The potential impact of the Comprehensive and Progressive Agreement for Prans-Pacific Partnership on Thailand's hepatitis C treatment program.

BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. METHODS: This study uses two scenarios to cost the impact the CPTPP would have had on Thailand's 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated. RESULTS: Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%. CONCLUSIONS: Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand's hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs.

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.

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.

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.

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.

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.

USMCA (NAFTA 2.0): tightening the constraints on the right to regulate for public health.

BACKGROUND: In late 2018 the United States, Canada, and Mexico signed a new trade agreement (most commonly referred to by its US-centric acronym, the United States-Mexico-Canada Agreement, or USMCA) to replace the 1994 North American Free Trade Agreement (NAFTA). The new agreement is the first major trade treaty negotiated under the shadow of the Trump Administration's unilateral imposition of tariffs to pressure other countries to accept provisions more favourable to protectionist US economic interests. Although not yet ratified, the agreement is widely seen as indicative of how the US will engage in future international trade negotiations. METHODS: Drawing from methods used in earlier health impact assessments of the Trans-Pacific Partnership agreement, we undertook a detailed analysis of USMCA chapters that have direct or indirect implications for health. We began with an initial reading of the entire agreement, followed by multiple line-by-line readings of key chapters. Secondary sources and inter-rater (comparative) analyses by the four authors were used to ensure rigour in our assessments. RESULTS: The USMCA expands intellectual property rights and regulatory constraints that will lead to increased drug costs, particularly in Canada and Mexico. It opens up markets in both Canada and Mexico for US food exports without reducing the subsidies the US provides to its own producers, and introduces a number of new regulatory reforms that weaken public health oversight of food safety. It reduces regulatory policy space through new provisions on 'technical barriers to trade' and requirements for greater regulatory coherence and harmonization across the three countries. It puts some limitations on contentious investor-state dispute provisions between the US and Mexico, provisions often used to challenge or chill health and environmental measures, and eliminates them completely in disputes between the US and Canada; but it allows for new 'legacy claims' for 3 years after the agreement enters into force. Its labour and environmental chapters contain a few improvements but overall do little to ensure either workers' rights or environmental protection. CONCLUSION: Rather than enhancing public health protection the USMCA places new, extended, and enforceable obligations on public regulators that increase the power (voice) of corporate (investor) interests during the development of new regulations. It is not a health-enhancing template for future trade agreements that governments should emulate.

Correction to: USMCA (NAFTA 2.0): tightening the constraints on the right to regulate for public health.

Following publication of the original article [1], the authors flagged an error concerning two missing article references, which were unfortunately not provided prior to publication of the article.

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.

Strengthening Aboriginal and Torres Strait Islander health policy: lessons from a case study of food and nutrition.

OBJECTIVE: To examine key factors influencing the prioritisation of food and nutrition in Aboriginal and Torres Strait Islander health policy during 1996-2015. DESIGN: A qualitative policy analysis case study was undertaken, combining document analysis with thematic analysis of key informant interviews. SETTING: Australia. PARTICIPANTS: Key actors involved in Aboriginal and Torres Strait Islander health policy between 1996 and 2015 (n 38). RESULTS: Prioritisation of food and nutrition in policy reduced over time. Several factors which may have impeded the prioritisation of nutrition were identified. These included lack of cohesion among the community of nutritionists, Aboriginal and Torres Strait Islander leaders and civil society actors advocating for nutrition; the absence of an institutional home for nutrition policy; and lack of consensus and a compelling policy narrative about how priority nutrition issues should be addressed. Political factors including ideology, dismantling of public health nutrition governance structures and missing the opportunities presented by 'policy windows' were also viewed as barriers to nutrition policy change. Finally, the complexity and multifaceted nature of nutrition as a policy problem and perceived lack of evidence-based solutions may also have constrained its prioritisation in Aboriginal and Torres Strait Islander health policy. CONCLUSIONS: Future advocacy should focus on embedding nutrition within holistic approaches to health and building a collective voice through advocacy coalitions with Aboriginal and Torres Strait Islander leadership. Strategic communication and seizing political opportunities may be as important as evidence for raising the priority of Aboriginal and Torres Strait Islander health issues.

Trade and nutrition policy coherence: a framing analysis and Australian case study.

OBJECTIVE: Maximising synergies and minimising conflicts (i.e. building policy coherence) between trade and nutrition policy is an important objective. One understudied driver of policy coherence is the alignment in the frames, discourses and values of actors involved in the respective sectors. In the present analysis, we aim to understand how such actors interpret (i.e. 'frame') nutrition and the implications for building trade-nutrition policy coherence. DESIGN: We adopted a qualitative single case study design, drawing on key informant interviews with those involved in trade policy. SETTING: We focused on the Australian trade policy sub-system, which has historically emphasised achieving market growth and export opportunities for Australian food producers. PARTICIPANTS: Nineteen key informants involved in trade policy spanning the government, civil society, business and academic sectors. RESULTS: Nutrition had low 'salience' in Australian trade policy for several reasons. First, it was not a domestic political priority in Australia nor among its trading partners; few advocacy groups were advocating for nutrition in trade policy. Second, a 'productivist' policy paradigm in the food and trade policy sectors strongly emphasised market growth, export opportunities and deregulation over nutrition and other social objectives. Third, few opportunities existed for health advocates to influence trade policy, largely because of limited consultation processes. Fourth, the complexity of nutrition and its inter-linkages with trade presented difficulties for developing a 'broader discourse' for engaging the public and political leaders on the topic. CONCLUSIONS: Overcoming these 'ideational challenges' is likely to be important to building greater coherence between trade and nutrition policy going forward.

An exposé of the realpolitik of trade negotiations: implications for population nutrition.

OBJECTIVE: To explore the formal and informal ways in which different actors involved in shaping trade agreements pursue their interests and understand the interactions with nutrition, in order to improve coherence between trade and nutrition policy goals. DESIGN: The paper draws on empirical evidence from Australian key informant interviews that explore the underlying political dimensions of trade agreements that act as barriers or facilitators to getting nutrition objectives on trade agendas. SETTING: Countries experiencing greater availability and access to diets full of energy-dense and nutrient-poor foods through increased imports, greater foreign direct investment and increasing constraints on national health policy space as a result of trade agreements. PARTICIPANTS: Interviews took place with Australian government officials, industry, public-interest non-government organizations and academics. RESULTS: The analysis reveals the formal and informal mechanisms and structures that different policy actors use both inside and outside trade negotiations to pursue their interests. The analysis also identifies the discourses used by the different actors, as they attempt to influence trade agreements in ways that support or undermine nutrition-related goals. CONCLUSIONS: Moving forward requires policy makers, researchers and health advocates to use various strategies including: reframing the role of trade agreements to include health outcomes; reforming the process to allow greater access and voice to health arguments and stakeholders; establishing cross-government partners through accountable committees; and building circles of consensus and coalitions of sympathetic public-interest actors.

Commentary on 'Communicating Messages About Drinking': Using the 'Big Legal Guns' to Block Alcohol Health Warning Labels.

Like the tobacco industry, the alcohol industry, with the support of governments in alcohol exporting nations, is looking to international trade and investment law as a means to oppose health warning labels on alcohol. The threat of such litigation, let alone its commencement, has the potential to deter all but the most resolute governments from implementing health warning labeling.

Moderating the impact of patent linkage on access to medicines: lessons from variations in South Korea, Australia, Canada, and the United States.

BACKGROUND: The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States' TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity, potentially enabling some flexibility in their implementation. In this study, we reviewed the features of the prototypic patent linkage mechanism established by the Hatch-Waxman Act in the United States, and compared these with the implementation of systems in three countries whose agreements with the US include patent linkage obligations. From these analyses, we draw lessons for moderating the impact of these mechanisms on access to generic medicines. METHODS: We reviewed the features of the patent linkage mechanism in the US, and undertook a detailed analysis of relevant treaty provisions and the manner of implementation in Canada, Australia, and South Korea. RESULTS: A key difference between the US implementation of patent linkage and that of its trading partners is the disparate treatment afforded to biologics. Because of the significant differences in the regulatory frameworks applying to small molecule and biologic medicines in the US, the Hatch- Waxman provisions do not apply to biologics and they are not subject to patent linkage. By contrast, the regulatory frameworks in Canada, Australia and South Korea do not reflect similar distinctions and thus patent linkage mechanisms also capture biologics. Additional variations in implementation, mainly the result of constructive ambiguities in the respective treaty texts, offer potential opportunity for mitigating the adverse impact of patent linkage provisions on market entry of generic medicines. Practical measures include ensuring the availability of an accessible, transparent and easily searchable database of patent information; avoiding automatic stays of generic marketing approval where possible; and requiring certification by rights holders to prevent abuse of the system. CONCLUSIONS: Where countries accept treaty obligations to establish patent linkage mechanisms, the impact on access to generic medicines may be moderated to a degree by retaining and exploiting constructive ambiguities in the treaty text and addressing practical aspects of implementation.

The Trans Pacific Partnership Agreement, intellectual property and medicines: Differential outcomes for developed and developing countries.

The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delaying the introduction of low-cost generics. While developing nations negotiated transition periods for implementing some obligations, all parties would have eventually been expected to meet the same standards had the TPP come into force. While the TPP has stalled following US withdrawal, there are moves by some of the remaining countries to reinvigorate the agreement without the United States. The proponents may seek to retain as much as possible of the original text in the hope that the United States will re-join the accord in future. This article presents a comparative analysis of the impact the final 2016 TPP intellectual property chapter could be expected to have (if implemented in its current form) on the intellectual property laws and regulatory regimes for medicines in the TPP countries. Drawing on the published literature, it traces the likely impact on access to medicines. It focuses particularly on the differential impact on regulatory frameworks for developed and developing nations (in terms of whether or not legislative action would have been required to implement the agreement). The article also explores the political and economic dynamics that contributed to these differential outcomes.

Effectiveness of a pressure-relieving mattress in an acute stroke ward.

Between the 10 May and 18 July 2016, St Helens and Knowsley Teaching Hospitals NHS Trust conducted a small, non-controlled evaluation set out to assess the performance of the Apex Pro-care Auto pressure-relieving mattress in an acute stroke ward. Seven patients, assessed as being at medium-to-high risk of developing a pressure ulcer (PU), were recruited into the evaluation; the mean age was 73.1 years. Three patients were bed bound and four had restricted mobility. The average length of time spent on the mattress was 31 days. At the end of the evaluation, none of the patients had developed a PU while using the mattress. These results indicate that, when combined with a robust PU prevention plan inclusive of repositioning, this pressure-relieving mattress is effective in preventing pressure ulceration.

Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement.

Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved. Three of the greatest concerns for Australia in the recent draft include provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms and extend monopoly rights over clinical trial data for certain medicines. Data from the 2013 Pharmaceutical Patents Review, and from various submissions made to it, show that pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars each year. Provisions still being considered for the TPPA would further entrench and extend costly monopolies, with serious implications for the budget bottom line and the sustainability of the Pharmaceutical Benefits Scheme.