The Human Cost of Politicizing Immigration: Migration Stigma, US Politics, and Health.

This Viewpoint discusses stigma and health consequences associated with migration in the context of the US election and identifies ways to develop structural competencies for physicians and future research.

Mexican-origin women's individual and collective strategies to access and share health-promoting resources in the context of exclusionary immigration and immigrant policies.

BACKGROUND: A growing literature has documented the social, economic, and health impacts of exclusionary immigration and immigrant policies in the early 21st century for Latiné communities in the US, pointing to immigration and immigrant policies as forms of structural racism that affect individual, family, and community health and well-being. Furthermore, the past decade has seen an increase in bi-partisan exclusionary immigration and immigrant policies. Immigration enforcement has been a major topic during the 2024 Presidential election cycle, portending an augmentation of exclusionary policies towards immigrants. Within this context, scholars have called for research that highlights the ways in which Latiné communities navigate exclusionary immigration and immigrant policies, and implications for health. This study examines ways in which Mexican-origin women in a midwestern northern border community navigate restrictive immigration and immigrant policies to access health-promoting resources and care for their well-being. METHODS: We conducted a grounded theory analysis drawing on interviews with 48 Mexican-origin women in Detroit, Michigan, who identified as being in the first, 1.5, or second immigrant generation. Interviews were conducted in English or Spanish, depending on participants' preferences, and were conducted at community-based organizations or other locations convenient to participants in 2013-2014. RESULTS: Women reported encountering an interconnected web of institutional processes that used racializing markers to infer legal status and eligibility to access health-promoting resources. Our findings highlight women's use of both individual and collective action to navigate exclusionary policies and processes, working to: (1) maintain access to health-promoting resources; (2) limit labeling and stigmatization; and (3) mitigate adverse impacts of immigrant policing on health and well-being. The strategies women engaged were shaped by both the immigration processes and structures they confronted, and the resources to which they had access to within their social network. CONCLUSIONS: Our findings suggest a complex interplay of immigration-related policies and processes, social networks, and health-relevant resources. They highlight the importance of inclusive policies to promote health for immigrant communities. These findings illuminate women's agency in the context of structural violence facing immigrant women and are particularly salient in the face of anti-immigrant rhetoric and exclusionary immigration and immigrant policies.

Federal transfers to municipalities through parliamentary amendments: implications for SUS funding. / Transferências federais por emendas parlamentares aos municípios: implicações para o financiamento do SUS.

The present article analyzes the transfers from parliamentary amendments by the Ministry of Health to municipalities to finance public health actions and services from 2015 to 2021. A descriptive and exploratory study was carried out with secondary data, including all Brazilian cities. Resources from amendments showed an increase, particularly from 2018 onwards, indicating the expansion of their relevance for financing SUS. From 2016 to 2021, over 80% was allocated to municipalities, representing 9.5% of all federal transfers, with 91.2% for operational expenses. Transfers from amendments differ from regular transfers due to greater instability and per capita variation among the amounts collected by municipalities and due to the fact that they allocate most resources to the Northeast and primary care to the detriment of the Southeast and medium and high complexity care. These transfers represent a differentiated modality of resource allocation in SUS that produces new distortions and asymmetries, with implications for intergovernmental relations, as well as between the executive and legislative powers, increasing the risk of the discontinuity of actions and services and imposing challenges for the municipal management.

O artigo tem como objetivo analisar as transferências por emendas parlamentares do Ministério da Saúde aos municípios para o financiamento de ações e serviços públicos de saúde, de 2015 a 2021. Foi realizado estudo descritivo e exploratório com dados secundários, abrangendo a totalidade de municípios brasileiros. Os recursos provenientes de emendas apresentaram aumento, em especial a partir de 2018, indicando a expansão de sua relevância para o financiamento do SUS. No período de 2016 a 2021, mais de 80% foram alocados aos municípios, representando 9,5% dos repasses federais, com 91,2% de natureza de custeio. As transferências por emendas diferem dos repasses regulares por possuir maior instabilidade e variação per capita entre os montantes captados pelos municípios, e por destinar a maior parte dos recursos ao Nordeste e à atenção primária, em detrimento do Sudeste e da média e alta complexidade. Configura-se uma modalidade diferenciada de alocação de recursos no SUS que produz novas distorções e assimetrias, com implicações para as relações intergovernamentais e entre os poderes executivo e legislativo, ampliando o risco de descontinuidade de ações e serviços e impondo desafios para as gestões municipais.

Health policy and regulatory authorities: challenges of technology regulation in Public Health Emergencies. / Política de saúde e Autoridades Reguladoras: desafios da regulação de tecnologias nas Emergências em Saúde Pública.

Public Health Emergencies (PHE) have had repercussions on health systems on a global scale, and timely access to new health technologies is a challenge for health policy. The national regulatory authorities (NRA) play a key role in the evaluation and regulation of these technologies. The present study aims to analyze the main strategies and regulatory instruments used to deal with the challenges of regulating new technologies necessary for the health system's effective response during a PHE. This research, based on WHO and Brazilian NRA norms and documents, considered dimensions related to strategies for strengthening regulatory activities and regulatory instruments used to accelerate access to technologies, especially during PHEs. International cooperation between the NRA and the WHO were important strategies for strengthening the NRA, with emphasis on the use of reliance, regionalization, accelerated assessments, and work/information sharing, as well as the processes of regulatory harmonization and convergence. In addition to the use of existing regulatory instruments, efforts were also identified in order to implement new ones.

As Emergências em Saúde Pública (ESP) têm repercutido nos sistemas de saúde em escala global. O acesso às novas tecnologias em saúde em tempo oportuno é um desafio para a política de saúde. As autoridades reguladoras nacionais (ARN) têm papel fundamental na avaliação e regulação dessas tecnologias. O estudo objetiva analisar as principais estratégias e instrumentos regulatórios utilizados para lidar com os desafios da regulação de novas tecnologias necessárias à resposta do sistema de saúde durante as ESP. Trata-se de uma pesquisa normativa e documental, tendo como fonte a OMS e a ARN brasileira. Foram consideradas as dimensões relacionadas às estratégias para o fortalecimento das atividades regulatórias e os instrumentos regulatórios utilizados para acelerar o acesso às tecnologias, especialmente durante as ESP. A cooperação e a colaboração internacional entre as ARN e com a OMS foram importantes estratégias para o fortalecimento das ARN, com destaque para o uso de confiança, regionalização, avaliações aceleradas e compartilhamento de trabalho/informações, bem como os processos de harmonização e convergência regulatória. Identificou-se, além da utilização de instrumentos regulatórios já existentes, esforços na implementação de novos, com destaque para Autorização de Uso Emergencial.

Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response.

During the COVID-19 pandemic, intellectual property licensing through bilateral agreements and the Medicines Patent Pool were used to facilitate access to new COVID-19 therapeutics in low- and middle-income countries (LMICs). The lessons learnt from the application of the model to COVID-19 could be relevant for preparedness and response to future pandemics and other health emergencies.The speed at which affordable versions of a new product are available in LMICs is key to the realization of the potential global impact of the product. When initiated early in the research and development life cycle, licensing could facilitate rapid development of generic versions of innovative products in LMICs during a pandemic. The pre-selection of qualified manufacturers, for instance building on the existing network of generic manufacturers engaged during the COVID-19 pandemic, the sharing of know-how and the quick provision of critical inputs such as reference listed drugs (RLDs) could also result in significant time saved. It is important to find a good balance between speed and quality. Necessary quality assurance terms need to be included in licensing agreements, and the potentials of the new World Health Organization Listed Authority mechanism could be explored to promote expedited regulatory reviews and timely access to safe and quality-assured products.The number, capacity, and geographical distribution of licensed companies and the transparency of licensing agreements have implications for the sufficiency of supply, affordability, and supply security. To foster competition and support supply security, licenses should be non-exclusive. There is also a need to put modalities in place to de-risk the development of critical pandemic therapeutics, particularly where generic product development is initiated before the innovator product is proven to be effective and approved. IP licensing and technology transfer can be effective tools to improve the diversification of manufacturing and need to be explored for regional manufacturing for accelerated access at scale in in LMICs and supply security in future pandemics.

Nanosimilars: A Scientific or A Regulatory Debate?

The paper highlights the necessity for a robust regulatory framework for assessing nanomedicines and their off-patent counterparts, termed as nanosimilar, which could be considered as 'similar' to the prototype nanomedicine,based on essential criteria describing the 'similarity'. The term 'similarity' should be focused on criteria that describe nanocarriers, encompassing their physicochemical, thermodynamic, morphological, and biological properties, including surface interactions and pharmacokinetics. Nanocarriers can be regarded as advanced self-assembled excipients (ASAEs) due to their complexity and chaotic behavior and should be evaluated by using essential criteria in order for off-patent nanomedicines be termed as nanosimilars, from a regulatory perspective. Collaboration between the pharmaceutical industry, regulatory bodies, and artificial intelligence (AI) startups is pivotal for the precise characterization and approval processes for nanomedicines and nanosimilars and embracing innovative tools and terminology facilitates the development of a sustainable regulatory framework, ensuring safety and efficacy. This crucial shift toward precision R&D practices addresses the complexity inherent in nanocarriers, paving the way for therapeutic advancements with economic benefits.

Vaccine Politics.

A vaccine law and policy expert reflects on the dangers of the influence of politics on public health decision making.

Association between socioeconomic and motherhood characteristics with receiving community-based treatment services among justice-involved young female drug users: a retrospective cohort study in Taiwan.

BACKGROUND: Drug-involved individuals who contact treatment services in Taiwan are mostly driven by criminal justice systems either as an alternative or adjunct to criminal sanctions for a drug offence. With a focus on justice-involved young female drug users, the present study examines the extent to which socioeconomic and motherhood characteristics are associated with receiving deferred prosecution, a scheme diverting drug offenders to community-based addiction treatment. METHODS: We identified a cohort of 5869 women under the age of 30 arrested for using Schedule II drugs (primarily amphetamine-like stimulants) from the 2011-2017 National Police Criminal Records in Taiwan. Information concerning socioeconomic characteristics, pregnancy and live birth history, and deferred prosecution was obtained through linkage with the 2006-2019 National Health Insurance, birth registration, and deferred prosecution datasets. Multinomial logistic regression was used to evaluate the association with stratification by recidivism status. RESULTS: Within six months of arrest, 21% of first-time offenders (n = 2645) received deferred prosecution and 23% received correction-based rehabilitation; the corresponding estimates for recidivists (n = 3224) were 6% and 15%, respectively. Among first-time offenders, low/unstable income was associated with lower odds of deferred prosecution (adjusted odds ratio [aOR] = 0.71; 95% CI: 0.58, 0.88). For recidivists, those with low/unstable income (aOR = 1.58) or unemployment (aOR = 1.58) had higher odds of correction-based rehabilitation; being pregnant at arrest was linked with reduced odds of deferred prosecution (aOR = 0.31, 95% CI: 0.13, 0.71) and correction-based rehabilitation (aOR = 0.50, 95% CI: 0.32, 0.77). CONCLUSIONS: For the young women arrested for drug offences, disadvantaged socioeconomic conditions were generally unfavored by the diversion to treatment in the community. Childbearing upon arrest may lower not only the odds of receiving medical treatment but also correctional intervention. The criminal prosecution policy and process should be informed by female drug offenders' need for treatment and recovery.

Using qualitative system dynamics modeling to understand overdose bystander behavior in the context of Connecticut's Good Samaritan Laws and identify effective policy options.

BACKGROUND: Good Samaritan Laws are a harm reduction policy intended to facilitate a reduction in fatal opioid overdoses by enabling bystanders, first responders, and health care providers to assist individuals experiencing an overdose without facing civil or criminal liability. However, Good Samaritan Laws may not be reaching their full impact in many communities due to a lack of knowledge of protections under these laws, distrust in law enforcement, and fear of legal consequences among potential bystanders. The purpose of this study was to develop a systems-level understanding of the factors influencing bystander responses to opioid overdose in the context of Connecticut's Good Samaritan Laws and identify high-leverage policies for improving opioid-related outcomes and implementation of these laws in Connecticut (CT). METHODS: We conducted six group model building (GMB) workshops that engaged a diverse set of participants with medical and community expertise and lived bystander experience. Through an iterative, stakeholder-engaged process, we developed, refined, and validated a qualitative system dynamics (SD) model in the form of a causal loop diagram (CLD). RESULTS: Our resulting qualitative SD model captures our GMB participants' collective understanding of the dynamics driving bystander behavior and other factors influencing the effectiveness of Good Samaritan Laws in the state of CT. In this model, we identified seven balancing (B) and eight reinforcing (R) feedback loops within four narrative domains: Narrative 1 - Overdose, Calling 911, and First Responder Burnout; Narrative 2 - Naloxone Use, Acceptability, and Linking Patients to Services; Narrative 3 - Drug Arrests, Belief in Good Samaritan Laws, and Community Trust in Police; and Narrative 4 - Bystander Naloxone Use, Community Participation in Harm Reduction, and Cultural Change Towards Carrying Naloxone. CONCLUSIONS: Our qualitative SD model brings a nuanced systems perspective to the literature on bystander behavior in the context of Good Samaritan Laws. Our model, grounded in local knowledge and experience, shows how the hypothesized non-linear interdependencies of the social, structural, and policy determinants of bystander behavior collectively form endogenous feedback loops that can be leveraged to design policies to advance and sustain systems change.

Motivations for using misoprostol for abortion outside the formal healthcare system in Colombia: a qualitative study of women seeking postabortion care in Bogotá and the Coffee Axis.

BACKGROUND: In 2006, a Constitutional Court ruling partially decriminalized abortion in Colombia, allowing the procedure in cases of rape, risk to the health or life of the woman, and fetal malformations incompatible with life. Despite this less prohibitive law, some women and pregnant people preferred self-managing their abortions outside the formal healthcare system, often without accurate information. In 2018, we undertook a study to understand what motivated women to self-manage using medications that they acquired informally. Colombia has since adopted a progressive law in 2022, permitting abortion on request through the 24th week of pregnancy. However, the implementation of this law is still underway. Examining the reasons why women chose to informally self-manage an abortion after 2006 may not only highlight how barriers to legal services persisted at that time, but also could inform strategies to increase knowledge of the current abortion law and improve access to services going forward. METHODS: In-depth interviews were conducted in 2018 with 47 women aged 18 and older who used misoprostol obtained outside of health facilities to induce an abortion, and who were receiving postabortion care in two private clinics. Interviews explored what women knew about the 2006 abortion law which was then in effect, and the reasons why they preferred informal channels for abortion care over formal healthcare services. RESULTS: Women's motivations to use misoprostol obtained outside the formal healthcare system were influenced by lack of trust in the healthcare system along with incomplete and inaccurate knowledge of the abortion law. Conversely, women considered misoprostol obtained outside the healthcare system to be effective, affordable, and easier to access. CONCLUSIONS: Obtaining misoprostol outside the formal healthcare system offered a more accessible and appealing prospect for some women given fears of legal repercussion and stigma toward abortion. Though this preference will likely continue despite the more liberal abortion law, strategies should be implemented to broaden knowledge of the recent change in law and to combat misinformation and stigma. This would support knowledge of and access to legal abortion for those who wish to avail themselves of these services.

Specialist vape store audit reveals poor compliance with new e-cigarette regulations.

AIM: Regulations announced in mid-2023 aimed to reduce youth vaping by curtailing the availability of cheap high-nicotine e-cigarettes (vapes). This study tested compliance with the new regulations for single-use vapes, which came into force on 21 December 2023. METHODS: A 20-year-old "mystery shopper" visited 96% of specialist vape retailers (SVRs) in Wellington, Porirua, Lower Hutt and Upper Hutt (N=74) in January 2024, and observed i) R18 signage, ii) age verification practices, and ii) prices and brands of the cheapest available vaping products. Low-price vapes were purchased and inspected for compliance with new nicotine limits and safety regulations. RESULTS: All but three stores (96%) displayed an R18 sign; however, signage in 29 stores (39%) was suboptimal. Only one store (1.4%) requested age identification (ID) on entry to the R18 premises. In 50% of stores, ID was requested when a purchase was made; however, a third of those retailers proceeded with the sale despite the buyer not providing ID. Single-use vapes remained available for NZ$10 or less in most stores, and reusable starter kits were also widely available for NZ$10-20. Discounted high-nicotine products were sold for as little as NZ$2.50 each. Most low-price products did not comply with the updated regulations. CONCLUSION: Cheap, high-nicotine vaping products remained widely available following the introduction of stricter regulations in December 2023; products for sale included discounted and non-compliant vapes. The majority of SVRs had poor age verification practices. There is an urgent need to clarify rules, increase enforcement efforts and disallow discounting and giveaways of vapes.

Using the International Alcohol Control (IAC) policy index to assess effects of legislative change in Aotearoa New Zealand.

BACKGROUND: The IAC Policy Index was developed to allow comparison in alcohol policy between countries and within countries over time including in low resource settings. It measures four effective alcohol policies and takes into account stringency of regulation and the actual impact on the alcohol environment, such as trading hours and prices paid. This framework was used to assess policy in Aotearoa New Zealand in a time period covering two relevant legislative changes. This is the first study to use an alcohol policy index to assess and describe legislative change within country. METHODS: Data to calculate the IAC Policy Index was collected for 2013 and 2022. Stringency of policy was assessed from legislative statutes and impacts of policy on the alcohol environment from administrative data and specifically designed data collection. RESULTS: The overall IAC Policy Index score improved over the time period. The scores for the separate policy areas reflected the legislative changes as hypothesised, but also independent changes in impact, given ecological changes including reduced enforcement of drink driving countermeasures and increased exposure to marketing in digital channels. The IAC Policy index reflects the changes in policy status observed in Aotearoa, NZ. DISCUSSION: The IAC Policy Index provided a useful framework to assess and describe change in alcohol legislation contextualised by other influences on policy impact over time within a country. The results indicated the value of assessing stringency and impact separately as these moved independently. CONCLUSIONS: The IAC Alcohol Policy Index, measuring both stringency and actual impact on the alcohol environment with a focus on only the most effective alcohol policies provides meaningful insights into within-country policy strength over time. The IAC Policy Index used over time can communicate to policy makers successes and gaps in alcohol policy.