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Background: The global pharmaceutical industry has a long history of prioritizing profits over public health through widespread practices such as price gouging, deceptive marketing, and fraud. A prominent example of this issue is the mislabeling and mass-marketing of OxyContin by Purdue Pharmaceuticals (Purdue) that catalyzed the opioid crises in and beyond the United States., Methods: Guided by Actor-Network Theory, this case study employs Visual Network Analysis to map the actors-networks involved in responding to the harms caused by Purdue. Data was generated from peer-reviewed and grey literature published between 2007 and 2022 (n = 40) and imported into Gephi visualization software where centrality metrics were applied., Results: A total of 39 actors and 99 relationships were visualized based on the relational thinking that actors who are heavily interconnected with others are rendered important. Centrality measures identified the socio-technical centrality of Purdue in influencing the response to the harms it caused. Purdue exerted influence through various avenues, most prominently through the creation and cooptation of pain advocacy groups, their close ties with United States elected officials, and through embedding pro-opioid messaging in international guidance documents. In doing so, Purdue was able to extend the reach and impact of their opioid promotion, while simultaneously limiting the capacity of regulatory bodies to pursue accountability and implement policies to mitigate opioid-related harms., Conclusion: This study advances understandings of the complex interplay between transnational pharmaceutical companies, global health systems, regulatory bodies, and public health. In doing so, we underscore the need for stronger regulation and increased transparency surrounding the interactions between pharma, patient groups, governments, and international organizations to better address and prevent future harms., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests Andrea Bowra reports financial support was provided by Government of Canada Social Sciences and Humanities Research Council. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities . This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country's domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance.

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., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests., (Copyright © 2023 by the Journal of Global Health. All rights reserved.)

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., (© 2023. BioMed Central Ltd., part of Springer Nature.)

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., (© 2022. The Author(s).)

Corruption is a global wicked problem that threatens the achievement of health, social and economic development goals, including Sustainable Development Goal # 3: Ensuring healthy lives and promoting well-being for all. The COVID-19 pandemic and its resulting strain on health systems has heightened risks of corruption both generally and specifically within health systems. Over the past years, international organizations, including those instrumental to the global COVID-19 response, have increased efforts to address corruption within their operations and related programs. However, as attention to anti-corruption efforts is relatively recent within international organizations, there is a lack of literature examining how these organizations address corruption and the impact of their anti-corruption efforts. This study addresses this gap by examining how accountability, transparency, and anti-corruption are taken up by international organizations within their own operations and the reported outcomes of such efforts. The following international organizations were selected as the focus of this document analysis: the World Health Organization, the Global Fund, the United Nations Development Programme, and the World Bank Group. Documents were identified through a targeted search of each organization's website. Documents were then analyzed combining elements of content analysis and thematic analysis. The findings demonstrate that accountability and transparency mechanisms have been employed by each of the four international organizations to address corruption. Further, these organizations commonly employed oversight mechanisms, including risk assessments, investigations, and audits to monitor their internal and external operations for fraud and corruption. All organizations used sanction strategies meant to reprimand identified transgressors and deter future corruption. Findings also demonstrate a marked increase in anti-corruption efforts by these international organizations in recent years. Though this is promising, there remains a distinct absence of evidence demonstrating the impact of such efforts on the prevalence and severity of corruption in international organizations., Competing Interests: The authors have declared that no competing interests exist. However, we point out that Dr. Jillian Kohler is the Director of the WHO Collaborating Center for Governance, Accountability and Transparency in the Pharmaceutical Sector, which is not a competing interest but should be noted given the topic.

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., (© 2021. The Author(s).)

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., (© 2021. The Author(s).)

Corruption is recognized by the global community as a threat to development generally and to achieving health goals, such as the United Nations Sustainable Development Goal # 3: ensuring healthy lives and promoting well-being for all. As such, international organizations such as the World Health Organizations and the United Nations Development Program are creating an evidence base on how best to address corruption in health systems. At present, the risk of corruption is even more apparent, given the need for quick and nimble responses to the COVID-19 pandemic, which may include a relaxation of standards and the rapid mobilization of large funds. As international organizations and governments attempt to respond to the ever-changing demands of this pandemic, there is a need to acknowledge and address the increased opportunity for corruption.In order to explore how such risks of corruption are addressed in international organizations, this paper focuses on the question: How are international organizations implementing measures to promote accountability and transparency, and anti-corruption, in their own operations? The following international organizations were selected as the focus of this paper given their current involvement in anti-corruption, transparency, and accountability in the health sector: the World Health Organization, the United Nations Development Program, the World Bank Group, and the Global Fund to Fight Aids, Tuberculosis and Malaria. Our findings demonstrate that there has been a clear increase in the volume and scope of anti-corruption, accountability, and transparency measures implemented by these international organizations in recent years. However, the efficacy of these measures remains unclear. Further research is needed to determine how these measures are achieving their transparency, accountability, and anti-corruption goals.

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., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s) 2020.)

The COVID-19 pandemic has unleashed unprecedented and complex public policy issues. One that has emerged as a challenge for many countries globally is how to ensure the efficient and effective procurement of quality medical supplies. Existing corruption pressures on procurement-everything from undue influence to the outright bribery of public officials-has been amplified by the pandemic, and thus demands commensurate policy responses. We argue that transparency and accountability in procurement are essential to preventing the corruption risks that threaten the health and well-being of populations., Competing Interests: Competing interestsThe authors declare that they have no competing interests. Tom Wright is a full-time employee of the Transparency International Health Initiative, which receives funding from GlaxoSmithKline, the Open Society Foundation, and the UK Department for International Development., (© The Author(s) 2020.)

Background : The goal of the public procurement of pharmaceuticals is to purchase sufficient quantities of high-quality pharmaceuticals at cost-effective prices for a given population. This goal can be undercut if corruption infiltrates the procurement process. Good procurement practices can help mitigate the risks of corruption and support equitable access to affordable and high-quality medicines. Objectives : This paper aims to 1) examine manifestations of corruption in the pharmaceutical procurement process and key factors behind them, and 2) identify how to design and implement effective anti-corruption, transparency and accountability mechanisms within this process. Methods : This paper was informed by a narrative literature review from 1996 to the present. The search focused on publications that addressed the issue of pharmaceutical procurement and governance and corruption issues. Our search included peer-reviewed literature, books, grey literature such as working papers, reports published by international organizations and donor agencies, and some media articles. Some documents used in this paper were already known to the authors. Results : Procurement is highly vulnerable to corruption particularly in the health sector. What is more, corruption in the procurement process does not appear to be limited to any one level of government or type of health system. The better integration of accountability, transparency and anti-corruption mechanisms in the procurement process is needed to reduce the risk of corruption. Conclusions : Lessons learned suggest that anti-corruption, transparency and accountability mechanisms in the pharmaceutical procurement process, such as open contracting and integrity pacts are helpful towards reducing the risk of corruption.

Background: Two billion people worldwide, predominantly in low- and middle-income countries, cannot consistently access required essential medications, thus affecting their ability to attain optimal health outcomes. Access to appropriate medicines may be compromised due to issues involving cost, availability, quality, and prescribing practices, and system-wide factors such as a lack of transparency and accountability. Pharmaceutical promotional practices impact many of these issues, thus influencing the use of appropriate medicines,. Good governance is ultimately the responsibility of national governments through strong health systems with transparent and accountable practices that facilitate appropriate medicine use. We designed a structured set of indicators, based on existing tools, to assess the strength of the national governance of pharmaceutical promotion. In this exploratory study, we trialed the indicators in Ghana., Methods: Two existing tools, one developed by the World Health Organization and the other by Health Action International with the Medicines Transparency Alliance , were adapted to examine the governance of pharmaceutical promotion, resulting in a hybrid framework of 45 indicators of system strength, grouped into four categories: a) Governance of prescription medicines, b) Health care professional codes and regulations, c) Anti-corruption governance, and d) Indexes. Evidence was gathered via desk-based research to establish whether indicator requirements were met., Results: Our desk-based research discovered the following: a) 21 of 45 indicators for the governance of prescription medicines were met in Ghana, including the existence of a national medicines policy, national medicines list, medicines regulatory authority and a national guide for the promotion of prescription pharmaceuticals; b) pharmacists have a code of conduct specific to ethical promotion though co-development with the pharmaceutical industry should be further examined; and c) anti-corruption indicators were met for 10 of 12 criteria; and d) two indexes were available that were relevant to Ghana., Conclusion: Our set of indicators identified gaps and opportunities for the governance of medicines promotion in Ghana. These indicators have the potential to highlight areas requiring improved governance and could therefore form a useful diagnostic tool for identifying key discussion points for policy strengthening within low- and middle-income countries., Competing Interests: Competing interestsThe authors declare that they have no competing interests.

In this commentary, I argue that corruption in health systems is a critical and legitimate area for research in order to strengthen health policy goals. This rationale is based partly on citizen demand for more accountable and transparent health systems, along with the fact that the poor and vulnerable suffer the most from the presence of corruption in health systems. What is more, there is a growing body of literature on the impact of corruption in the health system and best practices in terms of anti-corruption, transparency and accountability (ACTA) strategies and tactics within the health system. Still, we need to support ACTA integration into the health system by having a common definition of corruption that is meaningful for health systems and ensure that ACTA strategies and tactics are transparent themselves. The 2019 Consultation on a proposed Global Network on ACTA in Health Systems is promising for these efforts., (© 2019 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)

We discuss how corruption affects access to antiretroviral therapies (ARVs) globally. Recent cases of theft of ARVs, collusion, and manipulation in procurement found in countries such as Central African Republic, Bangladesh, Malawi, and Guinea, show there is still much work to be done to reduce the risk of corruption. This includes addressing the structural weaknesses in procurement mechanisms and supply chain management systems of health commodities and medicines., (© 2018 American Society for Clinical Pharmacology and Therapeutics.)

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.

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes - and to minimise conflicts of interest among researchers and clinicians.

The global fight against HIV/AIDS continues to pose challenges: infection rates are on the rise in many settings, stigma and discrimination remain rampant, and the global response is under increasing financial pressure. There is a high risk of losing what has been achieved so far in the fight against HIV and AIDS, but also the momentum to meet the so-called Fast Track targets for 2030. In light of these trends, it is fundamental to focus on the human rights of key populations (KPs)-especially to health, non-discrimination, access to information, and to equal and meaningful participation in political and public affairs-by placing them at the center of the global HIV response. Such rights, and the demand for more transparency, accountability, and participation (TAP), have been recognized as both a necessary social justice imperative, and as a way to build more responsive, inclusive, and sustainable health systems. This article will argue that embracing TAP as key guiding principles of the global HIV response (especially in low- and middle-income countries) could have the potential to create the conditions for KPs to have their human rights fulfilled, and to expand their participation in the decision-making processes that guide the efforts against the epidemic. It will then propose a number of avenues for further engagement between different communities of practice in terms of research, agendas, and policy and practices that could be beneficial in maximizing the impact of the global efforts to end HIV/AIDS., Competing Interests: Competing interests: None declared.

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.

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.

Background: Access to medicines and the development of a strong national pharmaceutical industry are two longstanding pillars of health policy in Brazil. This is reflected in a clear emphasis by Brazil's Federal Government on improving access to medicine in national health plans and industrial policies aimed at promoting domestic pharmaceutical development. This research proposes that such policies may act as incentives for companies to pursue a strategic Corporate Social Responsibility (CSR) agenda. CSR that supports Governmental priorities could help companies to benefit significantly from the Governmental industrial policy. We sought to determine whether CSR activities of Brazilian pharmaceutical firms are currently aligned with the Federal Government's health prioritization. To do so we examined key Brazilian health related policies since 2004, including the specific priorities of Brazil's 2012-2015 Health Plan, and compared these with CSR initiatives that are reported on the websites of select pharmaceutical firms in Brazil., Results: Brazil's national health plans and industrial policies demonstrated that the Federal Government has followed diverse approaches for improving access to medicines, including strengthening health care infrastructure, increasing transparency, and supporting product development partnerships. Case studies of six pharmaceutical firms, representing both public and private companies of varying size, support the perspective that CSR is a priority for firms. However, while many programs target issues such as health infrastructure, health care training, and drug donation, more programs focus on areas other than health and do not seem to be connected to Governmental prioritization., Conclusion: This research suggests that there are loose connections between Governmental priorities and pharmaceutical firm CSR. However, there remains a significant opportunity for greater alignment, which could improve access to medicines in the country and foster a stronger relationship between the Government and industry.

Background: Brazil created Health Councils to bring together civil society groups, heath professionals, and government officials in the discussion of health policies and health system resource allocation. However, several studies have concluded that Health Councils are not very influential on healthcare policy. This study probes this issue further by providing a descriptive account of some of the challenges civil society face within Brazil's Health Councils., Methods: Forty semi-structured interviews with Health Council Members at the municipal, state and national levels were conducted in June and July of 2013 and May of 2014. The geographical location of the interviewees covered all five regions of Brazil (North, Northeast, Midwest, Southeast, South) for a total of 5 different municipal Health Councils, 8 different state Health Councils, and the national Health Council in Brasilia. Interview data was analyzed using a thematic approach., Results: Health Councils are limited by a lack of legal authority, which limits their ability to hold the government accountable for its health service performance, and thus hinders their ability to fulfill their mandate. Equally important, their membership guidelines create a limited level of inclusivity that seems to benefit only well-organized civil society groups. There is a reported lack of support and recognition from the relevant government that negatively affects the degree to which Health Council deliberations are implemented. Other deficiencies include an insufficient amount of resources for Health Council operations, and a lack of training for Health Council members. Lastly, strong individual interests among Health Council members tend to influence how members participate in Health Council discussions., Conclusions: Brazil's Health Councils fall short in providing an effective forum through which civil society can actively participate in health policy and resource allocation decision-making processes. Restrictive membership guidelines, a lack of autonomy from the government, vulnerability to government manipulation, a lack of support and recognition from the government and insufficient training and operational budgets have made Health Council largely a forum for consultation. Our conclusions highlight, that among other issues, Health Councils need to have the legal authority to act independently to promote government accountability, membership guidelines need to be revised in order include members of marginalized groups, and better training of civil society representatives is required to help them make more informed decisions.

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.

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.

Background: We review procurement and pricing transparency practices for pharmaceutical products. We specifically focus on Brazil and examine its approach to increasing pricing transparency, with the aim of determining the level of effectiveness in lower prices using a tool (Banco de Preços em Saúde, BPS) that only reveals purchase prices as compared to other tools (in other countries) that establish a greater degree of price transparency., Methods: A general report of Preços em Saúde (BPS) and Sistema Integrado de Administração de Serviços Gerais (SIASG) pricing data was created for 25 drugs that met specific criteria. To explore the linear time trend of each of the drugs, separate regression models were fitted for each drug, resulting in a total of 19 models. Each model controlled for the state variable and the interaction between state and time, in order to accommodate expected heterogeneity in the data. Additionally, the models controlled for procurement quantities and the effect they have on the unit price. Secondary analysis using mixed effects models was also carried out to account for the impact that institutions and suppliers may have upon the unit price. Adjusting for these predictor variables (procurement quantities, supplier, purchasing institution) was important to determine the sole effect that time has had on unit prices. A total of 2 x 19 = 38 models were estimated to explore the overall effect of time on changes in unit price. All statistical analyses were performed using the R statistical software, while the linear mixed effects models were fitted using the lme4 R package., Results: The findings from our analysis suggest that there is no pattern of consistent price decreases within the two Brazilian states during the five-year period for which the prices were analyzed., Conclusions: While the BPS does allow for an increase in transparency and information on drug purchase prices in Brazil, it has not shown to lead to consistent reductions in drug purchase prices for some of the most widely used medicines. This is indicative of a limited model for addressing the challenges in pharmaceutical procurement and puts into question the value of tools used globally to improve transparency in pharmaceutical pricing.

Introduction: The Brazilian Government created Participatory Health Councils (PHCs) to allow citizen participation in the public health policy process. PHCs are advisory bodies that operate at all levels of government and that bring together different societal groups to monitor Brazil's health system. Today they are present in 98% of Brazilian cities, demonstrating their popularity and thus their potential to help ensure that health policies are in line with citizen preferences. Despite their expansive reach, their real impact on health policies and health outcomes for citizens is uncertain. We thus ask the following question: Do PHCs offer meaningful opportunities for open participation and influence in the public health policy process?, Methods: Thirty-eight semi-structured interviews with health council members were conducted. Data from these interviews were analyzed using a qualitative interpretive content analysis approach. A quantitative analysis of PHC data from the Sistema de Acompanhamento dos Conselhos de Saude (SIACS) database was also conducted to corroborate findings from the interviews., Results: We learned that PHCs fall short in many of the categories of good governance. Government manipulation of the agenda and leadership of the PHCs, delays in the implementation of PHC decision making, a lack of training of council members on relevant technical issues, the largely narrow interests of council members, the lack of transparency and monitoring guidelines, a lack of government support, and a lack of inclusiveness are a few examples that highlight why PHCs are not as effective as they could be., Conclusions: Although PHCs are intended to be inclusive and participatory, in practice they seem to have little impact on the health policymaking process in Brazil. PHCs will only be able to fulfil their mandate when we see good governance largely present. This will require a rethinking of their governance structures, processes, membership, and oversight. If change is resisted, the PHCs will remain largely limited to a good idea in theory that is disappointing in practice.

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.

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.

Background: Corruption in the health sector can hurt health outcomes. Improving good governance can in turn help prevent health-related corruption. We understand good governance as having the following characteristics: it is consensus-oriented, accountable, transparent, responsive, equitable and inclusive, effective and efficient, follows the rule of law, is participatory and should in theory be less vulnerable to corruption. By focusing on the pharmaceutical system, we explore some of the key lessons learned from existing initiatives in good governance. As the development community begins to identify post-2015 Millennium Development Goals targets, it is essential to evaluate programs in good governance in order to build on these results and establish sustainable strategies. This discussion on the pharmaceutical system illuminates why., Discussion: Considering pharmaceutical governance initiatives such as those launched by the World Bank, World Health Organization, and the Global Fund, we argue that country ownership of good governance initiatives is essential but also any initiative must include the participation of impartial stakeholders. Understanding the political context of any initiative is also vital so that potential obstacles are identified and the design of any initiative is flexible enough to make adjustments in programming as needed. Finally, the inherent challenge which all initiatives face is adequately measuring outcomes from any effort. However in fairness, determining the precise relationship between good governance and health outcomes is rarely straightforward., Summary: Challenges identified in pharmaceutical governance initiatives manifest in different forms depending on the nature and structure of the initiative, but their regular occurrence and impact on population-based health demonstrates growing importance of addressing pharmaceutical governance as a key component of the post-2015 Millennium Development Goals. Specifically, these challenges need to be acknowledged and responded to with global cooperation and innovation to establish localized and evidence-based metrics for good governance to promote global pharmaceutical safety.

Background: Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of chronic myeloid leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013, rejecting the appeal of the Swiss giant drug manufacturer. In 2006, the Indian Patent Office first refused Glivec's patent under Section 3(d) of the Indian Patent Act arguing that it was only a modified version of an existing drug, Imatinib, and therefore that the drug was not innovative. Novartis replied filing legal challenges against the Indian government but the final verdict in April of 2013 ends the battle. Indeed, the Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Glivec was not patentable., Methods: The research primarily focused on journal, newspaper and magazine articles relevant to the time frame of the lawsuit (from 1994 to 2013) as well as news searches through Google, Factiva, ProQuest, PubMed, and YouTube where press articles from court verdicts were obtained by using the following keywords: "India", "Novartis", "Glivec", "Patent", "Novartis Case", and "Supreme Court of India". The data sources were interpreted and analyzed according to the authors' own prior knowledge and understanding of the exigencies of the TRIPS Agreement., Results: This case illuminates how India is interpreting international law to fit domestic public health needs., Conclusions: The Novartis case arguably sets an important precedent for the global pharmaceutical industry and ideally will help improve access to lifesaving medicines in the developing world by demanding that patient health needs supersede commercial interests. The Supreme Court of India's decision may affect the interpretation of the article of the TRIPS Agreement, which states members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

Background: This study designed and applied accessible yet systematic methods to generate baseline information about the patterns and structure of Canada's neglected tropical disease (NTD) research network; a network that, until recently, was formed and functioned on the periphery of strategic Canadian research funding., Methodology: MULTIPLE METHODS WERE USED TO CONDUCT THIS STUDY, INCLUDING: (1) a systematic bibliometric procedure to capture archival NTD publications and co-authorship data; (2) a country-level "core-periphery" network analysis to measure and map the structure of Canada's NTD co-authorship network including its size, density, cliques, and centralization; and (3) a statistical analysis to test the correlation between the position of countries in Canada's NTD network ("k-core measure") and the quantity and quality of research produced., Principal Findings: Over the past sixty years (1950-2010), Canadian researchers have contributed to 1,079 NTD publications, specializing in Leishmania, African sleeping sickness, and leprosy. Of this work, 70% of all first authors and co-authors (n = 4,145) have been Canadian. Since the 1990s, however, a network of international co-authorship activity has been emerging, with representation of researchers from 62 different countries; largely researchers from OECD countries (e.g. United States and United Kingdom) and some non-OECD countries (e.g. Brazil and Iran). Canada has a core-periphery NTD international research structure, with a densely connected group of OECD countries and some African nations, such as Uganda and Kenya. Sitting predominantly on the periphery of this research network is a cluster of 16 non-OECD nations that fall within the lowest GDP percentile of the network., Conclusion/significance: The publication specialties, composition, and position of NTD researchers within Canada's NTD country network provide evidence that while Canadian researchers currently remain the overall gatekeepers of the NTD research they generate; there is opportunity to leverage existing research collaborations and help advance regions and NTD areas that are currently under-developed.

This research assesses informal markets that dominate pharmaceutical systems in severely disrupted countries and identifies areas for further investigation. Findings are based on recent academic papers, policy and grey literature, and field studies in Somalia, Afghanistan, the Democratic Republic of Congo and Haiti. The public sector in the studied countries is characterized in part by weak Ministries of Health and low donor coordination. Informal markets, where medicines are regularly sold in market stalls and unregulated pharmacies, often accompanied by unqualified medical advice, have proliferated. Counterfeit and sub-standard medicines trade networks have also developed. To help increase medicine availability for citizens, informal markets should be integrated into existing access to medicines initiatives.

Objective: The objective of the study was to explore the experiences of physicians prescribing gabapentin off label., Methods: We used a case study approach to explore the experiences of physicians prescribing gabapentin for off-label indications. Semi-structured interviews were conducted with 10 physicians (psychiatry, pain and neurology specialists) in the Greater Toronto Area. Data were collected to the point of saturation of key themes and analyzed using interpretive content analysis., Key Findings: Key informants appeared to rely primarily on informal information from colleagues and meetings, putting into question the accuracy of their information about the potential off-label uses of gabapentin. Our findings suggest the need for more evidence-based information on off-label drug use., Conclusion: There is a need for greater understanding of off-label prescribing practices as an important step toward improving rational prescribing and ultimately toward improving patient safety and health outcomes.

Background: In order to ensure their population's regular access to essential medicines, many least developed countries and developing countries are faced with the policy question of whether to import or manufacture drugs locally, in particular for life-saving antiretroviral medicines for HIV/AIDS patients. In order for domestic manufacturing to be viable and cost-effective, the local industry must be able to compete with international suppliers of medicines by producing sufficiently low cost ARVs., Methods: This paper considers the 'make-or-buy' dilemma by using Tanzania as a case study. Key informant interviews, event-driven observation, and purposive sampling of documents were used to evaluate the case study. The case study focused on Tanzania's imitation technology transfer agreement to locally manufacture a first-line ARV (3TC + d4T + NVP), reverse engineering the ARV., Results: Tanzania is limited by weak political support for the use of TRIPS flexibilities, limited production capacity for ARVs and limited competitiveness in both domestic and regional markets. The Ministry of Health and Social Welfare encourages the use of flexibilities while others push for increased IP protection. Insufficient production capacity and lack of access to donor-financed tenders make it difficult to obtain economies of scale and provide competitive prices., Conclusions: Within the "make-or-buy" context, it was determined that there are significant limitations in domestic manufacturing for developing countries. The case study highlights the difficulty of governments to make use of economies of scale and produce low-cost medicines, attract technology transfer, and utilize the flexibilities of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The results demonstrate the importance of evaluating barriers to the use of TRIPS flexibilities and long-term planning across sectors in future technology transfer and manufacturing initiatives.

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.

Background: The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR., Methods: Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR., Results: In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments., Conclusions: The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

Within the array of measures for improving medicines access for the world's neediest populations, governments of many countries have turned to compulsory licensing, a statutory mechanism to enable third parties to manufacture a product or process still under patent. In this paper, we focus on a historic case example from Canada and the present example of Thailand's use of domestic compulsory licenses as a policy tool for ensuring public access to affordable medicines. The overarching objective is to draw out policy and legislative insights that may be of value for countries with pharmaceutical manufacturing capacity and which are considering better access to patented medicines for their populations under the current global intellectual property regime. From these cases, it is apparent that although compulsory licensing is not a novel remedy, even in a post-Trade Related Aspects of Intellectual Property Rights environment, it remains a powerful policy tool in improving access to medicines in a variety of domestic settings.

Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific recommendations for regulating promotion for drugs that may have a high abuse potential.

There is often a gap between promises made politically and the will to implement these promises meaningfully. One example is Canada's Access to Medicines Regime (CAMR). CAMR was enacted following a WTO decision that changed global intellectual property rules, allowing countries to issue compulsory licences for the production and export of domestically patented medicines to countries without pharmaceutical manufacturing capacity. Ideally, CAMR would be a vital part of Canada's international assistance. However, in the three years since CAMR was implemented, this attempt to improve medicines access by the world's neediest appears instead to be largely a failure of Canadian humanitarian efforts.

International experts recognize that significant inequities exist in the accessibility of life-saving medicines among poor and vulnerable populations, especially in developing countries. This article highlights that drug access even for relatively cheap medicines is out of reach for the vast numbers of global poor. This badly affects people living with HIV/AIDS who face serious obstacles in accessing ARVs. The same concerns are attributed to neglected diseases. Despite international meetings, promises from the pharmaceutical industry and a lot of media attention little has changed in the past 20 years. The accessibility gap to life-saving drugs could be reduced by the UNITAID initiative to pool patents for the many different ARVs, but the reality is that UNITAID is still a promise. To surmount this global problem of inequity requires a rethinking of traditional models of drug access and health objectives that should not be compromised by commercial interests.

Background: In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process., Methods: We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives., Results: The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media., Conclusions: Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.

This article provides summaries of the four presentations made during this panel. Tenu Avafia describes the evolution of international agreements concerning intellectual property rights, which formed the basis of Canada's Access to Medicines Regime (CAMR). Cailin Morrison describes how the CAMR works, outlines the limitations of the CAMR, and discusses recent attempts to reform the CAMR. Bruce Clark, whose company, Apotex Inc. has provided a generic ARV drug to Rwanda under the only compulsory licence issued to date under the CAMR, discusses the challenges of the current CAMR and outlines what improvements are required. Finally, Jillian Clare Kohler describes recent development in India, which amended its patent law in 2005, and how this relates to what is happening with the CAMR.