Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

Cambodia has experienced exponential economic growth in recent years and is expected to graduate from least developed country (LDC) status within the next decade. Membership of the World Trade Organization (WTO) will require Cambodia to grant product and process patents for pharmaceuticals upon LDC graduation. This study aims to measure the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the price of HIV and hepatitis C medicine in Cambodia once it graduates from LDC status and is obliged to make patents available for pharmaceutical products and processes. Using scenarios based on likely outcomes of accession to the TRIPS Agreement, it measures the impact on the price of the HIV treatment program and compares that impact with the hepatitis C treatment program. Graduation from LDC status would be expected to result in a modest increase in the cost of the antiretroviral (ARV) treatment program and very large increases in the cost of the direct acting antivirals (DAA) treatment program. If annual treatment budgets remain constant, patent protection could see 1,515 fewer people living with HIV able to access ARV treatment and 2,577 fewer people able to access DAA treatment (a drop in treatment coverage of 93%).

Public health advocacy strategies to influence policy agendas: lessons from a narrative review of success in trade policy.

BACKGROUND: Despite accumulating evidence of the implications of trade policy for public health, trade and health sectors continue to operate largely in silos. Numerous barriers to advancing health have been identified, including the dominance of a neoliberal paradigm, powerful private sector interests, and constraints associated with policymaking processes. Scholars and policy actors have recommended improved governance practices for trade policy, including: greater transparency and accountability; intersectoral collaboration; the use of health impact assessments; South-South networking; and mechanisms for civil society participation. These policy prescriptions have been generated from specific cases, such as the World Trade Organization's Doha Declaration on TRIPS and Public Health or specific instances of trade-related policymaking at the national level. There has not yet been a comprehensive analysis of what enables the elevation of health goals on trade policy agendas. This narrative review seeks to address this gap by collating and analysing known studies across different levels of policymaking and different health issues. RESULTS: Sixty-five studies met the inclusion criteria and were included in the review. Health issues that received attention on trade policy agendas included: access to medicines, food nutrition and food security, tobacco control, non-communicable diseases, access to knowledge, and asbestos harm. This has occurred in instances of domestic and regional policymaking, and in bilateral, regional and global trade negotiations, as well as in trade disputes and challenges. We identified four enabling conditions for elevation of health in trade-related policymaking: favourable media attention; leadership by trade and health ministers; public support; and political party support. We identified six strategies successfully used by advocates to influence these conditions: using and translating multiple forms of evidence, acting in coalitions, strategic framing, leveraging exogenous factors, legal strategy, and shifting forums. CONCLUSION: The analysis demonstrates that while technical evidence is important, political strategy is necessary for elevating health on trade agendas. The analysis provides lessons that can be explored in the wider commercial determinants of health where economic and health interests often collide.

Influencing the global governance of alcohol: Alcohol industry views in submissions to the WHO consultation for the Alcohol Action Plan 2022-2030.

BACKGROUND: In 2020, the Secretariat of the World Health Organization (WHO) conducted an open consultation, with public submissions, for the purpose of developing an Alcohol Action Plan to "strengthen implementation" of the WHO's 2010 Global Strategy to Reduce the Harmful Use of Alcohol. The consultation process and public submissions provided an opportunity to critically examine alcohol industry perspectives and arguments in relation to the global governance of alcohol. METHODS: 48 alcohol industry submissions to the WHO's 2020 consultation were included for analysis. Directed content analysis was used to examine the policy positions and arguments made by industry actors. Thematic analysis was employed to further explore the framing of industry arguments. RESULTS: In framing their arguments, alcohol industry actors positioned themselves as important stakeholders in policy debates; differentiated "normal" drinking from consumption that merits intervention; argued that alcohol policy should be made at the national, rather than global, level; and supported industry self-regulation or co-regulation rather than cost-effective public health measures to prevent harms from alcohol. CONCLUSION: The alcohol industry's submissions to the WHO's 2020 consultation could be seen as efforts to stymie improvements in the global governance of alcohol, and repeats several framing strategies that the industry has used in other forums, both national and global. However, their arguments appear to have had little traction in the creation of the Alcohol Action Plan. Changes from the Working Document to the adopted Action Plan show little acceptance by WHO of industry arguments.

Global inequities in access to COVID-19 health products and technologies: A political economy analysis.

This paper presents a political economy analysis of global inequities in access to COVID-19 vaccines, treatments, and diagnostic tests. We adapt a conceptual model used for analysing the political economy of global extraction and health to examine the politico-economic factors affecting access to COVID-19 health products and technologies in four interconnected layers: the social, political, and historical context; politics, institutions, and policies; pathways to ill-health; and health consequences. Our analysis finds that battles over access to COVID-19 products occur in a profoundly unequal playing field, and that efforts to improve access that do not shift the fundamental power imbalances are bound to fail. Inequitable access has both direct effects on health (preventable illness and death) and indirect effects through exacerbation of poverty and inequality. We highlight how the case of COVID-19 products reflects broader patterns of structural violence, in which the political economy is structured to improve and lengthen the lives of those in the Global North while neglecting and shortening the lives of those in the Global South. We conclude that achieving equitable access to pandemic response products requires shifting longstanding power imbalances and the institutions and processes that entrench and enable them.

The victims, villains and heroes of 'panic buying': News media attribution of responsibility for COVID-19 stockpiling.

Societies often respond to a crisis by attributing blame to some groups while constructing others as victims and heroes. While it has received scant sociological attention, 'panic buying' is a critical indicator of such public sentiment at the onset of a crisis, and thus a crucial site for analysis. This article traces dynamics of blame in news media representations of an extreme period of panic buying during COVID-19 in Australia. Analysis reveals that lower socio-economic and ethnically diverse consumers were blamed disproportionately. Unlike wealthier consumers who bulk-bought online, shoppers filling trollies in-store were depicted as selfish and shameful, described using dehumanising language, and portrayed as 'villains' who threatened social order. Supermarkets were cast simultaneously as 'victims' of consumer aggression and 'heroes' for their moral leadership, trustworthiness and problem-solving. This portrayal misunderstands the socio-emotional drivers of panic buying, exacerbates stigma towards already disadvantaged groups, and veils the corporate profiteering that encourages stockpiling.

Tackling structural stigma: a systems perspective.

INTRODUCTION: Structural stigma in the global HIV response is a "moving target" that constantly evolves as the epidemic changes. Tackling structural stigma requires an understanding of the drivers and facilitators of stigma in complex community, policy and health systems. In this paper, we present findings from a study adopting a systems perspective to understand how to tackle structural stigma via the Meaningful Involvement of People with HIV/AIDS (MIPA), while highlighting the challenges in demonstrating peer leadership from people living with HIV (PLHIV). METHODS: Through a long-term ongoing community-research collaboration (2015-2023), the study applied systems thinking methods to draw together the insights of over 90 peer staff from 10 Australian community and peer organizations. We used hypothetical narratives, affinity methods and causal loop diagrams to co-create system maps that visualize the factors that influence the extent to which peer leadership is expected, respected, sought-out and funded in the Australian context. We then developed draft indicators of what we should see happening when PLHIV peer leadership and MIPA is enabled to challenge structural stigma. RESULTS: Participants in the collaboration identified the interactions at a system level, which can enable or constrain the quality and influence of PLHIV peer leadership. Participants identified that effective peer leadership is itself affected by structural stigma, and peer leaders and the programmes that support and enable peer leadership must navigate a complex network of causal pathways and strategic pitfalls. Participants identified that indicators for effective PLHIV peer leadership in terms of engagement, alignment, adaptation and influence also required indicators for policy and service organizations to recognize their own system role to value and enable PLHIV peer leadership. Failing to strengthen and incorporate PLHIV leadership within broader systems of policy making and health service provision was identified as an example of structural stigma. CONCLUSIONS: Incorporating PLHIV leadership creates a virtuous cycle, because, as PLHIV voices are heard and trusted, the case for their inclusion only gets stronger. This paper argues that a systems perspective can help to guide the most productive leverage points for intervention to tackle structural stigma and promote effective PLHIV leadership.

What is the impact of intellectual property rules on access to medicines? A systematic review.

BACKGROUND: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains 'flexibilities' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. METHODS: We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies' findings and evaluated their quality using a modified quality assessment template. RESULTS AND CONCLUSION: Five broad overarching themes and 11 subthemes were identified based on the articles' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

Industry influence over global alcohol policies via the World Trade Organization: a qualitative analysis of discussions on alcohol health warning labelling, 2010-19.

BACKGROUND: Accelerating progress to implement effective alcohol policies is necessary to achieve multiple targets within the WHO global strategy to reduce the harmful use of alcohol and the Sustainable Development Goals. However, the alcohol industry's role in shaping alcohol policy through international avenues, such as trade fora, is poorly understood. We investigate whether the World Trade Organization (WTO) is a forum for alcohol industry influence over alcohol policy. METHODS: In this qualitative analysis, we studied discussions on alcohol health warning labelling policies that occurred at the WTO's Technical Barriers to Trade (TBT) Committee meetings. Using the WTO Documents Online archive, we searched the written minutes of all TBT Committee meetings available from Jan 1, 1995, to Dec 31, 2019, to identify minutes and referenced documents pertaining to discussions on health warning labelling policies. We specifically sought WTO member statements on health warning labelling policies. We identified instances in which WTO member representatives indicated that their statements represented industry. We further developed and applied a taxonomy of industry rhetoric to identify whether WTO member statements advanced arguments made by industry in domestic forums. FINDINGS: Among 83 documents, comprising TBT Committee minutes, notifications to the WTO of the policy proposal, and written comments by WTO members, WTO members made 212 statements (between March 24, 2010, and Nov 15, 2019) on ten alcohol labelling policies proposed by Thailand, Kenya, the Dominican Republic, Israel, Turkey, Mexico, India, South Africa, Ireland, and South Korea. WTO members stated that their claims represented industry in seven (3·3%) of 212 statements, and 117 (55·2%) statements featured industry arguments. Member statements featured many arguments used by industry in domestic policy forums to stall alcohol policy. Arguments focused on descaling and reframing the nature and causes of alcohol-related problems, promoting alternative policies such as information campaigns, promoting industry partnerships, questioning the evidence, and emphasising manufacturing and wider economic costs and harms. INTERPRETATION: WTO discussions at TBT Committee meetings on alcohol health warnings advanced arguments used by the alcohol industry in domestic settings to prevent potentially effective alcohol policies. WTO members appeared to be influenced by alcohol industry interests, although only a minority of challenges explicitly referenced industry demands. Increased transparency about vested interests might be needed to overcome industry influence. FUNDING: None.

Tackling NCDs: The Need to Address Alcohol Industry Interference and Policy Incoherence Across Sectors Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool".

Ralston et al highlight the ways that different actors in global nutrition governance conceptualise and frame the role of non-state actors in governance arrangements, including the potential for conflict of interest (COI) to undermine global health efforts. The authors argue that the World Health Organization (WHO) draft tool on managing COI in nutrition policy is an important innovation in global health, but that further research and refinement is needed for operationalising the management of COI with diverse actors in diverse contexts. In this commentary, reflecting on strategic framing and industry interference in policy-making, we argue for the urgent need for states and intergovernmental organisations to prevent alcohol industry interference in the development of national and global alcohol policy. We argue that policy incoherence remains a key barrier, where governments pursue health goals in the health sector while pursuing exports and market liberalisation of health harmful commodities in the trade sector.

Two steps forward, one step back: the lead up to tobacco plain packaging policy in Turkey.

The Turkish government first announced its intention to proceed with tobacco plain packaging legislation in 2011; however, it was 7 years before the legislation passed in December 2018. This study (conducted in 2018 before the legislation was passed) explored the policy context in Turkey between the first announcement that plain packaging legislation would be introduced and the passage of the legislation in 2018, and identified barriers and facilitators influencing its introduction. Publicly available documents relevant to plain packaging in Turkey were analysed. Interviews were conducted in 2018 with ten key informants including academics, bureaucrats in government ministries and leaders of non-government organizations (NGOs). Thematic analysis was undertaken, using a framework for systematically analysing how issues reach the policy agenda. The introduction of plain packaging legislation proved to be problematic, with many false starts and delays. Findings suggest these were mainly due to political barriers including changes in government, tobacco industry opposition and the national economic crisis. However, plain packaging legislation in Turkey managed to advance on the policy agenda, primarily through the collaborative advocacy efforts of NGOs, academics, and leadership from particular tobacco control advocates and politicians. Turkey's experience provides lessons for the wider uptake of tobacco plain packaging legislation, illustrating the critical importance of building effective coalitions between a range of stakeholders and political support within government while raising public awareness. Lay summary This research provides insights into the barriers and facilitators of decision making and action that shaped the process of introducing tobacco plain packaging legislation in Turkey. Major barriers that slowed Turkey's progress in enacting plain packaging included the financial and national economic crisis in 2018, changes in health ministers and opposition by the tobacco industry. A major facilitator of the policy process was the collaborative advocacy efforts of non-government organizations, academics, politicians and the leadership of certain tobacco control advocates. The insights from this case study may help other low- and middle-income countries to anticipate and successfully navigate the challenges involved in introducing tobacco plain packaging, an important policy measure for reducing the burden of tobacco-related disease in their populations, and its social and economic impacts. Building effective coalitions and fostering and supporting leadership are important strategies for the successful introduction of plain packaging legislation.

The political economy of restricting marketing to address the double burden of malnutrition: two case studies from Fiji.

OBJECTIVE: To draw lessons from Fiji regarding the challenges and opportunities for policy initiatives to restrict (i) food marketing to children and (ii) marketing of breast milk substitutes, to inform policy for the double burden of malnutrition. DESIGN: Qualitative political economy analysis of two policy case studies. SETTING: Fiji. PARTICIPANTS: Eleven key informants from relevant sectors, representing public health, economic and consumer interests. RESULTS: This study used two policy initiatives as case studies to examine factors influencing decision-making: Marketing Controls (Foods for Infants and Young Children) Regulations 2010, amended in 2016 to remove guidelines and restrictions on marketing in the form of labelling, and the draft Advertising and Promotion of Unhealthy Foods and Non-Alcoholic Beverages to Children Regulation developed in 2014 but awaiting review by the Solicitor General's Office. Factors identified included: a policy paradigm in which regulation of business activity contradicts economic policy goals; limited perception by key policy actors of links between nutrition and marketing of breast milk substitutes, foods and beverages; and a power imbalance between industry and public health stakeholders in policymaking. Regulation of marketing for health purposes sits within the health sector's interest but not its legislative remit, while within the economic sector's remit but not interest. Opportunities to strengthen restrictions on marketing to improve nutrition and health include reframing the policy issue, strategic advocacy and community engagement. CONCLUSIONS: Restricting marketing should be recognised by public health actors as a public health and an industry policy issue, to support strategic engagement with economic policy actors.

Alcohol labelling rules in free trade agreements: Advancing the industry's interests at the expense of the public's health.

INTRODUCTION AND AIMS: The Trans-Pacific Partnership Agreement (TPP) included novel rules for wine and spirits requiring parties to allow wine and spirits importers to display information required by the importing country on a supplementary label rather than on the standard label. Since the TPP negotiations concluded, alcohol-specific supplementary labelling rules have begun to appear in other trade agreements. The aim of this paper was to map the new instruments containing these rules and examine developments in the rules with implications for health information on alcohol containers. DESIGN AND METHODS: Trade agreements signed after the TPP negotiations concluded were retrieved and searched for alcohol-specific labelling provisions. A legal analysis of these provisions and related exceptions was undertaken. RESULTS: Supplementary labelling rules similar or identical to those in the TPP have been included in five subsequent trade agreements. The United States-Mexico-Canada Agreement also includes several additional provisions about alcohol labelling. Exceptions in the agreements provide some space for governments to defend labelling measure that might otherwise breach the rules, in the event of a dispute. DISCUSSION AND CONCLUSIONS: By securing these rules, the alcohol industry is better positioned to claim the space on the standard label as industry 'real estate' and to oppose mandatory health information incorporated into the standard labelling. These risks can be mitigated by stemming the adoption of supplementary labelling rules in further trade agreements; clarifying the text of agreements and ensuring that regulators understand that the rules do not prevent the use of 'best-practice' warning labels.

Industry submissions on alcohol in the context of Australia's trade and investment agreements: A content and thematic analysis of publicly available documents.

INTRODUCTION AND AIMS: Alcohol use is a leading risk factor for death and disability, responsible for 3 million deaths in 2016. The alcohol industry is a powerful player in shaping trade and investment rules in ways that can constrain the ability of governments to regulate alcoholic beverages to reduce harm. This paper analyses publicly available submissions about alcohol in the context of Australia's free trade agreements to determine the key themes put forward by industry. DESIGN AND METHODS: We searched for submissions made to the Department of Foreign Affairs and Trade by alcohol industry trade associations, alcohol manufacturers, distributors and retailers, general industry association, and government agencies with responsibilities for alcohol trade, about specific free trade agreements involving Australia. Thirty-one submissions in relation to eight trade agreements were included for analysis. The analysis involved both descriptive content analysis and thematic analysis. RESULTS: Findings suggest that industry is actively seeking to shape trade negotiations around alcohol. Priority issues for the industry include improving market access, harmonising regulation, improving clarity and transparency, reducing the burden of regulation and preventing monopolies on product names. DISCUSSION AND CONCLUSION: The alcohol industry and associated business and government organisations are actively working to influence trade agreement negotiations for industry economic gain, arguing for rules which may undermine public health goals. The analysis suggests that public health experts should pay attention to trade and investment agreements and develop counter frames to ensure agreements do not create barriers for coherent health policies.

USMCA 2.0: a few improvements but far from a 'healthy' trade treaty.

The USMCA (NAFTA 2.0), although signed over a year ago, went through several months of renegotiation of certain of its new rules that the Democrat-controlled US Congress wanted altered or strengthened. In December a 'Protocol of Amendment' was agreed upon and signed by the three Parties (the USA, Mexico, and Canada). A number of tough, new measures governing pharmaceuticals were revised or deleted, making it potentially easier for generic competition and lower drug costs in all three countries. Rules on protection of labour rights were also strengthened, lowering the threshold at which a complaint of unfair labour practices could be initiated. Procedures for investigating such a complaint or resolving a formal dispute were also improved. Similar procedural improvements were made on measures affecting environmental protection. These Protocol agreements are more health-positive than health-negative, and in the case of pharmaceuticals are of significant impact. Overall, however, these amendments are simply a political fine-tuning of the agreement. Concerns raised in our earlier health impact assessment of the USMCA, notably how the agreement's regulatory reforms reduce public health policy flexibilities, remain. The agreement continues to subordinate known or potential health costs of many of its measures to dubious claims of aggregate economic gains. Moreover, these gains, if materialized, are likely to accrue to those atop the income/wealth hierarchies in all three nations.

Coverage of Aboriginal and Torres Strait Islander nutrition in the Koori Mail.

OBJECTIVE: To examine the extent and nature of coverage of nutrition in the Koori Mail. METHODS: Content and framing analysis were used to examine articles in the Koori Mail published between 2013 and 2017 that included the terms 'nutrition∗', 'diet∗', 'food', 'eating', 'weight', 'tucker' or 'sugary drinks'. The analysis focused on the portrayal of Aboriginal and Torres Strait Islander people/communities, inclusion of First Peoples' voices and the framing of nutrition issues. RESULTS: A total of 102 articles were included. Most articles (88%, n=90) portrayed Aboriginal and Torres Strait Islander communities in a neutral or positive way and more than half (53%, n=54) included an Aboriginal or Torres Strait Islander voice. While nutrition was often framed as an individual or community responsibility, articles predominantly promoted programs or initiatives undertaken in local communities. CONCLUSION: Despite the limited prominence of Aboriginal and Torres Strait Islander nutrition in the mainstream media, the coverage of nutrition issues in the Koori Mail demonstrates the salience of this topic for local communities. This study highlights how journalism can better reflect the diversity and strengths of First Peoples. Implications for public health: Including more Aboriginal and Torres Strait Islander voices and using a strengths-based approach in press releases may improve media advocacy.

Analyzing the impact of trade and investment agreements on pharmaceutical policy: provisions, pathways and potential impacts.

BACKGROUND: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research. A framework exploring the ways in which trade and investment agreements may affect pharmaceutical policy was developed, based on an analysis of four recently negotiated regional trade agreements. First a set of core pharmaceutical policy objectives based on international consensus was identified. A systematic comparative analysis of the publicly available legal texts of the four agreements was undertaken, and the potential impacts of the provisions in these agreements on the core pharmaceutical policy objectives were traced through an analysis of possible pathways. RESULTS: An analytical framework is presented, linking ten types of provisions in the four trade agreements to potential impacts on four core pharmaceutical policy objectives (access and affordability; safety, efficacy, and quality; rational use of medicines; and local production capacity and health security) via various pathways. CONCLUSIONS: The analytical framework highlights provisions in trade and investment agreements that need to be examined, pathways that should be explored, and potential impacts that should be taken into consideration with respect to pharmaceutical policy. This may serve as a useful checklist or template for health and human rights impact assessments and research on the implications of trade agreements for pharmaceuticals.