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.

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.

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.

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.

Sustainable Transition From Donor Grant Financing: What Could It Look Like?

Donor transition is an important aspect of sustaining the impact of donor investments after financial support has ceased. This article compares, contrasts, and critiques the transition policies of the top health donors in the Asia Pacific, which includes Global Fund to fight AIDS, tuberculosis, and malaria, Gavi-the Vaccine Alliance, World Bank (International Development Association), and the United States US Agency for International Development to gain a deeper understanding of what a sustainable financial transition could look like. A literature review of the academic and gray literature was undertaken to ascertain these donors' transition policies and to determine the success of these policies in ensuring sustainable and effective transition. It is proposed that sustainable transition requires a clearly articulated vision of long-term impact, explicit and transparent transition policies, clear time frames for transition, donor coordination, and evaluation of long-term impacts of donor withdrawal.

The Trans Pacific Partnership Agreement and access to HIV treatment in Vietnam.

In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam's eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement - more than halving the proportion currently treated.

Arresting HIV: Fostering Partnerships between Sex Workers and Police to Reduce HIV Risk and Promote Professionalization within Policing Institutions: A Realist Review.

In many countries around the world sex work is criminalised and its regulatory control is therefore often in the hands of the police. In addition to the impact of this criminalised legal environment, much literature describes the negative impact that certain police practices can have on the ability of sex workers and the programs that work with sex workers to access essential HIV prevention, treatment, care and support services. This situation has resulted in persistent concentrated HIV epidemics among sex workers in many countries of the world. The need for multi-sector partnerships between police and HIV programs is increasingly recognised in various UN declarations and resolutions yet descriptions of the process or key ingredients required to actually establish and sustain these necessary partnerships between police and sex workers [or the programs that provide essential services to sex workers] are sparse. The paper seeks to establish key considerations and critical processes that are required to foster partnerships that if further investigated and scaled up, could result in an enhanced enabling environment for the provision of essential HIV services for sex workers around the globe. This paper is based on a realist review that investigated isolated examples of partnership formation between law enforcement and HIV programs working with sex workers. This methodology research is designed to work with complex social interventions and is based on the emerging 'realist' approach to evaluation. A realist review methodology was chosen given the paucity of relevant literature in this vein and the authors' familiarity with the grey literature and relationships with experts who work in this sphere. The review found that political and police leadership, civil society strengthening and police reform in relation to HIV, are critical factors and key ingredients in changing the enabling environment in which sex work takes place to ensure that HIV prevention, individual and public health as well as HIV prevention and the promotion of human rights are the number one priority. Further research into this relationship is needed to provide evidence for effective HIV programming with police.

Barriers to and facilitators of adherence to antiretroviral therapy among people living with HIV in Lao PDR: a qualitative study.

Adherence to antiretroviral therapy (ART) is essential to its effectiveness and avoidance of the development of drug-resistant HIV strains. Many studies have been undertaken on factors affecting adherence to ART; however, there is little information about Laos. Hence, this qualitative study examines barriers to and facilitators of adherence specific to this context. In-depth interviews and focus group discussions were undertaken with 43 people living with HIV (PLHIV) currently on ART across 2 hospitals in Laos: Setthathirath hospital in the capital Vientiane and Savannakhet Province hospital. Interviews were based on semistructured question guides and were undertaken in Lao, translated into English and audio-recorded for later analysis. Major barriers to adherence reported by participants included transport costs, distance to the hospital, and stigma and discrimination. Key facilitators discussed were the perceived benefits of medication, social support, and the acceptance of HIV status.

Reasons for default from treatment of chronic illnesses in a primary healthcare program in rural Tamil Nadu.

Chronic illnesses are an increasing cause of morbidity and mortality in rural India. Many patients default from treatment, and exploring their reasons for the same may suggest strategies to improve service accessibility and acceptability. A qualitative study was conducted of 22 patient interviews, six key informant interviews, and two patient focus group discussions for investigating the reasons for default at the KC Patty Primary Health Centre and surrounding villages in Kodaikanal Taluk, Dindigul district, Tamil Nadu. The reasons included money or transport difficulties, frequent travel, feeling healthy, focus on work, fear of scolding from clinic staff, medication side effects, preference for alternative therapy, and depression. Some reasons were only divulged after an extended discussion. Support from families and village-level health workers (VLHWs) were also identified as important. Recommendations include more open and patient communication between health workers and defaulting patients, in addition to recruitment of more VLHWs.

Defining and redefining harm reduction in the Lao context.

The response to drug use in Laos has focused on reducing opium supply (supply reduction) and rates of drug use (demand reduction). However, recently there is increased interest among government counterparts to discuss and develop broader responses to injecting drug use (IDU) including the introduction of harm reduction programs. The concept of harm reduction has just been introduced to Lao PDR and as yet there is no agreement on a definition of the concept. We highlight here a range of issues that remain controversial in Lao PDR in the HIV, drug use and harm reduction discourse, the definition of 'harm reduction' and related terms; and the scope of harm reduction.This was a qualitative study, consisting of in-depth interviews with 27 law enforcement and 8 health officers who work in the fields of HIV and/or drug control about their understanding of HIV related to drug use, and concepts of harm reduction. Content analysis was performed to identify the coding, categories and themes.We found that law enforcement officers in particular had limited understanding about harm reduction and the feasibility and appropriateness of harm reduction services in the Lao context.Harm reduction should be a core element of a public health response to HIV where drug use and IDU exists. Recommendations include the necessity of increasing the awareness of harm reduction among law enforcement officers and providing appropriate evidence to support the needs of harm reduction policy and programs. HIV prevention and treatment strategies should be integrated within existing social and cultural frameworks, working with the task force for HIV/IDU and other government counterparts.

Laos case study.

Peuan Mit is a Lao organization working to address the needs of children and youth living and working on the streets. This case study outlines how a trusted and strong relationship with local police provides mutual benefit.