories d'informations nécessaires à la reddition de comptes: (i) normes et engagements; (ii) décisions et résultats; (iii) conséquences et mesures réactives. Des exemples sont présentés pour chaque catégorie. Un cadre théorique clair et des exemples pratiques d'informations nécessaires pour assurer la reddition de comptes peuvent aider les responsables politiques à déterminer les actions requises pour augmenter la transparence et la reddition de comptes dans leurs systèmes pharmaceutiques. Nous évoquons aussi les facteurs qui peuvent entraver ou faciliter l'utilisation des informations et engager la responsabilité des personnes chargées d'améliorer l'accès aux médicaments.

El acceso a medicamentos seguros, eficaces y de buena calidad puede verse comprometido por una mala gestión del sistema farmacéutico. Este sistema es particularmente vulnerable a las ineficiencias y a las pérdidas derivadas de la corrupción porque implica una compleja mezcla de distintos participantes con diversas responsabilidades. Un alto nivel de transparencia y responsabilidad es fundamental para minimizar las oportunidades de fraude y filtraciones. En la última década, el programa de Buena Gestión de los Medicamentos y la Alianza para la Transparencia de los Medicamentos se han centrado en mejorar la responsabilidad del sistema farmacéutico y en reducir su vulnerabilidad a la corrupción mediante el aumento de la transparencia y el fomento de la participación de una serie de partes interesadas. La experiencia con estos dos programas reveló que las partes interesadas interpretaban la transparencia y la responsabilidad de diversas maneras. Además, la implementación de los programas y las evaluaciones de progreso se complicaron debido a la falta de claridad sobre la información que deben divulgar los gobiernos y sobre cómo una mayor transparencia puede fortalecer la responsabilidad en el acceso a los medicamentos. Este artículo ofrece una explicación conceptual de cómo la transparencia puede facilitar la responsabilidad para un mejor acceso a los medicamentos. Se han identificado tres categorías de información como requisitos previos a la responsabilidad: (i) normas y compromisos; (ii) decisiones y resultados; y (iii) consecuencias y medidas de respuesta. Se ofrecen ejemplos de todas. La claridad de conceptos y los ejemplos prácticos de la información necesaria para garantizar la responsabilidad pueden ayudar a los responsables políticos a identificar las medidas necesarias para aumentar la transparencia y la responsabilidad en sus sistemas farmacéuticos. También se analizan los factores que dificultan o facilitan el uso de la información para responsabilizar a las personas responsables de mejorar el acceso a los medicamentos.

Promoting transparency, accountability, and access through a multi-stakeholder initiative: lessons from the medicines transparency alliance.

BACKGROUND: Barriers to expanding access to medicines include weak pharmaceutical sector governance, lack of transparency and accountability, inadequate attention to social services on the political agenda, and financing challenges. Multi-stakeholder initiatives such as the Medicines Transparency Alliance (MeTA) may help overcome these barriers. Between 2008 and 2015, MeTA engaged stakeholders in the pharmaceutical sectors of seven countries (Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia) to promote access goals through greater transparency. METHODS: We reviewed archival data to document MeTA activities and results related to transparency and accountability in the seven countries where it was implemented. We identified common themes and content areas, noting specific activities used to make information transparent and accessible, how data were used to inform discussions, and the purpose and timing of meetings and advocacy activities to help set priorities and influence governance decisions. The cross-case analysis looked for pathways which might link the MeTA strategies to results such as better policies or program improvements. RESULTS: Countries used evidence gathering, open meetings, and proactive information dissemination to increase transparency. MeTA fostered policy dialogue to bring together the many government, civil society and private company stakeholders concerned with access issues, and provided them with information to understand barriers to access at policy, organizational, and community levels. We found strong evidence that transparency was enhanced. Some evidence suggests that MeTA efforts contributed to new policies and civil society capacity strengthening although the impact on government accountability is not clear. CONCLUSION: MeTA appears to have achieved its goal of creating a multi-stakeholder shared policy space in which government, civil society, and private sector players can come together and have a voice in the national pharmaceutical policy making process. Assuming that transparency is in place to leverage accountability, the success of MeTA's efforts to promote accountability by the government as well as other stakeholders in the pharmaceutical sector will depend on how well efforts are sustained over time.

Matching safety to access: global actors and pharmacogovernance in Kenya- a case study.

BACKGROUND: The Kenyan government has sought to address inadequacies in its National Pharmaceutical Policy and the Pharmacy and Poisons Board's (PPB) medicines governance by engaging with global actors (e.g. the World Health Organization). Policy actors have influenced the way pharmacovigilance is defined, how challenges are understood and which norms are requisite to address drug safety issues. In this paper, we investigate the relationship between specific modes of engagement among global (exogenous) and domestic actors at the national and sub-national level to identify the positive or negative effect on pharmacovigilance and pharmacogovernance in Kenya. Pharmacogovernance is defined as the manner in which governing structures; policy instruments; institutional authority (e.g., ability to act, implement and enforce norms, policies and processes) and resources are managed to promote societal interests for patient safety and protection from adverse drug reactions (ADRs). Qualitative research methods that included key informant interviews and document analysis, were employed to investigate the relationship between global actors' patterns of engagement with national actors and pharmacogovernance in Kenya. RESULTS: Global actors' influence on pharmacogovernance and pharmacovigilance priorities in Kenya (e.g., legislation and adverse drug reaction surveillance) was positively perceived by key informants. We found that global actors' engagement with state actors produced positive and negative outcomes. Engagement with the PPB and Ministry of Health (MOH) that was characterized as dependent (advocacy, empowerment, delegated) or interdependent (collaborative, cooperative, consultative) was mostly associated with positive outcomes e.g., capacity building; strengthening legislation and stakeholder coordination. Fragmentation (independent engagement) hindered risk communication between public, private, and NGO health programs. CONCLUSION: A framework for assessing pharmacogovernance would support policy makers' evidence-based decision making regarding investments to strengthen capacity for pharmacovigilance and guide policies regarding the state and exogenous actor relationship pertaining to pharmacogovernance. Ideally, dependency on exogenous actors should be reduced while retaining consultative, collaborative, and cooperative engagement when inter-dependency is appropriate. The use of global actors to address Kenya's pharmacovigilance inadequacies leaves the country vulnerable to 1) ad hoc drug surveillance; 2) pharmacovigilance fragmentation; 3) shifting priorities; and 4) cross purpose interests.

Governance and pharmacovigilance in Brazil: a scoping review.

BACKGROUND: This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance. METHODS: Sixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated. RESULTS: Brazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information. CONCLUSIONS: Pharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil.

Policy versus practice: a community-based qualitative study of the realities of pharmacy services in Nunavut, Canada.

OBJECTIVES: Nunavut is an Arctic territory in Canada subject to many social, economic and health disparities in comparison to the rest of the nation. The territory is affected by health care provision challenges caused by small, geographically isolated communities where staffing shortages and weather related access barriers are common concerns. In addition to national universal healthcare, the majority of the inhabitants of Nunavut (~85 %) are Inuit beneficiaries of no-charge pharmaceuticals provided through federal and/or territorial budgetary allocations. This research examines how existing pharmaceutical administration and distribution policies and practices in Nunavut impact patient care. METHODS: This grounded theory research includes document analysis and semi-structured interviews conducted in 2013/14 with patients, health care providers, administrators and policy makers in several communities in Nunavut. Thirty five informants in total participated in the study. Interviews were audiotaped, transcribed and analyzed with qualitative data analysis software for internal consistency and emerging themes. RESULTS: Four distinct themes emerge from the research that have the potential to impact patient care and which may provide direction for future policy development: 1) tensions between national versus territorial financial responsibilities influence health provider decisions that may affect patient care, 2) significant human resources are utilized in Community Health Centres to perform distribution duties associated with retail pharmacy medications, 3) large quantities of unclaimed prescription medications are suggestive of significant financial losses, suboptimal patient care and low adherence rates, and 4) the absence of a clear policy and oversight for some controlled substances, such as narcotics, leaves communities at risk for potential illegal procurement or abuse. CONCLUSIONS: Addressing these issues in future policy development may result in system-wide economic benefits, improved patient care and adherence, and reduced risk to communities. The interview informants who participated in this research are best positioned to identify issues in need of attention and will benefit the most from policy development to address their concerns.

A call for a moratorium on the .health generic top-level domain: preventing the commercialization and exclusive control of online health information.

In just a few weeks, the Internet could be expanded to include a new .health generic top-level domain name run by a for-profit company with virtually no public health credentials - unless the international community intervenes immediately. This matters to the future of global public health as the "Health Internet" has begun to emerge as the predominant source of health information for consumers and patients. Despite this increasing use and reliance on online health information that may have inadequate quality or reliability, the Internet Corporation for Assigned Names and Numbers (ICANN) recently announced it intends to move forward with an auction to award the exclusive, 10 year rights to the .health generic top-level domain name. This decision is being made over the protests of the World Medical Association, World Health Organization, and other stakeholders, who have called for a suspension or delay until key questions can be resolved. However, rather than engage in constructive dialogue with the public health community over its concerns, ICANN chose the International Chamber of Commerce-a business lobbying group for industries to adjudicate the .health concerns. This has resulted in a rejection of challenges filed by ICANN's own independent watchdog and others, such that ICANN's Board decided in June 2014 that there are "no noted objections to move forward" in auctioning the .health generic top-level domain name to the highest bidder before the end of the year. This follows ICANN's award of several other health-related generic top-level domain names that have been unsuccessfully contested. In response, we call for an immediate moratorium/suspension of the ICANN award/auction process in order to provide the international public health community time to ensure the proper management and governance of health information online.

Health domains for sale: the need for global health Internet governance.

A debate on Internet governance for health, or "eHealth governance", is emerging with the impending award of a new dot-health (.health) generic top-level domain name (gTLD) along with a host of other health-related domains. This development is critical as it will shape the future of the health Internet, allowing largely unrestricted use of .health second-level domain names by future registrants, raising concerns about the potential for privacy, use and marketing of health-related information, credibility of online health content, and potential for Internet fraud and abuse. Yet, prospective .health gTLD applicants do not provide adequate safeguards for use of .health or related domains and have few or no ties to the global health community. If approved, one of these for-profit corporate applicants would effectively control the future of the .health address on the Internet with arguably no active oversight from important international public health stakeholders. This would represent a lost opportunity for the public health, medical, and broader health community in establishing a trusted, transparent and reliable source for health on the Internet. Countries, medical associations, civil society, and consumer advocates have objected to these applications on grounds that they do not meet the public interest. We argue that there is an immediate need for action to postpone awarding of the .health gTLD and other health-related gTLDs to address these concerns and ensure the appropriate development of sound eHealth governance rules, principles, and use. This would support the crucial need of ensuring access to quality and evidence-based sources of health information online, as well as establishing a safe and reliable space on the Internet for health. We believe, if properly governed, .health and other domains could represent such a promise in the future.

Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda.

BACKGROUND: Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. METHODS: A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants' experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. RESULTS: Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. CONCLUSIONS: This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher wages and benefits for workers could be important and initial steps in improving access orthopaedic care and OMDs, and managing the global injury burden.

Transparency in Nigeria's public pharmaceutical sector: perceptions from policy makers.

BACKGROUND: Pharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution. METHODS: Standardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability. RESULTS: The overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence. CONCLUSION: Despite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and consistently administered, limit the promulgation of corrupt practices. Other major contributing factors are the inconsistency in documentation of procedures, lack of public availability of such documentation, and inadequacies in monitoring and evaluation. What is most critical from this study is the identification of areas that still remain permeable to corruption and, perhaps, where more appropriate checks and balances are needed from the Nigerian government and the international community.